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Bulletin No.
12, December 18, 2001
NIGMS
Pharmacogenetics Research Network
The NIGMS
Pharmacogenetics Research Network has chosen the journal
Pharmacological Reviews to partner with the Network in publishing
summaries of data submissions to the Pharmacogenetics knowledge Base
(PharmGKB). In June
2001, the Network sought proposals for the journal partnership by
issuing a letter of invitation to interested journals. By
establishing the partnership, the Network wants to develop standard
print format reports that will help alert the scientific community
to the availability of new pharmacogenetic data sets.
The
Pharmacogenetics Research Network determined that Pharmacological
Reviews best met the criteria of: readership and impact factor;
free, full-text access to journal content; journal longevity; and
whether the publisher is mission or profit-driven. The Editor in
Chief of Pharmacological Reviews (published by ASPET) is Darrell
Abernethy, M.D., Ph.D.
PharmGKB data sets are expected to be published online in
Pharmacological Reviews in early 2002.
USP
Announces Launch of Dietary Supplement Verification Program
The
United States Pharmacopeial Convention (USP) is announcing the
availability of its Dietary Supplement Verification Program.
Based on USP's assessment of the manufacturer's capability to
produce a dietary supplement and testing to USP standards, USP will
issue a certification mark that can be used by the manufacturer on
the dietary supplement container label.
The presence of this mark on a dietary supplement product
container is an indication to the practitioner, consumer, retailer,
and other interested parties that the product contains the dietary
supplement ingredient in the designated amount, meets acceptable
limits of undesirable elements, and is manufactured appropriately.
USP
is named in the Dietary Supplement Health and Education Act
amendments (DSHEA) to the Federal Food, Drug and Cosmetic Act as the
nation's official compendium for dietary supplement standards.
USP will work with participating manufacturers in the coming
months to conduct rigorous assessments that will allow the use of
the verification mark. The
program includes: laboratory evaluation of product samples and
regular monitoring; evaluation of manufacturer's quality systems by
means of an audit; and quality control and manufacturing data
review.
The
DSVP Program does not address structure/function claims that were
created under DSHEA. The USP Council of Experts' (CoE) Dietary
Supplement Expert Committee will initially review all products
submitted for verification where safety concerns have been raised.
Commission Suggests Regulations and
Incentives Could Spur Research on Supplements
The
White House Commission on Complementary and Alternative Medicine
suggested at a recent meeting that one way to quickly spur research
on dietary supplements is to provide intellectual property
protections and patent laws that encourage research in this field.
The rationale is that if the government is going to regulate
dietary supplements as drugs it should give them similar incentives.
Industry has in the past been reluctant to the idea believing
that such changes would not be effective.
Industry maintains that it would be difficult to protect
claims on dietary supplements the way claims protect new drugs
because supplements are already in wide use.
If a company finds a new use for Vitamin C and gains
exclusive rights to a health claim, consumers would know that other
Vitamin C products have the same benefit.
If a supplement existed that was not sold on the market a
company can put the supplement through the new drug approval
process. Presumably
Congress could amend DSHEA for such legislation but there is strong
opposition by industry and among some key lawmakers to revisit
DSHEA.
Bulletin No.
11, November 12, 2001
Research
Community Focuses on Bioterror and Impact on Research
ASPET
is seeking members with expertise in various facets of chemical,
biological, nuclear, and neurobiological warfare. ASPET would like
to develop a list of individuals that could be recommended to
organizations (see below) and news organizations that are helping
develop recommendations to policy makers. Contact Jim Bernstein at Jbernstein@aspet.org.
The
AAAS is sponsoring a symposium that will look at how research
priorities are certain to be affected by the war on terrorism.
The Bush Administration and Congress are also considering
national security measures aimed at protecting citizens and vital
national interests. While many of these measures are necessary, it
is essential that the scientific community be engaged in evaluating
them and their impacts on the environment for research, as well as
carefully considering their own professional and personal roles in
this very dynamic and highly charged political environment. Speakers will include White House Science Advisor John
Marburger and
National
Academy of Engineering President William Wulf. This one-day
symposium (no-charge) will be held in the AAAS auditorium on
December 18. You may
register on-line now at: http:/www.aaas.org/spp/scifree/terrorism/regis.htm
The National
Academy of Sciences is also holding two upcoming meetings on the
subject:
November 27-28:
"Biological Threats and Terrorism: How prepared are we?
Assessing the science and our response capabilities".
Includes scientific sessions on biological agents: anthrax,
smallpox, and other toxins; barriers and opportunities to countering
large-scale disease outbreaks; control and early detection measures;
and the coordinated response and preparedness of the public health
system.
December
14: working title of the symposium is "September 11:
Implications for the Research University." This symposium
came out of a discussion hosted by the Science, Technology, and Law
Program. The theme of the symposium will be trying to assess
the implications of the terrorist attacks for the research
community. Three aspects of research universities will be
examined and the impact of terrorism assessed: (1) access to
scientific information and materials, (2) the flow and tracking of
students, scholars and faculty, and (3) the nature of research
programs. Following the workshop, working groups will be
established to analyze these issues in more depth.
