European Stars and Stripes (Newspaper) - November 15, 1991, Darmstadt, Hesse                                Friday november 15, 1991 the stars and stripes a Page 7 Fra review policy lauded 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 a 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 dd1, 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 s 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 9v4 years to 5 /2 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 a mass a and reps. John d. Dingell d-mich., 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 Quot its responsibility to make key questioned 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 nation s health care. The pharmaceutical manufacturers association s Jeff Trewhitt said the Industry considered the changes a very  a fall of these things we have talked about in the past Quot Trewhitt said Quot and we see Woven into the recommendations the Prospect for a More cooperative and collegial attitude in the relationship Between the Industry and the  transmission of his hire qua tors of Tho 8-10 million adults with Tho human immunodeficiency virus his svs Boon infected through heterosexual trans Leelon. United 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-Fotd 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 fold increase in the number o1 aids cases due to heterosexual transmission from 149 to 1,309. These aids cases provide Only a hint of the total number of infections. Latin 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 years. Sub saharan 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 his. Asia 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 organization a 1 in 60,000 get aids virus from transfusions study say thousands line up for aids test new York a 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 related 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 of 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 Section. By the Baltimore Sun Baltimore a 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. Konrad e. Nelson an epidemiologist at the Johns Hopkins school of Hygiene and Public health. The reason blood Banks can t 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 detect 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 a Likely 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 2h 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  says risks unclear on breast implants Gaithersburg my. A a food and drug administration advisory committee concluded overwhelmingly wednesday that safety data gathered by Dow Corning fails to show the company s Silicon gel breast implants Are Safe. The panel was to consider and recommend to the Fra on thursday whether the implants should be allowed to remain on the Market while More safety studies Are conducted and under what conditions. Committee members expressed concerns about the Lack of information on How Long the implants will last before deteriorating or rupturing whether the implants arc associated with cancer or immune disorders and whether they interfere with mammograms in detecting breast tutors. �?o1 did no to Sec sufficient scientific data to conclude these implants Are Safe Quot said Mary Davis associate professor in the department of pharmacology and toxicology at West Virginia University. The vote was 9-1 to not recommend approval of Dow coming s implants. E. James Potchin chairman of radiology at Michigan state University said he believes there is reasonable Assurance that the devices arc Safe. He said his major concern is related to breast cancer. If implants Are not available he said women who suspected breast cancer might not seek care because of fear they would lose their breast. A availability of an implant makes a difference to these patients Quot he said. This is a bigger concern he said than fears that mammography is impaired with implants which he believes Are unfounded. The committee is also considering silicone implants made by three other companies. Its meeting was to continue thursday during the Daylong meeting Corning officials  its products and maintained that the More than 33,000 pages of data it had submitted showed the implants Are Safe and effective and have few complications. A it is of vast importance that Fra allow this product to remain on the Market for All women Quot Robert r. Levier technical director of Dow coming s health care businesses told reporters. But an Fra official told the panel that the data the company had submitted was inadequate in several respects though they Quot do not show a hazardous device posing a major threat to the health of the  a however questions remain As to the presence of Long term risk the accurate measurement of the incidents of complications and the effects of the implants on mammography Quot said Daniel Mcgunagle an Fra scientist