European Stars and Stripes (Newspaper) - November 15, 1991, Darmstadt, Hesse                                Friday november 15, 1991 the stars and stripes Page 7fda review policy lauded questioned Washington apr the food and drug administration Hopes to Cut years off the approval process for most new drugs and give patients with diseases such As aids and cancer faster Access to treatments. The changes a will have the potential to save millions of lives and billions of dollars Quot said vice president Dan Quayle chairman of the group that made the recommendations wednesday for the most important new therapies the proposal could reduce the decision making time from 30 months to six months a we Are already moving mountains in aids treatment Fra commissioner David a. Kessler said noting the anti aids drug Didan Osine or did was approved in six months. Quayle and Kessler joined health and human services Secretary Louis w. Sullivan at a news conference to announce the plan. Capital Hill democrats expressed support for expediting approval of such drugs but warned the plan could lower safety standards and give too much Power to the drug Industry because of its financial links to potential private reviewers. The plan based on recommendations from the Council on competitiveness Calls for expanding the review process by using private medical staff under contract with Fra and blending the Agency a review standards with those of other industrialized nations. The Fra estimated the reforms would reduce the time needed for approval of drugs for life threatening diseases from 93a years to 5vi years. And with faster approval the Council said drug companies could save an average $60 million of the $231 million needed to develop a new drug. But sen. Edward m. Kennedy d-mass., and reps. John d. Dingell a Mich a and Henry a. Waxman d-Calif., told Kessler that by allowing private reviews and accepting foreign government approvals the Fra a appears to be abdicating its responsibility to make key decisions on the safety of drugs. They expressed support for expediting approval of drugs for aids and life threatening diseases but said the administration a should seek greater resources for the Fra rather than attempting to supplant it with less credible  Sidney Wolfe director of the Public citizen health research group called the measures on privatizing and accepting foreign data a the biggest threat to the safety of prescription drug Supply i have seen Quot in 20 years of monitoring the nations health care. The pharmaceutical manufacturers associations Jeff Trewhitt said the Industry considered the changes a very  a fall of these things we have talked about in the past a Trewhitt said a and we see Woven into the recommendations the Prospect for a More cooperative and collegial attitude in the relationship Between the Industry and the  line up for aids test new York apr when magic Johnson made a fancy pass basketball players everywhere emulated him. Now people Are lining up by the thousands to follow his example and get tested for aids. In the week since Johnson a Surprise announcement that he had tested positive for the his virus heterosexual transmission of his them quarters of Tho 8-10 million adults with the human  virus his Hava been infant so through heterosexual  Story on Page 28 health officials around the country say they have been swamped with requests for tests. A i think people Are saying to themselves a if it could happen to him it definitely could happen to me so maybe now its time to get tested a a said Valerie Kegebein chief of the prevention Branch of the san Francisco aids office. Health clinics that formerly could test patients immediately Are building up backlogs a week Long. Those clinics that already had waiting lists Are seeing them get longer. Most of the people seeking tests Are heterosexual health officials say. Some say they Are hearing from More women More Young people and More Blacks. Johnson retired from the los Angeles lakers a week ago As a result of his diagnosis. He has since said he was infected by having sex with a woman. The his virus is most commonly transmitted through homosexual relations or through intravenous drug use. The Gay menus health crisis in new York has been overwhelmed by Calls from heterosexuals seeking information about aids tests spokesman David eng said. In Detroit where the City health departments aids project usually gets 20 Calls a Day there were 250 last Friday said or. Melinda love Dick son communicable disease director. Of those she said 80 were to schedule tests and of those More than half were from women. Usually she said men outnumber women three to one. Atlanta a health department has been performing about double the usual number of aids tests compared with a week ago according to or Prad nya Tambe medical director of the sexually transmitted disease  states in 1985, Only some 250 aids cases due to heterosexual transmission were reported. In 1990, the annual number of cases had risen to 3,100, a 12-told increase. It is estimated that As Many As 100,000 