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FDA Action Handbook

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.EXCLUSION OF WOMEN, PEOPLE OF COLOR, POOR PEOPLE,
PEOPLE IN RURAL AREAS, IV DRUG USERS, HEMOPHILIACS,
PRISONERS & CHILDREN FROM EXPERIMENTAL DRUG TRIALS

Since virtually every drug used to fight HIV, or the concomitant opportunistic infections of AIDS, is experimental, very often one must be in a drug trial to get the drug. Yet AIDS drug trials exclude many of those infected with the virus. Women, IV drug users, hemophiliacs, children and people of color have been systematically excluded from most experimental drug trials for AIDS therapies. Most drug trial subjects are white, well-educated gay men living in urban areas. But this is nothing new. Drug trials have excluded most of these groups for years.

Exclusion of Women from Trials

For years, women have been systematically excluded from almost all drug trials. Practically the only trials that include women are those for contraceptives. The reason given for excluding women from drug trials is usually that the studies on the effects of the drug on a fetus have not been done. Researchers will argue that you can't trust women not to get pregnant. Researchers sometimes allow women into trials, including AIDS trials, only if they agree to be sterilized. Some researchers may allow women into trials if they show them that they are using birth control and have repeated negative pregnancy tests.

Researchers have a "moral" problem with allowing women into studies if a fetus may be harmed. But they do not have a problem with any birth defects that may be caused if a man in a study is sexually active, causing the birth of a child with birth defects.

Researchers also do not care about birth defects once a drug is released. Most drugs women will try have not been tested in women, and are tested in animals for birth defects only late in the drug approval process. So the likelihood of birth defects, or different results in women than in men, is high. Drug manufacturers are allowed to release and sell drugs that have not been tested in women, and are only required to put one of a variety of warnings about the effects on a fetus on the package. Methadone, for instance, has not been tested in pregnant animals, so methadone programs are supposed to warn pregnant women about that -- but they can still take it, and pay for it.

People of Color

Most trials have routinely excluded people of color. Researchers can discriminate blatantly on the basis of race, excluding people of color by not advertising trials, by putting trials at hospitals in white neighborhoods, by excluding women and IV drug users from trials and by pretending that all gay men are white.

Poor People

Poor people have traditionally been excluded from drug research. Researchers claim they make bad study subjects, missing appointments, etc. Researchers may exclude the poor deliberately even if they manage to apply for a clinical trial. They try to keep poor people from applying by not advertising trials and by locating them in neighborhoods that are difficult for poor people to get to.

People in Rural Areas

Most drug trials are in large urban areas at hospitals affiliated with medical schools. This means that people who live in rural areas are unable to participate in trials, even if they hear about them.

IV Drug Users

Drug research has for years exclude IV drug users. The reason given is that an IV drug user will not follow the protocol; e.e., he or she will take other drugs or will miss appointments. Researchers don't look at whether a person is currently using IV drugs or alcohol, but instead look at the past history of IV drug use, which has nothing to do with a person's current reliability. The bias of researchers leads to excluding all former IV drug users from some AIDS trials, or in the case of the ampligen trial, requiring former drug users to be drug free for the past seven years to be included in the study. Researchers either screen out poor people or make it very difficult for them to get to study sites.

The effects of excluding IV drug users from trials are major. AZT was approved without any trials in IV drug users. IV drug users who take AZT experience many more toxic side effects and require more blood transfusion than do non-IV using gay men. But since AZT wasn't studied in IV drug users, individuals found out the more severe side effects only when they took AZT.

Hemophiliacs

Most AIDS drug trials exclude hemophiliacs. This is very easy for researchers to do: they can say the trial is studying the drug in a population that was infected sexually. AZT has been approved for use, but the trial in hemophiliacs has yet to be completed.

Prisoners

Prisoners are excluded from clinical trials and are often prohibited from getting experimental drugs. The reason is that for years, the US did many drug, psychological and other studies, often extremely cruel ones, on prisoners. One study involved starving prisoners for many weeks to see if they would experience psychological damage.

As a result of protest over these inhumane policies, the Federal government and local governments have forbidden research on prisoners. This policy is often used as an excuse to deny prisoners adequate medical care, including experimental therapies. Prisoners should not be used as human guinea pigs, but they should have the right to receive AZT DHPG, etc.

Children

Children are excluded from most AIDS drug trials; those trials are for adults only. But this doesn't mean the idea is to protect children from participating in rigorous, cruel placebo studies. Trials for AIDS treatments in children are now ongoing, and almost all of them use placebos. Unlike adults, who refuse to participate in many placebo trials, children with HIV infection have little choice. They are largely poor children from families where one or both parents has HIV infection, AIDS or is dead. These children have almost no access to health care and their only chance at getting any treatment may be through a clinical trial. However, children have no access to aerosol pentamidine, fluconazole or most other trials. Ad to this, when trials for children do become available, foster children can't be enrolled in New York State because no adult of agency has been designated responsible for informed consent. (MM)

FDA & Discrimination in Drug Trials

The FDA requires that subjects for trials be treated "equitably." This should mean that women, people of color, IV drug users, etc., have access to experimental drug trials. The FDA has exacerbated this by discouraging researchers from including women in trials and by approving drugs that have only been tried in white, middle class, educated urban men for years and years. The FDA has the power to make regulations to require that trials include women, people of color, IV drug users, etc. If the FDA stated that they would no longer accept data that was not representative of the population with the disease, then drug manufacturers would have to do what they said.

