To medicate or not to medicate, that is the question. Though it lacks the existential flair of the Danish prince, it does not diminish its importance as a question. There is an increasing concern in America regarding the efficacy and safety of prescription medications. The recent outbreak of fungal meningitis (34 deaths at the time of writing) from tainted steroids speaks to the latter. Fortunately, given the millions of prescription drug capsules swallowed every day, this is obviously a rare occurrence. The safety of prescription medications is probably of less concern than their efficacy; whether the drugs perform as advertised. Why there should be less concern over safety is for the simple reason that no one profits from contaminated medications. No party in the business of health will derive anything positive from releasing tainted drugs. Any sensible drug company will pull out all the stops to curtail the release of contaminated drugs, at least in part to avoid criminal and civil lawsuits. Another strong motivation is that few consumers will continue to purchase drugs from a company that has released products known to be harmful. On the other hand, there is a strong financial motivation to release medications that are neither harmful or helpful.
Charles Seife wrote an interesting article in the December 2012 issue of the Scientific American regarding this aspect of drug research. The core of his argument is that consumers are lead to believe that their medications are the product of objective research. Most educated laypeople, though, are aware of the increasing conflicts of interest between medical researchers and drug companies. For example, drug companies give researchers money to travel and present their research at conferences. Occasionally, the speeches and slides used in the presentation are written by the drug companies. Drug companies produce articles intended for publication in peer reviewed journals, and pay a famous researcher to put their name on the article. There are companies whose sole mission is to ghostwrite articles for publication in professional journals. Perhaps the least conflictual relationship is to pay the researcher as a company consultant. While many researchers believe that their brilliance is being purchased, it is actually their good name.
Most, if not all, professional medical journals and institutions have strict rules about conflicts of interest, though it is largely up to the individual researcher to declare these conflicts. Journal police who crack down on these conflicts of interest do not appear to exist. A 2009 report by the Office of the Inspector General discovered that 90% of institutions receiving NIH grants leave it to the researchers to declare conflicts of interest. The failure to identify even possible conflicts of interest on National Institute of Health grants are against the law. When Mr. Seife confronted an NIH official about a known case of conflicted interest, she defended their errant position. When Mr. Seife attempted to discover if the NIH was investigating the case, the NIH refused to disclose any further information. Actual NIH emails obtained by the Office of the Inspector General revealed that the National Institute of Health discourages investigations of conflicted interest between NIH sponsored researchers and drug companies. American tax dollars at work.
Mr. Seife goes on to paint a less than rosy picture of the situation at the NIH. Most NIH institutes have not instituted a conflict of interest enforcement action since 2008. There is even mounting evidence that the advisory board to the National Institute of Health is receiving money from drug companies. Mr. Seife has found many drug company payments made directly to NIH advisory board members, though he could not conclusively prove that it was a conflict of interest. For example, he found a particular board member of the NIH disclosed owning drug company stock, but he failed to disclose over $50,000 received from just one drug company. The Office of Government Ethics is in charge of ensuring that government agencies, such as the National Institute of Health, are in compliance with ethics rules. Even though though NIH has issued dozens of ethics waivers since 2005, they have only consulted with the OGE three times in that period. It is a federal law for NIH to consult with the OGE for each waiver of ethics, which is essentially granting someone immunity from ethical and potentially criminal violations. If these allegations are true, it would appear that the National Institute of Health is willing to violate both ethical standards and federal law in order to receive money from drug companies.
The author of this article, Charles Seife, concludes that the best solution is for researchers to employ peer pressure in order to discourage colleagues from accepting drug company money. It is a rather surprising conclusion, given that his article is largely concerned with the failure of individual and group ethical standards. For example, in an earlier portion of the article, Mr. Seife reported that Stanford University has adopted one of the hardest lines against conflicts of interest. A ProPublica drug company database discovered several faculty members taking drug company money in defiance of Stanford’s ethical guidelines. Dozens of faculty members were discovered at other seemingly ethical institutions taking drug company money in similar defiance. So much for self-policing as a solution. It is a contradiction in terms.
The biggest loser in the this game is the consumer, and physicians are not far behind. The drug research used by both the physician and consumer are now so suspect that little may be taken at face value. Even if three quarters of the researchers and institutions were ethically and scientifically pure, the remaining impure quarter would still render drug research suspect. No one knows with certainty which group is ethical or not, such that in service of scientific objectivity, meaningful conclusions cannot be drawn from potentially purchased (biased) research. The current situation must be crippling for doctors who seek to find the best medications for their patients. It is difficult enough to find the meaningful pieces of honest and competent research, such that the added bias of corporate money may leave many physicians scratching their heads.
It is hoped that the current situation is not as incestuous as that painted by Mr. Seife, and that he adopted a rather biased viewpoint in search of notoriety. If his allegations are mostly if not completely true, than it has far reaching implications and consequences for most Americans. Perhaps it has come to the point that when a patient inquires about a particular medication, the only honest answer is “How should I know?”