The Bay Area Reporter - January 2, 1996
By Bill Thorne, ACT UP/Golden Gate Writers' Pool

Inclusion/Exclusion Criteria: These are the conditions that allow a patient to participate in any given trial, such as T-cell counts, age, gender, other illnesses they may have, or medicines they may be taking. For example, Serono Laboratories had required everyone in a trial of human growth hormone for wasting syndrome to be on an approved antiretroviral drug such as AZT. However, most patients with wasting had exhausted approved treatments, and were taking the then-experimental d4t, which prevented their participation in the study. ACT UP/Golden Gate successfully fought to have the protocol amended to allow d4t use. Until they allowed d4t, Serono had enrolled just one patient in a year; after making the suggested change they signed up 170 patients in two weeks.

Activists also continue to fight the arbitrary exclusion of patients with less than 50 T-cells from most studies.

Informed Consent Activists routinely belong to Community Advisory Boards (CABs), which advocate for patients who participate in a particular hospital's clinical trials. Activists on CABs draft and revise informed consent documents, crucial papers that inform patients of the possible risks/benefits of participation in a particular trial.

Placebo Controlled Trials: Many researchers continue to believe the only way to conduct a trial is to give some patients the drug and others a placebo ("sugar pill"), and wait to see which group dies faster. However, activists have severely criticized this system, especially when other models are readily available. Several years ago, ACT UP/Golden Gate demonstrated at UCSF protesting a placebo controlled study for children. Not only was the trial design reconsidered, but two years later, the Principal Investigator of the study in question joined an ACT UP demonstration protesting the refusal of a drug company to supply drug for a mother-baby transmission study. Because of the work of ACT UP, HIV clinical trials are now designed to compare therapies against the prevailing standard of care, not a sugar pill.

Crossovers and Endpoints Trials have traditionally waited for "clinical endpoints" - instances of disease or death - to judge whether a drug is working. Whenever possible, ACT UP/Golden Gate activists have pushed for use of surrogate markers - blood tests or other indicators that can show if a drug is working without waiting for people to get sick and die.

Activists have also successfully fought to allow patients who have been in the placebo or control arm of a trial to have the chance to "cross over" and try the drug being studied, once enough comparison data has been collected. However, we must fight this battle over and over for each clinical trial.

Drug Continuation: Patients should be able to receive the study drug after a clinical trial is over, in the absence of safety or toxicity problems. If patients are benefiting from a drug and have their supply cut off when the study ends, the result can be loss of quality of life or an early death. This was the case with human growth hormone, the gp120 vaccine and the majority of other AIDS drugs. Because pharmaceutical companies are not required to supply the drug (even if it is working) to patients after a study has concluded, ACT UP/Golden Gate has to fight for drug continuation in every single clinical trial. It is reprehensible that some companies do not voluntarily supply drug to needy patients.

Combination Trials: ACT UP/Golden Gate is currently working with both the Community Consortium (a group that organizes community-based studies) and the NIH to design feasible combination trials of multiple drugs for treatment of AIDS-related wasting syndrome. We are also represented on the CAB of the Inter-Company Collaborative providing input regarding combination antiretrovial research. (The Inter-Company Collaborative is a nationwide organization designed to help drug companies work together to study AIDS treatments.) In addition, activists' discussions with the Office of AIDS Research and AmFAR regarding multiple combinations and strategy trials are continuing.

Alternative Access Mechanisms: The whole concept of accelerated approval and expanded access to AIDS drugs came from AIDS activists in ACT UPs across the country, and their subsequent implementation came from community pressure, including meetings, zaps, and demonstrations. The first accelerated approval and expanded access programs ever created were written by three members of ACT UP/Golden Gate on the back of a placemat at Cafe Flore in San Francisco. They then petitioned and pressured the researchers and regulators into making those programs (for ddC) a reality. Bristol-Myers Squibb developed its expanded access program for d4t only after ACT UP/Golden Gate pressured the company to provide the drug to patients who did not qualify for the study. More recently, during Glaxo's 3TC expanded access program, activists met with Glaxo to help address their supply problems and devise an ethical mechanism for insuring that patients with greatest need continued to receive drug.

ACT UP/Golden Gate activists continue to push for expanded access to drugs when the clinical trials are small, demand for the drug is high, and many patients will not qualify for trials studying the drug. Researchers must recognize that compliance in clinical trials is undermined when patients feel they must lie to get into a study because it is the only way of accessing a promising therapy.

Activists also play an ambassadorial role in drug development, shuttling between paranoid pharmaceutical companies and the overcautious FDA. Companies have found that they can save time and money by getting activist help in preparing their drug for approval. Members of ACT UP/Golden Gate and other groups have a great deal of experience in dealing with the FDA approval process - experience that can help speed a drug's approval when activists anticipate and help solve problems before the FDA ever sees them.

Since 1990, ACT UP/Golden Gate has joined forces with the breast cancer community to insure cancer patients are given the same opportunities as people with AIDS. Our success can be measured in the recent announcement that Genentech is starting a compassionate access program for a promising new breast cancer drug.

To learn more about how activists work, attend an ACT UP/Golden Gate General Body Meeting, the last Thursday of every month at 592 Castro (at 19th, upstairs), at 7:30 p.m.

ACTion UPdate

Take Charge of Your Healthcare

ACT UP/Golden Gate is forming a new working group to teach patients self-advocacy. The group will meet the first and third Tuesdays of the month at 6 p.m., preceding the regular Treatment Issues Committee, which meets every Tuesday at 7:30 p.m.

If you or someone you care about are experiencing a problem getting the treatment or healthcare you need, please join us in learning techniques you can use to get the best healthcare possible. The first meeting is scheduled for Tuesday, January 16th. For more information call 252-9200.
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Always watch for outdated information. This article first appeared in 1996. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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