If
you have interest AND expertise in these areas and would like to
participate in the meetings, please send me your name and contact
information and we will forward your recommendations to FASEB.
FASEB will be coordinating names of qualified individuals
with the NAS.
Senate Passes HHS Spending Bill,
Conference Awaits
The
Senate passed its version of the FY 2002 Labor/HHS Appropriations
bill providing NIH $23.695 billion, a $3.4 billion or 16.8% increase
over FY 2001 and $820 million more than the House bill.
The conference committee to reconcile the differences between
the House and Senate versions is expected to begin this week.
Some
Disaster Relief AIDS Animal Rights Organizations
The
American Physiological Society has posted to its website an article
designed to inform readers that some of the animal rights
organizations that receive contributions from the United Way and
Combined Federal Campaign take positions against animal-based
research. The APS urges
those who contribute to the CFC and UW make informed decisions about
designating their contributions to specific charities. The article,
"Are You Giving Money to Undermine Medical Research?" may
be found at: http://www.the-aps.org/pub_affairs/leg_act_cntr/news/money.htm.
Bulletin No.
10, October 17, 2001
Senate
Proposes $3.4 Billion, House $2.6 Billion Increase for NIH
ASPET
Report Language Included in House Committee Report
On
October 11, the full House and Senate Appropriations Subcommittee
passed their respective FY 2002 Labor-HHS-Education appropriations
bills. The House bill appropriation of $22.875 billion for the NIH,
an increase of $2.58 billion or 12.7%. The Senate Committee version
provides $23.7 billion for the NIH, a $3.4 billion or 16.7%
increase.
The
$800 million difference between the House and Senate means that
conferees will have to reconcile the difference.
Congress must work within a $686 billion total discretionary
budget to meet the Senate figure for the NIH.
Included
in the House Committee Report that accompanies the bill is language
written and supported by ASPET that encourages increased research on
botanicals within NIH’s National Center for Complementary and
Alternative Medicine:
“Herbal Medicine-
The Committee encourages the Center to enhance research to study the
basic mechanisms of action and toxicity of herbal medicine through
all available mechanisms, as appropriate, including requests for
applications. The Committee also encourages the Center to enhance
research on the risk of unanticipated and potentially dangerous
interactions between botanical
and prescription drugs and to continue to seek collaboration with
other Institutes on research opportunities on botanical drugs that
could lead to the development of new therapeutics.”
Also included is
report language on NCI dealing with natural products drug
development:
“The Committee
encourages NCI to enhance the Natural Products Drug Development
program, particularly in the area of complementary and alternative
medicine. Recent surveys indicate that a majority of cancer patients
will include complementary and alternative therapies in their
treatment regime. NCI is encouraged to support high quality research
proposals investigating cancer therapies such as iscadore and other
botanical substances. Ayurvedic, homeopathic, traditional Chinese
approaches, and alternative dietary approaches. The Director of the
Institute should be prepared to provide a progress report at the
fiscal year 2003 appropriations hearings.”
ASPET Supports
Dietary Supplement, Ephedrine Legislation
Rep. Susan Davis
(D-CA) has introduced the Dietary Supplement Information Act (H.R.
3065) and the Ephedrine Alkaloid Consumer Protection Act (H.R.
3066). ASPET has
endorsed both bills joining other signatories that include the:
American Academy of Pediatrics, Neal Benowitz, M.D.- University of
California, San Francisco, Bill Gurley, Ph.D - University of
Arkansas for Medical Sciences, Christine Haller, M.D. - University
of California, San Francisco, Allen Solomon, M.D.- Georgetown
University Medical Center, American Association of Family and
Consumer Sciences, American Cancer Society, American College of
Clinical Pharmacology, American Heart Association, American
Institute for Cancer Research, American Public Health Association,
American Society for Clinical Pharmacology & Therapeutics,
Association of American Medical Colleges, Center for Science in the
Public Interest, National Consumers League, and the
Society for Nutrition Education.
The Dietary Supplement Information Act would mandate that
manufacturers, producers and distributors of dietary supplements
would be required to register with the Food and Drug Administration.
Manufacturers will also be required to register their
specific products with the FDA. The supplement industry will
be required to submit all serious adverse event reports to the FDA
within 15 days.
The Ephedrine
Alkaloid Consumer Protection Act intends to give consumers
information about the potentially lethal side effects and drug
interactions of ephedrine alkaloid products. The legislation
requires a standardized warning to be printed on the label.
The bill would prohibit the sale of ephedrine to minors under the
age of 18 years old.
Antiterrorism
Legislation Could Restrict Access to Biological Agents, Changes to
Student Visa Program
Legislation being drafted by the House and Senate Judiciary
Committees may tighten restrictions on biological agents, requiring
HHS to ensure all research and public health laboratories and
manufacturing facilities that possess certain hazardous
microorganisms and toxins meet regulatory standards.
