Originally published in the Richmond Times-Dispatch.
When an FDA panel voted to reject a new weight-loss drug this fall, many observers were outraged.
Their beef wasn't with the FDA's decision, but rather with its process. Not a single scientific expert on "animal toxicity" a field relevant to the drug was on the panel. The FDA has since expressed "regret" for its actions.
One of the primary reasons for the omission was the FDA's highly strict conflict-of-interest policies. These rules have become insensitive to the realities of American medicine and often preclude the best scientific minds from filling slots on FDA panels.
This is outrageous. The FDA's decisions affect millions of patients. To make certain that the FDA can work with the world's best scientists, our nation's conflict of interest rules must be reformed.
With common areas of expertise such as oncology or cardiology, finding a qualified expert without industry ties isn't a problem. But for drugs treating obscure diseases, there are often only a handful of people with sufficient knowledge.
If those experts, despite impeccable records, don't clear every conflict of interest hurdle placed in front of them, they can't sit on the panel. And because there are so few doctors in many specialized fields, it becomes very difficult to fill these panels at all. In fact, a third of the FDA's more than 600 advisory committee seats are currently vacant.
That's not to say that conflicts of interest don't exist. They do. And they need to be guarded against to ensure a fair approval process.
It makes sense to gauge when and where conflicts are most likely to arise, screen all parties' motives and relationships and mete out punishments when there's corruption. What doesn't make sense, though, is the current trend of across-the-board bans for qualified candidates based on superficial ties to industry.
By being overly cautious, regulators have made it tough to fill FDA panels, slowing down the approval process and putting American innovation at risk.
Right now, just about everyone in the medical community is excluded.
Anyone who has ever received research funds from a corporation is barred from serving on an FDA panel, as is anyone who owns corporate stock. The FDA prohibits those who have ever consulted for a corporation from serving and also bans those who have been paid to speak at a corporate event. Even those scientists and doctors who have eaten a corporate-sponsored meal or accepted a corporate-gifted fruit basket are forbidden from FDA duties!
Regulators dogmatically focused on conflict of interest have forgotten that many medical breakthroughs have come and will continue to come from the industry-funded research system. For instance, the University of California at San Francisco and Pfizer just announced an $85 million agreement over the next five years to help translate scientific research into treatments that patients can use.
The absurdity of the current conflict-of-interest rules becomes even more apparent when you look at who isn't being excluded. Doctors and researchers with long histories or current associations with groups such as PETA and Greenpeace can sit on panels. Those with fringe religious and political views can also join.
It's absurd for the FDA to so heavily weigh corporate associations while giving a free pass to other factors that could be just as or even more suspect. Indeed, the recorded instances of manipulated research from scientists looking to please corporate backers are far fewer than those of academics skewing results in order to land tenure or get top billing at a prestigious conference.
There is no guaranteed method for eliminating conflicts of interest in scientific research. But a fairer system would be primarily concerned with a candidate's actual performance. The FDA should be focused on questions, such as ""Did she fairly adjudicate in past panels?" and "What's the quality of her research projects?"
Instead, the FDA currently asks irrelevant questions such as "Did she accept a lunch from a medical company 10 years ago?"
The most talented individuals in the scientific community also are the ones with the most extensive networks. Inevitably, most are going to have some kind of corporate connection. But the overwhelming majority of researchers are able to separate themselves from those connections and make objective evaluations of new medical technologies both in the lab and on public panels.
Automatically disqualifying experts from critical advisory positions based on minimal industry relations undermines scientific progress and hurts patients. And the system cultivates unfounded mistrust in the American people about the very people who have dedicated their lives to helping others.
We need to reform the conflict-of-interest rules so that the FDA can continue to protect patients without precluding some of the country's brightest scientific minds from the medical approval process.