More MS news articles for Aug 2001

Bush to allow limited stem cell funding

Listen to speech on CNN:

Transcript of Bush Speech

August 10, 2001 Posted: 12:16 AM EDT (0416 GMT)

CRAWFORD, Texas (CNN) -- In a much-anticipated decision on what he called a "complex and difficult issue," President Bush on Thursday night said he would allow federal funding of research using existing stem cell lines.

Bush said there are about 60 existing stem cell lines in various research facilities -- cell lines that have already been derived from human embryos.

The president stopped short of allowing federal funding for research using stem cells derived from frozen embryos, about 100,000 of which exist at fertility labs across the country.

"I have made this decision with great care, and I pray that it is the right one," Bush said in a nationally televised address from his ranch here, where he is on a monthlong working vacation.

Scientists and advocacy groups view embryonic stem cell research as perhaps the best hope for finding cures for debilitating diseases like Alzheimer's and Parkinson's.

Other groups, such as anti-abortion activists, consider stem cell research the taking of a human life because embryos must be destroyed to harvest the stem cells.

Some of Bush's closest advisers -- including Health and Human Services Secretary Tommy Thompson -- had urged him to allow broader funding of the controversial science.

One compromise that Bush reportedly had been considering would have allowed the funding of research using stem cells from the excess embryos at fertility clinics.

Bush opted not to go that far. He said he would allow funding for research using existing stem cell lines only, "where the decision on life and death has already been made."

Conservative groups had called upon Bush to stick to campaign promises to reject any federal funding for embryonic stem cell research.

Bush said research using embryonic stem cells involved "great promise, and great peril."

"We must proceed with great care," Bush said.

The president said scientists have told him that research on the 60 existing stem cell lines "has great promise that could lead to breakthrough therapies and cures. 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 also endorsed increased funding for research on stem cells obtained from adults, umbilical cords, placentas and animals, saying the federal government will spend $250 million on this research this year.

In addition, he announced creation of a President's Council on Bioethics that will consider scientific and ethical considerations as the research proceeds. It will be chaired by Dr. Leon Kass of the University of Chicago. (More reaction from researchers.)

Reaction muted
Immediate reaction to Bush's announcement was somewhat muted.

Sen. Orrin Hatch, R-Utah, who has spoken in favor of embryonic stem cell research, called Bush's decision "thoughtful, decent and honorable."

"I'm very pleased," Hatch said on CNN.

But others questioned whether research using only the existing stem cell lines would be sufficient.

Research supporter Montel Williams, a talk-show host who suffers from multiple sclerosis, said it was not known whether the 60 cell lines referred to by Bush were "viable." He urged funding for research using stem cells from excess embryos that are to be discarded anyway.

Sen. Edward Kennedy, D-Massachusetts, another research supporter, welcomed Bush's decision as "an important step forward," according to The Associated Press. But, Kennedy added, Bush's decision "doesn't go far enough to fulfill the lifesaving potential of this promising new medical research." (More on the political reaction.)

Grappling with the issue

Bush, sources said, previously had decided to flatly oppose federal funding of research that involved or used embryos gathered solely for research purposes, or embryos created through cloning human cells.

The issue Bush grappled with was whether to stand by his previous statements opposing federal funding for any embryonic stem cell research, or to reverse course and support the position backed by many of his closest advisers, including Thompson, Vice President Dick Cheney, Chief of Staff Andy Card and White House counselor Karen Hughes, according to sources.

Among those who recommended against any change in position, these sources said, were strategist Karl Rove, the top White House liaison to conservative Republicans.

During the presidential campaign, Bush said he opposed federal funding of embryonic stem cell research.

And in a May 18, 2001, letter to a group called The Culture of Life Foundation, Bush wrote: "I oppose federal funding for stem cell research that involved destroying living human embryos." Bush went on to say he supported research using stems cells from adult donors.

But the president came under heavy pressure to reconsider and had grappled with the issue for more than two months, holding dozens of meetings with medical and scientific experts, ethicists, religious leaders and others.

He also raised the issue at events on other issues, including a meeting with doctors to discuss the patients' bill of rights and an event that included breast cancer survivors.

White House officials said Bush reached his decision since arriving in Texas for his working vacation and decided Wednesday he wanted to announce it on Thursday in the nationally televised address. These officials said he had made clear he wanted to be the first to disclose it.

Democrats to press for funding
A decision to allow broad federal funding for the research could have put Bush at odds with many cultural conservative organizations -- and key GOP leaders in the House.

Majority Leader Dick Armey and Majority Whip Tom DeLay, for example, had said they would lead an effort to block any Bush attempt to allow federal funding.

Leading Democrats, on the other hand, have vowed to press for legislative language allowing federal funding.

"To support federal funding for embryonic stem cell research is to come down on the side of hope for the millions of Americans suffering from diseases ranging from Alzheimer's to cancer to Parkinson's to diabetes," said Senate Majority Leader Tom Daschle, D-South Dakota. (More reaction from political leaders.)

© 2001 Cable News Network LP, LLLP.

Embryonic vs. adult stem cells Politics aside, it's too early to tell which type works better

August 10, 2001

Answers to some common questions about stem cells:

Q: What are stem cells?

A: Stem cells are master cells that have the ability to transform themselves into other cell types, including those in the brain, heart, bones, muscles and skin.

Q: What are embryonic stem cells?

A: Embryonic stem cells are cells contained in embryos that have the ability to transform themselves into virtually any other type of cell in the body. It is this quality that enables the tiny embryo to develop into a fully formed body.

About five days after fertilization, the human embryo becomes a blastocyst, which is a hollow sphere of about 100 cells.

Cells in its outer layer go on to form the placenta and other organs needed to support fetal development in the uterus. The inner cells go on to form nearly all of the tissues of the body. These are the embryonic stem cells used in research.

Q: What are adult stem cells?

A: The name is a misnomer because they are harbored in mature tissue, in the bodies of children as well as adults. Adult stem cells are more specialized than embryonic ones and give rise to specific cell types. The mature body uses these cells as "spare parts" to replace other worn out cells.

Recent research has suggested that adult stem cells can turn into many more cell types than scientists once believed possible.

Q: What is the source of embryonic stem cells?

A: Scientists generally harvest embryonic stem cells from embryos left over in fertility clinics after in vitro fertilization. These "test-tube baby" procedures, used to help infertile couples have a baby, involve fertilizing a woman's egg cells with a man's sperm cells in a laboratory dish.

Several embryos are created at a time, and not all are implanted into the woman's uterus to create live births. Embryos left over by the couple are slated for destruction by the fertility clinic. These can serve as the source for deriving stem cells, a process that involves removing the blastocyst's inner cells and destroying the embryo.

Q: What are the possible medical uses for stem cells?

A: Because stem cells can turn into many other cell types with the right prompting, doctors might be able to replace tissues and organs damaged by disease or injury to restore healthy function.

For example, in people with Parkinson's disease, injecting stem cells into the area of the brain that controls muscle movement, where the disease kills nerve cells, might regenerate the neurons and reverse the illnesses. This procedure would be called a stem-cell transplantation.

Therapeutic applications of stem cells also could treat diabetes; Alzheimer's disease; stroke; heart attack; multiple sclerosis; blood, bone and bone marrow ailments; severe burns by providing skin grafts; spinal cord injuries; and cancer patients who lost cells and tissue because of radiation and chemotherapy.

Q: What other medical uses are possible?

A: Using stem cells, researchers would be able to test a drug's therapeutic effects and toxic side effects in human tissue without using a laboratory animal as a proxy. In addition, scientists could harness and package stem cells to deliver gene therapies to specific targets in the body to treat genetic problems.

Q: Are embryonic stem cells better than adult stem cells?

A: It is too early to say. Embryonic stem cells boast two important qualities: They can become almost anything in the body, and they can be grown in culture in an unlimited quantity. The disadvantages are that a patient's immune system might reject transplants of embryonic stem cells just as some organ transplants are rejected, and that runaway growth of embryonic stem cells could produce tumors.

Because adult stem cells would be taken from the patient who would receive them later in treatment, there are no rejection issues. Disadvantages of adult stem cells include:

Q: What's the controversy?

A: For some people, the destruction of any embryo is tantamount to murdering a human being.

Q: Has the federal government ever funded research involving human embryonic stem cells?

A: No, it has not. Human embryonic stem cells were first isolated in 1998. A law passed in 1995 banned federal funding for any research "in which a human embryo (is) destroyed, discarded or knowingly subjected to risk of injury greater than that allowed on fetuses in utero," or in the womb.

In January 1999, the Department of Health and Human Services general counsel's office issued a legal opinion that the earlier law did not apply to stem cells derived, using private money, from spare embryos at fertility clinics because the stem cells themselves were not embryos and the destruction of the embryos was not financed by the government.

Shortly after being sworn into office in January, President Bush ordered the Health and Human Services Department to reconsider its legal opinion.

© Copyright 2001 USA TODAY

Scientists plan next stem cell projects

Saturday, August 11, 2001
The Associated Press

WASHINGTON -- The debate over stem cells is shifting to the halls of Congress, but the action is moving to the nation's laboratories as scientists begin the painstaking work of translating promise into actual treatments.

President Bush's decision to allow limited federal funding for the research offered both comfort and angst to advocates on both sides of the debate. And it complicated the politics all around. Bush may have satisfied just enough people just enough to stave off congressional action.

