July 21

Staff Survey Confirms FDA Officials Tamper with Science_ Grassley Seeks Investigation of FDA

Bloomberg News reports (below) that Senator Charles Grassley has asked the Inspector General to investigate collusion between FDA officials and Merck.

Citing handwritten notes prepared by a Merck executive document a meeting with FDA division director, Brian Harvey, suggesting a joint effort "to get the message out" to discredit  Dr. David Graham who blew the whistle on the lethal Vioxx effect.  FDA officials then tried to prevent Dr.l Graham from testifying in a deposition in the context of Vioxx litigation. Their interference was overruled by the judge.

A survey of  FDA employees (1,000 out of 6,000)  by the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER)  confirms Dr Graham’s testimony about intimidation by high ranking FDA decisionmakers.

The UCS-PEER survey confirms that the integrity of science is being undermined for political and commercial reasons. FDA scientists report being afraid to speak frankly about safety concerns and feel constrained in their roles as scientists:
*    Almost one in five (18 percent) rof those who responded, "I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document."

*    More than three in five (61 percent) knew of cases in which "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."

*    Three in five (60 percent) also knew of cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions." Fifty percent also felt that non-governmental interests (such as advocacy groups) had induced or attempted to induce such changes.

*    One-fifth (20 percent) say they "have been asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials." In addition, more than a quarter (26 percent) feel that FDA decision makers implicitly expect them to "provide incomplete, inaccurate, or misleading information."

*    Two in five (40 percent) said they could not publicly express "concerns about public health without fear of retaliation." More than a third (36 percent) did not feel they could do so even inside the confines of the agency.

Most important are the reforms FDA scientists believe are necessary to address some of their concerns:

*    Nearly two in three (63 percent) said that the "laws and regulations that govern FDA, including the agency’s structure, need change for the agency to better serve the public."

*    More than four in five (81 percent) agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."

UCS-PEER Survey results at: http://www.ucsusa.org/scientific_integrity/interference/fda-scientists-survey-summary.html

Congressional pressure is mounting: legislative proposals have been introduced in the Senate–by Senator Grassley, Finance Committee chairman–and the House–by Cong. Maurice Hinchey.

Reuters reports that Senators Enzi and Kennedy of the Senate committee on Health, Education, Labor & Pensions (HELP) have drafted legislaiton to strengthen FDA’s post marketing monitoring authority. http://news.yahoo.com/s/nm/20060720/hl_nm/drug_safety_dc

Following the release of the UCS-PEER survey, Cong. Hinchey issued a statement:
"When the voices of FDA scientists are heard, it is quite clear that comprehensive reform is needed. We must end the financial link and inappropriately close relationship between the drug industry and the FDA, eliminate conflicts of interest on FDA advisory committees, and vastly improve the agency’s post-market drug safety operations. We must return the FDA to a time when science was the only consideration for approving a drug, not politics."

Contact: Vera Hassner Sharav
Grassley Seeks U.S. Probe Into FDA’s Handling of Whistleblower
By Rob Waters
     July 19 (Bloomberg) — U.S. Senator Charles Grassley asked for an investigation into whether officials at the Food and Drug Administration worked with Merck & Co. to discredit an agency scientist who publicly questioned the company’s Vioxx painkiller.
     Grassley, an Iowa Republican who chairs the Senate Finance Committee, requested the probe in a letter today to the inspector general for the Department of Health and Human Services, which oversees the FDA. Grassley cites handwritten notes he said were prepared by Merck executive Ned Braunstein documenting a meeting with an FDA division director, Brian Harvey.

     The notes suggest a joint effort by the agency and the company “to get the message out” about David Graham, a 22-year  veteran of the FDA, Grassley said. Graham testified before Grassley’s panel in November 2004, saying he’d sought to prevent the agency from approving Vioxx. Merck withdrew the drug in September 2004, after a study showed it doubled the risk of heart attacks and stroke after 18 months of use.

     “It is no secret that Dr. Graham was and is a critic of the FDA,” Grassley wrote in his letter to Inspector General Daniel Levinson. “However, that does not mean the FDA should scheme with drug sponsors to discredit its own employees.”

     Agency spokeswoman Susan Bro said she had no immediate comment on Grassley’s letter. Telephone and e-mail messages left for Harvey at his  office after normal business hours weren’t returned.
 Amy Rose, a spokeswoman for Whitehouse Station, New Jersey- based Merck, didn’t immediately respond to a message left after normal business hours.

        Graham Testimony:     Graham, currently associate director of science and medicine in the FDA’s Office of Surveillance and Epidemiology told Grassley’s panel in 2004 that Vioxx was “the single greatest drug safety catastrophe” in U.S. history and that the FDA was “incapable of protecting America against another Vioxx.”
     More recently, Graham testified in a May 9 video deposition taken in conjunction with Vioxx litigation that he “experienced threats, intimidation and actually what, in my view, appears to have been a very organized and orchestrated campaign to smear and discredit me.”

     FDA officials worked “hand in glove” with Merck to tarnish him, Graham said, according to a sealed transcript of his remarks obtained by Bloomberg News in May.

     Graham said today he believes Grassley’s interest in the case has prevented agency officials from firing him. He said he experienced “a long period of ostracism, being marginalized,” before and after the Senate hearings on Vioxx.
     “I refer to it as being exiled to the gulag,” Graham said in a telephone interview. “You don’t get invited to meetings, you don’t get consulted on drug-safety problems where your expertise exceeds that of others.”

–With reporting by David Voreacos in Newark, New Jersey, and Justin Blum in Washington. Editor: Gienger

Story illustration: For a graph of Merck’s stock price for the past year, see {MRK US <Equity> GP D <GO>}. For top health
news, see (HTOP <GO>}. For more medical-science stories, see {TNI MEDICAL SCIENCE <GO>}.

To contact the reporter on this story:
Rob Waters in Washington at (1) (415) 743-3549 or

To contact the editor responsible for this story:
Robert Simison at (1) (202) 624-1812 or

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