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<title>Medical Products Insight RSS Feed</title><link>http://blog.insighthealthcaresolutions.com/index.php</link><description>Michael Simpson&#x27;s Blog</description><dc:language>en</dc:language><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><dc:rights>Copyright 2009 Michael W Simpson</dc:rights><dc:date>2009-12-16T22:09:03-08:00</dc:date><admin:generatorAgent rdf:resource="http://www.realmacsoftware.com/" />
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<lastBuildDate>Wed, 16 Dec 2009 22:43:32 -0800</lastBuildDate><item><title>Welfare for health insurance companies</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Healthcare Policy</category><category>Politics</category><dc:date>2009-12-16T22:09:03-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Welfare_for_health_insurance_companies.php#unique-entry-id-83</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Welfare_for_health_insurance_companies.php#unique-entry-id-83</guid><content:encoded><![CDATA[Up until last night, I supported the healthcare reform plans of President Obama.   I did so, despite the evisceration of important parts of the proposed law, including the public option, stricter controls on insurance companies, and broader coverage for more people.    What we are going to have is a law that is no more than a transfer of wealth from the taxpayers to rich health insurance companies.    Sure, those companies have to accept customers with pre-existing conditions, but they get to charge more.    Sure, they have to accept older individuals, but they get to charge them more.  


Moreover, this bill will charge people who do not have insurance so that they might be covered.    If they don&rsquo;t have the money, the government will give it to you, and it will go to the insurance companies.    Senators Joe Lieberman and Mary Landrieu, bought and paid for by the health insurance industry have sold out their values for these companies.    Neither of them, supposed Democrats, have shown any conviction, any morals or any beliefs that are not bought in cash.   The health insurance companies must be popping corks from bottles of Dom Perignon.  


Some people say that it&rsquo;s better to have a plan than none.    I disagree.    I think this plan will bankrupt the country, but in a wholly different way that the Republicans are saying.    Without real reform, the cost to the citizens will be tremendous.


Dr.   Howard Dean, a physician, a former candidate for president, and a man with true convictions and fortitude stated on Vermont Public Radio:


<quote>This is essentially the collapse of health care reform in the United States Senate.   And, honestly, the best thing to do right now is kill the Senate bill and go back to the House &hellip; You have the vast majority of Americans want the choices, they want real choices.   They don&rsquo;t have them in this bill.   This is not health care reform and it&rsquo;s not close to health care reform.</quote>


Later on MSNBC, Dr.   Dean said:


<quote>You talk to every healthcare economist out there and they will tell you that whatever ideas are &mdash; whatever ideas exist in terms of bending the cost curve and starting to reduce costs for families, businesses and government, those elements are in this bill.   There is no cost control of any substance.   &hellip; You&rsquo;re going to be forced to buy health insurance from a company that is going to take on average of 27% of your money &hellip; and there is no choice about that.   If you don&rsquo;t buy that insurance you are going to get a fine.</quote>


I wanted President Obama to change the healthcare industry in a way that would matter to me and my children.    I wanted a plan that would cover Americans and fix our healthcare system that barely ranks above a third-world country in quality yet is the most expensive per capita.    I wanted a civilized healthcare system.    Instead, because Senator Lieberman, whose moral fortitude is an embarrassment to all of us supported him over the years.    Lieberman is a prostitute for the healthcare insurance industry, and Obama is letting him be so.


Dr.   Howard Dean is the moral conscience for this effort, and Obama has shown me nothing but weakness.    He should have stood up to Lieberman and conservative Democrats.  


It&rsquo;s time for leadership, and it&rsquo;s time to dump this healthcare proposal.    It is time for someone lead this reform effort.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Book review&#x2013;Don&#x27;t Swallow Your Gum&#x21;: Myths&#x2c; Half-Truths&#x2c; and Outright Lies About Your Body and Health</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Book review</category><category>Pseudoscience</category><category>Quackery</category><category>Vaccines</category><dc:date>2009-12-04T10:16:31-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/dont_swallow_your_gum_book_review.php#unique-entry-id-82</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/dont_swallow_your_gum_book_review.php#unique-entry-id-82</guid><content:encoded><![CDATA[I just finished reading Don't Swallow Your Gum!: Myths, Half-Truths, and Outright Lies About Your Body and Health (ISBN:031253387X, 2009) written by Aaron Carroll MD and Rachel Vreeman MD, both pediatricians and researchers at the University of Indiana School of Medicine.


First of all, the book is an amusing, easy read, using terms like &ldquo;snot&rdquo; and &ldquo;poo&rdquo; to describe bodily secretions.    At some 200 pages, it was a quick read, not requiring a lot of time.    Obviously, the book was written for a wide audience, debunking many pseudoscientific myths about health.    For those of us who demand supporting research, it has a vast list of primary and secondary research citations for further reading.    In fact, for me, those citations are going to be invaluable in future articles.


The book goes about debunking silly myths such as &ldquo;don&rsquo;t swallow your gum because it will get stuck in your intestine for 5 (10, 20, whatever) years&rdquo; or the old &ldquo;five second rule&rdquo; which we all suspected wasn&rsquo;t wise.    There was one chapter on &ldquo;double dipping&rdquo;, which was popularized on a Seinfeld episode many years ago, in which the authors discussed research that showed that double dipping does in fact transfer a lot of germs from the chip to the dip.    Not that I would confess to being a double dipper, but I may not be a single-dipper at a party after reading this book!


The authors do take on serious topics.    They have a whole chapter on debunking several anti-vaccination movement myths such as &ldquo;vaccines cause autism.&rdquo;    Though many of us have said this over and over again, the authors make an important statement in very simple terms, &ldquo;good science is based on widely accepted principles and methods; anecdotal evidence is not research.&rdquo;    It is clear and to the point.


I enjoyed the book thoroughly.    At first, I was put off by the humorous style the authors were using, but then I realized that some of these myths are humorous.    And I also realized some of us write in very complicated, almost overly technical, language to debunk some of the myths we hear.    The authors made the science accessible and fun, and stayed serious when necessary, specifically when discussing vaccines.


Again, the book is going to stay on my shelf (well, not really, since I use a Kindle for reading) because I will use some of their comments to make a good quote, and it will give me quick access to some proof sources.


Read it if you get a chance.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Science&#x2c; lies&#x2c; and stolen emails</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Science</category><category>Global warming</category><category>Pseudoscience</category><category>Politics</category><dc:date>2009-12-04T01:19:59-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Science_lies_and_stolen_emails.php#unique-entry-id-81</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Science_lies_and_stolen_emails.php#unique-entry-id-81</guid><content:encoded><![CDATA[As this is a blog about medicine, I haven&rsquo;t written much about global warming.    Moreover, until a few months ago, I was a bit of a skeptic about the science behind global warming.    My skepticism was centered on a few key points that I didn&rsquo;t feel had been adequately addressed:


	&bull;	First, I was unconvinced that current temperatures exceeded that of the Medieval Warm Period, a period of warm climate in the North Atlantic from about 800 to 1300.    During this time, the weather was warm enough for the Vikings to colonize Greenland and to support a settlement in Newfoundland.


	&bull;	Second, California glaciers (yes California has numerous glaciers), like Palisade Glaciers in the Sierra Nevada mountain ranges were only about 700 years old, so obviously (to me), it&rsquo;s colder today than it was before these glaciers formed.


	&bull;	Third, the earth is just so complicated, it might take hundreds if not thousands of years of data to see any real trends.


Of course, my feelings on global warming would demolish my bona fides to be skeptical about alternative medicine and other pseudoscience.    However, I thought the true global warming deniers (and even more so, those who deny the human cause of global warming) were true pseudoscientists, so I decided to study it myself, learning as much as I could about the subject.    As I did, my skepticism faded.    I found out that the Medieval Warm Period wasn&rsquo;t as warm as I presumed, and that there is little global evidence that it was actually warmer then compared to today.    In fact, regional differences in temperature can be large.    I guess it goes back to correlation vs. causation.    I was being pseudoscientific in my early thinking about global warming.


Actually, my discomfort with the much of what I was hearing from global warming deniers was similar to what I read from the anti-vaccination crowd.    Each of the climate change denier&rsquo;s pseudoscience is easily debunked.


Recently, emails from Climatic Research Unit of the University of East Anglia (CRU) were hacked, stolen and publicized.    Setting aside the legality of stealing private emails, the issues that arose in the emails are three-fold:


	1	Did researchers attempt to hide or change raw data?


	2	Did that data contradict the scientific consensus on global warming?


	3	Did climate change supporters try to quash publication of research from climate change deniers?


Honestly, I don&rsquo;t care that much about the first two points, because this is just one data point in all of the research in climate change.    The evidence is still overwhelming.    In fact, this particular CRU research group was studying tree-ring data to correlate it to temperature change, one of many many data points that contribute to the analysis of global warming and its causes.    And if they actually did what is claimed (how we write emails is a subject of many studies, and sometimes we write in tones that may not make sense out of context) then those scientists should be upbraided.  


As for the third point, it just isn&rsquo;t true.    The two studies discussed in the emails were both published.    Science thrives on intense discussions to arrive at a consensus, so even though each study did not support the current theory of climate change, they were published.  


Nature, one of the most respected science journals, in a recent editorial stated &ldquo;a fair reading of the e-mails reveals nothing to support the denialists' conspiracy theories.&rdquo;    In other words, there is nothing there.    Whatever may be the truth or lie about what was done at the Clinical Research Unit, global warming is a fact.  

...First, Earth's cryosphere is changing as one would expect in a warming climate.   These changes include glacier retreat, thinning and areal reduction of Arctic sea ice, reductions in permafrost and accelerated loss of mass from the Greenland and Antarctic ice sheets.   Second, the global sea level is rising.   The rise is caused in part by water pouring in from melting glaciers and ice sheets, but also by thermal expansion as the oceans warm.   Third, decades of biological data on blooming dates and the like suggest that spring is arriving earlier each year.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Our place in the cosmos</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Science</category><dc:date>2009-11-23T21:27:14-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Our_place_in_the_cosmos.php#unique-entry-id-79</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Our_place_in_the_cosmos.php#unique-entry-id-79</guid><content:encoded><![CDATA[As I&rsquo;ve posted before, I really enjoy the auto-tuned videos from the Symphony of Science.    They have a new one posted that includes Carl Sagan, Richard Dawkins (one of the great evolutionary biologists), Michio Kaku (an American theoretical physicist who has made that field of science more understandable), and Robert Jastrow (a NASA astronomer who spent way to much time debunking the moon landing hoax conspiracy).  


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By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>The 124th Meeting Of The Skeptics&#x2019; Circle</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Science</category><category>Evidence based medicine</category><category>Quackery</category><category>Alternative medicine</category><dc:date>2009-11-21T08:19:01-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/The_124th_Meeting_Of_The_Skeptics_Circle.php#unique-entry-id-78</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/The_124th_Meeting_Of_The_Skeptics_Circle.php#unique-entry-id-78</guid><content:encoded><![CDATA[One of my favorite bloggers on debunking medical quackery and pseudoscience is hosting a little party.    Visit, and read some of the best articles on debunking myths, pseudoscience, quacks and anti-science.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>How pseudoscience makes its case&#x2c; Part 3</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Science</category><category>Vaccines</category><category>Alternative medicine</category><category>Evidence based medicine</category><dc:date>2009-11-19T09:12:21-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/How_pseudoscience_makes_its_case_Part_3.php#unique-entry-id-77</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/How_pseudoscience_makes_its_case_Part_3.php#unique-entry-id-77</guid><content:encoded><![CDATA[This is part of my ongoing discussion on how quacks use pseudoscience to push their myths and potions on the world.    Part 1 discussed the scientific method, which allows us to objectively analyze the natural world.    Part 2 discussed the best way for us to examine the difference between science and pseudoscience.


I just read an outstanding analysis, by Steven Novella, MD, a clinical neurologist at Yale University, of how pseudoscience (those who pretend to praise the scientific method, yet do it in a way that is not actually science) and anti-science (those who repudiate science outright, or even undermine science, with subjective analysis and untestable spirituality) to reject evidence-based medicine.  


...Novella clearly states how science in medicine works:


<blockquote>This leads us to the final continuum &ndash; the consensus of expert opinion based upon systematic reviews can either result in a solid and confident unanimous opinion, a reliable opinion with serious minority objections, a genuine controversy with no objective resolution, or simply the conclusion that we currently lack sufficient evidence and do not know the answer.   It can also lead, of course, to a solid consensus of expert opinion combined with a fake controversy manufactured by a group driven by ideology or greed and not science.   The tobacco industry&rsquo;s campaign of doubt against the conclusion that smoking is a risk factor for lung cancer is one example.   The anti-vaccine movement&rsquo;s fear-mongering about vaccines and autism is another.</blockquote>


...A conclusion that lacks sufficient evidence may eventually be supported by better analysis or groundbreaking research.    You&rsquo;ll notice that anti-science and pseudoscience pushers do not allow themselves to participate in the this continuum of research&ndash;they state emphatically that they are right.


Two of the most misused and misunderstood terms in evaluating scientific evidence are correlation and causation, two powerful analytical tools that are critical to evidence based medicine.    Correlation is the grouping of variables that may occur together.    For example, smoking correlates with lung cancer in that those who smoke tend to develop lung cancer at a statistically significant rate.    It&rsquo;s important to note that correlation does not prove causation.    However, once you have numerous well-designed studies that correlate lung cancer to smoking, along with adding in biological and physiological models that support the correlation, then we can arrive at a consensus that not only is smoking correlated with lung cancer, it causes it.


...But they are subjective observations for which we cannot state a causal relationship without substantial research.    The anti-vaccination movement is rife with these observations which they use to &ldquo;prove&rdquo; a cause.    An anti-vaccine conspiracy website claims that pregnant women are miscarrying babies after getting the shot.    The fact is that there is a statistical chance that women will miscarry during any pregnancy.    This is random not a cause.    In fact, based on the rate of miscarriage, we could expect that thousands of women would miscarry within 24 hours of getting the H1N1 flu shot.    But it&rsquo;s not really a correlation, it&rsquo;s just random chance.    For example, I&rsquo;m also sure that thousands of people broke a bone or had a desire to eat a burger after getting the shot, but that&rsquo;s because in a large enough population of individuals, you can find literally millions of different actions after getting a shot.


So, the miscarriage rate after receiving the swine flu shot is not correlated.    It&rsquo;s just a random observation.    And there is no biological cause that could be described.    I often use this logic to test the possibility of the usefulness of any alternative medicine&ndash;is there any physical, chemical or biological mechanism that will allow the quack procedure to work?    Nevertheless, the &ldquo;flu vaccine causes miscarriage&rdquo; conspiracy has been thoroughly debunked by research.


As I&rsquo;ve said in other posts, the internet gives us so much information, we tend to value it equally, as if every website provides accurate and logical data points.    Maybe you have a friend who had a miscarriage 24 hours after receiving the swine flu vaccine.    Maybe you&rsquo;ve heard that many people have.    But that&rsquo;s not science, that&rsquo;s just a subjective observation.  


...<blockquote>In conclusion, correlation is an extremely valuable type of scientific evidence in medicine.   But first correlations must be confirmed as real, and then every possible causational relationship must be systematically explored.   In the end correlation can be used as powerful evidence for a cause and effect relationship between a treatment and benefit, or a risk factor and a disease.   But it is also one of the most abused types of evidence, because it is easy and even tempting to come to premature conclusions based upon the preliminary appearance of a correlation.</blockquote>


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Flu vaccination locations</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Vaccines</category><category>Healthcare Policy</category><dc:date>2009-11-17T09:26:31-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Flu_vaccination_locations.php#unique-entry-id-76</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Flu_vaccination_locations.php#unique-entry-id-76</guid><content:encoded><![CDATA[Google maps has an interesting application that shows locations and availability of seasonal flu and H1N1 vaccinations.   I'm not sure how accurate it is, but you should give it a try.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Bill Maher is a science denialist</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Vaccines</category><category>Alternative medicine</category><dc:date>2009-11-17T08:36:46-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/bill_maher_is_a_science_denialist.php#unique-entry-id-75</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/bill_maher_is_a_science_denialist.php#unique-entry-id-75</guid><content:encoded><![CDATA[Bill Maher, a rather liberal talk show host, has recently been joining the anti-vaccination crowd, adding his voice to the Hollywood centered vaccination denialists.    He is a typical science denialist, ignoring the vast wealth of science, research and publications, to make statements, in this case about promoting pseudoscience in his dismissal of the value of vaccines.    Moreover, Mr.   Maher spends time denying he is a denialist, which usually is an indicator that one is a denialist.  


Interestingly, Maher is usually in sync with my feelings about global warming and evolution denialists, who use pseudoscience and outright denial to "prove" that there is no global warming or evolution.    Usually, skeptics or anti-denialists (one day we need to get this terminology right) are consistent, we dismiss pseudoscience outright.    I have no clue why he has chosen this particular pseudoscience and quackery to support, but maybe he just thinks Jenny McCarthy knows more than real scientists.   


Orac does an excellent job in showing that Maher is without any knowledge of the subject.    I've linked below to one of Maher's conversations with Senator Bill Frist, a successful physician and politician, but no friend of progressive thinking in science and medicine.    But in this case, he spares no quarter in beating down Maher's anti-vaccination points of view.


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Maher is picking and choosing his science.    He's rabidly against Intelligent Design, the pseudoscientific theory that denies the science behind evolution.    He has sarcastically dismissed the global warming denialists.    I had always presumed he did this because he had actually read and understood the science.    However, his anti-science comments about vaccination are so weak and unsupported, I am actually convinced he just chooses his points of view for dramatic effect and to be "controversial."    I used to enjoy Maher.    Now I think he's pathetic.    Does he understand how many children die each year in the United States because of the anti-vaccination movement?


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Debunking 2012 myths</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Science</category><dc:date>2009-11-12T23:59:16-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/debunking_2012_myths.php#unique-entry-id-74</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/debunking_2012_myths.php#unique-entry-id-74</guid><content:encoded><![CDATA[There's a new movie coming to a theatre near you tomorrow, which purports to show us how the world is going to come to an end.    The movie, 2012, looks like a typical blockbuster, heavy on special effects.    Now, many of us understand that movies are, well, fantasies, even when based on real events.    This movie is a fantasy based on myths.  


NASA, an organization filled with really smart scientists, has published a FAQ that debunks a couple of the myths that 2012 will mark the end of the world.    NASA will do a much better job about demolishing the pseudoscience than I will, but the two key issues are:


	1	A rogue planet or some other object, called Nibiru, will collide with the earth and destroy us.    There are no objects during the next few years that will destroy the earth.    Of course, it has happened in the past, destroying the non-avian dinosaurs, and will probably happen in the future.


	2	The Mayan Calendar long period calendar ends in 2012.    Of course, all calendars end, then restart with a new year.  


Anything that shows the world ending in 2012 is pseudoscience.    It has no basis in any type of reality, so rest assured that you will have to pay your credit cards in 2013.


More critically, why is that there is any credence given to this myth?    We can thank the internet, which has a curious effect to the untrained eye.    Orac, a prolific blogger on all things medical, puts it succinctly and clearly:


<quote>The other driving force behind the proliferation of pseudo-expertise is a very human trait that we all share, namely the tendency to confuse correlation with causation.   Once again, this is one of the first lessons in science, not to confuse correlation with causation, but those of us in science forget just how against human nature this is.   We are creatures that value personal experience over statistics and science.   One good anecdote trumps reams of evidence.   This produces, for example, anthropogenic global warming denialists who justify their rejection of climate science by their observation that this summer was unusually mild in their area or the alternative medicine maven who swears by homeopathy because the symptoms of their self-limited condition got better after they tried it.</quote>


I am not suggesting you see or don't see the movie.    It might be a good one, or it might be just filled with great special effects.    Just remember it's a movie and not science.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Debunking H1N1 Vaccine Myths</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Quackery</category><category>Vaccines</category><category>Evidence based medicine</category><dc:date>2009-11-05T10:06:08-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Debunking_H1N1_Vaccine_Myths.php#unique-entry-id-73</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Debunking_H1N1_Vaccine_Myths.php#unique-entry-id-73</guid><content:encoded><![CDATA[The internet is a wonderful place for getting information.    But it's also a disaster in finding good information.    The problem is that if you read medical facts on the internet, you tend to give equal value to both scientifically supported and outright pseudoscientific statements.    I read a few posts on Facebook, which seems to be the modern world's gossip center, that spouted all sorts of conspiracy theories and ridiculous myths about the H1N1 Vaccine.


Let me debunk and bury the four most common myths:


	1	Myth&ndash;the vaccine will actually transmit the swine flu to you.   This is patently untrue and is based on misinformation.    The injectable vaccine contains inactivated viruses, in other words, dead.    It causes an immune reaction, so that you are resistant to the disease.    The nasal spray vaccine uses an attenuated virus, which is weakened so that it cannot reproduce and infect the recipient.    The virus is developed to be able to survive in cold environments of the nose.   When it enters the bloodstream, the heat of the body destroys the virus, but induces an immune response.    Neither vaccine can cause the disease.


	2	Myth&ndash;the vaccine causes Guillain&ndash;Barr&eacute; syndrome (GBS).    In 1976, during the previous swine flu mass vaccination, there appeared to be a 1 in 100,000 increased risk of developing GBS.    About 500 individuals (above the normal background number) developed the disease, although the mechanism and cause is unknown.    Vaccine production technology is significantly different today than it was in 1976.    And the virus is different.    Finally, from a purely statistical standpoint, the risk of being hit by lightning is about 1 in 79,000.    Of course, preliminary data indicates that there were around 800 deaths out of 5.7 million Americans who contracted the H1N1 virus over the summer.    That rate is about 14 out of 100,000 people.    This is an easy one.    The risk of GBS, which may or may not be related to vaccines, is 1 out of 100,000.    The risk of dying if you get H1N1 is 14 out of 100,000.  


	3	Myth&ndash;the thimerosal preservative will lead to autism in children.    This myth has been thoroughly debunked.   In fact, thimerosal is only used in multi-use vials to prevent bacterial contamination, which is critical to its safety.    Single use vials or pre-filled syringes do not contain it.    But the fact is, thimerosal preserved vaccines are safe.  

...	4	Myth&ndash;the vaccine wasn't adequately tested.    Flu vaccines have been produced by the same manufacturers for decades, and their procedures for bringing seasonal flu vaccines to patients has been well studied and regulated.    In addition, the CDC and FDA closely monitor adverse reactions for vaccines, and they react quickly to any reports.    The H1N1 vaccine is really no different than other seasonal vaccines, which have been administered for years with only minor reactions like a stuffy nose or a slight allergic reaction (common if you are allergic to eggs).  


So far during this flu season, 65 children died in the US as a result of Swine Flu.    And we're a few months from the peak flu season.    That's not a risk that anyone should accept.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>How pseudoscience makes its case&#x2c; Part 2</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Science</category><category>Vaccines</category><category>Alternative medicine</category><category>Evidence based medicine</category><dc:date>2009-11-04T16:30:32-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/How_pseudoscience_makes_its_case_Part_2.php#unique-entry-id-72</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/How_pseudoscience_makes_its_case_Part_2.php#unique-entry-id-72</guid><content:encoded><![CDATA[A few days ago, I discussed how science works.    It's not a belief.    It's not a random set of rules.    It is a rational and logical process to determine cause and effect in the natural world.    Pseudoscience, by its very nature, ignores the scientific process; instead, it pretends to come to conclusions through science, although it does not.  


Again, be very wary if you hear someone say, "it's proven."    I've heard those words from both alternative medicine pushers and from well-trained physicians.    I have previously discussed the ineffectiveness of almost every alternative medicine therapy.    But what about your physician?    They are, by far, devoted to your health and well-being.    But they cannot know everything about medicine (thus, why we have specialists), so they may repeat information that is not valid.  


So how can you tell the difference between science and pseudoscience in medicine?    For me, I want to know if what I hear has been validated in one of two ways.


Almost any medical product, device, drug or procedure must, by law, must studied in a Randomized Controlled Trial, which is sometimes called a clinical trial.    Essentially, it is a scientific experiment, designed to test the hypothesis of whether the safety and efficacy of a particular medical product is better than a placebo.    That is, does the medical product produce results better than doing nothing at all.    This is the "gold standard" of investigation, and if the study does confirm the hypothesis, you can be assured it has a benefit to your life (although the degree may be subject to argument).    Alternative medicine just doesn't do this (most of their reasoning is that their beliefs just doesn't fit into the clinical trial model), so their is no proof that their products work.    A clinical trial usually has thousands of participants, and is done in a manner that the patient and the physician do not know who is and who is not receiving the treatment.    The results are analyzed statistically and published in peer-reviewed journals.    Furthermore, the results are reviewed and investigated by the FDA (and legal bodies in other countries), before a drug or device can be used by a physician.    This is an expensive and time-consuming process, in which alternative medicine hardly ever participates.


