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Thailand wins praise for AIDS vaccine trial

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Thailand wins praise for AIDS vaccine trial

An experimental AIDS vaccine that appears to be the first to protect people was mired for years in controversy, and credit for its success must go to Thailand where the trial was conducted, experts said.

The trial was criticised five years ago by 22 prominent U.S. scientists who doubted it would have any effect. Washington was accused of wasting more than a $100 million by funding it.

But Thai health authorities and their U.S. partners at the National Institutes of Health and the Walter Reed Army Institute of Research pressed on with the trial involving 16,000 volunteers in a country at the forefront of the battle against HIV.

“It was a tough decision. I am glad we made it,” said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, who defied the criticism and continued the trial.

The trial vaccine was made using two failed products — Sanofi-Pasteur’s ALVAC canary pox/HIV vaccine and AIDSVAX, made by a San Francisco company called VaxGen and now owned by the non-profit Global Solutions for Infectious Disease.

Donald Burke, dean of the University of Pittsburgh’s Graduate School of Public Health, said the trial was controversial from the start and had been dismissed by prominent U.S. scientists because of the failure of previous vaccine tests.

“But given the importance of the AIDS epidemic, the decision was made to go forward regardless of these criticisms. It was a difficult choice, but a courageous choice,” said Burke, who was head of AIDS research at Walter Reed before retiring in 1997.

Burke isolated the AIDS virus taken from a young HIV-infected Thai soldier in 1989 after Thai army doctors discovered an HIV outbreak among young recruits in Chiang Mai in northern Thailand. That virus sample went on to become one of the seed viruses in the experimental vaccine, Burke said.

To their credit the Thais did a remarkable job on this,” Dr. Eric Schoomaker, the Surgeon General of the U.S. Army, told reporters. “They did remarkable job of recruiting volunteers and conducting this trial almost flawlessly.”

The $105 million trial was sponsored and paid for by the U.S. government and results showed it cut the risk of infection by 31.2 percent among 16,402 volunteers over three years.

THAI TRIUMPH

Those results mark a triumph for Thailand, a country of 67 million people where a booming sex industry had stoked fears of a major epidemic. Local authorities battled hard against a disease that threatened to spiral out of control some 20 years ago.

Experts had predicted that 4 million people would be infected by 2000 if nothing was done to slow the spread of HIV. But a massive government-led Aids education and prevention campaign in the early 1990s had an enormous effect.

HIV prevalence among injecting drug users in Thailand was as high as 30-50 percent in 1991, and 33.2 percent among female sex workers in 1994, according to UNAIDS. The number of infections has since been reduced to 20,000 annually from 140,000 in 1991.

Billboards and airwaves were bombarded with safe sex messages while health workers promoted condom use in the country’s notorious sex trade. Leading the campaign was “Mr Condom,” family planner-turned Public Health Minister, Meechai Viravaidya.

Health check-ups were made available to sex workers for free. Men were discouraged from visiting prostitutes and condom usage in Bangkok’s brothels rose from 15 percent in the early 1990s to 98 percent by 2000.

Infection rates fell and the exercise remains widely cited as a model in disease prevention among health experts — although numbers have shown signs of creeping up in the last few years among some high risk groups, such as gay and bisexual men.

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Female Health’s condom available, no U.S. retail yet

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Female Health’s condom available, no U.S. retail yet

Female Health Co’s new version of its female condom is now available to state health agencies and nonprofit organizations, but the company is still trying to make it more widely available in stores.

The condom, known as FC2, will cost about 30 percent less than the original version at less than a dollar apiece, the company said on Thursday.

FC2, approved by the U.S. Food and Drug Administration in March, will be available at Washington, D.C.-area CVS stores in December, Female Health’s senior strategic adviser Mary Ann Leeper told Reuters. Female Health is still seeking a marketing partner to help advertise and sell the product and is in talks with several companies, she added.

“We need the other company to really make a dent into the consumer market,” she said.

The original female condom never had a large following in the United States, where consumers complained it made too much noise and spoiled intimacy. The FC2 uses a new, softer material that the company says is quieter and should be more acceptable.

But the female condom is used widely overseas, especially in countries hard-hit by HIV, where women see it as a way to protect themselves even if their male partners won’t. The U.S. Agency for International Development, which lobbied for the FC2’s approval, has said it plans to distribute it for global programs that aim to curb HIV.

U.S. state health departments and organizations such as Planned Parenthood can also buy it for their programs, which the company hopes will start to spread the word about the product’s improvements.

While FC2 may face an uphill battle at the retail level, it could see greater use with its new lower price.

The original female condom retailed for as much as $4 each. The new material and manufacturing have lowered the price of the new version from distributors to no more than 82 cents per condom, the company said. Male condoms, available in a variety of brands and styles, can cost as little as 50 cents apiece.

Representatives for CVS Caremark Corp, which operates CVS stores, could not be immediately reached for comment.

Shares of Female Health were down 5.7 percent to $4.76 in afternoon trading on Nasdaq.

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