In the first months of 1997, Sarah was preparing to start a new life. She'd recently secured a green card and was making the final arrangements to move from her native Nairobi to the United States. Her husband, who had immigrated eight months earlier, had found work in the Twin Cities. There was just one more detail to attend to: the blood screening required of prospective immigrants. It should have been a formality. Instead it seemed a death sentence.
"I was in shock," recalls the 29-year-old, who asked that her last name not be published. "I lost all of my hope. I cried all the time." Sarah had discovered that she, like millions of Kenyans, had contracted HIV. The news was especially devastating because she was two months pregnant at the time. Doctors in Kenya advised her to terminate the pregnancy at once: Because she had no access to the drugs that might prevent transmission of the virus to her unborn child, the baby would almost certainly arrive HIV-positive. Sarah refused. Getting an abortion would have meant she'd given up on herself.
Shortly after arriving in this country, Sarah visited an AIDS specialist at a Twin Cities hospital. Her viral load--a measure of the infection's advance--was around 4,000. That was within a safe range, her doctor told her, and she ought to wait before embarking on any treatment program. Sarah felt healthy. "When I came [to the U.S.] I was fine," she says. "I'd never been sick a day in my life."
As invariably happens, though, Sarah's viral load began to climb, and her doctor put her on a regimen of drugs to decrease the chance that her baby would contract HIV. The medicine was effective in combating the virus's spread, but the collateral damage was brutal: Sarah found her energy suddenly sapped, and the bitter, foul-smelling liquid drugs made her vomit.
As her due date neared, Sarah's doctor prescribed Ziagen, a drug developed at the University of Minnesota and one common component of the three-drug "cocktails" used in the aggressive early treatment of AIDS. The impact was miraculous: Her viral load plummeted to nearly undetectable levels, and the side effects virtually disappeared. The baby, delivered via cesarean section to further reduce the risk of transmitting the virus, arrived HIV-negative. Sarah named her daughter Faith.
Sarah is one of the lucky few.
Amanda Swarr has seen firsthand how drugs like Ziagen (pronounced zy-uh-jen) can rescue AIDS patients from near death. During a recent year spent studying in South Africa, the University of Minnesota women's studies graduate student and veteran AIDS activist also saw how few patients in Africa have access to those drugs. And the disparity makes her furious. "The difference between being HIV-positive in the U.S. and HIV-positive in Africa was really startling," says Swarr. "People were dying because they couldn't get access to drugs for prevention or treatment that people here can get with no problem."
Across Africa, AIDS claims 5,500 lives every day; another 11,000 people are infected daily. In Kenya alone, an estimated 1 million people--roughly one in every thirty citizens--have died of AIDS. In Zimbabwe life expectancy has already dipped below 40. In South Africa, epicenter of the epidemic, authorities believe that one in nine people is infected with the virus. In many parts of Africa, meanwhile, woefully inadequate healthcare, coupled with the stigma attached to the disease, confound any effective medical response. But according to Swarr, the most significant obstacle to treatment is the high cost of the drugs, called antiretrovirals, that are employed to slow the disease's progress. Even steeply discounted, a year's worth of the medicine that keeps Sarah healthy costs as much as $2,000 in Africa, while the average annual income often hovers below $350.
During her time overseas, Swarr became involved with the activist group Treatment Action Campaign, which was protesting a lawsuit 39 pharmaceutical companies had brought against the South African government in order to prevent the importation of generic AIDS drugs that cost as little as one-tenth as much as their name-brand equivalents. The point of contention was a South African law that allowed that nation to circumvent international intellectual-property regulations in times of national crisis. This past April, in the face of intense international criticism, the drug companies backed down.
At the same time, Swarr saw a way to draw attention to the issue in Minnesota. At Yale University, which had licensed its patent on the anti-AIDS drug d4T to Bristol-Myers Squibb, students, faculty, and the Nobel Prize-winning advocacy group Doctors Without Borders had successfully urged officials from the school and its corporate partner to loosen their patent claims in the developing world. Swarr hoped the University of Minnesota, which had licensed key patents on Ziagen to the London-based pharmaceutical giant GlaxoSmithKline in exchange for a projected $300 million in royalties, could be persuaded to do the same.
