Yale University is under growing pressure from its students to put conscience before profit and allow an Aids drug invented in its laboratories to be made affordable to millions of sufferers in developing countries.
Yale earns $40m a year in licence fees for the drug, d4T, but the university administration insists its hands are tied by an agreement signed with Bristol-Myers Squibb giving the giant pharmaceutical company exclusive manufacturing rights.
However, the university has so far refused to publish the agreement, outraging Yale students who say they do not want to be part of an institution complicit in denying essential medication to the poor.
An Indian drug producer has offered to produce d4T, an antiretroviral treatment otherwise known as stavudine or by its brand name Zerit, at a thirty-fourth of the price charged by Bristol-Myers Squibb, which would put it in range of hard-hit health systems in sub-Saharan Africa.
The case has highlighted the growing tension in US universities between their identity as icons of academic independence on one hand and wealthy "profit centres" for corporate sponsors on the other. Yale received a $250,000 donation from Bristol-Myers Squibb three years ago, and there are other close ties between research staff members and the pharmaceutical industry.
Most of the academic staff interviewed by the Guardian asked not to be quoted by name, saying the issue was too sensitive within Yale's administration. But the drug's inventor, Professor William Prusoff, now semi-retired, expressed support for a student campaign to make his discovery more affordable.
Some Yale law students have formed a pressure group aimed at shaming the university into taking greater responsibility for the social impact of the inventions it licenses for profit. The group, the Yale Aids Action Coalition, announced its first victory yesterday, an offer of a meeting from Yale's Office for Cooperative Research (OCR), in charge of patents.
One of the student group's founder members, Amy Kapczynski, said it was still not clear whether the OCR would relent from its earlier refusal to make available a copy of the Bristol-Myers agreement.
"We really hope they would give us a chance to look at this in a creative manner," Ms Kapczynski said. "There are probably things Yale can do to be a model actor in this situation."
The managing director of Yale OCR, Jon Soderstrom, issued a statement to say the university's hands were tied when it came to granting permission to other companies to produce d4T.
"Although Yale is indeed the patent holder, Yale has granted an exclusive licence to Bristol-Myers Squibb, under the terms of which only that entity may respond to a request," he said.
However, the students argue there is a lot more the university could do. They are backed by Prof Prusoff. Although he shares in Yale's Bristol-Myers royalties, Prof Prusoff has called on the company to make the drug affordable in poor countries.
"One of the things that should be done is that the pharmaceutical firms should reduce their prices and the industrialised nations, the US, Britain, France and Germany should give the WHO (the World Health Organisation) a certain amount of money to distribute to countries where the medication is needed."
The students have also allied themselves with the French-based medical aid agency, Medecins Sans Frontieres (MSF), which is spearheading a campaign to force the pharmaceutical industry into relaxing their patent rights and allowing generic forms of Aids drugs to be marketed.
In a letter to Mr Soderstrom on Friday, MSF pointed out that in Yale's own patent policy guidelines published in 1998, the university sought to pursue "the benefit of society in general" and to draw up li cencing agreements with manufacturers to "protect against failure of the licensee to carry out effective development and marketing within a specified time period."
Toby Kasper, who runs the MSF campaign for cheaper medicines in South Africa, said yesterday: "If the university says their hands are tied, they are violating their own policy."
Mr Kasper also said the university had the right to breach the terms of its Bristol-Myers Squibb licence, allowing the production of generic versions of d4T, and pay damages to the company. Those damages, he said, would only be a small fraction of the $40m Yale makes from the patent, as sales of all drugs in the same class of antiretrovirals in South Africa only amounted to $600,000.
Ms Kapczynski said the next steps taken by the Yale Aids Action Coalition would depend on the outcome of its meeting with Mr Soderstrom at the OCR. But she added that there was a groundswell among students over the issue.
"I've been amazed at how big this issue is among students in general," she said.
A university professor, a member of a university board which oversees the granting of patents but who supports the students aims, said that if Yale had sold its freedom of action to Bristol-Myers Squibb, it had made a mistake.
"There is the question of what Yale can do now, and the question of what Yale should have done at the time, and why we shouldn't tie our hands in future," he said.
Benefits and drawbacks
The west has brought the HIV virus under control by using combinations of powerful and relatively toxic drugs, writes Sarah Boseley. The first of these invented was AZT, now a class of drugs known as nucleoside reverse transcriptase inhibitors.
The drug invented at Yale - d4T or stavudine, which Bristol-Myers Squibb gave the brand name of Zerit - is in the same class as AZT. Both are now well-established drugs in the treatment of HIV/Aids and in terms of western Aids medicine, on the old side.
In the west, people used to be given a combination of two drugs, but now are given what is known as highly active antiretroviral therapy, or Haart, a cocktail of three medicines. Two of them are nucleoside reverse transcriptase inhibitors, like d4T, and the other is usually a protease inhibitor.
Drugs will not rid the body of the virus, but they can keep down the viral load and stop it damaging the immune system. One of the big problems with this virus is that it mutates very quickly and easily if the drugs being taken are insufficient to keep the viral load low. So a constant level of drug must be maintained in the body, which means the medicines must be taken at the right time of day and in the right dose, or there is a danger that the virus in the body will develop resistance.
When that happens in the west, the combination of drugs can usually be changed, but the pharmaceutical industry is constantly trying to develop new drugs to get ahead of the mutating virus. If d4T were available,and used in combination with other basic Aids drugs in Africa, there is little doubt the patients getting them would have no second chance if the treatment failed.
© Guardian Newspapers Limited 2001