"The president probably bought himself some time," said Thomas Mann, an expert on Congress at the Brookings Institution. "Pressure will build again, but it will take some time."

At issue is research involving days-old human embryos, each one smaller than the period at the end of this sentence, left over from fertility treatments. Inside sit stem cells that can develop into any type of tissue.

Scientists say these cells could help cure many diseases, but to get them out, the embryo must be destroyed. For some who believe life begins at conception, this amounts to taking one life to try and save another.

Trying to thread an ethical needle, Bush said Thursday that he would allow federal funding for research on stem cell lines, but only those that have already been created. Each embryo can yield one stem cell line, which can continue replicating indefinitely.

At the National Institutes of Health on Friday, researchers were beginning to catalog the existing stem cell lines, which officials now estimate at 60 worldwide. Around the country, scientists were beginning to hone their ideas for grant applications, which were expected to be submitted and awarded by early next year.

Dr. Harold Varmus, who led the NIH under President Clinton, predicted that hundreds of researchers would get into the field, even under limited federal funding. Ultimately, he predicted that the federal government would spend tens to hundreds of millions of dollars per year in this field.

Dr. Catherine Verfaillie, who directs the University of Minnesota Stem Cell Institute, said the political turmoil surrounding this research dissuaded her from applying for federal funding when it was initially offered last year.

"Many investigators were in the same boat," she said. But now that the matter appears settled, she plans to submit a grant application.

Also Friday, Bush defended his decision, saying he struck the right balance between the sanctity of life and the urgency of research, with enough funding to figure out whether promise will translate into a cure.

"I listened to a lot of people and did what I thought was right," Bush told ABC News from his ranch in Crawford, Texas. "I think this is the kind of decision where it does require prayer. Prayerful consideration."

In Washington, both sides expected debate over the issue to resume in Congress when lawmakers return next month.

Research proponents make up a majority of the Senate and close to it in the House, and some have pledged to push for broader funding.

"Restrictions on this lifesaving research will slow the development of the new cures that are so urgently needed by millions of patients across America," said Sen. Edward Kennedy, D-Mass.

Sen. Arlen Specter, R-Pa., said he would continue to push his legislation allowing funding with few restrictions, a measure that could be attached to spending bills that will move through Congress this fall. And Rep. Brad Sherman, D-Calif., urged Americans -- especially those in wheelchairs or whose relatives suffer from Alzheimer's disease -- to call their representatives while they are home over the summer break.

But some important allies, anti-abortion Republicans who support the research, are not likely to challenge Bush's plan.

"We just have to watch this play out," said Sen. Orrin Hatch, R-Utah. He told reporters in Salt Lake City that he would like to see more stem cell lines available but that Congress should hold back for now. "Let's give it a chance."

Senate Majority Leader Tom Daschle, D-S.D., predicted that "the Senate will want to take action" to open up more research funding. But he stopped short of saying he'll support it, and he praised the president's thoughtfulness.

On the other side of issue, many Christian conservatives were talking tough and warning the president that there is a limit to the number of times he can go against them.

Still, conservatives were markedly divided over Bush's move on stem cells. Some prominent anti-abortion groups and leaders welcomed it, but others accused him of crossing a moral line. Any effort to ban funding outright didn't have the votes before Bush offered his compromise, and it would attract even less support now.

Rather, opponents hope to stave off any attempt to allow for broader funding.

"The next step would be to hold the line against any kind of coalition created to expand funding," said Deal Hudson, editor of the Catholic magazine Crisis and an informal adviser to Bush.

Ken Connor, president of the conservative Family Research Council, said it will be more difficult to argue against any embryonic stem cell research now that Bush has endorsed it in part.

"We have to help the Congress understand that nothing less than life itself is at stake," he said. "Unquestionably there's an uphill battle in Congress."

At Rutgers University, a leading spinal cord injury researcher who had urged Bush to approve embryonic stem cell funding said the president's decision "was better than nothing."

But Dr. Wise Young added that limiting federal funds to existing cell lines will further delay finding treatments for Alzheimer's and other diseases.

"I think Bush did not close the door completely," said Young, a professor of cell biology and director of the W.M. Keck Center for Collaborative Neuroscience at Rutgers in New Brunswick.

But, he added, "Time is of the essence. As it stands now, clinical trials utilizing human embryonic stem cell treatments [for diseases such as Parkinson's and multiple sclerosis] are further off in the future."

Staff Writer Bob Groves contributed to this article.

Copyright © 2001 North Jersey Media Group Inc

Possibility of cures key in minds of many

Saturday, August 11, 2001

Dru Little has watched her mother’s memory deteriorate to the point where the 81-year-old woman doesn’t remember that her husband died in 1997.

“She’s waiting for him to come back from fishing or work,” said Dru Little, 57, whose mother, Adeline Little, is in the final stages of Alzheimer’s disease. “You have no idea unless you’ve lived through this. It’s horrendous.”

Dru Little isn’t familiar with the details of stem-cell research or President Bush’s decision regarding federal funding. But like several St. Joseph residents who have seen the devastating effects of Alzheimer’s and other diseases, she’s more interested in the potential for a cure than the ethics of harvesting cells from frozen embryos.

“I wish they had more funding,” Dru Little said. “More and more people are going to have this.”

Scientists believe stem-cell research might yield more effective treatment or cures for diseases and conditions like Alzheimer’s, multiple sclerosis, Parkinson’s, paralysis and diabetes.

“Diabetes runs in my family,” said Karen Organ, who was diagnosed with the disease in 1986 and has to give herself insulin injections at night. “It’s going to be carried on unless they find a cure. We need to do something for a cure.”

But for many, the euphoria of a potential cure is tempered with questions about destroying embryos to get the stem cells. Victoria Christgen, executive director of the Northwestern Missouri chapter of the Alzheimer’s Association, said it’s important to respect the views of those who oppose stem-cell research.

The Alzheimer’s Association supports federal funds for the research.

“It’s a very touchy subject,” said Ms. Christgen, who lost her father to the degenerative brain disease. “It’s a very personal issue for people. The Alzheimer’s Association reviews this every year.”

The association believes the research should go forward with strict ethical guidelines. “We’re all grasping for that straw,” she said.

Debra Merritt, the executive director of Midland Empire Resources for Independent Living, said she recognizes the benefits of the research but has personal concerns about the use of embryos.

MERIL provides services to individuals with multiple sclerosis and other disabilities. “It would be nice to think we could work ourselves out of a job,” she said. “I still contend with the ethical issue.”

Verlinda Hughes, a benefits specialist at MERIL, hopes scientists and the government can find a way to move ahead on the research while answering ethical concerns.

Ms. Hughes has MS.

“If there is a way there could be a cure, that would be well worth it,” she said.

Portions ©2001, The News-Press, St. Joseph, Missouri

Cell Claim Mystifies Scientists

By Earl Lane

August 10, 2001

Washington - While they welcomed President George W. Bush's decision to allow federally funded research on existing human embryonic stem cells, scientists said last night that they were mystified by Bush's claim that there are more than 60 such stem cell lines now available worldwide for use.

"I don't know of 60 existing cell lines," said Douglas Melton, professor of cellular and molecular biology at Harvard University and a specialist on stem cells. He said the published scientific literature involves only about 10 lines, some of which don't grow well in culture and are, he said, "largely useless."

"Maybe he knows something we all don't know," said Paul Berg, a Stanford University biochemist and Nobel laureate. He said he was willing to await clarification from the White House on the source of the cells and their availability to researchers.

The field of embryonic stem cell research is so new that scientists do not yet know how many cell lines - indefinitely dividing colonies of cells grown from individual embryos - will be required for basic studies of the cells' development and their potential use in treating such diseases as diabetes, Alzheimer's and Parkinson's.

Until Bush's announcement, scientists had generally agreed that perhaps a dozen human embryonic stem cell lines are established in laboratories here and abroad. In the United States, all of the lines have been established with private funding.

The WiCell Research Institute, a private spinoff of the University of Wisconsin - whose James Thomson first isolated embryonic stem cells in 1998 - is offering five cell lines for distribution. Cells have been shipped to about 30 other labs worldwide. A team based at Monash University in Australia has established four human embryonic stem cell lines and expects to distribute them to about 15 labs by summer's end.

A White House fact sheet, distributed after Bush's announcement, said "there are currently more than 60 existing different human embryonic stem cell lines that have been developed from excess embryos created for in vitro fertilization with the consent of the donors and without financial inducement." The lines are used in about a dozen labs in the United States, Australia, India, Israel and Sweden, it said.

"I can tell you that as of late last week, the NIH [National Institutes of Health] confirmed for us that there were in fact in excess of 60 stem cell lines in existence now," a senior administration official said.

It was unclear last night whether the cell lines mentioned by Bush all meet the stringent certification guidelines proposed by the National Institutes of Health during the Clinton administration, guidelines that were suspended by the Bush administration while it deliberated the future of stem cell research.

Thomson has said that his cell lines probably do not meet the National Institutes of Health guidelines and he was prepared to produce additional lines from surplus embryos that did meet the standards. Melton said it appears that Bush may be willing to allow use of the existing Wisconsin lines, but such questions will have to be clarified.

"There are just of host of questions," said Lawrence Goldstein, a professor in the Department of Cellular and Molecular Medicine at the University of California, San Diego.

He said he was "stunned" at the claim of more than 60 existing stem cell lines.