Emboldened by Yale's example, last spring Swarr organized a letter-writing campaign and student petition demanding that the university, in concert with Glaxo, sublicense its patent and pave the way for the manufacture of cheaper generic versions of Ziagen. In an April 19 statement, the school responded that it would welcome a price cut of Ziagen in sub-Saharan Africa "despite a potential reduction in its royalties."
To Swarr the announcement was a promising, albeit symbolic, first step. But, she contends, unless the university cedes its patent on Ziagen, the school's exclusive deal with GlaxoSmithKline will prevent generic equivalents from reaching AIDS patients in Africa. As Swarr sees it, the Ziagen controversy is only part of a larger debate simmering on campuses across the nation over the increasingly symbiotic relationship between academia and private industry, particularly pharmaceutical and biotechnology corporations. Advocates of licensing arrangements like the U of M's deal with Glaxo argue that they are the only way to move university research from the lab to the pharmacy shelf; critics contend that such deals make universities veritable R & D departments for private corporations--in effect, giving drug companies monopolies over research funded by the National Institutes of Health.
The heart of this debate is intellectual property: If licensing agreements create an unjust monopoly on publicly funded science, are universities still serving the public good? "Why should corporations get to dictate how a university invention is marketed and distributed?" Swarr asks. "And what does it mean for future research? If corporations have this power, does that mean researchers will only work on drugs that are profitable?"
Seated in his modest, neatly arrayed office just a few feet from his lab at the University of Minnesota, the man credited with creating Ziagen is flanked by portraits of Albert Einstein and Moe from the Three Stooges. The two figures seem to describe the poles of Robert Vince's professional persona--the combination of a rigorous mind and a strong creative impulse. Though his discovery has made him both famous and wealthy, the 60-year-old chemistry professor retains the stereotypical scientist's slightly owlish appearance and retiring demeanor; he's clearly a man more constitutionally suited to the lab than the public spotlight.
Not surprisingly, the attention his work has attracted in recent months has left Vince slightly wary; when he discusses Ziagen, he chooses his words cautiously and uses them sparingly. But when talk turns to the science behind the drug, he grows animated--a reflection of the passion that drew him from a summer job behind a pharmacy counter to a Ph.D. program in medicinal chemistry. "I was interested in science and medicine from a young age," he explains. "And medicinal chemistry incorporates a lot of basic sciences: You have to know drugs, biochemistry, and pharmacology. It's rare to have all these disciplines in one person."
After completing his doctorate in 1966, Vince was attracted by the relatively new field of antiviral medicine. Scientists had only recently begun to explain the behavior of viruses, and the first antiviral compounds emerged somewhat serendipitously from other research: While working with anticancer agents, scientists discovered that nucleotides--the basic components of DNA--could be chemically altered to disrupt the reproduction of a virus.
Early in his career, Vince also got a hard lesson in the business of science. In the mid-1970s he developed a compound that was effective in halting the spread of the herpes virus. Yet because he didn't obtain a complete patent on his work, it was impossible to interest a drug company in developing the research for market: Since companies couldn't be sure that they alone would have access to Vince's research, they were unwilling to expend time or money testing his new compound. "Without patent coverage," Vince explains, "when we design something, it's hard to engage pharmaceutical companies and get them interested.
"Before 1980 there were a lot of restrictions [on patenting]," he goes on. "It was very rare that anybody would pay attention to what you were doing. It wasn't typical that someone would come to you and want to get involved. Around 1985, though, things started to change. And that also coincided with the discovery of the AIDS virus."
Like most members of the research community, Vince began hearing about AIDS in the mid-1980s. It was clear from the outset that this virus represented a new kind of enemy. As with all viruses, its behavior might be compared to an invading army: HIV inserts itself into human cells, then, with an enzyme called reverse transcriptase, uses the cell's own reproductive machinery to replicate itself as many as 1 billion times every 24 hours. But this organism behaved differently from previously known viruses, depressing the body's immune system and mutating so quickly that attempts to understand its reproductive mechanism--much less confound it--could hardly keep pace.