Now it's not ethical to test every medical hypothesis with a clinical trial.    For example, we know that smoking is bad for your health.    Yet, tobacco manufacturers love to insist that there has never been a clinical trial that makes this conclusion.    The reason that is true is that it would be unethical to give one group of adults cigarettes for 20 years and another group nothing to see if one would die at a higher rate.    So we use epidemiological studies to determine if we can see in a population whether a cause has an effect.    We can review records of thousands of smokers to see what the effect will be.    Once again, pushers of alternative medicine therapies have not published a study of all the patients who might have used their therapy and see the result.    Epidemiology is a scientific process that is critical to preventative medicine&ndash;without it, we cannot know if some behavior or public health issue has a causal effect on health.  


Remember, anecdote ("my mother's friend's cousin's daughter was cured by eating this leaf") is not a reason to accept alternative medicine.    Even anecdotes that try to sound like science ("90 out of 100 people think this leaf does work") aren't a reason to "believe" in a pseudoscience. 


You might have heard that taking lots of Vitamin C helps prevent colds.    It doesn't.    And that is shown by large clinical trials, so unless you are afflicted by scurvy, there's no reason to take large doses of the vitamin.    And that's the difference between real science and pseudoscience.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Fox News and the flu vaccine</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Vaccines</category><category>Science</category><dc:date>2009-11-02T11:23:44-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Fox_News_and_the_flu_vaccine.php#unique-entry-id-71</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Fox_News_and_the_flu_vaccine.php#unique-entry-id-71</guid><content:encoded><![CDATA[Fox News is not even close to being a reliable source for anything.    They've been reporting about a young woman who claims that she developed dystonia, a neurological movement disorder, after receiving the season flu vaccination.    Of course, Fox News is trying to make a story where there is none.


<object width="425" height="344"><param name="movie" value="http://www.youtube.com/v/jP0QYLMUZb4&color1=0xb1b1b1&color2=0xcfcfcf&hl=en&feature=player_embedded&fs=1"></param><param name="allowFullScreen" value="true"></param><param name="allowScriptAccess" value="always"></param><embed src="http://www.youtube.com/v/jP0QYLMUZb4&color1=0xb1b1b1&color2=0xcfcfcf&hl=en&feature=player_embedded&fs=1" type="application/x-shockwave-flash" allowfullscreen="true" allowScriptAccess="always" width="425" height="344"></embed></object>


This story is being thoroughly debunked in a couple of places:


	&bull;	Dystonia from a flu vaccine?   Almost certainly not.


	&bull;	The Dystonia Flu-Shot Case


Of course, the anti-vaccination junk science groups have jumped in to claim that the vaccine is unsafe.    What is unsafe is that nearly 36,000 Americans die each year of the flu, so get your vaccine.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>How pseudoscience makes its case&#x2c; Part 1</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Science</category><category>Vaccines</category><category>Alternative medicine</category><category>Evidence based medicine</category><dc:date>2009-11-02T09:38:15-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/how_pseudoscience_makes_its_case_part_1.php#unique-entry-id-70</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/how_pseudoscience_makes_its_case_part_1.php#unique-entry-id-70</guid><content:encoded><![CDATA[I always get suspicious when someone makes an argument with the statement of "it's been proven to work", "the link is proven", or, alternatively, they state the negative.    Typically, I hear these kinds of statements from the pseudoscience pushing group.    Many of us have debunked the "there is a proven link between vaccines and autism."    Or that any number of alternative medicine (CAM) therapies don't actually work.    In fact, science rarely uses the term "proven", because the scientific method is not a system to make a definitive answer on any question&ndash;scientists always leave open the possibility of an alternative hypothesis that can be tested.    If the alternate hypothesis can be supported through experimentation, then it can replace the original one.    When an alternative medicine or junk science supporter states "it has been proven" then you can be assured that conclusion is unsupported by scientific research.


The scientific method is an unbiased systematic approach to answer questions about the natural world, including medicine.  

...	1	Define the question&ndash;this could be anything from "does this compound have an effect on this disease?"   or "how does this disease progress".


	2	Observations&ndash;this is the subjective part of science.  ...  Does a physician notice that ever patient from a town or neighborhood exhibit the same disease?    A lot of science arises from observations of the natural world.    One of the most famous stories in the early history of medicine is when Edward Jenner observed that milkmaids rarely were infected by smallpox because they were exposed to cowpox, a less virulent disease.  


	3	Hypothesis&ndash;taking the observations, create a hypothesis that can be tested.    In Jenner's case, he hypothesized that exposure to cowpox immunized individuals to small pox.  


	4	Experiment&ndash;simply, the scientist then tests the hypothesis with experiments and collect the data.    The experiments are not designed to solely validate the hypothesis but may also attempt to contradict it.


	5	Analyze&ndash;this requires statistics to determine the significance or results.  


	6	Interpret&ndash;sometimes the data leads to a revision of the hypothesis, which means the scientist has to return to steps 3-6.    Or it confirms or supports the hypothesis, which means the researcher can move to Step 7.


	7	Publish results&ndash;in today's scientific community, the results require peer-review, which subjects the data, analysis and interpretation to the scrutiny of other scientists before publication.    This is a critical step that ensures that the results can stand up to criticism.    It does not prove anything, but it does support the hypothesis.


	8	Retesting&ndash;Many times the research is repeated by others, or the hypothesis may be slightly revised with additional data.    Science is not static, it constantly revises theories as more data is gathered.    For this reason alone, science is not an absolute, it is constantly seeking new data.


Science is an evidence-based systematic analysis without inherent opinion or emotion.    In other words, it is a method to cut through opinions and anecdotal observations, so that one can have some reasonable expectation that a medicine or device will work as planned.  ...  Supporters of CAM usually perform experiments to confirm the hypothesis, never to contradict it.    It is the fundamental principle of falsifiability, that is, that if a hypothesis is false, it can be shown in experimentation that allows science to have an open mind about the world.    When you speak to a believer of CAM, they almost never assume that their treatment cannot work.


It's interesting that CAM and pseudoscience start out with observations of the real world.    For example, CAM therapies sometimes work, not because of the therapies themselves, but because humans get better.    CAM cold therapies, like Zicam, probably have no therapeutic benefit.    You always recover from a cold, and randomly, you might recover faster or slower.  

...Part 2 of this discussion will be out later today.    It will discuss how to tell what is "proven" or what is science.


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>One of the best</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Medical devices</category><dc:date>2009-10-28T00:32:32-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/One_of_the_best.php#unique-entry-id-69</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/One_of_the_best.php#unique-entry-id-69</guid><content:encoded><![CDATA[Last week, this blog was named one of the "99 Best Blogs for Pre-Med Students."    I started this blog to talk about the medical products industry, of which I have been proud to have been involved for over 25 years.    For the past couple of months, I've been busy, so I haven't focused on it as much as I wanted to.    I will rectify that situation starting today.    I also don't think the quality of my blog meets the standards of others like Respectful Insolence, Science Based Medicine, and The White Coat Underground.    But I will try.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Quality&#x2c; Mac vs. PC&#x2c; and my eyes</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical devices</category><category>Medical products</category><dc:date>2009-10-27T23:52:00-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Quality_Mac_vs_PC_and_my_eyes.php#unique-entry-id-68</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Quality_Mac_vs_PC_and_my_eyes.php#unique-entry-id-68</guid><content:encoded><![CDATA[The largest argument in the internet isn't Obama's healthcare plan, whether the Yankees should lose the World Series, or why does gas cost so much.  ...  Across the internet, it's the argument that gobbles up bandwidth in a never-ending discussion.    There are several websites that keep tabs on new technology.    They are interesting if you want to read about a new mobile phone or a new rice harvesting robot.    But whenever they talk about a new product from Apple or something from Microsoft, there's dozens, if not hundreds, of comments about one or the other.  

...I find these discussions amusing, because the arguments on both sides fall a little flat.    Now, this website is hosted on Mac servers.    And I wrote and designed this website on a Mac with a Mac-only web design program.    So, you might think I'm biased, which I am.    I'm not going to get into all the arguments between the two devices, but Windows based computers vastly outsell Macs.    Most Mac users tend to very loyal to the brand for a number of valid reasons, including ease-of-use and fewer problems.    Most PC users tend to look for lower prices without regards to the brand.    However, there is a small, but vocal, group of very technical individuals who are loyal to PC's because they are more adept at maximizing the potential of PC's.    I'm not convinced of all of their arguments, but they certainly are.


I was thinking about the "war", and I recalled an issue that happened to me a few years ago.    I had decided to undergo LASIK surgery to correct my severe myopia and astigmatism.    The procedure is quite complex and is usually performed by an ophthalmic surgeon.    The surgeon has one important job in the whole procedure, and that is to create a corneal flap, which is moved out of the way, and a computer guided laser remodels the cornea.    The laser equipment used in my procedure was controlled by a typical desktop computer running Windows XP.    During my procedure, the computer locked up.  ...  I'm laying on a table, my eyelids taped open, and a flap of my cornea laying to the side of my eye.  

...The technician immediately got on the phone with the company's customer service, which was closed, as it was 4PM in California, where I was getting the procedure done, and 7PM in the company's location.    They then tried to contact the local clinical and technical representative, who didn't return the phone call.    At that point, I suggested they just turn the computer off and turn it back on.    Windows booted back up, and after a long conversation between me, the surgeon, and his technician, we decided to complete the procedure.    Not completing it would have been very inconvenient.  ...  Apparently, though no one would officially admit it, the computer was infected by a virus.    Somewhere, a software hacker, who thought he was having fun, nearly made me blind.  


I learned a lot about how a medical product should be serviced after it's in use.


	&bull;	The most important lesson is that whatever is your commitment to quality, you're going to rely on another company whose objectives may not be in alignment with your company.    Microsoft probably (well I hope) didn't create a bad product intentionally.    But because Microsoft is not a medical company, it doesn't have the management DNA that reminds them that a mistake can cost lives.    The company who made the laser ought to have remembered this and did everything it could to mitigate issues.


...If you're going to have a product that is going to rely upon any type of software, have technical service available always.    Not during your working hours in your time zone.


Now, in full-disclosure, I have used a Mac since 1984.    After this experience, I won't touch a Windows product.    So when it comes to Mac vs PC, I hold a more personal level of interest that is beyond image, advertising, or technical knowledge.


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Connected to the universe</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Science</category><dc:date>2009-10-21T20:11:30-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/connected_to_the_universe.php#unique-entry-id-67</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/connected_to_the_universe.php#unique-entry-id-67</guid><content:encoded><![CDATA[I haven't been posting as regularly as I would like.    Life seems to get into the way of good writing.    Yesterday, I was pointed to this video, which celebrates the widom and intellect of four of the great scientists of our generation, Carl Sagan, Neil deGrasse Tyson (who was instrumental in the demotion of Pluto to a dwarf planet), Bill Nye (the Science Guy), and Richard Feynman.    The video uses a technology called Auto-tune, which converts the pitch of any spoken word into music (I'm really simplifying what it does, but then again I am neither a music scholar nor a sound engineer).    This video is both inspiring and, frankly, addicting.    Enjoy.


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By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Swine flu remedies</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Alternative medicine</category><category>Quackery</category><category>Evidence based medicine</category><dc:date>2009-09-20T23:47:42-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/swine_flu_remedies.php#unique-entry-id-66</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/swine_flu_remedies.php#unique-entry-id-66</guid><content:encoded><![CDATA[Sometimes, I just read the most awful pseudoscience with respect to swine flu, or the H1N1 flu variant.    I had to read this woo over at Daily Kos, a liberal blog site.    Let's review the authors "claims":


	1	Get sleep.    OK, this is probably a good piece of advice for anyone.    But there is no evidence whatsoever that sleep has any influence on subsceptiblity to infections.    However, I won't be too critical of this advice, because sufficient sleep is important.


	2	Eat right.    Once again, good advice.    The author mentions shiitake mushrooms, but the evidence is only in animal models, and even there, the in vivo results required an unorthodox method to detect a change.    The author mentions zinc, the effect of which has already been discredited.    The rest of the claims are similar.    No real research supporting it, or actually showing it doesn't work.


...Once again, good advice.    But it's not going to do anything to prevent you from getting the flu.


	4	Exercise.    The author makes two specious and unsupported claims.    First, a little exercise strengthens your immunity, but, second, too much exercise makes you more subsceptible.   Well, there's some evidence that aerobic exercise does improve immunity to certain infections.    But it doesn't say anything about "too much."    Of course, I would contend a healthy cardiovascular system through vigorous aerobic exercise would be worth the risk of a flu.


	5	Some woo about foods to eat if you do get the flu.    None of it works.    The flu will take its course, so it's important not to infect others, and if there are serious secondary infections, the patient should seek treatment.


The Centers for Disease Control makes these recommendations to prevent infection from swine flu: 


	&bull;	Cover your nose and mouth with a tissue when you cough or sneeze.   Throw the tissue in the trash after you use it.


	&bull;	Wash your hands often with soap and water.   If soap and water are not available, use an alcohol-based hand rub.


	&bull;	Avoid touching your eyes, nose or mouth.   Germs spread this way.


	&bull;	Try to avoid close contact with sick people.


Of course, I'm going to recommend getting a flu shot.    And the CDC says nothing about eating ginger, zinc or other pseudoscientific alternative medicine woo, because none of it works.    If swine flu becomes an epidemic in the US, you're going to hear lots of so called cures and preventions.    The CDC's recommendations are cheap, and, in fact, the only way to prevent a flu, short of getting a flu shot.  


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Civilized Medicine&#x2c; Part III. My Proposal</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Healthcare Policy</category><category>Politics</category><category>Obama</category><dc:date>2009-08-18T11:53:24-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/civilized_medicine_part_iii_my_proposal.php#unique-entry-id-65</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/civilized_medicine_part_iii_my_proposal.php#unique-entry-id-65</guid><content:encoded><![CDATA[Originally, I was going to make my proposals for healthcare reform as the last item.    But now there is so much debating, amending, backtracking, and all around lying, I can&rsquo;t figure out what&rsquo;s being proposed.    Well, I do know there are no death panels, even if Sarah Palin makes stuff up.    Since I&rsquo;ve installed myself as health care czar (in my own mind), let me make my proposals.


	1	There should be a single payer system.    Frankly, health insurance companies cannot be trusted to treat anyone fairly and ethically.    I&rsquo;ve been observing healthcare insurance companies for too long in my career, and I am convinced.    However, they can stick around to provide high priced supplemental insurance to those who want and can afford it.    Because they will have to compete for this business, market forces will force them to provide high quality services.    This healthcare insurance should be available to everyone living in the United States, irrespective of anything, including immigration status.    To pay for this system, each will be taxed in an amount similar to their monthly healthcare insurance costs, with those at higher incomes paying a higher percentage of their income.    It must be fully funded.  


	2	To remove the worst parts of the Medicare and apply it to a new system, a medical board should determine the formulary for drugs and devices (and to establish exceptions), to approve new procedures and treatments, and finally, to determine what the payment levels should be to hospitals and other healthcare providers.    And no, I do not think it&rsquo;s appropriate for a medical board to decide on a case by case basis, although there should be a legitimate, speedy, and fair appeals system.


	3	The new healthcare plan should have the ability to negotiate rates with providers, manufacturers and anyone else involved in the healthcare system.    Think of it.    Negotiating with these companies with the buying power of over 300 million US citizens.    Now, I&rsquo;m a pure capitalist, so will the pharmaceutical industry go bankrupt?    No.    They should prove, clinically and scientifically, that their products work, and then negotiate in good faith with the government.    And if the government doesn&rsquo;t want it on a formulary, I&rsquo;m still willing to bet that the supplemental insurance industry will be a lucrative area for the wealthier to get their erectile dysfunction drugs.    Managed Care Organizations, which can bundle provider services to either a single payer organization like Medicare or to private insurance companies, can prosper in this environment by providing high quality of care and by negotiating with government to reduce costs.    This gives a more direct relationship between the Payer (the US government) and the patient.


	4	Do not pay for woo.    Acupuncture, homeopathy, naturopathy, and whatever else that hasn&rsquo;t shown safety and efficacy in a clinical trial accepted by a peer-reviewed journal won&rsquo;t be reimbursed or included.    We can&rsquo;t afford to pay for junk medicine that hasn&rsquo;t done anything to improve the health of any human.    We need to keep Senator Tom Harkin&rsquo;s money-wasting ideas about healthcare far away.


I&rsquo;m sure my ideas need to be fleshed out.    I may be missing some unintended consequences here and there.    But, we really need to reform the healthcare system in the US, and half-baked plans won&rsquo;t do it.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Civilized medicine&#x2c; Part IIa.  Myths</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Healthcare Policy</category><category>Politics</category><dc:date>2009-08-15T14:49:17-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/civilized_medicine_part_iia_myths.php#unique-entry-id-64</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/civilized_medicine_part_iia_myths.php#unique-entry-id-64</guid><content:encoded><![CDATA[Although so many others have debunked this myth, I want to make sure that I add to the roar (of laughter, derision and anger) about the latest right-wing attempt to demonize healthcare reform.


Stephen Hawking, the world&rsquo;s preeminent theoretical physicist, has a form of ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig&rsquo;s Disease in the United States), a progressive neuromuscular disease, which has left him paralyzed and unable to communicate except through an advanced communication device.    Despite his disease, he has published numerous books and starred in an episode of Star Trek:The Next Generation.    On August 3, an Investor&rsquo;s Business Daily editorial stated, &ldquo;People such as scientist Stephen Hawking wouldn't have a chance in the U.K. where the National Health Service would say the quality of life of this brilliant man, because of his physical handicaps, is essentially worthless."


Well, Dr.   Hawking is having his disease treated by the UK&rsquo;s National Health Service.    And though I cannot begin to describe how he has dealt with the disease, he has survived and contributed to the world&rsquo;s knowledge.    And guess what?    Hawking says, &ldquo;I wouldn&rsquo;t be here today if it were not for the NHS.    I have received a large amount of high quality treatment without which I would not have survived.&rdquo;


I don&rsquo;t know for sure, but I doubt an American who depends on an HMO will get this type of treatment.    You know, with all of those preexisting conditions, lifetime caps and deductibles, the level of care we would receive would probably wouldn&rsquo;t be close to Dr.   Hawking&rsquo;s.    Maybe the insurance company would deny a benefit for whatever reason.    Or maybe they wouldn&rsquo;t.    But we know the UK&rsquo;s National Health Service provides outstanding care for it&rsquo;s citizens.    That&rsquo;s Civilized Medicine.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>And now&#x2c; for something lighter</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Politics</category><category>Humor</category><dc:date>2009-08-13T11:24:30-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/and_now_for_something_lighter.php#unique-entry-id-63</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/and_now_for_something_lighter.php#unique-entry-id-63</guid><content:encoded><![CDATA[I can&rsquo;t be serious all the time.  

...<object width="425" height="344"><param name="movie" value="http://www.youtube.com/v/dAfQhQJOquA&color1=0xb1b1b1&color2=0xcfcfcf&hl=en&feature=player_embedded&fs=1"></param><param name="allowFullScreen" value="true"></param><param name="allowScriptAccess" value="always"></param><embed src="http://www.youtube.com/v/dAfQhQJOquA&color1=0xb1b1b1&color2=0xcfcfcf&hl=en&feature=player_embedded&fs=1" type="application/x-shockwave-flash" allowfullscreen="true" allowScriptAccess="always" width="425" height="344"></embed></object>


...JE: Let&rsquo;s get it right.


ABS: Let&rsquo;s get it right.


...AH: The fact is that right now if you are black or hispanic,


...JE: Are you sayin we got thugs in the fuzz?


AH: Particularly when it comes to the war on drugs.


JE/ABS: Real talk, we got caught together smokin lettuce leaves.


...ABS: They put me in the slammer.


...ABS: He don&rsquo;t know a tiger from a giraffe.


...JE: I&rsquo;m keepin my glass of champagne full


...DB: If you are stopped by the police


Putcha head down and just wait.


...DB: Putcha head down and just wait, wait, wait, wait, wait!


ALL: Putcha head down, wait, wait, wait, wait, wait, wait!


AH: This is happening all the time


...PB: This has been a country built by white folks.


100% of the people who wrote the Constitution,


100% of the people who signed the Declaration of Independence,


...I look at the track team, and they&rsquo;re all black folks.


I think maybe those are the fastest guys we got.


...Doctor, doctor, can a shawty get a shot to the frontal lobe.


...AS: It&rsquo;s not always just black and white, black and white.


We&rsquo;re fighting right now for a young white male


Who we felt the police abused by sticking something in his rectum.


...SG: Can we please move on now, Reverend?


...DL: Trouble, we got trouble right here in Capitol City.


With a capitol T, and it rhymes with B, that stands for broke!


...DL: Right here in Capitol City, right here, we gotta figure out


a way to help the Americans who are about to choke!


...DL: Oh yes we&rsquo;ve got trouble. 

...KC: People who were text messaging were 20 times


more likely to have an accident than those who were


...EG: But I&rsquo;m a sucker for peer pressure. 

...KC: People on the road can turn an LOL into a great big OMG.


ALL: People on the road can turn an LOL into a great big OMG.


People on the road can turn an LOL into a great big OMG.


...Many thanks to creative, funny and obviously talented group at Auto-Tune the News.  


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Healthcare reform = Nazism</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Obama</category><category>Politics</category><category>Healthcare Policy</category><dc:date>2009-08-13T10:15:11-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/healthcare_reform_equals_nazis.php#unique-entry-id-62</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/healthcare_reform_equals_nazis.php#unique-entry-id-62</guid><content:encoded><![CDATA[I have been vaguely uncomfortable with the comparison of Obama&rsquo;s healthcare plan with Nazis or Hitler.    Use of that analogy in a discussion or debate is often referred to as Godwin&rsquo;s Law, which states that &ldquo;As a discussion grows longer, the probability of a comparison involving Nazis or Hitler approaches 1.&rdquo;    What has begun to trouble me is that either those opposed to healthcare reform are clueless about recent history, or they are representing a form of Holocaust denial, which is a belief that the murder of six million Jews during World War II did not happen.    I know that certain individuals in the healthcare debate are prone to rhetorical flourish, but there is no way that healthcare reform is equivalent to Nazi&rsquo;s.    Unless you believe that Hitler was engaged in &ldquo;healthcare reform&rdquo;, or worse yet, you think the death of six million Jews is not the worst thing that Hitler did (well, the Holocaust and being directly responsible for the deaths of tens of millions as a result of the war itself).


Many others are becoming convinced that the right wing is spreading Holocaust denial as a part of making their hatred against Obama and this new healthcare plan.    According to Arthur Caplan, a renowned bioethicist, &ldquo;Limbaugh, Glenn Beck, Sarah Palin and the rest of the loud-mouthed right wing are, when they even hint at an analogy to the Nazis in talking about Obama&rsquo;s health reform effort, engaged in something far worse than insanity.   They are engaged in the vile evil of Holocaust denial.&rdquo;


Those who are opposed to Civilized Medicine are so filled with hatred, that they cannot even provide cogent and positive points about healthcare reform.    You just can&rsquo;t make stuff up.


By Michael W Simpson


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]]></content:encoded></item><item><title>Immunization&#x2013;get the facts</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Vaccines</category><category>Evidence based medicine</category><dc:date>2009-08-09T14:17:38-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/immunization_get_the_facts.php#unique-entry-id-61</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/immunization_get_the_facts.php#unique-entry-id-61</guid><content:encoded><![CDATA[Just when I thought that the whole anti-vaccination movement was going to be eclipsed by the whole healthcare reform debate (or myth-pushing, depending on your point of view), I still realize that there are groups who think that vaccines are not usesful.    People are starting to stand up to the pseudoscience-based woo-pushing crowd:


<img src="http://farm3.static.flickr.com/2661/3796616497_d0007277d9_b.jpg" width= 650 alt="Immunisation_get the facts"  style="border: 5px solid red" />


You can read more about this story at Phil Plaitt&rsquo;s Bad Astronomy Blog.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Civilized medicine&#x2c; Part II.  Myths</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Obama</category><category>Healthcare Policy</category><category>Politics</category><dc:date>2009-08-09T10:17:53-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/civilized_medicine_part_ii_myths.php#unique-entry-id-60</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/civilized_medicine_part_ii_myths.php#unique-entry-id-60</guid><content:encoded><![CDATA[I have found the commentary against the proposed healthcare reform to be both disturbing (Limbaugh&rsquo;s comments dishonors the memory of the Holocaust) and silly (and kind of disturbing too).    But almost all of the comments are based on myths or half-truths, and as those of you who read this blog know, I can&rsquo;t stand myths.    The disinformation about Obama&rsquo;s healthcare plan is poisoning the debate, because rational people tend to dismiss an opposing viewpoint if it has no sound foundation in logic.    I think that there should be a reasoned debate on how to fix the healthcare system of the US.    It&rsquo;s not happening, because one side is channeling its hatred of the other side, and reason goes flying out the door.  


