During the Reagan era, the National Institutes of Health (NIH) was described by (then) Secretary of Health Human Services, Maegaret Heckler, as "an
island of objective and pristine research, untainted by the influences of commercialization." [1] http://www.piercelaw.edu/risk/vol1/fall/harnett.htm
Even if that assessment exaggerated reality a bit, today’s NIH scientists are so driven by commercial interests that their violations of Federal laws and regulations-first documented by David Willman of The Los Angeles Times-have betrayed the trust of the public and all but destroyed the integrity of NIH medical research, ,. [2] https://ahrp.org/infomail/03/12/07.php
On September 13, 2006, during the latest Congressional hearing probing the conduct of NIH scientists and administrators, congressman Joe Barton, Chairman of the House Energy and Commerce Committee, rendered a stinging appraisal of the NIH today: "This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave."
The hearing was the sixth since January 2004, focusing on the unseemly and seemingly unending saga of scientists’ refusal to give up their competing business ventures while employed as public servants. Specifically, the focus of this hearing was the agency’s failure to take action following an investigation of conflicts of interest by an NIH appointed panel. Despite the panel’s recommendation to terminate two senior NIH scientists whose activities on behalf of drug companies tainted their government research constituting, "serious misconduct" and violation of federal law and regulation, no action has been taken.
The Los Angeles Times reports: http://www.latimes.com/news/nationworld/nation/la-na-conflicts14sep14,1,273997.story
"A congressional subcommittee chairman and a top administrator of the National Institutes of Health agreed on at least one point Wednesday: Private financial deals between drug companies and NIH scientists that have come to light in recent years have posed the worst scandal in the agency’s history."
The Associated Press reports: <http://www.msnbc.msn.com/id/14795244 >
"Most of the federal scientists who improperly accepted personal money from drug or biotechnology companies walked away with reprimands or were allowed to retire unscathed. Only two of the 44 scientists found to have violated rules governing private consulting deals are being investigated for possible criminal activity, and they remain on the government payroll."
NIH’s failure to take action sends the message that high ranking government scientists who violate the law by engaging in commercial activities while on
taxpayers’ payroll-have little to fear, and reinforces the perception that their high level position will shield them from accountability. What other government employees disregard Federal regulations prohibiting outside activities with impunity?
The two senior NIH scientists who were at the center of the committee probe failed to obtain permission or to disclose their corporate financial ties to the agency-as required under Federal law. Dr. Trey Sunderland III, the Harvard University-McLean Hospital trained psychiatrist who is chief of Geriatrics at the National Institute of Mental Health, had refused to testify at a June 14 hearing of the House Energy and Commerce Committee (ECC), pleading the Fifth Amendment.[3] https://ahrp.org/cms/content/view/282/55
Dr. Sunderland is under an investigation by the Department of Justice for possible criminal offenses first reported by Pulitzer Prize winning investigative reporter, David Willman, of the Los Angeles Times in December 2004 and January 28, 2005 https://ahrp.org/infomail/04/12/22.php and
<https://ahrp.org/infomail/05/01/31/php . [4]
The congressional staff report of the ECC uncovered Dr. Sunderland’s income from consulting fees and speeches on behalf of Pfizer amounting to between $600,000 and $700,000. [5] http://energycommerce.house.gov/108/home/staff%20report.pdf
On June 14, 2006, Willman reported: The Committee staff estimated that. it cost the government $6.45 million to collect the samples that Dr. Sunderland had shipped to Pfizer." [3]
The Washington Post reports: http://www.washingtonpost.com/wp-dyn/content/article/2006/09/13/AR2006091302024_pf.html
"So lax has oversight of Sunderland’s activities been, legislators said, that NIH did not stop him from recently shipping — at government expense —
personal belongings to a New York hospital where he had hoped to continue his research. Those belongings were returned to Bethesda after the lapse was detected, an NIH spokesman said, again at government expense."