The few drugs available to treat AIDS--AZT, for instance, and d4T, which were first synthesized in the 1960s--had been developed to fight cancer. But Vince realized early on that the work he was doing with modified versions of basic DNA molecules--compounds known as nucleoside analogues--could be applied to AIDS. After a decade's worth of fundamental research into the behavior of viruses, he knew that altered nucleosides could act as chemical decoys, stopping reverse transcriptase from commencing the replication process, and thus effectively neutralizing the virus without destroying healthy cells. In 1986, with a research grant from the National Institutes of Health, he set out to synthesize the first compound ever designed specifically to combat HIV.
As he recounts the history of his discovery, Vince gravitates toward a chalkboard on one wall of his office and proceeds to diagram the molecular structure of a nucleoside called guanosine. In order to ensure that his compound would target only infected cells, Vince grafted a synthetic sugar to the nucleoside. Evolutionarily sophisticated human cells would recognize the synthetic compounds as impostors and reject them; the virus would not. Pointing to one of the pentagram's corners, he continues, "What we did is replace an oxygen molecule with a carbon. That makes the compound very, very stable." Less stable molecules, Vince explains, are likely to be broken up by stomach acids before reaching their target. To be effective, AIDS therapies, which are often taken in complex, multidrug regimens, must be able to pass easily through the body to the white blood cells and brain tissue where HIV hides.
Within only a few months, Vince and his fellow researchers had synthesized a series of new compounds and, despite the skepticism of the NIH officials who reviewed the work, sent them for testing at Alabama's Southern Research Institute. One family of compounds in particular, which Vince named carbovir, caught the testers' attention: They proved exceptionally effective in inhibiting the replication of HIV, while showing a low toxicity--meaning that they tended not to affect healthy cells. "I remember a guy from the NIH called me at home on a Saturday morning," Vince recalls. "He was really excited. He told me they wanted me to patent these right away, and they said they'd pay for preclinical testing to attract a pharmaceutical company."
The university duly patented the compounds, crediting Vince, along with a visiting researcher named Mei Hua, with the discovery. Vince says he didn't foresee the controversy that would follow. "I never thought, 'We're going to get a patent and make some money.' The patent was just a mechanism of getting our work out there and doing something with it. If we hadn't patented it, it'd have been like we were throwing it away. I thought we did something good. And then all of a sudden we became bad guys."
It was a propitious time to capitalize on carbovir. HIV had recently become public-health enemy No. 1, and new patent regulations made university research especially attractive for drug companies eager to develop antiviral therapies. Even so, it took a decade--and the second-largest lawsuit in Minnesota history (trailing only the tobacco settlement)--for Vince's compounds to become a marketable drug.
In 1988 the University of Minnesota licensed the patent for carbovir to the British pharmaceutical firm Glaxo in exchange for five percent of sales from any drug the company eventually developed using the compounds. But Glaxo shelved the project, and in 1991, in accordance with its contract, the university reclaimed its patent. In 1993 carbovir was licensed a second time, to North Carolina-based Burroughs Wellcome. As it happened, the Burroughs scientist assigned to work with carbovir, Susan Daluge, was one of Robert Vince's former postdoctorate researchers.
There were early problems with carbovir, says Daluge. For one thing, the family of compounds proved insoluble, which meant they could not be effectively administered orally. A more serious drawback arose during early clinical trials: Burroughs scientists discovered that the drug caused a violent, sometimes deadly, reaction in up to five percent of patients. (This side effect, called hypersensitivity, remains a major obstacle to the drug's widespread prescription.)
Meanwhile, the pharmaceutical industry was consolidating, and in a twist of fate for the U of M, Burroughs was acquired by Glaxo. (The new company merged again last year, with SmithKline Beecham, to form GlaxoSmithKline, the world's third-largest pharmaceutical conglomerate and the largest producer of AIDS drugs). In the midst of the corporate maneuvering, getting carbovir ready for market became a priority. Eventually Daluge turned Vince's work into a chemical called abacavir sulfate, later marketed as Ziagen.
