NIH Scientist Accused Of Misconduct

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NIH Scientist Accused Of Misconduct

TheDay - New London,CT

By Los Times, Willman

http://www.theday.com/re.aspx?re=62c019be-a7fc-43fe-bf8e-

629e742d088f

Published on 9/10/2006 in Health & Science

Washington — A senior researcher at the National Institutes of

Health engaged in " serious misconduct " by entering into dozens of

unauthorized private arrangements with drug companies and failing to

report annually the outside income, totaling more than $100,000, a

confidential internal review by the agency has found.

Officials at the NIH concluded late last year that the actions of

Dr. J. Walsh, who has helped lead major clinical trials

involving cancer patients, might result in dismissal from federal

government service. No disciplinary action has been taken.

The internal review, conducted by lawyers and other ethics

specialists within the office of the NIH director, found that from

1999 to 2004, Walsh received fees totaling $100,970 from

pharmaceutical and biotechnology companies. He accepted fees from 25

companies and has led government-sponsored research involving some

of those companies' drugs.

" Dr. Walsh has engaged in serious misconduct, in violation of the

Department's Standards of Conduct Regulations ... and federal law

and regulation, " the review concluded.

The previously unreported findings shed light on the depth of

conflict-of-interest problems that have persisted at the NIH — the

government's preeminent agency for medical research on humans. The

NIH's handling of disciplinary decisions related to Walsh and other

senior scientists is expected to be a focus of a congressional

hearing scheduled for Tuesday.

In written comments to NIH ethics officials, private attorneys for

Walsh said that the agency's rules were complicated and that his

motives were beyond reproach. NIH officials said the rules were well

known and should have been followed.

" Dr. Walsh fails to acknowledge that the reason for the " complex set

of rules' governing NIH staff in regards to real or potential

conflicts of interest is to prevent the integrity of the agency and

its science from being called into question, " the summary read. " His

assertions that his reputation is sufficient to dismiss any

questions about his impartiality cannot be the standard that he or

the agency use in deciding to adhere to well-publicized rules. "

The summary, dated in December, also said that Walsh's " conduct

continued over time and involved at least 38 separate instances

where he chose not to follow agency procedures. He actively chose

not to adhere to policies because it was inconvenient or time-

consuming; he knew it was likely his participation (with the drug

companies) would have been disapproved. His actions reflected

negatively upon the agency. "

The Los Angeles Times obtained copies of the internal findings and

conclusions last week. Based on interviews and documents gathered

earlier, the newspaper reported in July that Walsh had appeared

alongside company representatives at public and private meetings

held by the U.S. Food and Drug Administration and that he received

fees from Merck & Co. and Pfizer Inc., with whom he has collaborated

in his government work. Clinical trials he helped lead influenced

FDA approvals of four antifungal drugs.

Walsh's appearances at the FDA meetings — with representatives of

Merck, Pfizer Inc., and Fujisawa USA Inc. — are the subject of a

newly opened inquiry by the NIH director's Office of Management

Assessment, according to people familiar with the matter.

U.S. conflict-of-interest law generally prohibits a federal employee

from representing an outside party before a government agency,

regardless of whether the employee accepts payment for the

appearance.

Another NIH review, which ended three months ago, " did not identify

issues of concern with the design or methodology " used in two

clinical trials overseen by Walsh. When results of those trials were

published, in 1999 and 2004, other research physicians had

questioned in letters to the New England Journal of Medicine whether

cancer patients with suspected fungal infections were

given " control " drugs at dosages that were strong enough to be

effective.

Reached briefly by phone on Friday, Walsh referred questions to NIH

press aides. He earlier declined to answer questions from The Times

regarding details of his arrangements with several companies, but

also said that he had never served as a representative or advocate

for any pharmaceutical company.

At Tuesday's hearing, members of the House Energy and Commerce

Committee's investigative subcommittee are expected to question

officials about their handling of ethics matters, including the

cases of Walsh and another senior NIH researcher, Dr. P. Trey

Sunderland III.

Sunderland, who has specialized in researching Alzheimer's disease,

accepted hundreds of thousands of dollars in drug-company fees —

including about $612,000 from Pfizer — without obtaining required

advance approval. In June, Sunderland asserted his Fifth Amendment

right against self-incrimination while declining to answer questions

before the congressional subcommittee.

