Date: Wed, 07 Sep 1994 09:06:43 -0400 (EDT) From: "ANNE WILSON, CDC NAC" Subject: CDC AIDS DAILY SUMMARY 09/07/94 AIDS Daily Summary September 07, 1994 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 1994, Information, Inc., Bethesda, MD ************************************************************ "U.S. AIDS Research Switches Focus to Boost Immune System" "Liposome Seeks Approval of its AIDS-Cancer Drug" "In the Nation: Los Angeles Mayor Aids Needle Exchange Programs" "BC-AIDS-Zimbabwe" "Measurement of CD4: Percentage" "Free AIDS Info" "Rushing to Judgment" "Barron's: "Do We Have Too Many Drugs for AIDS?"" "Under Surveillance: Zvonko Pavelic" ************************************************************ "U.S. AIDS Research Switches Focus to Boost Immune System" Washington Times (09/07/94) P. A6; Krieger, Lisa M. The federal government has promised to allocate $25 million over the next four years for the development of innovative strategies to genetically attack HIV through the body's immune system. The studies will be conducted at medical centers selected by the National Institute of Allergy and Infectious Disease--including Stanford Medical Center, the New England Medical Center, the University of Pennsylvania, the University of Michigan, the Fred Hutchinson Cancer Research Center, and the University of California at San Diego. The studies involve the transplant of healthy dendritic cells from patients' siblings to boost the immune system, and the introduction of immune system cells called "killer cells" that destroy HIV-infected cells. Both studies are risky, according to Edgar Engleman, a co-director of research at Stanford, who says, "Anything that activates the immune system is capable of activating the virus, as well." "Liposome Seeks Approval of its AIDS-Cancer Drug" Wall Street Journal (09/07/94) P. A6 Liposome Technology Inc. has filed a new drug application with the FDA for its version of a medication for Kaposi's sarcoma, an AIDS-related cancer, for patients who do not respond to chemotherapy. The active ingredient, doxorubicin hydrochloride, is already widely available, but the company wants to deliver it with its "Stealth" liposome capsule system. This system allows the drug to stay in the bloodstream for at least two days. Liposome expects an answer from the FDA in six to nine months. "In the Nation: Los Angeles Mayor Aids Needle Exchange Programs" Baltimore Sun (09/07/94) P. 11A Stating that AIDS had reached epidemic proportions, Los Angeles Mayor Richard Riordan declared a local state of emergency Tuesday in an effort to circumvent state law and permit the distribution of clean needles to drug users to continue without interference from police. Riordan directed the city attorney and police department to avoid unnecessary investigations of the needle exchanges that have been taking place throughout the city for several years. "With his signing this declaration, the mayor acknowledged [through the signing of the declaration] the needs of IV drug users, their sexual partners, and their families," said Rene Edgington, who operated Los Angeles' Clean Needles Now. Needle exchanges as a means of lowering AIDS transmissions have been gained the approval of many city officials. "BC-AIDS-Zimbabwe" Reuters (09/06/94); Mdlongwa, Francis AIDS has killed thousands and infected nearly one million Zimbabweans, making it what one doctor has called "a threat to mankind greater than the bubonic plague." Condoms have become the highest-selling product in the country because of AIDS, but the disease has also prompted some bizarre changes. Insurance companies are now offering policies that allow clients to pay for coffins and church services in advance; coffin-makers and gravediggers are said to be making their fortune off of the epidemic. "The only problem is that the same people making this money may not live long to spend it, also for the same reason," said a local journalist. "Whole populations, entire labor forces--indeed economies of nations--are threatened," agreed the doctor. "Measurement of CD4: Percentage" Journal of the American Medical Association (08/10/94) Vol. 272, No. 6, P. 434; Olson, Patrick E.; Wallace, Mark R.; Naval Medical Center (et al.) Dr. Paul A. Volberding recently described the discovery of a stronger correlation between clinical stage and CD4 percentage than between clinical stage and absolute CD4 cell count. Volberding suggests that CD4 percentage is a more stable marker of progression. Many clinicians are not aware that the process of derivation of absolute CD4 cell count from CD4 percentage is a long, painstaking effort that involves redundant steps. The U.S. health care system could save several million dollars annually by ending the practice of reporting total CD4 cell counts, contend Drs. Patrick Olson and Mark Wallace of Naval Medical Center in San Diego, Calif. Counting CD4 cells has become a clinical habit that results in little or no useful information, they argue. They conclude that this method should be rejected and the CD4 percentage, which is more accurate and economical, should be adopted. "Free AIDS Info" Men's Fitness (09/94) Vol. 10, No. 9, P. 116 Community Prescription Service, a mail-order discount drug business specializing in HIV concerns, offers InfoPack. The quarterly newsletter provides a summary of recent medical studies, information on new drugs, and hints for self-care. Copies are available free of charge by calling 800-842-0502. "Rushing to Judgment" Barron's (08/15/94) Vol. 74, No. 33, P. 23; Edward A. Wyatt Only a few years ago, AIDS activists urged the FDA to speed up its approval process for AIDS drugs, resulting in the loosening of FDA approval standards. Some of those same activists are now joining physicians and drug companies in the push to do away with the accelerated approval program. They claim that the program has led to less stringent testing so that information about drugs' side effects and efficacy is not available. The tests are open to attack because they use an artificial yardstick, such as white blood cell count, instead of waiting to see if a drug actually prolongs life. Critics argue that accelerated approval removes the incentive to develop break-through drugs, and encourages only slight improvements on drugs already on the market. The FDA will convene next month to consider slowing down the approval process--a step which would have a dramatic impact on companies expecting to submit new AIDS drugs for FDA approval. Most affected would be Hoffman-La Roche, the leader in the race for an AIDS treatment that, if successful, could be worth hundreds of millions of dollars in annual sales. Smaller companies such as Vertex and Agouron would also suffer if the FDA eliminates accelerated approval. These companies have no products on the market and are counting on AIDS drugs, a situation that makes haste a matter of importance since every delay means greater competition. "Barron's: "Do We Have Too Many Drugs for AIDS?"" AIDS Treatment News (08/19/94) No. 205, P. 4; James, John S. AIDS Treatment News editor and publisher John S. James contends that an Aug. 15 article in Barron's, entitled "Rushing to Judgment," presents only one side on the debate over accelerated FDA approval for AIDS drugs. James argues that the article could be harmful for AIDS research if investors are scared away by hints that the FDA is going to eliminate its accelerated approval system. He also points out that Barron's reporter does not talk to any AIDS activists except the Treatment Action Group, which is strongly opposed by many other activist groups. In fact, James says, AIDS patients want a large pool of AIDS drugs to choose from and therefore do not support the elimination of accelerated approval. In addition, many patients and their doctors are not even aware of the controversy. Finally, James says that the Barron's article is not entirely accurate in its presentation of the problems facing AIDS research. Barron's identifies the problem as placebos when, in fact, the problem is drug trials conducted to obtain results of which the researchers already feel relatively confident. James feels the researchers should take a more experimental and innovative approach. "Under Surveillance: Zvonko Pavelic" Advocate (09/06/94) No. 663, P. 18 Zvonko Pavelic, a former police officer recruited for the defense team of accused murderer O.J. Simpson, has filed a disability claim against the Los Angeles Police Department for what he says is AIDS-based discrimination. Pavelic contends that when he left the apartment in 1992, he was suffering from asthma and hepatitis. The symptoms of these two conditions, he alleges, caused many colleagues--who thought he had AIDS--to shun him. .