Unlikely partners reach out to AIDS patientsBY NICHOLAS ZAMISKA
The HIV/AIDS pandemic in Africa in tandem with a dearth of low-cost treatment options has placed the peculiar marriage of industry, university, and scientist at the epicenter of recent criticism. Professors, along with others, have emerged as some of the most fervent supporters of Bristol-Myers Squibb (BMS), commending the company's swift action last week that dramatically cut drug prices in South Africa.
What would have made for strange bedfellows nearly 50 years ago, BMS, Yale, and William Prusoff, a pharmacology professor, have been wedded by the increasingly complex and capital-intensive process of realizing a laboratory discovery's life-saving potential. The popular image of the profit-minded pharmaceutical company pitted against the academic's idealist vision of fighting disease, with the university awkwardly occupying the middle ground, dominates public opinion. The three parties involved say this is unfairand untrue.
Prusoff and his late colleague Tai-Shun Lin invented the drug d4T (sold under the brand-name "Zerit"), which makes up one part of the three-drug cocktail that has relegated HIV to a manageable disease in many parts of the first world. Despite remarkable success in affluent countries, the drug's high price of $10,000 to $15,000 per year prevented most of Africa's afflicted population from reaping its life-saving benefits.
With an estimated 25 of the 36 million HIV-positive people worldwide in Africa, Doctors Without Borders (DWB), an international medical humanitarian group backed by a group of law students, demanded that the drug be made available at a reduced cost. Yale and BMS quickly came to an agreement resulting in the Wed., Mar. 14 announcement offering the drug in South Africa at around $1 a day, an agreement that Bob Laverty spokesperson for BMS, said, "was not the result of pressure" from DWB or from Yale.
Despite the apparent concession, Steven Berry, professor of economics, says that since demand was initially so low in South Africa due to the drug's exorbitant western prices, BMS will most likely forfeit little profit. Instead, drug companies fear possible pressure from the U.S. and Europe to lower inflated prices. Patients in affluent nations are essentially footing the bill for the research of drug development.
Jon Soderstrom, director of the Office of Cooperative Research, who has borne the brunt of much of the media's negative attention, is "tired" of reporters who consistently supplant "balanced reporting" with "good sound bytes." According to Sod-erstrom, this brand of opportunistic censure of his office and the companies with which he deals is misguided: "The pharmaceutical industry is an easy target. But BMS took a very high risk on d4T 12 years ago, a risk that has prolonged hundreds of thousands of lives," he said.
Prusoff champions the pharmaceutical industry for its critical role in drug development. "These are good people who are serious about fighting disease," he said. D4T would have been "shelved" if it were not for a company like BMS who put up the estimated $500 to $800 million it costs to bring a drug to market. Such a large sum accounts for the lost research money on drugs that fail the FDA's requirements for safety testing.
In sum, the potential for profit on a drug like d4T compels firms to front the necessary capital it takes to put a drug through its costly clinical trials. Without such a monetary incentive, the development of drugs would stall.
In 1948, drug patenting was rare and considered a threat to the "interests of medicine and to the public," Prusoff remembered.
However, "things have changed since the '50s," Soderstrom said. In 1962, Thalidomide, a new sleeping pill, was found to have caused thousands of birth defects in European infants. The unmasked threat of potentially harmful drugs prompted the Kefauver-Harris drug amendments that required drug manufacturers to prove to the FDA the safety and efficacy of their drugs. Thus, the FDA's emergence in the early '60s as a powerful regulatory agency placed new demands on firms to fund expensive checks on a previously lightly regulated pharmaceutical industry. Patents became the vehicle by which companies generated the capital to fund the costly FDA tests.
Soderstrom himself helped found the local biotech firm Achillion. In part, Achillion's goal was to develop a possible Hepatitis B treatment that was "sitting on the shelf" since there was no patent. No firm would accept without exclusivity rights in the form of patent protection. He recruited people from BMS to work on the development, secured a patent for ACH-126,443 and is currently in clinical trials. "None of this would have happened without the patent," according to Soderstrom.
Over the years, the line between industry and academia has grown increasingly blurred, and many see this merge as critical to the development of life-saving drugs. Nevertheless, professors will certainly articulate their reasons for remaining at the university-level and admonish administrators about a potential "direct involvement" between their research and the drug companies' interests. Amy Kapczynski, LAW '03, who organized fellow law students to pressure the University into taking action on the d4T issue, calls the University's aggrandized relationship with private industry "somewhat distressing" while nevertheless acknowledging the "inevitable and necessary link" between the two.
However, academic "freedom and liberty," as professors put it, has its price too. Sartorelli criticizes the process of securing multi-million dollar grants crucial to the funding of research as "tremendously burdensome." He complains of the inordinate amount of time he must devote to the "complex and competitive" application process as a process that will, in his estimation, persist for years to come. "It's simply the facts of life in academia," Sartorelli said.
Despite these arduous realities, Sartorelli and others have chosen to pursue their passions as they see fit without the guidance of a profit-minded executive keeping watch. Sartorelli, specializing in anticancer therapies, is currently working on a group of 10 compounds that are in the development and testing phase. Since the '50s, Prusoff's lab has produced "dozens and dozens" of antiviral compounds in which he had extreme faith. However, only two have successfully been brought to market.
Contrary to popular belief, BMS has not singled out South Africa for preferential treatment on a continent where nearly 70 percent of the world's HIV-positive persons live. Every other country in Africa is under no legal obligation to prevent the importation of low-priced generic versions of d4T.
Despite mounting public pressure, BMS, along with 39 other major drug companies, is still suing the South African government for passing a law signed under the end of Nelson Mandela's presidency that would greatly enhance the government's ability to secure the necessary drugs in the face of an epidemic. BMS sees the lawsuit as a "separate issue." Torgeson, a spokesperson for DWB, dubs this apparent inconsistency "disingenuous" and demands that BMS drop the lawsuit immediately.
While the legal battle in South Africa wears on, Yale might consider revising its patent policy to include a "humanitarian clause" to allow Yale to cancel its obligation to a drug company if Yale deemed the firm's behavior as seriously running afoul of the "public good." Both Soderstrom and Laverty say that such a clause would certainly interfere with future investment in Yale's research program while only providing "extraordinarily subjective" protection for humanitarian interests.
Ironically, BMS still has not yet contacted DWB to inform them personally of their newest policy initiative in South Africa.
All materials © 2000 The Yale Herald, Inc., and its staff.
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