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BUSH ADMINISTRATION THREATS TO SCIENCE AND SCIENTIFIC INTEGRITY
WHEREAS, the U.S. government uses vast amounts of information to make policy, guard against disease and protect the public health and welfare. It is critical that the government use accurate and unbiased scientific information to make policy; and
WHEREAS, there has been a pattern of suppression and distortion of scientific findings by high-ranking Bush administration appointees across numerous federal agencies involved in scientific findings related to air pollution, global warming, mercury pollution, childhood lead poisoning, reproductive health, and drug-resistant bacteria, all of which affect the health of all Americans and especially the health of children, including their ability to learn; and
WHEREAS, there have been irregularities in the appointment of scientific advisors and advisory panels that upset the legally mandated balance of these bodies; *and these committees are important to ensure that the best science is brought to bear to protect the public's health; and
WHEREAS, it is important that members of such scientific and public health advisory committees be the most qualified scientists and experts in their fields. Members of AFT who have served on these panels have been removed for failing political litmus tests that have no bearing on a nominee's expertise or advisory role; and
WHEREAS, the administration has placed people who are professionally unqualified or who have clear conflicts of interest in official posts and on scientific advisory committees, has disbanded advisory committees before their work was complete, and has censored and suppressed reports by government scientists; and
WHEREAS, the leadership of Health and Human Services (HHS) has taken actions to limit the free exchange of scientific information, intimidate researchers, including AFT members, and threaten the funding of peer-reviewed research relating to sexual behavior, sex education and sexually transmitted diseases including HIV/AIDS **; and
WHEREAS, these activities suggest an effort to inappropriately influence these committees, their scientific conclusions and the results of scientific research so that they will be in line with administration policy; and
WHEREAS, these actions have directly affected the service and research of AFT members as well as our health and the health of our students and clients; and
WHEREAS, the Office of Management and Budget (OMB), Executive Office of the President, through its "Proposed Bulletin on Peer Review and Information Quality,"1 is now considering requiring that all federal agencies institute a new system of "peer review" that includes procedures that differ markedly from those used that have been strongly endorsed by the academic and scientific community; 2,3,4,5 and
WHEREAS, there is no evidence that proposed new procedures are likely to improve the quality of science used in the regulatory process; 6,7,8 and
WHEREAS, the proposal unnecessarily limits agency discretion, is likely to result in delays in protecting the nation's health, safety and environment,9,10,11,12,13and may constrain public health officials from reacting quickly in times of national emergency;14,15and
WHEREAS, the proposal has conflict-of-interest provisions that could restrict many of the nation's leading academic and scientific experts from serving as peer reviewers, 16, 17 including most AFT members because they receive research funds from federal agencies such as the National Institutes of Health:
RESOLVED, that the AFT reaffirm the principle that scientific and expert advisory panels be free from the influence of parties that stand to gain financially from the panels' decisions, oppose the "Proposed Bulletin on Peer Review and Information Quality," request that OMB withdraw the proposal, and encourage other educational and scientific organizations to oppose this proposal; and
RESOLVED, that the AFT urge President Bush to issue immediately an executive order and take other actions to prohibit further censorship and distortion of scientific information from federal agencies and put an end to practices that undermine the integrity of scientific advisory panels; and
RESOLVED, that the AFT urge Congress to hold oversight hearings to investigate and assess the allegations of distortion of agency reports and the biasing of advisory panels, ensure that the laws and rules that govern scientific advisory appointments are followed, protect against the domination of such panels by individuals tied to entities that have a vested interest at stake, and that those appointed meet high professional standards and insure that the public has access to all government scientific studies and findings of scientific advisory panels; and
RESOLVED, that the AFT urge Congress to investigate and hold oversight hearings on recent attempts to undermine the scientific peer-review process at the National Institutes of Health, Substance Abuse and Mental Health Services Administration, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality; and
RESOLVED, that the AFT urge its members to encourage their professional societies and colleagues to become engaged in this issue, bring their concerns to their elected representatives, and communicate the importance of this issue to the public, both directly and through the media, including AFT publications.
