October 26

NIH Conflict of Interest Rules – "Option of Corruption" – children victimized

NIH Conflict of Interest Rules_”Option of Corruption”_ children victimized

Tue, 18 May 2004

Lawmakers accused leaders of the National Institutes of Health of encouraging “the option of corruption.”

NIH medical researchers, who receive the highest salaries in government, think they, unlike others, are entitled to moonlight while employed at taxpayers expense. NIH researchers have grown accustomed to increase those salaries substantially with lucrative collaborations with the biotech/ pharmaceutical industry. As the Pfizer-Neurontin documents reveal, pharmaceutical companies pay physician-scientists for their valuable service as product promoters–not for their scientific services.

For example, the NIMH Medications Booklet: Index of Medications lists drugs and their (recommended ?) use even when effectiveness has not been demonstrated. NIMH lists Neurontin as an anti-manic drug. See: http://www.mental-health-matters.com/articles/print.php?artID=237

When The Los Angeles Times revealed the nature and scope of moonlighting by NIH scientists (December, 2003), NIH officials began to pay lip service to the need for transparency, while simultaneously trying to conceal the facts. Instead of disengaging from the corrupting influence of corporate cash cows, NIH administrators brought their influence to bear on a panel convened to examine the researchers’ conflicts of interest. Together they tried to accommodate the researchers by exempting them from disclosure and disengagement requirements.

The culture at NIH is representative of a larger malaise that has infected the biomedical research enterprise: business contracts are today more valued in academia than scientific integrity. Those coveted commercial relationships have hurt the integrity of Science, the ethics of medicine, and the safety of treatments. See: Relman, A and Angell, M. America’s Other Drug Problem, New Republic, Dec. 16, 2002, 27-41.

Increasingly patients at prestigious medical institutions are careened into clinical trials against their best interest.

For example, an audit of 25 (out of 400) medical experiments at Harvard Medical School involving human subjects found ethical lapses in eight. Two of the experiments are taking place in China and Tanzania. The Boston Globe reported that “the Harvard IRB mistakenly approved six experiments in which patients were given inadequate or confusing” information on informed consent documents. The Globe reports that ethics specialists note that “research at Harvard is widely considered guided by a model of ethical conduct, and the lapses at Harvard would probably turn up at any medical school examined.” The Globe reports: “Neither the federal government nor Harvard would reveal the scientists involved in the experiments with ethical lapses.”

See: Lapses cited in Harvard clinical trials By Raja Mishra, The Boston Globe, May 13, 2004

The pervasive influence of the pharmaceutical industry has derailed medicine from its healing mission and precautionary “do no harm” principle. Alarmingly, American children–even toddlers–are being fed psychotropic drugs–for no medically justifiable reasons. A data analysis by MEDCO, the nation’s largest prescription benefit manager, clearly documents how such inappropriate prescribing has increased corporate profits. The New York Times reports, “Spending on drugs to treat children and adolescents for behavior-related disorders rose 77 percent from 2000 to the end of 2003.” The data shows that a 369% increase in spending on ADHD drugs for preschoolers. See: Associated Press; See: NYT

Inasmuch as the safety of these controlled psychoactive drugs is a matter of concern within the international medical community, the “off-label” use for children is improper and may qualify as child abuse. The failure to warn physicians and parents about these drugs’ hazardous effects, and the inaction of NIMH and the FDA amounted to a government seal of approval. Their inaction served industry’s financial interests; their inaction led to aggressive, profit-driven, direct marketing of the drugs and the increased exposure of mostly healthy children to the adverse effects of psychotropic drugs.

The medical establishment shares industry’s profits. By tacitly endorsing increased use of psychotropic drugs NIMH helps industry increase drug profits. The unintended consequences are obvious: children’s health is undermined and healthcare budgets are depleted, depriving the truly sick of needed medicines for lack of money.

Below, The Los Angeles Times report.

See also: The Philadelphia Inquirer editorial: Moonlighting Isn’t OK (excerpt) “With a budget of $28 billion and 18,000 employees, the NIH is rightly called the world’s crown jewel of medical research But beneath that glossy surface, the NIH is beset by an ugly controversy. Over recent years, too many of its directors and researchers have been padding their government salaries by moonlighting as consultants for private drug companies – the same companies using NIH research to endorse their products.”

