Scientific Integrity

Joseph Carson (73530.2350@CompuServe.COM)
05 Mar 97 21:45:38 EST

This information is taken for the website of the Government Accountability
Project (GAP), a non-profit law firm that represents "whistleblowers" who
voice concerns about worker and public safety, health, and environment
deficiencies or infractions. The website is

Joe Carson

Striking a Blow for

Scientific Integrity


At a time when the political winds are blowing against government
oversight, corporate accountability, and employee rights, a blue ribbon
commission on scientific integrity has struck a blow for all three.

Created by Congress in 1993, the Commission on Research Integrity was
charged with preparing recommendations for Health and Human Services
Secretary Donna Shalala on a complex and .scientific issue: how to restore
accountability in federally funded medical research programs. GAP Legal
Director Tom Devine was appointed to the twelve member commission, along
with prominent leaders of universities, medical schools, hospitals, and
research laboratories across the country.

In November, after 16 months of public hearings, the commission issued its
final report, a blueprint for serious structural reform. The cornerstones
of the reform are a new Whistleblower Bill of Rights expanded liability for
scientific misconduct, controls on the government's regulatory agency on
scientific fraud and an end to long-standing secrecy rules that undermine
the public's right to know.

For GAP, the commission's work holds the promise of progress toward our
twin objectives of strengthening government and corporate accountability,
and supporting the rights of employees to speak out about wrongdoing on the
job. The Whistleblower Bill of Rights in particular, observes Devine, is a
major breakthrough. It creates a system of legal protections for
researchers, students, and other members of the scientific community who
challenge wrongdoing in federally!funded medical research If adopted, the
Bill of Rights will be the most far!reaching private sector extension yet
of the free speech legal defenses. GAP helped win for government workers in
the 1989 Whistleblower Protection Act.

The political stakes are high. The need for adequate backing for medical
research has never been greater. Modern health problems from AIDS and
cancer to Alzheimer's disease and mental illness plague American families
from every walk of life. Public demand for government support of medical
research has kept the congressional budget!cutters away from these programs
to date. In fact, the budget for Public Health Service research through the
National Institutes of Health the funding source for all federally
supported medical research was the only non military scientific research
budget to increase this year.

But the future of federally!funded medical research is in jeopardy. Members
of Congress seeking deeper deficit cuts have their eye on these research
programs. Scandals and reports of ethical misconduct have fueled the
skepticism of policymakers and many citizens. Tales of fraud are familiar:
the exposure of federal funds diverted to yachts and gold plated bathroom
fixtures, for example, helped lead to the commission's creation in 1993.
Stories of wrongdoing ! with life and death consequences --are still more
troubling. The commission heard testimony from scientists who reported
suspect research on breast cancer, immune system response, neurological
disorders, Alzheimer's disease, fetal drug addiction, anorexia, bulimia,
arthritis, and toxicity. Commission members also heard about concealment of
possibly fraudulent scientific research from patient subjects and diversion
of funds that blocked vital research efforts. Such episodes have fed
suspicion and opposition.

[Photo] Tom Devine, Legal Director, GAP

"The only realistic way for universities and research institutes to preempt
a disastrous political backlash is by adopting credible structural checks
and balances," Devine agues. The profession needs new institutional
mechanisms for integrity and accountability to avoid these scandals and
restore credibility." The litmus test of such reforms is the profession's
treatment of whistleblowers. "Everyone pays lip service to the ideal that
science is the search for truth and scientific integrity is a concern for
all. But whistleblowers actually live those values. They personify the duty
of scientists to air their concerns in the free market of ideas by
discussing when institutions suppress the truth or exhibit the 'don't want
to know' syndrome."

But in the scientific community as elsewhere, witnesses to misconduct can
expect retaliation for speaking out: despite well!touted principles of
scientific and academic freedom, the profession is not immune to familiar
patterns of retribution against those who come forward to speak the truth.
Scientists Ned Feder and Walter Stewart of the National Institutes of
Health served for years as primary liaisons with whistleblowers in the
academic world, and eventually found themselves the targets of political
pressure (See Bridging the GAP, Spring 1995) The two scientists, who have
unofficially counseled dozens of employees about blowing the whistle,
testified before the commission and served as an important catalyst in its
work. "Where you have a relatively junior scientist accusing a relatively
senior scientist, which is a very common situation we never advise
potential whistleblowers to go ahead," Feder explains. "We invariably say
to them that if you go ahead, here's what's very likely to happen: the
person against whom you are making allegations will get off scot-free, your
allegations will not be investigated properly, and you will lose your
professional career - - you'll be out of science.. "

