7/11/14, "FDA recommendations on tobacco grants prompt transparency concerns," Reuters, Toni Clarke, Washington
"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
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.
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.
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
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
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
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
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
ON MERIT ALONE?
The FDA's explanation does not satisfy [Duke's] 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
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
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."
Comment to Reuters article:
State corruption?! Here we have the F.D.A. selling research grant money right out in the open!"
News that doesn't receive the necessary attention.
Saturday, July 12, 2014
FDA has steered millions in tobacco research grants to scientists who advise it on government regulations. Since tobacco regulation was given to FDA in 2009 advisors can influence acceptance of novel and lucrative products such as e-cigarettes-Reuters
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