From: "ANNE WILSON, CDC NAC" AIDS Daily Summary November 23, 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, and the CDC Clearinghouse should be cited as the source of this information. Copyright 1993, Information, Inc., Bethesda, MD "Disabilities Act Wins A Round in AIDS Case" New York Times (11/23/93) P. D2 (Freudenheim, Milt) A federal judge in New York Friday handed down the first decision upholding the authority of the Americans with Disabilities Act over health plans that discriminate against AIDS-infected employees. The Mason Tenders District Council Welfare Fund, which represents a group of New York construction companies and laborers' unions, slashed medical benefits for construction worker Terrence P. Donaghey Jr. and three other employees with AIDS--one of whom died recently. The Mason Tenders contended that it acted properly in denying AIDS coverage so that it could maintain its ability to reimburse members for other illnesses. Judge John E. Sprizzo rejected a motion by the fund, which claimed exemption from the act under a federal pension law called the Employee Retirement Income Security Act (Erisa). The ruling means that the burden of proof is on the fund to prove that it was not illegally discriminating against Donaghey. The ruling cannot be appealed without the judge's approval, and Sprizzo announced that he had no intention of certifying an appeal. He did, however, schedule a January conference to establish a timetable for further arguments and hearings. "Germany Finds 2 Blood Donors Had AIDS Virus" New York Times (11/23/93) P. A3 (Kinzer, Stephen) Two donors who sold blood to UB Plasma, a German firm suspected of distributing HIV-contaminated blood, are indeed infected with the AIDS virus, prosecutor Norbert Weise announced Monday. One donor was identified as Romanian; the other was identified only by a company-assigned code number. The HIV status of nine other donors could not be confirmed as negative, added Weise. Investigators had checked 25,018 blood samples from some 4,000 UB Plasma donors, but the results were not "absolutely reliable" because records were not fully in order. So far, however, none of the company's thousands of blood recipients who have been tested have contracted the AIDS virus. "These results suggest that the worst fears have not been confirmed," said Weise. "Canadian Red Cross Recalls Product Made With German Plasma" Reuters (11/23/93) Ottawa--The Canadian Red Cross on Monday recalled a blood product made with plasma supplied by UB Plasma, a German pharmaceutical company that was closed down for distributing HIV-contaminated blood. For fear that it may not have been thoroughly screened for the AIDS virus, the agency recalled Factor 9, a blood clotting agent used by hemophiliacs. The Red Cross is tracing 200 Canadian hemophiliacs who use Factor 9 in order to recover three million vials of the product. The agency has sent a team of officials to investigate Austrian manufacturer Immuno, which makes Factor 9 with plasma supplied by UB Plasma. According to Red Cross spokesperson Angela Prokopiak, the Red Cross also alerted Canadians to Immune Serum Globulin, another Immuno product, which is sold directly to Canadian pharmacies. "We are erring on the side of safety," said Prokopiak. "Most countries are withdrawing any product made with this plasma." "British Biotech Company Sets Up Shop Near Annapolis" Baltimore Sun (11/23/93) P. 11C (Shelsby, Ted) Maryland's emerging biotechnology industry advanced yesterday with the announcement by British Bio-technology Group PLC of England that it will open a U.S. clinical research subsidiary near the state capital. According to the company's vice president of research and development, the Annapolis office will cater to three primary roles, including the clinical testing of the parent company's experimental drugs. One of the drugs in development is one to delay the onset of AIDS in HIV patients. A second role will involve working with the Food and Drug Administration to obtain government input and to approve new drugs. The final primary purpose of the office is to attract investors. "Eve van Grafhorst, 11; Ostracized for Having AIDS" Chicago Tribune (11/22/93) P. 1-13 An 11-year-old girl who was shunned and ostracized by her Australian hometown because she had AIDS has died of the disease. Eve van Grafhorst contracted the virus after her birth in 1982, when she received a blood transfusion. AIDS was diagnosed three years later. Eve and her family were then confronted with hostile residents in Kincumber, Australia. Local people called for the child's ban from kindergarten and suggested that the family simply leave town. The van Grafhorsts finally moved to New Zealand and, although the town of Kincumber publicly apologized for its behavior, remained there. "Hers was a public courage which helped us compre1hend how people living with HIV and AIDS face a daily challenge of prejudice and ignorance," said Bruce Hammington, chairman of the New Zealand AIDS Foundation. "She helped to break down those barriers." "Immucell Announces Postponement of Milestone Payments Due to Support Clinical Program to Develop Treatment for Diarrheal Infections in AIDS and Other Patients" Business Wire (11/19/93) Portland, Maine--Instead of making the milestone payment owed to ImmuCell Corp., Univax Biologics Inc. will make three monthly installments of $10,000 each from December 1993 through February 1994. Univax has been conducting clinical trials of CryptoGAM, an ImmuCell product. "The additional three months are needed to adequately explore the outstanding dosage and drug delivery questions that must be answered before initiating Phase II/III studies," said Michael F. Brigham, chief financial officer of ImmuCell. CryptoGAM is an polyclonal antibody product which is administered orally for the treatment of cryptosporidiosis in AIDS patients. This infection, for which there is no effective treatment, occurs in 10 to 15 percent of American AIDS patients, frequently resulting in death. Cryptosporidium parasites invade the small intestine, causing severe and often debilitating diarrhea. CryptoGAM has been under study by Univax Biologics under an Investigational New Drug Application approved by the Food and Drug Administration. "Elton John's 'Duets' Ships Platinum in Stores on Nov. 23" PR Newswire (11/22/93) Universal City, Calif.