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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.
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