The LAT reports: http://www.latimes.com/news/nationworld/nation/la-na-conflicts14sep14,1,273997.story
"At a congressional hearing in June, Sunderland’s boss, Dr. Thomas R. Insel, director of the National Institute of Mental Health, said Sunderland’s receipt of more than $600,000 in fees from Pfizer Inc. was unacceptable. Yet Barton said Wednesday that several months earlier, Insel had "recommended a
$15,000 retention bonus" for Sunderland."
Dr. Insel did not attend last week’s hearing; he sent underlings who argued that NIH is unable to act against errant scientists if they are part of the Public Health Service Commissioned Corps (PHS). Since when is PHS staff guaranteed secrecy and immunity from prosecution for wrongdoing?
Although the nature of the misconduct may be different, the failure to take action is similar to the rationale offered by Catholic Church authorities who shielded sexual predator priests from being held accountable for decades as Church administrators facilitated their move from one parish to another.
Committee Chairman Barton noted that NIH public pronouncements notwithstanding, the culture at the Institute remains unchanged: "In spite of the public changes that have been made at NIH, there really does not appear to be a cultural change where the institution and the members of the institution condemn the kind of behavior that apparently Dr. Sunderland has exhibited. It’s really, really disappointing."
The other NIH scientist at the center of Wednesday’s hearing is oncologist, Dr. Thomas Walsh, head, Immunocompromised Host Section, Pediatric Oncology Branch, National Institute of Cancer, specializing in fungus infections. In July, 2006, Dr. Walsh declared in writing, that his advice to industry did
not conflict with his position at the NCI, or affect his scientific judgment. "I am not and have never been a representative of, or advocate for, any pharmaceutical company." [6] <http://www.latimes.com/news/printedition/front/la-na-walsh16jul16,1,7304685.story >
Internal government documents obtained by AHRP, however, refute that disclaimer: A June 1, 2005 memorandum from the Director of the NIH Ethics Office states that its review panel had examined two of Dr. Walsh’s "unapproved outside activities" on behalf of Merck and found that these activities "overlap directly with Dr. Walsh’s research at NIH.[and] present a serious ethical problem." [7]
The NIH Office of Management Assessment report (September 9, 2005) had been concealed for a year until the House Energy Committee requested it. The report reveals that only after NIH Director instructed all scientists to disclose all their outside activities, did Dr Walsh acknowledge that he had engaged in 36 additional industry-related activities on behalf of 24 pharmaceutical and biotech companies between 1999-2004, for which he received $97,970. [8]
A separate Infomail will address the broader significance of scientists’ conflicts of interest-and how those conflicts threaten the integrity of science and medicine. We will report about yet another medical journal providing the appearance of legitimacy to a biased article. A polemic attacking the journalist, David Willman, and the Los Angeles Times editors, for reporting on July 16, 2006, Dr. Walsh’s hitherto concealed conflicts of interest. The article, purportedly authored by 107 friends of Dr. Walsh, was accepted for publication by Clinical Infectious Diseases, the official journal of the Infectious Disease Society of America, the day it was received then posted electronically 7 days later (September 13), the day of the Congressional hearing where Dr. Walsh’s lawyer distributed it widely to the press.
Stay tuned for part II.
