Bitter Pills

The AIDS drug Ziagen has brought healthy windfalls to the University of Minnesota and GlaxoSmithKline. But it isn't doing anything at all for the millions who are dying of the disease in Africa.

AZT, the first drug used to treat AIDS, is a prime example of this phenomenon. The drug was initially developed entirely with public money, and when early clinical trials appeared promising, the federal government licensed the drug to Glaxo (which retroactively claimed credit for discovering it). The drug company promptly took advantage of its monopoly by marketing AZT as one of the most expensive drugs in history. Why, many observers wondered at the time, was the company recouping an investment it hadn't made in the first place?

It's still a pertinent question. One of the arguments commonly offered by the pharmaceutical industry for high drug prices is the spiraling cost of research and development: The industry's trade association, the Pharmaceutical Researchers and Manufacturers of America, estimates that it costs $500 million and takes 12 years to move a drug from lab bench to pharmacy shelf. But not everyone is convinced. James Love, of the nonprofit Consumer Project on Technology, pegs the cost at closer to $50 million, and says drug companies typically inflate their figures in order to justify high prices. Additionally, Love notes, drug companies often spend twice as much on marketing as they do on research. And the high cost of R & D certainly hasn't hurt the pharmaceutical industry's bottom line: Glaxo posted profits of 27.8 percent, or about $5.6 billion, last year.

But the cost of privatizing university research may ultimately be measured in more than high drug prices. Traditionally, large research universities have been the principal incubators of basic research, fostering the exploration of the underlying structures of science. While most scientific advances emerge from such fundamental research, the work doesn't always have commercial applications. If university scientists are expected to produce commercially applicable research, basic research might fall by the wayside, and along with it the kind of intrepid inquiry that led to Ziagen.

Craig Lassig

Already an entire class of diseases, termed "neglected" in public health circles, struggle for researchers' attention. And because most of these primarily affect populations in the developing world--malaria and tuberculosis are the prime examples--the world's poor will suffer (are suffering) the consequences.

"Where else are you going to do this work?" Krimsky asks. "If it doesn't continue to happen at universities, we'll all suffer in the long run."

 

This past Tuesday, as the United Nations General Assembly put the finishing touches on its plan to combat AIDS, two dozen U of M students and faculty members, including both Robert Vince and Amanda Swarr, held a symposium of their own. The setting, a sweltering East Bank conference room, was less rarefied, but the issue at hand was perhaps no less significant: What is the university's responsibility, both legally and ethically, to ensure that Ziagen reaches those who desperately need it? Cutting to the quick, Swarr asked Mark Rotenberg, the evening's featured speaker, whether the university might follow Yale's example by ceding its patent claims.

"On one level, the example Yale provides is unique," Rotenberg replied. "d4T, by orders of magnitude, doesn't have the market potential that Ziagen does. So Yale was conceding no economic benefit by making its statement and riding it into the sunset." But then the normally self-assured attorney balked. "I realize that's too facile, that it's sidestepping your question," he said. "This is an empirical issue, not a legal one."

At least implicitly, Rotenberg appeared to be acknowledging the school's difficult position: Its financial relationship with Glaxo forces it to defend a monopoly that is preventing medicine from reaching dying people.

At the same time, no one involved is under the illusion that cutting the price of Ziagen would stem the onslaught of HIV. Keith Henry, an AIDS specialist at Hennepin County Medical Center who has spent time treating patients in Africa, notes that the drug's potentially severe side effects make it difficult to prescribe widely in areas with substandard clinical care. "These drugs are miracles," Henry says. "I've seen with my own damn two eyes what they can do. But they can be harrowing for the first few months. They're not even easy to use here. I get nervous every single time I use them. In Africa resources are so scarce--they just don't have the infrastructure to manage the drugs."

Inadequate healthcare isn't the only thing keeping antiretroviral drugs from African AIDS patients. A clause in 1995's Agreement on Trade-Related Aspects of Intellectual Property Rights (one of the founding provisos of the World Trade Organization) allows nations in the midst of a health emergency to circumvent patent restrictions, either by buying lower-priced drugs through a third country or by forcing drug companies to allow generic manufacturing. But African nations eager to court the WTO's favor face enormous pressure from the U.S. and its powerful pharmaceutical-industry lobby not to invoke the clause. Thus far no African nation has done so. (South Africa has even declined to import the much-needed AIDS drugs, generic or otherwise.)

And though they've stumbled onto center stage in the ongoing debate over access to essential medicines, U.S. universities aren't ideally positioned to take action, argues Christine Maziar, the U of M's vice president of research. If school officials break an exclusive agreement with a drug company, they open themselves to liability. Nor is sublicensing to a generic manufacturer a viable option: No company would risk the litigious ire of a major drug company by infringing on its patent. Yale's decision to bend to student demands, Maziar suggests, may have been more a timely public-relations gambit than a philanthropic gesture, as the school's patent on d4T is about to expire. "It was an easy thing for them to give away," she says.

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