adults May already have been infected heterosexually. Western Europe Between 1985 and 1990, there was a nine told increase in the number of aids cases due to heterosexual transmission from 149 to 1,309. These aids cases provide Only a hint of the total number of  America some 10,000 children Are estimated to have been born infected with his. Central America has seen a 40-fold increase in reported aids cases during the last four  Africa heterosexual Intercourse is the predominant Mode of spread. Roughly 3 million men and 3 million women thought to be infected. An estimated 900,000 infants have been born infected with  pandemic is growing More rapidly than anywhere else. Predominantly transmitted heterosexually. India has reported that As Many As one million persons May be infected with his. Source world health organization1 in 60,000 get aids virus from transfusions study says by the Baltimore Sun Baltimore although the risk of getting aids from blood transfusions has diminished a major study of heart surgery patients has found that two were infected with the aids virus by blood transfusions from donors who slipped through screening tests since 1985. The study of 11,535 patients at three hospitals traced the infected blood to two donors who both tested negative for the aids virus at the time of donation but later tested positive said or. Kenrad e. Nelson an epidemiologist at the Johns Hopkins school of Hygiene and Public health. The reason blood Banks can to completely eliminate the aids risk is a two to six month a window Quot Between the time a person is infected with the human immunodeficiency virus and the time a blood test will select antibodies to the virus Nelson said. He gave a report on the study conducted at Hopkins and at hospitals in Houston and Chicago to the american association of blood Banks during its annual meeting in Baltimore this week. The risk of getting aids through transfused blood or blood products is about 1 in 60,000, Nelson said. But a Gallup poll released wednesday showed that Public perception of the risk is much greater than the reality. Slightly More than half of the american Public a 52 percent a believes it is a Likely Quot they could get the aids virus from a blood transfusion according to a nationwide random Telephone poll of 1,000 adults made in july and August. Asked what their greatest concern would be if they had to have an operation 26 percent answered their greatest fear would be the risk of getting aids from a blood transfusion. Twenty nine percent said their greatest fear would be complications due to errors by the surgical  ruling to be made by Jan. 6 Gaithersburg my. Up an. A advisory panel concluded thursday that breast implant makers have failed to prove their products Are Safe and effective. A final decision on whether the breast implants May still be sold will be made by the food and drug administration by Jan. 6. Fra commissioner David Kessler told reporters he would take the advisory panel s recommendations a under  a the advisory panel makes a recommendation on the scientific Issue but the regulatory options need to be decided by the Agency a Kessler said. Four firms Are seeking government approval to continue Selling seven different silicone gel filled breast implants. Each presented studies to support their claims that the products were Safe. The panel also was considering whether a Public health need existed for the continued availability of silicone breast implants even if their safety were not established. About 150,000 women each year receive the implants about 80 percent for breast enlargement and the remainder for reconstruction after surgery such As for breast cancer. In three Days of hearings the Fra panel heard from cancer victims who said other women would not seek cancer treatment if breast implants were unavailable. Consumer groups and women who said they were injured by implants urged a ban pending further study and proof of safety. The four firms seeking Fra approval for their breast implants were Bio pasty inc. Of Minneapolis Dow Corning Wright of Arlington Tenn. Mcghan medical corp. Of Santa Barbara Calif. And Mentor corp., also of Santa Barbara. A we were outraged and surprised Quot said Bobby Purkitt vice president of research for Mentor in commenting on the panels rejection. A the enormous amount of data the Fra has in its Possession has not been  officials of the three other companies also were sharply critical of the panel and the of Day a review process. A we seem to be facing a panel that was not Well informed a said Jan Varner president of Mcghan. A we will go on to pursue approval by having the Agency review supplemental data a he said. Or. James Potchen radiology professor to Michigan state University was in favor of approving six of the seven devices under consideration. A i would recommend approval with conditions Quot Potchen said suggesting that a registry of implant patients should be maintained for Long term follow up. �?o1 fear we May be establishing a threshold of safety above what is reasonable a he said