Certain antibioterrorism measures could result in additional
burdens on legitimate biological research, in spite of the need for
increased research on vaccines, biological sensors, new treatments
and other areas as a way to improve the nation's response to a
terrorist biological attack.
Senator Diane
Feinstein (D-CA) also was considering introducing legislation that
would reform the U.S. student visa program.
Feinstein’s bill would impose a temporary six-month
moratorium on the student visa program.
This moratorium would give the INS time to fully develop its
foreign student tracking system and to put into place the necessary
infrastructure to detect foreign students who have violated the
terms of their visas once they have entered the U.S.
At press time, Feinstein was reconsidering the moratorium
after meeting with representatives of colleges and universities.
Federal Vaccine
Manufacturing for Bioterrorism Products an Option
The
congressionally created Gilmore Commission (Gov. James Gilmore,
R-VA) that proposed the creation of the National Homeland Security
Agency recommends that the new agency’s primary responsibility be
in setting research priorities for federal agencies, including the
Department of Health and Human Services and to facilitate the
research and development of vaccines along with other non-medical
products to combat terror attacks.
The commission recommended that HHS develop a specific
comprehensive strategy for the health and medical fields and called
for the establishment of a National Advisory Board for Health and
Medicine.
The USP-NF
Becomes a Yearly Publication
Online Book Tour Highlights First Annual Edition
The U.S. Pharmacopeia (USP) has announced that its official
standards publication, the United States Pharmacopeia and the
National Formulary (USP-NF) will now be published annually with two
Supplements. The current edition, USP 24-NF 19, has been official
since January 2000. The new annual edition, USP 25-NF 20, which will
be available in November 2001, becomes official in January 2002 and
will be followed by Supplements in February and June-becoming
official in April and August 2002. An online book tour,
available at www.usp.org, will
provide interested ASPET members a quick informational overview of
the USP-NF.
Bulletin No.
9, September 26, 2001
War
Footing Refocuses Spending Priorities
Congress’ annual
end game run on federal spending priorities is usually nearing the
finish line this time of year and is characteristically marked by
partisan fighting. But
those plans and behavior were put on hold since the terrorist
attacks on New York and Washington.
Immediately and days after the attacks, all appropriations
matters, as well as scheduled hearings on stem cells, human subject
protections, and other policy matters, have been suspended.
Lawmakers unified response to the attack pushes partisanship
into hibernation.
All
past debate on spending the social security “surplus” is over.
A $40 billion emergency supplemental and future spending on
the war effort will mean that the money will have to come from
somewhere. The
non-human element of the tragedy means that all other domestic
discretionary spending programs, like the NIH, will have to wait and
see what happens next. But
no one really knows how recent events will effect future spending.
Will lawmakers be able to concede spending gains on their
favored programs? Some
details are now just beginning to emerge and it seems likely that
most programs, including the NIH, will get what was specified in the
President’s budget resolution for FY’02.
For NIH, that would mean an increase of $2.8 billion above
last years figure.
There had been talk
that Congressional leadership may postpone any action on the FY 2002
budget and pass open-ended “Continuing Resolutions”
(CR) that would keep the government funded programs operating
at current levels beginning on the new fiscal year, which begins
October 1. A two-week CR is being considered that would fund the
government through October 15.
Congress would like to finish all 13 individual spending
bills, but there is a good chance that some of them, including the
Labor-HHS spending bill that funds NIH, will be rolled in some sort
of omnibus spending bill. One
emerging contentious issue is whether the White House will support
$4 billion additional education spending without seeking $4 billion
in cuts from other spending. If
the President insists on these offsets, settlement of spending bills
once again becomes a problem.
Improved
Public Health Surveillance and Readiness Needed for Biowarfare
One week before the
terrorists’ attacks, Senate Foreign Relations Committee Chair Joe
Biden (D-DE) held the first of several planned hearings on
bioterrorism threats and the U.S. readiness to respond.
Former CIA Director James Woolsey and former Sen. Sam Nunn
(D-GA) said the country is unprepared for bio-terror attacks.
"We need to recognize the central role of public health
and medicine in this effort and engage these professionals fully as
partners on the national security team," Nunn said.
Nunn also recommended that stockpiles of pharmaceuticals and
vaccines should be built up, intelligence gathering and surveillance
be beefed up, and plans be made for the best use of hospital
resources in light of mass casualties.
According to the
Dept. of Health and Human Services, anti-bioterrorism efforts will
focus on improving the nation's public health surveillance network;
strengthening local medical response capability; expanding
pharmaceutical stockpiles; conducting more research on disease
agents and vaccines and regulating shipment of hazardous biological
agents. President
Bush’s budget proposed spending $1.75 billion for defense against
weapons of mass destruction in FY’01.
This number will certainly be increased significantly.
