AIDS TREATMENT NEWS No. 070 - December 2, 1988
John S. James

Like New York's CRI, San Francisco's CRA began under the fiscal sponsorship of the PWA Coalition. Initial funding came from pledges of $1000. from each of five organizations: AIDS Treatment News, The Healing Alternatives Foundation, Project Inform, PWA Coalition, and the San Francisco AIDS Foundation. Other donations, including office space, use of computers, and especially the work of a volunteer administrator, allowed the CRA to begin swiftly, without waiting for major funding.

Background on Community-Based Trials

Community-based trials is a concept pioneered in different ways by two organizations: the County Community Consortium in San Francisco, and the Community Research Initiative in New York. Within the last year this concept has won widespread recognition and support, from groups including the Presidential Commission on the HIV Epidemic which commended New York's CRI, from Congress which appropriated over $5,000,000 for community-based trials, and from the National Institute of Allergy and Infectious Diseases (NIAID), which is administering these Congressional funds. (See "NIH Announces Program for Community-Based Trials", page 10 in this issue.)

What are community-based trials?

Traditionally, clinical trials of experimental drugs or other treatments were done in major medical centers, usually con- nected with leading universities. Everyone agrees that some trials must be carried out in such specialized institutions -- for example, tests of dangerous treatments, or of chemicals never before taken by humans. But other trials do not need such special facilities.

Anything that happens in major medical centers is expensive and time-consuming. So in New York the Community Research Ini- tiative, started as a project of New York's PWA Coalition with $5,000 from that organization, set up all the arrangements legally required to conduct human trials with patient volunteers in the practices of private physicians. The CRI, which is now running five trials, is believed to be the first organization in history set up by patients to conduct fully sanctioned, professional scientific research for testing new treatments. (The current CRI trials are aerosol pentamidine, egg lecithin lipids, antabuse monitoring study, erythropoietin, and bovine milk immune globulin. Four more trials are in advanced planning: DHEA, lentinan, dextran sulfate, and pyrimethamine prophylaxis for toxoplasmosis. The aerosol pentamidine trial, originally financed by LyphoMed for one year, was recently extended for six months. The trials of lipids and of DHEA are financed by fundraising events organized by People Taking Action Against AIDS, a Long Island group which raises money for AIDS work.)

For more background on community-based trials and the CRI, see The New York Times, March 15, 1988. Also see our articles about the CRI in AIDS Treatment News #38 (August 14, 1987) and #45 (November 20, 1987).

Two Models of Community-Based Trials

The phrase "community-based trials" means scientific tests of experimental drugs or other treatments conducted through the practices of private physicians. But two different approaches to such trials have developed. Much confusion and sometimes debate stem from the failure to understand the differences.

The two approaches are illustrated by the two different organizations, the Community Research Initiative described above, and the County Community Consortium.

In San Francisco, the County Community Consortium (CCC), organized primarily by researchers at the University of California San Francisco Medical Center, conducted the first community-based trials anywhere. At this time, the CCC is conducting seven trials; its meetings are attended by almost every physician with an AIDS practice in San Francisco. This organization works closely with the AIDS Clinical Trials Group sponsored by the U. S. National Institutes of Health and located in San Francisco General Hospital, which has developed an efficient system of running clinical trials. (The seven trials currently open are two with aerosol pentamidine for pneumocystis prophylaxis, two monitoring studies (an AZT database, and an alternative treatments database), clofazimine for MAI prophylaxis, AZT with vitamin B12, and megace. None of these trials is sponsored by pharmaceutical companies.)

Both the Consortium in San Francisco and the Community Research Initiative in New York conduct trials through the practices of front-line AIDS physicians. Both run trials designed by leading researchers, approved for scientific merit by a Scien- tific Advisory Committee, and approved for ethical treatment of patients by an Institutional Review Board (IRB).

The difference is in the degree of PWA participation in the organization of the research.

In both cases, the scientific and medical issues are decided by qualified professionals. But the Community Research Initia- tive, operating under New York's PWA Coalition, includes much participation by PWAs in policy decisions concerning the research.

