Mar 2009
The anti-vaccination tragedy
Mar/31/09 10:07 Filed in: Vaccines | Healthcare Policy | Pseudoscience | Pharmaceuticals | Evidence based medicine
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. Read More...
Vaccines, once again and a bit irreverent
As I’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’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’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’s one too many.
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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’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’s one too many.
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Strength of the medical products industry
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.
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Politics and the FDA
Mar/26/09 10:50
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’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. Read More...
I personally object to political considerations taking priority for science and medicine. It’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. Read More...
Designing better medical products
Mar/22/09 11:35 Filed in: Medical devices | iPhone | Pharmaceuticals | Healthcare Policy | Medical products
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. More often than not, I find myself quite disappointed.
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’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. That’s the ballgame for me.
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’s free). Using iTunes, I can buy the apps (many are free, but you still have to “purchase” them) at the iTunes store, and upload them to my iPhone. At its essence, iPhone has made my life easier. Read More...
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’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. That’s the ballgame for me.
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’s free). Using iTunes, I can buy the apps (many are free, but you still have to “purchase” them) at the iTunes store, and upload them to my iPhone. At its essence, iPhone has made my life easier. Read More...
Wikipedia–bad medicine
The internet has become a great tool for researching information from new gadgets to statistical analysis of politics. One of the most popular websites for research is Wikipedia, an online, democratic encyclopedia. As I have discussed previously, I link to it frequently, to give an overview about a particular topic. 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. Wikipedia functions as a democracy, meaning anyone can edit it. Sometimes it appears that the project is more of an anarchy, but there are “police”, called administrators or admins, and several levels of bureaucracy above the police, to control the situation. The admins are elected by the community of editors. 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. Actually, a social scientist might find the whole system quite fascinating, as I do.
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’s the term used by Wikipedia cognoscenti to describe actions that aren’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. Read More...
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’s the term used by Wikipedia cognoscenti to describe actions that aren’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. Read More...
Syracuse Orange and 6 overtimes
Mar/14/09 23:42 Filed in: Syracuse University | University of Utah
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’s degree from Utah, and have been a fan of the Utah Utes for a while, but it’s always been the ‘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. Read More...
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. Read More...
New FDA Commissioner
Mar/13/09 11:08
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. Read More...
Successful Marketing Management
I haven’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’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’s hard to obtain exact data). If each one of those companies sent a sales representative into a physician’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–new product introductions are especially sales critical. Read More...
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’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’s hard to obtain exact data). If each one of those companies sent a sales representative into a physician’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–new product introductions are especially sales critical. Read More...
How to make a big profit in this recession
Mar/05/09 13:25 Filed in: Pharmaceuticals | Medical products
I got your attention, didn’t I? 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–if you do all of that, you can do well in this industry.
Oh, you want the easy way. 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’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’s hand and forearm became necrotic and were amputated in two stages. Read More...
Oh, you want the easy way. 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’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’s hand and forearm became necrotic and were amputated in two stages. Read More...
If it looks like a duck...then it must be Quack medicine
One of the largest wastelands of medical science is something that has evolved into being called Complementary and Alternative Medicine (CAM). What is CAM? There’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. The most common CAM therapies are homeopathy, chiropractic, acupuncture, naturopathy and herbalism. 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 I had a chronic and terminal disease, I might choose an alternative therapy. 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, “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” 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 “centers” 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’s more evidence that bee pollen will cause an adverse allergic reaction. Read More...
I think that individuals should choose the therapy that they want, especially if it does no harm. If I had a chronic and terminal disease, I might choose an alternative therapy. 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, “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” 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 “centers” 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’s more evidence that bee pollen will cause an adverse allergic reaction. Read More...