An interesting article written by Christopher T. Robertson titled “The Money Blind: How to Stop Industry Bias in Biomedical Science, Without Violating the First Amendment,” appears in the American Journal of Law and Medicine (vol. 37, pages 358-387, 2011).
The article discuses how the medical industry spends billions of dollars to create innovative products but also spends nearly as much to change the behavior patterns of those interested to make sure the products are purchased.
The author states
“As a veteran of the industry writes, ‘ in the pharmaeeutieal industry, there are two ways to market an approved drug for a new use: the ‘indication’ route—performing studies necessary for regulatory approval—or the ‘publication’ strategy, whieh stimulates off-label prescribing by using research ‘to disseminate the information as widely as possible through the world’s medical literature.’ “
A mention is made of a candid document by Pfizer which states
“What is the purpose of publications? The answer: the ‘purpose of data is to support, directly or indirectly, the marketing of our product.’ Or in short: “Purpose of Publications: The Bottom Line.’ “
The author mentions a quote by a judge
“The pervasive commercial bias found in today’s research laboratories means studies are often lacking in essential objectivity, with the potential for misinformation, skewed results, or cover-ups.”
The author later says
“Thus, as the industry succeeds in warping biomedical science to represent industry interests rather than physiological reality, it degrades the practice of medicine, harms patient welfare, and raids tbe treasuries of state and national governments.”
The author then goes in to discuss three current regulatory mechanisms 1) litigation, 2) peer review, 3) mandatory disclosure and then discusses why these mechanisms fail to solve the problem of corruption of industry on biomedical science.
The author then attempts to discuss the root cause of biased science by stating that the company chooses the investigator it wishes to support and may even ghost-write the article.
The author goes on to mention double-blind studies and how they are the gold standard:
“A double-blind study is one in which the human subjects are unaware of whether they are receiving a placebo or the studied intervention, and where the clinicians actually assessing the outcomes are also unaware of which subjects are in the “control” and the “treatment” conditions.”
The author states that even double-blind studies can cause biased studies and states that companies should be blinded to selection of investigators and not be allowed to handpick investigators who are likely to run favorable studies. Hence the author suggests some sort of intermediary between companies and investigators and mentions the NIH as possibly filling this role.
The author is wise enough at this point to mention that even the intermediary might become interested in helping out the companies for money and mentions scandals by the NIH in the early 2000s. The author then goes on to discuss some way sin which the money-blind can be implemented without violating the first ammendment.
The author states in conclusion
“There can be little doubt that biomedical science drives a significant portion of the practice of medicine and the billions of dollars of spent on healthcare in America each year. Thus the integrity of biomedical science would seem to be foundational to a well-functioning healthcare system. It is critical that biomedical science be objective, and tbat it appear objective, so that pbysicians and regulators can confidently rely upon it.”
“Money-blinding is thus a promising partial solution, even if it would not completely extirpate industry’s role in setting the agenda for biomedical science.”