[Executive Council, October 2004]
References
* Federal Advisory Committee Act, 5 U.S.C. Appendix 2, §5(b)(2); Federal Advisory Committee Act, 5 U.S.C. Appendix 2, §5(b)(3)
** HHS Seeks Science Advice to Match Bush Views. Washington Post. September 17, 2002. Bush's Science Advisors Drawing Criticism. New York Times. October 9, 2002. Advisors Put Under a Microscope. Los Angeles Times. December 23, 2002.
Kaiser, J. Politics and biomedicine: Studies of gay men, prostitutes come under. Science. 2003; 300(5618):403
1 Office of Management and Budget. Proposed Bulletin on Peer Review and Information Quality Bulletin. September 15, 2003. Available at: http://www.whitehouse.gov/omb/fedreg/030915.pdf
2 NAS President Bruce Alberts wrote to John Graham that "the highly prescriptive type of peer review that OMB is proposing differs from accepted practices of peer review in the scientific community, and if enacted in its present form is likely to be counterproductive." http://www.whitehouse.gov/omb/inforeg/2003iq/iq_list.html
3 "Calling their [the OMB] process peer review seems strange to us here" wrote Donald Kennedy, editor of Science magazine in "Disclosure and disinterest" (303 Science 15; January 2, 2004.) Kennedy is former President of Stanford University President and a former Commissioner of the Food and Drug Administration. He also chairs the National Academy of Sciences' Science Technology and Law Program.
4 According to Sheila S. Jasanoff, Pfozheimer Professor of Science and Technology Studies, John F. Kennedy School of Government, Harvard University, the OMB authors of the proposal fail to understand the difference between regulatory science and research science. "The reliability and success of regulatory, or policy-relevant, science cannot and should not necessarily be measured according to the same criteria as the reliability and credibility of ordinary research science, which is investigator-initiated or 'curiosity-driven.' …[T]he success of regulatory science includes its capacity to provide timely answers to pressing policy questions; research science operates under no comparable time pressures. Correspondingly, the procedures used to ensure the reliability and credibility may reasonably differ from one scientific context to another." [Letter to OMB, page 2]
5 Referring to its potential impact on FDA approvals of new drug applications, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserted that the proposed requirements "would contribute little value and would add to the time and expense of a gatekeeper function that has historically been criticized for obstruction and delay." [Letter to OMB, page 7] Available at:
6 Michael R. Taylor, Senior Fellow and Director, Risk, Resource, and Environment Division, Resources for the Future; and former Deputy Commissioner for Policy, Food and Drug Administration, noted "…I do think it is striking that it offers peer review as a solution, but it doesn't define the problem that it sets out to solve…[and] the proposal does not provide any examples…of cases in which the lack of adequate peer review has had important consequences for the regulatory process or society." Available at: http://www7.nationalacademies.org/stl/Peer_Review_Transcript.pdf [transcript page 210]
7 John C. Bailar III, Professor Emeritus, Department of Health Studies, University of Chicago remarked, "I would like to see a list of situations in which peer review would have been a substantial help. If nobody can produce such a list, to create such a list, that in itself would be very informative." Available at: http://www7.nationalacademies.org/stl/Peer_Review_Transcript.pdf [Transcript page 269]
8 The Association of Medical Colleges (AAMC), representing the nation's 126 accredited medical schools, 400 affiliated teaching hospitals and 94 medical societies, and the Federation of American Societies for Experimental Biology (FASEB) with more than 60,000 members "…we see no public benefit from mandating an additional layer of OMB imposition, peer review and public comment…" [Letter to OMB, page 3] http://www.whitehouse.gov/omb/inforeg/2003iq/iq_list.html
