kathi

From Oncology Issues
The Conflict of Financial Interests in Clinical Trials
Posted 10/01/2003
Susan W. Berson, J.D.

To advance scientific discovery and expedite the development of new
treatments, many researchers accept funding from private industry
(usually biotechnology and pharmaceutical). The drawback is that these
"partnerships" create complex relationships involving researchers,
private industry, and academic institutions. Some of these relationships
have raised serious concerns about conflicts of interest and liability
for errors, omissions, or adverse outcomes.

Over the last few years, a number of research studies failed to disclose
investigators' and institutions' financial stakes, often in cases where
the research has led to death or serious injury. The attention given in
these high-profile cases has brought about a number of legislative,
regulatory, and private-sector initiatives to address the issue of
conflict of interest in clinical trials. Some in the industry even
believe that disclosure alone is no longer an adequate safeguard for
conflicts of interest in clinical trials.

In what many consider to be the "granddaddy" of cases relating to
possible conflicts of interest in clinical trials, the California
Supreme Court held that researchers did not have an obligation to
disclose their significant monetary gain. In this case, the researchers
had realized significant profit by creating and patenting a distinct
cell line from a leukemia patient's spleen. (The spleen had been removed
to slow the progress of the cancer.) The court made this ruling despite
steps taken by the researchers to hide their research and commercial
activities from the patient. The researchers even went so far as to
require the patient to fly to California for several follow-up visits
under the guise of treatment.

The court also ruled that the patient had no property interest in the
cell line and no right to the significant monetary gain realized by the
researchers. [See Moore v. Regents of the University of California, 79 3
P.2d 479 (Cal. 1990), cert. denied, 499 U.S. 936 (1991).] The court
stated that the patient's interests had to be balanced with the need for
innovative research and that the appropriate balance could be achieved
by strengthening disclosure obligations. "So long as a physician
discloses research and economic interests that may affect his judgment
and the elimination of potential conflicts in certain instances, the
patient is protected from conflicts of interest."

In another high-profile case, the family of a teenager who died as a
result of participating in a clinical trial involving gene therapy sued
the University of Pennsylvania. The case was at least partly based on
the discovery that the trial's principal investigator had a significant
owner-ship interest in the company whose drug was being tested and that
the university also stood to benefit financially from the research, if
the trial was successful. (On a separate note, the study had grossly
underreported serious side effects from the trial.) Settled for an
undisclosed sum, the case received great publicity because it
highlighted the potential problems that exist when a researcher is
motivated by more than the desire to advance science. (See, Gelsinger v.
University of Pennsylvania.)

Although conflict of interest regulations currently mandate certain
significant financial interests be disclosed under some circumstances,
several initiatives being considered by the government and other
organizations call for much stricter over-sight of potential conflicts
in clinical trials. These new guidelines aim to be more explicit about
disclosure of financial interests and seek to identify scenarios where
these interests may create potential conflicts in clinical trials.
Congress has even tried to introduce legislation that would require
financial interest disclosures and impose additional requirements on the
institutional review boards that review clinical trials for, among other
issues, financial interests. While the legislation has not advanced,
further proposals are expected.

Most recently, two sets of guidelines have been published regarding
financial conflicts of interest. One is by the Department of Health and
Human Services and the other is by the American Society of Clinical
Oncology (ASCO). Both guidelines focus on disclosure and review of
financial interests, and the ASCO guidelines even recommend that certain
financial interests and circumstances simply should not exist. While
these policies go beyond the current requirements of disclosure of
financial interests in research, they also establish a new standard for
research that may be used in the future to assert liability for poor
outcomes.

These initiatives demonstrate the attention being paid to the issue of
clinical trials and conflict of interest. Maybe most importantly, these
legislative and regulatory actions send a strong message that the need
for innovative, cutting-edge research will not come at the cost of
endangering the safety or the lives of the human volunteers
participating in such studies.

Susan W. Berson, J.D., is a partner with the Washington, D.C., law firm
of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Oncology Issues 18(4):18, 2003. © 2003 Association of Community Cancer
Centers

http://www.medscape.com/viewarticle/461984?mpid=19481