Subject: CDC Summary Date: 4/6/93 (271 lines) From: National AIDS Info Clearinghouse Copyright 1993, Information, Inc., Bethesda, MD AIDS Daily Summary April 6, 1993 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. Copyright 1993, Information, Inc., Bethesda, MD "AIDS Study Casts Doubt on Value of Hastened Drug Approval in U.S." New York Times (04/06/93), P. C3 (Altman, Lawrence K.) The recent summary of a European study that revealed no benefit from early treatment with AZT in HIV infection has also raised questions about the validity of certain tests that the U.S. government has used to hasten the drug approval process. The tests are known as surrogate markers, and are designed to be quick substitutes for the standard, time-consuming approaches traditionally used in predicting the benefit of a treatment. The "Concorde" study challenged the efficacy of using the CD-4 count as a surrogate marker for AZT among asymptomatic HIV-positive people. The Food and Drug Administration relied heavily on studies that found an improvement in CD-4 counts when it licensed AZT for early treatment of HIV. It also used the same markers in approving DDI and DDC, two other anti-AIDS drugs. However, the British government rejected applications to approve DDI based on a decline in CD-4 cell counts that the United States observed. Tim Peto, an AIDS expert at Oxford University, said the primary reason it was rejected in England was widespread doubts among European experts, including himself, about the validity of CD-4 counts as a surrogate marker for the clinical benefit of an AIDS drug. Dr. David A. Kessler, Commissioner of the FDA, revealed his faith in the validity of the CD-4 count. "It is a reliable predictor," he said, adding that his agency would examine the complete data from the Concorde study when it is published in a few months. The researchers in the Concorde study said CD-4 failed as a surrogate marker because although the CD-4 count increased by 30 cells among the asymptomatic HIV-positive patients who were given AZT, the rise did not indicate any medical benefit. "Major Study of People With HIV, TB is Set" Philadelphia Inquirer (04/06/93), P. A8 (Dixon, Jennifer) The federal government yesterday revealed that it will launch the first major American study of drug treatment approaches for people infected with tuberculosis and HIV. Nearly 650 HIV-infected people with active TB will be involved in the clinical trials. Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said a substantial proportion of the subjects would probably be from New York City, where TB, particularly drug-resistant TB, is an increasing problem. In addition, the U.S. Department of Health and Human Services announced plans for a $2.1-million, five-year grant to Johns Hopkins University to examine the efficacy and appropriate use of AZT, DDI, and other anti-AIDS drugs. This move is a result of preliminary findings of the European Concorde study, which found that AZT is not effective when used in the early course of HIV infection. HHS Secretary Donna Shalala said, "While drugs have been reviewed for basic safety and effectiveness before they go on the market, these further studies should help physicians make the best treatment choices." The government will evaluate the clinical drug trials involving HIV-positive patients with TB for the benefit of adding a new drug for TB treatment, levofloxacin, to the usual four-drug therapy used in areas where TB organisms are commonly resistant to one or more anti-TB drugs. People who live in areas where drug-resistant TB is rare can also enroll in the trial and will receive the four-drug regimen without levofloxacin. "Around the Nation: HIV-Infected Haitians Arrive" Washington Post (04/06/93), P. A10 A total of 16 HIV-positive Haitian refugees and four non-infected children previously held in Guantanamo Bay, Cuba, arrived in Miami, Fla., yesterday as a result of a recent federal court order. This was the first group of Haitian refugees with HIV that have been sent to the United States. Justice Department authorities determined last week that 36 HIV-infected refugees would be admitted into the country after a court order ruled that they were receiving inadequate medical care at the base. A Justice Department spokesman said 12 of the Haitians would stay in the Miami area while eight will be taken to New York. He added that refugees will arrive in Miami this week. The Haitian refugees at the Guantanamo Bay naval base were either repatriated or allowed to enter the United States to pursue political asylum claims. Those infected with HIV who remained at the base were believed to have plausible claims of asylum, but their HIV-related conditions prevented them from being admitted into the United States. "Britain Announces New Guidelines for Health Workers With AIDS" United Press International (04/05/93) London--The British government issued new guidelines for HIV-positive health-care workers Monday, but decided against mandatory HIV testing for National Health Service employees. The new guidelines simply encourage physicians, dentists, nurses, and other health-care workers who believe they may have been exposed to HIV to seek medical advice and undergo HIV testing where appropriate. The government has called for health officials to inform every patient who may have been put at risk by a health-care worker found to have AIDS. The revised guidelines require that HIV-positive health-care workers be taken off high-risk duties, such as invasive surgery, where there may be a possibility of transmitting the disease. Dr. Kenneth Calman, the government's chief medical officer, opposes mandatory HIV tests and says that public safety will be ensured if health workers promise to voluntarily seek medical advice and undergo HIV testing where appropriate. The review of the guidelines was prompted by an influx of recent cases in which thousands of patients were tested for HIV after they learned they had been treated by HIV-positive physicians. "Thai Firms Face Up to Threat of AIDS" Toronto Globe and Mail (04/05/93), P. B7 (Stier, Ken) The World Health Organization estimates that by the year 2000, Asia will have more new AIDS cases each year than Africa, which is currently the continent hardest hit by the AIDS epidemic. That means that more than one million Asian adults will contract HIV each year--about 40 percent of the new cases expected globally. But in Thailand, where prostitution runs rampant, businesses are working to fight the spread of HIV. Fearing the loss of millions of young and middle-aged adults in their most productive years, the Thai business community is beginning to take steps to thwart the disease's spread. Escalating health-care costs will be dwarfed only by lost income. The indirect and direct costs of AIDS are estimated to increase to about $9 billion by the end of the decade, says a study conducted by Thai researchers along with Harvard University. Every year, about 7 percent of those HIV-positive Thais will develop AIDS, and more than 500,000 Thais are expected to die before the year 2000. Chookiat Pratoetong, human resources manager for a Thai department store chain, said, "In AIDS prevention, a businessman is more useful than a hospital. A business can prevent, say, 100 deaths, which a hospital cannot do." Thai companies have been known to distribute condoms along with products or services, and one bank's automatic teller machines flash an AIDS hotline number. The government is currently spending about $48 million a year on AIDS education, while the private sector contributes a similar amount. "White House Says Health Plan on Track, Changes for Insurers" Reuters (04/02/93) (Frank, Jacqueline) Washington--A leading White House aide announced Friday that insurance companies will be drastically changed by health reform and claimed that the administration's proposal will be released in May. Administration officials have revealed they have no estimate yet on the cost to bring health care coverage to the nation's 37 million uninsured and to expand coverage for other Americans. But regarding costly care for those with diseases such as AIDS, the task force is opting for a requirement that all health plans pay into a national reinsurance program to absorb the risk of these expensive illnesses, said Ira Magaziner, director of the White House health care task force. "ACT UP Schedules Emergency Meeting to Keep Betak Open" PR Newswire (04/02/93) AIDS advocacy group ACT-UP/Philadelphia was expected to conduct an "emergency meeting to keep Betak House open" yesterday at the offices of We the People Living With AIDS of the Delaware Valley in Philadelphia. Betak House is a nursing home for 43 AIDS patients located in the city's Mount Airy section. It was initially opened after much pressure from ACT-UP on Gov. Robert Casey's administration. Norman L. Baker, a member of ACT-UP, said, "We have invited Health Secretary Dr. Allen. S. Noonan, Welfare Secretary Karen Snider, Mayor Ed Rendell, all of the City Council members, and members of the Philadelphia delegation to the Pennsylvania General Assembly to attend this very critical meeting to once and for all settle the financial difficulties so that Betak House will stay open." He added, "It is our hope that with all the leaders of the city and state government assembled, we will solve this problem. However, based on the track record of Governor Casey and his administration on this matter, we are very dubious of the outcome. Bearing that in mind, we will take any and all actions necessary to keep Betak open." "Hysteria Over Doctors With HIV" Lancet (03/20/93) Vol. 341, No. 8847, P. 764 (Ellis, Simon J.) HIV-related policies among health-care