“Unless these and other ethics lapses are reined in, America’s scientific reputation will be sold to the highest bidder. The NIH is a good place to start a wave of reform” See: http://www.philly.com/mld/inquirer/8643849.htm

See also: THE WASHINGTON POST: By Rick Weiss “Angered by recent revelations that some high-level scientists at the National Institutes of Health are enjoying lucrative consulting arrangements with drug and biotech companies — and unsatisfied with a blue-ribbon panel’s recommendations for rectifying the problem — members of a House subcommittee yesterday told NIH Director Elias A. Zerhouni they were losing patience with him and his superiors at the Department of Health and Human Services.”

” The lawmakers warned they might take action if more comprehensive reforms are not instituted soon.

“It is clear from the cases we have reviewed that some NIH scientists are either very close to the line or have crossed the line” of ethical conduct, Rep. James C. Greenwood (R-Pa.), chairman of the Energy and Commerce subcommittee on oversight and investigations.” http://www.washingtonpost.com/wp-dyn/articles/A22425-2004May12.html

See also: The Fort Wayne News Sentinel – Fort Wayne,IN, USA: ETHICS and NIH – moonlighting isn’t OK… to keep in mind: Research ethics problems don’t end with the NIH. Equally disturbing is the blatant ethics bending at America’s top medical journals – http://www.fortwayne.com/mld/newssentinel/news/editorial/8656781.htm

Inexplicably, The New York Times has not seen fit to report about the NIH conflict of interest controversy.

Contact: Vera Hassner Sharav
Tel: 212-595-8974

Lawmakers Assail NIH Conflict Rules
They say the agency’s efforts to revise its policies on drug-firm payments fall short.

By David Willman, Times Staff Writer
May 13, 2004

WASHINGTON – Members of Congress from both parties on Wednesday riticized conflict-of-interest policies at the National Institutes of Health and told the agency’s director that the recent recommendations of his blue-ribbon advisory panel fell short of what was needed.

After listening to the criticisms at a hearing on Capitol Hill, NIH Director Elias A. Zerhouni conceded for the first time that the agency’s policies had “failed.”

Zerhouni said that, as of this week, he was seeking to force an additional 500 senior employees to begin publicly disclosing any fees paid to them by drug companies or other parties. Two months ago, Zerhouni compelled public disclosure from 93 other NIH leaders.

But members of the House Oversight and Investigations Subcommittee said the agency was not making a serious enough effort to stop or publicly report drug company payments to NIH scientists.

Leaders of the NIH have encouraged what one congressman called “the option of corruption.” Other subcommittee members said NIH officials or lawyers with the U.S. Department of Health and Human Services had not cooperated with congressional investigators.

The hearing Wednesday opened a new phase of the controversy focusing on payments from pharmaceutical and biotechnology firms to NIH scientists. The recommendations last week of Zerhouni’s blue-ribbon panel did not satisfy the members of Congress who spoke Wednesday. The panel proposed banning paid consulting deals for top NIH management, and banning payments of stock or stock options to all NIH employees. However, it would allow many agency scientists to continue consulting for industry while not reporting their income publicly.

The subcommittee has scheduled another hearing Tuesday.

The hearings have been called in response to Dec. 7 articles in the Los Angeles Times documenting hundreds of payments by drug firms to NIH scientists, totaling millions of dollars, and reporting that more than 94% of the agency’s top-paid employees were not required to publicly disclose outside income.

More than 4,000 of those employees would remain exempt from public disclosure under the initiative announced Wednesday by Zerhouni.

“It is clear from the cases we have reviewed that some NIH scientists are either very close to the line [of propriety] or have crossed the line,” said Rep. James C. Greenwood, chairman of the House subcommittee. “This has been a persistent problem at NIH for years – not because of confusion [about ethics rules], but because of a deliberate, permissive attitude.”

