The Public Policy

Risky Business

Sen. Kennedy should push to liberalize drug approval standards.

By 7.30.08

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Senator Ted Kennedy returned to the Capitol recently following successful surgery to remove a tumor from his brain. Soon, he'll begin radiation and chemotherapy treatments to help make sure the tumor doesn't return.

We wish the Senator well, and hope that his experience serves as a learning moment for him and his congressional colleagues. After all, the 76-year-old Senator Kennedy could benefit directly from the innovative new medicines produced by the pharmaceutical industry that he and other members of Congress take sport in chastising.

Unfortunately, demonization and over-regulation of the pharmaceutical industry is making it increasingly unlikely we'll have the innovative new drugs patients will need to treat the next generation of diseases that will become increasingly prevalent as Americans live longer than ever before.

We've conquered most of the age-old scourges that our grandparents had to confront. But growing older means treating the chronic and degenerative diseases of aging, such as heart disease, various cancers, and Alzheimer's. In fact, according to the Alliance for Aging Research, the average 75-year-old has three chronic conditions and uses five prescription drugs.

THE TROUBLE IS, discovering and prescribing medicines that treat chronic diseases pose safety issues that are substantially different from those we faced with the drugs of yesterday.

How can one-in-a-million risks of long-term toxicity be studied when clinical trials take just a year or two and include only a few thousand patients, for example? Or, what sort of risk tradeoffs will patients suffering from Alzheimer's disease or diabetes accept in order to keep their health conditions stable?

Historically, the U.S. Food and Drug Administration has been ill-equipped to answer these questions. So, a few years ago, agency officials embarked on a "Critical Path Initiative" in order to bring FDA science and analysis into the 21st Century.

Much of that progress has been short circuited, however, by political grandstanding in the wake of several high-profile drug safety scares -- such as the withdrawal of the pain medication Vioxx in 2004.

Today, the standard forced on the agency by American politicians is not "how can we get useful new drugs to market while minimizing risk?" Instead, members of Congress from both parties insist that there be zero risk -- a standard that cannot be met.

That political cynicism is having a toll. FDA's Center for Drugs approved just 16 new medicines with novel chemical compounds last year, down from a recent high of 53 in 1996 and 39 in 1997. The length of time it takes FDA to review and approve new drug applications has also risen, from 13.4 months in 1998 to 23 months in 2005.

And that's just the agency review, which comes after an average of eight or ten years of actual testing.

OF COURSE, there are many reasons why fewer new drugs are being approved, such as the increasing difficulty of tackling harder and harder diseases. But the bigger problem is heightened political scrutiny of FDA and congressional demands for tougher reviews.

Last year alone, the FDA rejected approval for five new cancer drugs, including a breakthrough treatment for prostate cancer called Provenge. Although a panel of cancer experts that advises FDA on new drug approvals unanimously agreed that Provenge was safe, and voted 13 to 4 that it was effective, FDA demanded still more testing that may delay approval for three more years.

Unfortunately, the Provenge rejection is not unusual, and this extra agency caution doesn't actually improve drug safety. 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 unsafe drugs that occasionally do make it to market.

One study by economists from the University of Chicago, MIT, Biogen Idec Inc., and Westfield Capital looked at all 662 drugs approved from 1979 to 2002 and concluded that, even if every withdrawn drug provided no benefits at all, the faster pace of approvals beginning in the 1990s benefited patients with an extra 180,000 to 310,000 years of life -- roughly three to five times greater than the worst case estimate of harms.

FDA is once again under enormous pressure to slow down reviews. But, since there is no way to rule out the possibility of even very serious side effects by testing a drug in a few thousand patients, the only way to ensure no withdrawals is to approve no new medicines.

That would be the real patient tragedy. Congress and the FDA need to skip the grandstanding and get serious about bringing safe and effective new treatments to market. For millions of Americans like Senator Kennedy, it truly is a matter of life or death.

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About the Author

Gregory Conko is a senior fellow at the Competitive Enterprise Institute.