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Administration News | Los Angeles Times Examines Conflict-of-

Interest Concerns Related to National Cancer Institute Researcher

[Jul 17, 2006]

The Los Angeles Times on Sunday examined conflict-of-interest

concerns related to a National Cancer Institute researcher and FDA

approval of two medications for severe invasive fungal infections.

Walsh, head of a medical research and treatment section

within the pediatric division of NCI, helped " design, oversee and

interpret " clinical trials of Cancidas, manufactured by Merck, and

AmBisome, manufactured by Fujisawa. According to the Times, some

researchers have raised concerns that the trials " artificially

boosted the new products by comparing them to drugs that were given

at doses that were too low. " Walsh has accepted consulting fees from

Merck and donations for research from Merck and Fujisawa. In

addition, Merck in 2001 called Walsh as a witness as part of a

presentation of the results of the Cancidas trial to an FDA advisory

committee. Walsh testified for Merck, although " U.S. law generally

prohibits a federal employee from representing an outside party

before a government agency, " the Times reports. Fujisawa in 1997

also called Walsh as a witness to an FDA advisory committee as part

of a presentation of the results of the AmBisome trial. According to

the Times, the " full extent of Walsh's ties with industry is not

open to view by outsiders " and is exempt from release under the

Freedom of Information Act (Willman [1], Los Angeles Times, 7/16).

Merck spokesperson Loder said that the company paid

Walsh fees of $2,000 in 1999 and $1,000 in 2001 for his

participation in " Merck meetings " but did not pay him to help

develop Cancidas (Willman [2], Los Angeles Times, 7/16).

Reaction

Walsh said he has testified before FDA advisory committees only as

an NCI researcher, adding, " I am not and have never been a

representative of, or advocate for, any pharmaceutical company. " He

said, " There is no conflict of interest, and the trials were well

and appropriately designed. " Walsh said his position " frequently

includes collaboration with companies that research and develop new

compounds " for the treatment of " life-threatening infections in

children and adults with cancer. " Three NCI officials who supervise

Walsh and seven researchers who participated in the Cancidas trial

or the AmBisome trial said that the results were scientifically

sound. NIH Director Elias Zerhouni in a statement said, " We revamped

our rules last year and continue to carry out a vigorous program of

education, oversight and enforcement. Violations of the ethics rules

are unacceptable, and I remain determined to pursue any information

brought to my attention. " Curt Furberg, former head of clinical

research for the National Heart, Lung and Blood Institute and a

professor at Wake Forest University, said, " I can see why the

companies are eager to get an easy comparison, a drug they can

beat. " Furberg added, " When you set up studies with controversial

comparisons, you risk misleading everybody -- regulatory agencies,

physicians and patients " (Willman [1], Los Angeles Times, 7/16).