A White House
report released to Congress prior to the attacks says the NIH is
looking to build a government owned and commercially run facility to
produce vaccines for bioterrorism attacks.
The Bush administration had asked for a $43 million increase
in FY’02 spending for vaccines.
A government owned
facility was thought of as one way to overcome the private sectors
reluctance to develop products with, what was believed to be the
case before September 11, no market.
In its FY’02 budget, the NIAID proposed to fund basic and
applied research of biological agents such as anthrax, plague, and
smallpox. NIAID has
already issued four requests for applications to stimulate research
in these areas.
BIO (the
Biotechnology Industry Organization) has been asked by HHS and FDA
to communicate with biotech companies regarding concerns that their
research, manufacturing or contract facilities become a source of
biological agents that could be used by terrorists; and whether
their company has in place procedures to raise an alert in the event
of an unusual order of a product that could relate to terrorist
activity.
NIH
Security Note
ASPET members
coming to Bethesda for NIH business should be aware that security at
the campus has been tightened and could delay your scheduled time
for arriving at a meeting. The
problem is particularly difficult during the morning rush hours with
hundreds, thousands of cars entering the campus and being stopped at
security checks.
Bulletin No.
8, August 16, 2001
Stem
Cell Research Advocates Plan Post-Recess Action
Legislation
to expand the federal government's role in funding human embryonic
stem cell research may gain momentum once Members of Congress return
from their August recess. The Senate Health, Education, Labor and
Pensions Committee plans to hold a September 5 hearing to review
proposals introduced by Sen. Bill Frist (R-TN) and one by Sen. Arlen
Specter (R-PA).
The
Chair of the Committee, Sen. Ted Kennedy (D-MA) is supportive of
moving beyond the Bush proposal that limited work on existing stem
cell lines. However,
the Committee’s ranking member, Judd Gregg (R-NH), said he
supports more funding for studying adult stem cells and no funding
to create or destroy human embryos.
Specter
hopes to pass a bill that would allow federal funding to extract
stem cells from embryos that would otherwise be destroyed. Specter's
bill would allow for federally funded research and require the
National Institutes of Health to write guidelines.
NAS
Report on Trends in Federal Research Funding
A National Academy
of Sciences report on trends in federal research funding confirms
what everyone knows: more money is going to biomedical sciences and
less to physical science and engineering.
The findings show that: in 1999, 46% of all federal funding
for research went to life sciences and 31% for physical sciences and
engineering; over a period from 1993-1999, funding for physics,
geology and electrical, mechanical, and chemical engineering dropped
by 20% or more in real terms; but funding for astronautical
engineering rose 80% and oceanography 47% in the same time frame. In fields where there is less federal support now than in
1993, both graduate school enrollment and the number of students
receiving PHD’s have declined.
The full report is available at http://www.nap.edu/books/0309075890/html/.
Animal
Rights Groups Asks Supporters for Tax Rebate
PETA
and the political action committee of the Humane Society of the
United States are asking their supporters to sign over their tax
rebate checks to the animal rights movement.
HSUS has asked that rebates be donated to Humane USA,
"the nation's first major political action committee singularly
devoted to the task of electing humane-minded candidates to federal
and state office."
"At
no other time in history have so many positive legislative actions
been taken to improve the treatment of animals," the rebate
appeal claims. The
letter, signed by Wayne Pacelle, Humane USA Chairman and Vice
President for Government Relations of HSUS, says "Our financial
and
campaign support for candidates is paying enormous dividends."
PETA is asking the public to "Put Your Tax Rebate Check
to Work" and specifically to support its campaign against
animal research by the U.S. Environmental Protection Agency.
Bulletin No.
7, July 16, 2001
NIH
Draft on Stem Cells Supports Need for Animal Models of Human Disease
A NIH report on
human embryonic stem cells prepared for HHS Secretary Tommy Thompson
in late June states that human stem cells should be transplanted
into animal models of human disease, and animal transplantation
models be used to help answer whether embryonic stem cells are more
versatile than adult stem cells. The draft says trials of stem cells
in humans cannot move ahead until the relationship between
unregulated growth potential and stem cells is further evaluated.
"It is essential that careful toxicology studies are performed
that are of the appropriate duration and that involve
transplantation into immunocompromised animals of undifferentiated
or partially differentiated embryonic stem cells, as well as adult
stem cells."
President Bush is
expected to make a decision sometime soon on whether to allow
federal funding of embryonic stem cells move forward.
Bush is grappling with the moral, ethical, and political
issues involved in allowing the research.
At issue in the controversy is the Clinton Administration's
interpretation of the existing federal ban on embryo research as not
applying to work with embryonic stem cells so long as the cells had
been extracted with private funding. NIH was to begin review of
grant applications for this research but HHS Secretary Tommy
Thompson stopped it pending a review of the Clinton Administration
interpretation.
NIH
Appropriations
With the
congressional appropriations process moving forward, bills that fund
the NIH and NSF face big problems.