Clinical trials proved promising, and by 1998 it was clear Ziagen would be a blockbuster; industry analysts predicted annual sales of up to $800 million. But as the drug was being readied for the market, trouble arose: Glaxo claimed that Ziagen bore so little resemblance to carbovir that the company was not obligated to pay the university royalties. In addition, Glaxo attorneys claimed that Robert Vince had taken credit for work Susan Daluge had done while at the university, thus invalidating the university's patent altogether.
A mere two months before Ziagen won approval from the U.S. Food and Drug Administration, the university filed suit against Glaxo. Months of rancorous legal proceedings ensued, during which both sides exchanged ugly accusations of scientific misconduct and legal two-stepping. Vince recalls this time of endless depositions with a hint of bitterness. "I'm not a lawyer," he says. "But it still consumed all of my time. I couldn't do anything else."
In October 1999 a protracted court battle seemed assured. Then, in a late-night session at St. Paul's federal courthouse, Glaxo backed down. Under the terms of the suit's settlement, the U of M would receive a lump sum of $7.25 million, plus royalties on a sliding scale beginning with five percent of worldwide sales and going up to ten percent. As mandated by federal law, two-thirds of those royalties would have to be reinvested in research--in this case, an endowment for graduate students and a new drug-development center. The rest--an estimated $10 million per year--would go to the patent holders, Robert Vince and Mei Hua.
Financial windfall notwithstanding, the most important aspect of the lawsuit was the precedent it set: In securing the largest settlement ever won by a university defending its patent rights, the university's victory signaled a sea change in university-industry relations. Mark Rotenberg, the school's general counsel, says the case demonstrated the university's increasing willingness to protect its patents with tooth and claw. "It's a phenomenon common in the pharmaceutical industry that if a company strikes it hot, they take the position that it's not really your property," Rotenberg asserts. "Our success was a sign to the drug industry that universities will defend their intellectual property."
The mood was euphoric. In a December 1999 Star Tribune opinion piece authored with local intellectual-property attorney Ken Liebman, Rotenberg wrote that the litigation was "the most public example of the university's recognizing its proper place in the commercial sphere." In a statement to the press, university president Mark Yudof compared the settlement to winning the lottery.
Had carbovir been developed before 1980, it probably wouldn't have received the same attention. Because Vince's research was funded by the federal government, the results could not have been licensed exclusively to a drug company. Instead, carbovir would have entered the public domain, and companies could have developed drugs based on it without paying the U of M a nickel.
But in 1980 Congress passed legislation that profoundly transformed the context for scientific research at public universities. Designed as a response to flagging productivity and concerns about U.S. competitiveness with Japan, the Bayh-Dole Act allowed universities to patent and license the results of federally funded research. The logic behind the legislation was simple: Allowing universities to profit from their research would spur development of marketable products and give private industry access to academia's bountiful trove. And the effect was dramatic: Before 1980, U.S. universities applied for about 250 patents a year; by 1998 they were applying for nearly 5,000 annually--and generating more than $34 billion per year from their discoveries.
Like other land-grant institutions, the University of Minnesota has always been an eager participant in the market economy. The school's numerous contributions to industry include taconite, vulcanized rubber, and retractable seat belts. The school also has a track record of forging fruitful partnerships with private industry. The first pacemaker, for instance, was implanted by a team of doctors from the U of M and the local medical-technology company Medtronic.
But if public-private liaisons are nothing new, Bayh-Dole substantially altered the terms of endearment: Whereas before the legislation, products developed at universities became public, universities now had a financial incentive to keep their corporate relationships monogamous. In other words, if seat belts had been invented circa 1980, it's conceivable that only Ford would be allowed to install them in cars.
Depending on who is describing it, Bayh-Dole amounted to either an inspired attempt to make universities relevant or an unprecedented giveaway to corporate America. Whatever the case, research institutions embraced the new model wholeheartedly, setting up offices to patent and license university inventions and bragging that royalty revenue would soon line academia's coffers. To date, however, these offices--engaged in a range of activities gathered under the broad rubric of "technology transfer"--have rarely proved profitable. Only a few inventions, such as the University of Florida's patent on Gatorade and Yale's patent on d4T (marketed under the name Zerit), brought substantial returns. But university administrators have continued to insist that intellectual property is the new coin of the academic realm.
