When beginning a discussion of a controversial topic I like to establish the common ground upon which most or all people can agree. Everyone seems to agree that real conflicts of interest in medical research and practice is a bad thing and steps should be taken to minimize, eliminate, and illuminate any such conflicts. The controversy revolves around what constitutes a real conflict of interest.
There is broad agreement that researchers should not have a personal financial stake in the outcome of their own research – they should not make more money if their research is positive than if it’s negative. That creates a clear and powerful bias. There is also now broad agreement and adoption of standards that speakers, authors, and researchers should disclose any potential conflicts of interest – primarily the source of their funding. If someone is being paid by a drug company to say that their drug is effective for a particular disease, they should disclose that up front.
These same standard are now being applied to IRBs – institutional review boards, and that seems apprpriate. Every institution that does biomedical research must have an IRB, which is a committee of appropriate professionals (and there are rules as to the IRB’s constitution) that review all human research proposals to make sure they meet ethical guidelines and that subjects are adequately protected. This is a good system that generally works.
A recent paper, however, discusses the fact that the same disclosure of conflicts of interest required for researchers is lacking when it comes to IRBs. This is a “who’s watching the watchers” type of concern. This is easy enough to fix – simply require IRB members to disclose their conflicts of interest to the institutions that appoint them. There are already stringent ethical guidelines for IRB members, so this would be, in my opinion, a small but necessary tweak to the system.
This is not to suggest that big problems with IRBs do not at times occur. For example, Mark and David Geier formed their own institute and therefore their own IRB, packed with friends and supporters, to approve their highly dubious and ethically questionable study of lupron and chelation therapy for autism. The hole here seems to be that IRB regulation is largely left to institutions – but what if those institutions are bogus?
Conflicts and Witch Hunts
While there is much common ground regarding conflicts of interest, there is also much controversy. The British Medical Journal recently published five contrasting views on what the relationship should be between industry and academia. Marcia Angell, former editor-in-chief of the NEJM and professor of social medicine at Harvard, takes the most extreme view – none. She feels that there should be no ties between industry and academia, doctors, or patients, because all such ties constitute marketing on the part of the pharmaceutical industry, and the purpose of marketing is to distort the practice of medicine (specifically to increase drug sales).
Others propose allowing but regulating industry-academic collaboration. These regulations would include eliminating direct to consumer advertising, funding continuing medical education (CME), and forgoing all industry gifts.
And at the pro-industry end of the spectrum Gordon Coutts, Vice President and General Manager at Schering Plough UK, argues that collaboration between academia and industry has the potential to foster innovation.
This is an important conversation to have, and I think it needs to be recognized that there are trade offs to consider – hence the conflict. I think the radical view of eliminating all ties will throw the baby out with the bathwater. On the other hand the medical profession and the pharmaceutical industry has to regain some lost public trust, and that might entail eliminating not only true conflicts of interest but the appearance of conflict.
The accusation of potential conflict of interest easily turns into a witch hunt, however, and can be used as a weapon – where the mere accusation of conflict is equated with guilt. Legitimate scientific opinions and research is often dismissed because of trivial connections to industry that do not constitute a legitimate conflict (anti vaccinationists are famous for this).
The “baby” in the bathwater of industry ties includes, in my opinion, CME. There are times when the interests of the industry and of good medicine are in line, and these include educating physicians as to the existence of a new drug and its proper use. There is just as much underprescribing going on in medicine as overprescribing – many patients are losing out on the preventive benefits of proven drugs because of inadequate education. Education is therefore a win-win that we should not casually dispense with.
The legitimate concern is that industry interests will drive the content of education – but that can be managed without eliminating industry funding. Pharmaceutical companies already have divisions between marketing and research. Educational activities could also be segregated from marketing. Funding for CME activities can be unrestricted. Buffers could also be put into place. For example, funding can only be directed at diseases, not drugs. So a manufacturer of a migraine drug can fund CME into migraine education, but not education about their specific drug. In order to avoid hand-picking academics known to be favorable to their products, perhaps funding can be restricted to departments, who then can decide which individuals will provide the content. In other words – the content of the CME needs to be buffered from industry influence. If the industry wants to pay for CME activities, they have to allow academics to completely determine the content. They will do this (and already do in many cases) because there are many win-win situations where increasing education and awareness helps everyone.
I and many others also think it is important to allow acadmics to consult for industry researchers. This is a vital flow of experience and information from those on the cutting edge or in the trenches of practice to the industry, to help guide future research and spawn innovation. If academics become paranoid about any industry ties, however, they will be reluctant to provide the industry with their expertise, and patients will ultimately suffer.
We are currently in a transitional phase. Conflicts of interest in the system are being exposed and purged, but this is also leading to a bit of a “witch hunt” mentality and risks purging the good with the bad just for the simplicity of having a clean slate. Hopefully in the end we will settle on a balanced and nuanced system, where legitimate conflicts are exposed and eliminated, but constructive collaboration between academia and industry is allowed to flourish.
I also think the playing field needs to be leveled. Right now there is a asymmetry where accusations of conflict are targetted at some industries (like the pharmaceutical industry) far more than others (like the supplement, malpractice, and CAM industries) – even though in many cases conflicts of interest in these latter industries are far worse than what it being criticized in the former.
As we develop a sophisticated system for revealing and minimizing conflicts of interest, the system needs to be applied fairly and universally – not selectively, politically, or punitively.