Thursday, May 6, 2010

How The FDA's Conflict-Of-Interest Rules Hurt Patients

Cross-posted from Critical Condition on National Review Online.

The New York Times has an editorial out endorsing the U.S. Food and Drug Administration’s stepped-up efforts to root out conflicts of interest within its advisory committees of outside experts. If you’ve ever wondered why FDA decisions have gotten increasingly erratic over time, you can thank those who agree with the Times:
For many years now, critics have complained that the votes of some committee members could be swayed by financial conflicts — such as owning stock in or consulting for a company whose product is under consideration, or for one of its competitors. Although laws and regulations are supposed to screen out scientists with financial conflicts, the F.D.A. routinely granted waivers to allow participation by specialists whose hard-to-find expertise was deemed essential.

Prodded by a 2007 law, the F.D.A. has greatly reduced the number of waivers and gone even further than the law requires. It had been granting waivers to more than 15 percent of the members participating in meetings but is currently granting waivers to less than 5 percent. That is a major accomplishment toward cleaner decision-making.
This sounds nice. Cleaner decision making. Who should want people with conflicts of interest to advise the FDA? Actually, patients should — because the physicians who have the most knowledge about a given disease are almost always those with the most conflicts.

There are two kinds of physicians: the vast majority, who do their job based on adherence to consensus-based standards of care; and the small minority, who investigate the basic biological causes of disease and conduct clinical trials based on the latest science to see if we can come up with new ways to better treat patients. They are the ones who try to change the consensus, for the better.

But those clinical trials of experimental new drugs cost money. A 1,000-patient trial, for example, might cost $100 million to run. Who has the money to pay for such a trial? The developers of the experimental therapy — that is to say, a drug company. Hence, doctors who participate in clinical trials are partially “funded” by drug companies. In the Left’s simplistic worldview, anything with the taint of industry is fundamentally corrupt. Hence, these doctors, simply because their trials are funded by industry, are corrupt by association.

In the old days, the FDA populated its expert panels with thought leaders in every major field of disease. But now, due to these draconian conflict-of-interest rules, most true medical experts are disqualified from participating. So the FDA fills its panels with non-specialists, or other doctors who are less familiar with the latest developments in a particular area of medicine. As a result, the FDA’s panels have become unpredictable, and have much less bearing on the actual clinical-trial data for a particular drug. The FDA, fully aware that its outside panels are less useful, now routinely disregards their advice and does whatever its internal reviewers want to.

A much simpler approach would be to completely eliminate these conflict rules and simply require panelists to disclose their funding sources. This way, the FDA can take potential biases into account when listening to their advice. But to cut off that advice in toto is irresponsible. It has made the FDA more insular and less able to solicit the advice of leading doctors in every field of medicine. This harms the agency’s ability to bring new, life-saving drugs to the market.

While the Times has its fun alleging that these doctors and companies are corrupt, the only interests that have been compromised are those of the actual patients who suffer from the diseases those innovators are trying to treat. Bravo.

1 comment:

  1. where in the hell does the $100mm come from? AS SOMEONE who participated in 2 trials, the patient pays for due process of care- Md visits, imaging, tests, etc inc travel and exp. The only item not paid was the drug, which costs pennies, unless one takes the US retail price. The payments not seen are for the Md principal investigator in form of fees, stock, options and other income. The hospital or clinic also receives some payments and when approved or milestone reached, another payment is made to both. These payments are excluded from the Sunshine Law reporting so patients are unaware of the payments made to the Md (creating COI) and clinics.
    The true charges are billed to the patient and insurance. They are not paid by big pharma for the trial!
    The amount noted it overstated and in line with the mis information which goes along with this type of debate....get the facts straight please!