Thursday, December 27, 2007

Stem Cells and the President — An Inside Account By Jay P. Lefkowitz

Source: https://www.commentarymagazine.com/viewarticle.cfm/Stem-Cells-and-the-President-br--An-Inside-Account-11024?page=all



January 2008

On August 9, 2001, President Bush announced a compromise decision on the contentious question of whether the federal government should provide financial support for research into the curative properties of human stem cells extracted from embryos.


Bush’s compromise allowed funding for research into embryonic stem cells that had already been harvested. At the same time, he disallowed funding for procedures that would collect stem cells from frozen (but still living) embryos, since doing so would require their destruction. In the case of those already collected, he said, “The life-or-death decision has already been made.” But that life-or-death decision would not be made anew with taxpayer dollars.


This decision pleased no one. The New York Times set the stage for what would become an enduring critique of Bush and the Republican party when it declared the next morning that the new policy would severely “hamper the government’s ability to spur this important new area of medical research.”


The President got a chilly reception from his supporters on the Right as well. Comparing certain kinds of stem-cell research to the practices of Josef Mengele, the notorious Nazi doctor, Ken Connor of the socially conservative Family Research Council called the decision a “blot” on Bush’s record. Judie Brown, the president of the American Life League, told the Times that the President “can no longer describe himself as pro-life.”


The criticism did not subside over time. Democrats sought to use the stem-cell issue to their advantage, and succeeded. Over the next years, to spectacular fundraising effect, the party would tout its vehement opposition to Bush’s policy. In 2006, a close Senate race in Missouri tilted decisively toward the Democrats after the airing of an emotionally affecting television advertisement featuring the actor Michael J. Fox, who suffers from Parkinson’s disease and who attacked the Republican candidate for his retrograde position on the matter. That victory in Missouri was a key factor in the Democratic takeover of the Senate from the GOP in November. When Democratic Congresswoman Nancy Pelosi assumed control of the House of Representatives in early 2007, she declared that undoing the Bush policy was one of her top priorities.


For their part, Republicans have mostly remained in a defensive crouch on the issue, and have tried to avoid discussing it at all. But Bush himself has never wavered, and last year he even used the first two vetoes of his tenure to repel congressional attempts to override the policy.


And then, in November 2007, something remarkable happened. Two of the world’s leading scientific journals, Cell and Science, published findings from researchers in the United States and Japan demonstrating a technique that allows, without the destruction of human embryos, the creation of stem cells identical to those taken from human embryos. The significance of the innovation was undeniable. George Daly, a researcher at the Harvard Stem Cell Institute, called it “just a spectacular, spectacular advance. It will change everyone’s thinking about the field.” Ian Wilmut, the Scottish researcher who became famous for his role in cloning Dolly the sheep a decade ago, told the Daily Telegraph he would no longer pursue cloning to produce stem cells, making use instead of this new and wholly uncontroversial method.


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We do not know enough yet to say whether, or to what degree, Bush’s refusal to allow federal funding to create new embryonic stem-cell lines played a role in compelling scientists to find a different approach to the issue. We do know that, in the aftermath of last November’s announcement, several leading scientists have suddenly testified in public to having harbored the very same moral doubts that led Bush to his 2001 decision. James Thomson, the foremost stem-cell researcher in the United States, put it plainly: “If human embryonic stem-cell research does not make you at least a little bit uncomfortable, you have not thought about it enough.”


This was not, to put it mildly, a view openly expressed by the scientific community in the years between Bush’s decision and the discovery of the new method. But remarks like Thomson’s, and the fact that a scientific advance unthinkable in 2001 has rendered one of the ugliest controversies of the decade all but moot, suggest that it is time to revisit Bush’s decision to see what lessons can be drawn from it.


In the United States, domestic policy is usually made when Congress sends the President a piece of legislation. He and his administration will often have been deeply involved in the crafting of that legislation, which he is then given to sign or to veto. In this case, in part by statute, and in part (as we shall see) because of a legal finding by the Clinton administration, Bush found himself with the sole authority to decide how the National Institutes of Health (NIH) should apportion its research dollars on stem cells. The decision was his to render, and his alone.