"It could mean that there are large numbers of unpublished lines, that they are this well kept secret," Goldstein said. "I'm concerned that if the characterizations [of the lines] have not been published, we don't know what the quality is."

The team in Australia was preparing to submit its cell lines to the National Institutes of Health for certification when the Bush administration suspended the process.

Some scientists said that unless the private labs are allowed to derive additional cell lines and distribute them to federally funded researchers, the field may still be constrained in the United States.

Embryonic stem cells are extracted from the inner cell mass of embryos that are about 5 days old. The cells, still in a blank state, have the capacity to turn into all of the cell types in the human body.

Critics say any research that destroys embryos to harvest their cells is immoral. They urged Bush to limit research only to adult stem cells taken from bone marrow and other adult tissues or from placentas and umbilical cords.

But stem cells from adult tissues do not appear to have the same capacity to change into many different cell types as the embryonic cells do, specialists say.

Scientists say it is impossible to say how many lines will be needed for adequate studies on the fundamental behavior and development of stem cells. But they said a dozen is almost certainly too few.

"If we had access to 50 to 100 cell lines, we are on the mark for establishing that embryonic stem cells are going to achieve the advances we've been predicting," Berg said. "What has been achieved to date has been very little."

"From a scientific perspective, there's no sense to any limit" on the number of cell lines, Goldstein said. "Ten would be way too few. And I can't believe you would need thousands, at least initially."

Goldstein and others said there were other issues regarding the existing human embryonic stem cell lines.

"How do I know those very first lines were derived in the optimal way?" Goldstein asked. He said it took several years for researchers to determine the best techniques for establishing mouse embryonic stem cell lines.

Since the existing cell lines were established under private auspices, there also are substantial questions about patenting and licensing rights. WiCell already has awarded broad and exclusive commercial rights on its stem cells to Geron Corp. of Menlo Park, Calif.

Craig Gordon contributed to this story.

Stem Cell Reaction

'Stem cell research will continue anyway [in private labs]. All this decision will do will determine whether it will happen in time for the patients who need it today.' - ALS patient Stephen Heywood, whose brother Jamie is helping coordinate research on the disease

'This reflects at least some recognition on the part of the government of the technology to advance techniques and benefit patients. But it is disappointing that what are largely political imperatives would limit developing these approaches to their fullest potential.' - Dr. Steven Goldman, endowed professor of neurology and neuroscience at New York Weill-Cornell Center in Manhattan

'Stem cell research is something I deeply believe in for myself and the millions of other people who could benefit. I think [celebrities] were able to bring information to people. We do have the ability to get the public's ear.' - Actress Mary Tyler Moore, who has battled diabetes for more than 30 years

'The Church believes that the embryo is a living human being and proclaims that no human being can ever be used as a means to an end, no matter how noble that end may be... We support aggressive research using adult stem cells so that we can achieve the benefits of scientific progress without allowing ourselves to be de-sensitized to fundamental human rights.' - Msgr. John Alesandro, administrator with the Diocese of Rockville Centre

'As far as the Islamic perspective goes, there is a big difference between stem cells and embryos. Anything that interferes with the natural divine creation of humanity is something we are not for. But we are for research and progress that will save lives, as long as there is no fetus involved.' - Al-Haaj Ghazi Khankan, director of interfaith affairs and communications for the Islamic Center of Long Island in Westbury

Stem cells hold the promise for treatment and possible cure for many diseases. This decision WILL affect tens of millions of people! President Bush will make his mark as to what his presidency will be remembered for. Stem-cell research is pro-life. It will save lives, not take them!' - Rob Senecal of Huntington, who has amyotrophic lateral sclerosis (Lou Gehrig's disease)

'In Judaism, the overriding concern is saving lives. When there's that possibility of saving lives the choice is very clear.' -

Rabbi Darryl Crystal, a Reform Jewish leader with the North Shore Synagogue in Syosset

Copyright © 2001, Newsday, Inc. 

US stem-cell debate makes strange political allies

August 9, 2001  3:25pm
Source: Reuters
By Deborah Zabarenko

WASHINGTON (Reuters) - The U.S. debate over embryonic stem-cell research has made strange political bedfellows, allying some social conservatives with abortion rights supporters, as polls show Americans cautiously favor using federal tax dollars to pay for these studies.

In the hours before President Bush's scheduled announcement Thursday on whether to allow such federally funded research to go forward, stem-cell partisans -- mostly research supporters -- flooded the media with comment.

"To support federal funding for embryonic stem-cell research is to come down on the side of hope for the millions of Americans suffering from diseases ranging from Alzheimer's, to cancer, to Parkinson's, to diabetes," Senate Majority Leader Tom Daschle of South Dakota told reporters.

Fellow Democrat, Rep. Richard Gephardt of Missouri, the

House minority leader, echoed those sentiments in a statement, "I hope that in his decision, President Bush will choose science over politics."

Current comments from their Republican counterparts were not instantly available, but their stance on this issue has long been clear.

Republican House Speaker Dennis Hastert of Illinois matter-of-factly said last month that the time was not right for federal funding of embryonic stem-cell research. Senate Republican leader Trent Lott of Mississippi and House Majority Whip Tom DeLay of Texas have been vocal in their opposition.

But this issue has not followed the expected political partisan divide.


Two Republican senators with solid records against abortion have made arguments for stem-cell research.

Sen. Orrin Hatch of Utah said in a much-quoted comment that he "just could not equate a child living in the womb, a child with moving toes and fingers and a beating heart, with an embryo about to be taken from a freezer."

This reference went to the heart of the question, since research would be done on stem cells taken from the frozen embryos created by in vitro fertilization that were already slated for disposal.

Sen. Bill Frist of Tennessee, a physician who has performed heart and lung transplants and who opposes abortion, suggested that both embryonic and adult stem-cell research should proceed with federal funding under a "carefully regulated, fully transparent framework" that would ensure "the highest level of respect for the moral significance of the human embryo."

The Roman Catholic Church has been a vocal opponent of the research, with Pope John Paul II characterizing it as evil in public remarks made July 23 when the American president visited him in Rome.

When some analysts suggested the pontiff's remarks left room to approve this study, the Vatican issued a clarifying statement two days later specifically condemning the use of embryos produced for in vitro fertilization.

The anti-abortion group National Right to Life Committee offers visitors to its Web site a petition against this research, saying "Urgent! Tell President Bush You Too Oppose Embryo-Destructive Research!"

Nancy Reagan, wife of former Republican president and current Alzheimer's patient Ronald Reagan, let it be known that she favors stem-cell research. During his presidency, Reagan opposed abortion.

Actors Christopher Reeve and Michael J. Fox, who suffer, respectively, from paralyzing spinal cord injury and Parkinson's disease, have also spoken in favor of stem-cell research. Scientists have said this research may offer hope for both these ailments.

A Zogby International poll released Thursday found 52 percent of respondents thought stem-cell research was an important step toward treatment of such ailments as Parkinson's disease and multiple sclerosis.

At the same time, the poll found 30 percent said another way must be found to do this research because using stem cells would "take the lives of innocent unborn children." The poll, taken July 26-29, had an error margin of 3.2 percent.

Copyright © 1999 Reuters Limited

Bush Stem Cell Policy Cools Fervor on Hill

Saturday, August 11, 2001; Page A10
By Amy Goldstein
Washington Post Staff Writer

President Bush's decision to allow limited federal support of research on stem cells from human embryos has cooled the widespread fervor in Congress to require far more expansive funding of the scientific work, according to lawmakers and interest groups on both sides of the issue.

But the delicate distinctions the president has drawn -- which will provide subsidies for studies using only stem cell lines that have already been created -- have not entirely deterred attempts on Capitol Hill to define the government's role in the highly charged research.

The chairman of two Senate committees that oversee medical research announced yesterday that they will press ahead with hearings on the issue immediately after Congress returns in September from its month-long break. But several senators and House members who favor broader funding said privately they now are uncertain how much political impetus will exist in the fall to alter the ground rules Bush has set. Rather than rushing to legislate, they said, lawmakers may wait to find out whether scientists believe they can make biomedical progress within the restrictions the president has imposed.

A day after Bush announced his decision on stem cell research during his first televised address to the nation, the reaction on and off Capitol Hill indicated the administration found an approach that may suit its political needs -- at least for now. "Members of Congress, like the American people, recognized that the president found a solution that advances science while adhering to the highest ethical standards," White House spokesman Scott McClellan said.

Nevertheless, White House officials moved to reinforce their portrayal of the decision as painstaking and deliberative, furnishing an unusual public accounting of the people -- and even the books -- Bush consulted. Meanwhile, reactions, many of them dissatisfied, poured forth from the most passionate proponents and opponents of the research.

After soliciting a wide spectrum of advice for three months, the president said in his speech Thursday night that he would move gingerly to allow the first federal help for research on embryonic stem cells. Scientists will be able to apply for grants from the National Institutes of Health starting next year, provided they want to experiment with cells from colonies, or "lines," that were created before the president reached his decision. No federal money would be allowed for research on cell lines from newly destroyed embryos or for the creation of embryos specifically for research.

Under the new rules, those lines must have been developed from extra frozen embryos that were created in fertility clinics -- and would otherwise have been thrown out. Donors must give permission and cannot receive any financial inducements. The president also reiterated his opposition to human cloning for any purpose, including research, and he urged researchers to explore the potential of stem cells derived from adults.

