(complimentary publication from Target Health Inc.)

Saturday, December 6, 1997

We would like to welcome our colleagues David Clark (Compliance Specialists Inc.), Karen Hammond (UAB), Rakesh Rughabanshi (Ferring Pharmaceuticals), Steve Fortunato (Proterm Inc.), Susan Slezak (Micropulse Inc.), Charlotte Lieb (Micropulse Inc.), Melinda Tully (Micropulse Inc.), Helen Jagielo (Micropulse Inc.), Gerry Montmorency (consultant) and Dennis Ferrero (Stockton, CA Board of Health). Please forward ON TARGET to your friends and colleagues so that they may be added to our unique and proprietary e-mail list.

TARGET HEALTH NEWS

TARGET HEALTH is pleased to announce the appointment of Anita Islam, Ph.D. as Manager of Clinical Research. Anita holds a Ph.D. in neurobiology with strong experience in clinical psychology and opiod receptors. In her first two weeks at TARGET HEALTH she has already completed the first draft of an IND in Women's Health. Anita will take charge of TARGET HEALTH's clinical operation and will add an exciting dimension in TARGET HEALTH's continuing growth.

The issue of performing placebo-controlled clinical trials in high-risk patients, where there is a current approved therapy, has hit the press with reports of placebo studies in HIV+ pregnant women in the third world. The studies were designed to address both practical and ethical issues concerning medical practice in developing countries. The ethical issue is that developing countries can't afford to treat HIV+ pregnant mothers in the same manner as is done in the U.S. In the U.S. it is standard practice for at-risk pregnant women to receive long-term AZT therapy. An alternative approach for developing countries is to develop a short-term regimen which is affordable. There has been controversy, however, about the use of placebo-controlled designs in foreign studies looking at short-term therapy. The question, of course, is how to design the study and how many studies are needed to prove the point. TARGET HEALTH excels in the strategic planning in the areas of drug and device development through FDA and has saved clients lots of dollars and time with solid up-front planning. It is not when and how a program begins, it is how and when it ends.

Wisely, Johns Hopkins University has now abandoned plans to use placebo in an experiment on pregnant HIV+ Ethiopian women. The NIH funded study, which is to begin next year, was initially designed to see whether a short course of the anti-viral drug AZT is more effective than a placebo in reducing transmission of the AIDS virus from a pregnant woman to her baby. The group at the Johns Hopkins School of Public Health said that a study under way in Thailand should prove that a short course of AZT is more effective than placebo. When the results become available in January, all studies will be re-evaluated, including current tests in the Ivory Coast and Tanzania and one planned for Uganda. Perhaps if the studies work in the third world, treatment in the U.S. may also change. Its too bad that the dosing schedule wasn't settled earlier in a Phase 2 program. Let TARGET HEALTH work with you in design and implementation of your next clinical and regulatory program.

Comments on this and any other controversial issues are welcomed.

TARGET HEALTH INC.
310 Madison Avenue, 22nd Floor, New York, NY 10017
Phone (212) 681-2100 - Fax (212) 682-0151

JulesMitchel@targethealth.com (Dr. Jules T. Mitchel, President)
JoyceHays@targethealth.com (Ms. Joyce Hays, CEO)