Date: Wed, 25 Jan 1995 09:08:21 +0500 From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com AIDS Daily Summary January 25, 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 ************************************************************ "SEC Investigates Florida Firm that Buys Policies from Terminally Ill" "Children's Drug Labels Reconsidered" "BioChem Shows Healthy Form" "Thousands of Bangladeshi Children Exposed to AIDS" "U.S. Bioscience Receives Additional European Clearances for Ethyol and NeuTrexin" "Pilot AIDS Study to Be Conducted in South Florida..." "ONCONASE Enters Phase III for Pancreatic Cancer" "Global Epidemiology of Tuberculosis" "AIDS in India" "Caregivers Have Hand in Intentional Overdoses" ************************************************************ "SEC Investigates Florida Firm that Buys Policies from Terminally Ill" Knight-Ridder/Tribune Business News (01/25/95) The Securities and Exchange Commission (SEC) has gone to court to force United Benefits Group, Fort Lauderdale, Fla., to turn over records of its investors, employees, financial results, tax returns, and other information. United Benefits Group, a viatical settlement broker which arranges the sale of AIDS patients' life insurance policies to investors, is refusing to tell regulators how it sells the policies and what becomes of the money. The company's attorney claims that because the company is not selling securities, it does not have to obey the SEC. The SEC needs to review the documents to determine whether there have been violations of securities law, argues SEC regional director Chuck Senatore. "Children's Drug Labels Reconsidered" New York Times (01/25/95) P. C11; Stone, Elizabeth Last month, the Food and Drug Administration (FDA) issued labeling regulations for prescription drugs for children. Eighty percent of the more than 2,000 prescription drugs currently on the market with FDA approval have never been tested for safety or efficacy in children. The new regulations allow companies to publish information about dosages for children without doing full-scale testing if the disease runs the same course in adults and children, as does strep throat. The regulations give the FDA the power to deny approval or recall a drug, but the agency cannot require a company to include children in its studies if the company states that the drug is not for use by children. Last year, the American Academy of Pediatrics' Committee on Drugs submitted a list of six drugs--three anesthetics plus Flagyl, Tagamet, and albuterol--it most wanted approved for children. While dosage information exists for Flagyl, Tagamet, and albuterol, none is available for the three anesthetics. Flagyl, which is approved for children with amoebic dysentery, is more frequently used to treat anaerobic infections in HIV-positive children. The new regulations would not include the pediatric labeling of these medications. "BioChem Shows Healthy Form" Toronto Globe and Mail (01/24/95) P. B11; Bell, Andrew Although Glaxo PLC's takeover bid for Wellcome PLC could be construed as the reason for BioChem Pharma Inc.'s 50-cent per share increase on Tuesday, analysts cite other factors. The proposed merger could make it easier for BioChem to sell its AIDS and hepatitis B drug, 3TC, which is licensed to Glaxo. Wellcome is already familiar with marketing AIDS drugs as the manufacturer of AZT. However, analysts point instead to a Jan. 20-Feb. 3 medical conference--at which trial results for AIDS patients and prospects for 3TC use against hepatitis B will be announced. "Thousands of Bangladeshi Children Exposed to AIDS" Reuters (01/24/95); Shahid, Shahriar Due to social discrimination and poverty, thousands of Bangladeshi girls are becoming prostitutes in major cities and, thus, are making themselves vulnerable to diseases--including AIDS. The girls and young women, mostly between the ages of 12 and 18, know little about healthcare and frequently carry infectious diseases they caught from their clients. "Though Bangladesh is one of the lucky countries not to have an AIDS epidemic, the situation is vulnerable here too as uncared-for prostitutes can spread the diseases," according to AIDS researcher Dr. Julia Ahmed. In Bangladesh, with a population of 110 million people, only 33 cases of HIV have been identified. Of those 33, three developed AIDS and died, and the others are under medical care. Although street prostitution is illegal in Bangladesh, the girls and women usually pay bribes to the police. A recent study found that most of the girls suffer from scabies, syphilis, abdominal pains, and jaundice. Most of the prostitutes know about contraceptives, but rarely use them. "U.S. Bioscience Receives Additional European Clearances for Ethyol and NeuTrexin" Business Wire (01/24/95) U.S. Bioscience announced on Tuesday that Ethyol (amifostine) and NeuTrexin (trimetrexate glucuronate for injection) were granted product licenses for marketing in additional European countries. Ethyol is used for the reduction of neutrophenia-related infection resulting from the use of the combination regimen of cyclophosphamide and cisplatin--two anti-cancer agents--in patients with advanced ovarian carcinoma. In addition to its previous approval in the United Kingdom, ethyol received marketing approval in Germany, Spain, and Luxembourg. NeuTrexin was cleared for marketing in the United