European Welfare Standards May Affect US Research
The Institute for Laboratory Animal Research (ILAR) held a workshop
in November 2003 on “Development of Science-Based Guidelines for
Laboratory Animal Care.” The event was intended to provide a forum for
laboratory animal veterinarians, regulators, and researchers from around
the world to discuss proposed revisions to European animal welfare
standards. Most participants were from the US, Western Europe, and Canada,
with a few representatives of Asian and African nations. The US sponsors
of the conference included the Office of Laboratory Animal Welfare and
National Center for Research Resources (both at the NIH) as well as AAALAC,
International.
Information about the program, plus some of the speakers’
PowerPoint presentations, is available at the ILAR website at
http://dels.nas.edu/ilar/SBG_agenda3.asp.
An expert working group assembled by the Council of Europe (COE) is
currently developing proposals to revise the animal welfare standards
contained in Appendix A of the “European Convention for the Protection of
Vertebrate Animals Used for Experimental and Other Scientific Purposes.”
This document is commonly referred to as European Treaty Series (ETS) 123
and is one of the framework treaties for the Council of Europe (COE). ETS
123 grew out of a 1971 debate in the European Parliament. However, the
consultation process was lengthy, and the original treaty was not
finalized until 1986 and only took effect in 1991 after ratification by
the requisite number of COE members.
The elements of the proposed revisions to Appendix A completed thus far
would require significant enhancements to animal facilities and would
mandate that environmental enrichment be provided for most lab animals.
The ILAR workshop was intended to provide a forum for representatives of
the scientific and laboratory animal medicine communities in the US to
discuss with their European counterparts the extent to which the ETS 123
proposals reflect current scientific understanding of the needs of lab
animals, as well as the proposals’ potential impact on science.
The COE is an international organization founded in 1949 to help
standardize social and legal practices across post-War Europe. COE
recommendations are advisory in nature, meaning that its treaties or
conventions are not binding on its 45 member nations. The COE is a broad
umbrella organization, and its conventions provide a non-binding social
consensus. However, the international organization known as the European
Union (EU) does have authority over its members’ internal affairs.
The EU, formerly known as the European Economic Community or Common
Market, is a political and economic union with the authority to set
standards to be applied within member nations. The goal of the EU is to
promote free flow of trade and create a “level playing field” in economic
interactions among its select group of 15 member states. EU members are
obliged to incorporate its Directives into their national laws, a process
known as harmonization.
In 1986 the EU approved Directive 86-609 based upon COE’s animal
welfare standards, and this made it necessary for EU members to pass laws
implementing these standards. Thus, the current draft of COE
recommendations would have the force of law if the EU adopts them.
The current draft revisions to Appendix A have been under
development for several years by a working group of experts from
international organizations representing groups ranging from scientists,
lab animal veterinarians, the pharmaceutical industry, and animal breeders
to animal activists. The diversity of its members makes it seem likely
that the working group was dealing with political as well as animal
welfare concerns. It was scheduled to complete its draft by fall 2003 but
it is unclear when the recommendations will be finished. The proposed
revisions will be submitted to COE member governments for review and then
will go to the European Parliament for approval before being submitted to
the member states for ratification. Certain elements of the draft have
already provoked concern because of the proposed requirements that would
be complex and expensive to implement and do not seem to be justified by
current scientific knowledge about animal welfare.
The draft proposals would require animals to be housed in enriched
environments that permit the expression of normal behaviors. More cage
space would be allocated per animal, and most would have to be housed in
compatible social groups. Enhanced mechanical systems such as ventilation
may also be required. AAALAC International has provided an overview of
some of these proposed changes at
http://www.aaalac.org/connection_3sp2003.htm.
Topics discussed at the ILAR conference included the draft
proposals themselves; the process involved in developing them; scientific
findings with a bearing upon the draft proposals; differences in animal
welfare systems among the nations represented; and the extent to which
efforts should be made to seek international “harmonization” of animal
welfare requirements.
Advocates of the changes argue that they will improve the welfare
of laboratory animals. However, some of those present at the ILAR workshop
asserted that there is insufficient evidence that animals would benefit
from them. In addition, some of the changes may affect the baseline of
variables being studied. For example, there is some evidence that cage
environments may influence physiological parameters. Although this
evidence has not yet been well documented or characterized, if this does
prove to be the case, the implementation of new standards in Europe may
make it difficult to compare European data with data generated elsewhere.
This could have an impact on the ability of scientists to compare their
findings or to collaborate internationally.
One frequent topic of discussion was how regulators should proceed
in the absence of sufficient scientific data. When adequate scientific
data are lacking, other kinds of “evidence” were suggested as possible
guidance, including scientific principles, expert opinion, and daily
experience with proven methods and practices. The term “good practices”
was generally seen as preferable to “best practices,” which tend to become
a de facto standard. John Miller, Executive Director of the Association
for the Assessment and Accreditation of Laboratory Animal Care (AAALAC),
said that when standards adequate to meet animal welfare needs are already
in place, the burden of proof to justify new requirements is on the
regulator. In such cases, proposed changes should be of clear benefit to
animals, should not interfere unnecessarily with research, and should be
science based.
There is also an animal welfare paradox inherent in the proposed
changes. Timo Nevalainen of the University of Kuopio Finland, told the
conference that there is sometimes an “either-or” choice to be made in
terms of refining a procedure or reducing animal numbers since refined
procedures may require larger numbers of animals to produce valid results.
Speaker Gilles Demers of the International Council for Laboratory Animal
Science said that in the area of testing, reduction of pain and distress
is considered a higher priority than reduction of animal numbers.
Nevertheless, the public is mainly concerned seeing a reduction in animal
numbers and may not appreciate the fact that higher animal numbers may be
one of the “costs” of reducing pain and distress.
Controversial VA Research Chief Resigns
Chief of the DVA Office of Research Development (ORD) Nelda Wray
resigned December 4, 2003. Wray’s 11-month tenure was marked by
controversy over cancellations of previously approved grants and an effort
to institute a mathematical formula to measure researcher productivity.
Wray cited health concerns in her resignation.
Previously associated with the Houston VA Medical Center where she
was in charge of the health outcomes research unit, Wray came to
Washington with ambitious plans to redirect VA medical research. She
sought to shift the DVA research portfolio away from basic research in
favor of outcomes research.
Wray made her mark on April 1, 2003, when 18 VA researchers received word
that funds for their work would not be forthcoming despite the fact that
they had previously been told that their merit review scores placed them
in the fundable range. Wray justified this “de-funding” on the basis of a
secondary review of researcher productivity using a new mathematical model
she had devised. In a June 6, 2003 interview with The Washington Fax, ORD
Deputy Director Mindy Aisen defended Wray’s action. Aisen said it was ORD
staffers who were at fault because they had assured investigators that
their grants would be funded at a time when the agency was operating under
a continuing resolution and did not yet know what its FY 2003 budget would
be.
Wray’s “de-funding” action set off a firestorm of protest within the
scientific community. The American Society for Biochemistry and Molecular
Biology called it “nothing less than an assault on the principle of peer
review.” Wray quickly reversed course, restoring at least one grant and
providing bridge funding for the remaining investigators. Nevertheless,
she continued to court controversy by proposing to require merit reviewers
to use a mathematical formula to determine research quality. The formula
weighed the number and quality of publications as well as other grant
funding from both VA and non-VA sources.
APS President John Williams urged Wray “not to implement this new
numerical scoring system but rather to provide appropriate guidance” to
peer reviewers. He emphasized that the “proposed performance criteria are
not reflective of productivity across disciplines and in different types
of research projects” and they “have not been validated as predictors of
performance.”
The controversy also came to the attention of the Congress. Senate
Veterans’ Affairs Chairman Arlen Specter (R-PA) and Ranking Member Bob
Graham (D-FL) raised the issue in a letter to Veterans Affairs Secretary
Anthony Principi. “Peer reviewed research is a well-established process
conducted consistently throughout the federal research community,” Specter
and Graham wrote. “Any changes to this clearly understood and
congressional supported mechanism must be well justified.”
Jonathan Perlin, formerly the Veterans Health Administration’s chief
quality and performance officer, has been appointed as Acting Chief
Research and Development Officer.
FY 04 Funds Await Final Nod; FY 05 Prospects Are Grim
Congress was scheduled to return on January 20, 2004, to begin the
second session of the 108th Congress. One of the first items on the
Senate’s agenda was expected to be final approval of fiscal year (FY) 2004
funding for the NIH. The House passed an omnibus funding measure on
December 8, 2003 to provide funds for the NIH and numerous other agencies.
