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 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.
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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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