These days the U of M manages its growing portfolio of intellectual property from an office in the fortresslike McNamara Alumni Center. The walls here are adorned with framed pictures touting the school's biggest tech-transfer successes to date, carbovir and Net Perceptions, Inc. The latter, a software company, was spun off by a group of faculty and students in 1996. In a common tech-transfer arrangement, the school, which holds the patent on Net Perceptions' software, took an equity interest in the company and made nearly $8 million when it went public in 1999.
Tony Strauss, vice president of patents and technology marketing, has worked in the office for 17 years, ever since graduating from the U of M's law school. During that time he has seen technology transfer go from a blip on academia's screen to a multibillion-dollar business. "In our little spheres," he says, "we felt like what we were doing was important. But most of us were just trying to survive."
Not so anymore. When carbovir was patented, the university had only one technology manager; Strauss's department now has 21 employees. According to Strauss, the school now has more than 450 active license agreements. Still, the $77 million generated by those contracts is due almost solely to carbovir and Net Perceptions. "From a financial standpoint, we've lagged behind [other large research universities]," Strauss admits. Nevertheless, he says, his office is making a concerted effort to expand its influence, meeting with researchers on a regular basis and keeping tabs on potentially marketable work.
"We're getting very popular for a variety of reasons," he says. "Much to our surprise, we're finding ourselves, somewhat reluctantly, out on the cutting edge of volatile issues--drug pricing in Africa being the latest. Part of the problem was that we didn't think of how we'd be perceived."
Strauss contends that despite Ziagen's enormous financial impact, technology transfer is not generally designed for profit. "We don't patent things just to make a buck," he contends. "Our basic reason for being here is to get things out to the public. We want to get a fair return to the institution. But our mission is to get ideas out. In a broad sense, everything is tech-transfer. Education is tech-transfer."
Others are less demure. General counsel Mark Rotenberg concedes that money is a driving force behind academia's push to commercialize its inventions. The ongoing divestment of public universities--and the attendant double-digit tuition spikes, tenure battles, and departmental "re-engineering"--has made commercialization not only attractive, but necessary. "Universities are under enormous financial pressure to find new sources of funding," says Rotenberg. "Major public universities like the U of M can no longer rely on public funds as their principal source of funding. We have to look to research activity as a point of revenue, and hope that people will see the value in that.
"There will always be people who say that the university is such an ivory tower that we're wasting time and money on research that doesn't mean anything in the real world," Rotenberg goes on. "And there'll always be people who say the university is too sensitive to issues of politics and the market. There's got to be a balance."
Two decades after its enactment, some observers have begun to wonder if Bayh-Dole hasn't tipped that balance irrevocably. Dragging science out of the ivory tower and into the marketplace, they argue, has had the corollary effect of transforming America's research universities into profit-driven enterprises. If Bayh-Dole invited the moneylenders into the temple of pure science, skeptics now see a situation in which the temple itself has gone into the money-lending business.
Philip Regal, a U of M ecology professor and longtime critic of university privatization, considers the focus on commercializing research symptomatic of current trends in academia. "This is a general systemic problem," Regal says. "There's an ongoing effort to leverage educational institutions into the service of corporate interests. It's happening everywhere. That doesn't necessarily make it right, though.
"In theory, universities are gaining power with these deals. They have a position of leverage," Regal continues. "But they don't have any moral spine, because they're in bed with corporations."
Jeffrey Kahn, director of the U of M's Center for Bioethics, says the debate over the school's deal with Glaxo may be the tip of a bigger iceberg. "This is an example of the kind of issues that come up when universities have a financial stake in the products they develop," Kahn asserts. "It's a species of a larger issue: The question is whether the institutional mission is in conflict with incentives for profitability."
Corporate partnerships have obvious advantages for cash-strapped universities, concedes Ronald Collins, director of the Washington, D.C.-based watchdog group Project for Integrity in Science. But these financial relationships, Collins argues, introduce a host of sticky ethical issues. "A university or a department within a university has an intellectual agenda," he says. "When a department or professor becomes heavily dependent on corporate funding, that can potentially define their intellectual agenda.