However, because a key Senate Democrat refused to allow the measure to go
through on a voice vote it was held over until the new session began.
The omnibus bill would theoretically give the NIH $27.98 billion,
an increase of 3.7% or $1.0 billion over last year’s funding. This sum
will be subject to an across-the-board cut of .59% to bring about a
reduction in total government spending. In addition, the NIH budget will
again be subject to administrative transfers of funds for program
evaluation and the global HIV/AIDS fund. Once these reductions are taken,
the NIH program level is expected to be $27.05 billion, providing an
effective increase of some $736 million or 2.8% over the FY 2003 funding
level of $26.98. The APS advocated $30.06 billion for the NIH in FY 2004.
The FY 2004 omnibus also contains $5.6 billion for the National
Science Foundation (NSF). This represents an increase of $300 million over
its FY 2003 level and includes a total of $4.3 billion for research, $156
million for equipment and $945 million for education. The APS advocated
$6.39 billion for the NSF to make it possible for its budget to double by
FY 2007.
Even while final action on FY 2004 funding was still pending, grim
news began to leak out about prospects for FY 2005 funding. The New York
Times reported on January 2, 2004 that President Bush would request an
increase of 3% or less for NIH in FY 2005. Unnamed administration
officials told the paper they were concerned about the ability of the
agency to manage another large infusion of funds. Some in the research
community were expecting the administration’s proposed increase for the
NIH to be as low as 2.5%.
Sustain NIH Increases, Nobelists Tell White House
On November 20, 2003, three Nobel Laureates met with Bush
administration officials to make the case for sustaining the nation’s
commitment to biomedical research in the coming years. Nobel Laureates
Thomas Cech, Sidney Altman, and Sherwood Rowland participated in the
meetings with Vice President Dick Cheney, Office of Management and Budget
Director Joshua Bolten, and senior White House staffers. FASEB President
Robert Wells accompanied the delegation.
FASEB sought these meetings to explain to top administration
officials the critical importance of sustaining the investment made during
the five-year doubling of the NIH budget. The Nobel Laureates explained
the danger to research efforts from rapid budget growth followed by sharp
funding reductions. They urged that a significant increase be recommended
for the NIH in the FY 2005 budget, which is scheduled for release in early
February.
“The legacy of the [NIH] budget doubling is at stake now,” the
Nobel Laureates told the White House officials. The group also discussed
the interrelatedness of all scientific disciplines and the importance of a
balanced funding portfolio. They urged that support for the life sciences
be complemented by investments in the physical sciences and mathematics.
FASEB President Robert Wells told reporters afterwards that the
message the group tried to convey was the importance of scientific
research, and that the discussions were “engaging.” In addition to the
meetings with Cheney and Bolten, the group met with White House Deputy
Chief of Staff for Domestic Policy Harriet Miers and White House Office of
Science and Technology Policy Director John Marburger.
NIH Issues Conflicts of Interest Rules
On January 5, 2004, NIH unveiled new rules to address issues
relating to conflicts of interests among scientists serving as peer
reviewers. The new rules were scheduled to go into effect on February 4,
2004.
The rules, published in the Federal Register on January 5, state
that scientists on peer review panels must recuse themselves from
reviewing grants in which they have a financial interest totaling more
than $10,000. This is an annual total that includes consulting fees,
honoraria, and ownership of corporate stock. However, the rule provides
that the NIH Director may still allow the scientists to participate in
reviews if they are deemed to have unique expertise and the conflict is
not substantial enough to bias the review.
The rule would also require that scrutiny be given to any peer
reviewer with ties that might constitute an apparent conflict of interest.
In those instances, NIH peer review staff would estimate the risk of bias,
but the NIH Director could provide a waiver.
The new rules were published at a time when financial conflicts of
interest involving NIH staff have come under intense scrutiny. In a
December 7, 2003 article, the Los Angles Times reported that some senior
NIH officials received thousands of dollars in consulting fees from
pharmaceutical companies whose products were being used in NIH clinical
trials. Anthony Demsey, a senior advisor for policy at the NIH’s Office of
Extramural Research, said the timing was coincidental because work to
develop the new rules began in 1996. The new rules provide an update and
clarification of 1982 rules.