Months before his final announcement, Bush personally set in motion a highly unusual process of deliberation inside the White House. The process combined philosophical and scientific research with investigations into both the morality and the practicality of various policy options. As the White House official primarily responsible for advising the President on this issue, I had a unique perspective on the controversy surrounding it and on the making of the policy announced in August 2001. Now that this policy appears to have been both vindicated and superseded, it seems to me legitimate to speak publicly about the mechanics of what happened inside the White House during those months.


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There are all kinds of stem cells. Adults and children have them, animals have them, and they exist in the placenta of pregnant women and in the umbilical cord of infants as well. Stem cells are of special interest because they can “differentiate”—i.e., transform themselves into other cell types—and this ability has suggested that they may present a key to curing diseases and abnormalities at the most basic level of life. As for stem cells derived in particular from human embryos, many scientists believe that they have a unique quality—they are able to transform themselves into any type of cell in the human body. Theoretically, then, an embryonic stem cell could ultimately play a part (in a process using recombined DNA) in replacing any defective body tissue or diseased organ.


When Bush took office in January 2001, only a handful of scientists, led by James Thomson, were conducting research on embryonic stem-cell “lines”—i.e., generations of cells from a single source that had been grown and replicated in test tubes. (Thomson, working with the Israeli scientist Joseph Itzkowitz, had first isolated human embryonic stem cells in 1998.) While no federal law banned such research if funded privately, there had also been no federal support of it. This was owing to the Dickey Amendment, a piece of legislation passed in 1995 that precluded federal funding of “research in which a human embryo or embryos are destroyed.”


In 1999, the situation changed somewhat when one of President Clinton’s lawyers advised that the wording of the Dickey Amendment might, after all, permit some public funding of human embryonic stem-cell research—if, to be precise, the embryos had been previously destroyed through the use of private funds. The technical rationale was that, under such circumstances, taxpayer dollars would not be going to research “in which” embryos were destroyed. The Clinton administration drew up guidelines to support federal funding based on this legal position, but did not implement them prior to Bush’s inauguration.


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My own involvement in the issue began several weeks after Bush took office in January 2001, when I was serving in the White House as general counsel in the Office of Management and Budget. On February 21, 80 Nobel laureates signed a letter to the President urging federal funding for research on embryonic stem cells. Then, on March 6, Tommy Thompson, the newly installed Secretary of Health and Human Services, told a Senate panel that a law restricting such research would trouble him. The next day, a member of the White House press corps asked Ari Fleischer, Bush’s press secretary, if the President agreed with Thompson. Fleischer responded, “The President is very understanding and respectful of the promises of science, but he’s very concerned about any procedure that would involve taking stem cells from fetuses that are viable.”


The very next day, Nightlight Christian Adoptions, an organization devoted to protecting frozen embryos and facilitating their adoption by potential parents, filed a lawsuit in federal court to prevent the government from implementing the Clinton guidelines. The suit claimed that the Dickey Amendment forbade such action.


The combination of Thompson’s comments and the new lawsuit put pressure on the President to articulate his position fully, and Joshua Bolten, who was then the deputy chief of staff, asked me to take the lead in investigating the issues involved and presenting Bush with options. Thus began a five-month odyssey that brought me—and, more important, the President—into direct and constant contact with scientists, doctors, ethicists, religious figures, advocates for research into countless diseases, and lawmakers.


In my first meeting with the President about stem cells, we discussed the basic issue in broad strokes. He was not being asked to assess the legality or even the wisdom of stem-cell research per se. No law in the country banned it, nor was anyone in either party pressing for such a ban. Rather, the question being put to him was whether he would authorize the use of federal funds—i.e., monies allocated by Congress for scientific investigation, to be conducted by the National Institutes of Health, in the area of embryonic stem cells alone.


I led a team of lawyers in our own evaluation of the Dickey Amendment. We decided that while spending federal dollars on such research might violate the spirit of the amendment, it would not violate the letter. Responsibility for adjudicating the divide between spirit and letter was necessarily the President’s as the nation’s chief executive officer.1


As a first step, Bush asked me to prepare a set of background reading materials on the scientific aspects of stem-cell research. He also asked for a summary of the relevant laws of other countries, and a description of what the world’s leading religions had to say on the issue. Once I began turning in my memos, a day rarely passed when he did not call with a follow-up request or a question about something he had read. It was clear that in addition to the material I submitted, he was also finding other things to read and was talking about stem cells with friends and intimates.


