Thursday, 4/17/97 Researchers battle manufacturer Dispute
tangles drug firm’s censorship vs. academic freedom
By Brooke Olson Daily Bruin Staff The results of a 7-year-old UC
San Francisco medical study were finally published Wednesday,
ending a long dispute between the hospital and the company that
sponsored the project. The battle has raised questions about
academic freedom and research integrity between the role of
university’s and commercial companies in developing more affordable
forms of treatment. The study shows that in treating patients with
thyroid disease, less-expensive generic drugs are just as
successful as the more expensive Synthroid, a brand-name product
that dominates the market. Knoll Pharmaceuticals Co., which
manufactures Synthroid, funded the UCSF study and then subsequently
fought to quell the results during a 7-year legal battle. The cost
savings to patients using a generic drug are substantial – up to
$356 million a year in prescription costs, according to drug
industry estimates and the study’s researchers. Published in the
Journal of the American Medical Association Tuesday, the report was
accompanied by letters from the Knoll’s chief executive arguing
that the study was flawed, even though company scientists played a
major role in the project. Knoll President Carter H. Eckert did not
return phone calls, but noted in the editorial that he believes the
UCSF study could have "significant health-care implications for
patients." But UCSF professors and researchers, as well as authors
of the journal conclude that the study was meticulously conducted.
"Every single one of (Knoll’s) objections was looked at carefully
and found to be trivial," said Dr. Drummon Rennie of UCSF’s
Institute for Health Policy Studies and deputy editor of the
medical association journal. "All sorts of good people at the
university had a good look at the study and they all agreed that it
was done very well," Rennie added. Other UCSF officials, including
Dr. Betty J. Dong, principal researcher for the project, declined
to comment on the articles or on the controversy. "We have said
consistently for the last few days that we prefer to let the
publication material serve as the university statement concerning
all of this," said Bill Gordon, spokesperson for UCSF. "Our
position has just been that given the long history of this we would
just rather let the publication serve as our comment." The study
could have a huge affect, especially in states where HMOs are
prevalent, experts said. "In the setting of cost containment, this
is something that is going to have an impact," said Dr. Andre J.
Van Herley, a UCLA medical professor, in an interview with the Los
Angeles Times. "HMOs themselves can make a decision and issue a
warning to physicians to use only the generic versions." According
to officials for the Food and Drug Administration, Synthroid had
come to control 85 percent of the $600 million a year market. Many
medical experts believe that Knoll attempted to conceal the data in
fear that the information would topple their market position.
"Obviously they wished to protect their sales … otherwise they
wouldn’t have gone to such extreme lengths for such an
extraordinarily long time to keep the data a secret," Rennie said.
Knoll officials refused to comment. Knoll’s censorship of
scientific information was a major assault on academic freedom,
said experts involved in the dispute. And the censorship has
renewed concerns that dangerous problems can arise when academic
research – particularly in medical science – is sponsored by
companies that have a financial stake in the outcome. "The purpose
of knowledge is not to put it into a safe and keep it away from the
people who could most benefit from data," Rennie said. According to
the UC Contract and Grant Manual, "freedom to publish is
fundamental to the university and is a major criterion of the
appropriateness of a research project." But Dong had signed a
contract in 1987 with the drug firm’s predecessor company that
barred her from making her results public without permission from
the firm. University counsel consulted by Dong advised her that
without permission from the firm, the researcher could be
reproached for breach of contract, according to editorials
published in the medical association journal. After Knoll’s
pressure tactics were revealed in the Wall Street Journal and the
San Francisco Chronicle, the U.S. Food and Drug Administration
intervened. The drug company and UCSF officials finally agreed to
let Dong submit her research report to the medical journal. UCLA
medical officials noted that it was highly unlikely that research
conducted at this university would be concealed. "To the best of my
knowledge I’ve not heard of any similar incident here at UCLA,"
said Kumar Patel, vice chancellor of research. "I very strongly
believe in the university being an open environment and we have
specific contracts which do not give any funding organization the
right to suppress results." A separate study published in the
medical journal notes that this case, although it was taken to the
extreme, is not unique. Research findings in the life sciences are
withheld periodically, more often among the most productive and
entrepreneurial faculty, determined Dr. David Blumenthal, from
Massachusetts General Hospital, as well as colleagues from the
Harvard Medical School. Nearly 20 percent of 2,167 researchers
surveyed said they had their research results delayed by more than
six months in the last three years. But none of the interferences
were as extreme as Knoll’s obstruction, Rennie said, noting that
the drug company’s behavior was "highly unusual." The dispute
serves as an example of the tentative relationship that exists
between researchers and commercial companies – two partners with
often two very different ideals, Renning said. "I think researchers
and university people everywhere should realize that when they get
into a partnership … with a commercial company, it’s likely that
the agendas are going to be very, very different," Rennie said.
"There are always going to be people who want knowledge to be out
there so patients and physician’s can make their judgements based
on public knowledge … but there are also some who are merely
trying to protect their economic security." University of
California, San Francisco Knoll Pharmaceutical Company