- The Washington Times - Wednesday, October 10, 2007


Two weeks ago, President Bush signed into law the comprehensive Food and Drug Administration Amendments Act. Passed by overwhelming majorities in both houses of Congress, the amendments are meant to reform the nation’s drug approval process, which has come under fire in the wake of recent high-profile drug safety issues. Critics say the agency has been reckless in approving new drugs and too slow to pull them from the market when safety questions arise. But, for patients with life-threatening illnesses who depend on new drugs making it to market quickly, slowing the drug approval process could be a death sentence.

Last Tuesday, dozens of cancer patients and their family members rallied outside the Food and Drug Administration headquarters in Rockville, Md., to condemn the agency for approving cancer drugs too slowly and rejecting many promising new treatments. This year alone, the FDA has rejected approval for five new cancer drugs, but it was the rejection in May of a prostate cancer drug called Provenge that forced these patients to act.

Provenge works like a vaccine to help a patient’s immune system fight off prostate cancer, a disease with few other available treatments. A panel of cancer experts that advises the FDA on new drug approvals unanimously agreed that Provenge was safe, yet the agency demanded additional testing before it would approve the drug.

The FDA’s main concern is that Provenge may not be effective enough. In one trial, 34 percent of patients receiving the drug were alive three years after treatment, compared to just 11 percent of patients receiving the placebo. But the median survival time for those taking Provenge was just 4½ months longer than for the placebo group. Still, Taxotere, the only currently approved alternative for advanced prostate cancer, extends survival for just half that time.

Is a mere two to four more months of life sufficient to justify approving this new drug? It certainly is for many of the men actually suffering from prostate cancer.

Bruce Towers, who has been fighting prostate cancer since 1996, participated in a Provenge trial two years ago. His moving testimony at the rally centered on what Provenge had given him: extra years with his young grandchildren, who now know firsthand how much he loves them. “Do you know what it means [to hear your] grandson say ‘I love you pa-pa’? That’s what Provenge has given me… it is the aspect in which my life is measured. And it’s measured by me, not you.”

The additional clinical trials ordered by FDA won’t be completed until 2010, though the agency could reconsider its decision after an interim assessment is released in 2008. Still, Mr. Towers fears the drug won’t be approved in time for him to receive another treatment if his cancer returns, and that others like him will be denied access altogether. More than 30,000 men die of prostate cancer each year, he says. “Why should they not have the same opportunity I had?” Indeed, if the FDA agrees Provenge is safe, why should these patients have to wait?

The reason is that the FDA has learned a lesson from the backlash that arose in the wake of recent drug safety scares — such as the withdrawal of the pain medication Vioxx in 2004. Members of Congress from both parties have accused the agency of recklessly speeding drugs to market for the sake of corporate profits and at the expense of patients. That attitude prompted many of the changes in the new legislation, and the FDA has been reminded there is rarely a penalty for delaying approval of drugs. Withdrawn drugs like Vioxx get lots of attention from the media and Congress, but hardly anyone has ever heard of Provenge.

Paradoxically, longer agency reviews don’t improve drug safety. Studies by the FDA itself show the rate of drug withdrawals has remained essentially unchanged over the last 25 years, despite rising and falling approval times during that period. On the other hand, the health benefits of faster approval decisions far outweigh the risks associated with the small number of drugs that are eventually withdrawn.

One study by economists from the University of Chicago, the Massachusetts Institute of Technology, Biogen Idec Inc. and Westfield Capital looked at all 662 drugs approved from 1979 to 2002 and concluded that the faster approvals beginning in the 1990s benefited patients with an extra 180,000 to 310,000 years of life — roughly 3 to 5 times greater than the worst case estimate of harms.

Those figures only scratch the surface of the vast human cost of needlessly delaying drug approvals and keeping others off the market. The Abigail Alliance for Better Access to Developmental Drugs estimates “the government may have contributed to a million premature deaths by delaying 12 cancer drugs in recent years.”

For terminally ill patients who depend upon new drugs making it to market quickly, this law may be a death sentence. People like Bruce Towers don’t have time to spare.

Gregory Conko is a senior fellow, and Erin Wildermuth is a research associate, at the Competitive Enterprise Institute.

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