Although more arcane than issues such as taxes and education that have dominated the administration's agenda, the stem cell decision has enormous political stakes. Fraught with profound ethical and scientific implications, the issue represents a collision of competing interests: those who argue that destruction of embryos violates the sanctity of life vs. those who argue that stem cells -- with their ability to develop into many kinds of human tissue -- hold vast promise to relieve human suffering from disease.

One of Bush's top aides, White House counselor Karen P. Hughes, said yesterday that the president had discounted political considerations. In an interview with ABC News, Bush said: "I didn't agonize. I thought. I spent a lot of time on it, listening to people."

At a briefing near Bush's ranch in Crawford, Tex., Hughes also contended the president's new rules were compatible with the stance he adopted as a presidential candidate last year. He said at the time that he opposed "federal funding for stem cell research that involves destroying living human embryos." Hughes said yesterday, "In the end, his conclusion is absolutely consistent with what he has felt all along, and that is that he does not feel it is appropriate for government to sanction further destruction of human embryos."

Since the prime-time speech, the president's position has been criticized as inadequate from supporters of stem cell research and opponents alike. Opponents, including antiabortion organizations and some other conservatives, contend Bush's action is immoral because it involves research that required the destruction of embryos, which they view as living humans. Proponents predict the restrictions will hinder scientific work.

Nevertheless, lawmakers on both sides said the political consequences would have been worse for the White House if Bush had banned all subsidies, as many conservative supporters had hoped.

Sen. Rick Santorum (R-Pa.), chairman of the Senate Republican Conference, said yesterday that Bush "did a very smart tactical move when he put together this compromise position," even though Santorum opposes any funding. At a time when a majority of the Senate and many members of the House want to broadly support such research, Santorum said in an interview that Bush had "probably cut that debate off at the pass."

Indeed, several lawmakers who have pressed for unlimited subsidies have sounded more patient after Bush's announcement. Sen. Tom Harkin (D-Iowa), one of the strongest advocates of embryonic stem cell research and chairman of the Senate subcommittee that funds medical research, said he was "surprised, pleasantly so" by Bush's position.

Harkin said in an interview that he does not want to move ahead right now with legislation he is sponsoring with Sen. Arlen Specter (R-Pa.) that would force NIH to provide wider subsidies. But he added that he might "have to revisit it" if leading scientists believe the number of existing stem cell lines is inadequate for "this research to reach its full potential."

A spokeswoman for Senate Majority Leader Thomas A. Daschle (D-S.D.) said he continues to favor "moving forward with federal funding for stem cell research without the restrictions the president put on the research." Meanwhile, a House GOP leadership aide said that with most lawmakers out of town, it is too early to tell whether that chamber will pursue wider subsidies -- or, conversely, whether it will insert the kind of ban on such funding in this year's appropriations bill that it has included for the past three years.

Yesterday, an administration official said Bush may have settled on his decision Aug. 2, when he met with NIH scientists who reported that they had canvassed researchers and companies in the United States and abroad and located at least 60 stem cell lines, twice as many as the institutes had suggested were in existence last month. The discovery implied to the president that the existing cell lines could provide enough material for researchers to make significant progress.

Jay Lefkowitz, who attended many of Bush's meetings on stem cells in his role as general counsel of the Office of Management and Budget, said the president considered the five dozen cell colonies "exciting news" because it would "provide a great deal of opportunity for research."

Some scientists yesterday questioned whether that many cell colonies exist.

But Health and Human Services Secretary Tommy G. Thompson said he expected NIH would continue to discover lines that had been created as of Aug. 9, the date of Bush's announcement.

Speaking at an afternoon news conference at the institutes' Bethesda campus, Thompson said NIH yesterday began to create a registry of the known cell lines and was beginning to design a process that would enable them to be shared among researchers.

At least one scientific leader in the field, James Thomson, the University of Wisconsin researcher who discovered human embryonic stem cells in November 1998, said he was satisfied with Bush's approach. "People have said they want dozens of cell lines. Well, 60 is dozens," Thomson said. "Even if some of those are no good, there's still going to be a lot to work with."

Staff writers Helen Dewar and Mike Allen contributed to this report.

© 2001 The Washington Post Company

A Stem Cell Ethics Rule Is Eased

Bush Decision May Add Colonies for Research

By Rick Weiss
Washington Post Staff Writer
Saturday, August 11, 2001; Page A01

For all the restrictions President Bush imposed on federal funding of human embryonic stem cell research, he also made a little-noticed policy change that in one area makes his rules more permissive than those of President Bill Clinton.

That policy change -- the removal of strict ethics guidelines governing the procurement of stem cell-laden embryos from fertility clinics -- means that colonies of cells that had flunked the Clinton administration's ethics guidelines will now be eligible for use in federally funded studies.

The subtle but potentially significant difference between the Bush and Clinton rules was one of several areas that federal officials tried to clarify yesterday in the aftermath of the stem cell announcement, highlighting some of the perils that Bush faced as he navigated through the sensitive, high-profile issue.

Bush announced Thursday night that he would permit federal funding only for research on existing lines, or colonies, of stem cells, barring taxpayer money for research involving the creation or destruction of new embryos as sources of cells.

The long-awaited announcement drew a range of reactions, but seemed, at least for the moment, to quell a drive in Congress to demand more funding for stem cell research, which scientists hope will lead to new treatments for a wide range of diseases.

Much of the reaction focused on Bush's decision to limit federal subsidies to existing cell lines, with some scientists challenging the administration's estimate of how many lines actually exist and questioning how useful those lines will be.

On the whole, Bush's new stem cell rules are far more restrictive than the ones Clinton had put in place because they limit research to cells derived from embryos that were destroyed before Bush made his announcement.

But on the question of embryo procurement, the Bush plan demands only that donors at fertility clinics give "proper informed consent," without defining what that means. By contrast, the Clinton rules specified in great detail how the informed consent process should proceed. It demanded that consent documents use specific wording to ensure that women did not feel coerced to donate their embryos.

In addition, the Clinton rules also required that only frozen embryos be used for research so that embryos would not be taken just as a woman was undergoing in vitro fertilization -- an emotionally vulnerable time that ethicists have said should be off-limits to researchers seeking embryos. Bush has made no mention of such a restriction.

Among the cells that now will be eligible for federal funding are colonies created at the University of Wisconsin, the leading academic research institution located in the home state of Health and Human Services Secretary Tommy G. Thompson, a National Institutes of Health official confirmed.

The cells were cultured by James Thomson and were the first human embryonic stem cells to be isolated in the United States. Thomson used fresh embryos and also used consent wording that differed slightly from the language specified under the Clinton rules.

Under Bush's new rules, however, a University of Wisconsin foundation that holds two key patents on Thomson's stem cells will be able to distribute those cells to researchers who want to study them -- and, if the research proves useful, perhaps collect substantial royalties.

HHS spokesman Bill Hall said the Wisconsin connection had nothing to do with Bush's decision to change the rules the way he did. "It played no role whatsoever in the deliberations" leading up to the new rules, Hall said. "It had nothing to do with who owned which [cell] lines."

Others said that in any case, Bush's dilution of the ethics rules was disturbing.

"It's very troubling to find that this policy may actually grandfather in cell lines that were ineligible on ethical grounds even under the Clinton guidelines," said Richard Doerflinger of the U.S. Conference of Catholic Bishops, which opposes federal funding of human embryo stem cell research.

"To be sure, our moral objection has not centered on how informed the parents' consent is," Doerflinger said, noting that it focuses instead on the well-being of the embryos. "But at least the Clinton guidelines spelled all this out. This is distressing."

Bush's statement Thursday that there are 60 human embryonic stem cell lines already in existence eligible for study with federal funds under the new plan caught many researchers by surprise. Even specialists in the field had been unaware there were more than 10 or 15 lines.

Lana Skirbol, NIH director of science policy, said the number Bush referred to was derived from a recent intensive round of inquiries to laboratories around the world by the agency. Many more lines are in existence than previously believed, she said, with several being kept behind closed doors to protect commercial and proprietary interests.

Some scientists said they suspect that many of those cells are not truly stem cells. The criteria for stem cells are quite strict; the cells must be able to reproduce without limit, and all progeny cells must be able to reproduce indefinitely and develop into every cell type in the body.

Many cells that at first appear to be stem cells have proven not to be, but Skirbol said the agency used strict definitional rules in its survey. Moreover, she said, all appear to be eligible for federally funded studies.

"The NIH believes that all 60 cell lines meet the president's criteria" for federal funding, she said. To meet the criteria, cells must be from embryos left over from fertility treatments (as opposed to having been created for research); parents must not have been compensated for donating the embryos; proper informed consent must have been obtained; and the embryos must have been destroyed before 9 p.m. Aug. 9 -- the day of the president's announcement.

In an interview, Skirbol acknowledged that a few of the existing cell lines may be found to be of little or no use, perhaps because they don't grow well or cannot be easily manipulated. But new lines are also expected to become available she said, as researchers reveal lines created in recent months.

The NIH will require documentation that the cells are from embryos destroyed before Thursday, she said. The agency is creating a registry of all eligible stem cell lines -- and, in a difficult task, devising material transfer agreements that specify the legal conditions under which cells can be shared -- so that researchers will soon be able to choose from a menu of embryo cells.

