| WASHINGTON, July 11
WASHINGTON, July 11 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
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
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
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.
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
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,
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
"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