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E-DRUG: WSJ - White House Gets Pressure on AIDS Plan
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Wall Street Journal
White House Gets Pressure on AIDS Plan
Activists, Drug Firms Duel Over Use of Funds
For Generic Combination Drugs in Africa
By SARAH LUECK
Staff Reporter of THE WALL STREET JOURNAL
March 25, 2004; Page A4
WASHINGTON -- Caught between its allies in the drug industry and its
promises to battle AIDS in Africa, the Bush administration is facing
mounting pressure to allow its multibillion-dollar AIDS fund to spend money
on generic combination drugs in Africa.
The generic drugs cost just a fourth as much as their name-brand
counterparts, a price that would make them available to many more of the 30
million Africans suffering from AIDS. They are being pushed hard by the
World Health Organization and various AIDS activist groups. But brand-named
pharmaceutical makers, already fighting a global flood of attempts to copy
their patented treatments, strongly oppose their use -- in part, they say,
for safety reasons.
The issue is likely to be hotly debated next week at a meeting in Botswana
on international standards for evaluating generic combination drugs, which
was called by the U.S. and involves regulatory and scientific experts from
numerous countries, U.S. agencies and WHO. It also is under discussion
among Bush administration officials, who pledged last year to spend $15
billion over five years on AIDS in Africa and say they must choose a course
by the fall at the latest, before a ramp-up in funding for AIDS programs.
That puts the issue at the doorstep of the presidential election.
BUSH ON GLOBAL AIDS
A brief look at President Bush's policy on combating AIDS overseas:
Jan. 28, 2003: Bush announces a 5-year, $15 billion plan to fight AIDS in
Africa and the Caribbean, alludes to the use of cheaper generic drugs.
Feb. 4: Bush requests $450 million for the first year of the initiative
in his FY 2004 budget.
Oct. 23: Clinton Foundation HIV/AIDS Initiative secures deal with four
generic companies to cut the annual cost of triple-drug regimen to $139 per
person from $201.
July 10: Bush tours Africa.
Dec. 1: World Health Organization officially condones the use of generic
AIDS medicines from two Indian companies.
Feb. 2, 2004: Bush pledges $2.8 billion for the effort in his FY 2005
budget.
Feb. 23: U.S. begins issuing grants to fight AIDS abroad but doesn't say
whether money can be used to buy generic drugs to fight AIDS.
March 29: U.S. participates in Botswana conference on generic drugs.
The big immediate question is whether treatment programs in Africa will be
able to use U.S. funds to buy the generic products used in the combination
treatment. They are made by two India-based companies -- Triomune, made by
Cipla Ltd., and Triviro, made by Ranbaxy Laboratories Ltd. The products
lack approval from the Food and Drug Administration, but they have won the
backing of WHO. The three patent holders on each drug in the WHO-listed
combination are GlaxoSmithKline PLC, Bristol-Myers Squibb Co. and Germany's
Boeringer Ingelheim.
Drug-industry trade group PhRMA says it is leaving lobbying on the issue up
to individual member companies, but also is raising safety concerns. "You
can't just mix them together and put them on the market," says PhRMA
spokesman Mark Grayson. "You have no idea how it's going to work in tandem.
You need to run at least a year's worth of clinical trials and testing."
Those who favor using American money for the generics believe the U.S. has
been signaling its opposition to their use. These pro-generic activists are
stepping up their efforts, arguing that not only are the drugs less costly
but also simpler to use because they require patients to take fewer pills.
They have been joined by several legislators on Capitol Hill who have
turned up the pressure on the administration ahead of the meeting, with
letters urging acceptance of the generic combination drugs.
In a letter, Sen. Edward Kennedy (D., Mass.) writes President Bush that he
is "concerned that your administration is developing a new process" to
review generics. "At worst, the new process will give the pharmaceutical
industry further opportunity to deny these urgently needed generic
medicines," he writes. Rep. Sherrod Brown (D., Ohio) sent a similar letter
to the administration yesterday.
The controversy is unfolding at a time when the drug industry already is
trying to fend off election-year calls to legalize importation of cheaper
prescription medications from Canada and Europe, as well as ever-louder
complaints about the cost of drugs. Some in the industry worry that
overseas generic combinations will flood developed countries.
Mark Dybul, deputy chief medical officer in the office of U.S. Global AIDS
Coordinator Randall Tobias, says the U.S. is "agnostic" on the question of
whether to purchase the combination drugs, adding that he is confused by
the anger of some in the advocacy community. It already is a big shift, he
says, for the U.S. to consider how it might give approval to medications
that aren't approved by its own FDA.
"Our predilection is to use them if at all possible," Dr. Dybul says. "The
activists should be jumping up and down and saying, 'Hallelujah, this is a
major movement in international health.' "
But the advocacy groups point out that President Bush's AIDS plan, released
last month, said procurement of drugs would have to comply with federal
intellectual-property protections. Moreover, they interpret recent
statements by Mr. Tobias -- a former chief executive of Eli Lilly & Co. --
as critical of generic drugs and WHO process for "prequalifying" them for
use in AIDS treatment. In testimony before a House subcommittee, Mr. Tobias
said, "The problem is there is no process, no principles, no standards in
place today, from a regulatory point of view, to make that assurance."
While WHO isn't a regulatory body per se, it set up a process to review the
combination generics that included evaluations by regulatory experts from
Canada, Europe and Australia of the drugs' safety and quality, as well as
inspections of the facilities where the pills are made. Some WHO officials
were irritated that the U.S. wanted to revisit the issue, but say they are
keeping an open mind.
Dr. Dybul says U.S. officials aren't trying to subvert the WHO process, but
need more information about the drugs in question. "We're the ones buying
them; we need to see the data," he says.
He adds that Mr. Tobias's comments during his congressional testimony
shouldn't be interpreted as negative. He says the U.S. suggestion to hold
the Botswana meeting was well received by an international community
clamoring for agreement on which drugs to use, and says he has seen no
interference or undue influence from the drug industry.
The advocacy groups say President Bush, in his January 2003 State of the
Union address announcing an unprecedented commitment to fighting AIDS
around the world, referred to the less-costly generic products. The cost of
antiretroviral drugs "has dropped from $12,000 a year to under $300 a year
-- which places a tremendous possibility within our grasp," Mr. Bush said
in that speech. "Ladies and gentlemen, seldom has history offered a greater
opportunity to do so much for so many."
Dr. Dybul agrees that Mr. Bush "had to have" meant the generic drugs. But
"that doesn't translate automatically to use," he says. "You still have to
consider quality, safety and efficacy."
Meanwhile, international health experts worry that if the U.S. decides not
to buy generic drugs, treatment could be a logistical nightmare.
Governments may have to decide whether to run separate programs with
generic and brand drugs and keep the U.S. funding stream separate.
Advocates for using the drugs say with a limited amount of money, every
dollar counts.
"If there were enough money for everyone, we would not care which drugs,"
says Peter Mugyenyi, head of the Joint Clinical Research Center in Uganda,
which provides the generic combination drugs to AIDS patients. "We have a
moral imperative and an ethical dilemma -- how to choose among the patients
who should live and who should die."
Write to Sarah Lueck at sarah.lueck@wsj.com3
submitted by:
Kate Evans
Program Associate, Campaign for Access to Essential Medicines
Doctors Without Borders/Medecins Sans Frontieres (MSF)
333 7th Ave, 2nd Floor *New York, NY *10001-5004*USA
Tel: +1-212-655-3773
Fax: +1-212-679-7016
E-mail: kate.evans@newyork.msf.org
http://www.doctorswithoutborders.org
http://www.accessmed-msf.org
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