These latest incidents have also drawn the attention of Congress.
In a December 8, 2003 letter, House Energy & Commerce Committee
Chairman W.J. (Billy) Tauzin (R-LA) and Oversight & Investigations
Subcommittee Chairman James Greenwood (R-PA) asked NIH for information
about the incidents reported in the Los Angeles Times. The items requested
included NIH memos and letters relating to the approval of NIH scientists
to serve as paid consultants for drug companies receiving NIH funding, as
well as a list of approved consulting agreements and other records.
“The receipt of outside payments, even though approved, raises concerns
about whether the integrity of NIH clinical research has been affected and
whether the honor system used by NIH to enforce recusals signed by NIH
scientists and other conflict-of-interest rules [have] been violated,”
Tauzin and Greenwood wrote in their letter. The Energy and Commerce
Committee is expected to hold hearings on this issue.
In response to the congressional inquiry, NIH Director Elias
Zerhouni has ordered a review of outside consulting arrangements made
within the past five years. He has also set up a blue ribbon commission to
look at solutions to this problem.
AAAS Launches Science and Security Web Site
In December 2003, the American Association for the Advancement of
Science (AAAS) launched a web site dedicated to the topic of science and
security in the post-September 11th world. The site can be accessed at:
http://www.aaas.org/spp/post911.
Visitors to this web page can find issue briefs and resource pages
on various topics involving the intersection of science and national
security since the World Trade Center attacks. Topics addressed include
visa restrictions for foreign students; new rules for working with select
biological agents; handling sensitive and classified information; and
scientific publication policies. For each of these topic areas there is a
background brief with hyperlinked citations to related publications as
well as a resource page with links to additional sources of information.
The site also features AAAS articles and publications, such as the
AAAS News article, “Fear of Foreigners May Slow Scientific Progress,” and
the AAAS Special Report, “Science & Technology in a Vulnerable World.” In
addition, the site offers an area where scientists can share their
experiences with post-September 11th security policies.
“Making Science News” Symposium Returns at EB
2004
The obesity epidemic…SARS…heart disease—the list of recent news
stories written on science-based issues goes on and on. These articles are
part of a growing niche in the media for science and health news.
Journalists are eager to report on new research in the life sciences. Many
reporters have a moderate knowledge of the sciences and some even have
subscriptions to scientific journals. They are becoming more receptive to
scientific information, especially that which affects human health and
personal quality of life. A growing number of reporters have become
proactive in their approach, contacting scientists to explore new research
on the horizon.
What does this mean to APS members? This ever-expanding interest in
scientific news is an opportunity to assist in public understanding of and
garner public support for scientific and biomedical research. Not only are
there many more occasions to publicize scientific studies, but there is
also a higher probability that scientists will be called upon by the media
to explain these studies. Helping scientists to take advantage of these
opportunities is the aim of the “Making Science News” symposium, sponsored
for the second consecutive year by the APS Communications Committee.
“Making Science News” will feature a panel of three journalists
(from TV, newspaper and radio) who will offer their insight into what
makes science news and the best practices for getting scientific research
covered. The symposium will also feature a hands-on session with medical
publicist Donna Krupa about how scientists can work with the media. This
will take the form of a mini-workshop where participants can engage in
practical exercises. Those interested in participating in the workshop
portion of the symposium are asked to register by April 2, 2004 at
http://www.the-aps.org/press/conference/eb04/sciencenews.htm or email
Stacy Brooks (sbrooks@the-aps.org)
for more information.
The goal of this symposium is to familiarize scientists with how the media
works. By preparing scientists to sculpt clear, media-ready messages, the
scientific community assists in bringing accurate information to the
public. The symposium is open to all and will be held in the Washington
Convention Center Room 140A on Saturday, April 17, 2004 from 2-5 pm.
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Experimental Biology ‘04
Public Affairs Workshops and Symposia
Open to all EB Registrants
Saturday, April 17
Human Research Protections 1a:
How to Navigate Human Research
Protection Regulations
http://www.asip.org/mtgs/EB04/hrtpp.htm
9:00 am-11:00 am
Convention Center, Room 101
This workshop will provide an introduction to principles of bioethics and
current US federal regulations for protecting human subjects involved in
research. The workshop will describe a comprehensive program of
protections that an institution can provide to protect human subjects and
conduct good scientific research. Emphasis will be on the roles of
Institutional Review Boards (IRBs) and investigators in protecting
research subjects and will include a comparison of the “Common Rule” with
HIPAA concerning the use of human biological materials. There is no
charge, but seating is limited so you must register to attend. Contact:
Tara Zeitner at 301-634-7950.
