San Francisco Examiner - November 1, 2000
Ulysses Torassa, Examiner Medical Writer

It's the second time in recent years that a company that paid for research conducted at UCSF has sought to keep control over how - or if - it is made public. The action comes in the midst of concern about the growing influence of corporate money on university research.

In the latest case, Immune Response Corp. of Carlsbad, San Diego County, wanted to have what a spokeswoman called a more "meaningful and detailed" analysis of the data on its drug Remune included in an article published by UCSF scientist James Kahn and colleagues.

When the researchers balked, Immune Response Corp. in September filed for arbitration against Kahn and the university seeking $7 million to $10 million.

Results of the Remune study are being published in Wednesday's edition of the Journal of the American Medical Association, along with editorials warning about the growing involvement of drug companies in medicine and university research.

Remune is a vaccine-like drug that is supposed to help the body's immune system fight HIV. But the study found that those who took it along with anti-retroviral drugs did not live longer or develop AIDS more slowly than those who didn't include it in their drug regimen.

The case is reminiscent of the controversy surrounding UCSF researcher Betty Dong, who was locked in a seven-year battle with drug maker Knoll Pharmaceutical Co. over publication of her study that found a competitor's cheaper drug just as effective as Knoll's thyroid medicine.

In that case, Dong had signed an agreement that allowed the company to block publication of the results, contrary to UCSF policy.

Drummond Rennie of UCSF's Institute for Health Policy Studies and an editor at JAMA, helped bring Dong's study to eventual publication in 1997. He was also a driving force in getting the Remune study published in the journal.

'People have a right to know'

"Negative results are just as important as positive ones, and people have a right to know," Rennie said. "We're in the business of making things plain to patients and doctors. If they've got contrary results, which they've never yet produced, let them publish them."

The Remune study, among the largest randomized HIV drug tests ever, began in 1995 and enrolled 2,500 patients from 77 medical centers. Immune Response spent between $30 million and $50 million to underwrite the research, according to spokeswoman Laura Hansen.

Last year, an oversight group of scientists and ethicists recommended halting the study, concluding there was little evidence of a positive effect from Remune.

The company agreed, but emphasized in a press release that patients in a more intensively studied sub-group of 252 patients seemed to have somewhat a less virus in their bloodstream and more disease-fighting immune cells after taking the drug.

Immune Response said it had wanted Kahn's article to include details from the sub-group. Those results were in the article, but were not analyzed the way the company wanted them to be, Kahn said.

Kahn called the company's conclusions regarding the sub-group overblown. He said Immune Response had reached its conclusions by analyzing the data in a way that was not called for in the original study design. He called their attempt "data dredging," in which researchers go back over their data and slice the numbers to come up with a positive outcome.

'Spin control'

"When the study proved to be negative, they scrambled to do spin control," Kahn said. "It's a shame they are putting their product ahead of patients here."

The company said it had taken legal action against Kahn because it believes that all parties, including the doctors at the participating medical centers, should have input and agree on the final article.

"Dr. Kahn can publish whatever he wants from his clinical site, but he has to reach some consensus from the clinical trial investigators" if he includes data from their sites, Hansen said.

Christopher Patti, an attorney in the UC general counsel's office, called the company's legal claim fanciful. UC has filed a counterclaim, seeking to force Immune Response to turn over data from the end of the study so that they can be included when the final analysis is written.

In a letter sent to Kahn and his colleagues earlier this year, the company said it would hand over the data only if the researchers agreed to give Immune Response final approval over any publication.

In September, Immune Response Corp. and its partner, Agouron Pharmaceuticals, launched a new set of clinical trials of Remune, this time with a different study design.

'Don't make a thing of it'

Rennie said the controversy over the Remune results is a very public and extreme example of what can go wrong with industry-sponsored academic research. More common than a formal legal challenge, he said, is the subtle pressure that scientists feel to forgo publishing findings that aren't favorable to whoever paid for the research.

"A lot of researchers have told me this, 'You don't make a thing of it, and you just go on with your life, and you hope you get money from the company again,' " Rennie said. "You don't want to p--- off your sponsors."

Even more worrisome to many in the medical establishment is a growing trend of researchers' building personal financial relationships with the companies sponsoring the research.

In Wednesday's issue of JAMA, an analysis of disclosure forms filed by UCSF researchers found that 7.6 percent of them have financial ties to companies that paid for their research. Of those, about a third received speaking fees, a third did consulting work and a third had paid roles on advisory boards or boards of directors.

California has stricter reporting guidelines than many states. Another article in the latest JAMA reported that few U.S. academic institutions have clear policies about what kinds of relationships are permitted between research sponsors and scientists.

Catherine DeAngelis, JAMA's editor, and David Korn of the Association of American Medical Colleges, wrote in separate editorials that greater safeguards are needed to protect the integrity of scientific research.

Without them, universities and academic researchers "are in grave danger of losing the support and respect of the public," DeAngelis wrote.

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