Hall wonders if Vioxx was overpromoted compared to what the alternatives are. While fingers are being pointed at pharma and
FDA, he says, "There's a basic question about how we reimburse for drugs. Your insurance company reimburses you for prescription
drugs—Nexium, Vioxx, what have you—while many over-the-counter drugs have to be paid for out of your own pocket. The patient
really has no choice after a while." Another thing: "If you have a $3 billion to $4 billion drug and you're spending a quarter
of a billion dollars on advertising, you've got to believe that it's being used beyond what the strict indications warrant,"
Will the Vioxx issue spur tighter regulation of DTC marketing? Says Morris: "The Democrats are interested in putting some
limits on DTC. It does provide them with ammunition."
Expect the Unexpected
The Vioxx recall underscores the need to do better postmarketing surveillance of drugs, says Sandy Schwartz, MD, professor
of medicine, health care management, and economics at the University of Pennsylvania School of Medicine. "We all recognize
that initial clinical trials are not designed to pick up unanticipated side effects," he says. "Unanticipated side effects
are just that—unanticipated. But statistically we know they're going to happen. And we don't have an adequate system in place
to detect them."
Morris says pharmacovigilance was a hot area before Vioxx. "The FDA just last May came out with new guidance for good pharmacovigilance
planning, for risk communication, for good premarket risk assessment," he says. "The recall will contribute toward that. I
suspect there will be a round of politicking, finger pointing, and lawsuits. But major change? I doubt it."
Schwartz says, "We're looking at the risk-benefit of drugs—something the public doesn't understand and the lay press doesn't
do a good job with. We're not talking about things that are good or bad. With all these drugs, it's a question of how good,
in which patients, under what conditions. Every drug, if enough people take it in pharmacologic doses, is going to have some
adverse events. The real question is whether the benefits of the drug are sufficient to significantly outweigh the risk. To
the degree a drug is used in the highest-risk patients, then even its chance of doubling the risk of a cardiovascular event
might be acceptable if the benefits are sufficiently high. However, to the degree it is used in people for whom the expected
benefit is minimal—people who don't really need it—then even a very small risk is unacceptable. FDA—the staff and advisory
committees—does an excellent job dealing with that. But it's not always appreciated by the general public. The public thinks
a drug's either good or bad."
But, he adds, "There's a tendency to use some of these new drugs rather indiscriminately instead of targeting them to the
people who would benefit the most. I don't think there's any question that overprescribing has been going on in this class
of drugs. Drugs should be used where there's a significant benefit. We have to recognize there are always going to be unanticipated
and unmeasured adverse events, what we call a Type 2 error. There's a chance you'll miss something because you're not looking
for it. In this case, we were lucky it was found."