Efforts to avoid the appearance of bias for its own sake are futile and ill-advised. This caused some headaches for the religious court that condemned Galileo for proposing that the earth revolves around the sun. Science vs. empiricism vs. pragmatism. Still a problem today.
Bias is compatible with truth and fact. My bias for disc brakes and airbags is evidence-based. Preference for specific commercial products may also be biased, objective and evidence-based.
Manufacture and promotion of products that do not yield beneficial medical outcomes, superior to the current standard of care, is the single greatest cause of corporate extinction. Think of Chrysler. They managed to collapse without paying a single fine for off-label promotion. This is economic and independent of liability. Products that do not perform or do not reduce risk do not sell.
The recent fiduciary concern by many of America's doctors for high medical costs and the self-appointed obligation to recommend generics over costlier ethical drugs is romantic but hardly reassuring. Death and "conservative management" are always the low-cost option. Generics play a valuable economic role in the life cycle of technology and the cost-effective delivery of care but to suggest that cheap drugs developed in 1960 are generally preferable to today's patented products is a menace to public health.
The biggest problem with the reports regarding industry influence on medical education is that they miss the whole point of industry-sponsored medical education: company's have an incentive and bias for medical progress. Journals are incentivized by subscriptions and advertising revenue, AMCs by research grants, tuition and billing CMS for clinical care; and professional medical societies (PMS) by tuition and fees for knowledge and advocacy. None of these entities have an explicit progress incentive.
Novel technology, by definition, works from an implicit evidence disadvantage. Journals and PMS guidelines are legend for dismissing the scanty data on breakthroughs, especially since few of their members have either incentive or motive to champion accompanying changes in practice. One of the authors derides industry reps for often lacking scientific training. Science only proves or disproves a hypothesis, nothing more or less. Promoting change through the continuum of accumulating evidence (often 30 years and longer) depends on more than just clinical science, to the chagrin of some. Incentives to change practice are almost always small when compared to the status quo incentive, even when outcomes are superior. In hindsight, most skeptics claim to have been early adopters and it's not impossible to remember history that way 20 years after the fact.
Right or wrong, industry drives change and progress does not occur without change
Showing posts with label Generics. Show all posts
Showing posts with label Generics. Show all posts
June 1, 2010
May 15, 2010
Forbes Tackles the Off-Label Question
A great article just published in Forbes highlights an often neglected topic; that "off label" usage of medications can lead to good outcomes. The authors correctly state that "off label" accounts for about 20% of all prescription writing and in some cases up to 50% as in cancer and cardiology. There are many cancer diseases where there is no "on label" option. For many patients not having on label options will mean no treatment. There is description of how malpractice can result if the standard of care includes "off label" use and a patient is not treated with such drug. Medicare allows for off label use and reimburses for that. Yet it is ironic that the off label aspect if often cited by industry critics as one of the key evil practices. So much so that the largest monetary settlements have occurred often associated with "off label" promotion. If the purist would insist that all CME communications be limited to on label that would be highly limited, destructive and infringing on First Amendment. CME events will become robotic interactions that will defeat their own purpose. This is what we see now in the case of drug reps who have to stay on label. Their value goes down if they have limited freedom speech. Freedom must prevail.
Labels:
Confluence of Interest,
Framing Bias,
Generics
May 9, 2010
Teva as an Example of Corporate Morality?
The New York Times (Natasha Singer) had a piece today regarding Teva and and other generic manufacturers. The tone of the story is that Teva is a better company because of the frugality of its operations, and its focus on the bottom line. Several examples highlight how Teva shuns the idea of a corporate plane and always looks for an appearance of egalitarianism.
Needless to say generic manufacturers play an important role in the production and distribution of medications. What the article fails to highlight is that today’s generics were the branded medications of the past. Without a healthy pipeline of new drug development Teva’s role is nonexistent. A mention is made of how Teva can produce drugs cheaper because it did not invest in R&D. But very little context is provided.
For people who criticize “me too” drugs, they should remember that the generics are the ultimate “me too” and that generics have no innovation. So unless we all agree that today’s medicine is “as good as it gets” then we should cherish the value of discovery and innovation.
As we have many times before stated, this innovation, as it relates to drug discovery comes mostly from the private sector. Do you think our cancer treatments are good enough and sufficient? Should we give up on dementia, MS and stroke research? Should we just allow folks with diabetes to finish their lives early? If you answered no to any of the above questions then you get the point. Now if Teva invested in R&D maybe that would be a sweet combo. Don’t hold your breath until that happens in large scale.
Needless to say generic manufacturers play an important role in the production and distribution of medications. What the article fails to highlight is that today’s generics were the branded medications of the past. Without a healthy pipeline of new drug development Teva’s role is nonexistent. A mention is made of how Teva can produce drugs cheaper because it did not invest in R&D. But very little context is provided.
For people who criticize “me too” drugs, they should remember that the generics are the ultimate “me too” and that generics have no innovation. So unless we all agree that today’s medicine is “as good as it gets” then we should cherish the value of discovery and innovation.
As we have many times before stated, this innovation, as it relates to drug discovery comes mostly from the private sector. Do you think our cancer treatments are good enough and sufficient? Should we give up on dementia, MS and stroke research? Should we just allow folks with diabetes to finish their lives early? If you answered no to any of the above questions then you get the point. Now if Teva invested in R&D maybe that would be a sweet combo. Don’t hold your breath until that happens in large scale.
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