When there are legitimate medical reasons that a drug trial have a homogeneous population, the FDA should mandate that there be parallel trials for all the affected populations. FDA should see to it that people at every stage of HIV infection have equal access to a promising drug. As it is, few PWA's have a choice of drugs other than AZT, and PWARC's with high T-cell counts are shut out of many trials.

Discrimination in drug trials is helped by the secrecy in which they are conducted. The FDA has regulations on advertising for clinical trials subjects, and they should require that researchers advertise widely for clinical trials subjects, and send out fliers to community groups.

The FDA should also require that manufacturers list their experimental AIDS drugs in a treatment and clinical trials AIDS registry that would be widely available to all people affected by AIDS, since one of the biggest problems is that no one knows about the clinical trials. The FDA has expressed some willingness to work on an AIDS trial database, but they must solidify this interest with a concrete proposal.

The Rights of Drug Trials Subjects:
Drug Trials are Health Care Too

It need not be said that persons with AIDS, ARC< or who are HIV infected are in a struggle to save their lives. Becoming a subject in a drug trial to have access to a new and promising but experimental drug is a mixed blessing. One's life is literally on the line in many different ways.

Even though the Belmont report of 1979 began codifying statues to protect human subjects from research risks in experimental drug trials, trials are, nonetheless, fundamentally designed to derive data on the drug's safety and efficacy, answering questions regarding toxicity and dangerous side effects. For immune-compromised persons, risking severe anemia or pronounced toxic reactions to an experimental drug may prove fatal. This is so if they are even being given the drug and not a placebo which intentionally allows the natural deadly progression of HIV to continue.

On the other hand, being part of a trial may allow a PWA, PWARC, or HIV infected person access to a drug which could prolong their lives significantly by successfully treating an opportunistic infection or retarding HIV. The problem here arises when the trial is over. Trial subjects, though they may often still receive the drug, do not have access to any of the data derived from the trial. They are left without the information necessary to gauge, with or without a physician, their position vis-a-vis the drug.

Based on these two unethical situations the following demands have been drawn up:

1) __ Persons with life-threatening illnesses are not reducible to "sick bodies" to be injected, studied and abandoned. Federal statutes must mandate that all testing organizations enter a sustained, responsible relationship with all test subjects through the person's life.

2) __ Subjects in a drug trial must not be forced to discontinue concurrent prophylaxis as a condition of participation; death or progression of opportunistic infections is an unacceptable corollary of the "science fore treatment" bias of many current trial.

3) __ The trial drug, if proven efficacious, must be available, at no cost, to all persons in the study upon its completion; this free availability must be continued throughout the subject's life or until the illness has been eradicated or cured.

4) __ All useful, helpful and pertinent data accumulated in the study must be available to the trial participant and his/her physician promptly upon completion of the trial. Also, trial participants must have access to all future data on the drug.

5) __ Placebo trials which have as an endpoint the death of members of the control group, or their progression to opportunistic infection, are unethical and unacceptable.

6) __ Drug trials subjects have the right to any results, even preliminary, from trials their participation has made possible. Putative drug company "proprietary" interests must never be used to deny subjects open access to this data. Informed consent guidelines must be strengthened to guarantee this. Ultimately, the entire AIDS community must have the right to timely, accurate information on any trials, underway or completed. Neither FDA nor drug companies may be permitted to sit on this information pending publication in "prestigious" scientific journals, at conferences or pending NDA approval.

This leads directly to the pressing need for a comprehensive, up-to-date, nationally-accessible registry of all AIDS drug trials, private and public: the AIDS Treatment Registry.

ATR: AIDS Treatment Registries, Local & National

The FDA knows the sites and the basic criteria for all AIDS drugs trials as soon as the sponsor applies for an IND. Despite the severity of the AIDS epidemic, the FDA has chosen to keep this information to itself and to drug sponsors which claim they own the information.

Thus accurate, up-to-date and complete information on drug treatment trials is not readily available. There is currently no registry of clinical trials for AIDS-related drug treatments at either the national or local levels. Physicians and PWAs and their service and advocacy organizations need centralized, accessible information on the current status of research drugs for AIDS and on the progress of those drugs toward government approval. All interested individuals should be able to discover which trials are open, where they are, and what they require of their participants. Activists need this information to monitor the performance of government and drug company sponsors.

Local AIDS activists have begun taking steps to rectify this lack. ACT UP/Boston has recently been named to occupy 2 seats on the newly constituted Treatment Subcommittee of the Governor's Task Force on AIDS, and there it has put its call for a Massachusetts AIDS Drug Trial Directory on the Task Force's agenda. With seed money from ACT UP/NY, members of its Treatment & Data Subcommittee have formed a spinoff organization, the AIDS Treatment Registry (ATR).

ATR has been established to develop and maintain a computerized database of all clinical trials underway in New York State that are testing drugs and therapies for the treatment of AIDS and AIDS-associated opportunistic infections and cancers, and to make that information readily available to all members of the communities affected by the epidemic. Research and data collection is ongoing, and the database has been designed to reflect developments in treatment pharmacologies. The database features cross-referencing capabilities and will also incorporate treatment experiences of trial participants and physicians wherever feasible.

By August 1988, ATR had gathered all pertinent trial information on AIDS drug trials underway at New York City owned hospitals. It has secured the services of tow noted New York clinicians, Dr. Iris Davis of the Bushwick clinic and Dr. Joseph Sonnabend of the Community Research Initiative (CRI), as advisors. It has also entered into a mutual information-sharing relationship with the American Foundation for AIDS Research (AmFAR), which has agreed to expand its Directory to list trials for cancer an opportunistic infection as well as the presently available antiviral trials. (JE/Michael Cowing)

 

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APPENDIX
: Federal Drug Law Timeline

 

 

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