New grants will not be available until next year, Skirbol said. But scientists who already have NIH grants can file for supplemental money for stem cell work -- a system that works faster than the normal grant approval process. And many researchers already working with conventional cells are expected to apply to NIH for permission to add stem cells to their experiments. That process does not require grant approval and can take just a few weeks.

Depending on how long it takes to work out legal arrangements, some stem cells could be available on this basis within a few weeks.

The Bush system will work much more efficiently than the Clinton system would have, Skirbol said, in part because it eliminates a layer of scientific and ethical oversight from a special committee called for under the Clinton plan. That committee was formed earlier this year but never met.

One of the more complicated aspects of getting the system in place will be coordinating patent and royalty arrangements that may be demanded by laboratories that have stem cells to share. The arrangement at Wisconsin in particular makes it difficult to predict how much profit, if any, the university may make from its stem cells.

Thomson and the university's alumni research foundation share two key patents on stem cell processes and products, with commercial rights licensed to Geron Corp., a Menlo Park, Calif., biotechnology company. A nonprofit corporation, WiCell Inc., distributes the Wisconsin cells to scientists for $5,000 per batch. That amount barely covers costs, said spokesman Andrew Cohn.

But scientists who find lucrative uses for those cells, such as a treatment for diabetes, may have to pay a portion of their revenue or profits to the university foundation, depending on what kind of arrangement they have made and how much of the work is covered by the university's patents. Cohn said he had no profit projections for the stem cell business, and said any suggestion that Thompson considered the university's finances during the stem cell decision-making process was "ludicrous."

Last year, the foundation made $35 million for the university.

© 2001 The Washington Post Company

Stem Cell Decision Only Adds To Debate

Many Oppose Bush Plan; Others Say It's Too Limited

Saturday, August 11, 2001; Page B01
By Michael E. Ruane
Washington Post Staff Writer

Betty Ann Krahnke watched President Bush's stem cell speech Thursday night from her wheelchair, where she has lain for much of the last two years, extensively paralyzed by Lou Gehrig's disease.

The former Montgomery County Council member thought Bush's backing of limited embryonic stem cell research, which may one day help Lou Gehrig's patients, was balanced and considered. But, she added yesterday via her computerized speaking machine, "I hoped he would go farther, because time is critical."

Cardinal Theodore E. McCarrick, the Roman Catholic archbishop of Washington, listened to the president's speech on the radio in his apartment in Hyattsville, also impressed by Bush's consideration of the issue, but pained that he may have opened a dangerous ethical door.

"Unfortunately, he does allow the allotment of federal funding . . . for something that many of us feel to be morally wrong," McCarrick said. "It opens the door to experimentation. What I'm afraid of is the restrictions are not going to hold. . . . Any time you lessen that respect for human life, you're on that slippery slope."

Their views -- one based on physical reality, the other on moral conviction -- were part of the sometimes anguished debate that spread across the Washington area and the country yesterday after the president told the nation that he supported federal funding of research into stem cells already taken from human embryos.

Opinions swirled in between and around those of the cardinal and the afflicted politician.

Krahnke, a Republican who was honorary chair of the county Bush campaign last year, had told the president her views about stem cells and her illness, which also is known as amyotrophic lateral sclerosis, ALS.

"Please do not change the one policy of former President Clinton with which I agree, allowing stem cell research," she wrote Bush this summer, in a painstakingly composed five-paragraph letter.

"Stem cell research holds the best hope for a cure for ALS and many other diseases," she wrote. "I urge you not to cut off this potential lifeline."

Some embryonic stem cell research has shown promise in research into ALS, a terminal and incurable disease that destroys the motor neuron cells carrying messages from the brain to the body, experts said yesterday. But the promise is remote.

"It's very early at this point," said Lucie Bruijn, science director and vice president of the ALS Association. "There's been some very interesting and provocative data, none of which has been published or scientifically reviewed."

"Although there's a hope," she said, "there's a real challenge."

There are about 30,000 Lou Gehrig's disease patients in the United States at any given time, the experts said of the disease named for the baseball great, who died of it in 1941. There are about 5,600 new cases each year.

The president "probably did as much as he could considering the political pressures," Krahnke's husband, Wilson, said yesterday. "You don't just leap right off the bridge. You sort of take a few steps at a time. . . . I think he came up with maybe the best practical solution at this time."

Among those most torn yesterday was Eileen Gould, of Montgomery Village, in Montgomery County.

Gould is a Roman Catholic, and the Church opposes embryonic stem cell research. But Gould's husband, John, has Lou Gehrig's disease. Her daughter, Pamela, has just undergone successful in vitro fertilization that has produced several leftover embryos that have now been frozen.

Eileen Gould said yesterday that she and her husband support embryonic stem cell research. "It would be wonderful if this led to any decrease in ALS, Parkinson's, [multiple sclerosis], or Alzheimer's," she said. "The end justifies the means in this case. . . . But I'm toeing a line with my own conscience."

The local Catholic Church leader respectfully disagreed.

"I just think there were so many political and other pressures on the president that he allowed something which I think is a mistake," McCarrick said.

McCarrick said he greatly preferred research into adult stem cells taken from umbilical cords and human placentas. "We can get them without killing people, without taking these little embryos, that, if you leave them alone, will grow into people like you and me."

Others who described themselves as religious also equated the embryonic stem cell research with the taking of lives.

"These stem cells are the beginning of life," Mark Senderling, 38, a Department of Energy engineer who lives in Sandy Spring and described himself as a committed Christian. "Life starts at conception."

"I believe [Bush] to be a devout Christian as well, and he's cut a very fine line here," Senderling said in an interview on the Mall yesterday. "But I'm afraid to see where this will go."

Claudia Escribano, who works for a Web design training firm in Reston, said she supports Bush's decision to back research on existing stem cells.

The 40-year-old, a Democrat, said she thinks the research could help those afflicted with spinal cord injuries, Parkinson's disease or Alzheimer's.

"The research in that area is so important. I think you have to look at both sides," Escribano said, enjoying lunch at the Mall with her 3-year-old daughter, Caitlin. "Why not help the people who are here now?"

Outside the Montgomery County Courthouse in Rockville, David Loughery, 53, a transportation planner from Gaithersburg, said he thought Bush had gone back on a campaign promise to oppose such research. "What else is new?" he said.

"I don't particularly approve of" such research, he said. "I'm afraid that what'll happen is that instead of being used for valid research, it'll become somebody's toy."

Loughery, who said he is neither a Democrat nor a Republican, said he doubted such experiments would stop with embryos. "Eventually, somebody's going to take it to the next step, to fetuses, then somebody's going to take it to full term. . . . It's already scary."

Nearby, Dave Warren, 43, a systems engineer from Westminster, said he thought the president had gone just far enough.

"Medically, you need to do the research," he said. "But I'm opposed to raising embryos just to do it. I think it's a responsible approach. There's too many paralyzed people that are depending on a successful outcome.

"I think it was a responsible way to go: Let the research continue, but stop short of farming embryos," he said.

The debate went on across the country.

In New York, Sherry Power, a 53-year-old teacher on vacation from Milwaukee, basked in the shade of St. Patrick's Cathedral, and called Bush's announcement a "safe" solution."

"I think he was trying to please everybody," she said.

"Being adopted, I have very personal feelings about abortion," she said. "It could have been me. I have great respect for the fact that life begins at conception."

But she said she had a close friend who died of Lou Gehrig's disease. "It's such a terrible thing to watch," she said. "I have great empathy for people who are dealing with these illnesses and have no cure and see this research as a beacon of light."

In Beverly Hills, Calif., one Bush critic was more biting.

Richard Quinn, a 55-year-old screenwriter who is disabled, argued that to let politics impede science was foolhardy.

"We've always been the leaders in medical research," Quinn said. "So to put any constraints on it sounds stupid."

In Washington, the Diabetes Research and Wellness Foundation had mixed views about the president's stand.

"In diabetes, we know stem cell research is going to be very important," foundation spokeswoman Kathy Gold said. "We're disappointed, but at least [Bush] didn't say no totally. Hopefully, with more work on this issue, we can expand their use. It's going to make a big difference in what we can do in the future in finding a cure."

Staff writers Leef Smith, Christine Haughney, Jeff Adler and Andrew DeMillo contributed to this report. Adler reported from California.

© 2001 The Washington Post Company

Researchers worry about Bush's stem cell decision

August 10, 2001 12:09am
Source: Reuters
By Will Dunham

WASHINGTON (Reuters) - Stem cell researchers and patients' advocates cautiously welcomed President Bush's decision to allow federal funds for embryonic stem cell research but said limits imposed on the work ultimately could ruin its promise for treating a variety of diseases.

Bush said he would allow taxpayers' money to be used on research involving stem cells harvested from live human embryos.

But he also said that the stem cells -- primitive master cells that can transform themselves into other cell types -- would have to come from 60 existing lines. Each cell line is a reservoir of stem cells derived from a single embryo.

Researchers Thursday questioned whether 60 cell lines existed and, since many are owned by private companies, whether federally funded researchers would be able to use them. Government funding allows researchers at universities to conduct work that previously limited largely to private companies or academic scientists with corporate backing.

"Well, at least they're allowing some federally funded work on human embryonic stem cells," Dr. Diane Krause, a stem cell researcher at Yale University School of Medicine, said in an interview.

But Krause said limiting the number of stem cell lines with which federally funded researchers could work meant there might not be sufficient genetic diversity in the cell reservoirs.


