|
[Subscribe
to SPIN]
Winding Up When We Normally Wind Down
As loyal SPIN readers already know, August tends to be a
slow news month here in Science Policy. Time spent preparing for, and
recovering from, APA Convention, along with the August Congressional
recess, usually leaves us with little to write about. However, the release
of the final report of the "National Commission on Terrorist Attacks
Upon the United States" (9/11 Commission Report) has generated
unprecedented activity on Capitol Hill during August with multiple
hearings in the House and Senate dedicated to examining the
recommendations of the Commission's Report.
Several recommendations suggest the need for greater
coordination of intelligence gathering and other counter terrorism
activities. To that end we are hopeful that the series of collaborative
workshops APA has co-sponsored through partnerships with the FBI's
Behavioral Sciences Unit, the CIA, RAND and others will inform at least
some of the legislative proposals under development. In this pre-election
season, there appears to be mounting political pressure for this Congress
to enact legislation codifying at least some of the Commission's
recommendations before adjournment on October 1. That pressure continues
to be reinforced in a bipartisan manner by individual Commission members
who regularly convey a mounting sense of urgency to overhaul the
organization of our domestic and international intelligence gathering,
analysis and dissemination efforts. Science policy staff will continue to
look for ways that psychological and behavioral science might inform those
changes. One opportunity should present itself shortly with the release of
a much anticipated report from the National Science and Technology Council
Task Force on Anti-Terrorism Research and Development which will highlight
research priorities and research resources within the social, behavioral
and economic sciences.
So in what would normally be a quiescent run-up to the
Presidential election, Congress now finds itself in the unenviable
position of having to develop a response to the 9/11 Commission Report (or
explain why it can't/won't) as well as finish work on 13 of the 14 annual
appropriations bills needed to fund the government. Science Policy staff
will be following all of the excitement under the sultry haze of an
ongoing orange alert in these, the dog days of summer.
 More
information about the hearings on the 9/11 Commission Report
[back to top]
APA Psychologists Central to Center Review
In the last issue of SPIN we reported on the release of
the Broad Agency Announcement (BAA) by the Department of Homeland Security
(DHS) for a university-based Center of Excellence in Behavioral and Social
Aspects of Terrorism and Counter-Terrorism. On August 4th, Geoff Mumford,
Director of Science Policy, met with DHS staff and staff of the White
House Office of Science and Technology Policy to discuss the progress of
the competition and how to develop a comprehensive, balanced external peer
review panel. Because letters of intent were not required under this
announcement it won't be clear until the September 30 deadline just how
many proposals DHS will ultimately receive, but DHS did receive 36 letters
of intent by the July 30 deadline, suggesting that this will be a vigorous
competition.
Inquiries from the field suggested that there are
individual scientists who have an interest in being part of a center but
may not have access to an established proposal network. In order to
facilitate requests by those trying to join an evolving center network,
DHS has developed a web database to allow would-be collaborators to
self-identify their interest area. By toggling on the "view
current opportunities" section of the website, those with
proposals under development can look for additional expertise that might
be useful in fleshing out their final proposal.
Responding to a request by DHS to nominate candidate peer
reviewers, Science Policy staff worked with the leadership of 14 APA
Divisions to solicit experts from a wide range of psychology
subdisciplines that we thought should inform the construction of a
comprehensive review. While it will be up to DHS staff to determine how to
balance the expertise from the psychology community against other
behavioral and social sciences, we are, as always, extremely grateful to
the Division leadership for their collective willingness to help with
these nominations on relatively short notice. The current tentative review
timeline would involve a mid-November external peer review, late November
site visits followed by an award in mid-December. We will continue to
monitor the
progress of this competition and report back in future editions of SPIN….may
the best Center win!
[back to top]
APA Offers Expertise for a New FDA Advisory
Panel
There has been much in the news recently about whether or
not the Food and Drug Administration has adequate safeguards in place to
govern the administration of pharmacotherapeutics to pediatric patients.
