The Wall Street Journal - 4 April 1996
Robert M. Goldberg

Under Dr. Kessler, the average amount of time it takes to a develop a new drug has climbed to an all-time high of 15 years. He cites a General Accounting Office study showing that review times have fallen to 19 months from 33 months, but that report looks only at the FDA's review of a final drug application. Since Dr. Kessler became commissioner in 1990, other phases of the FDA's review have gotten longer, driving up development time overall.

The reason? The number of people used in clinical trials has increased, the number of clinical procedures per patient has doubled, and the amount of information the FDA demands before accepting a new drug application has skyrocketed. In particular, the number of clinical procedures required in testing cancer drugs increased 153% since Dr. Kessler took office. Until last Friday, he defended this delay by waving the bloody shirt of safety. The sudden reversal of policy suggests that Dr. Kessler has known better for quite some time and had no good public health reason to delay drug development at all.

Indeed, drug development experts, including the former director of the National Cancer Institute, Samuel Broder, had fought courageously for years to accelerate the testing and review of cancer drugs by the FDA. Dr. Broder notes that the idea that the FDA "is the one gold standard for proving that a drug works is simply not true." There are many other scientifically valid types of studies, he says, "many of them based on newly emerging principles of pharmaco-dynamics."

Dr. Broder's observations are echoed by Carl Peck, former director of the FDA's own Center for Drug Evaluation and Research, who believes the FDA's approach to drug review is outdated and needlessly involves more than 25,000 people each year in drug trials. These are people who, instead of being exposed unknowingly to inactive placebos, could be receiving care or obtaining new medicines in the real world.

Rather than extending faster drug review and a more liberal definition of "benefit" to all drugs in development, Dr. Kessler has turned accelerated approval into political patronage. AIDS groups lobbied for faster approval and, lo and behold, the need for two trials disappeared. Republicans swept into office demanding FDA reform and -- presto! -- cancer drugs were placed on the fast track.

The sudden shift in cancer policy reveals the moral bankruptcy of the FDA's approach to drug development. It used to claim that accelerated approval was limited to drugs that held out a last-ditch hope of postponing or averting death. Under the new cancer policy, drugs that in some way will improve the quality of life will also get fast-tracked. If accelerated approval is no longer limited to potentially life-saving drugs, why leave drugs that might help patients with other serious diseases and conditions on the slow track? Where is the public health benefit of giving faster access to one group of Americans while denying access to others?

Moreover, Dr. Kessler's aggressive efforts to increase his agency's control over the dissemination of off-label drug information also endangers the public health. Jur Strobos, a former director of the FDA's policy staff, notes that rather than protecting the public health from unsafe drug use, the "current proscription on off-label promotion may actually facilitate, rather than limit, such unsafe practices," because many doctors remain unaware of effective treatments.

For example, studies conducted by the National Cancer Institute found that when used in the right combination with other anticancer drugs, etoposide is a less toxic treatment for non-Hodgkin's lymphoma in the elderly than drugs approved by the FDA for that same disease. Yet the FDA bars etoposide's manufacturer from distributing the NCI study and other off-label information on the best dose and drug combination.

Research conducted by the National Institutes of Health on the use of the clot-busting drug TPA found that a change in dosing strategy increased the survival rate of heart-attack patients. Proper dosing was also found to alleviate complications due to excessive bleeding as a result of using the drug. The new dosing regimen was deemed an off-label use and the drug's developer was barred by the FDA from telling doctors and patients about the new approach. In the process, Dr. Kessler's policies endangered thousands of heart patients. Indeed, several studies have shown that the absence of timely information on appropriate -- and usually off-label -- uses of drugs is implicated in 15% to 30% of the drug-related deaths or life-threatening drug reactions in hospitals.

Finally, Dr. Kessler has held up approval of an at-home test for HIV. When Dr. Kessler became commissioner, the FDA told the New York Times it would change guidelines to allow AIDS testing outside of health clinics. Six years later, and more than 10 years since the application for the home test was submitted, the test is still not on the market. The FDA has acknowledged that the test -- consisting of a lancet, a blotter, a Band-Aid and a mailer for the blood tests -- is accurate and safe. In 1994, an FDA advisory panel concluded that the public health benefits of the test outweigh the risks. Yet the test is still unavailable.

In a memo to White House Chief of Staff, Leon Panetta, Dr. Kessler as much as promised approval: "[A]ny remaining concerns about the impact of product approval on the public health will be examined through post-approval studies." That was 18 months ago. The FDA says the hold-up is (of course!) problems in developing "adequate" post-approval studies. The real reason for the delay is more detestable: An internal government memo summarizing a meeting between the FDA and the Centers for Disease Control states: "The CDC has serious concerns about the potential for a sudden increase in referrals to already overburdened health clinics if the kits should be used." In other words, the kits would encourage too much testing and detection of HIV.

As a result, more than 500,000 Americans who are HIV positive remain untested. The government's own data indicate that more than three times the number of people who currently get tested say they would do so if a home test were available. That amounts to more than 100,000 additional people getting tested each year.

The sudden reversal in the FDA's policy on cancer drugs reflects two sides of the same coin: A desire to hold on to power and a deep disdain for the notion that people can make important medical decisions for themselves. Dr. Kessler once wrote that: "If members of our society were empowered to make their own decisions about the entire range of products for which the FDA has responsibility . . . then the whole rationale for the agency would cease to exist." This mindset is at the heart of the public health threats he has created as commissioner. And it is for the sake of the public health that David Kessler should go.

---

Mr. Goldberg is an adjunct scholar at the American Enterprise Institute.

960404
WJ960406

Copyright © 1996 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.

Always watch for outdated information. This article first appeared in 1996. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1996. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .