After nearly a year of dispute, UC San Francisco and Immune Response Corp. have reached an agreement that will dismiss a multimillion dollar arbitration.
The Carlsbad-based biotechnology company had filed legal action against the university after the publication of a researchers’ conclusion that an AIDS immune modulator the company developed failed to demonstrate an increase in HIV progression-free survival.
Immune Response had funded the university’s research, led by UCSF and Harvard School of Public Health researchers, on the drug Remune, which is given to boost the immune systems of HIV patients and ultimately increase their longevity of life.
The results of the three-year study, published in the Journal of the American Medical Association on Nov. 1, 2000, reported there was no significant evidence that Remune, scientifically known as HIV-1 Immunogen, reduced the amount of HIV in the bloodstream.
The agreement, signed several weeks ago, calls for Immune Response to drop its demand for the university to pay between $7 million to $10 million in lost damages and to release the final data set from the study it initially withheld from UCSF researchers.
The final data set includes information from the last follow-up on some of the 2,500 patients who participated in the study, along with access to stored blood samples.
– Counterclaim Over Publication
The agreement also calls for the University of California, which represents all universities under the UC system, to drop its counterclaim arguing that the contract between the two parties granted the university permission to publish the data.
According to statements released by the university’s public affairs department, Immune Response Corp. refused to hand over the final data set to the research team unless the researchers agreed to include additional trial results of a subset study conducted by the company.
Immune Response reportedly demanded the right to approve all publications and tried to prevent the publication of the study results.
Immune Response Corp. refused to comment for the article.
A public relations spokeswoman for the biotech company said while the company will confirm there has been a mutually agreed-upon settlement, it has no further comment on the terms of the agreement.
“We’re happy to have received the data and are pleased with the outcome,” said Christopher Patti, university counsel for the University of California.
Patti said once the two parties consented to drop the charges, it was fairly easy to come up with the terms of the agreement.
“The whole dispute sort of ended without a whimper,” he said.
Patti added that the end results of the agreement takes researchers in a positive direction that allows for more researching of drug treatments with less interference from pharmaceutical companies.
“It’s (The settlement) a good thing for the ability of a researcher to be able to continue the study of data regarding treatment of AIDS and infection (hassle free),” he said.
– Review And Analysis
With the conclusion of the study, both parties will go their separate ways. UCSF researchers, however, will continue to review and analyze the final data set.
“We’re going forward to analyze trends, but the first part of the process is verification , making sure the database given to us by Immune Response represents previous information,” said Dr. James Khan, lead author of the study and associate professor in the university’s department of medicine.
Khan said the outcome of the agreement only stands to show that the research team did everything their contract with the biotech company specified them to do.
“Immune Response did not have the right to manipulate the data and the fact that we got everything we wanted shows that the university’s views on freedom of speech and academic integrity were upheld and are the most cherished and important values of the system,” he said.
Despite the dispute, Khan said it is still important for academics and drug companies to foster friendly relationships.
“It’s still an important part for academic parties to reach out to colleagues and the (medical) industry and it’s necessary to have a good relationship between (the two),” he said.
– Sponsorships Under Scrutiny
The controversy between the university and the biotech company has shed light on the issue of how much power corporate sponsorships have over the release of research.
“This situation has brought more attention on journals and scientific issues and how they (journals) handle it,” Patti said.
According to Patti, a number of journals are instituting new editorial policies regarding the publication of research studies.
“When a company goes to an independent research company, it loses control to some extent, but also gains credibility from them,” Dr. Jeffrey Drazen, editor-in-chief of The New England Journal of Medicine and a professor of medicine at Harvard Medical School.
“We’re concerned pharmaceutical companies were trying to have it both ways, meaning having full control on both the research side as well as the sponsorship,” he said, adding that this type of control takes away from the objectivity of the research.
Drazen said the results of this high-profile case has set a precedent for researchers to have better contracts with companies and provide for more research rather than marketing of drug products.
“We hope this will help investigators brought in to look at these cases make sure they have their fair shake,” Drazen said.
