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GENEVA
(AP) — U.N. health authorities Tuesday welcomed new U.S. guidelines on
drug approvals which they say will make it easier for AIDS sufferers in
developing countries to receive lower-cost treatment.
The United Nations-administered Global Fund to Fight AIDS, Tuberculosis and Malaria said the fast-track U.S. Food and Drug Administration review process could reduce approval time for generic combinations of drugs to as little as a few weeks. "Clearly FDA approval of these drugs would lead many more countries to choose them," said Richard Feachem, executive director of the Global Fund, which is financing a major scaling up of AIDS treatment in more than 100 developing countries. U.S. Health and Human Services Secretary Tommy Thompson said Sunday the FDA will propose new guidelines to ease the approval process for products which combine several expensive treatments already approved individually by the FDA. Thompson was announcing a review of President George Bush's US$15 billion emergency plan for AIDS relief — announced in Bush's January 2003 State of the Union address — to ensure that the United States is providing safe and effective drugs to 14 of the worst affected countries, 12 of which are in Africa and two in the Caribbean. "I welcome the announcement," said Lee Jong-wook, director general of the World Health Organization. "It is essential that medicines used in treatment programs financed by international donors be affordable and meet international quality, safety and efficacy requirements." The Global Fund also said an announcement by Randall Tobias — coordinator of the Bush administration's activities to combat AIDS — that drug patent issues should not impede purchase under the emergency plan would also help the fight against the virus. It "makes it much easier to harmonize drug protocols in countries where both the Global Fund and the ... emergency plan finance drug purchase," Feachem noted. "It is important that patients can expect the same drugs no matter who they go to." Mark Isaac, vice president of the U.S.-based Elizabeth Glaser Pediatric AIDS Foundation, said faster approval for combination drugs would mean his organization would be able to help more people suffering from AIDS. "For every additional person we are able to reach, this could literally mean the difference between life and death," Isaac said. "Now there must be a sense of urgency about implementing this new system as quickly as possible, both on the part of the administration and the pharmaceutical companies ... so that we can be certain of the safety and efficacy of the drugs provided. " Three major U.S. pharmaceutical companies have already said they will work to develop a new combination AIDS drug offering a single daily dose. In a joint statement, Bristol-Myers Squibb Co., Gilead Sciences Inc. and Merck & Co. Inc., said Sunday they will pursue research to combine three of their HIV medicines into a single tablet. this article at usatoday U.S. Shifts Strategy to Curb Hiv's SpreadNew York Times SyndicateBy David Wahlberg Friday, May 21, 2004 ATLANTA - In a controversial shift in AIDS strategy, the federal government Friday funded programs to prevent people with HIV from spreading the virus, instead of primarily targeting people at risk who are not infected. The Centers for Disease Control and Prevention announced $49 million in HIV prevention grants to 142 community organizations around the country. The money comes as the disease appears to be on the rise again. It is the first round of annual funding since the CDC launched an initiative last year aimed at keeping people with HIV from infecting others. The effort also tries to make testing more available -- largely through a new rapid HIV test -- so that the 200,000 or more people who have HIV but don't know it become aware of their status and take steps to curb transmission. "Testing itself and learning that one is HIV positive is an important HIV intervention," said Dr. Rob Janssen, director of the CDC's Division of HIV/AIDS Prevention. With proper information, two-thirds of people who find out they have HIV are willing to reduce risky behaviors, Janssen said, but only a third of those who aren't infected will alter their behavior. AIDS rates, which dropped dramatically in the 1990s, have stabilized. HIV, the virus that causes the disease, appears to be on the rise, especially among gay men, the CDC says. Public health officials say they must focus more on encouraging safe sex among those with HIV. In the new grants, $23 million is for "prevention for positives" as well as their partners and some people at highest risk for HIV; $14 million is for counseling and testing; and $12 million is for outreach and education. About 82 percent of the groups receiving funding target minorities, and 41 percent of the money is for programs for gay men. Two-thirds of the organizations previously funded by the CDC aren't getting money. They're being replaced by 75 newly funded groups. Some blame politics for the change. The Stop AIDS Project of San Francisco lost its funding after some Republicans in Congress complained last year about the group's workshops on oral sex, anal sex and "safe and friendly relations with escorts." In the "hypersexualized" world of gay San Francisco, frank discussions are necessary, the organization says. "I guess we are a politically high risk group," said spokesman Jason Riggs. Terje Anderson, executive director of the National Association of People with AIDS, said that focusing on people with HIV can be counterproductive. "When you start shaking your finger and saying, 'bad boy' and 'bad girl,' it's creating an environment that is stigmatizing," he said. Janssen said the funding is based on the groups' ability to meet CDC's goals, not on politics, with money allocated according to AIDS rates. The South, where HIV has substantially increased, will get 43 percent of the funds. Mark Wahlberg writes for The Atlanta Journal-Constitution. E-mail: mwahlberg@ajc.com Editor Notes:Story Filed By Cox Newspapers For Use By Clients of the New York Times News Service (с) 2004 Cox News Service |
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