Healthy Skepticism Library item: 1085

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Publication type: news

Ackerman T.
Doctors aim to end conflicts of interest: Cancer specialists issue new guidelines
Houston Chronicle 2003 Apr 29

Full text:

Less than a year after the University of Texas M.D. Anderson Cancer
Center’s president was criticized for not disclosing his financial
interest in a drug the center was testing, the world’s leading
organization of cancer doctors Tuesday issued new guidelines to
eliminate conflicts of interest.
Under a revised ethics policy, the American Society of Clinical Oncology
will now require clinical cancer researchers to disclose virtually all
financial ties involving trial sponsors and restrict the financial
interests of principal investigators and other clinical trial leaders.
“The rationale behind the new policy is the national abuses that came to
light in recent years,” said Dr. Lowell Schnipper, chairman of the task
force that reworked the policy. “While we remain confident in the
integrity of clinical investigators, the goal of this policy is to
increase the transparency of clinical cancer research overall.”
The society also called for independent regional boards, rather than
those at each institution, to provide oversight and review of clinical
trials. Schnipper said such centralization would streamline the review
process and improve patient safety.
The task force was formed in 2000, about the same time that numerous
conflict-of-interest cases began generating national attention. In one,
a University of Pennsylvania gene therapy experiment led to the death of
an 18-year-old. And in another, patients in a trial at the Fred
Hutchinson Cancer Research Center in Seattle weren’t told of the risks
or the center’s financial interest.
Schnipper said an increasing amount of private funding and a lack of
uniform policies among institutions necessitated the policy review.
M.D. Anderson’s policy came under scrutiny last July, when it was
reported that its president, Dr. John Mendelsohn, had not told
participants in a trial of the drug Erbitux that he owned large amounts
of stock in a company sponsoring its development. Mendelsohn made $6
million on the sale of 90,000, or 20 percent, of his shares last
November.
But the new guidelines do not require that an institution disclose
financial ties by institution leaders, such as the president, if the
people aren’t involved in the trial. That was the case with Mendelsohn.
Claiming it came “completely out of the blue,” Dr. Leonard Zwelling,
M.D. Anderson’s vice president for research administration, called the
new policy “a complicated issue that requires thought.” He would not
comment on specifics of the policy.
But M.D. Anderson faculty said the new policy was nothing revolutionary.
They said M.D. Anderson’s conflict-of-interest policies already call for
what’s in the society’s policy.
The society’s policy says that researchers must disclose financial ties
including money earned through an advisory role, employment, leadership
position or expert testimony; stock ownership (except when invested in a
diversified fund not controlled by the individual); honoraria; research
funding; and any other remuneration such as trips, travel and gifts with
a value more than $100.
It prohibits trial leaders from receiving or holding stock or equity
interest in the trial sponsor; royalties or licensing fees from the
product or treatment; patents for the product; positions with the trial
sponsor; and travel or trips paid by the trial sponsor.
Society President Dr. Paul A. Bunn Jr. said the fact that only 2 percent
to 3 percent of adult cancer patients participate in clinical trials —
and a crisis of public confidence in the trial oversight system — could
slow the already-tardy approval of new drugs. He estimated there are
about 400 compounds in various stages of development.