The source of this article is ScienceDaily: http://tinyurl.com/cze26

Survey: Drug companies influence studies
By STEVE MITCHELL
WASHINGTON, May 25 (UPI) -- A survey released Wednesday indicates many
university medical schools permit the pharmaceutical industry to influence
what gets published from industry-sponsored drug studies.

The findings raise concern because the industry provides 70 percent of
clinical drug trial funding in the United States and the potential of
pharmaceutical companies to withhold negative study results can have
devastating consequences.

"Partnerships between industry sponsors and academia are absolutely
essential to the advancement of medical science, and the public benefits
incalculably from them, but these relationships have to be carefully
managed to avoid problems," Michelle Mello of Harvard University, the
study's lead author, said in a statement.

"Further dialogue about how to structure them would be helpful in balancing
sponsors' needs against investigators' academic freedom and the public's
interest," Mello added. Her study appears in the May 26 issue of The New
England Journal of Medicine.

Dr. Peter Lurie, of the watchdog group Public Citizen in Washington, said
he is concerned patching up the gaps in academia will only shift the
problem to private companies, called contract research organizations or
CROs, that conduct research on behalf of the drug industry.

CROs may have less incentive to publish studies than academic researchers
and may be more likely to bury negative results, Lurie told United Press
International.

"Really, what we're facing here is a race to the ethical bottom," Lurie
said. "Absent national standards that apply to all of academia and private
companies, the temptation to engage in that race will always be there."

"The article discusses hypotheticals rather than reality," said Ken
Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of
America, or PhRMA, a trade group representing the industry.

Johnson told UPI that PhRMA has established principles for conducting drug
studies with university researchers. The principles stipulate "sponsors
have a right to review manuscripts, but ... not to suppress or veto
publications" in journals.

The principles also "indicate sponsors of studies typically own the
database of results of the trial, but agree to make the information
available to clinical investigators or authors," he said.

However, in two recent incidents -- the removal of Vioxx from the market
because of cardiovascular risks and the use of anti-depressants in children
-- there were allegations drug manufacturers did withhold data from
academic researchers that indicated there were safety problems.

In the new study, Mello and her colleagues sent 107 university medical
centers questionnaires about their policies for conducting research
sponsored by industry. They found more than 85 percent of medical centers
said they would not allow industry sponsors to revise manuscripts for
publication in journals or give them the authority to decide whether
results of a study should be published.

Some of the centers said they did allow industry significant control over
the handling of research results. For example, 24 percent said they
permitted industry sponsors to insert their own statistical analyses in
manuscripts, and half said they permitted industry personnel to draft the
manuscript. About 41 percent said they allowed industry to prohibit
investigators from sharing research results with third parties.

The influence of industry over what gets published has long been a concern
-- even before the problems surrounding Vioxx and anti-depressants gained
nationwide publicity.

The issue received national attention in the 1990s when Boots Co., which
later became Knoll Pharmaceutical, reportedly tried to suppress publication
of a study it funded at the University of California, San Francisco. The
study showed its thyroid drug was no better than three other competing
generic drugs.

Knoll eventually settled out of court, agreeing to pay $135 million, but
Betty Dong, the UCSF researcher who conducted the Knoll study, estimated
$356 million would have been saved annually if consumers had been
prescribed the cheaper generic drugs.

In 2001, 11 medical journals began requiring principal authors of studies
to state in writing they had full access to the data and they alone made
the decision to publish.

"In 2005, has anything changed?" Dr. Robert Steinbrook, a national
correspondent for the New England Journal of Medicine wrote in an
accompanying perspective. "The short answer is no."

Steinbrook noted that Congress and the medical community have begun to take
notice of the situation. Several medical organizations have embarked on
efforts to standardize clinical-trial agreements between industry and
academia. The Fair Access to Clinical Trials Act of 2005, introduced in the
Senate last February, would make it illegal for industry and academic
researchers to engage in agreements that limit or prohibit the publication
of study results.

The proposed law, however, has not gained much momentum in Congress and, in
the meantime, there are signs that industry may be shifting its research to
CROs, Steinbrook wrote.

Industry funding of trials at CROs increased from $1.6 billion in 1994 to
$7.6 billion in 2004.

Steve Mitchell is UPI's Medical Correspondent. E-mail: [log in to unmask]

Copyright 2005 by United Press International. All Rights Reserved.

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