Page 6 GAY PEOPLE'S CHRONICLE March, 1989

LIVING WITH AIDS

by Joseph Interrante

Director of Education'

Health Issues Taskforce

Access to Experimental Drugs

Last month's column discussed the protocols and phases of clinical trials for AIDS-related experimental treatments. One area of controversy around trials has been their inaccessibility to many people with AIDS or other HIVspectrum conditions. What are the other options for people who want access to these drugs?

The first is direct importation for personal use. Some drugs have been used with positive results in other countries, but have not been approved by the Food and Drug Administration for use in the U.S. From the beginning of the epidemic, some people with AIDS had tried to import these drugs. But it was a hit or miss situation: sometimes importation succeeded, sometimes the drug was seized by the FDA. In June of 1987 the FDA announced (after months of pressure from AIDS activists) that it would officially tolerate importation by individuals of certain drugs used with life-threatening illnesses. Imports are limited to a three-month supply, must be sent directly to the purchaser, and the order must be accompanied by a letter from the purchaser stating that the drug is for personal use under the care of a physician.

According to Project Inform in San Francisco, this policy did mark a change: It set up uniform, formal procedures to be followed by all offices; and it allowed drugs formerly prohibited, like dextran sulfate. But the major problem with this) option is that it depends upon an ability to pay. While the FDA will not allow U.S. companies or groups to buy and sell the

drugs at a profit, the policy does nothing for an individual who cannot afford the drug in the first place. In addition, individuals who can afford to import need to know the restrictions on the drug they wish to import. For example, the new FDA rules only lifted the restrictions on dextran sulfate made in Japan. The FDA has already blocked importation of Canadian dextran sulfate made by the Polydex Corporation (whose product had raised concerns among U.S. buyers). FDA rules only lifted the restrictions on dextran sulfate made in Japan. The FDA has already blocked importation of Canadian dextran sulfate made by the Polydex Corporation (whose product had raised concerns among U.S. buyers).

A second option for access is compassionate use. This option allows use of an experimental drug which may be helpful to a PWA for whom other therapies are not available or successful. If compassionate use is granted by the FDA and the drug company, the drug is given without charge.

However, compassionate use is filled with problems. It is granted on a case by case basis. A PWA's doctor must fill out a detailed application for justification. Review by the FDA can take weeks. The FDA has often disallowed such use. And even if the FDA approves it, the drug company can refuse to give it.

Part of the problem is a tension between compassionate use and the clinical trials needed for FDA approval of a drug for market sales. Consider the case of ganciclovir (DHPG), used to treat CMV retinitis. For several years the Syntex Corporation has given away DHPG for compassionate use. It did this without running a formal clinical trial. (One

Health Issues Taskforce

This space has been donated to HIT by the Chronicle. The following does not necessarily reflect the views of the Chronicle staff or management.

Thanks to everyone who helped make the As Is benefit a huge success. A more detailed article about the benefit will appear in the next issue of the HIT Newslet-

ter.

Art Expressions, the art program for people living with HIV-related conditions, has begun a quilting project. The project is open to anyone who would like to design and make a quilt panel for the NAMES Project. Quilting takes place Thursday afternoons from 1 to 3 p.m. at the HIT office. Bring ideas, fabric, scissors, thread and any items you want to incorporate into a quilt.

If you are considering participation in one of the experimental treatment clinical trials in Cleveland, or consider ing use of a particular drug, please be informed about them. The Resources Library contains a constantly updated

OF CL•E•V•E•L•A•N•D

file of materials about experimental drugs and other treatment options for in-house use. Simply drop by the office at 2250 Euclid Avenue, or call 621-0766.

The Information Committee has been reorganized and expanded. The committee welcomes volunteers, especially to work in the following areas: Gay/bisexual education, to develop innovative safer sex programs for the gay community; women's education, to develop programs and materials addressing the special concerns of lesbian, bisexual and heterosexual women; speakers bureau, especially to coordinate meetings and assist with training of new volunteers; and volunteer coordination, to help recruit, screen and assign volunteers to needed areas. If you are interested, call the office at 621-0766.

Do you have a morning or afternoon to spare? The office needs help with a variety of projects: clerical work, mailings, updating materials and the like. If you'd like to help, call Sue at 621-0766.

reason it ran no trial was that the company was in a court fight with BurroughsWellcome over rights of ownership, and neither company wanted to invest in a trial of a drug that it might not be able to sell.)

Although the drug had been effective (with side-effects) for many of the 3,000 people who used it, Syntex couldn't get FDA approval without a clinical trial. The FDA rejected evidence of individual reports which did not and could not meet trial protocols. It feared the case would undermine the regulatory process. But could Syntex ethically run a clinical trial where half the participants would get a placebo for a drug that was already known to work? The outcome was a compromise where those people taking DHPG would continue to get it, those whose sight was threatened would be put in treatment INDs (see next paragraph), and all others would be limited to clinical trials. Activists fear that the case of Syntex and ganciclovir will make drug companies even more reluctant to allow treatments for compassionate use.

A third option for access is treatment IND. Adopted by the FDA in 1987, it allows a drug company to apply for investigational new drug (IND) status when the drug has completed Phase 2 of a clinical trial. With IND status, a drug can be given in life-threatening situations upon approved application by a doctor. Although companies can charge for the drug, the trend has been to give it free of charge.

Although heralded as a panacea for PWAS unable to participate in a trial or wait for market approval, treatment INDS are widely regarded as a failure. The FDA has been reluctant to approve IND status. In the first year of the program, it released only one experimental drug, trimetrexate (used to treat the pneumonia PCP). And it did so under such tight restrictions that only 89 people received it during that year. Companies have also been reluctant to apply for IND status, partly because of the tensions with trials discussed above and also because INDS carry no liability protection regarding safety. Only four companies applied for IND status in the first year.

Three were denied.

In an effort to rectify some of th problems, the National Institutes Health (see next paragraph) recently nounced a new program. Commu Programs for Clinical Research on AI (CPCRA) is designed to link priv physicians to clinical studies already derway. The NIH and FDA hope t this program will give more people a cess to experimental drugs, especia people of color, women, and IV dr users who have tended to be exclud from trials for a variety of (often not ve good) reasons.

(The National Institutes of Healt through its sub-agency, the National I stitute for Allergy and Infectious D eases (NIAID), actually conducts dr trials along with private drug companie The FDA approves and regulates drug for marketing, and therefore regulat drug status.)

One impetus behind the new progra is the example of Community Researc Initiatives. These are communityco trolled programs which conduct trials community settings with subject recruited from participating doctors. I cities like New York and San Francisc the programs have had a more divers pool of participants. Most importan PWAS have been actively involved i coordinating the programs. The succes of the program in New York in particula has led to the establishment of CRIS in few other large cities around the countr (but not in Cleveland.)

Clearly, the present options for ac cess to drugs outside of clinical trials ar not numerous, and the record of succes is very uneven. Groups such as Projec Inform and ACT UP suggest we are facing a crisis in treatment access. The new CPCRA programs may help. But the government and drug companies need to do more.

Sources for this column wer GMHC's Treatment Issues, AIDS Treat ment News, PI Perspective, and Nationa Lawyers Guild AIDS Network's Ex change. These and other publications on experimental treatments can be con sulted at the Taskforce office. ▼

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