(Circulation. 2001;104:e9015.)
© 2001 American Heart Association, Inc.
Circulation Newswriter
Bush Stem Cell Decision Limits Research to Existing Cell Lines
In a compromise that pleased very few, President George W. Bush said he would limit research on embryonic stem cells to existing cell lines owned by private companies and institutions that funded the work with private money. In his first major speech to the nation on August 9, 2001, the President said, "While we must devote enormous energy to conquering disease, it is equally important that we pay attention to the moral concerns raised by the new frontier of human embryo stem cell research. Even the most noble ends do not justify any means."
Yet, he continued, "Embryonic stem cell research offers both great promise and great peril, so I have decided we must proceed with great care. As a result of private research, more than 60 genetically diverse stem cell lines already exist. They were created from embryos that have already been destroyed, and they have the ability to regenerate themselves definitely, creating ongoing opportunities for research. I have concluded that we should allow federal funds to be used for research on these existing stem cell lines, where the life-and-death decision has already been made. . .This allows us to explore the promise and potential of stem cell research without crossing a fundamental moral line by providing taxpayer funding that would sanction or encourage further destruction of human embryos that have at least the potential for life."
Bush’s contention that 60 viable human embryonic stem cell lines exist raised eyebrows in the research community, as did the limits on the research. Although some scientists express relief that he did not ban such research, they were concerned that he chose the most restrictive plan he could have, short of an outright ban. The Washington Post, in an August 10, 2001, story called the decision "essentially the most restrictive use of money the administration could have permitted short of a ban."
In a released statement, Jordan J. Cohen, MD, president of the Association of American Medical Colleges (AAMC) said, "The Association of American Medical Colleges commends President Bush for his thoughtful deliberations on the question of whether federal funding should be used to support embryonic stem cell research. While we are encouraged that the President has allowed limited federal funding for this vital area of scientific discovery, conditions he has placed on this funding may unnecessarily impede the full promise of research using embryonic stem cells. . .We recognize the significant ethical issues that are raised about embryonic stem cell research and we respect the view of those who oppose such research, including some in our own medical school community. However, we are persuaded otherwise by what we believe is an overriding consideration, namely, that it would be tragic to lose the unique potential for alleviating human suffering afforded by studying stem cells obtained from embryos destined to be discarded in any case. . .We urge the Administration to work quickly to guarantee the integrity of and access to the stem cell lines the National Institutes of Health has identified."
"It’s half a loaf," said David Baltimore, PhD, president of the California Institute of Technology, in a story in the August 10, 2001, online edition of the Chronicle of Higher Education. "In some ways, that makes political sense. In other ways, it is unfortunate."
"I was very disappointed," said Dr Cohen. The compromise "will end up satisfying no one." Paul Berg, a Nobel laureate and professor emeritus of biochemistry at Stanford University, told the Chronicle of Higher Education that he was unaware that 60 cell lines exist. Berg said he would be surprised if there are >10. However, 60 cell lines would be enough to begin meaningful research.
Many in the research community had hoped that Bush would approve research under guidelines already promulgated by the National Institutes of Health. Those rules would have limited research to embryonic stem cells coming from frozen embryos whose owners had agreed to their use in research because they were slated for destruction anyway.
The decision did not find favor with those opposed to abortion. The Pope had already urged the President to ban the research, and Catholics and fundamental Christians opposed the recommendation as well.
Bush plans to appoint a council to recommend a new set of regulations, to oversee the research, and to consider the ethical questions involved in the work. The council’s chair will be Leon Cass, MD, an ethicist from the University of Chicago.
Baycol Withdrawn From Market
Bayer Pharmaceutical Division voluntarily withdrew its statin medication Baycol (cerivastatin) from the market on August 9, 2001, because of reports of sometimes fatal rhabdomyolysis, according to the US Food and Drug Administration (FDA). A story in the August 9, 2001, New York Times said the move was made because of 31 deaths that had been linked to the cholesterol-lowering medication.
It is believed that >700 000 people in the United States took the drug to lower cholesterol. Those at highest risk for developing rhabdomyolysis were also taking a drug called Lopid or were taking the 0.8 mg dose of Baycol. The FDA advised those patients to discontinue the drug.
Bayer had attempted to make warnings about combining the 2 drugs or going immediately to the higher dose more apparent, but they apparently decided that the new labeling was not doing its job. Baycol will continue to be available in Japan, where neither the high dose nor Lopid is used.
Although rhabdomyolysis is known to occur in rare instances with other statins, the FDA, in a released statement, said it occurred more frequently with Baycol than with other drugs in its class. "We are not considering any regulatory action with regard to the other statins," John Jenkins, director of the agency’s drug evaluation office, told the Washington Post.
US Department of Health and Human Services Gives States Wider Latitude in Choosing Services to be Covered by Medicaid
In a move that the Bush Administration said would reduce the number of uninsured Americans, the US Department of Health and Human Services has decided to allow states to trim some optional benefits from Medicaid and use the money saved to increase the number of people covered. At the same time, Health and Human Services (HHS) Secretary Tommy Thompson assured members of the National Governors Association that the Administration had no plans to eliminate state family planning services, according to an August 5, 2001, story in the Washington Post.
Before the announcement on August 5, 2001, many family planning advocates had voiced concerns about the agency’s refusal to grant waivers that would allow states to enroll more women in family planning programs. Many such waivers had been in limbo, awaiting approval that some feared would never come. However, according the Post story, Secretary Thompson said he expected all pending applications to be approved soon.
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