In San Francisco, community-based trials developed dif- ferently. The County Community Consortium was started so that university researchers could inform community physicians about the latest AIDS medical information, and improve coordination between private-practice physicians and San Francisco General Hospital, which is closely affiliated with the University of California San Francisco Medical Center. Later, some of the physicians wanted to participate in trials of experimental drugs; as a result, community-based trials began. But patients had nothing to do with the development of the trials; their involvement began when they signed up for a study. Until a year ago, most persons with AIDS in San Francisco probably did not know that the Consortium existed. Recently, however, the Consortium has set up a Community Advisory Board, to improve communication and allow input from persons with AIDS/HIV and treatment advocates. (For more background on the Consortium, see "Conversations with Donald Abrams, M. D. ", AIDS Treatment News issue #54, April 8, 1988, continued in #56, May 6, 1988.)

New York's Community Research Initiative, started by a PWA Coalition, has much patient involvement in research policy. The PWA community has funded at least two trials through fundraising events, has set its own policies on placebo use, and has insisted that trials under its sponsorship be effectively open to women and minorities, not only to gay men. Such prior community involvement in policy issues around the selection and conduct of trials makes recruitment easier and increases patient-experimenter cooperation, for example by greatly reducing any need to "cheat" in the study by taking other drugs without telling the researchers.

Why the CRA?

Why should there now be a second organization (the CRA) to conduct community-based trials in San Francisco, when the Consortium is already doing so? The CRA has not officially answered this question, but the answers we suggest below seem representative of views found in the organization.

(1) The Consortium can only conduct a handful of trials at one time. More needs to be done. The CRA will not duplicate work of the Consortium. Instead it will do additional studies which otherwise would not have been conducted.

(2) PWAs want to be involved in the policy making, organiza- tion and administration of the research. Otherwise, the PWA community would remain only a passive recipient of research efforts conducted in its behalf by others.

(3) The Consortium does not have its own Institutional Review Board (IRB); the CRA plans to establish one. There is concern that existing IRBs may be too conservative to respond appropriately to the AIDS emergency. PWAs fear -- rightly or wrongly -- that many physicians will not be able to get approval for formal scientific tests of well-supported treatment options which they may in fact already be using in their practice. (Physicians do not need IRB approval to use non-approved "treatments" for their patients; they do need approval, however, if the same treatments are called "research". This system, intended to protect patients against exploitation and unconscionable risks at the hands of scientists or pharmaceutical companies using them to get data, has also had the unfortunate side effect of creating a physician underground, forcing legitimate, legal treatments out of the public arena, preventing proper research and open communication of results. An IRB created by PWA organizations would allow physicians to submit these treatments they are using without fear of automatic rejection.)

Research Policy Issues: The Need for Patient Involvement

There is a common assumption that since everyone is on the same side, doing their best to find treatments for AIDS, we can leave the whole matter to professionals, since the only decisions are scientific and medical ones which must be made by specialists, not policy decisions in which affected citizens need a voice. Some simple examples will show how this assumption is wrong:

(A) Drugs approved under the current system will be expen- sive, because pharmaceutical companies are only likely to support products which will provide them with the highest return. And because trials are expensive, scientists and physicians can only conduct research that someone will pay for. It is no coincidence that AZT, one of the most expensive drugs in history, has become most intensively studied -- while readily available treatments are hardly studied at all.

Persons with AIDS or HIV, by contrast, want affordable treatments. U. S. insurance companies, hospitals, employers, and public agencies are increasingly dumping patients who cannot pay the extreme costs of U. S. medicine. Patients want studies of treatments which could be made available to all, not only those with money or insurance.

(B) A number of antibiotics which may be essential for saving lives of persons with AIDS are in common use in Europe but not available in the U. S., because their manufacturers do not want to spend the years and tens of millions of dollars required for U. S. approval.

Here again the interests of patients and professionals differ. Patients want the drugs tested, and want their physicians to have the option of recommending them. If red tape gets in the way, they are willing to rock the boat.

But for scientists, the professional incentives are to stay away from drugs without commercial sponsorship in the U. S. Here again, the interests of patients and professionals differ.

(C) When preliminary studies of a new treatment show very good results, research professionals not surprisingly want to do more studies, which will take years. No one objects to the studies; the issue is access by patients who need the treatment now. There is no institutional incentive to provide this access until double-blind studies have been designed, cranked up, run, analyzed, and published, and then delayed several more years for FDA approval.

The interests of the research community, the pharmaceutical industry, and regulators have all been well represented. None of these have put the patients' needs first.

And unless the PWA community is involved in the many diffi- cult details of organizing actual trials, it will not have the depth of knowledge needed to effectively articulate and realize its interests. The PWA community must have organizations which understand the administration of AIDS research as well as any university, corporation, or government agency.

