Sabin Russell
Chronicle Medical Writer

Prostitutes protest AIDS-drug test Bay Area company hit with charges of exploitation

BANGKOK -- On the podium in the Grand Ballroom at the 15th International AIDS Conference, Johns Hopkins University infectious-disease researcher Dr. Joel Gallant suddenly found himself surrounded Tuesday by angry, chanting Cambodian prostitutes.

Gallant was presiding over a seminar on antiviral drugs, and the protesters were demanding a halt to a planned trial designed to determine whether a proven AIDS drug might have a second use — blocking infection with HIV as effectively as a vaccine.

About 30 protesters, who took over the stage for 15 minutes, held signs declaring the maker of the drug, Gilead Sciences of Foster City, "uses sex workers for free."

For Gilead, a little-known company, the disruption was another sign that it had hit the big time in the politically charged world of AIDS medicine, an inevitable outcome of its enormous success in bringing to market one of the safest and most effective antiviral drugs for patients with HIV.

"The fact that part of our pharmaceutical company makes a living in HIV — that alone draws attention. As these things go, you can't win," said Norbert Bishofberger, Gilead's executive vice president for research and development.

The protesters, led by ACT UP Paris, were demanding that Gilead, sponsor of the disrupted seminar, provide lifetime health care for any participant in the study who became HIV-positive — a price they felt the company should pay for allegedly endangering the lives of the young women who enrolled in the experiment.

Dr. James Rooney, the company's vice president for clinical affairs, said the study, which will involve the use of a placebo, was designed to comply with strict ethical guidelines. A community advisory board, he noted, calls the experiment "the hope of women."

At a conference that is virtually guaranteed to be short on major scientific breakthroughs, Gilead's drug tenofovir, or Viread, is grabbing the spotlight. In the two years since it came on the market, it has reshaped the prescribing patterns of AIDS doctors — and has added a new wrinkle in the debate over bringing low-cost drugs to the developing world.

"For us, tenofovir is an incredibly important drug," said Rachel Cohen of the French medical organization Doctors Without Borders. Because of its safety and relatively low cost, it is a prime candidate to serve as a second line of defense for patients in poor countries who fail to respond to less expensive "first line" therapies.

Although Gilead has offered to sell tenofovir for its stated cost of 80 cents a pill to 68 poor countries, Cohen said the price is not nearly low enough to ease the problem of treating millions of AIDS patients. Doctors Without Borders would like to see prices closer to 30 cents a day.

Cohen expressed skepticism that Gilead could make good on its offer. He noted that the company hasn't obtained government approval to market the drug in many of the poorest countries. "If it is not registered, then the offer of 80 cents is a virtual one," she said.

It was an entirely different issue, however, that brought out the protesters from ACT UP. Scientists have been eager to test tenofovir as a potential chemical shield against HIV after studies showed it worked 100 percent of the time on monkeys. Those tests used an intravenous form of the drug, however, and protected the animals against the simian immunodeficieny virus, a cousin of the AIDS virus that can kill macaques.

According to Rooney, 900 HIV-negative "beer girls," who work the bars in Phnom Penh, are being recruited for a study in which some will be given tenofovir and others, a placebo. After a year, the women will be tested to see whether there are fewer HIV cases among those who got the drug.

The study is in fact being conducted not by Gilead but by researchers at UCSF, funded by the federal Centers for Disease Control and Prevention. The CDC is sponsoring similar tests in Atlanta, and the Bill and Melinda Gates Foundation is underwriting pre-exposure prophylaxis trials in Africa. Gilead's role is to provide the drugs for free.

All the women will be counseled to use condoms and will be supplied with them following rules used in vaccine trials.

But in the view of Tuesday's vocal critics, the study offers only cursory safer sex counseling. Protesters called the test unethical and demanded that it be halted. The Cambodian prostitutes contend that the study won't work unless some of them become infected, leaving them pawns in a corporate drug development scheme. "Gilead Prefers Us HIV +" read one sex worker's placard.

The bottom line for protesters, however, was a bid to require Gilead to provide health care to any study participants who become ill.

Although Gilead itself is a relatively young company and new to the world of angry AIDS protests, it has a powerful board of directors familiar with corporate power and controversy. Among its members: former Secretary of State George Shultz, former Intel chairman Gordon Moore and Stanford Nobel laureate Dr. Paul Berg. And chairing Gilead's board, from 1997 until 2001, was none other than current secretary of defense, Donald Rumsfeld.

Tenofovir, a variant of AIDS drugs that block a key enzyme in HIV called reverse transcriptase, was acquired by Gilead from a Czech chemist, Antonin Holy, and cobbled into a once-a-day pill approved for marketing by the Food and Drug Administration in October 2001 — an event vastly overshadowed by the terrorist attacks only weeks before.

Just before the opening of this year's AIDS conference, the Journal of the American Medical Association published results of a three-year study comparing tenofovir to stavudine, or D4T, one of the most widely prescribed AIDS drugs. The study was led by Johns Hopkins' Gallant and showed that the Gilead drug was just as effective as D4T but caused only a fraction of the side effects, such as the disfiguring shifting of fat from the face and limbs to the belly.

Doctors have already been aware of the relative safety of tenofovir, and it has quietly become the most widely prescribed AIDS drug in the United States, according to NDC, a market tracking firm. Gilead's sales of Viread during the first quarter ended in March were $193 million.

Viread is not Gilead's only AIDS drug. A companion medication called emtricitabine, or Emtriva, also has been approved for marketing, and Gilead is in exploratory talks with Bristol-Myers Squibb to develop a single pill that would combine three AIDS drugs into a single, once-a-day pill. That could once again alter the dynamics of drug sales to the developing world, as it would offer a more expensive, but arguably safer, "fixed dose combination" pill than that being made for Third World patients for as low as 40 cents a day.

Such a pill, from a politically well-connected company such as Gilead, might also find favor with the President's Emergency Program for AIDS Relief, the Bush administration's $15 billion overseas AIDS initiative, which has not, to date, accepted any generic medicines.

E-mail Sabin Russell at srussell@sfchronicle.com.