Subject: Drug Trials Interview; Drug Price Comparison Date: Sep 9 1988 (557 lines) &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& J O H N J A M E S writes on A I D S &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& copyright 1988 by John S. James; permission granted for non-commercial use. Articles by John S. James are from AIDS Treatment News unless otherwise indicated. John may be contacted by telephone at (415) XXX-XXXX. AIDS TREATMENT NEWS issue # 64, September 9, 1988. CONTENTS: [***** appears here at each new item] Community-Initiated Drug Trials: Interview with Leland Traiman Prescription Drug Price Comparison Please Return Treatment Survey Questionnaires Hypericum Update New AmFAR Directory Out AIDS Reporters Wanted Major AIDS Bill in Congress San Francisco: AIDS Public-Administration Conference San Francisco: Stress and Hairy Leukoplakia Study In Memoriam: John Fox, 1948-1988 ***** Community-Initiated AIDS Drug Trials: Interview with Leland Traiman Leland Traiman, a nurse practitioner now working as clinical research manager for Marcus Conant, M. D. and managing Dr. Conant's trial of the experimental treatment TP-5 (thymopentin), discussed what makes the difference between a good or poor clini- cal trial, at the weekly public meeting of The Healing Alterna- tives Foundation on August 23. Mr. Traiman stressed that he was speaking for himself only, not representing Dr. Conant. 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 Initia- tive 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. Unfor- tunately 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 stu- dies, I encourage people to keep questioning about every treat- ment 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. Physi- cians 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. ***** Prescription Drug Price Comparison by Denny Smith and John James Are you getting the best prices for prescription drugs? Could you save money by using a mail-order pharmacy? AIDS Treat- ment News called pharmacies in seven cities, and also two mail- order pharmacies, to see how much prices varied. We found some great variations -- in one extreme case, a ten fold variation in price for equivalent products; it is a good idea to compare. Usually mail-order pharmacies are close to each other in price -- as would be expected, since geography doesn't matter and customers can easily call and compare. They consistently have good prices, but not always the lowest. At community pharmacies (not mail order), prices can vary greatly. We found that cities like New York and San Francisco usually had the highest prices, while smaller cities like Nash- ville had the lowest. This variation suggests that persons in big cities may save the most by filling their prescriptions by mail. But individual pharmacies often have surprisingly low or high prices for a particular drug. (And an earlier survey of five pharmacies in San Francisco, mentioned in AIDS Treatment News #52, found some price variations as much as 50 percent or more for the same drugs in the same city.) Generic drugs -- chemical equivalents of brand-name products for which patents have expired -- can offer the biggest savings; prices are often a fraction of those charged for the name brand. The most extreme price differences we found were for Septra DS. You could pay $154.65 at one pharmacy. Or you could buy a generic equivalent by mail for $11.19. Are the less expensive drugs as good? Few doctors insist on the more expensive brand-name drugs. Ask your doctor if he or she knows any reason not to use a generic equivalent. Mail-order pharmacies are poorly regulated at this time, and some critics have claimed that they may be more likely than oth- ers to make errors in filling prescriptions. Since errors are possible in any case, you might check when refilling a prescrip- tion to make sure that the pills look the same. If you want to check the first time you receive a medication, the Physician's Desk Reference, available in most public libraries, includes color pictures of prescription drugs. Some legal requirements can vary by state. In some states, if the patient wants a generic drug the physician may have to specify that on the prescription. In others (including Califor- nia), a pharmacist may substitute a generic equivalent (with the patient's consent), unless the physician writes "do not substi- tute" on the prescription; these days few physicians do. In these states you can get the generic (if one is available) by asking the pharmacist for it, even if you did not bring up the matter with your physician. Another legal technicality to note is that California and some other states prohibit refilling an out-of-state prescrip- tion. Therefore if you are using an out-of-state pharmacy, you will probably have to send a new prescription each time, even if you could otherwise just ask for a refill. Watch your drug supply to avoid running out; most physicians will mail you a new prescription when necessary, and then you can mail it to the pharmacy. The great price