The Labor, HHS bill that funds NIH will in all likelihood not
be marked up until September. The
problem for this bill is that despite having FY’02 $119.8 billion
for discretionary programs (10 billion more allocated than in FY
’01) like the NIH, the Congressional Budget Office estimates that
the Labor/HHS subcommittee actually would need $111.5 billion just
to keep programs at a freeze level.
Add in the proposed record NIH increase, Bush’s education
initiatives, additional funding for all other programs in the bill
and the $119.8 billion allocation suddenly is not enough.
In recent years,
Congress has “found” money to pay for programs.
But this has happened with record budget surpluses that
allowed Congress to be generous. Tax cuts and a slowing economy may
show that these surpluses have moved closer into deficit territory.
White
House Panel Suggest More $$$ for DSHEA
The White House
Commission on Complementary and Alternative Medicine is expected to
recommend increased funding for FDA that would allow for full
implementation of the laws regulating dietary supplements.
The Commission is also considering ways to improve FDA’s
adverse event reporting system and allowing incentives for
supplement makers to apply for NDAs order to make health claims.
A final report by the Commission is expected in March 2002.
A draft has not been made public but is reportedly on its way
to HHS secretary Tommy Thompson.
New NCI Web
Site For All NCI-Supported Research
NCI
has created a comprehensive, easy to use source of information about
current NCI-supported research. The Cancer Research Portfolio http://researchportfolio.cancer.gov/
is a new NCI web site containing information on approximately 9000
research projects, including grants, contracts, and clinical trials
active in Fiscal Year 2000. The site will allow research scientists
to more easily identify scientists doing similar work, as well as
contacts for multidisciplinary research and collaborations.
Bulletin No.
6, June 29, 2001
PRAT Fellowships
for Postdoctoral Scientists at the NIH
The Pharmacology
Research Associate (PRAT) Program of the NIGMS sponsors postdoctoral
fellows conducting research at the NIH in the pharmacological
sciences. This can include research in the areas of signal
transduction, drug metabolism, immunopharmacology, chemistry and
drug design, structural biology, endocrinology, neuroscience,
clinical pharmacology, among other areas. Potential fellows
make an application together with a preceptor to the PRAT program.
Selected fellows receive a two-year appointment, salary, supplies
and travel funds from the NIGMS to support research in the
preceptors’ laboratories. Candidates may apply prior to
coming to NIH or FDA, or they may have started postdoctoral research
at NIH or FDA within the 12-month period prior to the application
receipt deadline. Applications are due on or before January 3,
2002 for fellowships starting in October of that year. Only
U.S. citizens or permanent residents are eligible. Contact the
PRAT Program Assistant at 301-594-3583 or prat@nigms.nih.gov to
request a PRAT fact sheet and an application kit or visit the NIGMS
home page at http://www.nih.gov/nigms/about_nigms/prat.html
to view the PRAT fact sheet.
Bush Decision on
Stem Cells Imminent
A decision by the
Bush Administration to allow federal funding of human embryonic stem
cell research is expected soon and the issue has received widespread
publicity among all national news sources. There has been
increased pressure from within Republican ranks calling for
President Bush to change his campaign pledge opposing federal
funding for research utilizing human embryonic stem cells and to
instead allow the work to proceed. The message from some
conservative, traditionally pro-life Republicans is that supporting
stem cell research is in fact a pro-life position. Sen. Orrin Hatch
(R-UT) who once advocated a Constitutional amendment allowing
Congress and the states to ban abortions, wrote letters to Bush and
HHS Secretary Tommy Thompson urging them to allow the NIH to fund
stem cell research. "Mr. President, once you have
considered all the complexities of the questions at hand, I hope you
will conclude, as other pro-life, pro-family Republicans such as
Strom Thurmond (R-SC), Gordon Smith (R-OR), Connie Mack (R-FL,
retired), and I, that the best course of action is to lead the way
for this vital research.” Hatch, who until the recent
Democratic take-over of the Senate chaired the Judiciary Committee,
asserted "after reviewing the relevant statutes and
regulations, I conclude that there is no mandatory legal barrier
under federal law to federal funding of research on human
pluripotent embryonic stem cells."
Early this year Bush
held up NIH’s attempt to allow NIH grantees to work with stem
cells derived from embryos even though they are prohibited by law
from conducting research with the embryos themselves. Bush
said he wanted to review all the science and legal issues before
making a final decision on whether NIH should proceed with funding
the research.
Working Group
Calls for Major NIH Initiative on Construction of Extramural
Facilities
At the June 7 meeting
of the Advisory Committee to the Director of NIH, a special working
group called upon that agency and the federal government to
substantially increase direct funding and other financial support
for construction and renovation of extramural research facilities.
Among its many findings and proposals, the group urged Congress and
NIH to increase funding to support federal grants for facilities
construction and renovation, suggested the federal government create
a loan guarantee program to assist institutions in securing lower
interest rates on debt financed construction, and recommended that
OMB Circular A-21 be modified to allow a partial reimbursement of
the capital costs from monies contributed directly by institutions
to construction costs.