...Let me state upfront that there were so many to choose, and some of them were so laughable, I didn&rsquo;t know where to start.  


...The essence of this fable is that somehow healthcare reform is going to ration medicine so much that the government is going to decide who should die.  ...  Typical of politicians, they take a small kernel of truth and create a story surrounding it&ndash;Jenny McCarthy would be proud.    The facts are these:  the healthcare plan will allow Medicare to pay for counseling between physicians and patients for end-of-life decisions.    This is a very important issue in healthcare, because of the physical pain, emotional loneliness, and economic expense to the patient and their family.    This is not just an issue for seniors, but for anyone with a terminal disease or for anyone caring for someone with a terminal disease.    The counseling isn&rsquo;t mandatory, but now Medicare will pay for it.    They will help a family and the patient understand the decisions in front of them.    They can help them set up hospice care, a dignified way to treat patients with end-stage disease.  ...  And they can assist individuals with their end-of-life advanced directives, which are always specified by the patients themselves, their guardians, or their families.    It&rsquo;s never a government decision, and if I thought that the healthcare plan insisted that the government set the directives, then I&rsquo;d be opposed too.  

...One of the more amusing arguments I&rsquo;ve heard is that if they can&rsquo;t run the Department of Motor Vehicles or the US Post Office, how can they run health care.    First of all, the US government doesn&rsquo;t run the DMV, and here in California, I can do almost anything online.    And the US Post Office technically isn&rsquo;t government run, and once again, it&rsquo;s pretty efficient in delivering a few billion pieces of mail.    Of course, the government successfully manages two critical healthcare plans, Medicaid and Medicare, and two healthcare systems, the Veteran&rsquo;s Administration and US Military system.  ...  Consider this point:  no one, Republican or Democrat, would ever suggest eliminating Medicaid or Medicare, because they would be thrown out of office at the next election.


...This nice piece of mythology is one of the most irrational (amongst a long list of irrational myths that I&rsquo;ve heard), because private healthcare insurance does it all the time.    Unless you are incredibly wealthy or have a generous healthcare plan, your medical choices are made by a faceless bureaucrat at an insurance company.    A related comment is that you will lack choices in your medical care.    I hate to be the one to break the news to you, but your choices are limited, arbitrarily at times, by those insurance companies.    Do you think you&rsquo;ll will get to be included in a new therapy at the Mayo Clinic?  ...  The fact is Obama&rsquo;s healthcare reform proposal is all about paying, not about actually controlling.


	&bull;	The American Public doesn&rsquo;t want to give up their private insurance plan.  

...First, Obama does not want a single payer system and has excluded those from his own party who are pushing for it.    Secondly, the Canadian healthcare system is very effective, by some indicators more effective than the current US system.    For example, healthcare costs are far lower in Canada, who spends about 10.1% of their GDP on healthcare while the US spends 16.0%.  ...  And infant mortality, a key measure of the quality of healthcare, is substantially lower in Canada, 5.0 per 1000 live births vs. the US 6.7.  

...It is the most expensive, as I&rsquo;ve discussed previously, and which is reviewed in a recent article about the US healthcare system.  ...  The only other developed country that does not provide healthcare for all of its citizens is South Africa.    Some will state that we provide free health care through emergency departments and other facilities.  ...  Moreover, by using the ER as a clinic, it reduces its ability to focus on its primary goal, to treat emergencies and traumas.    Furthermore, the defining characteristic of a quality healthcare system is to improve the health of its citizens.  ...  For example, the infant mortality rate for white children is 6.0 deaths per 1000 live births, which still ranks near the bottom, while the rate for black children is 14.3.    That is not a sign of a civilized healthcare system, it indicates that there are weaknesses in our system


...Too many people are so insanely angry at Obama, for whatever reason, they are just making things up.
]]></content:encoded></item><item><title>Terrorists.  No not that kind.</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Science</category><dc:date>2009-08-06T00:31:35-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/animal_rights_terrorists.php#unique-entry-id-59</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/animal_rights_terrorists.php#unique-entry-id-59</guid><content:encoded><![CDATA[I&rsquo;m going to digress from the healthcare reform debate (or what should be a debate but has degenerated into yelling, but I digress from digressing). 


Last week animal right&rsquo;s protestors burned the vacation home of Daniel Vasella, CEO of Novartis.    This incident followed one where the same protestors desecrated his mother&rsquo;s grave.    Apparently, the protestors wanted Novartis to quit contracting Huntingdon Life Sciences for animal testing of its pharmaceutical products.   Now Huntingdon has a checkered past in animal testing* from which it has recovered, and instituted ethical policies that are admirable.


I&rsquo;m not going to get into an extensive debate on animal testing.    Basically, there are no alternatives to testing medical products on animals.    It is done in a safe and ethical manner.    The industry cannot test vaccines, medicines, and medical devices for safety and efficacy, prior to a human clinical trial, in any other reasonable or reliable manner.


These terrorists, yes they are terrorists by any definition, seek to harm humans to further their agenda.    Burning a vacation home or destroying the ashes of loved one is not going to change the fact that when these terrorists need medical treatment after being injured one day during their misguided activities, they will receive the best medical care because it was thoroughly researched and tested before being used.  


I understand their motivation.    I might even empathize with some of their goals.    But we should never support violence to further a goal.    Never.


By Michael W Simpson


*Once again, I want to reiterate my statement that Wikipedia articles are poor or even biased sources of just about anything, but its articles on animal testing rank well below its marginal medical articles&ndash;but it does give a good historical account, albeit very biased.


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Civilized medicine&#x2c; Part I.  Why?</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Obama</category><category>Healthcare Policy</category><category>Politics</category><dc:date>2009-08-05T01:01:54-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/civilized_medicine_part_i_why.php#unique-entry-id-58</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/civilized_medicine_part_i_why.php#unique-entry-id-58</guid><content:encoded><![CDATA[Unless you live in a world that does not include the media or internet, you must be aware of the level and tone of debate about healthcare reform.    Before we can discuss healthcare reform, we need to establish why we need healthcare reform.    Cutting through the rhetoric as to what needs to be done, we still need to know the reasons that have lead the US to the point where we need to seriously consider some level of reform of the system.    Setting aside some of the rhetoric and arguments, let&rsquo;s look at the key issues regarding healthcare in the US.


...From a national perspective, the US (government and private) spends over $2.5 trillion on healthcare.    Put another way, the US spends 16.9% of its Gross Domestic Product on healthcare, more than any other developed country in the world.    From an individual viewpoint, the costs of health care has been responsible for over half of the personal bankruptcies in the United States. ...  David Himmelstein of Harvard University, "Unless you're Warren Buffett, your family is just one serious illness away from bankruptcy...for middle-class Americans, health insurance offers little protection..."    What generates those costs is not just expensive equipment and drugs, but an antiquate health care record system that needs some serious upgrading.    Finally, the costs of insurance for small businesses and individuals have grown over the past few years.    The money spent on insurance has negative effects on the growth of employment in small businesses and the availability of discretionary spending for individuals.


...Over 45 million Americans, approximately 15.3% of the US are not covered by any insurance.    Of course, that means that about 85% of Americans are covered by insurance, one-third of those with insurance covered by government and military plans.    Even those covered individuals have insurance that might have high deductibles or annual limits which put them at risk, especially with catastrophic diseases such as cancer and cardiovascular impairment.    Furthermore, these private payers tend to make choices that maximize their profits as opposed to patient needs.


	&bull;	Prevention and public health.    One issue that has always concerned me about our healthcare system is it&rsquo;s focus on treatment rather than prevention.    Most healthcare plans will not pay for treating obesity (whether through pharmaceuticals or surgery) for reasons that escape many of us who study the healthcare industry.    I believe that the reasons lay in the fact that the healthcare plan does not expect the patient to be a &ldquo;customer&rdquo; by the time the benefits of reducing obesity are clear.  


...Although the vast majority of Americans are covered by some sort of insurance, there are a number of holes in the system.    One that has been mentioned frequently is excluding payment for pre-existing conditions.    This is a great fear for individuals who are changing jobs, and one of the covered family members has a serious medical condition.    It&rsquo;s a significant economic issue for small businesses who may try to attract talent to their company.    Several years ago, I was trying to hire a successful sales manager whom I believed could help grow my small company.    Sadly, his two children had a genetic issue that required expensive drugs (several thousand dollars per month), and we couldn&rsquo;t afford to cover his prescription benefit.    So, he lost the opportunity to take a promotion, and I lost out on a very talented individual.  


...Right now, every insurance company negotiates with providers (hospitals, physicians, and other key healthcare services) and medical products suppliers to manage costs.    Although it would be an anathema to the medical products industry, these healthcare insurers do not have the ability to negotiate the very best contracts to reduce costs.    In fact, the 2003 Medicare Prescription Drug Improvement and Modernization Act effectively bans the government from negotiating pricing on prescription drugs.    The Department of Veterans Affairs, which is not covered by that legislation, has negotiated lower prices for prescription drugs, thereby gaining substantial savings for the Department.


...Although there is a perception that the US has the best healthcare system in the world, that is not supported by facts.    For example, Canada healthcare spending is about 55% of the US per capita, yet it far exceeds the US in key healthcare quality measures, such as infant mortality and lifespan.    And Canada spends just 9% of its GDP on healthcare compared to the 16.9% for the US.    In other words, despite our very expensive system, the results underperform our immediate, and most similar, neighbor.


There are other reasons for examining our healthcare system.    But the fundamental issues are that it costs too much, it favors the very wealthy, and the results are not very positive.    But to debate what needs to be done, we need to understand what we have.  


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Civilized medicine</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Obama</category><category>Healthcare Policy</category><category>Politics</category><dc:date>2009-08-04T23:44:37-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/civilized_medicine.php#unique-entry-id-57</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/civilized_medicine.php#unique-entry-id-57</guid><content:encoded><![CDATA[I&rsquo;m titling this post &ldquo;Civilized Medicine&rdquo; as opposed to &ldquo;socialized medicine.&rdquo;    What I&rsquo;m really going to discuss is Obama&rsquo;s healthcare plan, but I wanted to start out by demolishing that old strawman argument that attempts to dismiss new ideas by calling them &ldquo;socialist.&rdquo;    A civilized society owes its citizens the right to a healthy life.    But that&rsquo;s just semantics, and a thorough review the Obama&rsquo;s proposal is warranted.    When I first started to write this entry, I thought I could do it one article, albeit a long one.    Instead, to make it easier to read, I&rsquo;ve decided to do it over four parts over the next few days.  


	I	Why.    I want to get some facts out there about why the country needs a healthcare reform.


	II	Myths.    There are so many myths being promulgated by various talking heads, I&rsquo;d like to take on some of them.    Dispelling myths is always fun.


	III	My proposal.    If they made me healthcare czar, what would I want?


	IV	The plan.    With so many stories being bandied about, I thought I&rsquo;d state what is being proposed.    And no, nowhere in the proposal could I find anything about socialism.


What is civilized health care?    The World Health Organization describes three goals for a good healthcare system:


	1	Good health&ndash;&rdquo;making the health status of the entire population as good as possible&rdquo; during a citizen&rsquo;s whole life.


	2	Responsiveness&ndash;responding to citizens&rsquo; expectations of respectful treatment by health care providers.


	3	Fairness in financing&ndash;ensuring financial protection for everyone, with costs distributed according to one&rsquo;s ability to pay.


This is civilized.    It&rsquo;s not socialized.


So, stay tuned.    The first chapter will be out tomorrow.


Note:  I&rsquo;ve decided that the &ldquo;Plan&rdquo; for healthcare is so fluid and subject to so much tweaking, I&rsquo;ve decided to make it the last chapter of this discussion.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Tom Harkin&#x27;s wants to waste money on healthcare</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Politics</category><category>Evidence based medicine</category><dc:date>2009-07-03T10:59:27-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/tom_harkins_money_wasting_ideas_on_healthcare.php#unique-entry-id-56</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/tom_harkins_money_wasting_ideas_on_healthcare.php#unique-entry-id-56</guid><content:encoded><![CDATA[Tom Harkin, Democratic Senator from Iowa, and one of the leading supporters of quack medicine is at it again.    As the US Senator who forced the junk science NCCAM onto the National Institutes of Health and has drained precious scientific research dollars, he is now putting his pseudoscientific ideas into health care reform.    As a member of the Senate&rsquo;s Health, Education, Labor and Pensions Committee (HELP), he is trying to be sneaky, because he has the power to do so.    He has been instrumental in attaching some amendments to the Affordable Health Choices Act (the formal name for the bill in Congress to reform healthcare policy), including:


	&bull;	A provision to allow medical students to defer loan repayment until they finish their residencies


	&bull;	Limits on the types of expenses medical students cover with loan funds


	&bull;	An provision to promote and fund research on pain management


	&bull;	Inclusion of alternative medicine workers in the bill's definition of "healthcare workforce"


I have no issue with the first two, especially since the cost of medical education is so large that some deferment is appropriate.    I might add that other health care students (pharmacy, nursing, and other technical specialties in medicine) should receive a similar consideration.


The pain management section and inclusion of alternative medicine workers into the definition of a healthcare worker are troubling.    Pain management is rife with pseudoscientific claims within the alternative medicine industry, most of which have no basis in science.    It is important that pain management research be funded, but it should be in a scientific and clinically responsible manner.    That means, keep it out of NCCAM.  


Defining alternative medicine workers as &ldquo;healthcare workers&rdquo; is an insult to the high level of education, experience, and overall knowledge of real healthcare workers, those who actually use scientific principles to treat your disease.    Naturopathy is quackery, so they cannot be healthcare workers.   Homeopathy is quackery, so they shouldn&rsquo;t be healthcare workers.    Chiropractic, when it moves beyond treating simple back pain (and the information is a bit debatable), is absolutely quackery.    Acupuncture just doesn&rsquo;t work.


Healthcare is an expensive proposition.    Paying for it is going to be difficult.    Wasting money on alternative medicine, which has not proven to do anything, makes no sense, when we have huge issues in paying for healthcare in the US.    We need to focus on paying for evidence based healthcare, not on ideas which are not only unproven, but may be dangerous.  


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Zicam&#x2c; Part II</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Alternative medicine</category><category>Evidence based medicine</category><dc:date>2009-06-17T10:01:38-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/zicam_part_2.php#unique-entry-id-54</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/zicam_part_2.php#unique-entry-id-54</guid><content:encoded><![CDATA[I discussed Zicam yesterday, but my comments were probably just gloating over the FDA dealing with a unproven supplement in the same manner as it does with regular prescription and over-the-counter drugs.    I want to go into some answers to questions I had in my own mind about this product.


	1	Why did the FDA issue a statement about Zicam?    There were some 130 reports from consumers that might have contracted anosmia (lack of smell) after using Zicam.    In addition, the FDA uncovered another 800 complaints that were reported to the manufacturer (Matrixx Initiatives, Inc.).    This is a relatively large number of adverse events that need to be investigated.    The company&rsquo;s statement says that the FDA action is &ldquo;unwarranted&rdquo;, but does not provide scientific evidence to support that statement.


...A temporary or permanent loss of smell is more serious than simply not being able to smell.    If you contracted anosmia, you couldn&rsquo;t tell if your food was spoiled, if your house was on fire, or enjoy the food you eat.    In other words, the loss of your sense of smell can put you in danger.


	3	The company claims that common viruses cause anosmia.    The active ingredient in Zicam is zinc gluconate.    It has already been reported in respected journals that intranasal zinc (at the concentrations found in Zicam) does cause anosmia.    Yes some viral infections cause anosmia, but the effect is not immediate, and the two reports eliminated viral infections as a possible cause.


...As I discussed yesterday, most of the research indicates that zinc gluconate has no or minimal effect on the duration or course of the disease.    At best, Zicam may reduce the length of the disease, but a common cold last 6-10 days on average.    By random chance, the patient may have an infection that spontaneously resolves itself on the lower end of the scale.  


	5	So Zicam may or may not reduce the length of my cold, yet it has a small, but significant possibility that I might lose my sense of smell?    Yes, the risk/benefit ratio is a bit troubling.    There have been about 1,000 reports of anosmia, while the company claims that over 1 billion doses have been sold.    Even though it&rsquo;s probable that many cases of anosmia have not been reported, and certainly not all 1 billion doses sold were used, using these extreme numbers, we get about a .0001% risk of anosmia.    We do things in life that have a much higher risk of an adverse event.    However, we manage risk by accepting a certain level weighed against a benefit.    All drugs sold have a risk, some significant.    But in accepting that risk, physicians and patients are convinced of a benefit.    If the benefit is small, nonexistent, or worthless (reducing the course of a common cold from 7 to 6 days would be essentially worthless), and risk is serious, though rare, I would conclude that the risk isn&rsquo;t worth the benefit.    At a minimum, I should know this information upfront so that I can make an informed decision.


	6	So why aren&rsquo;t these products regulated by the FDA more closely.   (Comments revised on 06/18/09)  Zicam specifically wasn&rsquo;t regulated closely, because it was considered a homeopathic potion, and as such was exempt from FDA regulation by the Dietary Supplement Health and Education Act of 1994 (DSHEA).    However, Zicam isn&rsquo;t really a homeopathic solution (which are diluted so much that there are zero molecules of the active compound in solution), since the concentration of zinc gluconate exceeds 2 parts per 100 which means there are billions and billions and billions of molecules in a one spray of your nose.    The FDA has a high burden of proof to regulate products that are covered by the DSHEA, but Zicam has met that proof.    Zicam should scientifically prove its safety and efficacy claims in a drug application to the FDA.    I am no defender of homeopathy (there is no way that 0 molecules of any substance in water will have any effect except taking money from your wallet), but it&rsquo;s ironic that Zicam, which is not a homeopathic product, is being criticized by &ldquo;real&rdquo; homeopaths for not being a real homeopathic potion.    Of course, that&rsquo;s not the point, it&rsquo;s that Matrixx characterized its product as homeopathic so that it would not be regulated closely.    Well, it&rsquo;s receiving it&rsquo;s comeuppance from the FDA and the stock market (Matrixx shares have dropped from around $20 to $6 per share in one day).


I am very concerned about these untested and unregulated substances, because it is clear that most are not useful, and harm people who might avoid treatments that actually have a medical benefit.    Also, I am detecting a move by the FDA to make decisions based on scientific evidence.  

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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Homeopathic product recall</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Alternative medicine</category><category>Evidence based medicine</category><dc:date>2009-06-16T20:04:58-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/homeopathic_product_recall.php#unique-entry-id-53</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/homeopathic_product_recall.php#unique-entry-id-53</guid><content:encoded><![CDATA[Today, the US FDA warned consumers to immediately stop using the product Zicam, a homeopathic remedy, because it may cause anosmia, the loss of sense of smell.    The FDA has received over 130 adverse reports from consumers who believe that they suffered anosmia after using Zicam.


Zicam is marketed a Big Herba company, Matrixx Initiatives, Inc., and is sold as a remedy for relief of symptoms of colds, flu, and allergies (all with different causes).    There is little or no evidence from respected peer reviewed journals that zinc gluconate, the active ingredient in Zicam, has any effect on the course, duration, or severity of common upper respiratory tract infections.    The Cochrane Reviews state that, the &ldquo;evidence of the effects of zinc lozenges for treating the common cold is inconclusive.&rdquo;    Infectious disease researchers from Stanford University have concluded that most positive studies of zinc gluconate are flawed in design and that the &ldquo;therapeutic effectiveness of zinc lozenges has yet to be established.&rdquo;    A well designed double-blind study published in Clinical Infectious Diseases concludes that the &ldquo;data do not support a role for intranasal zinc gluconate for prevention or treatment of the common cold.&rdquo; 


In support of Zicam is one study, that Matrixx hypes on its website, gives some positive results, but the populations are so small (40 patients) that it cannot be reliably interpreted.    In fact, the statistical analyses depend on one result in many cases.    That is no better than flipping a coin once.    Furthermore, Matrixx approved the submission of the article to a journal (and presumably funded the study).    Actually, I don&rsquo;t consider corporate funding and control of publication to be a serious issue, but how many times do I read the woo-pushing crowd accuse Big Pharma of doing the same&ndash;so for me, this is just part of the whole Big Herba hypocrisy.  


Nevertheless, Zicam probably is no more or less effective than a placebo, so it may benefit those individuals who benefit from placebo effects, if they exist.    The problem is that there appears to be a risk from the product.    So, it may not be efficacious and it may not be safe.    Until the company proves that the product is safe and efficacious, Matrixx needs to adhere to the standards of any pharmaceutical company&ndash;prove it.


Typical of Big Herba, Matrixx is making all kinds of claims on its website on how the FDA has it all wrong.    And of course, stating that they have medical and scientific evidence for the safety and efficacy of Zicam, though my brief review of the research indicates it&rsquo;s probably not effective, and little research on safety.    The alt-med woo-pushing crowd would, of course, be all over Big Pharma if this happened to them.    Let&rsquo;s see what happens to the product that is arguably the biggest selling homeopathic remedy ever.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Big Herba</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Pharmaceuticals</category><category>Medical products</category><category>Alternative medicine</category><dc:date>2009-06-11T15:03:26-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/big_herba.php#unique-entry-id-52</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/big_herba.php#unique-entry-id-52</guid><content:encoded><![CDATA[One of the strawman arguments I constantly hear is that Big Pharma (the pejorative term used by woo-meisters to describe ethical pharmaceutical companies) block natural therapies because they will lose profits.    My argument has always been that if these &ldquo;therapies&rdquo; actually worked, Big Pharma would find a way to patent them, bring them to market and make more profits.    Well, at least that&rsquo;s what I thought.


Then, Marilynn Marchione, an Associated Press medical writer (and quickly becoming a favorite of mine) recently coined the term Big Herba.    You see, the supplement, potion and herbal pill industry is not made up of altruistic, non-profit little companies bringing their magic to you the consumer.    Actually, far from the truth, apparently the supplement industry is $23 billion in the US alone.    One of the largest woo-meister companies, NBTY Inc., formerly known as Nature&rsquo;s Bounty.    Doesn&rsquo;t that name seem natural and healthy?    It&rsquo;s a $2 billion corporation, which doesn&rsquo;t have to follow the same rules as Big Pharma, which is strictly regulated by the FDA.    Big Pharma has to prove its claims through basic scientific research, multiple clinical trials, and post-marketing follow-up.    Big Herba, on the other hand, is regulated like a food&ndash;there&rsquo;s broad leeway for Big Herba to say whatever it wants, with little or no scientific support.    Oh, just in case someone says &ldquo;but they do science,&rdquo; I mean large double-blind clinical trials published in peer-reviewed journals.  


Henceforth, anyone brings up the Big Pharma strawman gets the Big Herba reply.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Alternative medicine&#x2013;waste of money</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Alternative medicine</category><category>Evidence based medicine</category><dc:date>2009-06-11T10:31:33-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/alternative_medicine_waste_of_money.php#unique-entry-id-51</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/alternative_medicine_waste_of_money.php#unique-entry-id-51</guid><content:encoded><![CDATA[As I&rsquo;ve discussed before, Complementary and Alternative Medicine (CAM) are so-called treatments that lack any scientific or medical support.   The National Center for Complementary and Alternative Medicine (NCCAM), which was funded by the US Congress to be a part of the National Institutes of Health, continues to discover that these treatments do not work.    And it wasted $2.5 billion to discover that they don&rsquo;t work.    I would have done it for $1.5 billion.    In fact, given that most of the CAM therapies rely upon ideas that have no foundation in physics, chemistry, biology, physiology or any other science, most of the studies shouldn&rsquo;t have been done at all.  