differences suggest that it would be wise to check prices at several pharmacies, including at least one mail- order pharmacy, before spending much money for prescription drugs. Price Ranges (September 1988) We agreed not to publish the prices of specific pharmacies; these change frequently in any case, so published prices would quickly become obsolete. Instead we show the range of prices -- the lowest and highest for traditional pharmacies (not mail order), and the lowest and highest for prescriptions filled by mail. Not mail order Mail order Low High Low High AZT (100 mg, 100 caps) $159.97 195.39 155.60 169.75 Acyclovir (200 mg, 100 caps) 56.97 75.35 56.77 60.35 Mycelex (10 mg, 100 tabs) 49.99 79.55 49.30 51.65 Septra DS (160 tabs) 75.00 154.65 92.00 98.08 Septra generic equivalent 25.19 49.60 11.19 19.40 Nizoral (200 mg, 50 tabs) 75.99 118.55 75.02 92.75 Dapsone (25 mg, 80 tabs) 14.50 18.75 12.75 14.45 Ativan (1 mg, 50 tb) 21.69 25.95 20.84 23.85 Ativan generic equivalent 9.39 17.34 9.49 10.55 Note: Stores sometimes sold the same medicines in different quantities, complicating comparisons. In these cases we asked the stores to prorate the prices they reported to us. The Pharmacies We did not select the pharmacies in this survey systemati- cally; we either picked ones we knew about, or we asked PWA organizations to suggest one in their city. While the pharmacies selected this way are probably better than average, there are many others which we did not consider. All those we did call were helpful and cooperative. The two pharmacies selling by mail were Family Pharmaceuti- cals of America (800/922-3444), and Huntington Plaza Pharmacy (818/397-3072). The seven others were The Apothecary (Bethesda, MD, near Washington, DC), Bigelow (New York), Corsons (Philadel- phia), Ike's (Nashville), Kaiser (San Francisco), Pay'n Save (Seattle), and Walgreen's (Minneapolis). ***** Please Return Treatment Survey Questionnaire If you have any first-hand knowledge of AIDS/ARC/HIV treat- ments, you can help PWAs everywhere by returning the "AIDS Treat- ment Survey" questionnaire attached to issue number 63. These must be returned by September 30 to be counted in the report, which will be published in AIDS Treatment News. If you know of any treatment which did work, or did not work, either for yourself, or for family, friends, acquaintances, or clients if you are a health professional, please let us know by completing and returning the survey. (If you don't have any- thing to tell us, however, there is no need to return the form.) We designed this survey questionnaire to be easy to use. For example, you don't need to answer every question; just tell us what you think we should know. Even if you only write a single word on the sheet -- the name of a treatment which did (or did not) work -- and leave everything else blank, that information will help us let people know which treatments others have or have not found successful. ***** Hypericum Update The major article in the last issue of AIDS Treatment News concerned hypericum (St. John's wort), a medicinal herb contain- ing an ingredient which showed strong anti-retroviral activity in animal tests. Hypericum, considered moderately safe but not totally safe by herbalists, has long been used for other medicinal purposes, and various preparations are available in some health-food stores. But there are doubts whether they contain enough hyperi- cin, the active ingredient, to be useful. And so far we do not have even anecdotal reports of human use for AIDS or HIV; no one has yet said that they think the herb did (or did not) help them, because no one has used it long enough. For these reasons, we do not think this potential treatment is ready for widespread use, until there is more experience with it. A few people are trying different extracts at this time. Also we have learned that chemical testing to compare the extracts should be inexpensive, around $30. for each sample analyzed. However we have not yet obtained a "standard", a sam- ple of the pure chemical to calibrate the testing equipment; without the standard, the laboratory can compare the concentra- tions of hypericin in different extracts, but cannot accurately measure absolute amounts. If you are using hypericum, or could help us test or research it, please call John or Denny at AIDS Treatment News, (415) 255-0588, to help us pool information for everyone's bene- fit. ***** New AmFAR Directory Out The August edition of the AIDS/HIV Experimental Treatment Directory is now available from the American Foundation for AIDS Research (AmFAR). Besides new and updated listings, this edition has improved maps and other aids for locating clinical trials, a new article on testing potential AIDS drugs in macrophages, and, for the first time, some information on experimental treatments for opportunistic infections. A one-year subscription, including the directory and updates, costs $30.00; a single issue is $10.00. AmFAR will con- tinue its policy of sending a free copy of the directory to any person with AIDS