Doctors aim to end conflicts of interest

Cancer specialists issue new guidelines

By TODD ACKERMAN
Copyright 2003 Houston Chronicle Medical Writer

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.