The Community Research Alliance is committed to always having effective PWA representation on all decision-making bodies: the Institutional Review Board (IRB), the Scientific Advisory Committee, and the board of directors. As far as we know, it is one of only two clinical-research organizations in the country to do so; the other is New York's Community Research Initiative.

The CRA Today

At this time the CRA board of directors includes people listed below. The board is seeking new members to broaden its base in all parts of the AIDS community. Because it is hard for a large group to conduct routine business, a smaller executive committee makes recommendations to the full board, which makes the final decisions.

To date (December 1) the Scientific Advisory Committee has not met. But 16 physicians and scientists have so far expressed interest in working with this group. And 19 physicians with private practices in the Bay Area have expressed interest in participating in the trials. (Nine are on both groups). Several physicians have already proposed research studies.

The Institutional Review Board has not yet been formed.

The CRA has an office and a full-time administrator, Tom Wilcox, who recently moved to San Francisco from New York, where he was manager of the PWA Health Group, and worked closely with the Community Research Initiative.

We list the current CRA board members below. Note that some of the organizations with which these people are affiliated have not taken any position on the CRA; therefore this listing does not imply organizational endorsement. Ron Baker Editor and co-author, Bulletin of Experimental Treatment for AIDS, San Francisco AIDS Foundation.

Keith Barton, M.D., C.A. Private practice in Berkeley, CA.

Terry Beswick Director, The Healing Alternatives Foundation, San Francisco.

Misha Cohen, O.M.D. Founder and Clinical Director, Quan Yin Acupuncture and Herb Center, San Francisco.

Martin Delaney Co-director, Project Inform.

Rick Graham PWA Coalition (alternate for Hank Wilson).

John James Editor and publisher, AIDS Treatment News.

Tom O'Connor Author of Living with AIDS: Reaching Out.

Jim Palazzolo Co-author, Bulletin of Experimental Treatments for AIDS, San Francisco AIDS Foundation (alternate for Ron Baker).

Curtis Ponzi Attorney.

Pat Sanders, M.S.N., C.A. Unit Manager, NIH HIV Research, Kaiser Permanente, San Francisco; and licenced acupuncturist in private practice, San Francisco (alternate for Tom O'Connor).

Hank Wilson PWA Coalition, San Francisco.

Tim Wilson National Task Force on AIDS Prevention, of the National Association of Black and White Men Together.

Funding

Because of donations of office facilities, and of the time of volunteer administrator Mike Lipson who was invaluable in starting the organization, little money has been spent. With pledges and a matching grant totaling $8,000 so far, about $4,000 additional will carry the organization through the next three months, which should be enough to complete the development of the Scientific Advisory Committee and IRB, and start evaluating research proposals from physicians and scientists.

Later, the organization will need major funding for the tri- als themselves. Trials can cost $2,000 or more per patient, mostly for laboratory tests, which are usually paid for by the study. There may also be additional physical examinations. Usually the drugs are donated by the manufacturer, so they would not be an expense for the CRA.

In New York, most of the studies now being conducted by the Community Research Initiative are financed by pharmaceutical companies, which were eager to participate because of their frustrations in getting their drugs tested through other channels. The CRA may also do such studies. But it hopes to raise money from foundations, corporations, individuals, and other contributors, so that it can focus research attention on what may be the fastest, most cost-effective way to get results -- including the study of medically promising treatment possibilities which have been overlooked so far because for various of reasons they are not commercially attractive.

CRA does not yet have this funding and will need community help in getting it.

How You Can Help

CRA is building a skills list of friends who can help this project in any way -- fundraising, organizational skills, helping us contact people we should be working with, technical skills such as computers, graphics, or printing, medical and scientific experience of course, etc. If you want to help, call Tom Wilcox at 415/626-2145, and let us know what you can do. Or write to Community Research Alliance, 273 Church Street, San Francisco, CA 94114.

The CRA greatly needs volunteers. It plans to follow the CRI model of having one person be volunteer coordinator, with most of the work done by volunteers. This approach not only con- trols expenses; it also allows for participation by PWAs who are on disability and not permitted to earn money without risking their benefits.

Contributions to CRA are tax deductible. Make checks payable to "PWA Coalition", and send them to the CRA at the address above.

The organization would like to form a "Friends of the CRA" auxiliary, to be a social organization which would also raise money, find volunteers, develop contacts and community coali- tions, and otherwise promote the work of the CRA.

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