Marilynn Marchione, an Associated Press Medical Writer, has written an article entitled, $2.5B spent, no alternative medicine cures.    You can&rsquo;t get any clearer than that, and it&rsquo;s really clear:


	&bull;	Echinacea for colds&ndash;doesn&rsquo;t work


	&bull;	Ginkgo biloba for memory&ndash;no


	&bull;	Glucosamine and chondroitin for arthritis&ndash;no way


	&bull;	Saw palmetto for prostate&ndash;don&rsquo;t waste your money


	&bull;	Acupuncture&ndash;no better than a placebo, if that.  


I could go on, but it would be ridiculous.    The government (I really mean we taxpaying US citizens) are funding studies for energy fields (they don&rsquo;t exist), distant healing (by what plausible physical process can that happen?), and other so-called therapies that lack any basis in science.    They are investigating nonsense.    Pure nonsense.


The United States should be investing in science and medical research since that provides real value to Americans whether it be jobs in research and manufacturing or making us healthier.    But spending it on research that is irrational and foolish, like seeing if homeopathy works, is a poor use of monetary resources, your tax dollars.  


Write your Congressman to stop this waste of money.    Unless, it&rsquo;s Senator Tom Harkin.    He thinks that we&rsquo;re not spending enough.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Healthcare IT&#x2013;the perfect product</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical products</category><category>Healthcare Policy</category><dc:date>2009-06-08T09:29:28-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/healthcare_IT_perfect_product.php#unique-entry-id-50</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/healthcare_IT_perfect_product.php#unique-entry-id-50</guid><content:encoded><![CDATA[As discussed previously, I am convinced that the healthcare IT market is poised for explosive growth.    I think there are going to be a few challenges to entrepreneurs and larger companies to participate in this growth, including FDA oversight, privacy and security, hardware/software incompatibility, and linking to medical devices.    Finally, marketing to the customer base, whether it is the alternate site (physicians, surgery centers, long-term facilities) or hospitals, is going to take individuals who are skilled in the medical products marketing instead of IT marketing.  


So, what would be the perfect product in healthcare IT?    It depends on the target market, but I would like to focus on the primary care physician (and other alternate site generalists and specialists), who may be the larger part of the market, may be less price sensitive, and will be more open to productivity improvements.    The perfect product would include:


...The HIPAA (Health Insurance Portability and Accountability Act of 1996) sets standards for confidentiality of healthcare records, and every healthcare worker knows this regulation.    Violating it can lead to lawsuits and fines, so any system must keep the highest level of security.    Not only do the servers need to maintain a high level of security, but also any clients (laptops, tablets, or PDA&rsquo;s).  


...I have discussed how difficult some medical devices are to use and set up.    Physicians provide their service by diagnosing and treating patients.    Trying to fix IT issues or learning how to use a complex software package is not going to limit adoption of products.    Product development should focus on the Apple model, which focuses on simplicity with performance.


	&bull;	Electronic medical records.    The perfect system would populate records with data from medical devices, with physician notes, diagnostic codes, laboratory results,  prescription, and other items.    The healthcare worker can just open up your file on a tablet PC or PDA, and review accurate information.    As an example, in the majority of medical offices, the blood pressure is taken during a visit.    What if the number is written wrong in the file?    There is a huge difference in treatment strategies between a patient with a BP of 115/70 and 145/70.    What if the number is directly and wirelessly transmitted from the blood pressuring monitoring equipment to the patient&rsquo;s record? 


...Linking the physician&rsquo;s office billing software to the electronic healthcare record would be great, but if they were one product, it would be a new paradigm in the market.    This link needs to work by drawing the key information from the electronic record into the appropriate billing template, which then can be electronically sent to the third part payor for reimbursement.    This feature alone can reduce billing errors and increase cash-flow to the physician&rsquo;s office.   Right now, it appears that many developers are focusing either the electronic records or billing, but few are integrating them into one product.


...This area is probably the area with the most complexity and regulatory oversight.    The FDA has authority over any product that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.    But thousands of medical devices and diagnostic products have undergone FDA review, so it is not insurmountable.    I think the ability for a PDA or laptop computer to receive patient data (either from home or from the hospital) can assist a physician in making decisions, especially in emergency or critical situations.    But it has to be done nearly perfectly&ndash;there is little room for errors.    For example, data which is not accurate or is mislabeled (the physician receiving the data of Patient X thinking it&rsquo;s for Patient Y) can be devastating.   That&rsquo;s probably why the FDA is going to tightly regulate this area.


That&rsquo;s what I think the perfect product should contain.    Underneath each, of course, are numerous details that must be completely understood through upstream marketing analysis (customer/product development interface) and through cost-benefit analysis of added features.


...I didn&rsquo;t mention price.    Unless all five issues are addressed, price might not matter.    And if all are, then price might not matter.    This could be a lucrative opportunity for the right products.


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Alternative medicine woo humor</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Pharmaceuticals</category><category>Alternative medicine</category><category>Quackery</category><dc:date>2009-06-03T21:54:36-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/alternative_medicine_woo_humor.php#unique-entry-id-48</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/alternative_medicine_woo_humor.php#unique-entry-id-48</guid><content:encoded><![CDATA[Yes, sometimes I need to be irreverent.  


<img src="http://simulatedcomicproduct.com/comics/2009-06-02-Null-Hypothesis.jpg" width= 650 alt="How alternative medicine is really discovered"  style="border: 5px solid red" />


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Healthcare IT&#x2013;growth drivers</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>iPhone</category><category>Medical products</category><category>Healthcare Policy</category><dc:date>2009-06-03T20:03:35-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/healthcare_IT_growth_drivers.php#unique-entry-id-47</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/healthcare_IT_growth_drivers.php#unique-entry-id-47</guid><content:encoded><![CDATA[As I have discussed several times before, there seems to be a significant amount of activity in health information technology.    President Obama&rsquo;s stimulus package includes $19 billion to fund hospitals and individual physicians to upgrade their IT systems, specifically to migrate from paper-based patient records to electronic health records.    In the near future, it would be possible for a patient record to be shared between all parts of the healthcare system.    For example, patient with a severe trauma can be treated more quickly and effectively, if the emergency room had access to the patients record knowing what health issues may be critical to decisions about treating the patient.    Having that information available within minutes can be crucial to saving the patient&rsquo;s life.    Anyone knowledgeable about the healthcare system in the US probably can list out many more examples where an online patient record can be the difference between success and failure in treating a patient.


There are many issues that must be addressed before products can come to market:


	&bull;	Privacy.    HIPAA (Health Insurance Portability and Accountability Act of 1996) sets standards for confidentiality of healthcare records.    With constant news reports on security issues with everything from the government to banks, it is troubling that healthcare information can be compromised.    It could be a large as a hacker breaking into a hospital server or as simple as a stolen iPhone that might have patient information on it.    I remain concerned that some software developers have not focused on HIPAA compliance.


	&bull;	Medical devices.    In an effort to decrease errors and increase healthcare worker productivity, online transmission of data from medical devices to the healthcare records would be important.    Everything from an electronic scale to EKG&rsquo;s could be wirelessly connected to a server that collects data on a patient.    Although this is happening in many hospitals, the primary care physician, the main point of contact for most patients, are woefully behind on upgrading their equipment, software and computers to provide this information.    And in cases where patients do monitoring of their health at home, the technology is barely evolved from writing it down on a Post-It note.    For example, Holter monitors (which record heart rate and rhythm over a 24 hour period of time) and blood glucose monitors require transmitting the data to the primary care physician in their office.    A world where those devices connect to the internet (securely, of course), to deliver the data to the physician would be a boon to treatment decisions.    Right now, there are so many different devices manufactured by a variety of companies, all with different standards of communication and connectivity.  


	&bull;	FDA.   The FDA has responsibility over any product that assists a physician in making a medical diagnosis; many of the software products that connect to medical devices (such as CT or MRI scans) would require FDA clearance to be marketed in the US.


	&bull;	Managed care.    In this perfect world of electronic health records, the right data can be collected from the patients to improve reimbursement to the physician, hospital and patient.    It can also be used to uncover healthcare trends.    I can even imagine how valuable it can be in analyzing public health issues such as epidemiology and occupational health.


There are several large companies entering this arena.    Microsoft has launched its Healthvault online application that connects everyone from patients to pharmacies to physicians (and much more) to share data to reduce errors, to improve patient outcomes, and to track healthcare trends.    It has recently signed an agreement with Walgreens that allows Walgreens&rsquo; customers to access their prescription data through Healthvault.    Intuit has set up Quicken Health Expense Tracker which helps patients manage their healthcare expenses.   If it could link to patient records, it could be a powerful tool for patients to control and manage their expenses.  


Right now, this is an open market with many opportunities for the right company.    Microsoft has the lead, but I&rsquo;m a bit skeptical of their potential for success, mainly because innovation is often driven by smaller companies.    Let&rsquo;s see what happens.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Blogosphere news (May 26&#x2c; 2009)</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Science</category><category>Pharmaceuticals</category><dc:date>2009-05-26T10:17:38-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Blogosphere_news_052609.php#unique-entry-id-46</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Blogosphere_news_052609.php#unique-entry-id-46</guid><content:encoded><![CDATA[Over the long weekend, I read a lot of blogs that were of interest to me.    I thought I&rsquo;d provide some short analysis and links for those of you who want to read about it.


	&bull;	So, you think dolphins are nice, cute creatures.    Typical of many animals, they&rsquo;re sexually aggressive, practice infanticide, and are violent against competing cetacean species.    Miriam Goldstein discusses the harsh reality of one species of dolphins.


	&bull;	I&rsquo;m sure you&rsquo;ve heard about Darwinius masillae.    Then apparently you&rsquo;re missing the hype.    Ed Yong has written an amusing (and a bit irreverent) piece about the 47 million year old fossil.    Other scientists are also weighing in on the over-hyped primate.    Though the fossil is important to understanding the evolution of primates, it is a bit troubling that a poorly written paper was published in conjunction with a History Channel special.    Eventually, the fossil will give us some clues to the evolutionary pathway since it appears to an example of a primate that lived right at the point where primates split into two broad groups:  strepsirrhines, which includes the lemurs and lorises, and the haplorhines, which includes hominids.    Of course, this has nothing to do with medical products, but I&rsquo;ve been reading so much about it, I just couldn&rsquo;t ignore it.


	&bull;	Then there&rsquo;s Orac&rsquo;s the case of Daniel Hauser.    If you&rsquo;re not aware, Daniel is a 13-year-old boy with Hodgkin's lymphoma who underwent one course of chemotherapy.    Then, he  decided he wanted to pursue a woo-based therapy that resulted from his fear of chemotherapy and his mother&rsquo;s suspiciously invented Native American religion.   A Minnesota judge ordered Daniel's parents to have Daniel visit a physician and then receive the appropriate care for the disease.    Soon after the legal order, his mother Colleen fled the jurisdiction last week and were last thought to be heading for Mexico.    Daniel was facing certain death.    His mother recently returned with Daniel, so that he might get the best medical treatment.    I hope this will end well, but I worry about Daniel&rsquo;s life with these parents.


	&bull;	Moving from medicine to geology, there seems to be some volcanoes ready to erupt in Saudi Arabia.    Or not.  


	&bull;	Back to medicine.    Another pseudoscientific and dangerous &ldquo;cure&rdquo; for autism.    Chemical castration??    Why hasn&rsquo;t their medical license been pulled?


	&bull;	There is no such thing as spontaneous human combustion.  


	&bull;	12-step programs for treating alcoholism are no better than a doctor saying &ldquo;quit drinking.&rdquo;  


That&rsquo;s it for now.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>The Jenny McCarthy Song</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Vaccines</category><category>Pseudoscience</category><category>Evidence based medicine</category><dc:date>2009-05-15T09:22:48-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/the_jenny_mccarthy_song.php#unique-entry-id-45</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/the_jenny_mccarthy_song.php#unique-entry-id-45</guid><content:encoded><![CDATA[Without making excuses, I really try to keep this blog focused on issues that might impact the medical business world.    I am, however, strongly offended by pseudoscience, the primary &ldquo;authority&rdquo; for most quack remedies, alternative medicine, and the anti-vaccine movement.    I have previously discussed Ms.   McCarthy a number of times, and without a doubt, I believe she&rsquo;s a danger to healthcare.    The consequences of the anti-vaccination push is evident by real science.


Then I ran across this amusing video, by Brian Thompson from the Amateur Scientist, which is pure genius.    I will digress from new medical devices to allow you to watch it.


<object width="425" height="344"><param name="movie" value="http://www.youtube.com/v/0v_85tAey9s&color1=0xb1b1b1&color2=0xcfcfcf&hl=en&feature=player_embedded&fs=1"></param><param name="allowFullScreen" value="true"></param><embed src="http://www.youtube.com/v/0v_85tAey9s&color1=0xb1b1b1&color2=0xcfcfcf&hl=en&feature=player_embedded&fs=1" type="application/x-shockwave-flash" allowfullscreen="true" width="425" height="344"></embed></object>


By the way, if any of you remain unconvinced of Jenny&rsquo;s intellectual prowess, read her blog (think before you read).    If anyone wishes to make medical decisions based on what she says, then at least I know you have been warned!


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>The value of blood-glucose monitoring</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical devices</category><category>Healthcare Policy</category><category>Medical products</category><category>Evidence based medicine</category><dc:date>2009-05-13T09:17:04-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/value_of_blood_glucose_monitoring.php#unique-entry-id-44</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/value_of_blood_glucose_monitoring.php#unique-entry-id-44</guid><content:encoded><![CDATA[One of the paradigms of managing patients with Type II diabetes includes regular home testing of blood glucose levels using one of the widely available blood glucose monitors.    The American Diabetes Association, one of the leading organizations that advocate for and provide information about diabetes, recommends home glucose monitoring for patients who have diabetes and are:


	&bull;	taking insulin or diabetes pills 


	&bull;	on intensive insulin therapy 


	&bull;	pregnant


	&bull;	having a hard time controlling your blood glucose levels


	&bull;	having severe low blood glucose levels or ketones from high blood glucose levels


	&bull;	having low blood glucose levels without the usual warning signs


These are probably good recommendations, based on good evidence.    Controlling blood glucose in those patients with Type 2 diabetes has strong positive benefits for reducing risks of chronic and acute diseases, such as peripheral artery disease, hypertension, diabetic dyslipidemia, heart attack and stroke.


Recently, a clinical trial published in the British Medical Journal analyzed the medical usefulness of home blood glucose monitoring in patients with Type II diabetes.    The trial was well designed enrolling 184 individuals with recently diagnosed type 2 diabetes mellitus.    The patients were randomized into two groups:  one that utilized a monitor and one that did not.    The patients were observed for one year.


The results of the trial were somewhat surprising:


	&bull;	Monitoring was associated with a 6% higher score on the depression subscale of the well-being questionnaire.    In other words, there was a significant (p=.01) increase in depression for those who used a blood glucose monitor.    We can speculate on the reasons, but it probably resulted from a constant reminder of their health status.


	&bull;	There were no baseline differences in mean hemoglobin A1c (a blood marker that provides information about a patient&rsquo;s blood glucose levels over the past three months) between those who monitored themselves and those who did not.


The authors of the study make this conclusion:


<blockquote class=bqfancy>In patients with newly diagnosed type 2 diabetes self monitoring of blood glucose concentration has no effect on glycaemic control but is associated with higher scores on a depression subscale.</blockquote>


That&rsquo;s a pretty solid conclusion.    And that calls into question the value of providing blood glucose monitors to patients.    In the United States, it&rsquo;s almost a standard of care that physicians will authorize and third-party payers (including managed care organizations) will pay for these products.    Are they gathering dust?    With these results, it&rsquo;s fair to state that providing blood glucose monitors to patients is a significant waste of money for the health care system.    There are approximately 17.9 million individuals with diagnosed diabetes, which probably means that the total cost of monitors for this group exceeds $1 billion annually.    That&rsquo;s a significant healthcare expenditure that seems to have a marginal usefulness.


I was personally surprised by these results.    I would recommend further studies including whether there is a subset of Type 2 diabetes patients who might benefit from the monitors.    For example, someone who has a strong desire to reduce blood sugar may, instead of being depressed, may be motivated by knowing that their diet and exercise maintains appropriate levels of blood glucose.    I have a difficult time reconciling these poor results with the obvious value of accurate monitoring of glucose levels given the long-term consequences of not doing so.


I have also been troubled by the design and ergonomics of medical devices, especially blood glucose monitors.    There has to be a lower cost, yet easier to use, product that can be designed.    Everything from using the lancets, to placing a drop on a strip to actually using the monitors makes it a challenge for a patient to be compliant.


We need to find out if these results have changed physician and third-party payer attitudes.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Harold Varmus interviewed on C-span</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Science</category><dc:date>2009-05-11T07:59:31-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/harold_varmus_cspan_interview.php#unique-entry-id-43</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/harold_varmus_cspan_interview.php#unique-entry-id-43</guid><content:encoded><![CDATA[Yesterday morning, I was listening to Harold Varmus being interviewed live (interspersed with listener calls) on C-SPAN Radio.    For those of you unfamiliar with Dr.   Varmus, he is currently the co-chair of the President's Council of Advisors on Science and Technology, CEO of Memorial Sloan-Kettering Cancer Center, former Director of the National Institutes of Health (NIH), and a recipient of the Nobel Prize in Physiology or Medicine in 1989.    In other words, Dr.   Varmus has all of the credentials of a scientists, if not one of the great scientists of our era.


I have been unable to find a transcript of the program, but a couple of points from the interview were particularly memorable to me.    First, he made a full-throated support of vaccination of children, and made a diplomatic criticism of the anti-vaccination movement.    The second point that stuck with me followed a call from an individual who had one of those &ldquo;my friend was dying of this, and they went to this website and was cured of that&rdquo; stories.    In this case, the caller said a &ldquo;friend&rdquo; of hers was suffering from diabetes (not sure how bad or what type), and her friend went to some website (I was driving, so I didn&rsquo;t have a chance to write it down) that told her to switch from a high carbohydrate diet to one with lots of proteins and fresh vegetables.    Only this diet would &ldquo;cure&rdquo; the diabetes.    Of course, my thought when I heard this story was, &ldquo;well, switching to a low carb diet may have been the reason.&rdquo;  


Well, Dr.   Varmus responded without discussing the claims, but went on to describe that the NIH supports research into complementary medicine through the National Center for Complementary and Alternative Medicine (NCCAM).    He then made a statement that we have to investigate these alternative medicines through science, reminding listeners that digitalis, from foxglove plants, was used by herbalists before becoming part of the drug armamentarium for treating certain cardiovascular conditions.    Unfortunately, he made a point, which I&rsquo;m not sure I understood completely, that a lot of alternative medicines cannot be studied through traditional scientific means.    He also gave some level of support for NCCAM.


I was very happy that he criticized the anti-vaccine crowd and stated that alternative medicine should be studied scientifically.    I was very disappointed in his support for the wasteful NCCAM.   I still think that NCCAM is an inappropriate waste of scientific research dollars.    Digitalis became a drug because there was a scientific basis of how it worked, there was a clinical trial to determine its safety and efficacy, and it is not an &ldquo;alternative medicine&rdquo;.    It is just medicine.


Most of what NCCAM studies has absolutely no basis in science.    Many of the alternative medicines can&rsquo;t even show a somewhat plausible reason for working, so it makes it difficult or even impossible to scientifically study it.  


I just wish Dr.   Vargus said, &ldquo;I&rsquo;m recommending to President Obama that we close down NCCAM immediately.&rdquo;    But he didn&rsquo;t, and for such an intelligent, successful scientist, that is disappointing.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Increased FDA scrutiny of medical devices</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical devices</category><category>Medical products</category><dc:date>2009-05-07T07:51:38-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/FDA_scrutiny_medical_devices.php#unique-entry-id-42</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/FDA_scrutiny_medical_devices.php#unique-entry-id-42</guid><content:encoded><![CDATA[In the early 1990&rsquo;s, Congress directed the US Food and Drug Administration (FDA) to gather more rigorous evidence before a they give approval to manufacturer to market medical devices that were considered the most risky, a category known as Class III  devices.    The FDA never implemented the law, and several hundred Class III devices were approved by the FDA based on a less rigorous path using a 510(k), which allows the manufacturer to establish that their products are &ldquo;substantially equivalent&rdquo; to products marketed before 1976.    Early this year, the Government Accounting Office (GAO) issued a report that stated these conclusions about the process:


<blockquote class=bqfancy>FDA has stated that eventually all class III devices will require FDA approval through the PMA process and FDA officials reported that the agency is committed to addressing this issue, but the agency has not specified time frames for doing so.   Without FDA action, the remaining preamendment class III device types&mdash;including device types that FDA identified in 1994 as presenting an unreasonably high risk to public health&mdash;may enter the U.S. market through FDA&rsquo;s less stringent premarket notification process.</blockquote>


The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process.    They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III.    Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices.


On April 9 2009, the  issued an order entitled:  &ldquo;Required submission of safety and effectiveness information for certain Class III devices.&rdquo;    It requires manufacturers of twenty five Class III devices to resubmit an application to the FDA to determine if the product should be reclassified or if the manufacturer will be required to gain approval through the PMA process.  


The most products covered in this order are automatic external heart defibrillators, dialysis catheters, hip joints, spinal screws, a heart pump and several others from several large companies, including Medtronic (NYSE: MDT), Phillips, Zoll (Nasdaq: ZOLL), Covidien (NYSE:COV), Zimmer (NYSE: ZMH), Johnson & Johnson (NYSE:JNJ), and Abiomed (Nasdaq: ABMD) are covered by this order.    It will take several years to go through this process, and the FDA has given a grace period for the manufacturers to go through the process.


The consequences of this regulatory action are that many of these products, which were approved through the 510(k) process available at the time, will have to go through the full PMA process, which is time consuming and puts somewhat more controls on the marketing of the product.    I also wonder if some of the products will be soon replaced by &ldquo;new and improved&rdquo; offerings from the company, and those manufacturers may not pursue a new submission.  


Going forward, it&rsquo;s clear that manufacturers will have to gain FDA clearance for Class III devices through the PMA process, and that&rsquo;s a good thing for medical products consumers.    Device companies may grumble a bit, but then move on, as they usually do.  


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Point-of-care diagnostics and the flu</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical devices</category><category>Medical products</category><category>Healthcare Policy</category><dc:date>2009-05-04T08:51:38-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/point_of_care_diagnostics_flu.php#unique-entry-id-40</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/point_of_care_diagnostics_flu.php#unique-entry-id-40</guid><content:encoded><![CDATA[I am enamored of the point-of-care (POC) diagnostics market.    It is clear that these tests bring benefits to patients, physicians and managed care.    Influenza A H1N1 (apparently, the pork industry does is not fond of the swine flu label) may open a huge opportunity for rapid testing for flu.


Quidel Corporation (NASDAQ GS: QDEL) manufactures and markets a rapid (less than 10 minutes from swab to results) diagnostic kit for Influenza A and B (and differentiates between the two).    As Quidel states, they are not sure if it detects the swine flu strain.    The test should be used for any patients that present with influenza symptoms, because a positive result may rule out other types of infections (and should involve contacting a local health department), although a negative result (if the test does not identify the swine flu type) may not rule out the disease.


At this time, Quidel&rsquo;s test is the only one on the market (as far as I am able to ascertain).    I expect sales of the product may increase substantially over the next few months, if the swine flu continues to be an issue that stays in the forefront of the news.    I&rsquo;m going to do some analysis to determine if the numbers support my subjective thoughts.


Full disclosure:  I don&rsquo;t own Quidel stock, I don&rsquo;t work for Quidel, and I do not stand to profit from Quidel.    In other words, I just think they have a good product that will meet a market need over the next few months.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Swine flu&#x2013;don&#x27;t panic</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Pseudoscience</category><category>Vaccines</category><category>Healthcare Policy</category><dc:date>2009-04-30T00:02:32-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/swine_flu_dont_panic.php#unique-entry-id-39</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/swine_flu_dont_panic.php#unique-entry-id-39</guid><content:encoded><![CDATA[With respect to the swine flu, I want to repeat myself, once again&ndash;Don&rsquo;t Panic.  


Yes, the World Health Organization revised the pandemic alert for swine flu from 4 to 5.    They did this to urge vaccine manufacturers to prepare a new vaccine, to warn governments to prepare in advance, and to request that government surveillance be heightened.


This does not mean that we will be returning to the Spanish Flu epidemic of 1918, where more than 20 million people died worldwide.    We are healthier, there are no major wars such as World War I, we have a better healthcare system, we have more focus from governments, and we have better treatments.  