References:
1. Christopher J. Harnett. Federal Technology Transfer: Should We Build Subarus in Bethesda? http://www.piercelaw.edu/risk/vol1/fall/harnett.htm
- David Willman, Stealth Merger: Drug Companies and Government Medical Research, The Los Angeles Times, December 8, 2003: https://ahrp.org/infomail/03/12/07/03.php The article won Willman the prestigious Worth Bingham Prize for investigative reporting—including $10,000: “His powerful examination of an unintended consequence of the push to speed up the transfer of research breakthroughs into widely available medical treatments – the grave financial conflicts of interest it created for government scientists." http://www.wpcf.org/Pages/Journalism.html
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Kevin Freking, Researcher Mum in Human Tissue Hearing, Associated Press, June 14, 2006; David Willman, Chief NIH Geriatric Psychiatrist Takes the Fifth Refusing to Testify about Tissues Sent to Pfizer, June 14, 2006; Rick Weiss, Serious Misconduct by NIH Expert Found, Washington Post: https://ahrp.org/cms/content/view/282/55
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David Willman, NIH: Public Servant or Private Marketeer? LAT, December 22, 2004: https://ahrp.org/infomail/04/12/22.php and Willman, NIH Seeks Outside Inquiry of Scientist, LAT, January 28, 2005: https://ahrp.org/infomail/05/01/31.php
-
See: Staff Report of the House Committee on Energy and Commerce. “Human Tissue Samples: NIH Research Policies and Practices,” June 13-14, 2006: http://energycommerce.house.gov/108/home/staff%20report.pdf
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David Willman. Drug Trials With a Dose of Doubt, The Los Angeles Times,
July 16, 2006, Front page: http://www.latimes.com/news/printedition/front/la-na-walsh16jul16,1,7304685.story?coll=la-headlines-frontpage
Contact: Vera Hassner Sharav
veracare@ahrp.org
http://www.msnbc.msn.com/id/14795244 ; http://www.forbes.com/business/energy/feeds/ap/2006/06/14/ap2815299.html
Associated Press
NIH: Scientists escape ethics punishment
By RITA BEAMISH
Tue Sep 12, 6:59 PM ET
Most of the federal scientists who improperly accepted personal money from drug or biotechnology companies walked away with reprimands or were allowed to retire unscathed.
Only two of the 44 scientists found to have violated rules governing private consulting deals are being investigated for possible criminal activity, and they remain on the government payroll, the National Institutes of Health told The Associated Press this week in the most detailed accounting it has released.
NIH spokesman John Burklow said his agency wanted eight others reviewed for possible crimes, but those cases were rejected by the investigating office at the U.S. Health and Human Services Department. The two still outstanding — Drs. Trey Sunderland and Thomas Walsh — both committed "serious misconduct," so grave that they would be fired if they were civilians, NIH internal ethics reports contend. NIH says it has been unable to act against the two because they are part of the Public Health Service Commissioned Corps, which provides medical help during disasters.
Lawmakers plan to push for answers Wednesday at a House Energy and Commerce subcommittee hearing, part of continuing scrutiny into how the agency polices conflicts of interest. Responding to congressional criticism, NIH last year barred federal scientists from the once-common practice of earning lucrative paychecks from private companies.
Rep. Bart Stupak, D-Mich., said he wants to know why it is taking so long to resolve the case of Sunderland, a leading Alzheimer’s disease researcher whose request to leave government service has been denied for two years. "Where’s the accountability? Where’s the response?" Stupak said. "This person should be dealt with severely." He referred to allegations that Sunderland improperly transferred human tissue samples from NIH patients to the drug company Pfizer. "These people thought they were helping other people, not some scientist profiting," he said. Sunderland, through his attorney, denies that his consulting payments from Pfizer were tied to samples he provided in his government capacity.
The Public Health Service Commissioned Corps is concerned about the allegations against Sunderland and Walsh and "will take appropriate action should wrongdoing be found," said spokeswoman Christina Pearson. However she cited "other reviews" of Sunderland that her agency must coordinate with.
Rep. Joe Barton, R-Texas, chairman of the House Energy and Commerce Committee, said the case points out deeper problems at NIH. "In spite of the public changes that have been made at NIH, there really does not appear to be a cultural change where the institution and the members of the institution condemn the kind of behavior that apparently Dr. Sunderland has exhibited. It’s really, really disappointing," he said.
The subcommittee is expected to question NIH officials about documents showing it approved several taxpayer-paid trips for Sunderland to attend conferences and events in places like Hawaii and Toronto, even after recommending his firing. Things changed last month when his superiors, a day after assuring Sunderland the agency would soon negotiate his release, suddenly restricted his access and activities and assigned him to administrative duties, his lawyers said in a letter to the subcommittee.