One morning at 6:30, my wife summoned me from the shower to answer a call from the White House; the President had been speaking about the issue the night before with a friend and had a barrage of questions he wanted me to answer or look into immediately. At a ceremony in the Rose Garden, Bush saw a physician he knew and invited him back to the Oval Office where they spent fifteen minutes discussing stem cells. During a birthday party for a member of the White House medical unit, the President asked each of the doctors present to set forth his own position. At a gathering with medical groups and doctors to discuss the pending Patients’ Bill of Rights, he queried each physician about the scientific potential of stem-cell research, the ethical quandaries involved, and what the best public policy would be.


Bush also discussed the issue on many occasions with individual members of Congress, and spoke about it to nearly all the members of his Cabinet. (After one Cabinet meeting, Secretary of State Colin Powell followed him into the Oval Office to make sure Bush was aware of his views.) Nor did he confine himself to the precincts of the White House or of Washington. In May, traveling to Notre Dame to give the commencement speech, he spoke with the university’s president, Father Edward Malloy, and a number of scientists on the faculty. The next day, at Yale, he sat down with Harold Varmus, who had served under Clinton as director of the NIH and was the president of Memorial Sloan-Kettering Cancer Center in New York.


In the meantime, the White House was inundated with calls and letters, many from scientists and advocates of one position or another. In my assigned job of keeping the President current, I held meeting after meeting with stem-cell researchers, molecular biologists, doctors, members of Congress, and activists on all sides. I also received an unforgettable phone call from the actor Christopher Reeve, who had been paralyzed from the neck down after a riding accident. He spoke passionately and poignantly, and very personally, about the promise of stem-cell research for spinal-cord injuries. Reeve would tell reporters on the night of Bush’s August 9 speech that it represented “a step in the right direction,” but before his death in 2004 he would become a vocal critic.


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In early June, after a meeting with Bush and the three other White House aides materially involved in the matter—chief of staff Andy Card, communications director Karen Hughes, and political deputy Karl Rove—I began to organize semi-formal private sessions for the President in the Oval Office. Card blocked off regular 30- minute sessions on the President’s schedule; remarkably, for a White House that prided itself on extreme punctuality, every one of these ran longer, sometimes considerably longer, because of Bush’s questions and challenges to the attendees.


On one day, he met separately with representatives from National Right to Life and then from the Juvenile Diabetes Research Foundation. Although the recommendations made by each group were predictable, the discussions in both cases were substantive and at times very personal. “We’re here on behalf of our children,” one of the leaders of the diabetes foundation told the President. “I’m defending my family.” When a member of the National Right to Life delegation took out a public-opinion poll to bolster his claim that opposition to stem-cell research would be a winning issue politically, Bush swatted the paper away and replied with uncommon sharpness: “This is too important an issue to take polls about. I am going to decide this based on what I believe is right.”


Often, even visitors who strongly supported funding for embryonic research acknowledged the complexities. “They are not a person. They are not alive,” insisted Doug Melton, a leading stem-cell researcher at Harvard. “On the other hand, they are not to be treated cavalierly. Part of this is the mystery of biology.” As with so many others, Melton had a view that went beyond the professional: his son suffered from diabetes and, he said, “there is nothing I won’t do to try to help my son.” Bush responded that he well understood childhood diseases, having lost his younger sister, Robin, to leukemia when he was seven.


On the hard science of embryonic research, the meetings reflected a greater ambiguity than boosterish media reports indicated was the case. Several scientists told Bush plainly that the efficacy of embryonic stem cells remained to be proved. As a result, some felt that only a few lines were needed to determine whether the field had genuine potential or was just a pipe dream. Indeed, in an interview with the New York Times shortly before Bush’s August speech, Irving Weissman of Stanford stated that “a finite number [of stem-cell lines] would be sufficient. If we had 10-15 lines, no one would complain.”


As with Christopher Reeve, Weissman would later change his tune and become one of the President’s most persistent critics. Given the state of play at the time, however, Weissman’s comment made perfect sense. There had already been two decades of research using embryonic stem cells derived from mice, and 90 percent of that research had been conducted using only five distinct lines.