Greenwood, a Pennsylvania Republican, said that NIH officials and attorneys for the Department of Health and Human Services had yet to divulge all the payments by drug companies to NIH employees and that the subcommittee would now request the information from the companies. A senior House Democrat, John D. Dingell of Michigan, backed Greenwood’s efforts, saying the subcommittee investigation “has been slow-rolled and stonewalled.”

“Unfortunately, certain scientists have been trusted to determine when their personal financial involvement with drug and biotech companies poses a conflict of interest with their responsibilities to the public,” Dingell said.

“And those scientists have not been subject to rigorous review or full disclosure.. The secret purchase of information and influence must stop.”

Rep. Joe Barton (R-Texas), who is chairman of the House Energy and Commerce Committee, warned Zerhouni that congressional investigators would obtain the fullest extent of information from the NIH about the financial ties to drug companies, with or without the agency’s cooperation. Barton described “the attitude often found at NIH: ‘The rules don’t apply to us.’ Now, I sense we are hearing a variation on this theme: ‘If the rules do apply to us, they shouldn’t.’ Such permissive attitudes and practices can no longer be tolerated.”

Rep. Michael Bilirakis (R-Fla.) said his reaction on learning that one-fourth of the NIH scientists who are now paid industry consultants had gotten company stock or stock options was, ” ‘Wow,’ very loudly.”

Zerhouni said at Wednesday’s hearing that he would try to promptly implement the recommendation by the blue-ribbon panel that such stock payments be stopped.

Some of the most pointed criticism at the hearing came from Rep. Peter Deutsch (D-Fla.), who urged Zerhouni “in the strongest possible terms to end the practice today of NIH researchers taking anything of value from a drug or biotech company.” Deutsch said current and former NIH leaders “have encouraged the option of corruption.” The NIH officials, Deutsch said, had been aided by lawyers at the Department of Health and Human Services who had helped thwart public disclosure of drug-company consulting fees and other payments.

Based on the still-incomplete information provided by the NIH, the subcommittee had determined that about 220 agency scientists were paid consultants to pharmaceutical or biotechnology companies as of December. With the increased attention on conflicts of interest at NIH recently, the number of scientists with paid industry arrangements has dropped, at least temporarily, to roughly 120.

Deutsch, the Florida Democrat, said the report of Zerhouni’s blue-ribbon panel was “an apology for the status quo.”

Under the panel’s recommendations, Deutsch said, NIH would retain conflict-of-interest policies amounting to “a system of careful twisting of the rules and overlooking of the consequences.”

“It is a report from a panel that blatantly refused to consider the most important facts,” Deutsch said. “The panel apparently felt compelled to base its recommendations on their misplaced need to excuse the inexcusable.” The co-chairmen of the panel, Bruce Alberts and Norman R. Augustine, said at the hearing that they were convinced that allowing paid-industry consultancies might help NIH attract or retain talented scientists.

Alberts said the panel had been on the verge of recommending that public disclosure be required for all NIH employees who accept drug company fees. Among the 500 additional NIH employees who would be required by Zerhouni to publicly disclose their outside income were laboratory and research branch chiefs and program managers, said John Burklow, an agency spokesman.

Zerhouni, whose aides reviewed and commented on drafts of the blue-ribbon report as it was being written, said Wednesday that he had “reviewed all the panel’s recommendations.” He would, he said, “move ahead as appropriate.”

Rep. Henry A. Waxman (D-Los Angeles), while applauding NIH’s research preeminence, said Zerhouni should seek more public disclosure.

“I am particularly concerned that some potential conflicts of interest will still go undisclosed,” Waxman said. “Americans need to know that when NIH reaches a conclusion, that conclusion is based on hard evidence and the scientific method.

“We need to act now to impose appropriate conflict-of-interest standards so that America and the global scientific community can continue trusting in NIH,” Waxman said.

If you want other stories on this topic, search the Archives at latimes.com/archives NIH Conflict Findings Left Out May 12, 2004 Curbs on Outside Deals at NIH Urged April 9, 2004 Ethics Policy Announced for NIH Officials March 2, 2004 NIH Directors No Longer Drug Firm Consultants January 23, 2004 U.S. Scientists’ Deals With Drug Firms Under Review December 29, 2003 Stealth Merger: Drug Companies and Government Medical Research December 7, 2003


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