Baltimore Alternative, March 1989

ТЬе ВаЫмопе MarcU 1989 ALTERNATIVE FREE \notUer VoicE . Another C ho ice. ■нанниявшншаашакнш Aerosol Pentamidine Pricing Angers Chicago Activists Charges May Violate FDA Regulations by Rex Wockner CHICAGO— Members of ACT UP/ Chicago say they are outraged that Chicago- based LyphoMed, Inc. will charge the same "exorbitant" price — $99.45 per 300 mg dose — for its newly approved aerosol pen¬ tamidine (AP) as for its older injectable pen¬ tamidine, and there is some indication that the pricing may violate Food and Drug Ad¬ ministration (FDA) rules. "LyphoMed is drooling at the thought at amassing millions more from the aerosol monopoly," said ACT UP/Chicago's Paul Adams. "If the AIDS community thought LyphoMed was engaged in profiteering on IV pentamidine, they ain't seen nothin' yet." ACT UP has staged numerous zaps and civil disobedience actions against the com¬ pany in the past year. LyphoMed received ’’Treatment IND (In¬ vestigational New Drug)" approval from the FDA Feb. 6 to distribute AP, which is be¬ lieved to prevent pneumocystis carinii pneu¬ monia (PCP) in persons with AIDS (PWA's) and others with damaged immune systems. The FDA recommended AP for "AIDS virus-infected individuals who have had at least one episode of the pneumonia or who have a T4 helper cell count of 200 per cubic millimeter or less." The agency also said AP "should be administered.. .through a Respir- gard II nebulizer at the...dosage of 300 mg every four weeks." Aerosol pentamidine's "Treatment IND" status — a preliminary okay to begin distribu¬ tion of the drug to seriously ill patients — was granted based on data from a compara¬ tive dose trial conducted by the San Francis¬ co Community Consortium (SFCC), a group of doctors experienced in treating PWA's. The study found that PWA’s taking more frequent but lower doses of AP were more likely to develop PCP. FDA Commissioner Frank Young has es¬ timated that 50,000 Americans will qualify for access to AP under the Treatment IND. Dr. Anthony Fauci of the National Institutes of Allergies and Infectious Diseases said the data from San Francisco was released "be¬ fore scientific publication to speed patient access to this stale of the art therapy." Pricing a Violation of FDA Rules? In the meantime, many observers say Ly- phoMed's decision to sell AP for $99.45 a dose is most likely a violation of FDA Treat¬ ment IND regulations, which limit charges on such drugs to what is "necessary to re¬ cover costs of manufacture, research, devel¬ opment, and handling." But FDA spokesperson Don McLeam see AP PRICING, page 2 AIDS Action and Chase-Brexton Clinic Plan Participation in Community Based Trials NIAID Unveils Community Research Plans , and Asks for Proposals by Garey Lambert BALTIMORE and BETHESDA — Officials of AIDS Action Baltimore and the GLCCB's Chase-Brexton Clinic have agreed to respond jointly to the Community Pro¬ grams for Clinical Research on AIDS Re¬ quest for Proposals from the National Insti¬ tute for Allergies and Infectious Diseases (NIAID). The NIAID, run by Dr. Anthony Fauci, is part of the National Institutes of Health with headquarters in Bethesda. The program was announced last Fall, and the Request for Proposals (RFP) was issued on January 17, 1989. On Tuesday, February 21, at a day-long meeting near NIH headquarters. Dr. Law¬ rence Deyton, the Chief of the Community Research Section, and a panel of officials from NIAID revealed their plans for the trials, and answered questions posed from an assembly of physicians, and officials from AIDS service organizations and other com¬ munity based organizations from across the country. "We're thrilled by the whole concept," said AAB's Lynda Dee, who attended the February 21 meeting with Chase-Brexton see TRIALS, page 3 Anti-Drug Abuse Act Bans 'Poppers' News Nicaragua's Safe Sex Cathedral . 2 AIDS Omnibus Bill Passes in Va . 4 Across America . 8 Religion . 34 Health Visualization Therapy . 15 Northern Lights Mastery . 16 AIDS Update . 19 JoAnn Loulan Talks...p. 12 Arts Henry Schoebel: Expressions of Modem Existence . 22 Balto. Concert — Blast From Past . 27 Alan Waldron: Grecian Formula Works at Source . 30 Travel Rainbow Mt. Resort . 32 L.A.'s Wild Drag Race . 33 Interview — Romanovsky and Phillips. ..p. 28 by Paula E. Langguth All across the country butyl nitrite prod¬ ucts ("poppers”) have been pulled from the shelves of bars and retail outlets in compli¬ ance with the Anti-Drug Abuse Act which was signed into law last November by for- community groups... applaud the decision to prohibit the sale or distribution of poppers mer President Ronald Reagan. The ban on poppers, a $60 million indus¬ try, took effect February 16. Doc Johnson, distributors of a wide variety of butyl nitrite products, has filed an injunction seeking a court order to have poppers removed from the list of drugs included in the bill. In the meantime. Doc Johnson and other popper manufacturers have released a new product, propyl nitrite. Propyl nitrite is not listed in the omnibus drug bill, but it is said to have the same phsyiological effects on the human body as does butyl nitrite. "The names are the same, they just changed the formula," says the proprietor at a local retail outlet who feels that the Feder¬ al Government tries to regulate everything and anticipates that the new poppers will be just as big a seller as the old ones. The initial ban of butyl nitrite products was introduced by Rep. Mel Levine (D-CA) and was accepted by Rep. Henry Waxman (D-CA), chairman of the House Subcommit¬ tee on Health and the Environment. Levine proposed the ban on the sale of butyl nitrite products because he believes that they pose a health hazard and that they should there¬ fore be regulated by the federal government. see POPPERS, page 14