"We need to see a variety of these in order to fully understand the applications to multiple different diseases," Krause told Reuters. "It will be good enough for some purposes. But it will be limited by its very nature of being a limited number of cell lines. What we can do with them will be limited."

Dr. Neil Theise, a stem cell researcher at New York University Medical Center, warned, "If this remains the decision for the long term, I think it could significantly inhibit our ability to get the sort of therapies that we're hoping for."

Dr. Douglas Melton, chairman of the cellular and molecular biology department at Harvard University, said Thursday that he had not been aware of as many stem cell lines as the president said existed.

"The 60 cell lines is news to me," Melton said. "I presume that many of them must have been derived by private institutes or companies, and whether they will be made available to (the National Institutes of Health) for federally funded researchers without restriction is an important question to ask."

Federal funds cannot be used to pay for creating stem cell lines because U.S. law bars funding research that harms a human embryo. The lines are thus largely in private hands, and many experts had believed that far fewer than 60 existed, with estimates ranging from fewer than a dozen to 30.


Dr. James Thomson, the University of Wisconsin researcher who isolated the first human stem cells in 1998, said in a statement Thursday: "I am very pleased that President Bush made a decision that will allow human embryonic stem cell research to go forward. The proposed compromise will slow the research, but the compromise is better than halting the research entirely."

Paralyzed actor Christopher Reeve, head of the Christopher Reeve Paralysis Foundation, which supports research seeking a cure for paralysis, said in an interview, "I'm very pleased that it wasn't a complete no, but I really think we must go further."

John Rogers, education and advocacy director for the Parkinson's Action Network, said, "While we have concerns about the number of lines, we're very pleased that the president has announced that we're moving forward with the research, and we think it gives hope to millions of Americans."

Stem cells are versatile primitive cells with the ability to transform themselves into many other types of cells, such as those found in the brain, heart, bones, muscles and skin. Embryonic stem cells have been able to become virtually any cell type in the body, while so-called adult stem cells, harbored in the bodies of adults and children, have shown more limitations.

Scientists hope to harness the cells' transformational powers to devise revolutionary treatments for a variety of diseases, using stem cells to regenerate healthy tissue to replace tissue damaged by disease or injury.

They hope to use the technique against juvenile diabetes, Alzheimer's disease, Parkinson's disease, stroke, heart attack, multiple sclerosis, severe burns, spinal cord injuries and other conditions.

Copyright © 1999 Reuters Limited.

Stem-cell research potential tempered by ethical issues

Embryonic stem cells may be the new kids on the block, but their promising attributes are attracting much attention.

Aug. 13, 2001
By Susan J. Landers, AMNews staff.

Washington -- Regardless of whether stem-cell research moves forward with embryonic stem cells or adult stem cells, with public or private funding, recent results have sparked enough enthusiasm, controversy and debate to carry the field forward for a long time.

If stem cells live up to their promise, they could dramatically improve physicians' odds of defeating a long list of serious conditions that include diabetes, Parkinson's disease, end-stage kidney disease, liver failure, heart disease, multiple sclerosis, spinal cord injury and stroke.

But, the promise of embryonic stem cells is not only a long way from being realized, it is also tempered by problematic ethical issues.

Meanwhile, the difficulties of working with adult stem cells has dimmed researchers' zeal.

Still, the potential of stem-cell research can be tantalizing.

"Over 3,000 people die every day in the United States from diseases that may someday be treatable as a result of stem-cell research," according to a report by the Progressive Policy Institute, a Washington, D.C.,-based think tank.

While much of the recent interest has been sparked by embryonic stem cells, which were first isolated from embryos only three years ago, the momentum for research on adult stem cells, which has been conducted for many years, has waned a bit.

Much remains unknown. "So far, adult stem cells have proven to be very different from embryonic stem cells," ventures Tony Mazzaschi, associate vice president for research at the American Assn. of Medical Colleges. He notes that the AAMC supports research on both types of stem cells. The AMA also strongly supports all stem-cell research, as do numerous other medical groups.

It isn't hard to find research success stories.

Dramatic findings released in mid-July by Johns Hopkins University researcher John Gearhart, MD, offered videotaped proof that previously paralyzed mice and rats regained some ability to use their legs after being injected with embryonic stem cells.

At about the same time, researchers in London revealed that they had coaxed adult stem cells found in bone marrow to develop as kidney cells.

The National Institutes of Health released a report on July 18 that also cites the promise of both types of stem-cell research.

All stem cells, whether derived from adults, embryos or fetuses, can, under certain conditions, reproduce themselves for long periods of time. They can also give rise to specialized cells that make up the tissues and organs of the body.

Where the similarities end
Embryonic stem cells have certain attributes that, so far at least, have not been found in adult stem cells. For one thing, embryonic stem cells are pluripotent, whereas adult stem cells are believed to have a more limited range.

In addition, "As far as we know, [embryonic stem cells] can replace themselves forever, unlike adult stem cells," said James Thompson, PhD, a developmental biologist at the University of Wisconsin-Madison and one of the first two scientists to isolate stem cells from human embryos. Dr. Thompson spoke at a National Academies of Science workshop in June.

Dr. Thompson derives embryonic stem cells from four- to five-day-old embryos called blastocysts, which are donated by couples undergoing in vitro fertilization. The embryos, which are destroyed in the process of extracting stem cells, are said to be extras and destined to be destroyed in any case.

There appear to be only two sources for human pluripotent stem cells: those isolated and cultured from early human embryos and those cultured from fetal tissue destined to be part of the gonads.

Dr. Gearhart, who takes honors with Dr. Thompson as the other researcher to have isolated human embryonic stem cells, uses the second approach to develop his stem cells, an approach that, so far, seems to have escaped controversy.

However, the destruction of the early stage embryos has sparked a strong debate over whether federal funding should support such research. President George W. Bush was still struggling with the issue at press time.

Congress is also divided on the issue.

But adult stem cells are free of the current debate. And those that oppose the destruction of the blastocyst in order to obtain embryonic stem cells gladly point to the successes of adult stem-cell research and the need to continue.

To date, adult stem cells have been identified in brain, bone marrow, peripheral blood, blood vessels, skeletal muscle, epithelia of the skin and digestive system, cornea, dental pulp of the tooth, retina, liver and pancreas.

Although they are found in many sites, they are rare and difficult to identify, isolate and purify, notes the NIH report.

But David Stevens, MD, executive director of the Christian Medical Assn. and an opponent of embryonic stem-cell research, believes the promise of adult stem-cell research is being unfairly overlooked.

"Adult stem cells have been used in rebuilding ears, tracheas in humans, and even have been used to regenerate heart tissue in mice," he said.

As Dr. Stevens sees the debate, "If we have two paths of promising research and one has ethical issues and the other does not, which one should we pursue? It seems to me we should pursue the one without the ethical problems."

He also points out potential difficulties with embryonic stem cells. "The biggest benefit of embryonic stem cells is that they can differentiate into so many different types of cells. But that's their biggest problem, too. How do you direct them?"

A federal ban on research would mean the NIH, the lead supporter of biomedical research, and an agency currently enjoying an increased funding level, would be prohibited from supporting embryonic stem-cell research. Privately funded research could continue, but outside the sphere of NIH guidelines, leading some to fear that research standards would suffer.

The funding debate has dragged on for many months now. In January, the AMA joined with more than 100 other medical groups in urging the president to release funding. The groups said, "Given the great hope that stem-cell research provides to those who are suffering or dying from devastating illnesses, we urge you to allow this research to move forward with federal support."

Stand on Embryo Research Separates LDS Senators From Traditional Allies

Thursday, August 9, 2001

Debate in the U.S. Senate over federal funding of embryonic stem cell research reveals a deep divide in personal religious beliefs and the theology of when life begins.

The five senators who are members of The Church of Jesus Christ of Latter-day Saints all have come out in favor of spending federal money to study whether cells taken from embryos in the first stages of development can be used to cure such problems as heart disease, multiple sclerosis, Parkinson's, Alzheimer's, cancer and diabetes.

The Mormon senators' stand is controversial because the collection of these cells would require the destruction of excess embryos produced at fertility clinics.

Since most of the Mormon senators strongly oppose abortion in all but a few circumstances, their decision underscores that LDS theology is unclear on whether an embryo created in the laboratory through in vitro fertilization is a living being.

The senators are leaning toward -- and sometimes coming right out and saying -- that these embryos are not yet truly alive.

"While I understand that many in the pro-life community will disagree with me, I believe that human life begins in the womb, not a petri dish or refrigerator," Sen. Orrin Hatch, R-Utah, said at a Senate hearing last month.

That position has separated the Mormons from traditional conservative allies in the Senate who consider the destruction of an embryo no different from aborting a developing fetus. By aligning with their more liberal colleagues, the Mormon senators have joined a coalition of two-thirds of the Senate who now support federal funding for the research -- enough to override a potential presidential veto.

The Mormon senators "have helped move the debate away from right-to-life absolutism without sacrificing pro-life theology. The LDS Church, not the Vatican, is playing the pivotal role in the struggle over stem cells," according to an analysis by Drew Clark in the Aug. 2 edition of Slate Magazine.

Central to the Senate debate is the question of when life begins.

The LDS Church has been clear about its opposition to abortion in all but rare cases "involving pregnancy by incest or rape; when the life or health of the woman is adjudged by competent medical authority to be in serious jeopardy; or when the fetus is known by competent medical authority to have severe defects that will not allow the baby to survive beyond birth."