NIH investigated 103 employees after revelations in 2004 that many had failed to report their paid relationships with drug companies. Of the 44 alleged offenders, six left NIH before they could be punished and two had offenses so minor they merited no sanction, Burklow said. The majority received reprimands or warnings for failing to properly obtain approvals for their outside consulting work, he said. Suspensions ranging from a week to 45 days were meted out to a few who did not get prior approval or did not report their drug company ties, said Burklow.
Sunderland is under investigation by the HHS inspector general and the Justice Department, officials have said. And a government official told AP that Walsh, a prominent cancer researcher, is the other case the inspector general is reviewing. The official requested anonymity because the investigation is ongoing.
Reached at his NIH office on Monday, Walsh declined comment.
NIH ethics reports allege the two scientists had unauthorized, unreported deals with drug companies — Sunderland earning more than $600,000 over eight years for consulting and speeches and Walsh more than $100,000 in five years — and that their consulting improperly overlapped with government duties.
Lawyers for both scientists said in written defenses to NIH investigators that the two put in exceptionally long hours at their government jobs, even if the proper paperwork was missing for taking leave to perform outside work.
Documents obtained by AP show Sunderland initially got a green light to retire in November 2004 and he had his 11-year research project transferred to a New York center where he planned to accept a prominent post. But NIH officials subsequently recommended against his departure and the center now is moving on to hire someone else.
Sunderland’s attorney Robert Muse cites a litany of mixed signals Sunderland received from NIH, including months of refusal to meet after stating a willingness to work out his release.
Burklow, citing privacy concerns, would not discuss any individual cases.
"The bureaucratic inaction," Muse wrote the congressional subcommittee on Monday, "has unreasonably interfered not only with Dr. Sunderland’s career but also with his important Alzheimer’s research," which he said cost the government millions of dollars.
Some scientists whose consultancies were negatively highlighted in 2004 congressional hearings and press accounts left NIH voluntarily. They suffered no repercussions.
Cancer researcher Lance Liotta said he retired in May 2005 with pension and benefits, accepting "a great opportunity" in research at George Mason University. His consulting activities, though questioned after the fact by Congress, were approved at the time, and he never was sanctioned.
Another former researcher, 33-year NIH veteran Michael Brownstein, had held nearly $2 million in stock with four companies whose boards he served on while he worked at NIH. The agency approved the consulting and never accused him of wrongdoing, said Brownstein, who continues his genetic research at the J. Craig Venter Institute in Rockville, Md.
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http://www.latimes.com/news/nationworld/nation/la-na-conflicts14sep14,1,273997.story
THE LOS ANGELES TIMES
Panel Challenges NIH Handling of Rules Violations
House members call disciplinary action tepid in the ‘largest scandal’ in agency history.
By David Willman, Times Staff Writer
September 14, 2006
WASHINGTON — A congressional subcommittee chairman and a top administrator of the National Institutes of Health agreed on at least one point Wednesday: Private financial deals between drug companies and NIH scientists that have come to light in recent years have posed the worst scandal in the agency’s history.
"This is the largest scandal in all of the NIH’s existence," said Rep. Edward Whitfield (R-Ky.), chairman of the House Energy and Commerce subcommittee on investigations. To which NIH Deputy Director Raynard S. Kington nodded and replied, "We certainly hope it will be the last."
Citing internal ethics investigations over the last three years, Kington said the agency had disciplined 34 NIH scientists who had violated conflict-of-interest rules. Six scientists were suspended or placed on probation and the others were admonished orally or by letter, according to NIH documents. NIH officials also assured the panel that they had recommended the termination of two other senior scientists who accepted drug company money without obtaining required advance approval. "When violations were found, NIH implemented sanctions ranging from oral admonishments to letters of reprimand to suspensions," Kington told the subcommittee. "In all cases where individual scientists failed to take [personal] leave to conduct outside activities, they were directed to pay back that leave to the government."