One child in Texas has apparently died from swine flu.   Although it is no small comfort to the family, who probably is grief-stricken by this death, there has always been a certain percentage of pediatric deaths from influenza infections.    Despite the &ldquo;all swine flu, all the time&rdquo; news broadcasts, the statements by the World Health Organization and Centers for Disease Control are measured and calming.    Please take the time review the CDC&rsquo;s recommendations to reduce your risk, which bear repeating here:


<blockquote class=bqfancy>


	1	Cover your nose and mouth with a tissue when you cough or sneeze.   Throw the tissue in the trash after you use it.


	2	Wash your hands often with soap and water, especially after you cough or sneeze.   Alcohol-based hand cleaners are also effective.    (So your parents were right.)


	3	Avoid touching your eyes, nose or mouth.   Germs spread this way.


	4	Try to avoid close contact with sick people.


	5	If you get sick with influenza, CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.</blockquote>


I&rsquo;m not an epidemiologist, so I can&rsquo;t tell you with a straight face that we&rsquo;re all going to get through this situation unscathed.    But I&rsquo;m going to trust the CDC and WHO on this issue rather than FOX News, that&rsquo;s for certain.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Swine flu</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Pseudoscience</category><category>Vaccines</category><category>Healthcare Policy</category><category>Evidence based medicine</category><dc:date>2009-04-29T15:34:22-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/swine_flu.php#unique-entry-id-38</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/swine_flu.php#unique-entry-id-38</guid><content:encoded><![CDATA[Well, actually I&rsquo;m not going to say too much about swine flu, except that my initial impression is that it&rsquo;s not that much different from other types of flu in terms of severity.    For example, during the 2007-2008 flu season, there were 83 pediatric mortalities in the US that resulted from influenza infections.    In other words, like a lot of diseases that we think are minor, there are serious health consequences that often fly &ldquo;under the radar.&rdquo;    There is a certain fascination with this disease because of where it started (Mexico), conspiracy theories, and for other reasons that are beyond my ability to understand.    I am personally not concerned, because, as I mentioned above, the morbidity of the infection probably is similar to other types of influenza.


There are a number of bloggers who are passing along sage and sane advice.    Basically, don&rsquo;t panic.    Wash your hands.    And that&rsquo;s about it for really good medical information.


Of course, the woo-meisters have weighed in with their useless advice.    I won&rsquo;t even begin to explain the logical and scientific fallacies of colon cleansing, but it isn&rsquo;t going to either prevent or lessen the severity of swine flu.


Since the purpose of this blog is to discuss the medical products market, there are a couple of predictions, as a consequence of the swine flu &ldquo;epidemic&rdquo;, I am willing to make:


	1	The flu vaccination rate will be up this fall.    This might mean shortages of vaccines if any of the key manufacturers fail to deliver sufficient lots of vaccine.    It also will mean increased usage of syringes, needles and other ancillary supplies (so go long on BD).


	2	Oseltamivir (Tamiflu), an oral anti-viral drug, will have strong sales.    I remember in 2005, during the avian flu scare, physician&rsquo;s offices purchased the drug for their offices (not necessarily for patients, since most physicians don&rsquo;t give out anything but sample drugs).


So, I haven&rsquo;t much else to say about swine flu.    Don&rsquo;t panic!


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Obama&#x27;s science policy </title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Obama</category><category>Science</category><dc:date>2009-04-27T08:10:49-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/obama_science_policy.php#unique-entry-id-37</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/obama_science_policy.php#unique-entry-id-37</guid><content:encoded><![CDATA[Today, President Barack Obama gave a speech (audio version can be found here)  to the National Academy of Sciences, the nation&rsquo;s prestigious science advisors.    The speech reaffirms his campaign promises regarding science policy (how refreshing that a politician actually follows up on promises made in the heat of the campaign) and follows up on his executive order to reverse George Bush&rsquo;s ill-founded partial ban on stem-cell research.    Below are a few key points of the speech that deserve repeating.


<blockquote class=bqfancy>At such a difficult moment, there are those who say we cannot afford to invest in science.   That support for research is somehow a luxury at a moment defined by necessities. ...  Science is more essential for our prosperity, our security, our health, our environment, and our quality of life than it has ever been.   And if there was ever a day that reminded us of our shared stake in science and research, it&rsquo;s today.</blockquote>


<blockquote class=bqfancy>Federal funding in the physical sciences as a portion of our gross domestic product has fallen by nearly half over the past quarter century.   Time and again we&rsquo;ve allowed the research and experimentation tax credit, which helps businesses grow and innovate, to lapse.


...Our students are outperformed in math and science by their peers in Singapore, Japan, England, the Netherlands, Hong Kong, and Korea, among others.   Another assessment shows American fifteen year olds ranked 25th in math and 21st in science when compared to nations around the world.</blockquote>


These statements were from two different parts of his speech, but they deserve to be discussed together.    Investment in science is critical for the long-term economic growth, since most medical technologies result from basic or applied research.    Without strong investment in science education, the US will lack enough trained researchers to maintain or even build leadership in these areas.    It should be embarrassing to the country that we rank 21st in science.


<blockquote class=bqfancy>We are closely monitoring the emerging cases of swine flu in the United States.   This is obviously a cause for concern and requires a heightened state of alert.   But it is not a cause for alarm.   The Department of Health and Human Services has declared a Public Health Emergency as a precautionary tool to ensure that we have the resources we need at our disposal to respond quickly and effectively.   I&rsquo;m getting regular updates on the situation from the responsible agencies, and the Department of Health and Human Services as well as the Centers for Disease Control will be offering regular updates to the American people so that they know what steps are being taken and what steps they may need to take.   But one thing is clear &ndash; our capacity to deal with a public health challenge of this sort rests heavily on the work of our scientific and medical community.   And this is one more example of why we cannot allow our nation to fall behind.


Unfortunately, that is exactly what has happened.</blockquote>


Right now, it appears that we are still at the stage of being prepared rather than actually dealing with an epidemic.    I think there are many others who are giving sound and reasonable advice.    Don&rsquo;t panic is about as sage as I can get.    Back to Obama&rsquo;s speech.    He&rsquo;s absolutely right about public healthcare, &ldquo;we cannot allow our nation to fall behind.&rdquo;  


<blocquote class=bqfancy>On March 9th, I signed an executive memorandum with a clear message: Under my administration, the days of science taking a back seat to ideology are over.   Our progress as a nation &ndash; and our values as a nation &ndash; are rooted in free and open inquiry.   To undermine scientific integrity is to undermine our democracy. 


That is why I have charged the White House Office of Science and Technology Policy with leading a new effort to ensure that federal policies are based on the best and most unbiased scientific information.   I want to be sure that facts are driving scientific decisions &ndash; and not the other way around.</blockquote>


Two sentences in his whole speech are the most important.    Science should never take a back seat to ideology.    The blocking of stem cell research and the ideological control of the FDA were not helpful to our leadership in the sciences. 


It&rsquo;s good to have a President willing to place a strategic effort in the sciences.    There will be money for education, research, and programs that will have a long-term effect of building up the basic foundation of science in the US.  

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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Wikipedia&#x2013;more bad medicine</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Wikipedia</category><category>Pharmaceuticals</category><dc:date>2009-04-21T16:24:03-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/wikipedia_more_bad_medicine.php#unique-entry-id-36</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/wikipedia_more_bad_medicine.php#unique-entry-id-36</guid><content:encoded><![CDATA[The usefulness of the medical articles in Wikipedia is coming under a lot of scrutiny lately.    I&rsquo;ve made my opinion of Wikipedia known in the past.    In this article published in the Annals of Pharmacotherapy in December 2008, the authors conclude:


<blockquote class=bqfancy>Wikipedia has a more narrow scope, is less complete, and has more errors of omission than the comparator database.   Wikipedia may be a useful point of engagement for consumers, but is not authoritative and should only be a supplemental source of drug information.</blockquote>


There are several other recent criticisms of the quality of Wikipedia&rsquo;s medical entries in other medical journals:


	&bull;	Proceed with caution: using Wikipedia as a reference.     Neonatal Netw.   2007 May-Jun;26(3):140-1.


	&bull;	Does WIKIPEDIA provide evidence-based health care information?   A content analysis.    Z Evid Fortbild Qual Gesundhwes.   2008;102(7):441-8.    The authors conclude that &ldquo;the quality of the healthcare information provided by Wikipedia...do not meet important criteria of evidence-based patient and consumer information.&rdquo;


	&bull;	Wikipedia comes second.    Br Dent J.   2008 Nov 22;205(10):525.


Once again, as long as Wikipedia articles are near or at the top of google searches, this is a serious issue.    I still wonder why Wikipedia&rsquo;s attorneys haven&rsquo;t stepped in.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Denialism and pseudoscience</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Healthcare Policy</category><dc:date>2009-04-21T14:18:36-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/denialism_and_pseudoscience.php#unique-entry-id-35</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/denialism_and_pseudoscience.php#unique-entry-id-35</guid><content:encoded><![CDATA[Today, I commented to a blog entry at Beyond the Short Coat, which is one of my daily stops on the medical blogosphere.    The author, like a lot of bloggers in the medical arena, has been taking on the world of medical woo, that is, those ideas in medicine that completely lack verifiability and scientific credibility.    I have a similar disdain for woo, for essentially the same reasons as the physicians who write in those various blogs.    Mostly, they are troubled that patients turn to these useless therapies because they may not be getting adequate medical care, or even that those fake therapies may have terrible consequences for the patient.    I take it a step further in that I believe that this woo has a substantial economic consequence with increased costs for patients, providers, and third-party payors.


There are several hallmarks that indicate to most educated individuals as to what is or is not pseudoscience.    Let's list them and see how the anti-vaccine movement does:


	1	Use of vague, exaggerated or untestable claims.  ...  They make vague scientific claims, failure to make use of parsimony (see Occam's razor), that is to find the explanation for autism that requires the fewest assumptions, lack of boundary definitions, meaning the areas where vaccines might not have an effect on autism, and, finally, lack of effective controls, such as placebo and double-blind, in experimental design.    


	2	Over-reliance on confirmation rather than refutation.  ...  In other words, the anti-vaccine woo-meisters fail to accept the possibility that experiments or observations may show their theory to be false.   Most scientists make no such absolutist claims.    In fact, many researchers will state, that there might be a possibility that vaccinations cause autism, but they can find a mechanism for it to happen and they haven't seen any results that support such a theory.    Scientists are completely open minded to any result, whereas the anti-vaccine league of undistinguished playboy playmates are completely closeminded to logic.


	3	Over-reliance on testimonial, anecdotal evidence or personal experience. 

...	4	Lack of openness to testing by other experts.  ...  Evasion of peer reviewed publications and use of popular press is precisely the lack of openness that prevents discussion.    Jenny McCarthy and company complain that science is hiding the truth.    Nothing could be further from the truth.    Scientists, despite the lack of a scientific foundation in the vaccine causes autism hypothesis, spent years trying to test the theory.    They found nothing that supports the link.


...Check (note that very little research has actually been done, most of it is nonscientific refutation of clinical studies).  ...  As new results appear, science develops new theories that may modify or even replace the old one.    When I was working on my graduate degree in Biochemistry, we did not know what caused AIDS.    Every biochemistry lab in the world was trying to figure it out.    There were a whole slew of theories on what caused it (some of them were laughable), but now we know that HIV infection causes AIDS.    That's how science works.


...Those vaccine denialists resort to name calling (we are all bought out by Big Pharma), appeal to authority or whatever other appeal that's handy, and, of course, conspiracies.   Better than I can do, a point by point refutation of the specious attacks can be found here.


...Denialists of all sorts use scientific jargon to make superficial claims that the theory is scientifically sound.    Like a couple of denialist comments here, there is a constant use of fancy terminology that makes no sense when read.


I can do the same thing for such failed therapies as Orthomolecular medicine, homeopathy, and radionics.    It&rsquo;s not that science has the answer to every question.  ...  But when a questioned is asked of science, it either agrees, disagrees, or says that more information is needed.    It does not place a value on the answer. 


The problem is that pseudoscience pushing individuals are loud, so an unbiased public gives equal weight to the comments of pseudoscience and real science.    The public needs to reduce the weight given to medical woo, until they bring forward evidence with scientific strength.  


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Who&#x27;s a skeptic?</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><dc:date>2009-04-18T18:42:42-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/who_is_a_skeptic.php#unique-entry-id-33</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/who_is_a_skeptic.php#unique-entry-id-33</guid><content:encoded><![CDATA[I don&rsquo;t know what happened, but several people I know have accused me of being a skeptic.   What is a skeptic?    Is that like a psychic?    Maybe I got the label because I would roll my eyes and laugh when someone would say, &ldquo;take these zinc/vitamin C/echinacea tablets to cure your cold.&rdquo;    That statement is usually followed up by, &ldquo;my mother&rsquo;s friend&rsquo;s sister-in-law&rsquo;s cousin never gets colds after taking these pills.&rdquo;


It might be mildly humorous to a wide range of &ldquo;skeptics&rdquo; whose blogs I read, but I just don&rsquo;t like the term.    I&rsquo;m actually not skeptical of homeopathic ultra-diluted solutions, I just accept that there is absolutely no science that supports the idea that 0 molecules of a substance (yes, homeopathic potions are nothing but water) has any effect on anything.    It&rsquo;s the pseudoscience types that are skeptical of science, but somewhere the term has morphed into a pejorative term that almost says, &ldquo;you science types are skeptical because you aren&rsquo;t open-minded.&rdquo;


Actually, almost every scientist I know is quite open-minded, because it&rsquo;s impossible to be a scientist without being able to explore the natural world by seeing infinite possibilities.  


I guess all I can be is a lonely voice that thinks being labeled a skeptic smacks of a pejorative eptithet.    I&rsquo;m going to stay out here on the edge claiming it&rsquo;s not I who is a skeptic, but the pseudoscience crowd.    This is probably a lost cause.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>First iPhone application for medicine</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>iPhone</category><category>Medical devices</category><category>Medical products</category><dc:date>2009-04-16T07:29:01-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/first_iphone_app_for_medicine.php#unique-entry-id-32</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/first_iphone_app_for_medicine.php#unique-entry-id-32</guid><content:encoded><![CDATA[I receive a lot of announcements of new medical products through various trade journals and email alerts.    I read most of them, just to see what&rsquo;s coming out of product pipelines of various medical products companies.    Since I&rsquo;m more of a technology person, I enjoy innovative devices that fill a need in the market.    As I&rsquo;ve said before, I think it&rsquo;s critical that medical device and equipment companies bring products to the market that improve user ergonomics, reduce errors, and are easy-to-use.


So, I was pleasantly surprised to read a press release from AirStrip Technologies announcing a new mobile medical application for the iPhone.    At first blush, it appears to be just a new iPhone application, but a further review of the technology and the product itself, makes it appear to be a fascinating product.    AirStrip Technologies develops and markets software solutions that allow information to be transferred wirelessly to PDA devices, like the iPhone.    The iPhone app just cleared by the FDA, allows the user to remotely and securely access real-time and historical waveform and numeric data via a wireless internet connection through the AirStrip OB&trade; software, which sits on the hospital or clinic&rsquo;s server.    It allows the iPhone user to receive data from several hospitals, so the obstetrician with several patients in different hospitals can real-time data on each of these patients.


Because the software client is on the iPhone, which has certain software design features that make it highly intuitive, the physician can easily receive and read data that they need.    I want to contain my excitement about this product, but it&rsquo;s difficult since I am convinced that software solutions to patient data transmission is critical to improved healthcare and reducing costs.    And as an avowed capitalist, a market opportunity being serviced by a company like AirStrip Technologies is also quite intriguing.


Now, I wonder if some of the $19 billion available for the healthcare providers to upgrade their IT can be spent on this technology?


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>The cost of medical woo</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Pharmaceuticals</category><category>Quackery</category><category>Vaccines</category><category>Evidence based medicine</category><dc:date>2009-04-15T22:45:46-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/Costs_of_medical_woo.php#unique-entry-id-31</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/Costs_of_medical_woo.php#unique-entry-id-31</guid><content:encoded><![CDATA[My blog entries wander between three broad topics: medical woo (pseudoscience, science denialism, vaccine denialism, and alternative medicine), market opportunities for medical products and healthcare policy.   And one discussion about my beloved Syracuse Orange.    My three broad interests in the medical arena are interrelated in such a fashion that medical companies (both pharmaceutical and medical devices) need to prepare strategic plans that maximize their success despite some difficult market forces.


First, let&rsquo;s talk about the whole area of medical woo.    The anti-vaccine movement (which I will continue to label as vaccine denialism), if it continues to gain traction in social consciousness, will require more investment in studies that continue to confirm that there is no link between vaccines and autism (OK, yes the proper scientific method would force me to say that there is a possibility that a link could be found, but after 100&rsquo;s of clinical papers, I&rsquo;m firmly on the side that this issue has been decided).    If this movement becomes problematic, we might be dealing with infectious disease epidemics unseen in a generation.    Can hospitals and clinics deal with these diseases?    How large are the infectious disease wards in hospitals?    How many infectious disease specialists are there?    And what kinds of medical products will need to be available to treat these diseases?


It&rsquo;s hard to predict how much effect the vaccine denialists are having on the vaccination rate.   The herd immunity level, that is, the minimum rate of vaccination in a population that will probably provide protection to the unvaccinated minority, runs between 75 and 95%, depending on the disease.    If the vaccination rate falls significantly below those levels, which means the Jenny McCarthy crowd does not have to convince a majority of individuals to quit vaccinating their children, just a significant minority.    The most recent data from 2007 seems to indicate that the rate is above the 75% level, but just barely.    There is also some large variation between states, which might be a cause for concern.  


In the one case of woo, vaccine denialism, any further public relation successes by the anti-vaccine group, however small, might push the USA&rsquo;s rate of vaccination below the herd immunity level, leading to a large increase in childhood diseases.    This situation will stress medical services, push up spending in healthcare, and harm healthcare policy to such a point that any reasonable fix to the system will be difficult, if not impossible, to implement.


See, it&rsquo;s all related.    Even other types of medical woo, such as naturopathy, practitioners of which are trying to become primary care physicians (PCP&rsquo;s) with respect to managed care, can lead to cost increases in healthcare coverage.    Since naturopathy lacks the diagnostic capabilities of evidence-based medicine, and places reliance on &ldquo;homeopathic potions&rdquo; for treatment, all of which may result in a delay in real medical treatments, patients will either become more seriously ill or miss treatments that may reduce long-term medical issues.    These delays lead to increased costs.


The medical industry, to be successful, has to be a part of evidence based medicine.    Right now it is.    Well, there is that annoying Big Pharm commercial that pushes an over-50 vitamin pill containing gingko.    It&rsquo;s supposed to help memory.    Except for the tiny issue that gingko has no effect on cognitive impairment.  


By Michael W Simpson


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<a href="http://blogs.icerocket.com/tag/pharmaceuticals" rel="tag">pharmaceuticals</a>]]></content:encoded></item><item><title>Healthcare IT growth potential</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Healthcare Policy</category><category>Obama</category><category>Medical products</category><category>Politics</category><dc:date>2009-04-13T07:09:04-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/healthcare_IT_growth_potential.php#unique-entry-id-30</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/healthcare_IT_growth_potential.php#unique-entry-id-30</guid><content:encoded><![CDATA[Today, Kim Hart at the Washington Post wrote an interesting column about one of the positive effects of the recently passed American Recovery and Reinvestment Act of 2009 (stimulus package) for the health care industry.    Approximately $19 billion of the package is specifically targeted for health information technology (HIT) upgrades for providers such as hospitals, clinics, and individual physician practices.    As discussed previously, improved HIT is a cornerstone of a long-term plan to improve the quality and decrease the costs of health care in the US.


Investment in HIT should have some positive consequences to the healthcare industry:


	&bull;	Improve health care quality


...	&bull;	Reduce health care costs


...	&bull;	Expand access to affordable care


Much of the investment will be targeted to digitize health records, which will require interoperable software and hardware, along with fast data networks.    Some of the benefits of such systems would be early detection of infection, improved management of chronic diseases, and better analysis of the price and quality of procedures.    These benefits can lead to reduction in costs of healthcare.


There is clearly a vast market opportunity here for companies that can provide the right software and hardware solutions for the physician office or clinics.    A recent article that analyzed HIT in the physician&rsquo;s office provided some interesting information:


	&bull;	As of 2008, only 14.5% of physicians offices had fully converted to electronic health records (EHR).    Another 14.7% had partially converted to ERH.


	&bull;	Many offices that had not converted to EHR were concerned about issues such as privacy, security, costs, limited benefits, intrusion into the clinician-patient relationships, and lack of knowledge.


	&bull;	100% of offices had adopted software to manage billing and coding, although few were linked to an EHR system.


	&bull;	Adoption of key technologies, such as wireless data streaming from medical equipment to records, to implement an EHR system was small.


	&bull;	Solo and small practices had much lower adoption of ERH than larger practices.


With the $19 billion to be invested in acquisition of these technologies, software and hardware companies that provide the right solutions for medical office can profit handsomely in the upcoming years.    There are several key growth opportunities in this market:


	&bull;	Software for billing and coding.    Products that can link to both third-party payors and to the EHR can benefit the physician&rsquo;s office by both increasing accuracy and cash flow.    There can be added benefit of higher productivity for the office staff, but training and other issues may make it a higher investment at first.


...Most physician&rsquo;s offices contain medical equipment ranging from scales to EKG to blood pressure, and transferring data from them to the ERH will improve the accuracy of patient records (which will lead to better patient management).    In fact, having easier data transfer will reduce intrusion into the patient/physician relationship, so that the clinician can spend more time with their patients in conversation rather than entering data.


	&bull;	ERH software.    Obviously, an easy-to-use and manage system is critical for this whole system to succeed.


To get these products into the physician&rsquo;s or clinic offices is going to be challenging.    Any marketing effort by resellers, consultants, or companies is going to take knowledge of physician&rsquo;s needs and time.    If one goes in with the attitude of &ldquo;I&rsquo;ve got a better mousetrap, and they&rsquo;ll beat a pathway to my door&rdquo; is going to fail spectacularly.    Marketing of pharmaceutical products and medical devices has been refined over the past 40 years (give or take a few years), and a lot of this knowledge will need to be transferred to the software and hardware industry.


A lot of companies, such as Welch-Allyn has made a lot of investment into hardware and software that links into EHR systems.    However, they aren&rsquo;t developing the actual software for ERH and billing.


The successful EHR and billing software idea needs to link to several different technologies, overcome resistance in medical community, and build a strong marketing effort.    There&rsquo;s a huge opportunity here, but the software companies need to look to how the big medical products companies have been successful to understand what it will take to get the right products to be adopted by the physician customer.    Anyone who thinks it&rsquo;s going to be easy is the one that will fail.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Scientific medicine and Big Pharma</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical devices</category><category>Pharmaceuticals</category><category>Pseudoscience</category><category>Healthcare Policy</category><category>Evidence based medicine</category><category>Medical products</category><dc:date>2009-04-08T08:42:06-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/scientific_medicine_and_big_pharma.php#unique-entry-id-29</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/scientific_medicine_and_big_pharma.php#unique-entry-id-29</guid><content:encoded><![CDATA[I keep reading across the blogosphere that Big Pharma (for the sake of this discussion, defined as all medical products companies, including ones that don&rsquo;t manufacture or market pharmaceuticals) somehow blocks either positive or negative results to further their profits.    The accusations come from a wide variety of sources, some of the more vocal being the anti-science proponents, such as the anti-vaccination movement.   Utilizing an ad hominem argument of personalizing the issues and then attacking the motives or character of others, usually those who dispute the claims made by pseudoscience.


Even during the recent Larry King interview, Jenny McCarthy and her fellow Google University graduate, Jim Carrey, make wild accusations about the ethics of the pharmaceutical industry:


<blockquote>KING: Drug companies want to keep this (allowing vaccines to stay on the market) going?...  Vaccines are the largest growing division of the pharmaceutical industry. $13 billion.<br>   MCCARTHY: They control medical schools.   I mean these doctors are not learning about prevention or vitamins or diet.<br>   CARREY: What we're asking is for them to take a loss for the good of our children.   That's a tough sell in a board room.</blockquote>


The implication from this conversation is that somehow the profit motive of medical products corporations supersedes ethical and scientific considerations.    Instead of providing evidence that there is some kind of link between autism and vaccines, they instead accuse the medical industry of some nefarious conspiracy to keep information from the public, thereby harming children.


