Baltimore Alternative, July 1989

ALTERNATIVE FDA Approves Aerosol Pentamidine & Ganciclovir Community-based Trial Is Basis for Pentamidine Approval- Experimental Anemia Treatment Given “IND" Status by Garey Lambert ROCKVILLE, MB— The Food and Drug Administration (FDA) has approved both aerosolized pentamidine and ganciclo¬ vir. Additionally, the FDA will permit ex¬ panded pre-market distribution of r- erythropoietin, an experimental protein product that has shown a remarkable ability to treat the severe anemia that results from taking AZT. The FDA has been under in¬ tense pressure from AIDS activists, physi¬ cians, and People With AIDS to make these dugs more widely available. Department of Health and Human Ser¬ vices Secretary Louis W. Sullivan made the announcement of the aerosolized pentami¬ dine approval on June 15th. The Food and Drug Administration is part of the U.S. Pub¬ lic Health Service under the Department of Health and Human Services. In a prepared statement, Sullivan said, ‘Today’s approval will help many of those infected with the AIDS virus avoid one of the most deadly opportunistic infections as¬ sociated with AIDS. It may help an estimat¬ ed 100,000 or тете individuals who are at risk of developing first or subsequent epi¬ sodes of pneumocystis carinii pneumonia (PCP) and will, therefore, significantly im¬ prove the quality of their lives.” FDA approval of aerosol pentamidine was based largely on data collected from a clinical trial conducted by the San Francisco Community Consortium. This is the first major drug to be approved from results ob¬ tained in a community based trial. Aerosol pentamidine may be used for any patient who has had at least one case of PCP, or whose CD4 lymphocyte cell count is 200 or less. The Respirgard II nebulizer is specified in the drug’s approval labelling. Aerosol pentamidine will be marketed under the trade name ’’NebuPent.” A Maryland Blue Cross & Blue Sheild spokesman told The ALTERNATIVE, that the insurer, Maryland’s largest, is now pre¬ pared to reimburse for aerosol pentamidine “if the treatment is administered under the guidelines of FDA approval.” “We pay for approved treatments,” the spokesman added. Ganciclovir, also known as DHPG, was approved on June 26th. Ganciclovir, which will be marketed as Cytovene, has shown ef¬ fectiveness against cytomegalovirus (CMV) retinitis. The drug slows progression of the disease. It does not stop the infection, and is not considered a cure. see FDA APPROVES page 17 The Compound Q Story What Really Happened in San Francisco? — Does Compound Q Work?— The Truth From Project In form’s Martin Delaney AIDS Update by Garey Lambert By any account, the underground Com¬ pound Q trials now going on in San Francis¬ co, Los Angeles, and New York are daring, probably heroic. Project Inform, the radical San Francisco organization that has been our strongest advocate for faster drug trials and more access to experimental treatments, has now taken its most courageous step yet. It has House Approves Hate Crimes Statistics Act Dannemeyer Continues Offensive, Quotes Gay Press by Cliff O' Neill WASHINGTON — After an afternoon of largely one-sided debate, the U.S. House of Representatives passed the the Hate Crimes Statistics Act by a landslide 368-47 margin June 27th, over the loud protests of anti-gay Rep. William Dannemeyer (R- CA). The Hate Crimes Statistics Act (H.R. 1048) would order the Justice Department to collect statistics on crimes motivated by race, religion, ethnicity or sexual orientation. Although the landmark bill was passed last year by the House by an equally wide mar¬ gin, a last minute tactic from Sen. Jesse Helms (R-NC) kept the bill from the Senate floor, effectively killing it for that session of Congress. June 27th, the House was set to again vote on the bill, this time on the House suspension calendar, on which amendments are not allowed. In the House Judiciary Committee, Dan¬ nemeyer amendments to limit the scope of the bill and the spending allowed under it were defeated by nearly one-sided margins, with only Dannemeyer voting for the riders. Before the bill came to the floor, Danne¬ meyer took the House floor to denounce the bill’s inclusion of sexual orientation as an attempt to “derail the freedom train” launched by the Civil Rights Act of 1964. “I would say this is our biggest victory to date, hands down.” —Peter Staley, ACT UP/NY Dannemeyer argued that the bill would “elevate homosexuality above gender, age, mental capacity, and economic circumstanc¬ es as a legitimate category of redress under our civil rights laws,” although the bill contains a disclaimer which states that the see HOUSE APPROVES page 6 Lambda Rising Book Report inside NEWS Chase-Brexton Clinic Moves . p. 2 Mapplethorpe Show Canceled .... p. 5 Hate Crimes — Statistics & Solutions . p. 6 “Foley Out of ... Closet” . p. 8 Across America . p. 11 Around The World . p. 13 Pride '89 — Celebrate Community Growth .. p. 35 Religion . p. 37 involved itself not just in the importation of unapproved drugs (like Ribavirin, which it imported from Mexico in the early days of AIDS), or advocacy for experimental treat¬ ments; Project Inform is now involved in the conduct of an unapproved, unsanctioned, though thoroughly scientific study of the efficacy of Compound Q with volunteer human subjects. Project Inform sent “an experienced smuggler" to the factory in Shanghai, China, where Compound Q is manufactured. The study, involving over forty p24 posi¬ tive People With AIDS, is being conducted by physicians using established scientific methods, but without a placebo control. Dr. Alan Levin, the physician overseeing the treatment of volunteers in San Francisco has said, “We’re doing good science, and we’ll do it in 10 percent of the time at one percent of the cost of government approved research. The Compound Q story broke on Mon¬ day, June 26 on NBC Nightly News. It should not have. NBC, and other news organizations that knew of the underground Compound Q trial had sworn secrecy until such time as conclusive results either suc¬ cess or failure, could be reported. NBC chose to break its promise, and justified its betrayal by claiming that one of the “study subjects” had died as the result of “severe” side effects of the drug. But the profound significance of this story did not, and has not stopped at this unfortunate patient’s death. The study is con¬ jee AIDS UPDATE page 19 HEALTH AIDS Update . p. 19 Steve Gavin Speaks . p. 20 ARTS Artscape '89 - The Visual Arts.... p. 23 Art Interview with Eric Miller.... p. 25 Family Masks - 'Puts on a Happy Face' . p. 29 Lambda Literary Awards . p. 31 Wonderland - A 'Gay Thriller' AIDS Benefit p. 33