9 Two professors from Rutgers University, Stuart Shapiro (who had been a desk officer at OMB under Dr. Graham) and David Guston, provided an estimate of the costs and benefits of the proposal, applying the methods OMB would use if it were a proposal sent by an agency. Professors Shapiro and Guston's best estimate of the cost of the proposed peer review system is $325 million annually: the monetary value of the effects of delaying regulation that saves lives, protects the environment or produces other societal benefits. Available at: http://www.whitehouse.gov/omb/inforeg/2003iq/iq_list.html. Michael R. Taylor, Senior Fellow and Director, Risk, Resource, and Environment Division, Resources for the Future; and former Deputy Commissioner for Policy, Food and Drug Administration noted: "Public health agencies act all the time on the basis of emerging information, and in the face of scientific uncertainty. That is what we want them to do. This doesn't mean they should act capriciously or without careful review of the information before them. The stakes are too high to accept anything less than great care and allegiance to sound scientific practice. But if we want our public health agencies to act like public health agencies, we should not impose formal review requirements that may preclude their doing so. Thus, any OMB review mandate should include an explicit exception for cases in which the FDA commissioner, not the OIRA administrator, determines that action must be taken to protect public health." Available at: http://www7.nationalacademies.org/stl/STL_Peer_Review_Agenda.html [Transcript page 218]
10 Sheila Jasanoff, (noted above, and the author of The Fifth Branch: Science Advisors as Policymakers Harvard Univ. Press, 1990) and one of the nation's leading thinkers on the use of science in public policy warned against using peer review to "…offset the need for public-health type judgment or governmental judgment on the behalf of people, I think would be a serious mistake." Available at: http://www7.nationalacademies.org/stl/STL_Peer_Review_Agenda.html [Transcript page 87]
11 Professor Sheila Jasanoff noted further in written comments to OMB, "Through its wide-ranging application and the stringency of its requirements, the proposal is likely to have significant impact on the time and cost of policy development—and, by extension, on the capacity of regulators to effectively protect public health, safety and the environment." Available at: http://www.whitehouse.gov/omb/inforeg/2003iq/iq_list.html
12 Criticizing OMB with unusually direct language, the Pharmaceutical Research and Manufacturers of America (PhRMA) asserted that the proposed requirements [on FDA] "would contribute little value and would add to the time and expense of a gatekeeper function that has historically been criticized for obstruction and delay." [Letter to OMB, page 7] Available at: http://www.whitehouse.gov/omb/inforeg/2003iq/iq/118.pdf
13 Warren M. Washington, Chair, National Science Board; Senior Scientist and Head, Climate Change Research Section, National Center for Atmospheric Research noted: "…in some of the emerging areas of innovative research, we are finding that we only have a limited number of peers to serve as reviewers. And therefore, we have to be fairly careful about overusing some of these people. …And so, we are quite seriously concerned about imposing another layer of review burden on the science community." [Transcript, page 232]. Available at: http://www7.nationalacademies.org/stl/Peer_Review_Transcript.pdf
14 Michael R. Taylor, Senior Fellow and Director, Risk, Resource, and Environment Division, Resources for the Future; and former Deputy Commissioner for Policy, Food and Drug Administration said, "this is why I characterize this particular element of the bulletin as radical, because it does put in the hands of the OIRA administrator, the decision whether there is enough evidence to act on a public health issue. And that arguably [is] not the job there." Available at: http://www7.nationalacademies.org/stl/STL_Peer_Review_Agenda.html [Transcript page 222]
15 The Association of Medical Colleges (AAMC), representing the nation's 126 accredited medical schools, 400 affiliated teaching hospitals and 94 medical societies, and the Federation of American Societies for Experimental Biology (FASEB) with more than 60,000 members, expressed concern about "…the proposed requirements' likely interference with timely, responsible public health announcements to the detriment of the public weal. …[A]gencies in the Public Health Service must be acknowledged to have special prerogatives for evaluation and announcements of timely information important to the public health."
16 Jeffrey M. Drazen, MD, Editor-in-Chief of The New England Journal of Medicine, criticized the proposed bulletin because it would disqualify the most expert scientists from serving as peer reviewers. He notes, "In the United States, where the Federal Government is the single largest source of funds for cancer research, it would make no sense to disqualify scientists who had received federal funds to support their research from the peer review process." Available at: http://www.whitehouse.gov/omb/inforeg/2003iq/83.pdf
17 Robbins A. Science for special interests. Boston Globe, December 7, 2003.
(2004)