Setting aside the blatant falsehoods that drug companies control medical schools (I think that medical schools allow too much pseudoscientific woo in their teaching as it is) or that physicians aren&rsquo;t taught miracle prevention techniques to keep children from being infected by polio or whooping cough, why would medical products companies act unethically?    Are we to assume that only sociopaths find careers in the pharmaceutical industry?


Most of the research into the links between autism and vaccines, for example, has been done in respectable research institutions, who base their reputations on being independent from corporate pressure.    In a review of all literature that investigated the possible link, the Cochrane Reviews, one of the most respected reviewers of clinical research, has concluded that:


...	1	There is no credible link between the MMR vaccine and any long-term disability,including Crohn&rsquo;s disease and autism.


	2	MMR is an important vaccine that has prevented diseases that still carry a heavy burden of death and complications where the vaccine is not used consistently.


	3	The lack of confidence in MMR has caused great damage to public health.


	4	People arguing for or against the use of any therapy need to make sure that they base their conclusions on carefully collected evidence, not just on biased opinion, speculation or suspicion.


...That&rsquo;s a scientific review by an independent group, and it&rsquo;s not a tool of Big Pharma.    But more importantly, I am personally offended that some individuals can make such a broad and libelous accusation against this industry.    The industry is staffed by scientists, physicians, and engineers who use the scientific method to develop new products that prolong human life.  ...  Probably not, but in general, they are highly ethical.    There are just too many controls on the industry, from litigation to regulatory agencies.    Of course, the ethical standards of much of the industry is incredibly high, as opposed to the suspect ethics of the anti-vaccination movement.    Before any product comes to market, there are years of pre-clinical and clinical research performed before it can even be reviewed by regulatory bodies.    And after the product is on the market, there are constant post-market studies to rule out possible issues.


Then there are the physicians who prescribe the products.    It is true that some accept the statements of Big Pharma without a serious critique, but most want to do what&rsquo;s best for their patient.    My guess is that the physician&rsquo;s training tells them that the prevention of serious diseases with vaccinations far outweighs the risks.    And I&rsquo;m not considering the autism link a risk, since it doesn&rsquo;t appear to exist.


I once helped manage an important clinical trial in interventional cardiology.    If it worked, there would have been a significant revenue stream for the organization.    It didn&rsquo;t, and it was published as such.  


The anti-science, woo-pushing crowd should bring scientific evidence, not appeals to emotion.    Since there is no scientific evidence, then we can continue to expect these silly arguments and false accusations about the ethics of the pharmaceutical industry.


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<a href="http://blogs.icerocket.com/tag/pharmaceuticals" rel="tag">pharmaceuticals</a>]]></content:encoded></item><item><title>Jenny says....</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Vaccines</category><category>Pharmaceuticals</category><category>Pseudoscience</category><category>Quackery</category><dc:date>2009-04-07T08:22:21-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/jenny_says.php#unique-entry-id-28</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/jenny_says.php#unique-entry-id-28</guid><content:encoded><![CDATA[If you read my blog, you know I don&rsquo;t have much respect for the anti-vaccination movement, and I have contempt for Jenny McCarthy, JB Handley, Andrew Wakefield, Generation Rescue and others for the damage they have done to health care.   One of my favorite blogs to read is Science Based Medicine, which has several physicians editors (and guest editors) who discuss medicine from a scientific perspective.    I share their point-of-view on medicine, and since my background is from the industry perspective, I cannot obviate the need for good scientific reasoning for product development.   In Welcome back, my friends, to the show that never ends: The Jenny and Jim antivaccine propaganda tour has begun, David Gorski, MD, tears apart, in about as civil a manner as he can, Jenny&rsquo;s recent interview.


First, let&rsquo;s watch the interview.


<script src="http://i.cdn.turner.com/cnn/.element/js/2.0/video/evp/module.js?  loc=dom&vid=/video/us/2009/04/04/lkl.jim.jenny.autism.pt1.cnn" type="text/javascript"></script><noscript>Embedded video from <a href="http://www.cnn.com/video">CNN Video</a></noscript>


Read Gorski&rsquo;s comments, he does a fine enough job in countering the fallacies presented by Jenny.    There&rsquo;s not much for me to add.   Simply put, Jenny has studied at the University of Google, in which any quack or person with an agenda, can put information that ends up with a high google rank.    It is not science and it is not ethical to continue to this anti-vaccination movement.    Why is anyone listening to this former Playboy playmate?


The problem is that we (you know, scientists, rational parents, Big Pharma) is always playing catch-up.    It&rsquo;s a public relations problem in some sense.    The attractive Jenny McCarthy starts a sad, very uninformed discourse on the evil of vaccinations.    We (the bad guys) can only counter with science.    And intelligence.    And rational comments.    I don&rsquo;t have a picture of David Gorski, so he may well be photogenic, but Jenny just wins the day based on something that has nothing to do with good medicine.    And in the world of public relations, the battle for the minds of the audience, propaganda starts the debate, and medicine needs to discuss the issues defensively.  


I guess if we could predict the future (pseudoscience), we might have predicted this would happen, and we could have taken leadership in the debate.   In 1995, no one was studying autism and vaccines, because there is no link between the two.   Then Wakefield's lies became public, and it's been catch up for medical science  ever since.   So, if only we could go back in time, one of us would have published an article on how safe vaccines are, wrote a book about the all of the cute children growing up without measles, mumps, rubella, polio (you get the point), and how they were doing so well in school.   Being a PR ploy exclusively, we find a beautiful actress who's child received all of the vaccines, and had her promote her new book: Vaccines and how they allowed my children to grow up.    I guess we all sat around in the early 90&rsquo;s thinking, &ldquo;let&rsquo;s cure cardiovascular disease.&rdquo;    Well, I was.


We lost the first rounds of the propaganda wars.    But none of us lack courage and determination, so we&rsquo;ll keep at it.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>The anti-Jenny blogosphere</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pseudoscience</category><category>Pharmaceuticals</category><category>Vaccines</category><dc:date>2009-04-02T15:17:34-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/the_anti_jenny_blogosphere.php#unique-entry-id-26</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/the_anti_jenny_blogosphere.php#unique-entry-id-26</guid><content:encoded><![CDATA[Medical and science blogs are aghast at Jenny McCarthy&rsquo;s comments that I reviewed earlier today.    Let me list some of the more choice comments.


Orac at Respectful Insolence says:


<blockquote class=bqfancy>In Jenny's warped world, your children are acceptable collateral damage in the cause of promoting her unscientific belief that vaccines cause autism.   Here's a hint for you, Jenny: We already do have vaccines that are safe, and neither you (nor the antivaccine loons) are changing.   The government and pharmaceutical companies are listening to you far more than your idiotic pseudoscientific nonsense deserves and even though you are a scientific illiterate.   Scientists are wasting millions of dollars studying over and over again the question of whether vaccines are associated with autism and keep finding the same answer: They aren't.</blockquote>


Dr.   David Gorski at Science Based Medicine states:


<blockquote class=bqfancy>Here&rsquo;s a hint for you, Jenny: We already do have vaccines that are safe.   The government is listening to you and your fellow antivaccine activists far more than your pseudoscientific nonsense deserves and even though you are a scientific illiterate.   They do it because you and your fellow antivaccine activists whose public face you have become are endangering public health on the basis of no good science, and they are trying to prevent that.   Indeed, scientists continue to waste millions of dollars studying over and over again the question of whether vaccines are associated with autism and keep finding the same answer: They aren&rsquo;t.</blockquote>


Beyond the Short Coat opines:


<blockquote class=bqfancy>The scientific case for &ldquo;Vaccines cause autism&rdquo; is just slightly better than the scientific case for &ldquo;The earth is flat&rdquo;.</blockquote>


I could go on, but I&rsquo;m trying to not be too snarky.    It&rsquo;s very difficult.


By Michael W Simpson


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]]></content:encoded></item><item><title>Jenny McCarthy again&#x21;</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Vaccines</category><category>Pharmaceuticals</category><category>Pseudoscience</category><dc:date>2009-04-02T12:35:26-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/jenny_mccarthy_again.php#unique-entry-id-25</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/jenny_mccarthy_again.php#unique-entry-id-25</guid><content:encoded><![CDATA[Why is anyone listening to Jenny McCarthy?    She just published a new books continuing her unscientific and unsupported rants about how vaccines cause autism.    As of today, there are still no links between the two, but because she was a Playboy Playmate of the Year, she has a soapbox to promote her views.  


Yesterday, Jenny talked to Time Magazine about her views on vaccines.    One answer in particular confirms to me how harmful she is to children:


<blockquote class=bqfancy>Your collaborator recommends that parents accept only the haemophilus influenzae type B (HIB) and tetanus vaccine for newborns and then think about the rest.   Not polio?   What about the polio clusters in unvaccinated communities like the Amish in the U.S.?   What about the 2004 outbreak that swept across Africa and Southeast Asia after a single province in northern Nigeria banned vaccines?


I do believe sadly it's going to take some diseases coming back to realize that we need to change and develop vaccines that are safe.   If the vaccine companies are not listening to us, it's their f___ing fault that the diseases are coming back.   They're making a product that's s___.   If you give us a safe vaccine, we'll use it.   It shouldn't be polio versus autism.</blockquote>


First, polio vaccine does not cause autism.    Second, even if there was the slightest deleterious effect from these vaccines, the complications of contracting polio itself is so huge, that the risk benefit ratio skews to the benefit side so much, that it&rsquo;s impossible to see the risk.


As I&rsquo;ve said before, this is a tragedy.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Point-of-care diagnostic&#x2013;market opportunity</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical products</category><category>Pharmaceuticals</category><dc:date>2009-04-01T10:11:22-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/POC_diagnostic_market_opportunity.php#unique-entry-id-24</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/POC_diagnostic_market_opportunity.php#unique-entry-id-24</guid><content:encoded><![CDATA[Over the past year, I&rsquo;ve been observing the growth of a class of medical products called point-of-care diagnostic testing.   These tests are easy to use, are accurate, and provide rapid results for the patient and clinician.   Some are intended for home use, but the market growth is in the physician office, hospitals (especially the point of entry such as emergency departments), managed care, and other clinical areas.    Several companies are in the market, including Quidel, Inverness Medical Innovations, OraSure, and Bayer.    The diagnostic tests, manufactured and marketed by these companies (and several others, too numerous to mention), are used mainly for drug abuse screening, cholesterol levels, infectious diseases (including HIV), urine chemistry, blood glucose, hemoglobin A1C, prothrombin time, cancer screening, fecal occult blood, pregnancy, and other areas of clinical diagnostics.   The tests can provide results in a manner of minutes, rather than sending the patient to a laboratory to await results hours or days later.


To be used in a physician&rsquo;s office, these tests need to be waived by the US Department of Health and Human Services Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA).    To be waived, the test needs to meet three criteria:


	1	Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible


	2	Pose no reasonable risk of harm to the patient if the test is performed incorrectly


	3	Are cleared by the Food and Drug Administration for home use


As of now, there are over 110 analytes that have been approved for home use by the FDA and are CLIA-waived.    To use these tests in a clinical setting, a Certificate of Waiver is necessary.    The regulatory requirements are clearly less stringent than those for laboratories performing moderate or high complexity.


It is clear that these products have a number of features and benefits to the clinical market:


	&bull;	Alternate-site (non-hospital).    There are two major benefits of this type of testing for this market:  first, improved patient care by providing results faster and before the patient leaves the office.    For example, a rapid strep test can provide results immediately, allowing the clinician to write a prescription for some type of antibiotic immediately, saving the patient time and worry.    Secondly, for many of the CLIA-waived tests, the physician can apply for reimbursement directly from the third-party payor.    This payment can be an additional source of income for the physician&rsquo;s office.


	&bull;	Hospital.    Similarly, the rapid nature of obtaining results from these type of tests can have a strong benefit at the point of entry into a hospital, usually an emergency department.    Many of these tests are already part of the armamentarium of diagnostic tests available in this area of the hospital.


	&bull;	Managed care.    As the third-party payors attempt to manage long-term costs of their patients, one area that is a potentially large market opportunity for point of care diagnostics is providing the ability to cost-effectively screen large number of patients to identify diseases early.    For example, hemoglobin A1C testing can be used to screen for early signs of Type II diabetes.    With that information, the managed care organization can proactively treat the patient, possibly reducing risks of cardiovascular disease.


From a qualitative and quantitative perspective, I believe that point-of-care testing can be a critical foundation for lowering health-care costs in the US.    Insulin resistance pathophysiology in Type II diabetes is becoming an epidemic in the US, and early screening can help prevent difficult to manage and potentially costly complications.    Rapid testing for infectious diseases such as flu, hepatitis C, HIV, and others will be useful to managing care appropriately at a lower cost.    The short-term cost may be high if we employ this type of testing at the primary care level, but the long-term savings can be large&ndash;isn&rsquo;t that the goal of Obama&rsquo;s healthcare plan?


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>The anti-vaccination tragedy</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Vaccines</category><category>Healthcare Policy</category><category>Pseudoscience</category><category>Pharmaceuticals</category><category>Evidence based medicine</category><dc:date>2009-03-31T10:07:08-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/the_anti_vaccination_tragedy.php#unique-entry-id-23</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/the_anti_vaccination_tragedy.php#unique-entry-id-23</guid><content:encoded><![CDATA[I have written about the anti-vaccination movement several times recently, yet every day, I read another article or another comment somewhere that reminds me of this situation.    Today, I came across a recently published article in The Lancet, one of the most respected peer-reviewed medical journals, which reinforced one of the consequences of the anti-vaccination movement.    The article, Measles in Europe: an epidemiological assessment, states that there were 12,232 cases of measles in Europe during 2006 and 2007.    Most cases were unvaccinated or improperly vaccinated children.  


Since we appear to have lost the collective memory of the consequences of measles, let&rsquo;s review the complications of this disease:


	1	Otitis media (ear infection) occurs in 7&ndash;9% of cases


	2	Otosclerosis, an abnormal growth of bones of the middle ear which leads to deafness, is nearly eliminated by prevention of measles through vaccination.


	3	Encephalitis, a serious viral inflammation of the brain, develops in approximately one in 1,000 measles cases.


	4	Pneumonia is a complication in 1-6% of measles cases.


	5	Diarrhea arises in 8% of cases.


	6	Death occurs in 1 in 5000 cases of measles.


Measles simply should be eradicated in the developed world.    Sadly, because relatively intelligent and well-educated individuals are making bad choices, based on bad science, for their children, childhood disease will increase.    Who are they going to blame when their children contract measles, mumps or any other childhood disease, and there are complications?    Maybe themselves?


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Vaccines&#x2c; once again and a bit irreverent</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Vaccines</category><category>Healthcare Policy</category><category>Pseudoscience</category><category>Pharmaceuticals</category><dc:date>2009-03-30T22:55:37-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/vaccines_once_again_and_irreverent.php#unique-entry-id-22</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/vaccines_once_again_and_irreverent.php#unique-entry-id-22</guid><content:encoded><![CDATA[As I&rsquo;ve discussed previously, I find the anti-vaccine movement, linking cases of autism to pediatric vaccinations, to be based on pseudoscientific principles.    There are several individuals that have pushed this quackery, but one of the more visible is Jenny McCarthy, ex-Playboy Playmate of the Year (no, I&rsquo;m not going to link to it), bad actress, and failed game-show host.    I am flabbergasted that anyone would listen to this woman, a scientific illiterate, about anything outside of how to model and possibly how to choose bad movies.    That parents are making decisions about vaccinating their children based on her bogus beliefs is beyond my simple understanding of the world.


There are always consequences to every action, and there are many by delaying or refusing vaccinations.    The Jenny McCarthy Body Count is a website that lists every vaccine-preventable case and death that has occurred since Jenny made public her belief that vaccines caused autism in her son (which many believe is a misdiagnosis) in June 2007.    Since then, there have been 720 preventable cases and 142 preventable deaths (as of today).    As the website says, she&rsquo;s not responsible for everyone one of these cases or deaths.    But if she convinces just one person to not adhere to a vaccine schedule for their children, then it&rsquo;s one too many.


This body count, and Jenny McCarthy&rsquo;s involvement, would be funny in any other context.    Children contracting diseases that can be easily prevented, with few or any side effects, is irresponsible and abusive.    An 18 month old child cannot decide whether they receive a vaccination or not, so we must rely upon well-informed parents to make certain it happens.    The anti-vaccine movement, based on junk science, causes harm.  


Time to return to your movies Jenny.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Strength of the medical products industry</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Medical devices</category><category>Medical products</category><category>Politics</category><dc:date>2009-03-30T09:11:10-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/strength_of_the_medical_products_industry.php#unique-entry-id-21</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/strength_of_the_medical_products_industry.php#unique-entry-id-21</guid><content:encoded><![CDATA[There continues to be quite a bit of anecdotal data that the medical products industry, including medical device, biotechnology, and pharmaceutical sectors of the industry, is healthy and employment is running counter to the recession.    I do not have definitive evidence why hiring is strong in this industry, but the assumption must be that most medical products companies are flush with cash, have products ready for launch in the next year, or are building staff in advance of an upswing in the economy.    It could be all of the above.    As discussed previously, the medical products industry is currently undervalued, especially if the predicted decrease in unemployment and improvement in the economy occurs late in 2010.


A spot check of employment opportunities at a few medical products companies indicates that there is strong reason for optimism:


	&bull;	Amgen has nearly 50 sales positions available nationwide.    This is a strong indicator of future revenue growth at the company.


	&bull;	Medtronic has over 200 positions at various levels.


	&bull;	Boston Scientific has over 240 positions.


I could go on, but it wouldn&rsquo;t be practical.    The point is that there appears to be strength in the medical products segment of the economy.  


I&rsquo;m just trying to be optimistic.    We need that particular trait these days.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Politics and the FDA</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Obama</category><category>Healthcare Policy</category><dc:date>2009-03-26T10:50:56-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/politics_and_the_FDA.php#unique-entry-id-20</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/politics_and_the_FDA.php#unique-entry-id-20</guid><content:encoded><![CDATA[With the election of Barack Obama, many believe that there would be a change in healthcare policy, reversing some of the policies of his predecessor.    I had discussed some of the predicted changes several times recently.    Additionally, with the appointment of a new FDA Commissioner, Margaret A.   Hamburg, I was becoming confident that the FDA would become an advocate for consumers and industry, and that many of the more egregious political decisions that harmed the medical products industry would be overturned or modified.    It is clear that the change would be take time because of the many priorities in the new Obama administration, but decisions such as the executive order clearing the way for research using embryonic stem cells are moving medicine and science in a healthy direction.


I personally object to political considerations taking priority for science and medicine.    It&rsquo;s a waste of money, it places undue burdens on both the medical products industry and the agencies that regulate them, and it increases the amount of time to get products onto the market.    In addition, it allows foreign companies, whose regulatory agencies may not have these egregious political issues, to bring to market products that help their citizens.    In some cases, foreign subsidiaries of US companies provide newer products to residents of those countries than they do for US residents.


Plan B, an emergency contraception drug, composed of two (levonorgestrel, 0.75 mg) progestin-only tablets, was approved by the FDA in 1999 and is currently still the only emergency contraception drug approved.    Plan B is not RU-486 (mifepristone), also known as the abortion pill, since Plan B cannot terminate a pregnancy, just prevent it.   Additionally, Plan B does not require a prescription to obtain.    In August 2006, the FDA restricted sale of the drug to women 18 years or older.    Women 17 years or younger could only obtain the drug by prescription from a physician.    The intent of this labeling change was to restrict minors from easily obtaining the drug, although I am unconvinced as to ruling&rsquo;s effectiveness.  


This week, Judge Edward R Korman, a United States District Judge for the District of Eastern New York, ordered the FDA to allow 17 year olds to obtain Plan B in the same manner as other women.    Essentially, Judge Korman stated that the FDA restricted the availability of Plan B without any scientific or medical basis, probably as a result of pressure from the Bush administration.


Korman&rsquo;s ruling actually blasted the FDA on a number of points:


<blockquote class=bqfancy>The FDA considered the Citizen Petition in tandem with a number of proposals &ndash; referred to as supplemental new drug applications (&ldquo;SNDA&rdquo;) &ndash; submitted by Women&rsquo;s Capital Corporation, the drug&rsquo;s original manufacturer.   Women&rsquo;s Capital Corporation sold its right to market Plan B to Barr Pharmaceuticals, Inc. during the course of the proceedings described below.   I refer to them collectively as the &ldquo;Plan B sponsor.&rdquo;   The first SNDA, like the Citizen Petition, sought non-prescription access to Plan B for women of all ages.   After the FDA denied such access, the Plan B sponsor submitted a second SNDA, seeking non-prescription access for women 16 and older.   The FDA rejected that application too despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively.   The Plan B sponsor then submitted a third SNDA, which proposed making Plan B available without a prescription to women 17 and older.   While FDA scientists and senior officials found that 17 year olds could use Plan B safely without a prescription, the FDA Commissioner determined that, because of &ldquo;enforcement&rdquo; concerns, Plan B would be available without a prescription only to women 18 and older.   Putting aside for the moment the specifics of the many claims brought by plaintiffs and the details of each of the FDA&rsquo;s decisions, the gravamen of plaintiffs&rsquo; claims is that the FDA&rsquo;s decisions regarding Plan B &ndash; on the Citizen Petition and the SNDAs &ndash; were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.</blockquote>


In other words, the FDA took political expediency rather than sound medical and scientific review to change the availability of the drug.    The Judge then proceeded to attack the interference from politically appointed commissioners in the decision process:


<blockquote class=bqfancy>These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making.   Indeed, the record is clear that the FDA&rsquo;s course of conduct regarding Plan B departed in significant ways from the agency&rsquo;s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use, referred to as a &ldquo;switch application&rdquo; or an &ldquo;over-the-counter switch.&rdquo;   For example, FDA upper management, including the Commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter switch application; the FDA&rsquo;s denial of non-prescription access without age restriction went against the recommendation of a committee of experts it had empanelled to advise it on Plan B; and the Commissioner &ndash; at the behest of political actors &ndash; decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews.</blockquote>


Medical products should be available to citizens because they are safe and efficacious, not to set social policy.    I trust the NIH and the FDA on scientific matters.    It&rsquo;s important that science remains their focus.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Designing better medical products</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical devices</category><category>iPhone</category><category>Pharmaceuticals</category><category>Healthcare Policy</category><category>Medical products</category><dc:date>2009-03-22T11:35:51-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/designing_better_medical_devices.php#unique-entry-id-19</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/designing_better_medical_devices.php#unique-entry-id-19</guid><content:encoded><![CDATA[I am an early adopter of any new technology, not only because I like new gadgets, but because I always expect the newer technology will have improved quality, power, and ease-of-use.    Sometimes, I am quite pleased with the results, my iPhone from Apple being one of the better examples.  

...Without intending to be an uncritical fan of Apple (you can find those discussions in several other locations on the web), there are real reasons that the iPhone is simply the best cell phone on the market.    First, it holds a good sampling of my music collection, eliminating one other device to carry with me.    And that music is transferred to my iPhone by simply the most elegant piece of software I&rsquo;ve ever used:  iTunes.   I hear people tell me that they can get music on their phones, but it takes work.    I have no time to figure out arcane programming steps to get music on some other device.    The music simply gets onto my iPhone, I can access it.  

...Second, I have downloaded and installed onto my iPhone dozens of Apps, which are the programs for the iPhone.    I have games, access to sports scores real time, business news, stock prices, maps, movies, Kindle books (this is a whole story in itself), and an amazing program that listens to music and identifies it (and it&rsquo;s free).    Using iTunes, I can buy the apps (many are free, but you still have to &ldquo;purchase&rdquo; them) at the iTunes store, and upload them to my iPhone.  

...The iPhone is designed to be used easily and quickly, it is the perfect marriage of form and function.    It is not overly complex, yet it is useful beyond what can be expected of a cell phone.    It makes my life easier in a lot of ways, from allowing me to know when my Syracuse Orange are playing in the NCAA Tournament to quickly accessing information about a new medical product through a web browser that is no different than the one on your laptop computer. 


...About two years ago, Amy Tenderich, a San Francisco-based freelance writer who was diagnosed with Type I Diabetes in her late 30&rsquo;s, wrote an open letter to Steve Jobs, CEO of Apple, in her blog.    Basically, she was asking Apple to design medical equipment, specifically consumer blood glucose monitors.    In other words, if Apple can make a great iPod or iPhone, what about an iMonitor!