If our meetings with scientists and advocates were memorable, our discussions of the moral issues were disturbing and haunting. One session involved the bioethicist LeRoy Walters from Georgetown University; another was with John Mendelsohn, the head of the M.D. Anderson Cancer Center in Texas. During a meeting with several participants, the President laid out a series of moral challenges. For example, if an embryo was going to be destroyed anyway, was it not appropriate, perhaps even desirable, to use its stem cells to save other human lives? In response, one person asked whether, on the same grounds, it should not be considered equally acceptable to extract organs from a death-row inmate moments before his execution; after all, society had already decided that he had forfeited his right to live. Another suggested that federal funding might have the unintended consequence of creating financial incentives that would encourage the creation of frozen embryos in order to destroy them.


A few days later, I brought into the Oval Office my copy of Brave New World, Aldous Huxley’s 1932 anti-utopian novel, and as I read passages aloud imagining a future in which humans would be bred in hatcheries, a chill came over the room.

“We’re tinkering with the boundaries of life here,” Bush said when I finished. “We’re on the edge of a cliff. And if we take a step off the cliff, there’s no going back. Perhaps we should only take one step at a time.”


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On July 9, the President held the discussion in which, I believe, he began to conceive the outlines of his new policy. Two bioethicists—Leon Kass of the University of Chicago and Daniel Callahan of the Hastings Center for Bioethics—came into the Oval Office together. Bush opened the discussion with these words:


I must confess I am wrestling with a difficult decision. It’s a difficult issue for me. On one hand, it offers so much hope; on the other, so much despair. I worry about a culture that devalues life. I think my job is to encourage respect for life. On the other hand, I believe technologies and science will help solve many medical problems, and I have great hope for cures.

One of the two guests responded: “You are not alone. There are a lot of people who, the more they know about this issue, the more complex they realize it is and the more ramifications it has.”


There then ensued a broad discussion of the ethics of stem-cell research—in particular, the implications of utilizing the fruits of already destroyed embryos to try to develop cures for people suffering from truly deadly diseases. Kass averred: “We at least owe them [the frozen embryos] the respect not to manipulate them for our own purposes.” After all, he continued, “We are dealing with the seeds of what could be the next generation.” But then Bush asked what Kass thought of conducting research on stem cells that had already been extracted from embryos. Kass, who would later become chairman of Bush’s Council on Bioethics, responded: “If you fund research on lines that have already been developed, you are not complicit in their destruction.”


In late July, Bush called Karen Hughes and me into his office and shared with us his tentative decision—his compromise. He asked us to begin drafting a set of remarks. A couple of days later he met with Ruth Kirschstein, the acting director of NIH, and three leading NIH researchers. The President pointedly asked how many embryonic stem-cell lines were already in existence. Soon afterward the report came back that more than 30 lines had already been created, and more might be found in laboratories elsewhere around the world. According to the final NIH tally, more than 60 embryonic stem-cell lines existed in varying stages of development.2


We spent the next week writing, editing, and revising with Bush. Then he asked us to join him at his ranch in Crawford where he would deliver the speech, his first major address to the nation since the State of the Union in late January. On the morning of the speech, the President invited me to go jogging with him under the already blistering Texas sun. Only a few hundred yards into our three-mile run, I knew that if I were to survive, much less keep up, I would have to concentrate on breathing and let him do all the talking. So I asked how he felt about his decision.


He said he was content with it, even though he knew he would be attacked from both the Left and the Right. He expected, correctly as it turned out, that the initial reaction would be harsher from his friends than from his opponents (because he would be crossing a bright line by funding any kind of embryo research). In fact, about fifteen minutes before he spoke, he asked Karl Rove to brief five leading Congressional opponents of stem-cell research on what he would say. All five expressed disappointment.


In his speech that night, Bush took his audience through the moral ambiguity of stem-cell research as well as its medical promise, treating the arguments on both sides with equal respect. Until the end, it was unclear where he would come out. “Even the most noble ends,” Bush observed, “do not justify any means, ” and 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.” Nevertheless, he concluded, because of its enormous promise, which “we all hope will be fulfilled,” he would now authorize federal funding on, and only on, those embryonic lines that had already been created.


