It is now difficult to know what to do with the information provided in the disclosure section of journal articles. I am puzzled as to how are we supposed to train residents and fellows into how to incorporate this information into the decision making process. After all, we want the readers to formulate impressions about disclosures so that they attain objectivity about content. And objectivity is about measurement. So how is one supposed to do so? Until now no one knew for sure.
As background I would suggest we needed a simplified statistical system for an audience who is known on occasions to struggle with stats. For example many very smart colleagues still struggle with the significance of the p value. Less than 0.05 Biblical! Anything else discard immediately... Let alone understanding a Bonferroni correction.
So to try to solve this problem I tackled a recent paper in the NEJM where C1 inhibitor deficiency is successfully treated by a new intervention (one of 3 papers in the same issue). (Zuraw et al N Engl J Med 2010; 363:513-522August 5, 2010). By the way congratulations to the authors on such important study. (This comment is about the irony of disclosures not the value of their paper, which is truly outstanding). The methods did not tell me how to account for the disclosures (Top figure). So if you look at the results section there were 1006 words. The disclosure text was almost as long (798 words). There must be a way! After many hours I took it upon myself to calculate the significance of disclosures and suggest the following formula for correction.
For the sake of providing due credit I thought about the "CANDAB correction" which is an acronym with the first letter of some of the most intense pharmascolds. (HINT: Solving this is much simpler than my formula). So here it is finally! Do this for every author. X stands for the age of the author, y is the net compensation received in the last 12 months and n is the number of times they have participated in CME or consulting. You add it all and move the p value as many decimal points as the result shows to know the truth.
Late breaking news: I heard JAMA will include automatic computation in their website.
Showing posts with label Bias. Show all posts
Showing posts with label Bias. Show all posts
August 14, 2010
June 8, 2010
No free latte, unless you are not from the US!
A new MSNBC poll looks at the absurdity of the current regulations regarding interactions between physicians and industry. The vast majority of poll responders agree, and thankfully so, that the regulations have gone to far. At medical meetings there are now booths for international attendees only. Once you swipe your card you can go inside and get a coffee and a biscotti. To keep this under veils they have posted guards at the entrance of these international lounges. The general public seems to finally have gotten it and at least 80% of poll votes go for the regulations having gone too far.
Labels:
Bias,
Framing Bias,
Medical Societies,
Transparency
June 1, 2010
Bias Towards Medical Progress
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
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
Labels:
Bias,
CME,
Generics,
Innovation
Subscribe to:
Posts (Atom)


