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Senate Measure Would Jeopardize
Research
On September 20, 2005 the Senate agreed to
a provision that would bar USDA and FDA funding from research institutions
that lawfully purchase animals from certain USDA-licensed animal dealers.
The amendment, sponsored by Sen. Daniel Akaka (D-HI), was intended to stop
research institutions from purchasing random source dogs and cats from
so-called Class B dealers. The measure was added to the FY 2006 agriculture
funding bill on a voice vote. Although it was intended to apply to
non-purpose-bred dogs and cats, the amendment was so broadly worded that it
would affect institutions that purchase any animal from a vendor with a
Class B license.
The Akaka amendment consisted of a single sentence: “None of the funds made
available by this Act may be used to provide funding to a research facility
that purchases animals from a dealer that holds a Class B license under the
Animal Welfare Act.”
The APS has urged Congress to reject the Akaka amendment because it is
represents a misguided effort to protect pets through a mechanism that would
seriously disrupt medical research. It would have a particularly significant
impact on land grant colleges and universities that receive USDA funds not
only for research but also for education and extension activities. APS
called upon the members of the House and Senate Agriculture Appropriations
Subcommittees—who are expected to serve on the conference committee—to strip
the Akaka language from the final version of the bill. “I emphatically
disagree with Sen. Akaka’s claim that USDA has failed to enforce existing
pet protection laws,” APS Executive Director Martin Frank said in a
September 26 letter. The Society is “deeply concerned about both the
intended and unintended consequences of this measure.”
The USDA licenses and inspects two categories of animal dealers, Class A and
Class B. These categories apply to those who sell any animal species
regulated under the AWA. Class A dealers are breeders who raise animals on
their own premises, while Class B dealers buy, sell, or transport any
animals they did not breed and raise themselves. The USDA currently licenses
some 1,247 Class B dealers. Some 50-100 of these Class B dealers provide
animals for biomedical research, including several major suppliers. About a
dozen Class B dealers were the intended targets of the legislation because
they supply dogs and cats for medical research and education. Akaka had
previously introduced a bill that would make it illegal for research
facilities to purchase non-purpose-bred dogs and cats from Class B dealers.
That legislation would have changed the AWA rather than blocking funding to
those who abide by it. What both measures share is the goal of eliminating
Class B dealers as a source for the non-purpose-bred dogs and cats needed
for medical research and education.
This issue revolves around a relatively small number of animals: probably
fewer than 36,000, about 40% of the total number of dogs and cats used in
research. This number is an estimate because the USDA tracks the number of
dogs and cats but does not break them down by source. In FY 2004 the USDA
reported less than 90,000 dogs and cats in biomedical research. The
proportion of purpose-bred vs. non-purpose-bred dogs and cats is based upon
reporting by research facilities in a survey the National Association for
Biomedical Research (NABR) conducted during the mid-1990s.
At one time, many of the random-source dogs and cats needed for medical
research and education were supplied directly by pounds and shelters.
However, animal activists have implemented laws and policies that make it
effectively impossible for pounds and shelters to provide animals for
research even though 3-5 million unwanted dogs and cats are put to death
each year. USDA-licensed Class B dealers are only permitted to obtain dogs
and cats from pounds and shelters, from individuals or breeders who have
raised the animals on their own premises, or from other Class B dealers. For
some research institutions, Class B dealers, who are permitted to play the
role of middle-man, are the only legally-permissible source for non-purpose
bred dogs and cats.
In his statement on the Senate floor, Akaka asserted that Class B dealers
“routinely violate the Animal Welfare Act” by obtaining dogs and cats
illegally and failing to provide appropriate husbandry and veterinary care.
He specifically mentioned one “notorious” Class B who recently pleaded
guilty to violating the AWA by falsifying animal acquisition records, but he
treated this individual’s behavior as if it were the norm. The USDA, which
has been working to enforce existing pet protection laws, clearly was
successful in prosecuting this case, but Akaka drew the conclusion that USDA
cannot enforce existing laws. Rather than urging proper enforcement, Akaka’s
solution was to bar the purchase of dogs and cats from Class B dealers. No
legislative hearings were held to provide evidence supporting Akaka’s belief
that Class B dealers ought to be eliminated.
In his floor remarks Akaka also claimed that dogs and cats with varied
genetic backgrounds are “unsuitable as research subjects in any case, since
they cannot be used as control cases or experimental animals.” However,
research protocols are designed to answer specific questions, and in some
cases animals with varied genetic backgrounds represent the most appropriate
research subjects. In addition, some research and training activities in the
areas of heart disease, diabetes, digestive conditions, or shock-trauma
requires dogs that are large in size. Such animals are readily available
from Class B dealers but not from Class A breeders. Research into conditions
related to aging obviously requires older animals, but the animals provided
by breeders are typically quite young. Moreover, in the future there may be
instances where non-purpose-bred dogs or cats represent the best animal
model of a human disease.