IACUC 101 for Scientists: Dealing With Problem Areas
http://www.the-aps.org/pa/IACUC/eb04.htm
11:00 am-3:00 pm
Convention Center, Room 146B
This presentation moves beyond the basics of IACUC to address
issues that may require special attention from the IACUC, including the
role of IACUC as facilitator or research, conducting semi-annual program
review and facility inspection, protocol approval monitoring and more.
Participants will be able to pose questions to representatives of USDA,
OLAW, and AAALAC. There is no charge for this session, but seating is
limited so pre-registration is encouraged. Contact: Alice Ra’anan at
301-634-7105 or araanan@the-aps.org.
Making Science News
http://www.the-aps.org/press/conference/eb04/sciencenews.htm
2:00 pm-5:00 pm
Convention Center, Room 140A
The goal of this symposium is to familiarize scientists with how
the media works. The ever-expanding interest in scientific news is an
opportunity to assist in public understanding of and public support for
biomedical research. Helping scientists to take advantage of these
opportunities is the aim of this symposium. A panel of three journalists
will offer insight into what makes science news and the best practices for
getting scientific research covered. Contact: Stacy Brooks at 301-634-7253
or sbrooks@the-aps.org.
Sunday, April 18
The New CSR Review Process: An NIH Review
1:00 pm-2:30 pm
Convention Center, Room 147A
This session will present an overview of the changes to Initial
Review Groups at NIH’s Center for Scientific Review that are being
implemented as a result of the recommendations of the Panel on Scientific
Boundaries of Review.
Monday, April 19
Scientific and Regulatory Challenges Involving Dietary Supplements and
Botanical Products
12:30 pm-2:00 pm
Convention Center, Room 143/AB
Confirmed Speakers:
Marc McClellan, Commissioner, Food and Drug Administration
Paul Coates, Director, Office of Dietary Supplements, NIH
Stephen Straus, Director, National Center for Complementary & Alternative
Medicine, NIH.
Topics to be addressed include: how to promote a stronger
scientific foundation at the FDA and the need to promote better health
through better research; how new collaborations with NIH will help to
improve our understanding of the underlying mechanisms of action and help
to improve safety and efficacy of these products; research opportunities
for the extramural community; and regulatory perspectives on the Dietary
Supplement Health & Education Act of 1994 (DSHEA).
Will You Still Fund Me Tomorrow?
The Deficit, Bioterror, and the NIH Roadmap
3:00 pm-4:30 pm
Washington Convention Center, Room 207B
Join NIH Director Elias Zerhouni, MD, and several NIH institute
directors in a panel discussion to address how a radically changing
environment will impact NIH grantees in the coming years. Zerhouni and the
other speakers will discuss the prospects for NIH funding in light of
increasing federal budget deficits, the need for biodefense spending, and
the NIH Roadmap. They will also address how the roadmap initiatives will
complement or compete with investigator-initiated research and how the
various institutes and centers will implement and plan for future Roadmap
projects.
Tuesday, April 20
Sustaining Integrative & Organ Systems Sciences: Problems,
Opportunities, Solutions
12:30 pm-2:00 pm
Convention Center, Room 143C
Confirmed Speakers: Jerry Buccafusco, Medical College of Georgia; Gerald
Schaefer, Wil Research Laboratories, Inc.; Steve Zeisel, University of
North Carolina; Irv Zucker, University of Nebraska; Stanley J. Wiegand,
Regeneron Pharmaceuticals, Inc. Other speakers to be announced.
The advent of molecular biology has produced a vast wealth of
information on human health and disease. However, there has been a
diminishment in the number and ability of trained investigators-and
students pursuing training and research-in the integrative and organ
systems sciences. Science cannot effectively study disease or treatments
for a disease simply by using isolated molecules, cells, or organs.
Speakers will give their perspectives on the challenges and opportunities
for enhancing the integrative & organ systems sciences by addressing its
impact on both academic and industrial concerns.
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