AIDS Daily Summary December 13, 1995 The Centers for Disease Control and Prevention (CDC) National AIDS Clearinghouse makes available the following information as a public service only. Providing this information does not constitute endorsement by the CDC, the CDC Clearinghouse, or any other organization. Reproduction of this text is encouraged; however, copies may not be sold, and the CDC Clearinghouse should be cited as the source of this information. Copyright 1995, Information, Inc., Bethesda, MD ************************************************************ "Americans Receive New Medicines as Quickly as Others, FDA Asserts" "One AIDS Virus Strain Apparently Weakening" "Merck's Medco Unit Moves 'On Track,' Chairman Gilmartin Assures Analysts" "Across the USA: Alabama" "Chronicle: Guests Squeezing in to Honor Judy Peabody and Her AIDS Work" "Interfaith Task Force Marks 10th Year" "U.S. Prosecutors Drop Charges for AIDS-Infected Man" "Japan Activists Urge Action in HIV Blood Scandal" "First 500,000 AIDS Cases--United States, 1995" "The Shocking Truth about Studies: Scientists' Love/Hate Relationship with AZT" ************************************************************ "Americans Receive New Medicines as Quickly as Others, FDA Asserts" Washington Post (12/13/95) P. A3; Schwartz, John Food and Drug Administration Commissioner David A. Kessler said Tuesday that Americans receive new medicines as quickly as citizens of other countries, including treatments ranging from AIDS therapies to drugs for ovarian cancer, multiple sclerosis, cystic fibrosis and osteoporosis. Kessler said the average total development time for a U.S. drug is 11.5 years and cited an FDA study showing that 96 percent of all applications for new drugs and "biologics" are acted upon within the 12-15 month period required by law. Another FDA study revealed that, in cases where approval for a single drug was sought in the United States and another country, the FDA was more likely to have approved the drug first. Gerald J. Mossinghoff, president of the Pharmaceutical Research and Manufacturers of America, said the average total drug development time is really 15 years and fundamental FDA reforms are still a necessity. Related Story: New York Times (12/13) P. C13; Washington Times (12/13) P. B9 "One AIDS Virus Strain Apparently Weakening" Washington Times (12/13/95) P. A16 A strain of HIV found primarily in West Africa has been weakening in strength over time, thus enabling infected individuals to live longer, a U.S. scientist reported at an AIDS conference. According to the Harvard AIDS Institute's Phyllis Kanki, a study of nearly 200 HIV-2-infected Senegalese women revealed that only one of the women developed full-blown AIDS after nine years. "Merck's Medco Unit Moves 'On Track,' Chairman Gilmartin Assures Analysts" Wall Street Journal (12/13/95) P. B6; Tanouye, Elyse Merck & Co.'s managed medical care division is living up to expectations, according to Merck Chairman Raymond Gilmartin, who was attempting to eliminate speculation that Merck was fighting to make the acquisition worthwhile. Medco is "on the track" of internal performance measures set for the unit, Gilmartin told analysts, noting that 13 percent of the drugs the unit sells are from Merck--up from 10 percent two years ago, when Medco was purchased. Meanwhile, the executive also said that Merck would try to reduce costs by as much as $250 million in manufacturing and $100 million in other areas of the company. Gilmartin added that the company intends to file for U.S. Food and Drug Administration approval of its AIDS drug Crixivan in early 1996. "Across the USA: Alabama" USA Today (12/13/95) P. 10A The case against 41-year-old Willie Robinson, who was accused of raping a seven-year-old girl when she was four, has been declared a mistrial. Prosecutors claim the girl contracted HIV during the incident, and that she may not live to testify at next month's retrial. "Chronicle: Guests Squeezing in to Honor Judy Peabody and Her AIDS Work" New York Times (12/13/95) P. B9; Brozan, Nadine The Gay Men's Health Crisis in New York has honored Judy Peabody for her 10-year commitment in the fight against AIDS. For the majority of those years, Peabody has been the leader of a support group for the caretakers of AIDS patients, has worked to improve services, and has raised funds. She has helped hundreds of people affected by the disease. In her own words, Peabody said, "I stopped counting at 70 or 80. I don't need to know. I just need to keep going." "Interfaith Task Force Marks 10th Year" Boston Globe (12/12/95) P. 38; Ribadeneira, Diego Established in 1985, at a time when many churches hesitated to deal with AIDS because it was thought of as a homosexual disease, the Ecumenical Task Force on AIDS has provided comfort and catharsis for thousands of people affected by the epidemic. Tuesday marked the interfaith organization's 10th anniversary, which was recognized at a service in Boston's South End. Episcopal Bishop M. Thomas Shaw was to