Date: Wed, 8 Nov 1995 11:06:29 +0500 From: "Martha Vander Kolk" Subject: CDC AIDS Daily Summary 11/08/95 AIDS Daily Summary November 8, 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 ************************************************************ "FDA Committee Urges Approval of First AIDS Drug in New Class" "FDA Graded Highly On Relative Speed of Review Process" "HIV Scholarship" "Britain Sends Faulty Condoms to Zimbabwe" "SEQUUS Pharmaceuticals, Inc. Announces Third Quarter Results" "Suit Alleges Minn. Mutual AIDS Bias" "Health Bodies Urge Backing for Early Warning Procedures" "HIV Risk Practices of Male Injecting-Drug Users Who Have Sex with Men--Dallas, Denver, and Long Beach, 1991-1994" "World AIDS Day Resource Booklet, Centers for Disease Control and Prevention, November 8, 1995" ************************************************************ "FDA Committee Urges Approval of First AIDS Drug in New Class" Washington Post (11/08/95) P. A2; Schwartz, John A U.S. Food and Drug Administration (FDA) advisory committee called on Tuesday for the rapid approval of saquinavir, the first of a new class of AIDS drugs called protease inhibitors. In a six to one vote, the panel voted to recommend that saquinavir, which will be sold under the trade name Invirase, be approved for use in conjunction with nucleoside analogs. However, the panel also unanimously rejected a request by the drug's manufacturer, F. Hoffmann La Roche & Co. of Nutley, N.J., to recommend saquinavir's approval for use as a single-drug treatment in people with AIDS for whom nucleoside analogs are not an option. FDA Commissioner David A. Kessler said Tuesday "that as a class...[he believes protease inhibitors] are the most active agents we have seen to date," though he described saquinavir as "inferior" to other potential products. Related Stories: Wall Street Journal (11/08) P. B13; New York Times (11/08) P. A20; Washington Times (11/08) P. A3; USA Today (11/08) P. 1D; Philadelphia Inquirer (11/08) P. A3 "FDA Graded Highly On Relative Speed of Review Process" Washington Post (11/08/95) P. A15; Schwartz, John A report just released by the General Accounting Office concludes that the U.S. Food and Drug Administration (FDA) is actually comparable in the quickness of its review process to its U.K. counterpart. This first independent assessment of the FDA found that the agency cut its time to review new drugs by 40 percent between 1987 and 1992 from an average of 33 months to 19 and has improved even more since. The assessment comes at a time when at least three FDA reform proposals are in the works and the agency is under attack for allegedly being too restrictive and overzealous in protecting the public by delaying or rejecting lifesaving drugs. Gerald J. Mossinghoff, president of the Pharmaceutical Research and Manufacturers of America claims the new report is "misleading" and does not take into account "total development time." Related Story: Washington Times (11/08) P. B7 "HIV Scholarship" Washington Times (11/08/95) P. A2 Twenty-year-old University of Colorado student Luke Gold has created the Positive Future Fund, a scholarship for HIV-infected students. Gold says he was inspired by a story in his campus newspaper about a student who tested HIV-positive, and said he hopes that the fund will help alleviate some of the stigma that infected persons experience. "I want to change the misconception people have about living with HIV," he explained. The first benefit for the scholarship was held last week, and though Gold is still tallying the proceeds, he notes that he is looking for large donors and foundations to match what has already been raised. "Britain Sends Faulty Condoms to Zimbabwe" Reuters (11/08/95) A report by Britain's National Audit Office has revealed that the country sent 24 million condoms to Zimbabwe and then spent 100,000 pounds ($157,000) for disposing of them and replacing them when laboratory tests found the condoms to be faulty. Britain's Overseas Development Administration ordered the prophylactics, which were manufactured by Malaysia's Dongkuk Techno Industries, and then had to ensure that the condoms were destroyed, for fear that they might be marketed illegally. "Zimbabwe was left severely short of condoms," an audit office spokesman said, because the replacements were delayed. "SEQUUS Pharmaceuticals, Inc. Announces Third Quarter Results" Business Wire (11/07/95) SEQUUS Pharmaceuticals, based in Menlo Park, Calif., announced on Tuesday a third quarter loss of $7,953,000, versus a net loss of $6,655,000 in the third quarter of the previous year. The net loss for the first nine months of 1995 was $23,872,000, compared to $22,013,000 for the same period in 1994. The rise in third-quarter net loss was attributed to preparation for the expected release of the company's DOXIL Injection product upon receipt of marketing approval from the U.S. Food and Drug Administration. Meanwhile, the increase in net loss for the nine-month period is also related