Bulletin No.
5, May 15, 2001
NCCAM Explores New Opportunities for Future
Collaboration with Industry
NIH’s National Center for Complementary and
Alternative Medicine (NCCAM) held a colloquium on May 14, 2001, to
explore opportunities to collaborate with industrial stakeholders
that produce, label, and market dietary supplements and other
biologically based treatments, and organizations that develop and
apply standards to determine quality and safety of these products.
The purpose of the meeting is to begin a dialogue on how NCCAM and
industry can work together to definitively evaluate CAM therapeutic
products for composition, safety, and efficacy, and to obtain input
from the broad stakeholder community. Meeting planners announced
that JAMA would provide a complete summary of the meeting in an
upcoming publication.
Leaders from key federal government regulatory
agencies, major industrial, non-profit, consumers, and researcher
groups addressed important topics including: the role of NCCAM and
the NIH Office of Dietary Supplements in studying CAM therapeutics
within the context of the NIH mission, the scope of interests and
needs of the CAM therapeutics industry in developing and marketing
CAM therapeutics, which aspects of the existing NIH models for
NIH-industry collaboration are relevant and which are not?, and do
issues of intellectual property and proprietary reagents enter into
the ability of the NIH to undertake or collaborate in studies of CAM
therapeutics?
Sen. Harkin Opposes Amending DSHEA; States
Seek Regulatory Guidance
Sen. Tom Harkin (D-IA), who wrote the 1994
Dietary Supplement Health and Education Act (DSHEA) that governs FDA
regulation of dietary supplements, said that he is against amending
the existing law. Harkin stated at a policy conference that
the legislation already provides adequate safety with the authority
it gives FDA to pull unsafe supplements from the market.
Harkin admitted that FDA’s adverse event reporting system is
broken but that this is not DSHEA’s fault. FDA is
currently reviewing the legislative history to see if the law allows
the agency to implement mandatory adverse event reporting.
A HHS Office of the Inspector General report has called for
mandatory adverse event reporting.
The Association of Food and Drug Officials
(AFDO), an association of state regulatory officials, has been
working with FDA to develop some understanding of how the agency
interprets DSHEA. Because FDA does not have resources to carry
out inspections of food retail markets and restaurants, states
assume much of this burden. AFDO notes that states’ main
focus is food not drugs but that they would like to be at least
knowledgeable about DSHEA even if they can’t help with its
implementation. AFDO notes that dietary supplements are
pharmacologically active drugs and provide more than nutrition, but
they do not have expertise to begin to regulate these products.
Thus, some states are seeking regulatory guidance from FDA.
Animal Rights Coalition Hires Bob Dole
Lobbyist and former Senator Bob Dole
reportedly has signed on with a coalition of animal-rights groups to
promote coverage of rodents and birds under the Animal Welfare Act
(AWA).
According to the May 11 issue of Science magazine, Dole signed a
letter for advertising purposes for the Working Group to Preserve
the AWA. In that letter, Dole reportedly says that arguments
claiming the AWA does not cover rodents are "preposterous…We
certainly did not intend to exclude [from regulation] 95 percent of
the animals used in biomedical research." Dole helped
write portions of the AWA while a U.S. Senator.
Stem Cell Review Meeting Canceled;
Administration Review Continues
The NIH cancelled a scheduled April 25 meeting
of the Human Pluripotent Stem Cell Review Group (HPSCRG). NIH
canceled the meeting due to the ongoing department review of the
stem cell issue. During recent testimony before the Senate Labor/HHS
& Education Appropriations Subcommittee, HHS Secretary Thompson
said that the HHS General Counsel legal opinion that allowed the NIH
to pursue stem cell research activities is currently under review.
He also indicated that NIH is in the process of "conducting a
scientific review" of stem cell research. According to
the secretary, the legal review and the NIH scientific review will
be submitted to him in early June.
Congress Debates NIH/CDC Funding Dilemma
Congressional appropriators are faced with
their annual dilemma of which agency will pay for the NIH increase.
This issue has become more pronounced as NIH is enjoying the
successful momentum of the five year to double the agency’s
budget. At odds with this bipartisan support for NIH is
growing awareness that other federal agencies conducting important
research will pay for NIH’s success. President Bush has
proposed that $164 million be cut from the Centers for Disease
Control but that NIH receive a $2.8 billion increase. Both
agencies are funded by the same appropriations subcommittee.
Any attempt to restore funds to CDC would likely come from any
increases to the NIH budget. "My responsibility as
chairman and as a member of this committee is to make the best
judgment about the use of the resources that we have," House
Labor/HHS Subcommittee Chair Ralph Regula (R-OH) noted. "We
have difficult priority choices and CDC is obviously very
important...These are decisions that the committee will have to
make, and I'm not prepared to make a flat out statement as to how we
will allocate resources."