I once spent a few days testing out a few consumer blood glucose monitors for my own use.    I wanted to monitor my blood sugars during the day, especially after strenuous exercise.    If you haven&rsquo;t used one, I cannot even begin to explain the difficulty in using them.  ...  Not a lot, so most companies provide lancets that a spring loaded, so that the needle penetrates the skin to just a few millimeters.    There are a couple that are easy to use, but most require a bit of effort to put together.    I did not like most of them, and chose to use a fairly expensive, but well-designed BD Genie Lancet.    It uses a push button that quickly extends and retracts the needle into a protective housing.  


But the monitors themselves must have been designed by individuals who never once spoke to a user.    None of them are backlit, so they are impossible to read in low lighting.  ...  It was difficult to figure out how to save information for logging elsewhere.    Of course, it&rsquo;s asking way too much to find a way to transfer the information from the monitor to your computer for analysis.  


Moving on from blood glucose monitoring, most medical equipment just isn&rsquo;t designed to be simple yet accurate and informative.    Electronic blood pressure monitors can give variable results if not used properly, but the instructions for use can be complex, and the design does not provide ergonomic hints on proper use.    As the equipment&rsquo;s function becomes more complex, the requirement for proper design becomes higher, yet it almost appears as if engineers at medical products companies surrender to the trolls of complexity and make little effort to marry simple design with accurate results.


As the medical world moves to a paperless office, various medical equipment needs to work with one another, probably over a wireless network.    Welch-Allyn, a manufacturer of physician-office equipment, is one of the leaders in connectivity of various medical instruments.    Unfortunately, they don&rsquo;t make a blood glucose monitor.


...Strategically, they are probably not going to get into the medical products arena (they&rsquo;re making too much money from the iPod franchise, I suppose; the lack of marketing knowledge of medical products probably is another).   Last week, they announced the next version of the operating system, iPhone OS 3.0.   Exciting to iPhone users, but also to users of medical products, the new operating system supports accessories.  ...  In fact, Johnson & Johnson&rsquo;s LifeScan division was a part of the media blitz surrounding the new OS, by discussing a new blood glucose monitor that works with the iPhone.    In one program, the iPhone reads your blood glucose (still have to lance your finger to get that drop of blood) from the OneTouch Ping, tracks food intake and exercise, and makes estimates on insulin dosage.  

...Now Apple, if you have time, can you redesign...oh never mind.  
]]></content:encoded></item><item><title>Wikipedia&#x2013;bad medicine</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Healthcare Policy</category><category>Wikipedia</category><category>Pseudoscience</category><dc:date>2009-03-16T10:25:22-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/wikipedia_and_bad_medicine.php#unique-entry-id-17</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/wikipedia_and_bad_medicine.php#unique-entry-id-17</guid><content:encoded><![CDATA[I admit I go to the website many times a day to get more information on a topic of interest to me, sometimes just for entertainment, and occasionally to laugh at the quality of articles.  ...  Sometimes it appears that the project is more of an anarchy, but there are &ldquo;police&rdquo;, called administrators or admins, and several levels of bureaucracy above the police, to control the situation.  ...  They can block editors (kind of a punishment), and as best as I can tell, every single action by anyone is subject to a lot of yelling, screaming, whining, and complaining.  

...A Wikipedia article is almost always the #1 hit when a google search is done on a subject.    This might be useful if you are interested in episodes of 24 or need to know all about the Boston Red Sox.    In most cases, the quality of the articles are not a life and death issue.    If a Yankees fan chooses to vandalize (yes, that&rsquo;s the term used by Wikipedia cognoscenti to describe actions that aren&rsquo;t approved by the general Wikipedia community) the article, I am relatively certain that the world will not collapse into barbarism and a new Dark Age.  


Now, if Wikipedia just focused on useful, but not critical to human life articles, I would not be writing a  about it.    The issue, at least for me, is that Wikipedia is almost always the number one hit for just about any medical issue that I can imagine.  ...  Will there come a time that Wikipedia is sued for providing &ldquo;medical advice&rdquo; that causes a death?  

...However, analyzing articles for their level of quality is well within my background and skills, and I have examined more than a few of these articles.  

...The best medical article that I have read on Wikipedia is Alzheimer&rsquo;s disease.  ...  The article appears to be well written, but it suffers from a jarring style resulting from too many editors participating in the writing.    It is extremely well sourced, with over 220 citations (many of them current and from respectable peer-reviewed journals).    Wikipedia has tried to create a manual of style for medical articles called MEDMOS, which appears to be an admirable strategy for keeping these articles focused, and it works well with the Alzheimer&rsquo;s article.    Some of the verbiage is very technical and somewhat difficult to follow, almost written for a physician or researcher rather than the average reader.  ...  The worst part to me is the research directions section which gives a lot of information about clinical trials that may or may not be successful.    The article wanders too much from overly simplistic to overly technical, so I wonder about its usefulness to a general population.  ...  And if you are a physician interested in the evidence-based information about the disease, you can access the more technical information (for a fee, of course).    In other words, I&rsquo;m not appalled by the Wikipedia article, but I doubt that its very useful to the typical reader.  


...I admit to not reading every medical article on Wikipedia, but I have read many of them doing research.  ...  The articles are mediocre for broad information about a disease or medical procedure, and often times contain information that just isn&rsquo;t appropriate.    As an example, the hypertension article is the number one google search hit, but is poorly written and confusing.    For example, the causes section is written like a list, and really doesn&rsquo;t help the common reader.  ...  The treatment section, probably the reason why anyone goes to these articles, is of such poor quality that I consider it somewhat useless.    The graph that describes thresholds of drug therapy is outstanding, and can be followed up with a brief description of medications for each underlying pathology.  

...There are so many bad medical articles on Wikipedia, I&rsquo;m not sure where to start.    Acupuncture is a typical article which reads very balanced and neutral, yet makes a nonsense statement like, &ldquo;there is general agreement that acupuncture is safe when administered by well-trained practitioners using sterile needles, and that further research is appropriate.&rdquo;   Well, there is no scientific evidence whatsoever for the efficacy of acupuncture in every medical condition studied and published in peer-reviewed journals.    Part of the problem is that it&rsquo;s almost impossible to double blind the trial, since both the patient and the practitioner can&rsquo;t be fooled.    In the best controlled studies, patients actually believed they got better, with or without actual acupuncture&ndash;typical placebo effect.  ...  Urine therapy makes the implication that drinking one&rsquo;s urine is curative, based on the long history of doing so.    Or even the Alzheimer&rsquo;s disease article in its form over a year ago, where it states that ginkgo biloba as a promising treatment for the disease, when most studies say quite the opposite.    Of course, the ginkgo article itself, which is probably under the radar of most of Wikipedia&rsquo;s medical article is extremely dangerous since it does not clearly state the scientific position, that it does not work for dementia, instead allowing, through the Wikipedia anarchy, to allow contrary opinions.  

...I take the time to read the citations, and I determine the quality of those citations based on reading them, and based on the quality of the publication.  ...  It appears that there are devoted medical and science editors, who do everything they can to make the articles better.  

...Even though Wikipedia is the usually the first source most people will search for medical information, it is mediocre at best.    The quality varies so much that it makes it impossible to know whether an article is useful or not, unless one spends a lot of time reviewing citations.    At that point, you almost want to delve into editing it (which I have tried in a limited way).  

...Just to make sure you aren&rsquo;t confused by the Wikipedia article, acupuncture has no efficacy not because science is against it.  ]]></content:encoded></item><item><title>Syracuse Orange and 6 overtimes</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Syracuse University</category><category>University of Utah</category><dc:date>2009-03-14T23:42:30-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/syracuse_orange_and_6_overtimes.php#unique-entry-id-16</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/syracuse_orange_and_6_overtimes.php#unique-entry-id-16</guid><content:encoded><![CDATA[OK, I know that this blog is supposed to reserved for intellectual matters like healthcare, politics, Big Pharma, and other related subjects.    However, like most people, I have a diverse set of interests, some of it revolves around my two college alma maters, Syracuse University and the University of Utah.    I received my bachelor&rsquo;s degree from Utah, and have been a fan of the Utah Utes for a while, but it&rsquo;s always been the &lsquo;Cuse which has a prime place in my heart, as I went there to get my graduate degree in biochemistry.


This year, Utah beat Alabama handily in the 2009 Sugar Bowl, a rare event for a non-football power from the lesser-known (dare I say obscure) Mountain West Conference.    I am not a big fan of football, but I will admit watching every second of the game, and cheering on the Utes.


On Thursday night, I watched the Syracuse Orange (it used to be the Orangemen, but I guess that&rsquo;s now pass&eacute;) play the University of Connecticut (known to sports fans as the UConn Huskies) in the quarter finals of the Big East Tournament.    Typically, I will do work using my laptop, paying little attention to the game.   So for the first 38 minutes of the game (of course I mean game clock, as opposed to the actually two hours that had elapsed), I cleaned up a financial analysis, read a few of my favorite blogs, and barely noticed the score.     Then a friend who went to SU with me sent a text message saying &ldquo;great game.&rdquo;    I looked up, and barely touched my computer for....well, another two and a half hours.


What I watched was a six-overtime college basketball game that was variously described as the greatest non-tournament game ever, game for the ages, and a masterpiece.    Even the nation&rsquo;s financial paper, the Wall Street Journal, discussed the story, albeit from a statistical analysis, it was interesting nevertheless.    For me, it was probably the most exciting game I&rsquo;ve ever watched on TV.    That Syracuse won the game after six overtimes (and never leading in any overtime period until the last one) was a bonus.  


Syracuse ended up losing in the finals this past evening, but honestly, the 6 OT game held enough drama, excitement and exhilaration to last a long time.    As a fan of Syracuse, I am content.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>New FDA Commissioner</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Medical devices</category><category>Medical products</category><dc:date>2009-03-13T11:08:55-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/new_FDA_commissioner.php#unique-entry-id-15</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/new_FDA_commissioner.php#unique-entry-id-15</guid><content:encoded><![CDATA[On March 11, President Obama appointed Margaret A.   Hamburg, MD to be the new FDA Commissioner.    She has a substantial educational background including an MD degree from Harvard and training in neuropharmacology.    She has had long public service at the U.S.   Office of Disease Prevention and Health Promotion, the National Institute of Allergy and Infectious Diseases at NIH, where her work focused on AIDS research, and Health Commissioner for New York City.   President Clinton selected her in 1997 to be assistant secretary for policy and evaluation at the U.S.   Department of Health and Human Services.   Not only does she have a background in healthcare policy, medical research, and the bureaucracy that controls both, she has experience with industry, sitting on the Board of Directors of Henry Schein.


She might be the perfect choice between someone totally acceptable to industry and to consumer advocates, a narrow path tread by few.  


The FDA needs upgrading and leadership.    It&rsquo;s clear that both industry and consumers have lost some faith in the FDA, possibly because of a few drugs such as Merck&rsquo;s Vioxx, which has been withdrawn from the market.


From her background in public service, to her understanding of science, to her knowledge of the medical products industry, it&rsquo;s clear she&rsquo;s a good, if not perfect, choice to lead the FDA.    I&rsquo;m impressed so far, but I hope she can lead that cantankerous organization to have a vision for how to regulate medical products effectively.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Successful Marketing Management</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Healthcare Policy</category><category>Medical devices</category><category>Medical products</category><dc:date>2009-03-12T19:47:17-07:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/successful_marketing_management.php#unique-entry-id-14</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/successful_marketing_management.php#unique-entry-id-14</guid><content:encoded><![CDATA[I haven&rsquo;t done an entry in about a week, because I have been focused on a consulting assignment on pricing strategies in a couple of medical device segments.    Interestingly, it was for a large investment banking firm.    In this down-market, research into medical companies, because they are spending more time analyzing the fundamentals of these corporations.  


Part of my assignment was to give a one day training session on how manufactured products get to the market.    Trying to condense 20 years of knowledge in this industry down to a six hour Powerpoint presentation (yes, too long, but they didn&rsquo;t have 20 years to get up to speed) is challenging, but it was critical to their understanding of the medical products market.


I often relate a story about the medical products market whenever I am interviewing someone for a marketing position in this industry which helps define the almost every challenge for product marketing managers in this business.    There are over 50,000 medical products companies in the United States (probably more, but it&rsquo;s hard to obtain exact data).    If each one of those companies sent a sales representative into a physician&rsquo;s office, surgery center or hospital, there would be no time for patients.    Since the primary (but hardly exclusive) method for marketing a medical product is through the sales process&ndash;new product introductions are especially sales critical.


A system has evolved to make this system efficient, but makes pricing strategy and analysis difficult.    First, most products flow from the manufacturer to the health care customer through a distribution system.    For larger customers, such as hospitals, the market is dominated by Cardinal and Owens & Minor, and a few regional or super-regional distributors.    For smaller non-hospital customers, often described as alternate site, the market is dominated by PSS, McKesson, Henry Schein along with a fairly large number of smaller regional distributors.    The manufacturers sell their products, provide significant co-marketing assistance, and train distributor sales representatives.


The distributors set their own pricing to the customer.    Usually.    But control of pricing has mostly moved to Group Purchasing Organizations (GPO), such as Novation and Premier, who negotiate national contracts with manufacturers.    The customers who participate in the GPO&rsquo;s get lower prices for products.    The distributors have to sell at lower prices, but receive rebates from the manufacturers for every product sold to a GPO customer.    The distributor has some control over pricing, but only in a narrow band.


At the manufacturer level, pricing strategy has essentially become the negotiation of national contracts with GPO&rsquo;s.    For a smaller manufacturer, gaining or losing one of these contracts can have a significant effect on their revenues and EBITDA.    GPO&rsquo;s may sign contracts with several manufacturers for one type of product, which means that the market shares of each company in the segment does not change much.    Sometimes, GPO&rsquo;s sign exclusive contracts with one manufacturer (in the hope of receiving the lowest possible price for a product or product line), which can effectively lock out competitors for the length of the contract.


At the distributor level, pricing is often out of their control (except in alternate site accounts, with some exceptions), so it becomes a game of maximizing rebates to maximize gross margin.    ERP software solutions for medical distributors often include modules to manage rebates.


Of course, I just digested the whole pricing strategy of the medical products market into a few paragraphs, and it still shows how complex it is.    But most manufacturers in this market are doing well, but pricing strategy is paramount to success.    Marketing managers for these companies need to have skills beyond simply promotion and sales support, but more in maximizing pricing.    It becomes critical for the successful marketing manager to fine tune pricing to the customer segment.  


As a CEO of a medical products company once said to the marketing group, &ldquo;we don&rsquo;t pay you to lower prices.    We pay you to professionally raise prices.&rdquo;  


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>How to make a big profit in this recession</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Medical products</category><dc:date>2009-03-05T13:25:42-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/big_profit_in_this_recession.php#unique-entry-id-13</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/big_profit_in_this_recession.php#unique-entry-id-13</guid><content:encoded><![CDATA[You thought I was going to write a tome on how to make money in the medical industry.    Well, if you go to college, get an MBA, take a sales position in medical products, learn the ropes, move into middle management, introduce a few big products to the market, get promoted to VP-level, and work hard&ndash;if you do all of that, you can do well in this industry.


...Then, get a law degree and sue a drug or medical device manufacturer because a physician used the product exactly according to its label, which was approved by the FDA before it was released to the market.    No, seriously, the Supreme Court just ruled in Wyeth v.   Levine that you could do that.   (Since I&rsquo;m going to be discussing this ruling, and no one wants to read an 80 page legal document, the New York Times provides an analysis of it.)


Just to review, Diana Levine, who was suffering from migraines, visited a medical clinic in Vermont.    At first she was given injections of Demerol (pethidine) for pain and Phenergan (promethazine, Wyeth) for nausea.    Generally, Phenergan is administered by intramuscular (IM) injection or through an intravenous (IV) line, because if the drug is exposed to arterial blood, it can cause severe gangrene at the area of injection.    A physician assistant (PA) administered the drug by IV-push, directly into what the PA thought was vein, but was actually an artery.    Within weeks, Levine&rsquo;s hand and forearm became necrotic and were amputated in two stages.


...Levine eventually sued Wyeth in Vermont, arguing that first, Wyeth should have placed stronger warning language about the risks of delivering the drug into an artery, and second, that Wyeth should have known the dangers of IV push, and contraindicated Phenergan for that delivery method. ...  The Vermont Supreme Court affirmed the verdict, which usually would end the story.    However, Wyeth then appealed to the US Supreme Court stating that Federal Law, in this case the FDA approving the use of Phenergan with appropriate labeling, pre-empted Levine&rsquo;s claims in state court.    The Supreme Court affirmed the Vermont ruling by a 6-3 vote.


Essentially, the court ruled that state juries can award damages for the use of drugs that cause harm, even if the manufacturer of the drug met the standards set by the FDA.    In other words, lay juries, who may or may not have any scientific or medical knowledge, are allowed to evaluate the medical accuracy of FDA approved package inserts.    I don&rsquo;t know how many of you have ever been involved with the writing of package inserts, but I have, many times.    It is written by the best clinical talent in a company, it is reviewed by the medical director and his staff, and it is then once again read, critiqued and approved by the FDA.    Some of the leading experts, from pharmacology to physiology, in the development of the drug are involved in this process.    In general, these people are ethical, intelligent, and, to the frustration of every marketing person in the industry, extraordinarily careful.


Phenergan has been delivered over 200 million times over the past 50 years or so.    There is about a 1 in 20,000,000 risk of an adverse reaction of gangrene.    Wyeth did everything it could to warn about that extremely small risk.  


Every drug has a risk.  ...  The physician&rsquo;s assistant made a terrible error with tragic consequences for Ms. ...  I am extremely empathetic to what happened to her, and I&rsquo;m not sure what I&rsquo;d do if I lost my arm.    But Wyeth did everything within the law to provide the best information to clinicians, up to and including huge boxed warnings on the package insert.    When it comes to litigation, Wyeth has the deep pockets and the PA did not.


The consequences of this ruling are huge.    The FDA, continually understaffed, will have to review every possible nuance in labeling to make certain that warnings are taken seriously by health care workers.    Companies that develop and market drugs are now going to have to wonder if a minor risk will end up being a lawsuit.    Access to drugs, all of which carry inherent risk, may be restricted, or become more expensive.  


If a company acts in an unethical manner, covering up evidence of negligence, and then harms patients ought to be run out of business.    The chain of command that makes those decisions should be treated in the same manner as any other criminal.    But Wyeth did everything it could to warn of the risk.


When I was at Johnson and Johnson, I was in a meeting with our corporate legal staff discussing final labeling for an important therapeutic product.    The attorney said, &ldquo;don&rsquo;t assume that a jury reading this label is going to agree with what you think it&rsquo;s going to say.  

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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>If it looks like a duck...then it must be Quack medicine</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Politics</category><category>Pseudoscience</category><category>Quackery</category><category>Evidence based medicine</category><dc:date>2009-03-03T22:29:30-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/ducks_and_quackery.php#unique-entry-id-12</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/ducks_and_quackery.php#unique-entry-id-12</guid><content:encoded><![CDATA[One of the largest wastelands of medical science is something that has evolved into being called Complementary and Alternative Medicine (CAM).  ...  There&rsquo;s no clear definition, but the epicenter for this pseudo-medicine is the National Center for Complementary and Alternative Medicine (NCCAM) which was funded by the US Congress to be a part of the National Institutes of Health.    They define CAM as CAM is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.  ...  Typical of most pseudosciences, it does not rely upon the scientific method to generate results, it usually appeals to emotion, such as the great Big Pharma conspiracy against these potentially life-saving therapies.


I think that individuals should choose the therapy that they want, especially if it does no harm. ...  If someone chooses to consume vast amounts of vitamin C to prevent cancer, despite little or no evidence that it works, that is their choice.    What is troubling is when CAM is offered as an appropriate replacement to evidence based medicine, that is, &ldquo;the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.&rdquo;    Best evidence relies upon scientific and clinical research, publication in peer-reviewed (and respected) journals, and sometimes, the opinions of respected authorities in the field.


The National Institutes of Health is a US government agency responsible for biomedical and health related research.    One of the &ldquo;centers&rdquo; of NIH is NCCAM, which was established in 1991 by order of Congress.    In fact, Senator Tom Harkin (D, Iowa) pushed for the formation of the center because he had been cured of allergies by taking bee pollen supplements, despite the fact that there is no scientific evidence that bee pollen would do so.   In fact, there&rsquo;s more evidence that bee pollen will cause an adverse allergic reaction.


...During that time precisely few, if any, alternative therapies have been shown effective by NCCAM.    I reviewed some of the studies (reading how much is wasted here causes tachycardia, so I have to limit my reading), and I was singularly unimpressed.  ...  I just picked two that were published, but most of the studies weren&rsquo;t published because they were utter failures.  


The problem with NCCAM, other than wasting money that go to real medical research, is that it funds research based on theories that are not scientific.    Homeopathy, one of the most laughable CAM therapies, is a two step process.    First, you need to find a compound that causes symptoms similar to the medical condition that one has.    I suppose hot peppers placed in the nasal cavity would be a compound that causes symptoms of a common cold.    Then, the homeopath makes a potion by serially diluting the compound to the point where no molecules of the compound exist in solution.  ...  Homeopathy is based on a theory that is not grounded in basic physics or chemistry. 

...Surprisingly, Senator Harkin agrees that it&rsquo;s a waste, but for a somewhat different reason than I or other science-based professionals would consider.    NCCAM has shown that most alternative therapies are, in fact, worthless.    I&rsquo;m not sure that there are many ways for me to put it, but these therapies waste money for individuals and heath care plans, while providing no benefit to patients.  

...<blockquote class=bqfancy>&ldquo;Clearly, the time has come to &ldquo;think anew&rdquo; and to &ldquo;disenthrall ourselves&rdquo; from the dogmas and biases that have made our current health care system &ndash; based overwhelmingly on conventional medicine &ndash; in so many ways wasteful and dysfunctional.&ldquo;</blockquote> 


...Waste is sending money to NCCAM, even when it has brought no magical therapy into medical use, despite 15 years and $1 billion of effort.  

...<blockquote class=bqfancy>The FDA considered the Citizen Petition in tandem with a number of proposals &ndash; referred to as supplemental new drug applications (&ldquo;SNDA&rdquo;) &ndash; submitted by Women&rsquo;s Capital Corporation, the drug&rsquo;s original manufacturer.   Women&rsquo;s Capital Corporation sold its right to market Plan B to Barr Pharmaceuticals, Inc. during the course of the proceedings described below. ...  The first SNDA, like the Citizen Petition, sought non-prescription access to Plan B for women of all ages.   After the FDA denied such access, the Plan B sponsor submitted a second SNDA, seeking non-prescription access for women 16 and older.   The FDA rejected that application too despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively.   The Plan B sponsor then submitted a third SNDA, which proposed making Plan B available without a prescription to women 17 and older.   While FDA scientists and senior officials found that 17 year olds could use Plan B safely without a prescription, the FDA Commissioner determined that, because of &ldquo;enforcement&rdquo; concerns, Plan B would be available without a prescription only to women 18 and older.   Putting aside for the moment the specifics of the many claims brought by plaintiffs and the details of each of the FDA&rsquo;s decisions, the gravamen of plaintiffs&rsquo; claims is that the FDA&rsquo;s decisions regarding Plan B &ndash; on the Citizen Petition and the SNDAs &ndash; were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.</blockquote>


In other words, the FDA took political expediency rather than sound medical and scientific review to change the availability of the drug.  

...<blockquote class=bqfancy>There is no alternative medicine.   There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.   Whether a therapeutic practice is &ldquo;Eastern&rdquo; or &ldquo;Western,&rdquo; is unconventional or mainstream, or involves mind-body techniques or molecular genetics is largely irrelevant except for historical purposes and cultural interest&hellip;&mdash;Fontanarosa PB, Lundberg GD, &ldquo;Alternative medicine meets science&rdquo;, JAMA 280:1618&ndash;9, 1998</blockquote>


...But as long as NCCAM funds research based on unscientific hypotheses, then they will never discover a new medical therapy.    Research should always stretch the bounds of imagination&ndash;progress happens when a visionary finds a new path to a solution.  ]]></content:encoded></item><item><title>Vaccines...Part II</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Vaccines</category><category>Healthcare Policy</category><category>Pseudoscience</category><category>Pharmaceuticals</category><dc:date>2009-02-25T09:37:56-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/vaccines_part_2.php#unique-entry-id-11</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/vaccines_part_2.php#unique-entry-id-11</guid><content:encoded><![CDATA[If you read what I have written so far, I am firmly against pseudoscience influencing healthcare policy.    Anti-vaccinationists, who have harmed human beings with their pseudoscientific assertion that MMR vaccines cause autism, are now on the run as I&rsquo;ve stated earlier.