But Kington’s assurances were challenged by Republicans and Democrats on the subcommittee. They noted that despite previous statements of concern and outrage from senior NIH officials, no employee had been fired, and they said most of the disciplinary actions had been tepid.
The session marked the sixth congressional hearing since January 2004 that centered on NIH conflicts of interest. "This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave," said Rep. Joe L. Barton (R-Texas), chairman of the Energy and Commerce Committee.
Much of the contentious afternoon session focused on two researchers: Dr. P. Trey Sunderland III, a geriatric psychiatrist who has researched Alzheimer’s disease, and Dr. Thomas J. Walsh, who has researched fungal diseases in cancer patients.
Their cases are pending before an administrator at the U.S. Public Health Service Commissioned Corps, a uniformed branch of the service. A resolution of Sunderland’s case has been delayed because of a separate investigation by the U.S. Justice Department, Bush administration officials said.
Panel members pointed out that Sunderland had been allowed until last month to retain most of his NIH privileges and that he had taken several trips at the expense of the government, visiting Hawaii and Geneva.
At a congressional hearing in June, Sunderland’s boss, Dr. Thomas R. Insel, director of the National Institute of Mental Health, said Sunderland’s receipt of more than $600,000 in fees from Pfizer Inc. was unacceptable.Yet Barton said Wednesday that several months earlier, Insel had "recommended a $15,000 retention bonus" for Sunderland.
Barton and other subcommittee members also said that Sunderland had shipped samples of spinal fluid drawn from patients at the NIH to a New York hospital, where he had intended to take a new position. Those samples were returned in recent months after the shipments came under fire from the congressional panel. Officials said the samples should not have been transferred out of NIH custody.
Barton chided Dr. John O. Agwunobi, the Bush administration’s assistant secretary for health, for not demanding swift resolution of the Sunderland case. "You’re sittin’ on your bottom, and you’re not doing anything about it," Barton said, adding that Sunderland had been allowed to flout rules with impunity. "It’s a farce."
In Walsh’s case, the researcher accepted about $100,000 in fees from drug companies without required advance permission. On Wednesday, Barton criticized the director of the National Cancer Institute, Dr. John Niederhuber, as doing little to address Walsh’s conduct except to recommend termination by the Commissioned Corps.
Niederhuber confirmed that he had recommended in December that Walsh be fired. But Niederhuber also lauded Walsh as "probably the world’s expert on antifungal agents."
Documents distributed at Wednesday’s hearing suggested that Walsh was paid $12,000 by Pfizer to help prepare the company for an October 2001 meeting held by a Food and Drug Administration advisory committee. Walsh had collaborated with the company in leading a major study of its antifungal drug, Vfend.
The NIH recently opened a separate internal review of Walsh’s appearances with pharmaceutical companies at public and private FDA meetings. Merck & Co. identified Walsh as a consultant when he appeared at a January 2001 FDA advisory committee meeting that focused on the company’s new antifungal drug. Walsh vouched for the effectiveness of Merck’s drug, and the committee voted unanimously to recommend its approval.
Kington told the subcommittee on Wednesday that the NIH was now "clarifying its policies regarding the presentation of scientific information" to FDA advisory committees.
U.S. conflict-of-interest law generally prohibits a federal employee from representing an outside party before a government agency. Walsh and his attorneys have said he did not make any appearance before the FDA as a representative of any company.
In addition to all of the internal reviews, Kington noted that a policy enacted last year prohibits all NIH employees from accepting consulting fees, stock or stock options from drug companies. The previous rules allowed agency scientists to accept unlimited sums of compensation from industry.