Kingdom, Spain, the Netherlands, and Luxembourg. NeuTrexin is recommended with concurrent leucovorin administration as an alternative treatment of moderate-to-severe Pneumocystis carinii pneumonia in AIDS patients who are intolerant of or for whom standard therapy is contraindicated. It received marketing clearance for the United States and Canada in December 1993. "Pilot AIDS Study to Be Conducted in South Florida..." Business Wire (01/24/95) Advanced Viral Research Corp. announced on Tuesday that its product Reticulose will be used in a pilot study conducted by a physician in a South Florida hospital and AIDS research center. One part of the study will measure the effects of Reticulose on the viral load within the cells of HIV patients during treatment. Reticulose, a non-toxic anti-viral peptide nucleic acid solution, is believed to be safe and effective against a variety of viral diseases. "ONCONASE Enters Phase III for Pancreatic Cancer" Business Wire (01/24/95) Alfacell Corp. announced on Tuesday that it will commence Phase III clinical trials for ONCONASE, which is being tested in combination with tamoxifen to treat pancreatic cancer. The FDA approved the company's Phase III protocol design--which calls for a randomized, multi-center trial--on Jan. 23. ONCONASE has been established as a novel enzyme in both structure and function, and is now recognized as the smallest known member of the superfamily of pancreatic ribonucleases. Alfacell is also working with the National Institutes of Health to study promising anti-viral activity exhibited by ONCONASE in in vitro tests against HIV-1. A study recently published in the Proceedings of the National Academy of Sciences found that ONCONASE inhibited HIV in vitro by 99 percent. "Global Epidemiology of Tuberculosis" Journal of the American Medical Association (01/18/95) Vol. 273, No. 3, P. 220; Raviglione, Mario C.; Snider, Dixie E.; Kochi, Arata Nearly 3.8 million cases of tuberculosis (TB) were reported in the world in 1990, 49 percent of which were in Southeast Asia. The highest prevalence of TB infection and estimated yearly risk of infection are found in that region and in sub-Saharan Africa. Notification rates increased in all World Health Organization regions, except the American and European regions, from 1984-1986 to 1989-1991. Throughout the world, there were an estimated 7.5 million cases of TB and 2.5 million deaths in 1990. HIV is a partial reason for the increase in TB cases, especially in Africa. Increases are also expected in Southeast Asia. The disease has not declined in many industrialized countries, and cases and deaths are increasing in eastern Europe and the former Soviet Union. Unless worldwide control of TB improves, 90 million new cases and 30 million deaths are expected during the 1990s. "AIDS in India" Village Voice (01/17/95) Vol. 40, No. 3, P. 31; Mehta, Suketu India, with a population of 850 million, has approximately 1.62 million cases of HIV and 20,000 cases of full-blown AIDS, according to the World Health Organization. A widespread perception in India, however, is that AIDS is a "foreigners' disease," or one that only affects the socially unacceptable. At least one top government official has urged banning sex with foreigners. The National AIDS Control Organization has no shortage of resources to fight the disease, but a lack of political backing has hampered the agency's attempts to implement its action plans. The publicity about AIDS has scared people away from donating blood; as a result, the available blood supply has dropped by as much as 50 percent. Thus, the government must rely on people like Jagdish Bhardwaje, who sells his blood for a living. He might become infected through a contaminated needle if he continues to donate blood, he says, but will definitely die of hunger if he does not. Groups such as hemophiliacs, prostitutes, and truck drivers have high rates of HIV-infection. It is estimated that 50 percent of the prostitutes in Bombay and 10 percent of the approximately 5 million truck drivers in the country are HIV-infected. "Caregivers Have Hand in Intentional Overdoses" AIDS Alert (01/95) Vol. 10, No. 1, P. 14 A University of California, San Francisco (UCSF) study found that more than one out of nine AIDS caregivers reported that drugs were given to their ill partners to accelerate death, and that the caregivers often initiated the discussion of assisted suicide. Researchers followed 136 couples in the San Francisco area for five years, focusing on caregiver behavior before and after the death of a partner. In each couple, one partner was well--either HIV-positive or HIV-negative--and the other had AIDS. The caregivers of 66 of the 136 patients who died during the study reported that their patients received an increase in medication prior to death. In 17 cases, the intent was to hasten death. The researchers also found that assisted suicide was a stressful issue for many of the caregivers. In 80 percent of the cases where assisted suicide was discussed with a physician, a member of the couple initiated the discussion--not the doctor, said Molly Cook, associate professor of clinical medicine and director of clinical medicine at UCSF. The researchers concluded that physicians should discuss the issue with their patients and that the patients' caregivers should be involved in the discussions. THE END.