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And there the matter stood. Research into embryonic stem cells continued, with and without federal funding. Democrats sought political advantage. Republicans fretted. In 2004, voters in California approved $3 billion in taxpayer dollars to fund embryonic stem-cell research in their own state. Last November, voters in New Jersey went in the opposite direction, rejecting a measure similar to California’s that would have cost them $450 million. And then, only days after the New Jersey vote, came the announcement that it would no longer be necessary to use embryos to do embryonic stem-cell research.


Now that the debate seems to be over, what can we say about Bush’s policy and the long months it took for him to devise it? I think it is fair to look upon it as a model of how to deal with the complicated scientific and ethical dilemmas that will continue to confront political leaders in the age of biotechnology. Bush refused to accept the notion that we must choose between medical research and the principle of the dignity of life at every stage. He sought both to advance biomedical science and at the same time to respect the sanctity of human life. In the end he came to a moderate, balanced decision that drew a prudent and principled line. The decision was both informed and reasoned, based on lengthy study and consultation with people of widely divergent viewpoints. It was consciously not guided by public-opinion polls.


As I write these last words, I am aware that they may sound like political spin. That is far from the case. There were many other contentious issues on which I advised the President—affirmative action, gay marriage, contraception, offshore oil and gas exploration, international trade, patent protection, even veterans’ benefits. In each of these, political considerations and calculations played at least some role in the development of policy, as they always have and always will. What made our deliberations on the stem-cell issue unique was, precisely, the absence of that element. Bush knew that whatever his decision, it was bound to alienate millions of Americans. Their ranks would include both political supporters and many who, if the decision went another way, might be drawn to reconsider their aversion to him. Our discussions were focused throughout on reaching a coherent and consistent position where the President could stand with honor for as long as the facts on the ground remained as they were. We did not dwell at all on how that position would play politically.


In the coming decades, scientific advances will compel Presidents and politicians to confront vexing choices on subjects that were once solely the province of dystopian science fiction: human cloning, fetal farming, human-animal hybrid embryos, and situations as yet unimagined and unimaginable. If we are to benefit from the great promise of the age of biotechnology while preventing grave ethical abuses, we can only hope that future Presidents will be guided by the same seriousness with which George W. Bush pursued the question of stem-cell research, as well as by his stout refusal to be seduced by the siren song of political expediency.



Footnotes


1 Bush had never taken an official position on this matter, though in the course of running for the presidency, and before the Clinton administration had formulated its legal analysis, his campaign responded to a question with the statement that “the Governor opposes federal funding for stem-cell research that involves destroying a living human embryo.”


2 There are currently 21 fully developed lines available for federally funded research, and NIH has sent out more than 700 shipments of such embryonic stem cells.


Jay Lefkowitz, a lawyer in New York City and Washington, D.C., has served on the White House staffs of President George W. Bush and George H. W. Bush.

Sunday, December 23, 2007

Ways to Maintain a Healthy Level of Insanity

Ways to Maintain a Healthy Level of Insanity

1. At lunch time, sit in your parked car with sunglasses on and point a hair dryer at passing cars. See if they slow down.

2. Page yourself over the intercom. Don't disguise your voice.

3. Every time someone asks you to do something, ask if they want fries with that.

4. Put your garbage can on your desk and label it "In."

5. Put decaf in the coffee maker for 3 weeks. Once everyone has gotten over their caffeine addictions, switch to espresso.

6. In the memo field of all your checks, write "for smuggling diamonds."

7. Finish all your sentences with "in accordance with the prophecy."

8. Don't use any punctuation

9. As often as possible, skip rather than walk.

10. Whenever you go out to eat and with a serious face
order diet water.



11. Specify that your drive-through order is "to go."

12. Sing along at the opera.

13. Go to a poetry recital and ask why the poems don't rhyme.

14. Put mosquito netting around your work area and play tropical sounds all day.

15. Five days in advance, tell your friends you can't attend their party because you're not in the mood.

16. Have your co-workers address you by your wrestling name, Rock Bottom.

17. When the money comes out the ATM, scream "I won! I won!"

18. When leaving the zoo, start running towards the parking lot, yelling, "Run for your lives, they're loose!"

19. Tell your children over dinner. "Due to the economy, we are going to have to let one of you go."

20. And the final way to keep a healthy level of insanity.......

Send This To Someone To
Make Them Smile.

It's called..... Therapy