Date: Tue, 19 Dec 1995 14:21:40 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com Subject: CDC AIDS Daily Summary 12/18/95 AIDS Daily Summary December 18, 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 ************************************************************ "AIDS Patient Who Received Baboon Cells Is 'Doing Well'" "Animal-to-Human Transplants Worry Disease Controllers" "Voices: Is It Morally Acceptable to Use Baboon Cells to Combat AIDS?" "On AIDS Drug, Profits over Patients" "The Fight Goes On for Thalidomide's Victims" "Potent New Weapon" "Blood Processing Plant Crucial, Red Cross Says" "Across the USA: Nebraska" "Grapefruit Juice and Saquinavir" "The Czar Trip" ************************************************************ "AIDS Patient Who Received Baboon Cells Is 'Doing Well'" New York Times (12/18/95) P. A15; Altman, Lawrence K. Physicians report that Jeff Getty, the man who received a baboon bone marrow transplant last week in an attempt to fight AIDS, is "doing very well." Getty is in an isolation room at San Francisco General Hospital to help prevent infection while his immune system is even more weakened by the chemotherapy and radiation he received prior to the surgery. The doctors check Getty twice a day--looking for signs of infection and signs of internal bleeding caused by a lack of platelets, and checking his white blood cell count. As expected, Getty's level has dropped from last week's counts because it takes time for his own immune system to be suppressed by the chemotherapy and radiation. "The hope is that his white blood cell count goes very low, but only for a brief period of time," said Dr. Paul A. Volberding, one of the primary investigators in the experiment. Volberding explained that if the number does not drop enough, there would be concerns that they did not give enough conditioning from the chemotherapy and the radiation to make room for the baboon cells. Another investigator, Dr. Steven Deeks of San Francisco General, noted that the most dangerous time for Getty will be in two to four weeks, at which time the immune suppression from the two treatments will be greatest. Related Story: USA Today (12/18) P. 1D "Animal-to-Human Transplants Worry Disease Controllers" Washington Times (12/18/95) P. A8 The U.S. Centers for Disease Control and Prevention (CDC) is entering the debate over the federal government's role in regulating cross-species transplants, or xenotransplants. CDC epidemiologist Louisa Chapman says that the question of whether such transplants could spread new diseases among humans is real. Some 150 diseases can be transmitted from animals to humans, and some can become even more dangerous in humans. Xenotransplants could facilitate that transmission, Chapman says, noting that the greatest fear is another pandemic like AIDS. "It probably won't happen, but it would be an event that could have a tremendously adverse public health impact," she explains. The CDC is developing guidelines for xenotransplants because both it and the U.S. Food and Drug Administration (FDA) want to be prepared in case the method is found useful and can help alleviate the nation's organ shortage. Some xenotransplant experts claim that the government has no cause to intervene and say the CDC and FDA are overstating the risks. "Voices: Is It Morally Acceptable to Use Baboon Cells to Combat AIDS?" USA Today (12/18/95) P. 10A Last week, AIDS patient Jeff Getty had baboon bone marrow cells infused into his body in an attempt to slow disease progression. The technique is controversial, with concerns being voiced about transmitting animal diseases to humans and cruelty to animals. USA Today surveyed its readers on these issues, asking whether it is morally acceptable to use baboon cells in the fight against AIDS. A researcher from Herndon, Va., observed, "If this is an issue of disease transmission, then this is an issue of technology, not morality." Meanwhile, an Emlyn, Ky. agency director said, "I guess it's OK to see if the baboon cells will help this man develop immunity to AIDS, but it is regrettable that the baboon died." Also supporting the transplant is a high school student from Center, Texas, who said, "Experimentation like this is justified for medical purposes." Furthermore, a Lynwood, Calif., aircraft mechanic said, "I don't see a problem if it doesn't pose a risk to humans, and I do have some concern for a new human disease cropping up. But synthetic drugs pose risks too." "On AIDS Drug, Profits over Patients" New York Times (12/18/95) P. A16; Greene, Jeffrey B.; Kramer, Larry The U.S. Food and Drug Administration's (FDA's) recent approval of Hoffmann-La Roche's Invirase will be welcomed by HIV-infected individuals and health care providers, write Jeffrey B. Greene, a clinical associate professor of Medicine at New York University, and Larry Kramer, co-founder of Gay Men's Health Crisis, in a letter to the editor of the New York Times. Until that point, the authors note, the protease inhibitor had only been available to 1,500 advanced HIV patients. Concurrent with the approval announcement, however, was the news that those subjects in Hoffmann's "compassionate" protocol were informed that both their participation and their supply of the drug were finished. Greene and Kramer note that the company obtained substantial pre-marketing information from the data it required for entry into the lottery. Also, by having the lottery itself, they conclude, Hoffmann focused on the demand of the drug before Invirase's efficacy in AIDS had been clinically determined. "The Fight Goes On for Thalidomide's Victims" Reuters (12/18/95); Fox, Maggie Thalidomide, the drug that was found in 1961 to have caused thousands of severe birth defects when taken by pregnant women, is making a comeback. The drug is being tested as a possible treatment for AIDS, Alzheimer's