AIDS TREATMENT NEWS No. 064 - September 9, 1988
John S. James

Due to audience interest in actually organizing and conduct- ing community-based clinical trials in San Francisco -- following or changing the model created by the Community Research Initiative in New York, which was organized within the People With AIDS Coalition there and is now conducting several AIDS drug trials -- discussion at the meeting shifted to how such an effort might work here. For continuity and easier reading, we selected the most important information and arranged it under the headings or questions below.

JJ: What are the most important differences between good vs. poor clinical trials?

LT: "The researchers must define very clearly at the begin- ning of a study whom they will admit, what medical entry criteria will be required.

"Also, a trial needs a clear definition of success; not an amorphous goal like "we want people to get better", but a clear clinical definition of success or failure: symptoms, blood work, skin immune assays, and activity of the virus in the blood.

"Unfortunately, we still do not have very good tests to measure viral activity. The more we use the P24 test (a test for a viral protein), the less reliable it seems to be. The beta-2- microglobulin test might be a good one, but it's still too early to tell. Until we get a better test, much of this research is going to be iffy."

JJ: Meanwhile, people are making treatment decisions.

LT: "While it's empowering to take treatments such as AL 721 substitutes or whatever, the buyer should beware. People are basing large investments on anecdotes and sketchy science. Unfortunately there is little more than sketchy science, so we should encourage people to do as much of their own research as possible, and keep asking questions."

JJ: Explain some of the problems with anecdotes.

LT: "Here is an example. A person I know, a friend of a physician, had a T-helper count of 800 a few years ago. He decided to adopt a healthier lifestyle. So he stopped smoking, drinking, and hard drugs -- he had used a lot of drugs. He lost weight, went to the gym, etc.

"But after a year his count was 600. So he figured why bother, and he started drinking, taking drugs, abandoning his healthy lifestyle. A year later his count was 1300, and has stayed that way for the next several years.

"You can find an anecdote for everything. Helper cells can improve, spontaneous remissions can happen, regardless. If a person had started taking substance X before it happened, then people say it must be working.

"Until we get better information, more well-designed studies, I encourage people to keep questioning about every treatment or study, and question those answers."

JJ: How can we support people in making better decisions?

LT: "Since so many people are using treatments, I wish we could set up our own entry criteria and run our own community study, on AL 721, or dextran sulfate, or whatever. We could organize 15 to 20 people in each group and follow them for three, six, eight months and see what happens. Chart them on a number of medical parameters.

"There are so many people doing many things, and many doing just one thing, and people starting all the time, that we could surely find 15 to 20 people to study the treatments which are already popular in the community. I wish this could happen, but it needs somebody to organize it.

"If people are going to be using treatments, then it would be very helpful if there were some way of organizing 15 or 20 people using the same treatment, and monitoring them -- whether they are using dextran sulfate, ozone, hydrogen peroxide, or whatever."

From a member of the audience: "I'm doing dextran sulfate, and acyclovir, and just three pills a day of AZT; I tried higher doses of AZT but couldn't tolerate that much. I feel a need for people who are using the same treatments to get together to talk about our experiences, to learn from each other."

From the audience: "Stay up on the research, write letters to the researchers. We can pool our brain power."

From the audience: "Keep a diary."

LT: "If we can find 15 to 20 people interested in the same treatment, who decide exactly what they are going to do and do it for three months -- the same dosage, etc. -- and if we follow up everybody and get consistent data, from the same laboratory, then we can take that data to any reputable physician who's a sentinel physician in this town, and he or she will take notice. Physicians will start saying that maybe they should look into this. That's the only way to convince physicians about the value of a treatment."

From the audience: "If everybody is doing combinations, you are never going to find enough people who are just doing AL 721, or just doing dextran sulfate."

LT: "I disagree. I talked with over a thousand people, to recruit them for the TP-5 study. I put an ad in the newspaper.

"As of tomorrow, we will have 32 people in the study. Over 150 people have come in to be screened. 110 of them couldn't be in that study because their viral cultures didn't grow. (A posi- tive viral culture is one of the entry criteria for the TP-5 study.) These people want to be in a study.

"Many people don't believe in doing anything by themselves, but they do want to be part of research -- thousands of people."

JJ: Meaning that it's not true that it's impossible to study anything because people are using so many treatments on their own already.

LT: "You could put an ad in the newspaper for people who are not doing anything and say we are going to start on whatever. And take baseline tests. You'll get 15 to 20 people, I guarantee you.

"If there was a person running these studies, a physician or nurse practitioner, to do clinical evaluations on these people to go along with all their blood work, it can happen. I've spoken to a thousand people."

From the audience: "We're a tremendous resource amongst ourselves. We might have a lot of pieces of the puzzle, we have to respect that, although we don't have the titles, we don't have the M. D. or Ph.D.

"We're ready to go to the next level, because we have thousands of us now. It's fascinating that we're not able to get into the regular research projects. When you can desire to be studied, contribute to humanity.

"We can get, say, ten people, and it's up to each individual to do his or own treatment. We don't have to wait for the FDA."

From the audience: "Set up your own research trials, put an ad in the paper, say I'm on dextran sulfate, I'm here because I want to go on something...

"You set up a group, and each person in the trial, through their own individual doctor, says I'm on dextran sulfate."

JJ: One way to handle the drug-combination issue is to organize trials to test the combinations that people want to do anyway.

From the audience: "It needs a leader, some group to hire the nurse practitioner. The same thing has come up for months. I don't have the time; everybody is busy with what they are doing already. The project doesn't get off the ground."

Terry Beswick, Healing Alternatives: "I'm pulling together a meeting, getting the ball rolling. This is an idea we can plug into a CRI (Community Research Initiative) model."

From the audience: "If the gay dating services can organize to bring people together, then we can, to save lives."

From the audience: "Agree with your doctor that for six months you're going to take dextran sulfate, acyclovir and AZT -- or whatever -- then put an ad in the paper."

From the audience: "A lot of it is each individual's ini- tiative. Each person does it on their own, through their own doctor."

From the audience: "Everyone participating instead of wait- ing for someone else to do it."

LT: "The only caveat: along with the other criteria, one of the defining things is to agree to use lab X for the study, so that the data from different people is compatible. And if your doctor doesn't use that lab, just say send it there. They'll take the business."

Note: The PWA Coalition of San Francisco is looking for an administrator to help organize community-based trials. For more information see the announcement in AIDS Treatment News #63, page 7, or call Terry Beswick, (415) 626-4053. Volunteers are also needed.

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