In the wake of the Vioxx/Celebrex flap, there’s been lots of finger-pointing, but it seems to me not enough consideration of what principles ought to guide policy when it comes to approving new drugs or ordering existing drugs off the market.
Given patient-to-patient variability, the idea that a drug is “safe and efficacious” (or not) generically can’t really be right. What if a drug is helpful to some patients and harmful to others and the difference between the two groups is observable, either in advance or by monitoring the patient during a trial period? There are almost certainly patients who, given the alternatives, would be better off staying on Celebrex rather than switching to the older generation of NSAIDs. But there’s no guarantee that those are the patients who will actually be continued on the drug if it isn’t yanked from the market.
The FDA is necessary partly because of the economics of data collection and analysis suggest that those tasks be done centrally, and partly because patients and physicians are imperfect decision-makers. But not all patients, and not all physicians, are equally imperfect.
Some know much more than others about pharmacology generally, or about a specific drug or class of drugs. While it makes sense to have a regulator in the middle to protect the less-knowledgeable from the persuasive powers of the drug companies, it make no sense to overrule the decisions of doctors and patients who may be as knowledgeable about a drug as the FDA regulators themselves, and are certainly more knowledgeable about the details of a particular case.
The SEC came up with a fix for the analogous problem in capital markets: the “sophisticated investor” rule. In the securities case, “sophistication” means no more than deep pockets and experience in high-risk investing. But in the case of drugs, why not craft categories of “sophisticated” doctors and patients who could, by passing examinations, win for themselves the right to prescribe, or to use, drugs not yet approved for marketing to the general public?
It would be reasonable to require, as a condition of participation in the program, agreement to collect and submit appropriate information about the use of the drug and its outcomes to the drug-review process. That would somewhat compensate for what might otherwise be the reduced pressure to participate in clinical trials.
Of course, mistakes would continue to be made. But is there any reason to think that, given the option of using non-approved drugs, truly knowledgeable physicians and patients would in fact make choices that led to worse outcomes rather than better ones? None that I can think of.
Note that the proposed rule would be more liberal than the current policy in some respects, but more restrictive in others.
For example, the benzodiazepines — the class of “minor tranquilizers” that includes Valium, Ativan, and Xanax — are highly useful drugs that also carry very substantial risks of iatrogenic dependency if not used properly. Most of the physicians who write benzo prescriptions have only sketchy knowledge of the subject; typically, for example, a given physician, even one who writes many benzodiazepine prescriptions, prescribes no more than three of the drugs in this class, which suggests a suboptimal job of matching drugs to patients. The same is true of the opiate and opioid pain relievers.
It’s far from clear to me that every physician in the U.S. ought to be able to prescribe the full range of benzos and opiates, or ought to be able to prescribe the benzos at all. Perhaps prescribing those drug classes ought to be restricted to physicians who have passed an exam showing that they know what they’re doing.
Maybe there’s a case for the existing one-size-fits-all regulation, but I haven’t seen it made.
2 thoughts on “Drug approvals and removals:
the case for a “sophisticated doctor” rule”
"Sophisticated Doctors" – another approach
Mark A. R. Kleiman suggests that doctors may often know more about a patient's needs and risks than the FDA. Some know much more than others about pharmacology generally, or about a specific drug or class of drugs. While
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