News (Updated August 28, 2004)
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Friday August 27, 11:08 PM
Feza Pharmaceuticals will be allowed to manufacture, import and sell antiretrovirals containing GSK's two patented products zidovudine, also known as AZT, and lamivudine, the British-based company said in a statement.
Feza will initially import the drugs but the firm hopes to start manufacturing them locally once it has received the necessary clearance from regulators.
GSK said the move underlined its commitment to improving access to medicines in developing countries.
Critics, however, have complained that its voluntary licensing schemes have failed to get cheap drugs to those in need. At last month's International AIDS Conference in Bangkok, AIDS activists slammed the programme as a failure.
GSK granted its first voluntary licence to Aspen Pharmacare three years ago, but no pills have yet been produced locally.
GSK says the delay is simply a result of the medicine not yet winning approval from South African regulators.
A second licence was granted to Thembalami Pharmaceuticals, a joint venture between Adcock Ingram and India's Ranbaxy Laboratories , in June this year and GSK said it was making progress towards a fourth deal.
Local production of cheap generic drugs is viewed as increasingly important as more countries around the world seek to make AIDS treatments widely available.
More than half of the estimated 38 million people infected with the AIDS virus worldwide live in Africa and 8,000 Africans are infected each day. South Africa alone has 5.3 million HIV-positive people, the single highest caseload in the world.
Mon 23 August, 2004 20:54
SAN FRANCISCO (Reuters) - San Francisco has petitioned federal regulators to warn that the anti-impotence drugs like Viagra use could increase the risk of sexually transmitted disease and HIV, officials said on Monday.
The request to the Food and Drug Administration earlier this month is a response to recreational use of Viagra among gay men who use it to enhance promiscuous sex.
"The predominant problem that we see in San Francisco is that widespread use among gay men with multiple partners," said Jeffrey Klausner, director of sexually transmitted disease prevention at the city's health department.
"It increases their ability to have more sex partners, particularly in multiple partner environments, and reverses the chemical impotence associated with methamphetamine and crystal use," Klausner said.
By petitioning the FDA, San Francisco's Department of Public Health has triggered a 180-comment period for the agency to review the issue. It also comes at a time when Viagra's manufacturer Pfizer is airing a new advertising campaign with a friskier tone to encourage use of the drug.
San Francisco Department of Public Health officials seek a health warning on Viagra and similar drugs such as Levitra, sold by GlaxoSmithKline Plc and Bayer AG, and Cialis, sold by Eli Lilly & Company and Icos Corp. "Viagra use may increase the risk for sexually transmitted diseases and HIV infection," was one suggested warning.
Viagra generated sales of $1.9 billion in 2003.
GREATER PHYSICAL RISK
For all the smiles of middle-aged couples portrayed in these commercials, San Francisco health officials say they know of 10 men in the city who used Viagra and developed HIV.
"We think that because of the increased duration of erection, the increased blood flow, that actually increases the physical risk of getting an STD or HIV infection when having sex with an infected partner," Klausner told Reuters.
The Stop AIDS Project in San Francisco said a third of gay men they interviewed on the street had used Viagra. "It is well-known in the gay community that Viagra is used as a recreational drug," said Darlene Weide, the group's director.
In recent years, U.S. public health officials have reported higher rates of sexual disease and HIV infection in the gay community in general.
The lure of Viagra, which acts by increasing blood flow, may be especially attractive to some in the gay community because of the nature of homosexual sex.
"Some have suggested that anal intercourse requires a firmer erection than either oral sex or vaginal sex," Klausner said.
Spokesman Daniel Watts said Pfizer opposed changing the labeling and said the firm had long engaged in a public education campaign, including in a Web site called sexualsmarts.org.
"We can only give so much education material. Ultimately the people have to decide the kind of behavior they are going to engage in that will minimize the risk," he said. "It also comes down to taking personal responsibility for your own behavior."
Tue Aug 24, 2004 10:25 AM ET
By Amy Norton
NEW YORK (Reuters Health) - A program aimed at cutting rates of sexually transmitted disease among minority women at heightened risk seems to have lasting benefits, according to a new study.
Researchers found that women who attended small-group meetings on STD prevention had a lower risk of gonorrhea and chlamydia for two years afterward. Compared with women who did not go through the program, those who did were more than one-third less likely to be infected during the study period.
The findings are published in the journal Sexually Transmitted Diseases.
In the U.S., African-American and Hispanic women account for the large majority of new cases of chlamydia, gonorrhea and HIV among women. Helping minority women reduce their STD risk is "critical," according to the authors of the new study.
Their study followed 775 black and Hispanic women who had been recently treated for a non-viral STD, such as chlamydia or gonorrhea. The women were assigned to one of three groups aimed at cutting the risk of future STDs: one that went to three weekly small-group sessions; a group that participated in an "enhanced" version of the program that added the option of monthly support-group meetings; and a "control" group that received standard STD counseling.
The researchers had previously found that the weekly small-group sessions cut rates of gonorrhea and chlamydia over the following year.
These latest findings from a new study with a different group of women show that after two years, women who attended these meetings were about 34 percent less likely than those in the control group to become infected. The risk was more than 40 percent lower among women who also had the option of meeting with a support group.
The results are "probably better than we expected," lead study author Dr. Rochelle N. Shain told Reuters Health, because the benefit in this study was so similar to that found in the earlier, one-year study.
According to Shain, who is with the University of Texas Health Science Center at San Antonio, the program likely succeeded for a number of reasons.
One is that it was designed based on discussions with women about their beliefs, lifestyles, and knowledge of STDs, among other things. In addition, the group meetings consisted of discussions, games and role playing, and Shain said she believes the women "gained strength" from interacting with their peers.
The added support-group meetings in the enhanced program were not necessary to curb STD risk. However, Shain said, the support groups appeared to give the greatest help to those women most in need.
The overall program, according to the researcher, could be tailored for public STD clinics, ideally in a format of weekly group sessions that allowed women to drop in "as needed."
SOURCE: Sexually Transmitted Diseases, July 2004.