David H.   Gorski, MD, PhD, says it better than I ever will.    His conclusion bears repeating:


<blockquote class=bqfancy>That is a religious, cultish attitude.   A little thing like a news report revealing the hero of the antivaccine movement to be a scientific fraud or a court ruling that, even under the most favorable standards of evidence imaginable, vaccines do not cause autism will not change the mind of someone like this, nor will it make the antivaccine movement have second thoughts about its cultish beliefs.   The only hope that we who support science-based medicine can have is that these two body blows to the antivaccine movement will finally&ndash;finally!&ndash;drive home the message to the media that, when it comes to the claim that vaccines cause autism, there&rsquo;s no there there, as they say.   We can also hope that the fence-sitters, those parents who may have heard Jenny McCarthy ranting about how vaccines caused her son Evan&rsquo;s autism and how she cured him with various biomedical interventions may see these two repudiations of the myth that vaccines cause autism and be reassured.</blockquote>


Read the whole article by Dr.   Gorski.    Let&rsquo;s save children&rsquo;s lives but making certain they don&rsquo;t fall victim to childhood diseases that vaccines prevent.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>The recession and the medical industry</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Pharmaceuticals</category><category>Medical devices</category><category>Politics</category><dc:date>2009-02-23T15:12:50-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/reccession_and_the_medical_industry.php#unique-entry-id-9</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/reccession_and_the_medical_industry.php#unique-entry-id-9</guid><content:encoded><![CDATA[I have been in numerous positions within the pharmaceutical, biotechnology and medical device industries over the past 20 years.    The one paradigm upon which we all relied during those years was very simple:  &ldquo;the medical industry was recession-proof.&rdquo;    In fact, way back in 2008, medical products stocks, including Big Pharma and medical device manufacturers, were considered safe locations to invest during a economic downturns.    Industry analysts, executives, and investors believed that people would continue to buy medical services, who would then buy all of the products from table paper to expensive capital equipment.  


Current speculation seems to reinforce the old paradigm.    A recent article published in Tech Journal South offers up the following optimistic forecasts:


	&bull;	M&A activity will increase significantly.


	&bull;	Biotech stocks will outperform the rest of the market (which shouldn&rsquo;t be hard given the continued implosion of stock values)


	&bull;	Most investors consider biotech undervalued


	&bull;	Most expect biotech to rebound either this year or next


But if I stand back from the my own personal involvement in this industry, would there be economic issues that trouble me?    Absolutely.    First, the unemployment rate is high and getting higher.    The actual unemployment rate, that is the rate that includes those unemployed and who have given up searching for jobs, and that accounts for underemployment (declining hours for those who remain employed), may be at 13.9%.    The unemployment rate troubles me because health insurance becomes a luxury expense, and is therefore eliminated, and people quit going to their physicians and hospitals.    Elective procedures are going to fall precipitously.  


I&rsquo;m also concerned about the large budget deficit that will be created by Obama&rsquo;s stimulus plan.    Although there are some short-term benefits for the medical industry, such as a $15 billion injection in to state&rsquo;s Medicaid budgets, I remain concerned that over the long run there will be fewer dollars available for Medicare and Part D drug reimbursement.


On the other hand, my own personal, and subjective, analysis of the biotech, pharmaceutical and medical device job markets leads me to conclude that it is still healthy.    But the growth of jobs (and by logical progression, health of the companies) is not in the large companies like Abbot, Medtronic, or Boston Scientific.    It&rsquo;s with the small innovative companies such as Intuitive Surgical.    They market a robotic surgical system for minimally invasive surgeries.    And they have 30-40 positions available in sales, engineering and other areas.    Merit Medical, a Salt Lake City based cardiovascular products company, as has over 41 positions available.    I could go on for a few more paragraphs, but from my standpoint, the job market is healthy in this industry.


And then there&rsquo;s one more paradigm--once the recession is over, everyone runs to their doctors and dentists to get caught up.    Elective surgeries get backed up because everyone wants one.    And the industry recovers.


I remain optimistic about the medical products industry.    But maybe I&rsquo;ve just been indoctrinated after all of these years.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Ethics and medical sales</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Medical devices</category><category>Pharmaceuticals</category><dc:date>2009-02-20T13:28:51-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/ethics_and_medical_sales.php#unique-entry-id-8</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/ethics_and_medical_sales.php#unique-entry-id-8</guid><content:encoded><![CDATA[While searching for information on another blog entry of mine, I came across a story where a Stryker sales representative in Ohio pled guilty to felony &ldquo;misbranding of a medical device.&rdquo;    As an executive and manager in the medical device and pharmaceutical markets, my rules were quite explicit to all sales people--do not violate applicable regulations and laws for marketing medical product.    Stryker has a similar statement on its website (though I cannot know if they placed it there after the criminal actions, but most ethical companies have the policy in place).  


There are many issues that make it difficult to implement this policy:


	&bull;	Frankly, the physician customer wants to do what they want with any device or drug.    In my experience surgeons and cardiologists tend to &ldquo;push the envelope&rdquo; on technologies.    Short of a strong contra-indication for a particular use, physicians will often use a product off-label.


	&bull;	Oftentimes, there is high level pressure on sales reps to essentially &ldquo;wink and nod&rdquo; to the physician about off-label uses, hinting that it can be used safely.    Companies will hand out copies of peer-reviewed medical articles that discuss future indications of products.


	&bull;	Worse yet, there are often company cultures that establish confusing direction on off-label marketing.    The legal and medical departments of a company may set strict regulations (as I bet happened at Stryker).    But the sales and marketing departments may casually mention off-label uses.    A sales rep, usually working independently, while fighting competition and pricing declines, is put in a difficult position--sell more or get fired.


Most medical products companies (the vast majority, in fact) set a singular tone on labeling--don&rsquo;t sell off-label.    I worked for a company where the sales management would confiscate home-made sales pieces that reps constructed.    Some companies make it clear that any sales representative that makes any off-label claims is immediately terminated.    But there are rogues in sales and in corporate management, and I think prosecutions of medical products sales representatives will set the tone--don&rsquo;t do it.


I haven&rsquo;t a clue as to how many medical sales reps there are in the United States, but the number prosecuted for this off-label selling is so small as to be insignificant.    The vast majority of medical sales reps are well-trained, ethical, intelligent, and professional.    But I bet the next sales meeting for Big Pharm will include a review on off-label selling.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Vaccines...who are you going to believe?</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Vaccines</category><category>Healthcare Policy</category><category>Pseudoscience</category><dc:date>2009-02-19T15:51:55-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/vaccines_who_are_you_going_to_believe.php#unique-entry-id-6</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/vaccines_who_are_you_going_to_believe.php#unique-entry-id-6</guid><content:encoded><![CDATA[In one corner, we have Jenny McCarthy, former Playboy Playmate of the Year, Dr.   Andrew Wakefield, and pseudoscience with an extra dose of quackery.    In the other corner, we have the Centers for Disease Control, the Institute of Medicine for the National Academy of Sciences, UK&rsquo;s National Health Service, and the National Vaccine Injury Compensation Program (what is commonly called the Vaccine Court).    The battle is over MMR vaccine, a mixture of three live attenuated viruses administered by injection for immunization against measles, mumps and rubella (formerly known as German measles).


Let&rsquo;s take a close look at the participants.    First, Jenny McCarthy, whose extensive medical and science education includes....not much.   In 2005, she announced that her child was diagnosed with autism, a diagnosis about which there is some doubt.    McCarthy believes that vaccines caused her son&rsquo;s autism, although that view is unsupported by any scientific or medical evidence.    Her public appearances and statements have increased the public perception of this link, and may have led to decreased immunization rates and increased incidence of measles.   McCarthy has stated that chelation therapy helped her son recover from autism.   Essentially, McCarthy claims that mercury in vaccines causes autism, which has been rejected by scientific and clinical studies.    In fact, the National Institute of Mental Health has concluded that autistic children will not receive any benefit to balance the risks of cognitive and emotional problems induced by the chelating agents used in this treatment.    Really, she should stick to modeling and bad movies.


...Andrew Wakefield is a whole different story.    He, and 12 other researchers, published a paper in the British medical journal in 1998, The Lancet, which reported on 12 (yes 12) children with developmental disorders.    They linked eight of these children to MMR vaccinations.    The paper described several bowel symptoms and the possible link to the vaccine.    He even gave a name to the syndrome, autistic enterocolitis.    After publication of the paper, confidence in the MMR vaccine fell; pediatricians in the United Kingdom thought the British government was either hiding evidence of the link, or was failing to prove it. 


...But soon, Wakefield and his seminal study would be in disrepute:


	&bull;	In February 2004, a newspaper article established that Wakefield had received funding from attorneys who were seeking evidence to use in litigation against vaccine manufacturers.   Wakefield failed to tell The Lancet, his co-authors, and others of his conflict of interest.


	&bull;	In March 2004, 10 of the twelve co-authors of the paper retracted the interpretation that MMR vaccine caused autism.


	&bull;	In November 2004, it became public that Wakefield had patented a vaccine that would compete with MMR, and that his own laboratory had test results that contradicted his claims about the link.


	&bull;	Very recently, The Sunday Times reported that Wakefield had manipulated the data and misreported results, all to create the appearance of a link between MMR vaccine.    (To be fair, Wakefield has denied these allegations.)


	&bull;	Last week, the Vaccine Court ruled against the plaintiffs in three cases, concluding that the evidence presented did not validate their claims that vaccinations caused autism.


	&bull;	A recent review of studies of the links between vaccines and autism find that there is no scientific support for the link.


This might be an intellectual or philosophical discussion of science, except for one major problem.    Vaccination rates have dropped in the UK, to as low as 85%.    In 2006, there were 449 cases of measles in the UK.    Before Wakefield&rsquo;s report, there were only 56 cases in the UK in 1998.    In the US, there have been measles outbreaks attributed to the falling vaccination rate (falling from 98% to 92% in a few years).  


So, when it comes to medicine and science, we shouldn&rsquo;t listen to Playboy Playmates.    What worries me is what do we do when a scientist and professional like Andrew Wakefield publishes an article that sets the medical world on its respective head?  ...  It&rsquo;s clear science and clinical research works best in an open atmosphere, which allowed the science to set aside the pseudoscience.  

...The risk from measles far outweighs the non-risk of autism.


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Obama &#x26; Healthcare 2</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Healthcare Policy</category><category>Politics</category><category>Obama</category><dc:date>2009-01-25T08:50:06-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/obama_and_healthcare_2.php#unique-entry-id-5</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/obama_and_healthcare_2.php#unique-entry-id-5</guid><content:encoded><![CDATA[According to a report from The Center for Public Integrity, which produces original investigative journalism on public issues, there are over 45 million Americans who lack health insurance.    Politicians of all political outlooks have constantly promised Americans a plan for health insurance.   Nothing has happened.


President-elect Barack Obama made health care a critical part of his election platform and is now a  central facet of his presidential agenda.    I can assume that with the current economy, there will be opposing forces of &ldquo;we can&rsquo;t afford it&rdquo; and &ldquo;we need it for the unemployed&rdquo;, so it still will not be easy.


Obama&rsquo;s plan has several goals in mind, some of which have substantial effect on medical products industry.    The plan claims that it will save up to $2,500 (I assume annually, but it&rsquo;s not exactly clear) as it phases in:


	&bull;	Lower drug costs through higher imports from other countries, increasing use of generics, and &ldquo;taking on drug companies that block&rdquo; importation of cheaper generics.    Analysis:  Generic drugs should be used whenever possible is not in question.    However, the importation of generic drugs that violates the intellectual property of proprietary drugs still on the market is problematic--it could have the unintended consequence of actually increasing the price of non-generic products since the return on investment time period for non-generics may shorten.


	&bull;	Require hospitals to collect and report health care cost and quality data.    Analysis:  I personally believe that the gathering of data has a long-term benefit, but I remain unconvinced how this may actually add anything to the $2,500 savings, especially since there is not a lot of choice in which health care provider one may utilize.


	&bull;	Reduce the costs of catastrophic illnesses for employers and their employees.    Analysis:  This will be helpful to everyone, but unless the government takes on the responsibility (which has a cost), then it cannot provide any benefit that adds to the $2,500. 


	&bull;	Reform the insurance market to increase competition by taking on anticompetitive activity that drives up prices without improving quality of care.    Analysis:  This is very popular with politicians, but the insurance companies, though not exactly altruistic in their decisions, are constrained by the higher costs at the provider level.


The most important part of President Obama&rsquo;s health care strategy is to make health insurance available to the largest group of Americans possible.    He proposes the following:


	&bull;	Require insurance companies to cover pre-existing conditions so all Americans regardless of their health status or history can get comprehensive benefits at fair and stable premiums.


	&bull;	Create a new Small Business Health Tax Credit to help small businesses provide affordable health insurance to their employees.


	&bull;	Lower costs for businesses by covering a portion of the catastrophic health costs they pay in return for lower premiums for employees.


	&bull;	Prevent insurers from overcharging doctors for their malpractice insurance and invest in proven strategies to reduce preventable medical errors.


	&bull;	Make employer contributions more fair by requiring large employers that do not offer coverage or make a meaningful contribution to the cost of quality health coverage for their employees to contribute a percentage of payroll toward the costs of their employees' health care.


	&bull;	Establish a National Health Insurance Exchange with a range of private insurance options as well as a new public plan based on benefits available to members of Congress that will allow individuals and small businesses to buy affordable health coverage.


	&bull;	Ensure everyone who needs it will receive a tax credit for their premiums.


In the end, a better healthcare insurance system benefits the public and helps the medical products industry.    Physicians and hospitals that get reimbursed for more patients, even if the reimbursement is reduced, only helps this industry.    Small businesses along with the unemployed are the most helped by this proposal.    This is good for the medical products industry. 


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Obama &#x26; Science</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Healthcare Policy</category><category>Politics</category><category>Science</category><dc:date>2008-11-10T16:35:40-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/obama_and_science.php#unique-entry-id-4</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/obama_and_science.php#unique-entry-id-4</guid><content:encoded><![CDATA[It was an issue that did not drive polls or voter behavior.    It was an issue that did not bring a lot of interest from policy wonks or political pundits.    But science is one issue that has significant impact on individual, cultural, and national growth and security.    If one takes a long-term strategic view of America, investment, education and training in science will profit America financially.  


The Bush administration led a war on science, especially in the areas of stem-cell research and global warming.    Even in areas such as the teaching of creationism in schools, the Endangered Species Act, and NASA, there is a profound anti-science attitude exhibited by the current administration.    Economic security, as well as national security, result from innovative and competitive scientific and technological leadership.


But now Obama is the President-elect, and I am convinced that there will be a significant change in direction in America&rsquo;s science policy.    In early October, Obama released a letter that clearly states his positions on the Federal government&rsquo;s role in science.    He intends to appoint an individuals to provide advice and establish policy on science and technology.    He wants to remove any attempts to &ldquo;distort or ignore scientific research.&rdquo;    This is a clear first step in rebuilding the country&rsquo;s scientific position.    Early in the campaign for president, he answered several questions posed by scientists, which outlined his point of view.


In two key scientific areas, Obama has established positions that are a clear break from Bush:


	&bull;	Stem Cell research.    This policy may be reversed by default, since Congress wants this change prior to Obama&rsquo;s election.    Since Bush won&rsquo;t be in office to veto any legislation, and both houses of Congress are controlled by Democrats, we can expect that policy will change soon after the change of power.    In addition, Obama&rsquo;s opinion on embryonic stem cells is quite clear&ndash;&rdquo;As president, I will lift the current administration&rsquo;s ban on federal funding of research on embryonic stem cell lines created after August 9, 2001 through executive order, and I will ensure that all research on stem cells is conducted ethically and with rigorous oversight.&rdquo;


	&bull;	Global warming.    This doesn&rsquo;t require much analysis.    He&rsquo;s not a global warming denialist, so we can expect change here.   This author is a firm capitalist, so Obama&rsquo;s proposal for trading of carbon credits is a great first step.    It is more important that Obama has also stated that he supports finding solutions to the country&rsquo;s, and maybe the world&rsquo;s, challenges in increasing energy efficiency, finding alternative sources of energy, and reducing greenhouse gas emissions.


There is a sea change for science with the election of Barack Obama.    I know how politicians work, and the rhetoric we hear before the election is usually not the one they use in governing, but the clouds were so dark under George W Bush, I think most scientists are wildly optimistic that there is significant clearing in the forecast.    Obama did not ignore science in his victory speech, reminding us that, &ldquo;A man touched down on the moon, a wall came down in Berlin, a world was connected by our own science and imagination.&rdquo;


I can&rsquo;t wait.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Linking to Wikipedia</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Wikipedia</category><category>Pseudoscience</category><dc:date>2008-11-06T12:16:23-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/linking_to_wikipedia.php#unique-entry-id-3</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/linking_to_wikipedia.php#unique-entry-id-3</guid><content:encoded><![CDATA[Many of the links in this blog will point to an associated Wikipedia article.    I, in fact, read and edit those articles, so I won&rsquo;t make a link to an article that doesn&rsquo;t make my point.    It is supposed to be the epitome of a democratic encyclopedia, one that anyone can edit.    It is free to read, and it has become the number one hit for almost any key subject, whether popular or obscure.    Other than Obama&rsquo;s own websites, the Wikipedia article about him is the first google hit.  


...There has been significant criticism of the project, which reduces its quality and its usefulness.    My concerns about these articles rest in a few key areas:


...Some of it is a result of poor writing skills from English-speaking and non-English speaking contributors.    But some of it is also from a waffling or trivial writing style.    Worse yet, the prose is often not very engaging.    Sometimes, it&rsquo;s so difficult to read it, that one is apt to dismiss the article as being useless, even if it has useful knowledge.


...Wikipedia has a vaunted policy called the Neutral Point of View, often abbreviated as NPOV.    At its core, it states that an article should be written to represent all significant views that have been published by reliable sources.  ...  First, since it is very subjective, editors literally beat each other over the head with this policy.    Second, and more importantly, NPOV drives articles to their worst.    Academic articles usually state a point of view.    You cannot read a book about the holocaust without reading the point of view of the author.    A medical article nearly always presents a point of view, albeit one supported by scientific research.    Worse yet, editors will claim that a neutral article should include fringe theories.    I edit medical and science articles anonymously, and I find myself either editing out strange, unscientific ramblings from these articles.  


...Because articles are almost always available to be edited by anyone, there is a certain level of vandalism that occurs, everything from &ldquo;Joe was here&rdquo; to profanity to much more subtle, insidious vandalism that is difficult to identify.    More often than Wikipedia is willing to admit, this subtle vandalism remains in the article, often leading to inaccurate or incorrect information.    This edit to the article on Martin Luther King, Jr remained for over 4 hours, despite the over racism written into the article.    There are numerous cases of these type of problems.


...Because most editors are anonymous (a small subset of editors use their real names), it is nearly impossible to know the quality of edits from specific editors.  ...  But, lacking an education in neurophysiology, how do I know if the article on dementia is of high or low quality?    Whenever I read an article, I check the references.    A high number of references means that usually the writing is supported by academic research.  

...As a corollary to the lack of expertise is the pervasive contempt amongst Wikipedia editors against expert editors.    There is a class of editors called &ldquo;admins&rdquo; who, more or less, act as the police, judge and jury for the project.    They have the ability to pass summary judgement upon any editor.    As a class, they are a part of the anti-intellectual core of the project.    There are a few admins with expertise on science, historical, medical and other areas, but they generally keep a low profile.  


So why do I link to Wikipedia articles?    They may not be the best I can find on the internet, but these articles are, in general, fairly useful and provide an adequate background for a topic.    When I find better sources for particular information, I use it.


I leave my readers with this warning about Wikipedia:  read the articles with a critical eye as you do anything else you read.    The problem is critical reading is not a skill I see very often these days.  


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>Obama &#x26; Healthcare</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Politics</category><category>Healthcare Policy</category><dc:date>2008-11-06T10:12:00-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/obama_and_healthcare.php#unique-entry-id-2</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/obama_and_healthcare.php#unique-entry-id-2</guid><content:encoded><![CDATA[What politicians say during their campaign is usually not what they do when they are in office.    We are all cynical about their statements, but there are reasons why we should think that his policies might be implemented.    First, and most importantly, he will have a presidential honeymoon, where he will have the goodwill of the country, including other politicians.    For three to four months, he will have the ability to push through legislation that otherwise might founder in the legislative process.    Second, he has a solidly Democratic congress, many of whom have an interest in healthcare policy.


Of course, the huge elephant (not referring to metaphorical Republicans) in the room is that the economy and the cost of saving the country&rsquo;s financial institutions may only leave a few dollars for healthcare.    In other words, funding healthcare may take a literal back seat to other spending, which will exacerbate the problems of individual medical issues.    During economic downturns, not only do individuals under stress become more prone to illness, but they lack the means to pay for health care either directly or by maintaining health insurance.


Barack Obama proposed a fairly comprehensive healthcare plan during the election.    The key points are:


	1	Lower costs


	2	Affordable healthcare coverage for all


	3	Prevention and public health


These are admirable goals of any healthcare plan.    But, as we often hear, &ldquo;the devil is in the details.&rdquo;    In future entries, we will analyze each of these goals, examining those devilish details, and making a determination if they would be effective, and, to be sure, at what cost.


By Michael W Simpson


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<script src="http://digg.com/tools/diggthis.js" type="text/javascript"></script>]]></content:encoded></item><item><title>US Election 2008</title><dc:creator>msimpson@insighthealthcaresolutions.com</dc:creator><category>Politics</category><category>Obama</category><dc:date>2008-11-05T12:32:06-08:00</dc:date><link>http://blog.insighthealthcaresolutions.com/files/a80b417120dcc5b460de6ed4c7f3cc8f-1.php#unique-entry-id-1</link><guid isPermaLink="true">http://blog.insighthealthcaresolutions.com/files/a80b417120dcc5b460de6ed4c7f3cc8f-1.php#unique-entry-id-1</guid><content:encoded><![CDATA[Yesterday evening, I watched history being made when Barack Hussein Obama II was elected the President of the United States.    For me, the historical importance had nothing to do with his race or color, but it had everything to do with a number of critical issues that are of importance to not only the US, but the world.  


	1	Economy and taxes.    I am not quite as worried about the economy as others might be, because I believe the equity markets overreact to news, oftentimes increasing the perception of economic problems.    I am convinced that credit markets need restructuring and the world banking system needs to restructure so that their capitalization funds their credit.    I am also convinced that both John McCain and Obama would have needed to raise taxes.    That being said, I am confident that Obama, with a Democratic congress will be able to provide the right stimulus package, the right stimulus package, and the level of regulatory control over the banking system that will be required.


	2	Environment.    Time to fix this.    McCain&rsquo;s &ldquo;drill baby drill&rdquo; did not instill any confidence in this writer that McCain would be able to end the conservative paradigms concerning the world&rsquo;s environment.    The US consumes over 20 million barrels of oil per day.    The US produces about 7.5 million barrels of oil per day.    The US has total proven reserves of 21.8 billion barrels of oil, so if the country drills every drop, there are there is just over 3 years of oil.    &ldquo;Drill baby drill&rdquo; just isn&rsquo;t going to work.


	3	Iraq.    Time to come home.    And for those who think this represents a lack of support for our troops.    Well, no, nothing of the sort.    In fact, so that our troops aren&rsquo;t being shot and maimed, it&rsquo;s support.    For those troops who might be losing their houses to foreclosure, then getting them home is support.    And for those troops whose families are suffering through a bad economy, saving the billions of dollars is really supporting them.    Time to come home.


	4	Social issues.    Enough with the discussion about gay marriage, prayer in schools, creationism, and abortion.    They have nothing to do with government, and the Republican party&rsquo;s kowtowing to the Christian right instead of focusing on the economy and the world is their downfall.    Religion doesn&rsquo;t belong in politics.    Period.


	5	The World.    The US economy is inextricably intertwined in a world economy.    A strong world economy brings peace to the world.    This is a simple equation that George W Bush seemed to fail to understand.


To me, the election was a logical conclusion to the needs of middle-class Americans.    Obama may well have been the best answer to the needs of the US at this time.    But, and there is always a &ldquo;but&rdquo;, he needs to step away from the election and confirm that the faith that Americans have put into his election is well-founded.    But that&rsquo;s a discussion for another day.


By Michael W Simpson


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