workers should be based on medical facts of transmission and not media-induced hysteria, writes Simon J. Ellis of Green College in Oxford, U.K. The media reaction in the United Kingdom to the discovery of health-care workers infected with HIV has been spurred by response from the Department of Health or the health officials concerned. The risk of HIV infection to patients is infinitesimal and theoretical since there have been no reported cases of surgeons infecting patients and only one case of a dentist who allegedly infected a patient. The latest commotion involved the media naming the unfortunate gynecologist and reporting his lifestyle and sexual orientation. This is a severe invasion of privacy. There is no legal basis for informing the patients treated by this person other than political expediency. Physicians are much more likely to contract HIV from patients than vice versa. In the United States, some surgical personnel may be facing a 2 percent per year risk of contracting HIV. Over a professional lifetime of 35 years, more than half such surgeons would become infected with HIV. The U.K. General Medical Council's recommendations that doctors who discover that a colleague is HIV-positive should report the result to the authorities violates patient confidentiality. Therefore, doctors' civil liberties are jeopardized, concludes Ellis. "HIV Blood Test Counseling" American Medical News (03/22/93-03/29/93) Vol. 36, No. 12, (special insert) The American Medical Association (AMA) has developed its second edition of physician guidelines for HIV blood test counseling. The guidelines urge physicians to educate the public and provide patients with specific counseling on the HIV antibody blood test. The AMA says that the ELISA (enzyme-linked immunosorbent assay) is the most widely used HIV test. But for someone to be considered to be HIV-positive, results of three tests conducted on the same serum specimen must be reactive. These confirmatory tests include the Western Blot, the radioimmuno precipitation assay (RIPA), and the indirect immunofluorescence assay (IFA). The AMA states that HIV tests should be readily available for anyone requesting testing. Also, doctors should encourage voluntary HIV testing for anyone whose history or clinical status suggests risk for HIV infection. Pretest procedures include providing HIV education; providing information about the test; conducting risk assessment, including sex and drug history; and counseling about risk reduction. The pretest counseling should be conducted face-to-face and should involve the discussion of the medical, psychological, and social implications of HIV testing. Adolescents and women have special considerations regarding HIV that should be addressed, such as women's more ambiguous manifestations of HIV infection. The AMA supports routine HIV testing, which is the testing of all patients regardless of their risk. But such testing should involve consent that can be provided as part of the general consent for treatment. Every patient should subsequently be informed of his or her test results, according to the AMA. "The New Faces of the Epidemic" American Nurse (03/93) Vol. 25, No. 3, P. 16 (Cassetta, Robin A.) The AIDS epidemic is no longer primarily concentrated among the white male homosexual population, and now the fastest growing groups of HIV-positive individuals are women, children, young adults, African-Americans, and Hispanics. Nearly every 13 minutes another American contracts HIV infection, and every 17 minutes someone dies of AIDS. About one in 800 adult females is HIV-positive, and AIDS is the sixth leading cause of death in women between the ages of 25 and 44. This high rate of HIV is partly due to the fact that many women were not aware of their partner's sexual practices or IV-drug use. In addition to improved research and health care for women, they must be educated on safer sexual practices and taught the skills needed to communicate with their partners. Many babies born from infected women will also contract the virus--about 25 percent. Moreover, nearly 100 percent of the new cases of HIV infection in children result from the virus being transmitted from an infected mother to her newborn. Children are possibly at the greatest disadvantage in getting AIDS care and education because they must depend on parents and a health-care system that often fails to meet their needs. But minorities are becoming infected with HIV at a much higher rate than any other group. African-Americans constitute 30 percent of the nation's reported AIDS cases and many have contracted the virus as a result of IV-drug use. Hispanics comprise 17 percent of the reported AIDS cases, and many contracted the virus through IV-drug use. A more widespread and aggressive anti-AIDS education campaign must be targeted at these new groups of HIV-positive people.