Several internal investigations have found that Dr. Thomas Walsh, head of pediatric research at the National Cancer Institute, has been engaging in--what the agency calls, "serious misconduct."
The LAT reports that internal investigations have found that between 1999-2004, Dr. Walsh
had entered into dozens of unauthorized private arrangements with drug companies, failing to report the outside income, totaling more than $100,000.Dr. Walsh
is reported to have "accepted fees from 25 companies and has led government-sponsored research involving some of those companies' drugs."Yet, despite evidence of violations no penalties have been issued--and Dr. Walsh
continues in his
job at taxpayer expense.
is reported to have helped his
corporate benefactors obtain FDA approval for their products.Until he
became Acting Commissioner of the FDA
(in 2005), Dr. Andrew von Eschenbach headed the National Cancer Institute
(beginning, December 2001) during the time of Dr. Walsh's
activities.Was Dr. von Eschenbach aware of NCI researchers' financial ties to industry--and did he
condone these relationships?
See also: http://www.ahrp.org/cms/content/view/292/55/ The Los Angeles Times A TIMES INVESTIGATION.
Officials at the NIH
concluded late last year that the actions of Dr. Thomas 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.
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 Thursday.
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.
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 said."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 three 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.Members of the House Energy and Commerce Committee's investigative subcommittee are expected to question officials at the hearing this week about their handling of ethics matters, including the cases of Walsh and another senior NIH researcher, Dr. P. Trey Sunderland III.
...Neither Sunderland nor Walsh has been publicly disciplined, 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.
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 John O. Agwunobi, said through an aide that he could not discuss details of the pending cases because of privacy concerns.
...Walsh was referred to a corps administrator nine months ago "for action" by a deputy NIH director, Dr. Raynard S. Kington, and by Dr. John Niederhuber, the then-acting director of the National Cancer Institute.
...Walsh, 54, a medical graduate of Johns 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 advisor 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 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.
One company, Merck
, listed fees to Walsh
that had not been reported to the NIH
, 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.
A subsequent summary of the NIH's internal review added, "this situation is one in which a reasonable person could question Dr. Walsh's
The new documents show that when Merck
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