Firm That Paid for UCSF Study Seeks Damages
Furious at report that AIDS drug came up short
Sabin Russell, Chronicle Staff Writer
Wednesday, November 1, 2000
©2000 San Francisco Chronicle
URL: sfgate.com
A Southern California drugmaker is seeking millions in damages from the University of California at San Francisco after university
researchers insisted on publishing a report showing that the company's experimental AIDS drug did not work as planned.
The dispute has spilled over into a national debate about the inherent conflicts of interest found in the financial web tying private business to
independent university research.
Immune Response Corp. of Carlsbad, San Diego County, initially attempted to block UCSF researchers from publishing data in the Journal
of the American Medical Association showing that the company's AIDS drug, Remune, failed to slow the progression of AIDS in a test
involving 2,500 patients.
The report is being published intact, however, in today's issue of the prestigious medical journal, along with a series of articles commenting
on the report and looking at unrelated conflict of interest issues.
``Our decision to publish this study is based on the belief that the integrity of the research process must be protected and preserved,'' wrote
the journal's editor, Dr. Catherine DeAngelis, in an editorial accompanying the piece.
Dr. James Kahn, a UCSF AIDS clinician who was principal investigator for the drug trial, said the drug company was attempting to force
its own spin on some bad news. ``The question we posed in the study is, `Does it work?' and the answer is, `No, it does not,' '' he said.
``There is no ambiguity here.''
Immune Response maintains that UCSF improperly used its data and published its report based on incomplete information. It is seeking
between $7 million and $10 million through an arbitration proceeding that could be resolved in several months.
Company executives concede that their drug did not work in the two-year clinical trial, but they contend that Kahn is ignoring findings
within that same study suggesting that Remune was having a beneficial effect that could be proven over time.
Remune was developed originally by the late Dr. Jonas Salk, inventor of the polio vaccine. Made from killed copies of a strain of the AIDS
virus, the drug was designed to stimulate the immune system of patients already infected with the virus.
At issue is an Immune Response analysis of data on 10 percent of the patients whose blood was tested more frequently. The company
contends those results show the drug reduced the level of virus in patients' blood -- which other research depicts as closely correlated with
better health.
``The crux of the matter is that we wanted this 250 patient cohort included,'' said Dennis Carlo, Immune Response's president and chief
executive.
Kahn said that the data from the 250 patients was included in his report, but his analysis of it showed there was no significant effect. ``Here
is a company manipulating data to try to have a positive outcome,'' Kahn said. He described it as a well-known tactic known in research
circles as ``data dredging.''
The major findings of the study -- that Remune did not halt the progression of HIV infection to AIDS or reduce AIDS deaths -- have been
known since a review board halted the clinical trial in May 1999, more than two years after it began. A peek at interim data showed the drug
was not working.
The dispute with Kahn broke out shortly afterward, when the company put out a press release which stressed the findings of the smaller
cohort. Kahn strongly disagreed with the company's optimistic spin, and relations with Immune Response deteriorated to the point where he
said the company would no longer share information with him.
``Like a bully in a sandbox, they pulled their data and said, `We're outta here,' '' he said.
Some investigators who worked on the Immune Response trial say, however, that it is the UCSF researcher who is being heavy-handed.
``I am stunned. I was floored when I found out they were coming out with a paper about which I knew nothing,'' said Dr. John Turner, a
Philadelphia AIDS clinician who said he enrolled the largest number of patients in the trial. Turner said Kahn never shared his manuscript
with him.
Turner said he believes the data on the smaller cohort clearly show some important effects.
``You don't selectively report something to make a drug look ineffective,'' Turner said. ``I'd hate to feel that was done here, but there's not
much of any other way to interpret it.''
Editors at the medical journal are siding with UCSF, contending that such interference violates the independence of academic research.
``We thought it was good work, and very important to have published,'' said Dr. Drummond Rennie, a professor at the UCSF Institute for
Health Policy Studies and also a deputy editor of the medical journal.
Rennie said it is the ``duty'' of academics to publish the results of their research, whether they are positive or negative. ``If things come out
badly, you've got to publish it. That's just life,'' he said.
Kahn's study is accompanied by several articles in today's issue of the medical journal that focus on the question of conflict of interest in
academic research. Rennie himself is the co-author of one report, which examined written conflict of interest policies at 89 institutions
which receive the highest amount of funding from the National Institutes of Health.
Rennie's study found ``wide variation'' in the policies of those institutions. ``Most lack specificity about the kinds of relationships with
industry that are permitted or prohibited,'' he said. ``When you just say academics should do good, that isn't good enough.''
Only 55 percent of the institutions studied required conflict of interest disclosures of all faculty, while the rest required disclosures only of
principal investigators or those conducting research.
Another report in the journal, authored by UCSF Institute of Health Policy researchers Elizabeth Boyd and Lisa Bero, made a case study of
UCSF's own conflict of interest policies. It found that in 1999, 7.6 percent of faculty investigators reported personal financial ties with
sponsors of their research, compared to 2.6 percent in 1985.
The financial ties varied widely. One third of those disclosing ties during a 20-year period (1980-1999) involved income from speaking
fees, which ranged from $250 to $20,000 per year. Another third had consulting contracts that paid between $1,000 and $120,000 per year.
The remaining third held positions on the board of directors, or scientific advisory boards, of the sponsoring companies.
One in seven researchers reported holding stock in the sponsoring companies, and 12 percent had more than one financial relationship with
the sponsors.
Author Bero said that 26 percent of conflicts of interest at UCSF were deemed significant enough to require university intervention, such as
requiring the investigator to sell stock, refuse additional payment for speeches, resign from a board, or require that the sponsor name a
different principal investigator. |