No Guidance: But Mormon leaders have provided no guidance on exactly when life begins.

"There is no direct revelation upon the subject of when the spirit enters the body," church spokesman Dale Bills said this week.

Mormon theology holds that people existed as "spirit children" of God prior to receiving an earthly body. Thus, there is some point where the spirit unites with the physical body to create life.

In the church's scriptural Doctrine & Covenants, there is a passage that reads: "And the spirit and the body are the soul of man."

Church leaders have not said whether this joining of spirit and body occurs at conception or sometime later in the development of the fetus.

On the issue of embryonic stem cell research, LDS Church leaders issued a statement last month saying they had no position but added the idea "merits cautious scrutiny."

That left the Mormon senators free to explore their personal beliefs on the issue, and to balance the possible health benefits of the research against the moral quandary of destroying embryos.

Sen. Gordon Smith, R-Ore., a Mormon, offered his view that laboratory-produced embryos are no more than the "dust of the earth" that lack the spark of life until they are implanted in the mother's womb.

"They are essential to life, but standing alone, will never constitute life," Smith said at a Senate hearing. "A stem cell in a petri dish or frozen in a refrigerator will never, even in 100 years, become more than stem cells. They lack the breath of life. I believe that life begins in a mother's womb, not in a scientist's laboratory."

The other Mormon senators supporting the research are: Bob Bennett, R-Utah; Mike Crapo, R-Idaho, and Harry Reid, D-Nev.

Collision Course: Such views clash head-on with the beliefs of Catholics and many Jews. Owen Cummings, who tutors new deacons for the Utah diocese of the Catholic Church, said the church's position on this issue has been consistent since at least the 1300s.

"Life begins when life begins, and that is at the moment when an ovum is fertilized with a sperm," said Cummings. "We are not left with the concept that something is there which might become a person, but a person is there in the process of becoming."

Catholics have no objection to research using stem cells collected from the placenta, umbilical cord or from adults, Cummings said, but the embryo is "sacred" and must not be destroyed.

Many Jews also believe life begins when the egg is fertilized, said J. David Bleich, a rabbi and professor of Jewish law and ethics at Yeshiva University in New York City.

Bleich acknowledged there is debate among Jewish scholars over whether the soul enters the embryo at the moment of fertilization or 40 days later.

"If it is 40 days, no one can object if you kill [the embryo] for a good purpose," he said. "But the weight of authority, I contend, is that all of this happens at the moment of conception, in which case you have a problem."

The rabbi said the federal government should not finance work in which embryos are destroyed to collect stem cells.

"The government has no business funding things that are morally offensive to huge sectors of society," he said.

But if stem cells are collected through privately funded work from excess embryos at fertility clinics, he said their use should be allowed in government-funded research.

"If you have a homicide victim and want to salvage organs, no one is going to be opposed," the rabbi said. "Does that mean I've condoned the act of homicide? No."

The excess embryos awaiting destruction are like those homicide victims, he said. He does not condone their destruction and contends the federal government should not support it. But since they are going to be destroyed anyway, Bleich said federal funding should be available to study the stem cells that are "harvested."

In a recent letter to the secretary of Health and Human Services, Tommy Thompson, Hatch said that he understands and respects those who believe that destruction of excess embryos is akin to abortion. But he disagrees.

"To me, a frozen embryo is more akin to a frozen unfertilized egg or frozen sperm than to a fetus naturally developing in the body of a mother," he wrote. "In the case of in vitro fertilization, extraordinary human action is required to initiate a successful pregnancy while in the case of an elective abortion an intentional human act is required to terminate pregnancy. These are polar opposites."

© Copyright 2001, The Salt Lake Tribune

Decision will unleash scores of proposals to NIH

August 10, 2001
By Bob LaMendola

FORT LAUDERDALE, Fla. -- For stem-cell scientists, President Bush just popped the lid off of a $17 billion treasure chest that had been locked to them.

The president's approval of limited funding for stem-cell research will unleash scores of proposals to the nation's largest single source of medical research, the huge grants budget of the National Institutes of Health, scientists said on Thursday.

Research teams have countless ideas on how stem cells can be manipulated to treat a list of ills: Diabetes, Alzheimer's, Parkinson's, stroke, heart attacks, multiple sclerosis, Lou Gehrig's disease, bone marrow disorders, failed organs and spinal cord injuries. Stem cells may regrow the skin of burn victims and replace tissues lost in cancer treatment.

"This will push us forward on many, many fronts," said W. Dalton Dietrich, scientific director of the Miami Project to Cure Paralysis, who oversees several stem-cell projects.

"We would like to say that one day we'll be able to take these cells, put them in a petri dish with some chemical growth factors and be able to control what they turn into," he said.

On the flip side, it may turn out that the body rejects the implanted stem cells. Or, the new cells could grow too fast and create tumors.

The cells are derived from five- to 10-day-old embryos made in fertility labs to implant in prospective mothers. Privately funded research currently takes unused embryos, which are routinely discarded, for study. Once created, the tiny balls of cells divide almost indefinitely so labs have a big supply.

Stem cells were first isolated in 1998, but a 1995 law banned federal funding for any research that "destroyed, discarded or knowingly subjected to risk" any human fetus, no matter how microscopic.

In his compromise decision, Bush imposed two key restrictions. First, all stem cells used for research must come from embryos originally created for fertility treatment. Second, researchers must use stem cell lines cultured from 60 embryos that already have been killed by privately funded researchers.

"I'm quite happy. That would be acceptable to any reasonable researcher," said Dr. Luca Inverardi, co-director of the cell transplant center at the University of Miami's Diabetes Research Institute.

The NIH is expected to require labs that presently have the stem cells to either sell or share them with other researchers, possibly as a condition of their federal funding, Inverardi said.

Inverardi's lab -- now growing to five scientists -- has been studying how to convert mouse stem cells into replacements for faulty pancreas tissues that cause diabetes. Three teams have succeeded in doing so, one in Israel using human cells.

With NIH dollars available, Inverardi anticipates landing as much as $4 million over the next 10 years to work on human stem cells.

The spinal cord lab that Dietrich oversees also has been studying mouse cells, and will go after NIH grants to begin work on human cells.

The goal: Creating new nerves that could grow across broken spinal cords to eliminate paralysis. Groups elsewhere are trying this in humans using private funds, he said. Harvard doctors reported they "cured" Parkinson's in rats.

Signs of progress abound. An Israeli team coaxed embryo stem cells to grow into heart muscle. A privately funded team created nerve cells that repaired the brains of monkey fetuses.

Last year, the NIH gave $256 million to researchers studying adult cells, a non-controversial area using tissue derived from patients.

After Bush's action, it's unclear how big a slice of the NIH's $17 billion budget would go for embryo stem-cell work. NIH scientists award grants to studies they deem to be the most promising, regardless of subject matter, spokesman Don Ralbovsky said. Competition is fierce, and the evaluations will be deliberate.

"The first checks would not be cut until early in the new year," Ralbovsky said.

The prospect of big dollars for stem-cell projects excited advocacy groups for diseases that stand to benefit from the research.

"We see lots of promise," said Jerry Franz, a spokesman for the American Diabetes Association. "People with diabetes are often promised more than what actually is delivered. But it offers hope and we want to be supportive of offering hope."

"I'm no scientist," said Alison Landes of Boca Raton, Fla., who started the group Cure Parkinson's Inc. after her sister was diagnosed with the incurable brain disorder. "It seems too promising to turn away. Maybe people wouldn't have to take drugs, which don't work forever and are not a cure."

Researchers and disease groups had feared that Bush would continue the ban on federal funds for stem-cell work, because of pressure from those with ethical or religious objections to using embryos.

A rejection likely would have driven some of the limited number of U.S. embryo researchers to other countries that support it, Inverardi said.

U.S. drugmakers and biotechnology firms, which generally supported Bush, favored the federal funding.

Copyright © 2001, South Florida Sun-Sentinel 

Woman with MS doesn't want embryo research

She joins state lawmakers who plan bill placing limits on study

Last Updated: Aug. 9, 2001
of the Journal Sentinel staff

Madison - Though stem cell research might hold a cure for her, Mary Lynn Bielinski of Brookfield said Thursday she would rather endure multiple sclerosis than live, knowing the cure involved destruction of embryos.

Seated in a wheelchair during a Capitol news conference, Bielinski voiced support for a bill to prohibit the creation and destruction of embryonic cells for research. She said she realized such research one day might enable multiple sclerosis sufferers like her to walk again.

"But if babies are going to be lost in the process, no thank you, I'd rather just stay the way I am," Bielinski said.

"I'm totally against any kind of stem cell research that would take these little - I call them babies," she said. "After all, a seed is going to grow into a mighty oak, just as these embryos, if allowed to grow, will become babies."

Bielinski, 61, who was diagnosed with multiple sclerosis in 1979, said that when people suffer a miscarriage, they grieve over the loss of their child.

"And I would grieve terribly over the loss of these babies if this stem cell research is allowed to continue," she said.

Bielinski joined Rep. Steve Freese (R-Dodgeville) and Barbara Lyons of Wisconsin Right to Life at the news conference to announce the legislation.

Freese said the bill he and Sen. Bob Welch (R-Redgranite) would introduce within a week was more comprehensive than the stem cell research ban proposed by Assembly Republicans during budget negotiations but later rejected.

