Tobacco Documents Online

ti.os ans=fes t^resr a~o~9b f~•~. ~Atr4 • • • We Need an FDA Leader, i Not a Regulatory Czar Is Health care: AIDS, cancer and Alzheimer's are among the issues where David Kessler has compromised science and ethics. By JAM1S P. DRISCOLL, W ILLIAM K. SUMMERS and BEVERLY ZAKARIAN activists are more politicaffy powerful. Another instance of misguided leader- ship is Kessler's campaigri against "off-la- bel" 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 compa- nies welcomed Kessler's policy because it justified their ever-narrowing reimburse- ment policy. This "off-label" policy also restricts exchange of information. Kes- Astonishingly, cohorts of Dr. David Kes- sler's campaign barred doctors from using sler are working behind the scenes to effective combinations of cancer drugs. induce President Clintnn to retain him as Unneeded barriers to optimal treatment eommissluner of Lhe Wund and Drug Ad- are rusting patients their lives. mntlstrattun. 'L'he habdiues of retaining After consigning tacrine to limbo, driv- •ssler are numusttOd~Awa~..j~,.~ i,DDC Into the underground and taking Tpealth-care go y~~ arogp ~octors, last Cli aywill need a prag- winter Kes31gl~decided Ur it*atrltrwYw+ publioageti8a for the FDA. Clinton American medical-device_ matie industry the . _ , 9s e•,ntmiltui both to improving access-to world's largest and most innovative. Yet hcallh cale and to restraining its cust. The Kes.~ler's regulatory jihad threatens to Clinton commissioner for L•DA must be a furec rclucation of U.S. mukers to uthcr loyal aad pragmatic team player. Kessler is not a team player. He follows hjqown agenda with a headline-grabbing style. Kessler betrayed former President Bush and he woutq bp6rpy,CBntorn: $f6., sler'e slow, overly cautiops philosophy- with moments of inappropriate regulatory zeal-restricts access to life-saving thera- pies while it increases the cost of inedica- tions 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 combi- nation therapy for one year, waiting for data that never arrived. During that year, he sanctioned an illegal, underground drug market to silence AIDS activists demand- ing 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 Kes- sler's delay. Second, the DDC underground collapsed because of defective quality con- trol. The FDA was facing the scandal of sanctioning a dangerous bootleg product. Rather than expediting scientific proce- dures, Kessler merely yielded to pressure. The illusion that Kessler accelerated approval of drugs for life-threatening dis- eases ia dispelled by continued delays with the Alzheimer's drug tacrine (aiso known as THA or by the brand name Cognex) While I,Ot)0 Alzheimer's victims die each day, tacrine has heen delayed 2'h years. acrine is effective and clearly is less toxic an the AIDS drugs AZT, DD1 and DDC. nother promising drug for Alzheimer's, entane, was recently scuttled' by Kes- ler's FDA. Why do Alzheimer's patients keceive unequal treatment? The AIDS countries, ott the heels uf their pharmaceu- tical counterparts. And denying patients life-saving devices such as brain aneurysm balloons is killing people. I America must have an FDA etoner who mg/tes decieionp on the bj4,o; - science and ethics. The needs of AIDS, cancer and Alzheimer's patients should become the priority. The biotechnology, medical-device and pharmaceutical inno- vative edge must stay in America. At FDA, the time for change is now. James P. Driscoll, a nationally known AIDS patient advocate, is vice president of Direct Action for Treatment Access in San Francisco. Dr. William K. Summers of Arcadia is a member of the Atzheimet's Rights Alliance. Beverly Zakarian is chief execntive of the Cancer Patients Action AUiance of Brooklyn, N.Y.