deliver the sermon, as well as panels from AIDS memorial quilt. The task force has held more than 150 of its healing services in 90 different places of worship in Boston and eastern Massachusetts, including Martha's Vineyard. "U.S. Prosecutors Drop Charges for AIDS-Infected Man" Reuters (12/12/95) U.S. Attorney Robert Pitman announced on Tuesday that a British man who has been charged with receiving millions of dollars stolen from AT&T will not be tried because he has AIDS. Pitman explained, "It's twofold--first it is not humanitarian to send someone for his remaining days to prison, and [second] to house and care for a terminally ill person is very expensive." Bill White, the attorney for Michael Lindsey Faulkner, said that charges against his client were dropped because he agreed to a civil settlement that involved turning over some assets to AT&T. Prosecutors claim that Faulkner's partner wired millions of dollars to U.S. banks, and that Faulkner then withdrew that money and spent it on business and numerous luxury items. Last week, AT&T Global Information Solutions and its London affiliate won a civil judgment against Faulkner for $16 million. "Japan Activists Urge Action in HIV Blood Scandal" Reuters (12/12/95) Some 2,000 Japanese students and labor activists protested outside the Health and Welfare Ministry in Tokyo on Tuesday, demanding that the Health Minister and other officials relinquish their positions for not having done more to stop the use of contaminated blood products in the 1980s. Nineteen-year-old Ryuhei Kawada, a university student who contracted HIV through blood products, implored the government to acknowledge its responsibility in allowing many of the country's hemophiliacs to become HIV-infected by permitting pharmaceutical companies to sell tainted blood products at that time. Statistics from Japan's Health Ministry show that as of August 1995, there were 1,026 cases of AIDS and 2,893 cases of HIV infection. Of the estimated 5,000 hemophiliacs in Japan, 1,803 were infected with HIV and 530 had AIDS. "First 500,000 AIDS Cases--United States, 1995" Morbidity and Mortality Weekly Report (11/24/95) Vol. 44, No. 46, P. 849 A total of 501,310 AIDS cases had been reported to the U.S. Centers for Disease Control and Prevention as of Oct. 31, 1995. More than 62 percent of these individuals have died. Nearly half of the cases were reported between 1993 and 1995, while 10 percent were reported in the years between 1981 and 1987 and 41 percent were reported from 1988 to 1992. Also, the proportion of female AIDS patients grew from 8 percent in the 1981-1987 period to 18 percent during 1993 to October 1995. The rate of AIDS among whites fell from 60 percent to below 45 percent, yet the rate among blacks and Hispanics increased 13 percentage points to 38 percent and 4 percentage points to 18 percent, respectively. Meanwhile, the proportion of AIDS cases among injection drug users rose from 17 percent between 1981 and 1987 to 27 percent in the most recent reporting period. A full 10 percent of the cases resulted from heterosexual contact, up from 3 percent, and 45 percent of the cases were among men who have sex with men, down from 64 percent. Across the country, the rate of reported AIDS cases per 100,000 population was highest in the Northeast during 1994--a trend which differs from the periods between 1988 to 1992 and 1993 to 1995, in which the South had the largest number of cases, as well as the largest proportionate increase in reported cases. "The Shocking Truth about Studies: Scientists' Love/Hate Relationship with AZT" Men's Fitness (11/95) Vol. 11, No. 11, P. 100; Gower, Timothy It often seems as if scientific research "flip-flops," with studies contradicting each other for such reasons as flawed data or differences in scientific methodology. For example, a double-blind, placebo-controlled study of the safety and efficacy of AZT was stopped early for ethical reasons in 1986 because the death rate in the placebo group was nearly 20 times greater than in those who received AZT. The results of the study led to the drug's 1987 approval by the U.S. Food and Drug Administration for use in people with full-blown AIDS. However, the trial sparked controversy. John Lauritsen, author of "Poison by Prescription: the AZT Story," claimed that the Phase II AZT trials were rife with violations of protocol that influence the results. Nevertheless, the drug's reputation rebounded, supported by 1990 research by Paul A. Volberding, who concluded that AZT prolongs life in HIV-infected asymptomatic individuals. Researchers at the Harvard School of Public Health, however, discovered that Volberding's study ignored the fact that AZT delayed disease progression by only about two weeks and that the people who took it experienced many unpleasant side effects. Overall, although AZT is still a popular choice for controlling HIV infection, it was recently further attacked by a British study which found that AZT delayed AIDS progression, but did not extend life.