Bulletin No. 4,
April 30, 2001
NCCAM Explores New Opportunities for Future
Collaboration with Industry
NIH’s National Center for Complementary and Alternative Medicine
(NCCAM) will hold a colloquium on May 14, 2001, to explore
opportunities to collaborate with two key groups: Industrial
stakeholders that produce, label, and market complementary and
alternative medicine (CAM) therapeutics (e.g., dietary supplements
and other biologically based treatments), and organizations that
develop and apply standards to determine quality and safety of these
products. The purpose of the meeting is to begin a dialogue on how
NCCAM and industry can work together to definitively evaluate CAM
therapeutic products for composition, safety, and efficacy, and to
obtain input from the broad stakeholder
community.
Senator Tom Harkin (D-IA), who spearheaded legislation to create
NCCAM (formerly the Office of
Alternative Medicine), will open the colloquium: Exploring
Opportunities for Collaboration with Industry with an overview of
NCCAM's legislative mandate. Stephen E. Straus, M.D., Director of
NCCAM will discuss NCCAM's perspective with respect to opportunities
to establish collaboration with industry.
Leaders from key federal government regulatory agencies, major
industrial, non-profit, consumers, and researcher groups will
address important topics to include: (1) The role of NCCAM and the
NIH Office of Dietary Supplements in studying CAM therapeutics
within the context of the NIH mission, (2) The scope of interests
and needs of the CAM therapeutics industry in developing and
marketing CAM therapeutics, (3) Areas of interest common to NCCAM
and the CAM therapeutics industry, (4) Areas of complementary
expertise contributed by NCCAM and the CAM therapeutics industry,
and (5) Regulatory authorities and responsibilities of other federal
agencies. Additional information, including an agenda and featured
speakers at this meeting is available at: http://www.nccam.nih.gov/nccam/colloquium.
Stem Cell Review Meeting Canceled; Administration Review
Continues
The NIH cancelled a scheduled April 25 meeting of the Human
Pluripotent Stem Cell Review Group (HPSCRG). NIH canceled the
meeting due to the ongoing department review of the stem cell issue.
During recent testimony before the Senate Labor/HHS & Education
Appropriations Subcommittee, HHS Secretary Thompson said that the
HHS General Counsel legal opinion that allowed the NIH to pursue
stem cell research activities is currently under review. He also
indicated that NIH is in the process of "conducting a
scientific review" of stem cell research. According
to the secretary, the legal review and the NIH scientific review
will be submitted to him in early June.
Bulletin No. 3,
March 1, 2001
Bush Budget Proposes 13.8%, $2.8 Billion
Increase For NIH
President Bush’s FY 2002 budget proposal includes a $2.8 billion
increase to $23.1 billion for the NIH. This would be a 13.8%
increase over the FY 2001 appropriation of $20.3 billion. The
president’s proposed increase would be the largest in percentage
and real dollars in NIH history. But it also falls short of
Congressional efforts to double the NIH by 2003 (a 16.5% increase to
$23.7 billion would be needed to remain on track for the doubling).
Several days prior to his formal release of the budget to Congress,
the President unveiled his budget priorities that included education
and health care needs: “We recognize the federal government plays
a very important role in researching cures for disease, and
therefore, our budget increases the NIH budget for 2002 by $2.8
billion, the largest increase in that department's history." By
almost any measure, the President’s proposal is remarkable and
medical research advocates hope they can increase that amount to
maintain the momentum towards the doubling effort.
The budget proposal indicates the administration intends to save
money in HHS with unspecified cuts to programs to help train health
professionals, and the elimination of the $125 million Community
Access Program, launched by the Clinton administration to try to
better integrate the delivery of healthcare services.
HHS Secretary Visits NIH, Encourages Applications For Stem Cell
Grants
The Bush Administration will decide this summer if it will allow
federal funding of embryonic stem cell research. HHS Secretary Tommy
Thompson visited the NIH campus February 28 and said that scientists
are encouraged to submit stem cell research applications to meet the
grant deadline of March 15. He indicated the decision would be made
within the four months between the March 15 deadline and the time
awards are now scheduled to be made.
An interpretation of the law by the Clinton Administration's HHS
General Counsel's office has ruled a provision forbidding research
on human embryos does not cover embryonic stem cell research because
"such cells are not human embryos."
Thompson also met with acting director Ruth Kirschstein and other
institute directors to discuss what could be accomplished with the
Bush Administration's first budget proposal for the agency.
Thompson noted that one problem is how to keep researchers and
physicians at NIH and how to attract bright young minds to science
and medicine. Thompson indicated that he did not think the naming of
a new “permanent director” would be done soon although it is a
high priority. He said the White House had two or three names
and asked NIH directors to provide him with additional names for
consideration.