--MCA recording artist Elton John will release his new album Wednesday, with proceeds from one of the singles benefiting an AIDS charity. The 'Duets' album features John and an all-star list of duet partners. The debut single from the album is a remake of "True Love," the Cole Porter classic. All royalties from the recording will go to the Elton John AIDS Foundation, a non-profit, charitable organization established in 1992. The foundation provides money for two critical areas of the AIDS crisis--direct patient care and AIDS education. Earlier this fall, the organization announced that, in its first year of existence, it raised $1.65 million. "True Love" is already a Top-10 success on adult, contemporary radio and premieres this week on Billboard's Top 100 chart. "FDA to Impose New Safety Rules on Trials" Washington Blade (11/19/93) Vol. 24, No. 49, P. 35 (van Hertum, Aras) In an effort to prevent harmful side effects of experimental drugs from endangering patients participating in trials, the U.S. Food and Drug Administration recently proposed new rules for clinical testing. The recommendations would require scientists conducting clinical trials to report any deaths, serious symptoms, and situations that force patients to stop taking the experimental drug, regardless of whether or not it appears to be linked to the drug. Scientists would also have to describe each case and explain why they believe they are, or are not, linked to the drug's side effects. The proposal was drafted following the deaths of five patients enrolled in a trial of fialuridine (FIAU), an experimental hepatitis B drug. FIAU may also have been responsible for the deaths of five other patients in a previous trial. "Forging the Magic Bullet" Vanity Fair (11/93) Vol. 56, No. 11, P. 42 (Hitchens, Christopher) A small group of doctors has formed a small start-up biotechnology company called Seragen, where they are working on a "magic bullet" for AIDS that calls for the mutation of a deadly disease from the past to combat the most deadly disease of today. This promising new approach is known as DAB 389 IL-2 or IL-2 fusion toxin, and involves the application of genetic engineering to diphtheria bacteria. Dr. Clyde Crumpacker, associate professor of medicine at Beth Israel Hospital in Boston, who is the principal investigator of a select HIV research team of physicians and patients, describes the treatment as one that is "safe and well-tolerated, and inhibits the production of HIV RNA at a very low dosage." Crumpacker claims that fusion toxin can "eliminate virally infected cells and not harm the noninfected ones." Dr. John R. Murphy, professor of medicine and chief of biomolecular medicine at Boston University Medical Center Hospital, made the first progress in the development of IL-2 fusion toxin. When Murphy and colleagues suggested experiments, they met with objections reminiscent of Michael Crichton's novel, The Andromeda Strain, which raised fears that researchers could create a new pathogen rather than a new therapy. The first fusion toxin was finally developed and proved that the scientists had not created a new pathogen, and that fragments of diphtheria toxin could be cloned and redirected toward a selected receptor. If all this is possible, what is the catch? The fact that, although experts are well-informed about the virus, little is actually known about AIDS itself. Still, Seragen holds the patent on the development of fusion toxins and, while it conducts an ongoing trial, is preparing its facilities in anticipation of FDA approval of the promising treatment. "Thalidomide Redux" Discover (11/93) Vol. 14, No. 11, P. 22 Although thalidomide caused British and German women to give birth to babies with serious defects in the 1960s, the drug has once again emerged in clinical applications. In recent studies at Rockefeller University, scientists discovered that thalidomide stops the growth of HIV in laboratory cell cultures. If clinical trials produce similar results, thalidomide may someday become a powerful new therapy for those infected with HIV. According to Gilla Kaplan, an immunologist at Rockefeller, thalidomide functions selectively by aiming for tumor necrosis factor (TNF), a powerful physiological stimulator of HIV. TNF transmits immune signals, such as stimulating certain white blood cells. The AIDS virus appears to attack activated cells, and TNF offers HIV a means to replicate itself. Thalidomide prevents TNF from synthesizing. Kaplan and her group insert the drug into infected cells removed from patients with HIV. In the treated cells, Kaplan found the rate of TNF production and the rate of HIV replication slowed by an average of 60 percent. ------- End of Forwarded Message