Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date. 
Wall Street Journal - March 25, 2004
Sarah Lueck, Staff Reporter of The Wall Street Journal
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.
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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.com
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