E-DRUG: Has the White House Really Changed Its Tune on AIDS Drugs?
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[copied from Pharm-Policy; WB]
[http://newsweek.com/nw-srv/printed/us/na/a10740-2000feb1.htm ]
This is forwarded as a fair use. Jamie
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Has the White House Really Changed Its Tune on AIDS Drugs?,
Washington says it has shifted its policy on patents. But not
everyone has gotten the message.,
By Michael Hirsh,
With Gregory L. Vistica, Feb 01 2000
Newsweek.com: Newsweek US Edition:
Nation: Has the White House Really Changed Its Tune on AIDS
Drugs?
It was with great fanfare that Bill Clinton announced a dramatic
shift in America's policy on AIDS drugs at the World Trade
Organization meeting in Seattle. The president, in one of several
moves intended to appease raucous protesters, declared on Dec. 1
that Washington would no longer stand in the way of cheaper
medicines for AIDS victims. Until then, the Clinton
administration had mostly taken the side of major pharmaceutical
manufacturers, which in order to preserve profits and royalties
have sought to ban cheap knockoff drugs. But in Seattle, Clinton
said that drug-patent rights were secondary, and "people in the
poorest countries won't have to go without medicine they so
desperately need." On Jan. 10, more than a month after Clinton's
announcement, Vice President Al Gore reaffirmed the policy shift
during a historic appearance before the U.N. Security Council,
which convened to address AIDS in Africa.
All well and good. So why in late January was the administration
still pursuing its hardline policy of protecting corporate
patents in Thailand, one of the worst-hit AIDS countries? A few
days after Gore's U.N. appearance, on Jan. 14, an official with
the U.S. Trade Representative's office warned the Thais that they
could face trade sanctions if they issued a "compulsory license"
to manufacture ddI, a drug like AZT that helps to fend off
full-blown AIDS. Such a license would compel the U.S.
pharmaceutical company that makes the drug, Bristol-Myers Squibb,
to allow Thai or other overseas manufacturers to produce it
themselves more cheaply. A key reason for Clinton's Seattle
announcement was to facilitate that process. Again on Jan. 19,
the U.S. embassy in Bangkok presented the Thais with a position
paper that still emphasized U.S. disapproval of compulsory
licensing.
Such actions were typical before the administration's policy
shift. AIDS activists complained that the administration applied
the same unfeeling standard to defending U.S. intellectual
property rights whether the issue was cassette tapes or
life-and-death drugs. Yet in Thailand the U.S. actions were
"particularly irritating," says James Love, head of the Consumer
Project on Technology, a Ralph Nader-affiliated legal advocacy
group. It wasn't just the obvious hypocrisy of announcing a
policy shift in public and then ignoring it in practice, he says.
Worse, ddI had actually been invented on a grant from the U.S.
government, which itself held the patent. Bristol-Myers Squibb
was trying to patent a formulation process for the drug in
Thailand when it hadn't even been able to do so in the United
States, Love says. (The company was not immediately available for
comment.)
It was only after the intervention of Leon Fuerth, Gore's
national security advisor, that the Thai issue was resolved late
last week, Newsweek has learned. Following a complaint from Love,
Fuerth asked the U.S. Trade Representative's office to clearly
state the new policy to the Thai government, according to an
administration official familiar with the matter. The USTR's
assistant trade representative for the issue, Joseph Papovich,
finally responded with a letter on Jan. 27, which the U.S.
ambassador to Thailand hand-delivered to the Thai Health
minister. A copy was also faxed to the Commerce minister. "The
United States will raise no objection," the letter said, if the
Thai government decides that it needs to issue a compulsory
license. Thai officials, who previously had said they would
refrain from issuing a license because of U.S. pressure, are now
reassessing what to do. Love says similar changes of approach
have not yet been seen in other countries such as the Philippines
and Dominican Republic. The U.S. trade representative's office
did not respond to repeated requests for comment.
Why have Clinton officials persisted in implementing the
administration's old trade agenda of protecting the drug
companies-after the president himself switched position? Some
activists suggest Clinton's announcement was largely a matter of
presidential politics. ACT-UP, an AIDS activist group, has
repeatedly interrupted the vice president's campaign stops with
"zaps," or well-orchestrated disturbances, focused on the drug
licensing issue. These included the unfurling of a protest banner
at Gore's kick-off announcement in July in Carthage, Tenn.
But some activists believe that Gore and Clinton have genuinely
come around on the issue. Love says the slowness to respond
probably has more to do with the bureaucratic difficulties of
altering a long-entrenched policy. When it comes to defending the
intellectual property of U.S. companies, U.S. trade officials
"have been fired up and [focused] on these countries for 15-to-20
years, and they have got great relationships with these
companies," he says. Indeed, to persuade the trade
representative's office, Fuerth had to argue that Thailand is a
key ally of America's in Asia and that, as Gore outlined in his
U.N. speech, the administration now sees the AIDS epidemic abroad
as a national security issue.
That's not just rhetoric. A new U.S. national intelligence
estimate has found that that millions more people will die of
AIDS-related deaths than official estimates have calculated,
Newsweek has learned. The estimate, which is now classified but
is scheduled to be released to the public within days, was
prepared by the National Intelligence Council, a government body
that draws officials from most of the federal intelligence
agencies such as the CIA as well as from experts in the private
sector.
A U.S. government official who is familiar with the estimate said
it concludes that, globally, 33.4 million people are infected
with AIDS or HIV, the virus that causes the disease, with more
than two-thirds of these cases in Sub-Saharan Africa. Previous
predictions said that 1.7 million were expected to die by 2005.
"We exceeded that last year with 2.5 million," says the
government official. He says that there could be as many as 13.9
million deaths by 2008. "It's not slowing in the developing
world," he said. "There is no money and they may never get it."
Most of these will occur in Africa, but the estimate also
concludes that the highest growth rate of infection is not in
Africa, but in Asia and in India, Ukraine and Russia. By 2010,
says this official, HIV infection in Asia will likely equal that
of sub-Saharan Africa.
Echoing Fuerth's view of AIDS as a national security issue in
Africa as well as Asia, the official says, "the U.S. has equity
in these countries. We look to South Africa and now Nigeria to
bring stability to the region." He says the worst-case scenario
in the new intelligence report is that "Aids is a catastrophe,
unstoppable." But the final prediction is this: "We believe we're
likely to see a worsening of the situation in the next ten
years." After that, he says, education programs and other
remedies, possibly including cheaper anti-AIDS drugs, will
hopefully lead to a slowing of the disease.
With Gregory L. Vistica
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ADDENDUM:
Michael Hirsh's Newsweek.com story was updated to include a quote from
Patrick Donahue from BMS and Sean Murphy from USTR, included in the
paragraph below:
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Most big drug corporations fear that a compulsory license for any AIDS
drug would open a Pandora's box, setting a precedent for other drugs and
robbing the companies of royalties. "You're looking at the possibility
that a compulsory license could impede research," says company spokesman
Patrick Donahue. U.S. trade official Murphy, meanwhile, says he intended
no threat of sanctions to Thai officials. But he concedes that the
government was concerned that in Thailand compulsory licensing "was the
only option being looked at." Asked whether he also reminded the Thais
that the president had announced a new policy on AIDS drugs, Murphy said
only that he "may have alluded to it
Jamie
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James Love, Consumer Project on Technology
P.O. Box 19367 | http://www.cptech.org
Washington, DC 20036 | mailto:love@cptech.org
Voice 1.202.387.8030 | fax 1.202.387.8030