John Ioannidis is the academic leading the charge to bring reproducibility and integrity back to some of our scientific publications. It is fair to call him our most outspoken conscience, although the academic term, “thought leader” may be more comfortable. He is writing now about the role professional societies should or should not play in authoring professional guidelines. Let me use a quote to provide a quick summary:
“…these guidelines writing activities are particularly helpful in promoting the careers of specialists, in building recognizable and sustainable hierarchies of clan power, in boosting the impact factors of specialty journals and in elevating the visibility of the sponsoring organizations and their conferences that massively pro-mote society products to attendees.”
His concern, “do they improve medicine or do they homogenize biased, collective, and organized ignorance?” As is frequently the case with Dr. Ioannidis, a succinct, insightful question. He goes on to point out several potential conflicts of interest; the financial ones have been getting a lot of coverage lately, at least concerning individual physicians. But professional societies are also entangled with industry; he cites 20% of the American Heart Association’s $912 million budget as coming from industry, and 77% of the European Society of Cardiology’s budget of almost $70 million. He also describes a guideline ecology, where experts already consultants with industry, write the guidelines, develop appropriate use criteria as well as measures of performance.
I would term this ecosphere of expertise, a “bubble of eminence,” a bubble that because it is so restricted in membership has its own bias – a bias that is hard to see, in the same way, a fish doesn’t recognize water. [1] There is no need to posit bad intentions, the participants who develop, affirm and promulgate are wholly unaware, for the most part, that they are in a bubble at all. Again, Ioannidis phrases it best, “Would a society advise its members to change jobs, if evidence proved their medical services a waste?
That last quote speaks far better to conflicts of financial interest than all the pages and page views wasted in the previous few weeks on Memorial Sloan Kettering. The relationship between industry and academia is like that of sin to confession; without one, you have nothing to say in the other. Physicians have a vested interest in their beliefs about what causes disease and how best to treat it because their beliefs drive their actions. Industry provides technologies that facilitate the ideas of physicians. But industry is not in the business of caring for patients, although that is a welcomed spin-off, they are in the business of caring for physicians. So industry’s interaction with physicians is more about talking to their best customer, not some cabal intended to defraud and create windfalls.
We have got to move away from thinking about conflicts of interest as purely financial; the real disputes are about beliefs in what makes care better. When a physician reports the results of a drug or device trial, the conflict of interest is not necessarily found in funding, it is found in the beliefs that drugs, in particular, this drug, is a better treatment making more patients better or that this device works best. A disclaimer is not necessary, assume that the authors state their bias up front in the hypothesis. Funding by industry can then be thought of as a way of “putting their money where their mouth is.”
We should then only be concerned with the studies we do not see, and we have already taken measures to require that these studies be publicly listed and reported. (Although, as I wrote previously, this is a requirement we often honor in words rather than deeds)
Dr. Ioannidis goes on to question the composition of these guideline committees, suggesting that specialists be banned from developing guidelines in their field. Knowing that this is “impossible to impose” he recommends methodologists, physicians in other specialties, and patients serve as the authors with oversight by the specialists whose guidelines are being written. Methodologists are individuals trained in abstract “truth” from the multiplicity of statistical techniques used in meta-analysis and systematic reviews that provide the evidence in evidence-based thought.
They would be helpful additions, lending expertise to selecting evidence, but without clinical experience, their judgment is not wholly useful.
I agree on the need to expand the membership of these committees to other physicians and patients and also believe Ioannidis is right in pointing out that while patient advocates and others “stakeholders” (the preferred MBA term) have been added that their voices are drowned out by the voice of the eminent, expert majority. But their inclusion raises a question of who speaks as a patient, leaders of patient advocacy groups or someone plucked from the at-risk population? He recommends other unrelated specialists, impacted by the guidelines have a seat at the table. Of course, that still leaves, different experts with their own industrial connections, firmly enmeshed in the process. I did find it concerning that no mention has been made of our other team members, nurses, especially nurse practitioners who more and more frequently find themselves at the “tip of the spear” in using guidelines clinically.
I would propose an alternative that makes use of the many physicians rushing the exit from burnout, disenchantment or even the desire to retire. Certainly, there are enough retiring and retired physicians, with many years of practical experience, financially more entangled with patients than industry, that can weigh the current evidence and make recommendations. Physicians at the “top of their game” today are no less capable and insightful tomorrow when they retire. Their financial conflicts, if any, are now behind them; they have an opportunity to give back to their specialty and patients. Seems like a win-win.
Should you want an insider’s view of these guideline committees, consider the commentary by Dr. Milton Packard writing at MedPageToday. As he writes, “We need to understand what the guidelines really are. Guidelines represent the opinions of its authors. Nothing more and nothing less. Their text is worth reading, but the document should not be the focus of worship. Guidelines are not biblical scripture.”
Citation: Professional Societies Should Abstain From Authorship of Guidelines and Disease Definition Statements, Circulation Cardiovascular Quality and Outcomes DOI: 10.1161/Circoutcomes.118.004889
NOTE:
[1] It is also an ecology that reflects the hierarchy and friendships of academics itself, the way a mentor brings along and supports their mentees; or the academic status that follows from being among the experts chosen to develop guidelines.