to the launch preparation but is offset by a reduction in costs for clinical trials of DOXIL in AIDS patients with Kaposi's sarcoma. "Suit Alleges Minn. Mutual AIDS Bias" National Underwriter (Life/Health) (10/30/95) Vol. 99, No. 44, P. 3; West, Diane Mark LaBonte, a California man, has filed a $1 million lawsuit against Minnesota Mutual Life Insurance Co. of St. Paul, Minn., claiming the insurer refused to issue him a life insurance policy based on the fact that his live-in partner has AIDS. Paul Wotman, LaBonte's San Francisco-based attorney, reports that Minnesota Mutual denied his client coverage even though he tested HIV-negative. The suit charges that the insurer's actions violate both state law and the Americans With Disabilities Act. Additionally, Wotman alleges that Minnesota Mutual reported its findings to the Medical Information Bureau, a national database of medical records which insurers often use to determine underwriting risk. "Health Bodies Urge Backing for Early Warning Procedures" Nature (10/26/95) Vol. 377, No. 6551, P. 668; Appel, Adrianne; Masood, Ehsan The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) have requested additional funds to finance both joint and separate efforts to identify, control, and ultimately eliminate emerging infectious diseases. The WHO's 190 member states have been asked for $5.5 million of the $7-million global early warning system, which could include a network of rapid response units to place experts at any world disease location within 24 hours of an outbreak. The CDC, meanwhile, has called upon the U.S. Senate support an increase in its budget to equal the $125 million annual operating costs once the results of its report, "Addressing Emerging Infectious Disease Threats: A Prevention Strategy for the United States," are in place in an estimated seven years. The CDC's program is akin to the WHO's in many ways, though it is limited to the United States. But the similarity between the CDC and the WHO projects is not coincidental. The U.S. government contributes 25 percent of the WHO's budget, a contribution which is now threatened by proposed Senate cuts. The WHO therefore would like to see the CDC receive more funds because the move would imply a positive vote not only for the CDC project, but for the WHO as well. "HIV Risk Practices of Male Injecting-Drug Users Who Have Sex with Men--Dallas, Denver, and Long Beach, 1991-1994" Morbidity and Mortality Weekly Report (10/20/95) Vol. 44, No. 41, P. 767; Wolitski, R.J.; Corby, N.; Wood, J.; et al. As part of the AIDS Community Demonstration Projects, which are sponsored by the Centers for Disease Control and Prevention, data on male intravenous drug users (IDUs) who have sex with men (MSM) were collected in Dallas, Denver, and Long Beach, Calif., from 1991 to 1994. In the survey, trained interviewers approached likely respondents on the street to conduct a screening interview concerning HIV risk activity. At-risk individuals then completed a second interview about perceived risk for HIV infection, drug-injection practices, and sexual behavior. Of the nearly 1700 men who completed the second interview, 297, or 18 percent, claimed to have had one or more male sexual partners in the previous 30 days. In addition, 75 percent of the MSM IDUs reported having traded sex for money or drugs during that same time. A total of 95 percent of the MSM IDUs said they had engaged in anal intercourse at some point. Meanwhile, 250 of 292 MSM IDUs claimed to have shared syringes or other drug-related equipment in the past 60 days, and just 73 of 248 said that the last time they shared drug paraphernalia they used bleach to sterilize the needle or syringe. World AIDS Day Resource Booklet, Centers for Disease Control and Prevention, November 8, 1995 World AIDS Day, observed annually on December 1st, is an organized effort designed to provide education and awareness of issues surrounding HIV/AIDS worldwide. It encourages public support for and development of programs to prevent the spread of HIV infection. The 1995 theme, "Shared Rights, Shared Responsibilities," highlights the importance of equality and solidarity in the global response to AIDS. World AIDS Day is coordinated by the World Health Organization Global Programme on AIDS, the Pan American Health Organization, the American Association for World Health, the U.S. Department of Health and Human Services, and the Centers for Disease Control and Prevention. World AIDS Day Resource Booklet. Prepared by the American Association for World Health (1-202-466-5883), this booklet provides facts and suggestions to help in planning for World AIDS Day 1995. The file is located at the CDC National AIDS Clearinghouse World Wide Web home page, http://cdcnac.aspensys.com:86/aidsinfo.html. The file you will be retrieving is a .PDF file. This file format contains hypertext links and is viewable only with the Adobe (TM) Acrobat (TM) Reader which can be downloaded for free from Adobe Systems Incorporated.