Bringing the Consumer Revolution to the FDA
April 25, 2005
If aspirin were invented today, the U.S. Food and Drug Administration might not approve it. We should keep this in mind when thinking about Vioxx, Bextra and other pain-relief drugs that have recently been taken off the market. This is not to say that the new pharmaceuticals are “safe,” but rather that all pharmaceuticals involve tradeoffs. The real question is: who is to make those tradeoffs, patients and doctors or the FDA?
Robert Bucholz had been taking Vioxx for years when it was removed from the market and naturally he was upset at the FDA. Upset that the FDA had approved an unsafe drug? No, upset that the one drug that he could take without irritating his stomach was being taken away from him. “I’ve got my own personal supply of Vioxx and I’m not about ready to destroy it,” he said. “All life is a series of risks, and you’ve got to measure the risks versus the benefits. And that’s true of any drug.”
Should the FDA restrict Bucholz’s choice “for his own good”? Perhaps, but Bucholz is not exactly an uninformed consumer; he’s president of the American Academy of Orthopedic Surgeons and chair of the orthopedic surgery department of the medical school at the University of Texas Southwestern in Dallas.
When the FDA forces an old drug off the market, patients have very little say in the matter. Patients have even less of a say when the FDA chooses not to approve a new drug. Instead, we are supposed to rely on the FDA’s judgment and be grateful. But can the FDA really make a choice that is appropriate for everyone? Of course not. If Tylenol works for your occasional pain, then Vioxx or Bextra may not be right for you. But if Tylenol doesn’t work and your pain is so debilitating that you can’t enjoy life, isn’t an option with risk better than no option at all?
The FDA currently works on a paternalistic model: One choice to rule them all. But another approach, what I call the Consumer Reports model, would meet the needs of diverse health-care consumers much better. Consumer Reports doesn’t try to replace consumer choice. Instead, by carefully evaluating and testing new products and providing this information to readers, Consumer Reports helps consumers to make better choices. Similarly, a less paternalistic FDA would provide more information to patients and doctors, but it would also leave more choices in their hands because only patients and their doctors have the particular knowledge that allows each patient to be treated as an individual.
A consumer-oriented FDA does not mean an end to the agency. On the contrary, an FDA reorganized on the Consumer Reports model would produce and disseminate more information to patients and doctors, it would be more independent of the industry and it would be more willing to counter puffed-up pharmaceutical industry advertising.
It may seem odd, but if the FDA had fewer powers over the industry it could be more independent. Consumer Reports, for example, has no power over the industries that it monitors and because of that fact it can answer to consumers alone. Consumer Reports, for example, does not accept any advertising. In contrast, a large share of the FDA’s budget comes directly from pharmaceutical firms through the Prescription Drug User Fee Act. (PDUFA is a good law that cuts delay in the approval of new drugs caused by Congress’s perennial under funding of the FDA, but it is not as good as true independence.) Furthermore, Consumer Reports conducts its own testing (or contracts that testing out to independent labs) while the FDA relies on the pharmaceutical manufacturers to test their own products—an inherent conflict of interest.
A consumer-oriented FDA would also help consumers decide which drug is best for them by testing products in head-to-head comparisons. Imagine how much less useful Consumer Reports would be if it issued only “acceptable” or “not-acceptable” recommendations—but this is precisely the focus of the FDA.
In addition to comparing drugs head-to-head, a consumer-oriented FDA would, along with the National Institutes of Health, spend more time testing novel therapies. At present, once a pharmaceutical has been approved for sale, the FDA does not evaluate new uses for that pharmaceutical. But the few times this has been done in the past have proven to be very valuable. NIH sponsored trials on hormone replacement therapy for women, for example, demonstrated that a popular treatment intended to reduce heart attacks was actually increasing them, as well as causing a host of other problems.
Throughout the field of health care, consumers have become empowered to take greater responsibility for their own wellbeing. Rather than succumb to a paternalistic status quo that reduces our health, it’s time for the consumer revolution to breach the walls of the FDA.
