We Need an FDA Leader, Not a Regulatory Czar : Health care: AIDS, cancer and Alzheimer’s are among the issues where David Kessler has compromised science and ethics.

Astonishingly, cohorts of Dr. David Kessler are working behind the scenes to induce President Clinton to retain him as commissioner of the Food and Drug Administration. The liabilities of retaining Kessler are numerous and grave.

To achieve its health-care goals, the Clinton Administration will need a pragmatic, public agenda for the FDA. Clinton is committed both to improving access to health care and to restraining its cost. The Clinton commissioner for FDA must be a loyal and pragmatic team player.

Kessler is not a team player. He follows his own agenda with a headline-grabbing style. Kessler betrayed former President Bush and he would betray Clinton. Kessler’s slow, overly cautious philosophy--with moments of inappropriate regulatory zeal--restricts access to life-saving therapies while it increases the cost of medications and health care.

For example, Kessler claims to champion faster AIDS drug approval. But ignoring the advice of AIDS activists and clinicians, he delayed approval of DDC/AZT combination therapy for one year, waiting for data that never arrived. During that year, he sanctioned an illegal, underground drug market to silence AIDS activists demanding DDC. If Kessler had no new data, what made him finally approve DDC last April? First, California AIDS activists and Vice President Quayle’s office criticized Kessler’s delay. Second, the DDC underground collapsed because of defective quality control. The FDA was facing the scandal of sanctioning a dangerous bootleg product. Rather than expediting scientific procedures, Kessler merely yielded to pressure.

The illusion that Kessler accelerated approval of drugs for life-threatening diseases is dispelled by continued delays with the Alzheimer’s drug tacrine (also known as THA or by the brand name Cognex) While 1,000 Alzheimer’s victims die each day, tacrine has been delayed 2 1/2 years. Tacrine is effective and clearly is less toxic than the AIDS drugs AZT, DDI and DDC. Another promising drug for Alzheimer’s, mentane, was recently scuttled by Kessler’s FDA. Why do Alzheimer’s patients receive unequal treatment? The AIDS activists are more politically powerful.

Another instance of misguided leadership is Kessler’s campaign against “off-label” use of drugs. Most cancer drug therapy is “off label”--that is, used for cancers other than that for which it is FDA-approved. Health insurance companies welcomed Kessler’s policy because it justified their ever-narrowing reimbursement policy. This “off-label” policy also restricts exchange of information. Kessler’s campaign barred doctors from using effective combinations of cancer drugs. Unneeded barriers to optimal treatment are costing patients their lives.

After consigning tacrine to limbo, driving DDC into the underground and taking cancer drugs away from doctors, last winter Kessler decided to assault the American medical-device industry, the world’s largest and most innovative. Yet Kessler’s regulatory jihad threatens to force relocation of U.S. makers to other countries, on the heels of their pharmaceutical counterparts. And denying patients life-saving devices such as brain aneurysm balloons is killing people.

America must have an FDA commissioner who makes decisions on the basis of science and ethics. The needs of AIDS, cancer and Alzheimer’s patients should become the priority. The biotechnology, medical-device and pharmaceutical innovative edge must stay in America. At FDA, the time for change is now.