FDA’s biggest concern should be consumers health, not of Big Pharma

Conflict of interest is a major theme on our blog.

When a person is on trial, friends and family are not allowed on the jury because they would have biased judgment. When someone has interest in the outcome, it is virtually impossible to expect a fair decision.

Such has been the case with the FDA, particularly in recent years. Now, a bill that would reform the FDA is before the House. The proposed legislation includes language that would limit FDA advisory committees to only one scientist with a conflict of interest per meeting.

That may sound like one too many — but in the world of the FDA, that would be real progress.

According to Merrill Goozner,

Currently, nearly a quarter of all scientists appointed by the FDA to advisory panels have ties to companies with a stake in the outcome of the committees’ deliberations, whether the sponsors of the drug or device, or their competitors…

Since passage of the Prescription Drug User Fee Act in 1992 and comparable legislation for drug devices a few years later, the FDA’s resources, increasingly dependent on industry fees, have been targeted towards expediting the approval of new drug and device applications. The result has been a mindset at the agency that downgrades concerns about safety.

The advisory committee system, which brings in outside physicians and scientists to review the clinical trial data about new drug and device applications, has been similarly transformed. Most committees, whose advice the FDA usually follows, are filled with physicians whose primary professional interest is in having more options for their patients. Many have close personal and financial relationships with the industry.

They don’t bring a green eyeshade mentality to the advisory committee proceedings, they bring a green light mentality.

Pharma apologists contend that there simply aren’t enough qualified scientists with no ties to the drug industry, and furthermore, that many who do have industry ties are not unduly influenced by them. Free-market fundamentalists (like those in the Bush Administration) join in, too, arguing that objective regulation will bog down the system and slow down the time it takes for drugs to reach the marketplace.

To these arguments, Goozner responds,

Any company that has a true breakthrough product, one that will cure a disease or slow its advance where none existed before, or ameliorate its symptoms, need not fear an objective review. Even if there are safety risks like the heart attacks recently associated with the diabetes drug Avandia, the new drug will gain approval because the clear benefits of taking the drug outweigh the occasional risks. On the other hand, new drugs for conditions where there are already many options on the market — like Avandia — may have a harder time getting through.

I agree with Merrill that a more objective, thorough review system would only increase consumer safety; it would not prevent the approval of truly innovative drugs.

And if I did have to make the choice between innovation and safety, I’d take safety every time. Wouldn’t you?

57

Leave a comment