Ex-NIH Director Lifted conflict of interest rules, Now favors limits on Drug-Company Ties – LAT

Ex-NIH Director Lifted conflict of interest rules, Now favors limits on Drug-Company Ties – LAT

Sun, 14 Mar 2004

Former Director of the National Institutes of Health, Harold Varmus, MD, appeared before a blue ribbon panel convened by his former agency, ostensibly to shed light on conflict of interest at NIH, and on Dr. Varmus’ policy when he was director. Dr. Varmus exempted NIH employees from federal regulations restricting government employees from having financial ties to bio-tech and pharmaceutical industry.

As reported by The Los Angeles Times (Dec 7, 2003), Dr. Varmus instituted a laissez faire policy in 1995, that encouraged NIH researchers to collaborate with pharmaceutical and bio-tech companies. The LAT reports that 94% of NIH employees had financial ties with industry thanks to this policy of self-interest. NIH researchers enriched themselves while simultaneously collecting a paycheck from taxpayers.

Such collaboration between NIH employees and industry helped the industry gain a substantial foothold in NIH. Industry’s influence affected the grant awarding process–ensuring that NIH grants would be awarded to companies that collaborated with NIH scientists. Industry also influence the research approval process, and the safety of human subjects in clinical trials.

Citing the example of Dr Stephen Katz, the LAT reports that his consulting clients won four NIH research grants from 1999 through 2001 administered by his institute. Furthermore, “as NIH director, Dr. Varmus played down the extent of conflict of interest in the aftermath of the May 1998 death of a woman in an agency-sponsored diabetes-prevention study. The NIH official who was responsible for overseeing that study was simultaneously a paid consultant to the Warner- Lambert Co., whose drug resulted in the woman’s liver failure.”

Dr. Varmus acknowledged to the panel that “sensitivity or standards regarding potential conflicts of interest must be heightened when decisions affecting research on humans is involved.” Not discussed by the panel is the culture that emerged within NIH as business ethics prevailed. Increasingly, patients were exploited in sometimes radical experiments whose risks for subjects were unjustifiable. Ethical standards were largely violated as researchers increasingly adopted the fast-track research process favored by business.

The consequences of conflict of interest in medical research are profound: the credibility of scientists is undermined by bias; the safety of patients is undermined by target goals; and the integrity of the scientific literature is corrupted by reports based on partial (favorable) data, often ghostwritten by public relations firms.

An example is the recently issued summary of an unpublished report by the American College of Neuropsychopharmacology (ACNP): A Preliminary Report of the Task Force on SSRI and Suicidal Behavior in Youth, January 21, 2004.
http://www.acnp.org/exec_summary.pdf

The Summary is based on partial data, and the authors and the ACNP task force have ongoing substantial financial ties to the manufacturers whose drugs ACNP proclaims to be safe and effective for children. The FDA makes no such pronouncements. Furthermore, FDA notes that at least 2 published articles by ACNP task force members claiming positive beneficial results, were in fact, negative in that they failed to demonstrate a benefit. See: Laughren T. Background Memorandum to Advisory Committee, January 5, 2004, Re: Suicidality Associated with Antidepressant Drug Treatment at:

http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006B1_03_Background%20Memo%2001-05-04.htm

Of note, ACNP’s summary was (until recently) available only through ACNP’s public relations firm, GYMR. See: www.ahrp.org/risks/SSRI0204/Healy.ppt, or for an html version of Healy’s power point presentation, use google’s cache. Also: http://www.ahrp.org/risks/healy/FDA0204.php and http://www.ahrp.org/infomail/04/11/15.php

The consequences of conflict of interest are demonstrated by scientifically indefensible encouragement given by the National Institute of Mental Health to the exposure of–millions of mostly healthy American children–to powerful psychotropic drugs. The drugs may cause children permanent harm. The drugs include: stimulants, antidepressants, and anti-psychotics, and are prescribed singly and in combination (“cocktails”). Inasmuch as the scientists know that these drugs pose serious risks of harm for some children, with no scientifically demonstrable health benefit for most children, why is NIMH promoting their widespread use, and sponsoring an experiment that exposes preschool children to the psychostimulant, methylphenidate? The drug was studied by Dr. Nora Volkow, Director of the National Institute of Drug Abuse, and was found to be more potent than cocaine! Despite the fact that the long-term effects on children’s developing brains are largely unknown, NIMH is supporting the unrestricted use of psychotropic drugs in children.

