The Bush Administration Proposal on Peer Review - A Cause for Concern?
Late last year the Bush Administration proposed a new policy that would block the adoption of new federal regulations unless the science being used to justify them meets the requirements of a new, centralized peer review process that would be overseen by the White House Office of Management and Budget (OMB).
The Administration issued a proposed rule -- technically a "bulletin," an OMB term for legally binding language meant to guide federal agency actions -- that would require a new layer of OMB-approved peer review of "any scientific or technical study that is relevant to regulatory policy." The proposal details exhaustive procedures that federal agencies would be required to follow, from tallying which documents will be reviewed to screening out anyone with a potential conflict of interest.
Under the current system, individual agencies typically invite outside experts to review the accuracy of the science and the scientific information they offer -- whether it is the approval of new prescription drugs, restrictions on stem cell research, health effects of diesel exhaust, or details about food safety. The proposed change would take away much of that independence. It lays out specific rules regarding who can sit on peer review panels -- rules that, to critics' dismay, explicitly discourage the participation of academic experts who have received agency grants but are almost silent on the involvement of industry-funded researchers. In addition, the proposal would grant the Administration final say as to whether the peer review process was acceptable.
ASH sent comments to the OMB on the proposal. The ASH letter described the Society's serious concerns regarding the potential negative impact of the proposal on respected and demonstrated practices in determining scientific merit and its potential effect on the public's health. In particular, ASH noted the following concerns: First, the proposed peer review selection criteria would severely and unnecessarily restrict an agency's access to the most qualified expertise; second, the proposal sets forth an extensive list of reporting requirements that could discourage candor or even participation in review panels; and, third, the proposed requirements would delay the implementation of important public health protections by public health service agencies. The letter, signed by ASH President Stanley L. Schrier, M.D., concluded by urging the OMB to withdraw or significantly alter this proposal to allow regulatory agencies to adopt review processes that are most appropriate for their charge and mission.
Since publication of the ASH comment, a number of scientific organizations, public health associations, citizen advocacy groups, and even a group of former government regulators have publicly expressed their concern that the proposal appears to be an effort to inject politics into the world of science and is an attempt to delay rules that could cost regulated industries millions of dollars.
Administration officials say the approach reflects President Bush's commitment to "sound science."
The debate over the OMB effort is just one in a series of recent battles involving claims of politicization of science under President Bush. The latest of these disputes regards the president's dismissal of two members of his council on bioethics.
As of press time for The Hematologist, OMB had not yet finalized its proposal. For more information about the OMB Proposed Bulletin on Peer Review and Information Quality and/or to review a copy of the ASH comment letter, please go to the ASH Web site.
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Stem Cell Research Could Be A Ballot Issue in California
A group of prominent researchers and patient advocates is gathering signatures to get a proposition on the November California state ballot that could make $3 billion available to California scientists for human embryonic stem cell research.
The coalition, Californians for Stem Cell Research and Cures, aims to counter a 2001 order by President Bush that limited federal funding of the work, as well as attempts by Congress and an increasing number of states to ban the research by Congress.
President Bush ordered the National Institutes of Health (NIH) not to fund any research on stem cells that were harvested from embryos after August 9, 2001. The NIH identified 78 cell lines that met all the restrictions; only 12 of those lines remain available for study.
The proposed "California Stem Cell Research and Cures Act" would create the California Institute for Regenerative Medicine to administer grants and loans for stem cell research, including nuclear transfer or research cloning. The money would be raised from the sale of state-backed bonds. $3 billion in state bonds would be authorized to provide an average of $250 million per year over a ten-year period to fund stem cell research by scientists at California's universities and other advanced medical research facilities throughout the state. About one-third of the money would be spent on separate facilities to keep federally funded research at arms' length. By comparison, the federal government awarded $10.7 million for stem cell research in 2002.
The measure has the support of the Christopher Reeve Paralysis Foundation and the American Diabetes Association. Researchers who support the proposal include Nobel laureates Paul Berg of Stanford University, University of California San Francisco Chancellor J. Michael Bishop, and California Institute of Technology head David Baltimore.
While the initiative allows for the replication of stem cells, it specifically prohibits cell cloning aimed at reproducing life. However, many religious and anti-abortion groups oppose this initiative.
In addition, because of California's large budget deficit, any measure with a cost associated with it is likely to face opposition. Supporters point out, however, that the proposal protects the state budget because the initiative is designed so that the state would share in royalties that result from the research.
A study paid for by the initiative's supporters found that those royalties could generate revenue for many decades. Interest and principal payments on the bonds would be postponed for the first five years. During those years, construction and new jobs that the research would generate are expected to create about $70 million in new tax revenue. Further, proponents argue that the initiative could eventually lead to disease cures that would significantly reduce the state's health care costs, which are now more than $112 billion annually.
The campaign's organizers report that they have raised $2.5 million toward a goal of $20 million. They need to gather 600,000 voter signatures by April 16 to qualify for the November ballot. More information about the California Cures initiative and coalition is available at www.curesforcalifornia.com.
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