"It's not like corporate funders come in and say, 'Research whatever you want and we don't care about the results,'" Collins explains. "If there's no money in X, then they're not going to fund research in that area. Science is being directed by profitability."
And corporate ties can infringe on academic freedom, Collins maintains, particularly when they come in the form of exclusive agreements that keep researchers from publishing their work or sharing trade secrets. As an example he cites the case of James Kahn, a researcher at the University of California in San Francisco. In 1999 Kahn was conducting early clinical tests on a promising HIV vaccine called HIV-1 Immunogen, which was produced under the trade name Remune. His research was supported in part by the drug's manufacturer, Immune Response Corporation, which had signed a contract with the university for clinical testing of its product. There was only one problem: Kahn discovered that Remune didn't work.
When he and his colleagues attempted to publish their findings, Immune Response tried to force Kahn into altering his data to make the clinical trial look less damning. Kahn refused, and the company sued him, arguing that a negative study would disclose proprietary information. Kahn published anyway. In turn, Immune Response published its own clinical data to refute his findings. To observers of the case, which has yet to be resolved, the lesson is clear: The ethics of business and the ethics of science mix like gasoline and water. "If industry is a coequal partner with government, should we give up the illusion that the academic-research side is pure and admit that it is going to be part of the market?" asked University of Pennsylvania bioethicist Arthur Caplan in the May issue of The Scientist.
Sheldon Krimsky, an urban studies professor at Tufts University who has studied university-industry relationships extensively, cites statistics demonstrating the increasing prevalence of corporate largess: In 1992 universities received a total of $1.28 billion in private support; by 1999 that number had climbed to $2.05 billion. "The downside to all this is that researchers have to wear several hats," says Krimsky. "They're expected to be both disinterested scientists and entrepreneurs. And those two things can come into conflict more often than we like."
In 1996 Krimsky examined the 14 leading scientific journals and made a startling discovery: In 34 percent of the 900 articles he reviewed, he found that the authors had a financial stake in their research--either through corporate sponsorship, a patent on the work, or equity in a company developing their research for market. And in almost no cases were those financial ties disclosed.
Bayh-Dole, Krimsky contends, set off an "intellectual property gold rush," during which corporations have ransacked the ivory tower. Scientists themselves are no longer simply under pressure to publish their work; they are compelled to patent and sell it. Furthermore, he argues, though Bayh-Dole was intended as an economic impetus, it may actually be impeding competitiveness by giving corporations monopolies over vast areas of science and technology. "It's an odd turnaround from competitive capitalism: The public is taking all the risks and the benefits are channeling into the private sector," says the professor. "With pharmaceuticals, the question is whether the public is paying [for research] twice."
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.
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.
Still, the debate over Ziagen has inspired some institutional soul-searching: For the past few months, Mark Rotenberg has been meeting quietly with GlaxoSmithKline officials to discuss the university's options. The talks, he says, are partly concerned with protecting Glaxo's trade secrets from public scrutiny. But he says he has also questioned company representatives about Ziagen's affordability and availability in Africa.
Rotenberg believes the experience may lead to changes in the way the university licenses its inventions. "There needs to be a clause in these agreements to deal with public-health crises," he says, describing a loophole that might give the university some leeway to sublicense to a generic manufacturer if its patent comes into conflict with efforts to distribute affordable drugs in the developing world. "We don't want to be frozen into a market structure that's keeping affordable drugs off the market. It would be very worthwhile to explore that in the future."
Swarr and her fellow activists want the school to act now. If the university were to waive its patent rights in the developing world or sublicense to a generic manufacturer, she suggests that the impact could be enormous. Swarr points to the example of Brazil, which has used compulsory licensing and government-produced generic AIDS drugs to drastically cut both death and infection rates. Because Ziagen is now sold almost exclusively in North America and Europe, she notes, the school wouldn't suffer any drop in royalty revenue by allowing it to be produced generically for use in Africa.
If nothing else, Swarr adds, it would set a powerful precedent: namely, that universities are willing to stand up to industry when monopolies restrict access to essential medicines. "It's one of those rare moments when doing the profitable thing and doing the morally courageous thing aren't in conflict," she says. "The worst tragedy I can imagine would be to look back after millions of people have died and realize we could have done something more."
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