The FDA has recently acknowledged that “the preponderance of evidence” shows that antidepressant drugs are of no greater benefit for children than placebo. Mounting evidence from clinical trials and family testimonies shows that some children who take these drugs are at increased risk of harm, including suicide. Yet, NIMH disregards the evidence and continues to promote the marketing interest of drug manufacturers with whom the agency and its researchers collaborate.

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

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http://www.latimes.com/news/nationworld/nation/la-na-nih13mar13,1,2083657.story?coll=la-headlines-nation
THE LOS ANGELES TIMES
THE NATION
Ex-NIH Director Now Favors Limiting Drug-Company Ties

Harold Varmus lifted conflict-of-interest rules at National Institutes of Health. Many agency officials have consulting deals with the industry.

By David Willman
Times Staff Writer

March 13, 2004

BETHESDA, Md. – The National Institutes of Health should prohibit its top officials from accepting many consulting payments from drug companies, and require public disclosure of any payments made to such officials, former NIH Director Harold E. Varmus said on Friday.

Appearing before the NIH’s blue-ribbon panel on conflict of interest, Varmus also said the agency should discourage its scientists from accepting large amounts of money from companies or spending too much time on nongovernment work.

The comments marked a turnabout for Varmus, who is now president and chief executive officer of the Memorial Sloan-Kettering Cancer Center in New York. As NIH director in late 1995, Varmus lifted an array of conflict-of-interest restrictions, including a policy that had barred the heads of the agency’s research institutes and centers from accepting consulting payments from drug companies.

Varmus at that time also jettisoned a $25,000 annual cap on the amount of money that an NIH employee could accept from outside employers and a limit of 500 hours a year on outside activities. Varmus also freed all NIH employees to accept stock or stock options from industry.

The NIH Blue Ribbon Panel on Conflict of Interest Policies is aiming to make recommendations to the current NIH director, Dr. Elias A. Zerhouni, by early May.

Zerhouni named the panel in response to a Dec. 7 report in the Los Angeles Times bringing to light hundreds of payments of consulting fees and stock options from biomedical companies to NIH employees, including two institute directors.

The Times also reported that more than 94% of the top-paid NIH employees were not filing public income-disclosure reports. The panelists on Friday did not press Varmus directly about his actions as director.

Varmus lifted the restrictions in 1995 to bring NIH policies more in line with less-stringent policies throughout the executive branch of government. At the time, Varmus did not respond to an invitation from the Office of Government Ethics to adopt more rigorous rules that would apply specifically to the NIH.

Varmus, who served as NIH director from November 1993 through 1999, said Friday that his relaxing of the restrictions “had a very salubrious effect” on hiring and retaining scientists.

On the other hand, Varmus said that he now believed top-level NIH officials should not take payments from any company that holds or plans to seek a grant from the agency. Varmus unveiled his new position in his prepared remarks to the panel and elaborated afterward with reporters.

“Institute directors should not be consulting for companies – possibly for any companies, but certainly not companies that might be candidates for grants in the NIH,” Varmus said afterward, adding that other senior officials also should be prohibited from certain outside activities.

Among the senior officials who would have been affected by the new standard recommended by Varmus is Dr. Stephen I. Katz, director of NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases. One of Katz’s consulting clients won four NIH research grants from 1999 through 2001 that were administered by his institute. Katz, who withdrew from any further drug-company consulting following the report in The Times, has said that all of his arrangements were properly approved by NIH officials.

Varmus also told the panel that sensitivity or standards regarding potential conflicts of interest must be heightened when decisions affecting research on humans is involved. Yet Varmus also advised against “overreacting” to what might be an isolated conflict of interest.

Varmus did not cite examples from his own experience. As NIH director, he played down the extent of conflict of interest in the aftermath of the May 1998 death of a woman in an agency-sponsored diabetes-prevention study. The NIH official who was responsible for overseeing that study was simultaneously a paid consultant to the Warner- Lambert Co., whose drug resulted in the woman’s liver failure.

In February 1999, Varmus told Rep. Henry A. Waxman (D-Los Angeles) that his staff had found only three other instances of potential conflicts. “These cases appear to be isolated,” Varmus wrote.

Varmus said Friday that he had concluded that institute directors, deputy directors, scientific directors and clinical directors should be required to file yearly income reports that are open to the public.

Varmus did not say how much money from, or time devoted to, industry consulting should be considered excessive. If NIH personnel are being paid by outside parties, Varmus said, the standard might be “what does someone think about when they’re taking a shower.”

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