disease, arthritis, multiple sclerosis, and other conditions; has been approved for use in AIDS patients with severe wasting; and has been used to treat leprosy for years. While some doctors, including William McBride, one of the first to speak out about the dangers of thalidomide, think the drug is useful provided patients are aware of its risks, others think it should not be permitted back on the market. Nigel Brown, an expert in birth defects for Britain's Medical Research Council, thinks the drug is far too dangerous to be approved as patients frequently share drugs and the effort to regulate dangerous medicines often breaks down. "Potent New Weapon" Los Angeles Times--Washington Edition (12/15/95) P. A9; Cimons, Marlene Protease inhibitors are an apparently effective new class of AIDS drugs that attack HIV at a later stage than the family of drugs known as nucleoside analogs do and cause a remarkable drop in the amount of virus detectable in HIV-infected patients' blood. However, like the older nucleoside analogs, such as AZT, ddI, ddC, D4T, and 3TC, protease inhibitors are also subject to drug resistance when the virus mutates into new forms. When taken in combination with other drugs, however, protease inhibitors can blunt the virus' ability to resist these and other drugs. At present, at least six protease inhibitors are undergoing various stages of development, and researchers predict that even stronger versions of this class of drugs may be in development soon. "Blood Processing Plant Crucial, Red Cross Says" Toronto Globe and Mail (12/15/95) P. A8; Picard, Andre To avoid a tainted blood tragedy similar to the one experienced in the 1980s, the Canadian Red Cross must proceed with construction of a $300-million fractionation plant, the head of the agency said. According to Douglas Lindores, secretary-general of the humanitarian group, if the organization loses control of the blood it collects from donors, it might have to leave the blood program. "We have serious reservations about our continuing willingness to operate a blood program, collection plasma under the Red Cross symbol, and giving up our stewardship in the view of the events in the 1980s," he said. Lindores noted that at that time, large amounts of donated blood were wasted because of a "highly politicized and highly inefficient decision-making process." Currently, the Canadian Red Cross and pharmaceutical maker Bayer Inc. are building the Canadian Red Cross Fractionation Corp, which is expected to save the blood program more than $400 million in the next decade. Consumer groups oppose the plant, claiming that it will inhibit their ability to get state-of-the-art products and that Bayer alone should construct the plant. "Across the USA: Nebraska" USA Today (12/15/95) P. 8A The Nebraska Supreme Court will not review a case in which a court ruled that a four-year-old child should be returned to the home of a foster mother who has AIDS. The boy has been cared for by the woman and her husband since he was three months old. "Grapefruit Juice and Saquinavir" AIDS Treatment News (11/17/95) No. 235, P. 5; James, John S. Hoffmann-La Roche's saquinavir has very low bioavailability, in part, because it is poorly absorbed and because it is quickly destroyed by an enzyme called CYP3A4. A small study of the protease inhibitor in 12 HIV-negative subjects showed that chemicals in grapefruit juice inhibit that enzyme. Participants who drank one glass of grapefruit juice with the saquinavir, and then another glass an hour later saw their AUCs (areas under the curve, a measure of the total exposure of the drug) increase 50 percent to 150 percent. The AUC of saquinavir was increased to 220 percent when double-strength grapefruit juice was given. Despite such results, there could be some uncertainties or drawbacks in taking grapefruit juice saquinavir to increase the efficacy of a low dose. First, the effects of the juice--which can vary from batch to batch--can also vary from person to person. Also, there is no way to determine for oneself whether the juice is working because the test to measure saquinavir in the blood is not generally available. A third concern is that some other drugs are also metabolized by the same enzyme and large amounts of grapefruit juice could therefore increase their levels in the blood enough to cause toxicity. For these and other reasons, Hoffmann-La Roche will not pursue the grapefruit juice method, and is instead designing a new formulation of saquinavir which raises bioavailability by about 300 percent. "The Czar Trip" Advocate (12/12/95) No. 696, P. 22; Moss, J. Jennings The Dec. 6 White House conference on AIDS will mark President Clinton's most public involvement with the disease since he took office. However, one difficulty that the president--and thus Patricia Fleming, the national AIDS policy director--may face is that his dealings with AIDS often produce two contradictory criticisms. Clinton has done more for the disease than his two predecessors, some say, yet he has not lived up to his campaign promises. "Some critics would say that this administration, like those before it, opted for the political equation rather than for the public-health equation," notes Kristine Gebbie, the Administration's first AIDS policy coordinator. Meanwhile, Fleming points out the current administration's successes in battling for more funds for AIDS programs, streamlining the regulations related to the disease, and enabling local governments and organizations to develop their own AIDS prevention programs. For her part, Fleming's greatest battle now is to keep Medicaid safe from congressional attempts to release it to the states. AIDS activists want her to ensure that Clinton will not make a deal with Republicans that will substantially change the program, but Fleming merely says, "I will do what I can."