The American Spectator

Unfortunately, medical research is uncertain: developing new remedies is not like finding manna from heaven. Worthwhile discoveries require sorting through thousands of compounds, most of which end up dry holes.

Moreover, regulation and price controls would most discourage firms from investing to develop new products with more uncertain, though potentially more lucrative, payoffs. Blockbusters warrant higher prices because their discovery cannot be predicted and their success cannot be guaranteed. The European experience demonstrates that price controls drive companies toward the more certain reward of me-too products.

Anyway, me-too drugs often offer important therapeutic advantages. The more drugs available to treat a given condition, the more options a doctor has in treating a patient. A medicine that works well for most people might not help everyone; sometimes a slightly different formula proves substantially better for some consumers. “There’s a lot of patient variability,” explains rheumatologist John H. Kippel. “It’s not unusual for patients to try several options before finding one that works.”

The Food and Drug Administration encourages creation of competitive products. Observes Dr. Janet Woodcock of the FDA’s Center for Drug Evaluation and Research, the agency favors “a choice of drugs within the same class, since not every patient responds to every drug in the same manner.” The availability of many drugs has proved to be invaluable in treating AIDS, as treatment resistance increases.

The importance of having more than one option is dramatically illustrated by Merck’s decision to withdraw its COX- 2 inhibitor Vioxx because of adverse side-effects. Patients requiring relief from inflammation but vulnerable to stomach problems have an alternative: Pfizer’s Celebrex. But the future of that medicine is now in question, even though the company says it plans to keep it on the market (while discontinuing advertising). Happily, a half dozen more COX-2 inhibitors are being developed.

Further, “me-too” products help lower prices of existing therapies. One way to bring down the cost of patented products is to speed generics to market. The other is to encourage creation of competing drugs. If patients have no choices, they will pay much more.

One might as well ask: Why produce more than one brand of automobile or computer? We don’t need competing versions of the same thing.

Ironically, the New England Journal of Medicine, which Angell used to edit, recently published an article which observed that me-too drugs had driven down the price of statins. Added the NEJM, “Lower costs for me-too drugs are also seen in other commonly used classes of drugs.”

Finally, predicting which drugs will be blockbusters and which will not is impossible. Angell defines as innovative drugs “new molecular entities” which receive priority review by the Food and Drug Administration.

But not all NMEs end up as great medical advances; some seemingly less important products unexpectedly provide significant treatment advances. Boring drugs can develop exciting uses: Celebrex might be effective in preventing and treating Alzheimer’s Disease and colorectal cancers.

Angell’s desire to limit patent protection is similarly myopic. The length of patents is arbitrary, but drugs are no different from other products in this regard.

Patents provide a temporary monopoly to encourage innovation. Cut the patent life and cut the incentive. There’s no escaping that trade-off. Maybe the current compromise isn’t the best, but there is no inherently “right” answer.

ULTIMATELY, DR. ANGELL BELIEVES that patients should have no say in what medicines they receive: The FDA should approve fewer drugs, do so more slowly, and limit what consumers are told about their options. Yet every day a life-saving medicine sits unapproved or unused means more suffering and dying patients. FDA foot-dragging has been responsible for hundreds of thousands of unnecessary deaths over the years.

Angell is particularly critical of direct-to-consumer advertising. But patients should learn about available treatments; in many cases people didn’t even know that answers were available for their problems.

Anyway, doctors remain gate-keepers by prescribing medicine. Whatever abuses exist are not solved by restricting the supply of new drugs.