alan@garp.mit.edu (Alan Shaw) (10/17/89)
The Treatment & Data Digest A Review of issues addressed by ACTUP's T&D committee during its past week of activities Number 16: October 16, 1989 PEPTIDE-T AVAILABLE: The Dallas Buyers' Club now has Peptide-T in stock. The price is $250 for a 50 day supply; however, the price will go down if the club gets enough users to buy in larger quantities. The drug can be used in two ways: by inhaling it nasally or by injecting it subcutaneously. Inhaling is the easier method -- and is how most people who are buying the drug are using it -- but there is some worry that this method doesn't always get a consistent dosage into the body. The subcutaneous route ensures a consistent dosage but requires extensive preparation, getting hold of needles, and learning how to inject yourself. (Subcutaneous means under the skin. Thus, unlike the typical vaccination you would receive from a doctor or clinic, the needle is not put into muscle. Rather, the needle is slipped right below the skin's surface. After the substance is injected, there will be a "bubble" of fluid that can be seen and felt. Over a short period of time, the fluid will be absorbed and the bubble will disappear.) For the $250 purchase price, you receive 25 mg of the drug: enough for 50 once-daily doses of .5 mg each. Ron Woodruff who runs the Dallas Buyers' Club states that the .5 mg dosage is an upper limit and that smaller dosages might be just as useful. Peptide-T appears to give direct clinical benefits: that means it should actually make you feel better and make clinical symptoms disappear. In particular, it might clear up skin problems, intestinal disorders and some neurological symptoms. (People report dreaming more.) It takes about 1 1/2 months for those clinical benefits to become noticeable. It is still unclear whether it raises T-cells or lowers p24 antigen levels. The phone number for the Dallas Buyers' Club is (214) 526-3038. There is a one time fee of $25 to become part of the club. ACTUP TO MEET WITH FAUCI: This Thursday night, October 19th, Dr. Anthony Fauci -- head of the National Institutes of Allergies and Infectious Diseases -- will be in New York to talk with ACTUP members. The purpose of the meeting is primarily scientific, i.e. to discuss theories of how HIV progresses in the body. Researchers are slowly beginning to devote more time to investigating co-factors that might play a part in HIV's destruction of the immune system. Fauci, in particular, has been examining cytomegalovirus' role in speeding up the activity (replication) of HIV. Of course, there will be opportunities to question Fauci on other matters -- why the CRI didn't receive an NIH grant or why there is not any community representation on the committee which prioritizes the drugs the NIH puts into clinical trials. The meeting will be this Thursday at 8:00 p.m. in the Sandy Moss room at the Lesbian and Gay Community Services Center. All are welcome to attend. COMPOUND Q ALSO AVAILABLE: The Dallas Buyers' Club is also making Compound Q available. The current price is $450 which covers the cost of the sample vial (which is used to test for allergic reactions) and the three treatment vials. The club will sell the drug only to those people who submit a letter from the doctor who will administer Q to them. As with any treatment decision, it is important to become aware of both the risks and possible benefits of using Q before deciding to go ahead with the infusions. That could involve talking to people who have already used Q as well as reviewing the Project Inform data. (Getting hold of that data might not be too easy right at this moment.) The Dallas Club has been receiving some pressure to take Q off the market. Consequently, the club is trying to get a sense of how the community/communities feel about its policy of selling Q. If you feel strongly one way or another, give them a call at (214) 526-3038. As of now, the Club plans on taking a vote of everyone on its mailing list and going by whatever the majority wants it to do. MORE PEPTIDE-T STUFF: The development of Peptide-T has been a mess. Last May, Bristol Myers decided it no longer wanted to test or develop the drug, and it turned over all of its rights to Integra Institute, the other group to which the government had awarded a license. This left Integra Institute in a precarious position; it's a small company and doesn't have the capabilities to manufacture and distribute the drug on its own. Yet it couldn't go looking for another partner because Bristol Myers was still officially a licensee. For months, Integra tried to get Bristol Myers to send a letter to the Department of Commerce (which awards licenses) informing the government of its decision. For some reason, and we are still not sure why, Bristol Myers was refusing. Last week, Actup threatened Bristol Myers with a demonstration. Two days later the company sent the government the letter. Integra claims it is now negotiating with a couple of major pharmaceuticals to find a new partner. Hopefully, Peptide-T will be back on track soon. LOWERING THE PRICE OF PENTAMIDINE: Two weeks ago a meeting was held with Frank Young and other FDA officials to discuss what could be done about the high price of pentamidine. The initial catalyst for the meeting was the letter which Lyphomed, the U.S. maker of pentamidine, sent to the FDA requesting that all shipments of pentamidine coming in from other countries be seized. Lyphomed claimed the FDA had the legal responsibility to enforce Lyphomed's exclusive license to the drug. Therefore, Lyphomed argued that the FDA should stop the PWA Health Group from importing the drug from England. (The PWA Health Group sells pentamidine for $40 a treatment -- far less than the $120 to $200 price it costs for the Lyphomed product. Obviously, Lyphomed felt that its parasitically high profits were in danger.) The FDA wanted to hear the activist response to Lyphomed's letter before they implemented an import alert. They got it, and as a result of the meeting the FDA decided to wait for another week or two while it further studied the issue. More importantly, in my mind at least [poster's note: this is probably Jim Eigo speaking -- ais], was something else that came out of that meeting: a way in which the FDA could regulate the price of a drug. The FDA has always claimed that it has no way to do this: it claims its jurisdiction is solely the review of a drug's safety and efficacy. Yet when the FDA awards a company an exclusive license to a drug under the Orphan Drug Act it does so to make available that wouldn't otherwise be on the market. The group who met with the FDA argued that a drug is not really "available" unless it is affordable. Interpreted this way, the Orphan Drug Act dictates that the FDA should only award a license to those companies that will sell the drug at a reasonable price. A company that sells at high prices is not fulfilling its obligation to make the drug available. The FDA listened to this position and seemed very interested. If we continue to push them, we could get them to take away Lyphomed's license. The threat alone would probably get the price lowered. IMPORTANT NUMBERS: AIDS Treatment Registry: information about trials in the New York area: 212-268-4196. Project Inform: information on different experimental treatments: 800-822-7422. National Trial Hotline: information on trials throughout the United States: 800-TRIALSA. Bristol Myers ddI Hotline: information on how to get ddI outside of the official phase II trials: 800-662-7999. QUESTIONS? Call Stephen Gendin at (718) 636-9254 or Mike Barr at (212) 765-7127.