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Forty-four government scientists have violated ethics rules on collaborating with pharmaceutical companies, a preliminary review by the National Institutes of Health shows.
Nine of the scientists may have violated criminal laws, the report said.
The review was outlined in a July 8 letter the agency's director, Dr. Elias A. Zerhouni, sent to the House Energy and Commerce Committee, which is investigating conflicts of interest by government researchers.
Because the N.I.H. is investigating 103 people who have been accused of ethics violations, Dr. Zerhouni had asked the committee to keep his letter confidential. But its leaders — Representatives Joe L. Barton, Republican of Texas and John D. Dingell, Democrat of Michigan — said in a statement yesterday that they were releasing it because of "the compelling public interest."
"The ethical problems are more systemic and severe than previously known," Mr. Barton said.
The institutes' review found that the 44 scientists had either failed to disclose income from outside work, had failed to get permission to consult or had done the work on government time rather than their own.
Eight of the scientists no longer work for the institutes and are not subject to administrative punishment, the review said. It did not describe what criminal laws might have been violated in the nine cases that were turned over to the inspector general of the Department of Health and Human Services.
Of the 103 people being investigated, 37 have been cleared, Dr. Zerhouni said in his letter, which did not name any researcher.
In February, Dr. Zerhouni banned all consulting deals between agency researchers and drug or biotechnology companies. For the top scientists, he also forbade owning shares in such companies, accepting gifts worth more than $200 and accepting many research prizes.
The rules are not final, and Dr. Zerhouni has said he could lose talented scientists to agencies that are less strict. Committee leaders are urging him to make the rules final.
The investigations Dr. Zerhouni's letter cited concern deals made before the ban, which followed disclosures that some government researchers were paid thousands of dollars by drug makers.
source: http://www.nytimes.com/2005/07/15/politics/15ethics.html 15jul2005
WASHINGTON — Forty-four government scientists who also worked as consultants for drug companies violated agency regulations designed to prevent conflicts of interest, a review by the National Institutes of Health shows.
The review centered on whether the scientists had properly disclosed their work for the drug companies on financial disclosure forms, whether they had prior approval to do such work from their superiors and whether they took personal leave to do private work. In the 44 cases, scientists were found to have violated one or more existing NIH rules.
In an additional 37 cases reviewed, scientists did have prior approval for their work, had properly reported the work on their financial disclosure forms and took approved leave when necessary, the NIH reported.
The House Energy and Commerce Committee asked for the review when it compared NIH records to consulting agreements maintained by 20 pharmaceutical companies. It found 81 cases between 1999 and 2004 where the agreements were not listed in the NIH records provided to the committee. It asked NIH to investigate those cases.
Even as NIH investigated those cases, NIH Director Elias Zerhouni issued a ban on NIH employees consulting with drug and biotechnology companies. The agency also issued ethics rules that it is monitoring before making permanent.
The chairman of the committee, Rep. Joe Barton, R-Texas, said the agency's findings revealed the ethics problems at NIH were worse than he had anticipated.
"These findings indicate that the ethical problems are more systemic and severe than previously known," Barton said. "They also demonstrate the need for NIH to issue the final ethics rule as soon as possible."
Of the 44 scientists found to have violated agency rules, 36 are still employed at NIH and have been referred for possible disciplinary action. Nine of those thirty-six have also been referred to the HHS Office of Inspector General for investigation of possible criminal violations.
Zerhouni made the details of the NIH investigation known in a letter to the committee dated July 8. The findings were released, despite Zerhouni asking that they be treated as confidential.
"You have my pledge that I will continue to work with the committee on this matter as we move forward by correcting deficiencies and ensuring public trust," Zerhouni said.
Committee leaders released the data and letter anyway because of the compelling public interest, said Kevin Schweers, a spokesman for the panel.
source: http://www.newsday.com/news/politics/wire/sns-ap-nih-ethics-lapses,0,1195147,print.story?coll=sns-ap-politics-headlines 15jul2005
WASHINGTON, July 14, 2005 – An internal National Institutes of Health (NIH) review shows that dozens of scientists employed by the government have done work for pharmaceutical companies in violation of ethics requirements, indicating the scope of the agency’s ethical woes is greater than previously known.
The findings come in response to a bipartisan letter the full committee chairman and ranking member — U.S. Reps. Joe Barton, R-Texas, and John Dingell, D-Mich., respectively — sent on March 10th to NIH Director Elias Zerhouni, concerning the status of NIH's internal review of possible unreported and undisclosed outside consulting agreements by NIH scientists. Committee leaders released the data today due to the compelling public interest.
Last year the Committee staff identified a sample of 81 individual scientists hired by drug companies between 1999 and 2004 whose consulting agreements were not listed in NIH information provided to the committee. For example, the agreements reported by drug maker Pfizer, Inc., ranged from a minimum of $500 to a maximum of $517,000 over the five year period, and typically involved several thousand dollars per scientist. Once notified of the discrepancies between NIH and drug company records, the NIH launched an internal review of the 81 individual scientists.
