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FDA recommendations on tobacco grants prompt transparency concerns

By Toni Clarke

WASHINGTON (Reuters) - Last year the U.S. Food and Drug Administration recommended that millions of dollars in research grants be awarded to scientists serving on its tobacco advisory committee, even as it rejected several projects deemed by a National Institutes of Health panel to have greater scientific merit, according to confidential scores reviewed by Reuters.

    That has raised hackles among some researchers who were passed over. They argue that FDA officials may have favored the outside experts who counsel the agency on tobacco-related regulatory matters, and that the process lacked transparency.

    Jed Rose, director of Duke University's Center for Smoking Cessation, was one of those who was rejected, despite the relatively strong score given his project by the NIH panel. He has voiced his concerns to the FDA.

    "The close association between the people who recommended which grants should be funded, and the advisers whose grants actually received funding, could have influenced the evaluation process," Rose said in an interview, adding that he was speaking on his own behalf and not for the center he heads.

    The FDA says no favoritism was involved. David Ashley, director of the office of science within the FDA's tobacco division, said the awards to the advisory committee members was "purely coincidental."

    Ashley declined to elaborate on why one project was recommended over another, saying to do so would breach confidentiality. But he said it is not unusual for scientists, including those on government advisory committees, to receive research funding since they are typically leaders in their field.

    A spokeswoman for the NIH, which administers the grants, said that while funds typically go to the best-scoring proposals exceptions may be made if a particular research niche needs to be filled. Ashley said that is what happened in this case.

    Still, some independent experts said that in the absence of any detailed rationale for the recommendations, it is legitimate for the researchers who were passed over to raise questions about the process.

    "It has an odor of insiderness and friendliness," said Dr. Jerome Kassirer, distinguished professor of medicine at Tufts University School of Medicine and former editor-in-chief of the New England Journal of Medicine.

   

    SHAPING REGULATION

    The grants were awarded in September in conjunction with the NIH to help the FDA shape tobacco regulations at a time of sweeping change in the industry. The agency is poised to regulate the nascent e-cigarette industry for the first time, yet many questions remain unanswered about the products' risks and benefits.

    The funding includes an initial $53 million, potentially rising to more than $273 million over five years.

    More than 50 research proposals were reviewed by an independent NIH panel, which scored each application based on its scientific and technical merit.

    Among the grant recipients were teams that include Thomas Eissenberg, professor of psychology at Virginia Commonwealth University; Suchitra Krishnan-Sarin, associate professor of psychiatry at the Yale School of Medicine and Dr. Jonathan Samet, a professor at the Keck School of Medicine at the University of Southern California.

    All three are members of the FDA's tobacco advisory committee, which has seven voting members and has met as many as 12 times a year since 2009, when the Tobacco Control Act gave the FDA the authority to regulate tobacco for the first time.

    What bothers critics is that the proposals from Virginia Commonwealth and Yale were deemed by the NIH review panel to have less scientific merit than rival proposals from Duke and SRI International which were rejected, according to documents reviewed by Reuters and interviews with researchers.

    Neither Virginia Commonwealth's Eissenberg nor Yale's Krishnan-Sarin would comment on their scores. USC's Samet confirmed that his score was better than the one received by Duke. The FDA and NIH declined to comment on individual scores, citing confidentiality.

    David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies, who applied for a grant but was rejected due to what he conceded was an "awful score," said the FDA's recommendations in favor of its advisers were not necessarily unreasonable.

    "You could argue that it's not totally surprising because they are some of the best scientists," he said. Still, he added, "it certainly does look a little odd."

   

    ON MERIT ALONE?

    The FDA's explanation does not satisfy Rose, who in a September letter to the agency argued that it was critical for its Center for Tobacco Products to be specific and transparent about the objective criteria underlying its recommendations.

    "Working closely with CTP in an official advisory capacity creates an aura of greater-than-usual regard and credibility that could lead CTP to value the applications of these individuals more than they would otherwise judge, based on merit alone," he wrote.

   Since some scores were skipped over, "what otherwise would have served as protection against bias on the part of CTP was abrogated," he added.

    In an October letter of response, Ashley told Rose that the awards were based on the scientific and technical merit of the project, the availability of funds, and the relevance of the proposed project to the agency's priorities. The overall score, Ashley said in the letter, which was reviewed by Reuters, "was not the sole determinate for funding recommendations."

    According to publicly available synopses of the proposals that received funding, Virginia Commonwealth's research focuses on analytical methods for evaluating whether novel products such as e-cigarettes are any healthier than traditional cigarettes, while the Yale project focuses on the impact flavors may have on initiating and maintaining tobacco addiction.

    Duke's proposal, which is not publicly available but was provided to Reuters by Rose, would have evaluated the role of an array of tobacco constituents in promoting nicotine addiction and would have studied the role of menthol in vulnerable populations, including African American smokers, among whom menthol cigarettes are popular.

    All three proposals appear to have addressed areas of research previously identified by the FDA as key. SRI International declined to discuss its project.

(Reporting by Toni Clarke; Editing by Michele Gershberg and Martin Howell)

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