The APS supports the enforcement of existing pet protection legislation and
opposes efforts to interfere with research and educational activities
involving non-purpose-bred dogs and cats.
PETA settles Covance Suit
On October 17, 2005, Covance
announced that PETA and undercover operative Lisa Leitten reached a
settlement in the lawsuit suit the company filed against them in June.
Covance brought the suit after PETA accused the contract testing company of
animal cruelty. PETA bolstered its claims with video footage of primates
being handled by technicians that Leitten secretly recorded while working at
a Covance facility in Vienna, Virginia. A Covance announcement of the
settlement may be found at
http://www.covance.com/animalwelfare/media-resources.php.
In the settlement agreement,
Covance agreed to drop its suit in exchange for PETA’s promise not to
conduct undercover investigations of Covance or any of its affiliates for
five years. PETA also agreed to inform the company about any infiltrations
currently in progress. Leitten agreed never to seek future employment with
Covance or its affiliates and not to conduct undercover operations at a
commercial animal testing facility for three years. PETA and Leitten further
agreed they would not make public any materials obtained from the
infiltration other than the previously published five and a half minute
video. However, PETA and Leitten were permitted to retain a single copy of
the materials she obtained for the sole purpose of providing them to
investigators at the USDA, FDA, and the Fairfax County Virginia
Commonwealth’s Attorney. At the end of five years, PETA and Leitten will
destroy their copies of the materials.
Covance filed the suit in June charging Leitten with lying about her true
intentions to gain employment with the company and deliberately violating
her a confidentiality agreement that was part of her terms of employment.
The suit also accused PETA of engaging in a conspiracy with Leitten to harm
the company’s business and asserted that PETA interfered with Covance’s
employment contract with Leitten. According to a June 6 press release on the
Covance website, the company asked for a court order to block similar
improper acts in the future and sought “the return of all video, audio and
other materials taken by PETA and Ms. Leitten in light of their legal
obligations, except copies already provided to the regulatory authorities.”
The company wanted Leitten’s original video footage “so that it can be
examined for evidence of both (i) what Covance considers PETA’s
unsubstantiated claims of misconduct and (ii) potential distortion by PETA
to further its aim to end all animal-related research for new treatments for
serious diseases such as AIDS, cancer, and diabetes.”
Based upon a comparison of what Covance sought in its lawsuit with the terms
of the settlement agreement, the company appears to have achieved its goals.
APS Supports Multiple P. I.
Policy
The APS has provided comments
supportive of a proposal to permit more than one principal investigator on
federal grants and contracts. On July 18, 2005, the federal Office of
Science and Technology Policy (OSTP) issued a request for information on
specific topics related to the implementation of a new policy to allow
multiple principal investigators (PIs) on research grants and contracts (see
The Physiologist, vol. 48, no. 1, p. 23). “As scientific advances
increasingly require collaboration between investigators in diverse areas of
research,” the APS letter said.
“The APS believes that it is important to recognize the unique contributions
of multiple principal investigators (PIs) to research projects.” The letter
went on to say that by allowing multiple PIs on federal grants, the
scientific community “will be taking a positive step towards fostering
communication between disciplines.” Excerpts from the sections of the letter
addressing various topics are provided below. The full text of the letter is
available at
http://www.the-aps.org/pa/action/news/multipleinvestigators.htm.
On the definition of Principal Investigator: “APS believes that in order for
the multiple PI policy to succeed, the role of the PI must be clearly
defined. Each PI should have a defined responsibility for some aspect(s) of
the project and contribute creatively in a way that is critical to the
success of the research. Participation in a multiple PI grant project should
be in line with each investigator’s current, demonstrable research interest,
and should represent a major effort and not a side-involvement. Designation
as a PI should require a minimum percent effort from all parties
(approximately 20%). A researcher who contributes only a service or
technique, however specialized, but no novel concept, should not be
considered a PI. APS believes that there should be a limit on the number of
PIs allowed per project, perhaps not more than 3 for individual investigator
initiated grants (R01’s, RFA’s, etc.), as more than that would make
efficient coordination and management unwieldy.”
On the application process: “Applications for multiple PI grants should
include a rationale for the designation of more than one PI, a management
plan and individual budgets for each PI. The rationale should include a
description of the role of each PI. The management plan should include a
process for resolving any disputes, and a plan for how decisions affecting
the scientific direction of the project will be made. The individual budgets
should reflect the anticipated allocation of the grant money, but there
should also be a process put in place for reallocating funds as necessary,
with the agreement of all PIs on the project. While the preparation of these
documents may seem onerous, we believe that clear plans from the outset will
ensure maximum transparency and facilitate open communication between all
PIs and the grant-making agency.”
On PIs at different institutions: “APS supports collaboration of PIs in
different departments and institutions through participation in multiple PI
grants. The preparation of individual budgets at the outset of the grant
application process will facilitate such collaboration. By preparing
separate budgets, each institution or department will be able to determine
their share of the indirect costs of the grant and recognize the
participation of their faculty. The recognition of multiple PIs at different
departments or institutions will allow a fair distribution of credit for
important collaborations.”