In a July 8th letter to the Committee, the NIH reported that of those 81 scientists, 37 were “cleared” and 44 were found to have violated one or more of three existing NIH rules: reporting the income on financial disclosure forms (where necessary), taking personal leave to do private work; and seeking prior approval for the arrangements. Thirty-six of the scientists are still employed at NIH and have been referred for possible disciplinary action. Nine of those thirty-six have also been referred to the HHS Office of Inspector General for investigation of possible criminal violations.
Barton and Dingell commended Dr. Zerhouni for his ongoing efforts to adopt a more stringent ethics policy and they renewed calls for Congress to approve the first NIH reauthorization bill since 1993.
“The NIH is home to many of the best and brightest scientific minds the world has to offer,” Barton said. “Congress has advanced their work to fight disease and save lives by doubling their budget in recent years.
“But, along with financial backing, the NIH must have the support of the American people. These findings indicate that the ethical problems are more systemic and severe than previously known. They also demonstrate the need for NIH to issue the final ethics rule as soon as possible. I wholeheartedly support the work of Dr. Zerhouni to root out any conflicts of interest – real or apparent – while ensuring that scientists can collaborate with the private sector to advance public health. Dr. Zerhouni is to be commended for handling a difficult matter with great skill,” Barton said.
“Dr. Zerhouni has provided extraordinary leadership at the NIH during an ethical crisis that was not of his making,” said Dingell. “He analyzed the mounting evidence of misconduct among a minority of NIH employees, determined the systemic basis of the problem, moved carefully to identify those involved, and revised the rules to uphold proper ethical standards.”
Barton also underscored the need for Congress to reauthorize the NIH this year. “The Director should have the authority to direct and the flexibility to move dollars among institutes and centers to encourage promising research. We must recognize that expanding biomedical research in the 21st century requires the NIH to function efficiently,” he said.
Since the Oversight and Investigations subcommittee launched its review in 2003, its actions include the following:
The Committee on Energy and Commerce 2125 Rayburn House Office Building Washington, DC 20515 (202) 225-2927
source: http://www.pharmalive.com/News/index.cfm?articleid=256559&categoryid=54 15jul2004
WASHINGTON — Results from an ongoing internal review of drug company consulting payments to scientists at the National Institutes of Health show the agency's ethical problems are serious and widespread, a House committee chairman said Wednesday.
The review examined whether a sample of 81 NIH scientists had moonlighted for industry without getting required permission from the agency, whether they disclosed company payments on annual forms and whether they performed company services on government time.
More than half, 44, were found by NIH officials to have violated the agency's then-existing policies or recommendations.
Excerpts from the findings, provided in recent days by NIH Director Elias A. Zerhouni to three members of Congress, were obtained by the Los Angeles Times.
"We discovered cases of employees who consulted with research entities without seeking required approval, consulted in areas that appeared to conflict with their official duties, or consulted in situations where the main benefit was the ability of the employer to invoke the name of NIH as an affiliation," Zerhouni said in a letter to the congressmen dated Friday.
The chairman of the House Energy and Commerce Committee, Rep. Joe Barton (R-Texas), said Wednesday that the findings showed the "ethical problems [at the NIH] are more systemic and severe than previously known."
Barton elicited the information by posing written questions to Zerhouni in March. Barton's letter had been cosigned by the committee's most senior Democrat, Rep. John D. Dingell of Michigan.
The 44 scientists cited by the internal review "violated policies or regulations and were recommended for administrative action," said the summary of information that the NIH provided to the members of Congress.
Eight of the alleged violators have left the NIH and are not subject to administrative action, the agency said.
Nine individuals — none of whom were named in the agency's summary — were referred for further investigation to the inspector general of the Department of Health and Human Services.
After announcing an agency-wide ban Feb. 1 on accepting company consulting fees or stock, Zerhouni was urged by some NIH employees and their defenders to relent.
Zerhouni has said he would continue to assess whether the new rules, including a planned restriction against owning biomedical stocks, had adversely affected the hiring and retention of qualified scientists.
The violations identified in the internal NIH review reflected a partial examination of industry consulting deals that had involved hundreds of agency scientists.
In spring 2004, after it was unable to obtain documentation from the NIH of the extent of such deals, the House Energy and Commerce Committee wrote to 20 companies and asked executives to voluntarily identify consulting fees paid to NIH scientists.
Scores of other companies that employed moonlighting NIH scientists were not contacted.
The information received from the 20 companies revealed 81 names that were not on the list of moonlighting scientists that had, by then, been delivered to the committee by the NIH.
The agency did not identify any of the 44 government scientists found to have committed violations.
An NIH spokesman, John Burklow, said that officials had sought to respect employees' rights to due process and privacy.
Zerhouni, in his letter to the members of Congress, said that because the internal investigation was ongoing, "I request that all the information provided in the enclosure [summarizing the findings] be treated as confidential."
source: http://www.latimes.com/news/nationworld/nation/la-na-nih14jul14,1,2291837,print.story?coll=la-headlines-nation 15jul2005
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