AEGiS-WashBlade: Medical Report: FDA to consider approving rapid, easy at-home HIV test Washington BladeImportant note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
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Medical Report: FDA to consider approving rapid, easy at-home HIV test

Washington Blade - October 21, 2005


NEW YORK - A Pennsylvania company will get a chance to convince

federal health officials that it should be allowed to sell the first rapid, at-home HIV test to make such testing similar to easy home pregnancy kits, the New York Times reported. Officials at the Food & Drug Administration and AIDS advocates have expressed concern that people who got an HIV-positive diagnosis at home might panic and even consider suicide. Such fears stopped federal drug officials from lifting a requirement that counseling and professional support accompany HIV tests. Now, with improved treatment that makes HIV a chronic disease that often can be managed for many years, some of that fear of patient panic has dissipated. "If we're going to win the war against AIDS, we need to make HIV testing as easy as pregnancy testing," Dr. Freya Spielberg, a researcher in the Center for AIDS Research at the University of Washington, told the newspaper. Federal officials will discuss the proposal for an at-home HIV test on Nov. 3. OraSure Technologies, based in Bethlehem, Pa., the test's maker, said it likely would make a formal application to sell the method over-the-counter once the federal panel meets.

AIDS drug maker to pay $704M in settlement

WASHINGTON (AP) - Serono Laboratories agreed Monday to pay $704 million and plead guilty to federal conspiracy charges that it increased the market for the AIDS drug Serostim by offering kickbacks to doctors and manipulating a test for AIDS patients. Eighty-five percent of prescriptions written for Serostim, accounting for roughly $615 million in sales, were unnecessary, said Michael Sullivan, the U.S. attorney in Boston who led a four-year federal investigation. The cost of many of those prescriptions, $21,000 for 12 weeks of treatment, was paid by Medicaid and other government insurance plans. Serostim is used to treat AIDS "wasting," an often-fatal condition involving severe weight loss. Prosecutors began their investigation after several U.S. employees of Swiss-based Serono claimed fraud.

Mich. judge denies request to halt ruling on DP benefits

LANSING, Mich. (AP) - An Ingham County judge last week denied the state attorney general's request to temporarily halt a ruling that allows public-sector employers to provide health insurance to the partners of gay employees. Republican Attorney General Mike Cox had asked Circuit Judge Joyce Draganchuk to halt her ruling and stop the state and city of Kalamazoo from offering domestic partner benefits until the issue can be decided by the appellate courts. Draganchuk declined to issue a temporary restraining order. She ruled last month that public universities and governments can provide domestic partner benefits without violating a gay marriage ban approved by voters last year. Cox is appealing that ruling.

Same-sex parents raise well-adjusted children: study

WASHINGTON - New research shows that children who have gay parents do not necessarily have differences in self-esteem, gender identity or emotional problems from children who grow up with heterosexual parents, WebMD reported. "There are a lot of children with at least one gay or lesbian parent," Ellen C. Perrin, M.D., professor of pediatrics at Tufts University School of Medicine in Boston, told the online medical site. Perrin, who detailed findings at the American Academy of Pediatrics Conference, said between 1 million and 6 million children in the nation have committed lesbian or gay couples as parents. The children in the study were evaluated on possible stigma, teasing, adjustment and self-esteem, opposite gender role models, sexual orientation and strengths.

Court says same-sex partner can't sue hospital for malpractice

NEW YORK (AP) - A divided state appeals court ruled last week that a man cannot sue a Manhattan hospital for malpractice in the death of his longtime partner, saying it could not provide tacit approval of same-sex marriages. The court overturned a judge's 2003 decision that John Langan of Vermont could sue St. Vincent's Hospital for alleged malpractice in the death of Neil C. Spicehandler. The appeals court, in a 3-2 vote, decided that Langan had no standing to sue the hospital despite the couple's 2000 civil union in Vermont. Attorneys for Langan claimed the civil union gave him standing as a spouse to sue the hospital under New York law. Any ruling favoring Langan would be "taken as judicial imprimatur of same-sex marriages and would constitute a usurpation of powers expressly reserved by our Constitution to the Legislature," the court ruled. Adam Aronson, the attorney for Langan, said he would discuss a possible appeal with his client.


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