Perhaps because a number of ethical and methodological issues complicate
research involving minors, most pharmacotherapeutics have been evaluated
for safety and efficacy in adult populations and then, if administered to
children, their use has been considered "off-label" (i.e., the
use of FDA-approved drugs for purposes/populations that have not been
approved by the agency). Several high-profile controversies of interest to
psychological scientists and a range of mental health professionals appear
to have evolved as a result. Recent examples have included concerns about
whether certain acne medications or antidepressants may cause suicidal
ideation in subsets of pediatric patients. In 2003, the President signed
The Best Pharmaceuticals for Children Act (Public Law 107-109), and as amended by the Pediatric
Research Equity Act of 2003 (Public Law 108-155), it provides for the establishment of a new FDA
Pediatric Advisory Committee (PAC).
This committee "will provide advice and make
recommendations to the Commissioner of Food and Drugs on matters relating
to pediatric therapeutics, pediatric research, and any other matter
involving pediatrics for which the Food and Drug Administration has
regulatory responsibility". Although NIH and FDA have worked up a preliminary
list of 25 medications for which pediatric studies are needed (two of
which have psychotherapeutic indications), it is likely that others will
be added to the list down the line.
In August, Science Policy staff worked with Division leadership to solicit
nominations for scientists with research expertise in pediatric
populations for FDA's consideration as it assembles the new committee. A
subcommittee of the parent Committee has been established "to address
pediatric ethical issues, as well as IRB referrals related to clinical
investigations involving children as subjects and IRB referrals that
involve both FDA regulated products and research involving children as
subjects that is conducted or supported by the Department of Health and
Human Services". Interestingly, one of the first issues that the
Pediatric Ethics Subcommittee will consider at its September 10 meeting is
an NIMH intramural study to evaluate the use of dextroamphetamine in
attention deficit hyperactivity disorder (ADHD) in which both children
with ADHD and healthy children will serve as participants.
Read
background materials related to discussion of the Dextroamphetamine
protocol
Watch
a webcast or order a video/DVD of this meeting
Read relevant notices from the Federal Register
Establishment
of a Pediatric Advisory Committee
Formation
of a Pediatric Ethics Subcommittee
Notice
of a meeting of the Pediatric Advisory Committee
Notice
of a meeting of the Pediatric Ethics Subcommittee
Solicitation
of Public Review and Comment on Research Protocol
[back to top]
Stemming Drug Abuse One Formulation At A
Time
Following a very successful "Conference on the Abuse
Liability Assessment of CNS Drugs" held in October 2002 (see Drug and
Alcohol Dependence, Vol 70, Issue 3 Supplement, June 5, 2003 and November
2002 SPIN) APA will again partner with other professional scientific
societies to co-sponsor a conference examining the "Impact
of Drug Formulation on Abuse Liability, Safety and Regulatory
Decisions" to be held here in DC April 19-20, 2005. The
conference, conceptualized by the College on Problems of Drug Dependence (CPDD)
has been designed to bring together scientific, public health and
regulatory stakeholders to review the history, current issues and research
needs for the future of drug formulations. CPDD Past-President and APA
Fellow, Charles (Bob) R. Schuster will serve as Co-Chair of the conference
and CPDD member and APA's Director of Science Policy, Geoff Mumford, will
reprise his role as liaison to the co-sponsoring scientific organizations
trying to garner as much support as possible from the academic science
community.
View
the CPDD conference program for the "Impact of Drug Formulation on Abuse Liability, Safety and Regulatory
Decisions" [PDF 380K]
[back to top]
Any questions?
If you have any questions regarding SPIN or specific
science policy issues, please feel free to contact any of APA’s Science
PPO staff.
Geoff
Mumford, Ph.D., Director of Science Policy
Pat
Kobor, Senior Science Policy Analyst
Heather
O'Beirne Kelly, Ph.D., Senior Legislative and Federal Affairs Officer
Karen
Studwell, J.D., Legislative and Federal Affairs Officer
Sara
Robinson, Legislative Assistant
| 
APA's
Science Policy Insider News