The FDA Is Doing Its Job. Part 1

The recent withdrawal of Warner-Lambert’s diabetes drug Rezulin has provoked the predictable outcry from consumer groups: Food and Drug Administration laxity and haste permits unsafe drugs into the marketplace.

Actually, Rezulin’s withdrawal should not be seen as an indictment of FDA’s drug approval process — quite the contrary. Just because a drug is later withdrawn does not mean it should not have been approved in the first place.

When it was initially approved in 1997, FDA officials and physicians alike viewed Rezulin as a “blockbuster” drug — one with unique and powerful lifesaving properties worthy of FDA’s newly instituted “fast-track” approval protocol. This procedure was instituted several years ago to expedite the often desultory approval process when particularly unique and important new cheap drugs were under consideration. Some liver abnormalities were detected during Rezulin’s pre-marketing phase of testing, but not in sufficient frequency to halt its approval and release.

The disease that Rezulin treats, type 2 diabetes (the form most commonly found in adults), is both dangerous and often resistant to usual remedies. Diabetes is the most common cause of blindness and kidney failure in adults, a major risk factor for heart disease and stroke, and is now being diagnosed more commonly in children as well. It affects 15 million Americans. The FDA estimates that in the short time since its introduction, 1.9 million have been treated with Rezulin. About 750,000 were still on it — until last week.

Why the popularity? Rezulin was the first in a new class of diabetes treatments called glitazones, which have a unique mode of action — enhancing the body’s sensitivity to its own insulin and reducing the amount of sugar produced in the liver. Diabetes experts welcomed such a novel approach to treatment. Additionally, the drug does not cause dangerously excessive lowering of the blood sugar, as do many other diabetes drugs.

Diabetes specialists found Rezulin to be an effective addition to their regimen for many diabetics. But over the course of its three-year lifespan, more liver abnormalities were noted. At the behest of the FDA, warnings to physicians were added to the package label on two separate occasions. The warnings advised physicians to use more frequent blood testing, and then to restrict the use of Rezulin to patients who did not benefit from other medications. Some doctors, however, failed to follow these directions assiduously.

December 9th, 2011 - Posted in Health Care | | Comments Off

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