Bulletin No. 2,
February 15, 2001
Bush Budget for NIH Due Soon? House Science
Committee Chair Speaks on NIH
President Bush is expected to submit his outline for the
administration’s FY 2002 budget proposals in late-February but
that might be delayed. A more comprehensive budget will be
unveiled, possibly in late March or April. Bush has stated he
supported the doubling effort for the NIH and OMB officials are
telling advocacy groups that this commitment is firm although no one
will confirm numbers. Keep in mind that a large increase for the NIH
proposed by the President will make NIH a big target for later cuts
since any significant increase will come at the expense of other
programs.
House Science Committee Chairman Sherwood Boehlert (R-NY) said his
committee would look into the balance between biomedical and other
federal research funding and of the impact of growing links between
research universities and industry. The Science Committee has no
jurisdiction over NIH funding. Boehlert, speaking before the annual
meeting of the Universities Research Association said that he would
continue to support increases in research funding, particularly for
“physical sciences.” However, Boehlert said that while NIH
increases the past few years "certainly gives one the feeling
that things may be out of whack…given the public concern with
health and the advances in biology, why shouldn't NIH get a larger
share of the pie?"
Boehlert also said "an honest, open look" at
university-industry partnerships "should help make them more
productive rather than hampering them." Rep. Boehlert's speech
to the Universities Research Association is available online at http://www.house.gov/science/ura_013101.htm
Specter Stays As Chair of Senate Labor/HHS and Education
Subcommittee
Senator Arlen Specter (R-PA), Chair of the Senate Appropriations
Subcommittee on Labor, Health and Human Services and Education,
announced that he would remain as chair of the Subcommittee. Specter
last summer announced that he would resign his chair largely due to
the frustration he felt over what has become annual dueling over
priorities and growth of the spending bill. Specter is a strong
supporter of the NIH and his previously announced “resignation”
concerned the biomedical research community, particularly with the
retirement of Specter’s House counterpart John Porter (R-IL), that
NIH would be without its most effective congressional advocates.
Specter cited the importance of “continuity” of efforts to help
ensure the doubling of the NIH budget by FY 2003 and to help
“liberate medical researchers from any restrictions on the use of
discarded embryos to produce stem cells and discarded fetal tissue
which are key to curing Parkinson's, Alzheimer's, spinal cord
injuries, heart disease and, perhaps cancer and other diseases.”
Also, Specter together with Senator Tom Harkin (D-IA) introduced a
resolution (S. Res. 19) to express the Sense of the Senate that the
funding for the NIH should be increased by $3.4 billion in FY 2002.
Eleven other senators cosponsored the resolution. Both the Ad Hoc
Group for Medical Research Funding and FASEB have proposed a $3.4
billion increase in the NIH budget as the fourth step in doubling
the NIH budget by FY 2003.
FASEB
FASEB is planning to develop a high-profile publication to highlight
research of the FASEB member societies involving animals. This
publication would be disseminated to media and also to Voluntary
Health Associations.
Bulletin
No. 1, January 16, 2001
FIRST DIRECTOR OF NEW NIH CENTER
John Ruffin, Ph.D., was named the first Director of the newly
established National Center on Minority Health and Health
Disparities (NCMHD) at the National Institutes of Health. The new
Center will conduct and support research, training, dissemination of
information, and other programs about minority health conditions and
about populations with health disparities.
The specific goals and purposes of the new Center include the
following:
· To assist in the development of an integrated national health
research agenda, across disciplines, that reflects the current and
emerging health needs of racial and ethnic minorities and other
health disparity groups.
· To promote and facilitate the creation of a robust minority
health research environment with sustained funding for a wide
breadth of studies -- basic, clinical, and population research;
studies on the influences of health processes; and research on the
societal, cultural, and environmental dimensions of health -- all
aimed at identifying potential risk factors for disparate health
outcomes.
· To promote, assist, and support research capacity building
activities in the minority and medically-underserved communities,
focusing on research infrastructure development, faculty career
development, and increasing the number of underrepresented minority
students and students
from health disparity groups with an interest in careers in
biomedical and bio-behavioral research.
Dr. Ruffin has over 25 years of experience in developing and
administering innovative programs designed to train the next
generation of minority scientists and improve the health of minority
populations. He received his Baccalaureate Degree from Dillard
University and Master's Degree from Atlanta University. He earned a
Ph.D. at Kansas State University in Systematic and Developmental
Biology, followed by Postdoctoral Studies at Harvard University.
NIH Increases Training Stipends
NIH will increase stipends for National Research Service awards
(NRSA) to pre-doctoral and postdoctoral trainees. The new
predoctoral stipend is $16,500; postdoctoral stipends range from
$28,260-$44,412. The budgetary changes will take effect for NRSA
Awards made with FY
2001 funds.
New Labor-HHS Subcommittee Chair
Rep. Ralph Regula (R-Ohio) succeeds retired Rep. John Edward Porter
(R-Ill.) as the chair of the Labor, HHS, Education, and Related
Agencies Subcommittee. The Subcommittee has jurisdiction for funding
the NIH. Rep. Henry Bonilla (R-Texas) will chair the Agriculture
Subcommittee, which has jurisdiction over FDA.
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