who cannot afford one. To order the directory, call AmFAR at (800) 992-2873, or at (212) 333-3118. ***** AIDS Reporters Wanted Freelance writers able to cover AIDS public policy and pol- itical issues can contact the San Francisco Sentinel, one of the major gay newspapers in San Francisco. Writers can live any- where, not necessarily in the San Francisco area. Rates are negotiable. Those interested should send clippings to: Tim Taylor, San Francisco Sentinel, 500 Hayes St., San Francisco, CA 94102 ***** Major AIDS Bill in Congress The most important AIDS bill yet, HR 5142, will be con- sidered by the House of Representatives in late September. This comprehensive bill includes many different research, prevention, and treatment programs. Congresswoman Nancy Pelosi, a friend of persons with AIDS, has asked for help in supporting the bill. You can help by asking your Representatives to vote for HR 5142, for Pelosi's amendments on early-treatment research and on mental health treatment programs, for Congressman Henry Waxman's amendment to provide compassionate access to drugs shown to be potentially effective, and against all amendments which would eliminate the confidentiality and consent provisions of HR 5142. ***** San Francisco: AIDS Public-Administration Conference The 2nd annual National AIDS Conference, sponsored by the San Francisco Department of Public Health and co-sponsored by the U. S. Conference of Mayors and over 20 other organizations, will be held September 28 through October 1 in San Francisco's Civic Auditorium. The conference will "examine how systems of AIDS education, prevention and care are designed, implemented and evaluated. Administrative issues and policies related to AIDS programs will be addressed. The role of the local health department and its interaction with community-based organizations will be emphasized." Registration is $175.00 regular, $50.00 for staff of non- profit community-based agencies, and complementary for persons with AIDS or ARC. Continuing-education credit is available. For registration information, contact: AIDS Conference Registrar, c/o Krebs Convention Management Services, 555 DeHaro Street, Suite 200, San Francisco, CA 94107, 415/255-1297. ***** San Francisco: Stress and Hairy Leukoplakia Study Persons in the San Francisco area who have had hairy leuko- plakia and are not currently taking antivirals are wanted for a one-month study at the University of California, San Francisco. The study, conducted by Doctors Tom Coates, Marcus Conant, and Susan Folkman, is non-invasive; participants will fill out ques- tionnaires daily for 28 days. If you are interested in participating and would like more information, call Dr. Folkman, Glenn Strome, or Mike Ward at (415) 476-0981. ***** In Memoriam: John Fox, 1948-1988 John Alan Fox, one of the founders of the Healing Alterna- tives Buyers Club, died in Glenwood Springs, Colorado on August 26, 1988. He had had AIDS since October 1986. The immediate cause of death was never diagnosed. John was a leading organizer and president of the board of directors of the buyers club (now The Healing Alternatives Foun- dation) until three months ago when he became too ill to be active. He had become a leading expert on AIDS treatments, spending much of his time on the phone with physicians, scien- tists, and persons with AIDS throughout the United States and beyond. People in San Francisco will remember his talks on treatments almost every Tuesday night, at meetings of Healing Alternatives. He also answered questions on treatment options from hundreds of persons around the country, especially on new therapies for KS. John worked with his oncologist and other phy- sicians to devise a successful low-dose triple chemotherapy. John tried many experimental treatments. He obtained len- tinan through Japanese connections in 1987 -- one of the first Americans to do so. He had his own ozone machine, which he believed was helpful. Occasionally, however, he suffered serious side effects from some of the treatments he tried. John had access to the best medical care, but during his final illness was unhappy with what was available for AIDS. In our last conversation he commented that physicians "don't think"; that even the better doctors simply ordered the obvious diagnos- tic tests and then gave up when they all came back negative. No one could diagnose his repeated fevers, weakness, and shortness of breath. On August 6, accompanied by his brother and an attendant, John went to Glenwood for a last treatment attempt, with an unorthodox therapy there. Before leaving, he had made plans for his memorial service. Friends of John Fox are looking for a permanent memorial to him and his contribution -- perhaps through Healing Alternatives. John's courage, enthusiasm, and willingness to help others will never be forgotten by those who knew him. ***** [Obsolete subscription information has been removed. See the latest issues for up-to-date information. -- sysop] &&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&& End of display