Pharmaceuticals
Swine flu–don't panic
Apr/30/09 00:02
With respect to the swine flu, I want to repeat myself, once again–Don’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. Read More...
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. Read More...
Swine flu
Apr/29/09 15:34 Filed in: Pharmaceuticals | Pseudoscience | Vaccines | Healthcare Policy | Evidence based medicine
Well, actually I’m not going to say too much about swine flu, except that my initial impression is that it’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 “under the radar.” 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’t panic. Wash your hands. And that’s about it for really good medical information.
Of course, the woo-meisters have weighed in with their useless advice. I won’t even begin to explain the logical and scientific fallacies of colon cleansing, but it isn’t going to either prevent or lessen the severity of swine flu. Read More...
There are a number of bloggers who are passing along sage and sane advice. Basically, don’t panic. Wash your hands. And that’s about it for really good medical information.
Of course, the woo-meisters have weighed in with their useless advice. I won’t even begin to explain the logical and scientific fallacies of colon cleansing, but it isn’t going to either prevent or lessen the severity of swine flu. Read More...
Wikipedia–more bad medicine
Apr/21/09 16:24 Filed in: Wikipedia | Pharmaceuticals
The usefulness of the medical articles in Wikipedia is coming under a lot of scrutiny lately. I’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:
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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.
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Denialism and pseudoscience
Apr/21/09 14:18 Filed in: Pseudoscience | Healthcare Policy
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. Read More...
Scientific medicine and Big Pharma
Apr/08/09 08:42 Filed in: Medical devices | Pharmaceuticals | Pseudoscience | Healthcare Policy | Evidence based medicine | Medical products
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’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. Read More...
Jenny says....
If you read my blog, you know I don’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’s recent interview. Read More...
The anti-Jenny blogosphere
Medical and science blogs are aghast at Jenny McCarthy’s comments that I reviewed earlier today. Let me list some of the more choice comments. Read More...
Jenny McCarthy again!
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. Read More...
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...
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...
Vaccines...Part II
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’ve stated earlier. Read More...
The recession and the medical industry
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: “the medical industry was recession-proof.” 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:
Current speculation seems to reinforce the old paradigm. A recent article published in Tech Journal South offers up the following optimistic forecasts:
- M&A activity will increase significantly.
- Biotech stocks will outperform the rest of the market (which shouldn’t be hard given the continued implosion of stock values)
- Most investors consider biotech undervalued
- Most expect biotech to rebound either this year or next
Ethics and medical sales
Feb/20/09 13:28 Filed in: Medical devices | Pharmaceuticals
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 “misbranding of a medical device.” 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). Read More...