The pattern was confirmed by some thirty whistleblowers who testified
before the commission. Some reported censorship. Others faced termination
or academic expulsion. Still others were denied access to their data and
laboratories after blowing the whistle. A few were threatened with
deportation or physical harm. Dr. Faith Fenderson's case was not unusual.
She challenged cancer research study results that consistently came out a
perfect match with what the laboratory chief announced he needed at the
beginning of the day. When she protested, she was fired. After government
investigators supported Dr. Fenderson, the cancer institute reassigned her
without duties to a room formerly used for storing hazardous wastes. She
has since resigned and gone to work for a toy company

The fear generated by such retaliation, observed commission chair and
Harvard Medical School professor Kenneth Ryan, creates "a chilling effect
on the willingness of people to come forward. "The impact on science,"
Stewart and Feder add, "is devastating: in a largely self!regulating
profession, whistleblowers are the primary vehicle through which misconduct
is exposed."

The commission's report describes the seriousness of the problem, and
recommends far reaching changes. The report proposes thirty reforms to
strengthen scientific integrity, the Whistleblowers Bill of Rights is one
of ten recommendations to curb repression while strengthening employees'
ability to effectively challenge research misconduct. The report's next
stop is the Office of Secretary and Health and Human Services (HHS) Donna
Shalala, who is charged with formally proposing government regulations on
the issue. "The past sixteen months are only the beginning of the reform
effort," observes Devine, "The larger challenge will be to move from a
paper blueprint to actually changing the law, and from there to enforcing

Meanwhile, however, the Office of Research and Integrity (ORI) at HHS will
issue interim guidelines implementing the Whistleblower Bill of Rights. The
guidelines are the government's precedent for the eventual regulations. If
universities and research institutes adopt the system voluntarily in the
interim, ORI will accept that commitment as a substitute for conventional
oversight. Currently, ORI has the impossible task of policing the entire
medical research community with a staff of less than two dozen, and has
earned a bad reputation with frustrated whistleblowers. But Devine, who
worked closely with ORI to finalize the guidelines, has nothing but praise
for the final draft guidelines, which have been endorsed by the commission
pending review by department lawyers. "ORI exercised creative leadership
with a new model for whistleblower protection. The Office could not have
gone further under current law to create an incentive for universities and
other institutions willing to prove their commitment to scientific

[photo] HHS Secretary Donna Shalala

The Commission on Research Integrity has launched an important and
innovative effort for scientific freedom and accountability. If fully
realized, the commission's work will serve the public interest in numerous

In the end, its value will be most deeply felt by those in the scientific
community who seek to speak out against wrongdoing - - scientists like
Margot O'Toole. As a postdoctoral fellow in 1986, O'Toole charged a
well!known immunologist with faking data in an important journal article.
When an ORI investigation confirmed O'Toole's findings, she faced a flood
of criticism from other scientists and heated public hearings on the
matter. Now a staff scientist at Genetics Institute, Inc., in
Massachusetts, O'Toole says, "I feel I'll always be paying the price, but I
would have to do it again. Is science or is science not based on truth and
honesty? Does accuracy of data and reporting of data matter? If you're
going to be in science, the answer has to be 'yes "

Please contact us for more information on what you can do to help in GAP's
work on scientific integrity.

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Scientific Integrity

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Research scientist Dr. Suzanne Hadley was the Deputy Director of the Office
of Scientific Integrity at the National Institutes of Health. Before her
forced removal from her position, Dr. Hadley headed official investigations
into scientific misconduct. When she investigated a Nobel Laureate, her
career ended, even though she confirmed allegations made against him.


G.A.P.'s scientific integrity program protects whistleblowers within the
research sciences who have spoken out against the pervasive problem of
scientific misconduct, misuse of funds, abuse of authority, or the
suppression or manipulation of scientific data at government agencies, in
states or major research facilities that rely on government grants.
According to the research scientists with whom we have worked, significant
research breakthroughs over the past decade, including those related to
breast cancer, diabetes, anorexia nervosa, and AIDS, have been stalled,
undermined, or impeded. For several years now, G.A.P. has worked with
scientists and researchers to expose and rectify this wrongdoing. G.A.P.'s
advocacy on behalf of scientific whistleblowers prompted Congress in 1993
to create the Commission on Research Integrity to explore and create new
standards and guidelines to address this pervasive problem.

Recent Accomplishments

* In early 1994, G.A.P. attorney Tom Devine was appointed by Health and
Human Services Secretary Donna Shalala to serve on the new Commission
on Research Integrity.
* G.A.P. crafted a Whistleblower's Bill of Rights for the Commission,
adopted unanimously.
* GAP attorneys worked informally to compel the withdrawal of a National
Institutes of Health reprimand against well-known scientific
misconduct sleuths Ned Feder and Walter Stewart.


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