May 23, 2001
By HOLMAN W. JENKINS JR.
Next time she's in Washington, Estelle Bober ought to stop in and give the FDA a piece of her mind.
She and her late husband, Martin Bober, were name plaintiffs in class action against Glaxo, maker of Zantac, the ulcer medicine available in both prescription and over-the-counter strengths.
Mr. Bober, it seems, devoted considerable effort to trying to find out from Glaxo whether it was safe to substitute two of the 75-mg over-the-counter pills for one of the 150-mg prescription version, saving 67 cents on the larger dose. He called the consumer help number. He surfed the Web site. But all he got were variations on "If your physician has prescribed a medicine, you should not substitute any other medicine for your prescription."
Both drugs are ranitidine, though the FDA authorizes them for different afflictions. The prescription strength is for "duodenal ulcers" while the consumer version is for "gas." Yet it hardly takes a pharmaceutical engineer to figure out that two of this equals one of that.
So why didn't Glaxo just say so? "The pharmaceutical industry is highly regulated," explained a federal appeals court in dismissing the Bobers' suit. "Technical requirements abound, and it is not only possible but likely that ordinary consumers will find some of them confusing, or possibly misleading."
This has relevance to the debate about over-the-counter status for the new generation of non-sedating allergy drugs. Medically, the FDA decision is a no-brainer: The new drugs are safer than the knockout pills already sold over the counter for allergy relief, and the law says anything the consumer can take safely after reading the label should be available without a prescription.
Five will get you 10, though, that when the FDA weighs up the "medical" evidence, Claritin, Allegra and Zyrtec will be approved as "dual status" drugs -- i.e., a lower dose will be sold over the counter and a higher dose by prescription. This will have nothing to do with "technical requirements" and everything to do with allowing patients to go on charging their insurance companies.
That a scientific agency, focused on "safety and efficacy," finds itself bollixed up in these compromises is evidence of the rivet-popping pressures building up in our system. When a drug goes OTC, usually the price falls. Yet, perversely, FDA worries about insured patients being priced out of the market.
At the same time, the drug industry depends on insured customers for the bulk of its revenues but can also boost its return on R&D with additional sales to the sort of people who won't put up with doctors and insurance forms. Thus the FDA becomes directly complicit in the industry's price-discrimination strategies (as the Bobers should have learned).
These compromises can only become more strangulating as the future of medical care becomes increasingly a matter of pills, pills, pills. These won't just treat what ails you but your future propensity to disease and, blurringly, your lifestyle and "aspirational" goals.
The FDA is hardly suited to deciding who will pay for this, but the mess lands in its lap by default. Of the $4.7 billion spent on allergy medicines last year, fully half was raked off by doctors giving demonstrations of their penmanship. But such is the inevitable nuttiness of a system that creates a huge tax incentive to channel every ache and pain through the third-party payment mill.
To their credit, forward thinkers at the agency's OTC branch have looked beyond the distortions and noticed that the new consumer-centric medicine offers distinct advantages over the old doctor-centric version. Already the national experiment in drug advertising has worked wonders in getting people to seek treatment and stick to it. Next up will be an eye-opening debate over OTC cholesterol fighters.
Doctors have been notably inefficient at getting these drugs to the people who might benefit from them, yet now the National Institutes of Health has issued new guidelines tripling the target population -- to 36 million people, which is about 90% more than are likely to see a physician and get good advice about cholesterol.
Last summer, the FDA rejected appeals by Merck and Bristol-Myers to sell Mevacor and Pravachol over the counter. The argument was that patients still need to see a doctor to find out how high their cholesterol is. But this was already beginning to seem a pointless quibble even before the latest NIH recommendations.
Anyone can back a truck up to a health-food store and get unlimited quantities of Chinese red yeast, containing the same molecule as Mevacor. But the final nail may have been a British Medical Journal study, which found that cholesterol drugs can cut heart attacks by 30% even among people with normal cholesterol and no sign of coronary disease.
This means that, no matter how lousy they are at self-diagnosis, self-medicating cholesterol worrywarts should still be able to do more good by accident than doctors do on purpose. And the same is probably true for a host of other drugs trapped behind the counter, including sleep aids, antibiotics, pain relievers and antidepressants. Which raises the question: Why do we need "prescriptions" anyway?
Insurers don't need the FDA to tell them which pills to cover. Indeed, the industry will soon sink under a red tide unless it starts drawing sensible lines of its own.
Nor is the old system working for drug makers. Willy nilly, liability is being shifted to them for the prescribing errors of doctors (accounting for perhaps 20,000 deaths each year in hospitals alone). In a bracing decision, the New Jersey Supreme Court held that drug makers may no longer hide behind the "learned intermediary" defense (it's the doc's fault) when they pitch their ads directly at the public.
Instead, drug makers may have to take a more active hand in how their pills are used. Courts have long recognized that manufacturers can have a legitimate interest in controlling the downstream fate of their products. Rulings routinely uphold their right to restrict distribution to authorized dealers and ban discounting. And given their vast investment in brand promotion, drug makers have more stake than most in making sure their products are used safely and effectively.
Plus, ask the Bobers: The mere fact that people clamor for over-the-counter drugs, even despite the enormous tax subsidy to prescription medicine, shows that self-medication is the wave of the future whether the drug industry likes it or not.