In my last post I raised the possibility that Steve Nissen, a highly influential cardiologist who has been an outspoken critic of industry influence in medicine, might have his own conflict of interest (COI) problem. In response, another cardiologist, James Stein, said that my post was unfair in its treatment of Nissen and failed to consider important distinctions and subtleties in the academic literature about conflict of interest.
Let me first of all confess that Stein– for whom I have the highest possible regard– makes some excellent points. And I further admit that my piece pretty much ignored some of these fine academic distinctions. But I also think it’s likely that we may have a forest and trees situation here and that by focusing on subtle COI distinctions it is possible to lose sight of the larger issue.
A Simple Test
Rather than focus on the subtle distinctions between different types of COI I’d like to propose a much simpler way to think about this problem as it exists in the real world. Here’s the test I would propose: can you imagine Nissen, or indeed anyone in a similar situation (running a large multimillion dollar trial of a drug) publicly saying something decidedly negative or critical about the drug?
Last week Nissen told NBC nightly news that “these drugs are breakthrough drugs, they are blockbuster drugs that are very likely going to have a big impact.” What is the likelihood that someone in his position would publicly state that there is a good chance that the drugs won’t be a breakthrough, that maybe they won’t be blockbusters, or that they shouldn’t be approved right away or broadly used?
The answer to this question is clear. I can’t recall ever seeing the leader of an ongoing trial express major doubts about the value of a drug or publicly differ with the sponsor about its potential significance. (And yet, somehow, so many of these promising breakthrough products have failed utterly.)
To be clear: this doesn’t mean that the opinions of trial leaders should be ignored or that they have no value. But it does mean that the audience for these opinions should be fully aware of the full context of the remarks, and that additional sources should be sought.
I think this could be a useful general test to evaluate the problem of COI: Given specific circumstances what is the likelihood that a perspective opposed to a financial supporter will receive fair play? This test could be used to assess the independence of news sources, teachers, guideline writers, regulators, and many others.
As an example, consider commercially supported continuing medical education (CME), another area where the problem of COI has been hotly debated. Supporters of commercial CME point to elaborate safeguards designed to insure the integrity of their programs. Many of us believe these safeguards are just window dressing or, less politely, lipstick on a pig. But instead of debating the details of the CME “safeguards,” let’s just look at the final product. Consider the hundreds of CME programs funded by Sanofi and Amgen in the last few years on the PCSK9 inhibitors — the same drugs that sparked this discussion. These programs have relentlessly promoted the need for and the importance of these drugs. Far less emphasis has been placed on the many caveats and concerns raised by FDA reviewers and the independent panel advisors. People following last week’s FDA panel would have been surprised by these issues if they had only relied on information derived from the ubiquitous commercial CME of the past few years.
Of course we will never completely remove COIs– financial or other– from medicine. But a first step to restore integrity is to make sure the system permits and encourages a wide diversity of views, including those without sponsorship.