Freese said the bill would allow research on adult stem cells, but not cells taken from embryos 6 to 8 days old. The University of Wisconsin-Madison has been the leading research institution on embryonic stem cells. Freese said UW researchers should work on adult stem cells, not embryonic cells.

Freese said the bill would make the intentional destruction of a living human embryo a crime. Anyone providing researchers a human embryo, knowing it would be destroyed, also could be prosecuted, he said.

The legislation also would prohibit cloning. Finally, it would call for a legislative council study on ways to regulate infertility clinics and the production of embryos, and to facilitate adoption of spare embryos.

In an opening statement, Freese talked about the medical experiments the Nazis conducted during the Holocaust and the United States' Tuskegee experiment, in which the U.S. Public Health Service withheld penicillin and watched poor, uneducated African-American men die of syphilis.

In drawing the comparisons, Freese said later, he was only attempting to illustrate a need to understand the consequences of research and have controls in place.

Freese said 11 other states, including Minnesota and Michigan, prohibit experiments on human embryos outside a woman's body. He acknowledged the bill would face strong opposition in the Senate, controlled by Democrats. UW officials also oppose the measure.

Another opponent, Rep. Sheldon Wasserman (D-Milwaukee), said embryonic stem cells hold the most promise for cures and that prohibiting such research would prolong suffering and cost lives.

"I think we have to protect people who are dying and suffering from these horrible diseases. Don't they have a voice?" said Wasserman, a practicing physician.

If people want no part of such research because their religious convictions, that is their choice to make, Wasserman said. But he said they should not deny others the benefits of such research.

"Don't impose your value system that says my kids can't get healthy, my kids won't be cured, my wife won't be spared from breast cancer," Wasserman said.

Answering questions after speaking at the annual Governor's Forum Luncheon in Milwaukee on Thursday, Gov. Scott McCallum said he had not seen the bill and wasn't familiar with its language.

But he added that he supports "steps necessary to support an ethical course in stem cell research." If the finished bill contains such a provision, "it may be signed," he said.

Avrum D. Lank of the Journal Sentinel staff, reporting from Milwaukee, contributed to this report.

Appeared in the Milwaukee Journal Sentinel on Aug. 10, 2001.

© Copyright 2001, Milwaukee Journal Sentinel

'Explore the Promise'

Transcript of President Bush's Speech to Nation

C R A W F O R D, Texas, Aug. 9 - Following is a transcript of President Bush's first nationally televised address to the nation. In his speech, Bush announces his support for very limited federal funding of research using stem cells derived from human embryos.

Good evening. I appreciate you giving me a few minutes of your time tonight so I can discuss with you a complex and difficult issue, an issue that is one of the most profound of our time.

The issue of research involving stem cells derived from human embryos is increasingly the subject of a national debate and dinner table discussions. The issue is confronted every day in laboratories as scientists ponder the ethical ramifications of their work. It is agonized over by parents and many couples as they try to have children or to save children already born. The issue is debated within the church, with people of different faiths, even many of the same faith, coming to different conclusions.

Many people are finding that the more they know about stem-cell research, the less certain they are about the right ethical and moral conclusions.

My administration must decide whether to allow federal funds, your tax dollars, to be used for scientific research on stem cells derived from human embryos.

A large number of these embryos already exist. They are the product of a process called in-vitro fertilization which helps so many couples conceive children. When doctors match sperm and egg to create life outside the womb, they usually produce more embryos than are implanted in the mother.

Once a couple successfully has children, or if they are unsuccessful, the additional embryos remain frozen in laboratories. Some will not survive during long storage, others are destroyed. A number have been donated to science and used to create privately funded stem cell lines. And a few have been implanted in an adoptive mother and born and are today healthy children.

Based on preliminary work that has been privately funded, scientists believe further research using stem cells offers great promise that could help improve the lives of those who suffer from many terrible diseases, from juvenile diabetes to Alzheimer's, from Parkinson's to spinal cord injuries. And while scientists admit they are not yet certain, they believe stem cells derived from embryos have unique potential.

You should also know that stem cells can be derived from sources other than embryos: from adult cells, from umbilical cords that are discarded after babies are born, from human placentas. And many scientists feel research on these types of stem cells is also promising. Many patients suffering from a range of diseases are already being helped with treatments developed from adult stem cells.

However, most scientists, at least today, believe that research on embryonic stem cells offers the most promise because these cells have the potential to develop in all of the tissues in the body.

Scientists further believe that rapid progress in this research will come only with federal funds. Federal dollars help attract the best and brightest scientists. They ensure new discoveries are widely shared at the largest number of research facilities, and that the research is directed toward the greatest public good.

The United States has a long and proud record of leading the world toward advances in science and medicine that improve human life, and the United States has a long and proud record of upholding the highest standards of ethics as we expand the limits of science and knowledge.

Research on embryonic stem cells raises profound ethical questions, because extracting the stem cell destroys the embryo, and thus destroys its potential for life.

Like a snowflake, each of these embryos is unique, with the unique genetic potential of an individual human being.

As I thought through this issue I kept returning to two fundamental questions. First, are these frozen embryos human life and therefore something precious to be protected? And second, if they're going to be destroyed anyway, shouldn't they be used for a greater good, for research that has the potential to save and improve other lives?

I've asked those questions and others of scientists, scholars, bio-ethicists, religious leaders, doctors, researchers, members of Congress, my Cabinet and my friends. I have read heartfelt letters from many Americans. I have given this issue a great deal of thought, prayer, and considerable reflection, and I have found widespread disagreement.

On the first issue, are these embryos human life? Well, one researcher told me he believes this five-day-old cluster of cells is not an embryo, not yet an individual but a pre-embryo. He argued that it has the potential for life, but it is not a life because it cannot develop on its own.

An ethicist dismissed that as a callous attempt at rationalization. "Make no mistake," he told me, "that cluster of cells is the same way you and I, and all the rest of us, started our lives. One goes with a heavy heart if we use these," he said, "because we are dealing with the seeds of the next generation."

And to the other crucial question - If these are going to be destroyed anyway, why not use them for good purpose? - I also found different answers.

Many are these embryos are byproducts of a process that helps create life and we should allow couples to donate them to science so they can be used for good purpose instead of wasting their potential.

Others will argue there is no such thing as excess life and the fact that a living being is going to die does not justify experimenting on it or exploiting it as a natural resource.

At its core, this issue forces us to confront fundamental questions about the beginnings of life and the ends of science. It lives at a difficult moral intersection, juxtaposing the need to protect life in all its phases with the prospect of saving and improving life in all its stages.

As the discoveries of modern science create tremendous hope, they also lay vast ethical mine fields.

As the genius of science extends the horizons of what we can do, we increasingly confront complex questions about what we should do. We have arrived at that brave new world that seemed so distant in 1932 when Alduous Huxley wrote about human beings created in test tubes in what he called a hatchery.

In recent weeks, we learned that scientists have created human embryos in test tubes solely to experiment on them. This is deeply troubling and a warning sign that should prompt all of us to think through these issues very carefully.

Embryonic stem-cell research is at the leading edge of a series of moral hazards. The initial stem-cell researcher was at first reluctant to begin his research, fearing it might be used for human cloning. Scientists have already cloned a sheep. Researchers are telling us the next step could be to clone human beings to create individual designer stem cells, essentially to grow another you, to be available in case you need another heart or lung or liver.

I strongly oppose human cloning, as do most Americans. We recoil at the idea of growing human beings for spare body parts or creating life for our convenience.
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. Even the most noble ends do not justify any means.

My position on these issues is shaped by deeply held beliefs. I'm a strong supporter of science and technology, and believe they have the potential for incredible good - to improve lives, to save life, to conquer disease. Research offers hope that millions of our loved ones may be cured of a disease and rid of their suffering. I have friends whose children suffer from juvenile diabetes. Nancy Reagan has written me about President Reagan's struggle with Alzheimer's. My own family has confronted the tragedy of childhood leukemia. And like all Americans, I have great hope for cures.

I also believe human life is a sacred gift from our creator. I worry about a culture that devalues life, and believe as your president I have an important obligation to foster and encourage respect for life in America and throughout the world.

And while we're all hopeful about the potential of this research, no one can be certain that the science will live up to the hope it has generated.

Eight years ago, scientists believed fetal tissue research offered great hope for cures and treatments, yet the progress to date has not lived up to its initial expectations. 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 indefinitely, 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.

Leading scientists tell me research on these 60 lines has great promise that could lead to breakthrough therapies and cures. 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.

I also believe that great scientific progress can be made through aggressive federal funding of research on umbilical cord, placenta, adult and animal stem cells, which do not involve the same moral dilemma. This year your government will spent $250 million on this important research.

I will also name a president's council to monitor stem-cell research, to recommend appropriate guidelines and regulations and to consider all of the medical and ethical ramifications of bio-medical innovation.

This council will consist of leading scientists, doctors, ethicists, lawyers, theologians and others, and will be chaired by Dr. Leon Cass, a leading bio-medical ethicist from the University of Chicago.

This council will keep us apprised of new developments and give our nation a forum to continue to discuss and evaluate these important issues.

As we go forward, I hope we will always be guided by both intellect and heart, by both our capabilities and our conscience.

I have made this decision with great care, and I pray it is the right one.

Thank you for listening. Good night, and God bless America.