Neither Sunderland nor Walsh has been disciplined publicly, and each

maintains his senior government position. Directly or through their

lawyers, Sunderland and Walsh have said that they aimed to advance

research that benefits patients. Both have worked for more than 20

years at the NIH as members of the U.S. Public Health Service

Commissioned Corps, a uniformed branch of the service that is led by

the surgeon general.

Officials at the NIH have said recently that they lack authority to

discipline members of the corps — several of whose members have

drawn scrutiny related to conflicts of interest.

The summary of the NIH internal report on Walsh noted, implicitly,

his status within the corps: " It has been determined by the Office

of Human Resources (at NIH) that if he were a civilian employee, his

actions would lead to a recommendation for his proposed removal. "

The Bush administration official that oversees the surgeon general

and the corps, Assistant Secretary for Health O. Agwunobi, said

through an aide that he could not discuss details of the pending

cases because of privacy concerns.

" The commissioned corps is very concerned about these allegations

and will take appropriate action should wrongdoing be found, " said

Pearson, a Health and Human Services Department

spokeswoman. " However, our review must be coordinated with other

reviews already in process. "

Walsh was referred to a corps administrator nine months ago " for

action " by a deputy NIH director, Dr. Raynard S. Kington, and by Dr.

Niederhuber, the then-acting director of the National Cancer

Institute.

Walsh, 54, a medical graduate of s Hopkins University, arrived

at the National Cancer Institute in 1986 and now heads a pediatric

research and treatment unit. Walsh is well recognized in his field

and has won government honors. Along the way, he collaborated with

drug companies in his official role and, privately, as a paid

adviser or speaker.

The industry compensation received by Walsh and Sunderland came to

light because of a series of events over the past three years: After

the Los Angeles Times reported in December 2003 that ranking NIH

officials had received hundreds of company consulting payments or

grants of stock or stock options, the House committee asked the

agency to disclose all such transactions over a five-year period.

When the NIH was slow to respond to the committee's broad request,

lawmakers elicited the information from 21 drug companies.

The companies' responses identified scores of NIH researchers who

were not known previously to have received payments. One company,

Merck, listed fees to Walsh that had not been reported to the NIH.

Meanwhile, NIH Director Elias A. Zerhouni also was urging employees

to report any previously undisclosed outside arrangements.

For Walsh, the first questions from NIH ethics officials centered on

his arrangements with Merck. The NIH's internal review found that,

at the same time Walsh accepted $3,000 in fees for attending

separate Merck-sponsored events in 2000 and 2001, he was leading a

formal " cooperative research and development agreement " between

Merck and the National Cancer Institute.

Months before his case was referred for possible disciplinary

action, the NIH ethics review panel concluded privately that Walsh

should not have engaged in the simultaneous, government and paid

arrangements with Merck.

" The review panel finds that the scientific subject matter of the

activities overlap directly with Dr. Walsh's research at NIH, " the

agency's chief ethics lawyer, Holli Beckerman Jaffe, wrote in June

2005.

" In addition, while Dr. Walsh was a paid speaker for Merck on two

occasions, he was collaborating with Merck, and one of its

competitors, in his official capacity, " Jaffe said. " Accordingly,

the panel finds his unapproved outside activities with Merck to be

highly problematic. "

A subsequent summary of the NIH's internal review added, " This

situation is one in which a reasonable person could question Dr.

Walsh's impartiality. "

The new documents show that when Merck paid Walsh a $2,000 fee in

September 2000, it was to discuss the company's new antifungal drug,

Cancidas, at a company-sponsored meeting with medical-opinion

leaders in Montreal.

Four months later, Merck identified Walsh as a consultant at an FDA

advisory committee meeting at which the company made its case for

the drug's approval.

Walsh told the FDA committee on Jan. 10, 2001, that, based on his

and his government staff's review of data from a Merck study,

Cancidas effectively combats a fungal infection called aspergillus.

The committee unanimously recommended approval.

Later that month, FDA staff approved Merck's application to market

Cancidas. Through 2005, the drug had generated $859 million in U.S.

sales.

And, in the months leading up to an October 2001 FDA advisory

committee meeting on Pfizer's antifungal drug, Walsh received

$12,000 in fees for conferring three times with company

representatives, the internal NIH documents show.

Walsh's lawyers have said in letters to NIH officials that his

government decisions were not swayed by the compensation from Merck

or any other company. They also have stressed Walsh's diligence

throughout his career.

Jaffe, the NIH ethics lawyer, told officials in a memo that if Walsh

had sought permission to accept compensation from Merck, " it is

highly unlikely that Dr. Walsh would have been granted approval. "