A July 2005 report by the U.S. Office of Government Ethics concluded that the NIH was infused with a "permissive culture." Kington said Wednesday that agency officials were confident that the problems were a thing of the past, "with new restrictions in place and a more efficient and rigorous ethics program underway." The subcommittee members appeared unconvinced. "I believe that the tentacles of the drug companies influence the research at NIH, much to the consternation of the American people," said Rep. Bart Stupak (D-Mich.).
david.willman@latimes.com
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THE WASHINGTON POST
NIH Punishments Criticized
Members of Congress Complain That Sanctions Are Too ‘Soft’
By Rick Weiss
Thursday, September 14, 2006; Page A19
Angry members of Congress took federal health officials to task yesterday for what they said was a pattern of being "soft" on government scientists found to have violated ethics rules. One National Institutes of Health scientist is still on the job a year after the agency determined he had improperly accepted more than $700,000 in consulting fees — and has taken recent trips to Switzerland and Hawaii on the government’s tab — lawmakers said at a hearing. Another researcher is still at NIH after investigators found he had improperly accepted about $100,000 from more than 25 companies, members complained.
And although six NIH scientists deemed to have broken ethics rules left their jobs in the past year or so before disciplinary action could be taken, not one of the remaining 36 violators identified in an NIH-wide investigation was fired — and most have endured punishment no more severe than a "letter of caution."
"I do recognize that NIH has taken needed steps to improve its ethics program," said Rep. Edward Whitfield (R-Ky.), chairman of the subcommittee on oversight and investigations, which for years has been dogging NIH over alleged ethics violations. "But more action is needed."
Agency officials denied that they have been less than rigorous in meting out punishment to those who broke the rules that once governed such arrangements. NIH banned all outside consulting with drug and biotech companies more than a year ago, when it became clear that a few dozen had not reported their arrangements as required. NIH Deputy Director Raynard Kington said that at the conclusion of its investigation, NIH began administrative actions against 34 scientists and referred 10 others to the Office of Inspector General for possible prosecution. That office decided to pursue only two — Alzheimer’s disease researcher Trey Sunderland and cancer researcher Thomas Walsh.
But while NIH officials long ago expressed a desire to fire those two, neither the inspector general nor NIH has the power to do so because both scientists are members of the Public Health Service’s Commissioned Corps. The corps’ disciplinary rules — including the right to a formal corps hearing — trump NIH’s.
Sunderland’s corps hearing has been delayed indefinitely at the request of the Justice Department, which is considering criminal charges, according to testimony yesterday by John O. Agwunobi, assistant secretary for health. Walsh’s hearing has been delayed because it was awaiting completion of Sunderland’s. Last week the corps decided to bump Walsh’s case ahead of Sunderland’s and began to organize a hearing for him, Agwunobi said.
Meanwhile, both researchers have continued to work at NIH, with travel and other job restrictions imposed only recently in the wake of fresh congressional inquiries. So lax has oversight of Sunderland’s activities been, legislators said, that NIH did not stop him from recently shipping — at government expense — personal belongings to a New York hospital where he had hoped to continue his research. Those belongings were returned to Bethesda after the lapse was detected, an NIH spokesman said, again at government expense.
Several members complained that the punishments doled out to violators were not tough enough. Rep. Bart Stupak <http://projects.washingtonpost.com/congress/members/s001045/> (D-Mich.) pointed to one case in which a researcher was found to have received nearly $475,000 without proper approval or disclosure and received a penalty of a 45-day suspension without pay "So where is the deterrent?" Stupak asked, calculating aloud to show that the scientist still came out ahead financially. "What does it take to get an NIH scientist terminated?"
NIH officials responded that in some cases, including that one, punishment was less than might seem appropriate because although the researcher did not report the income properly, the outside work was found to have posed no conflict of interest and would have been approved under the rules in place then.
Undaunted, Stupak asked why federal scientists cannot maintain the same ethical standards as members of Congress. Often, he said, legislators get letters in the mail with a dollar bill inside to encourage them to reply. "Do you know what would happen to any of us," Stupak asked, "if we kept that dollar?"
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