On young investigators and peer review: “The APS has worked for years to
help NIH foster programs that supported the careers of young and new
investigators. Currently the NIH’s Center for Scientific Review recognizes
such investigators in peer review of their grant applications at Study
Section in an effort to promote those careers. If the multiple PI policy
were to preclude such investigators from seeking such special review, that
policy could undermine efforts to enrich the scientific community with
entering scientists. Young scientists who work with an internationally
recognized senior scientist are at particular risk even if they have been
designated a “PI” in that reviewers of their subsequent individual grant
applications would likely consider their having failed to show their own
independence of their senior colleagues.
“Regarding scientific review of multiple PI grants, the APS believes that
each grant should be evaluated by only one study section. Given the
diversity of scientific specialties that may be involved in multiple PI
grants, this may require formation of special study sections staffed by
pertinent experts.”
The letter concluded by noting that the APS believes that allowing multiple
PIs on federal grants will substantially benefit inter-disciplinary
collaboration, although “implementation of this new research model will be a
challenge.”
“This is an important policy change that we believe will allow scientists in
all disciplines to take advantage of the best new technologies and ideas,”
the letter stated.
The Challenges of Dual-Use Research:
Formation of the National Security Advisory Board for Biosecurity
In mid-October, Science (3) and Nature (2) published papers
characterizing the genome of the 1918 Spanish influenza virus. Publication
of these studies and the deposition of the genome sequence into publicly
accessible databases raise questions regarding the possible misuse of
legitimate science. Biological research on influenza can be considered
“dual-use research,” defined as work that has legitimate scientific purpose,
but that could pose a threat to the public if misused. Research on botulism,
anthrax, and smallpox has highlighted the need to manage the risks
associated with certain kinds of biological research. While most biological
research is not considered dual-use, the regulations employed have broad
influence over the scientific community as a whole, affecting who can enter
the country to study and work, who can participate in certain research
projects, and how research results are communicated. Scientists are now
facing new challenges as they deal with biosecurity regulations, even when
their work does not involve high-risk pathogens such as those listed above.
Safeguarding the public against the use of chemical and biological weapons
is a complex and difficult task. Government oversight is provided by the
many federal agencies with jurisdiction over the various aspects of
biological research, including the departments of Health and Human Services
(HHS), Commerce, Defense, Treasury and Agriculture. Without an
organizational structure in place, the process of regulating dual-use
biological research can be confusing, and risks putting in place overly
restrictive rules. In order to be effective, the government, universities
and scientists must work together to develop regulations that achieve a
balance between the free exchange of ideas and appropriate security.
For the past two decades, universities and scientists have functioned under
a National Security Decision Directive issued during the Reagan
administration (NSDD-189), which affirms the importance of openness in
research, and establishes control of potentially dangerous information by
defining research as either classified or fundamental. This bright line
definition ensures that any non-classified, fundamental research can be
freely shared in the scientific community. Following the events of September
11, 2001, worries about the misuse of research results by terrorists have
increased. A National Academy of Sciences report issued in 2003
(“Biotechnology Research in an Age of Terrorism”) recommended the formation
of an advisory council to provide guidance to the federal government on
issues of dual-use biological research. This has taken shape as the National
Science Advisory Board for Biosecurity (NSABB, see
http://www.biosecurityboard.gov).
The NSABB is charged with defining dual-use research, establishing criteria
for recognizing such research, recommending strategies for effective federal
oversight, developing a code of conduct for scientists and advising on the
publication and dissemination of dual-use research. The NSABB had its first
meeting in June, 2005 and is made up of 25 voting members appointed by the
Secretary of HHS from the fields of molecular biology, public health,
infectious disease, and national security, among others. Another 18 members
are ex-officio and drawn from federal agencies. The first meeting focused on
the Board’s goals, and discussion centered on how to achieve the appropriate
balance between an open environment for the conduct of research and the
scientific community’s obligation to protect the public from the misuse of
their work.
The efficiency of the NSABB system was tested by the publication of the
influenza papers referenced above. While editors at Science reviewed the
manuscript submitted by Tumpey et. al. (3) for biosecurity concerns, and
further consulted the director of the Centers for Disease Control, the
director of the National Institute of Allergy and Infectious Diseases and
the director of the Office Biotechnology Activities at NIH (home of NSABB),
officials at the department of HHS insisted on last minute review of the
paper by the full NSABB (1). This was accomplished in time for publication;
however, it highlighted the need to establish uniform procedures for
biosecurity review.
The establishment of the NSABB will begin to address some of the complex
problems in the field of biosecurity. Further measures will be needed to
address problems with immigration and visas for foreign scholars, control of
knowledge export and development of appropriate countermeasures.
1. Kennedy, D. Science 310, 195. 2005.
2. Taubenberger, JK, et al. Nature 437, 889-93. 2005.
3. Tumpey, TM, et al. Science 310, 77-80. 2005.
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