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Researchers, policy-makers, and patient advocates watching the first few weeks of the new Bush administration didn’t have to wait long for indications that U.S. health policy will see some dramatic shifts in the next four years. In addition to announcing plans to craft new patients’ rights legislation, expand coverage of prescription drugs by Medicaid and Medicare, and improve access to health insurance for the working poor, newly appointed U.S. Secretary of Health and Human Services (HHS) Tommy Thompson used the first few days of his position to announce several controversial policy shifts.
Following his Senate confirmation hearing, Thompson indicated the department would launch a new safety review of the already approved early abortion pill mifepristone (Mifeprex), re-examine federal funding of research involving the use of embryonic stem cells, and begin a new initiative to increase the number of people willing to become organ donors.
The announcements sent tremors through the research community and reproductive freedom organizations as they moved to protect their interests and those of their constituents. "One of our biggest concerns is the plan for a safety review of mifepristone," says Monica Hobbs, federal legislative counsel for the Center for Reproductive Law and Policy (CRLP) in Washington, DC. "It is our position that there is no need to review the drug; it went through a lengthy approval process by the [U.S. Food and Drug Administration] already and has been proven safe and effective to use." To re-review mifepristone at this point is simply inserting politics into a previously objective safety evaluation process, she claims.
Noting the former Wisconsin governor’s support of a state ban on "partial-birth" abortions that called for a sentence of life in prison for physicians who performed the medical procedure, the CRLP had opposed Thompson’s nomination as secretary, arguing his political stance against abortion would bias his decisions on health policy and medical research. Now, they fear their concerns may be justified.
Coming on the heels of new legislation introduced by Sen. Tim Hutchison (R-AR) and Rep. David Vitter (R-LA) to require physicians who prescribe mifepristone to meet additional regulatory standards, the new review is just another effort to block women’s access to safe, early abortions, she claims.1
Though as governor, Thompson was supportive of family planning funding, advocates are worried that President George W. Bush’s opposition to abortion will put federal Title X funding at risk. "Title X funds are the largest source of support for family planning clinics in this country," Hobbs says. "Under the previous administration, [HHS] Secretary Shalala repeatedly went to Congress to ask for increases in funding for family planning. We are concerned that this administration may want to allocate funds elsewhere previously designated for family planning. Or, they may institute the federal gag rule [prohibiting clinics receiving federal funds from giving out information about abortion]."
The CRLP and 29 other organizations recently sent a letter to President Bush asking for his support in increasing Title X funding, noting that Thompson expressed support for the program at his Senate confirmation hearing. The CRLP also is concerned about continued support for the new medical information privacy regulations announced by the HHS late last year, and the FDA’s plan to consider allowing over-the-counter distribution of emergency contraception, the "morning-after pill," says Hobbs. "We have a Top 10 list of items that we have concerns about with this administration, and those issues are on the list," she says.
Advocates for research involving pluripotent stem cells also are holding their breath as the new administration considers reversing a prior HHS policy allowing use of federal funds for stem cell research, provided it was conducted under strict guidelines.
Pluripotent stem cells, which have the potential to become any type of tissue in the human body, can be derived only from human embryos. Federal law prohibits the use of federal funds that involve the destruction of human embryos, but, last year, the HHS issued an opinion that stated federal funds could be used for embryonic stem cell research as long as federal funds were not used to derive the cells themselves (not used to fund projects that destroyed human embryos).
The department just issued guidelines on what kinds of stem cell research could be funded with federal money and outlined an approval process last spring, says Tim Leshan, director of public policy at the American Society for Cell Biology (ASCB) in Bethesda, MD. ASCB led a coalition of patient groups, medical researchers, universities, and medical societies in advocating for federal funding of stem cell research. "No projects are currently under way — researchers have just started applying for funding — but, this is absolutely the worst time to withdraw the funds. It just puts everything at a standstill," says Leshan.
Scientists believe that pluripotent stem cells may hold the key to obtaining a cure for several genetically linked diseases, such as Parkinson’s disease and Alzheimer’s, as well as hundreds of other illnesses and injuries, says Leshan.
Ironically, University of Wisconsin researcher James Thomson was one of the leaders in discovering the potential of pluripotent stem cells, and then-governor Thompson praised his and others’ efforts at the time. However, President Bush has indicated his opposition to any research using cells from aborted fetuses. Most stem cell research uses cells from embryos left over from assisted reproduction procedures or aborted fetuses. Researchers have been unable to use embryonic cells from other sources, such as embryos spontaneously aborted in a miscarriage, says Leshan.
Asked about his earlier support for stem cell research during a press conference his first day in office, Thompson indicated his position may have to change. "I’ve found out I am a cabinet member now," he told reporters.
In response to the decision, the ASCB drafted a letter to President Bush urging that he carefully consider all the implications before issuing an executive order withholding federal funds, says Leshan. The letter was signed by more than 100 professional societies, research institutions, and advocacy groups, including the:
"We are encouraged that they are examining this issue and not immediately taking action," says Leshan. "We did not get a response to our letter. But, conversations we have had with administration officials indicate that they are seriously considering the issue."
Many people in the organ transplant community speculated Thompson also might decide to make changes in the new HHS organ allocation policy, which mandated organ sharing across wider geographic regions. Wisconsin has a high rate of organ donation, and officials there filed suit against HHS, claiming the new policy would punish the state and unfairly benefit states with poor organ procurement programs. However, since that time, the impact of the change in allocation has not been as drastic as many feared, says Richard Cooper, MD, professor and director of the Health Policy Institute at the Medical College of Wisconsin in Madison. "My understanding is that the allocation approved by UNOS [the United Network for Organ Sharing] hasn’t in fact created the problem that some of the people anticipated, and therefore, we had objected to earlier," he says.
Ann Pasche, spokeswoman for UNOS in Richmond, VA, the nonprofit agency that has the government contract to administer the nation’s organ allocation lists, says they have had no indication from Thompson that he intends to seek a change in organ allocation policies. "There has been an awful lot of speculation about this in the media, but we haven’t heard anything. Right now, we are just going to wait and see," she says.
Thompson also announced plans to unveil a program to increase organ donations within the first 100 days of his term, she says. UNOS is encouraged about the news, but the organization has no details about the administration’s plans, she adds.
1. Entous A. Republicans launch new attack on abortion pill. Reuters. Feb. 6, 2001.
• Center for Reproductive Law and Policy, 120 Wall St., New York, NY 10005. Web: www.crlp.org.
• Medical College of Wisconsin, Health Policy Institute, 8701 Watertown Plank Road, Milwaukee, WI 53226. Phone: (414) 456-8762. Fax: (414) 456-6529.
• United Network for Organ Sharing, National Transplantation Resource Center, 1100 Boulders Pkwy., Suite 500, P.O. Box 13770, Richmond, VA 23225-8770. Web: www.unos.org.