More MS news articles for Aug 2001

Rochelle Riley: Living things should help each other

http://www.freep.com/news/metro/riley17_20010817.htm

August 17, 2001

My mother lies in a North Carolina nursing home, unable to feed herself, dress herself or walk down the hall to the Sunday services conducted by a deacon who has preached there nearly every Sunday for 15 years.

She was stricken in what is typically called the prime of life. After years of being the debutante, beauty queen and majorette, she is now former all of those things. She has multiple sclerosis. And there is no cure.

But I can tell you this: She asks to be put in a wheelchair every Sunday so she can be pushed to those services. And she can still tell a joke.

And if there was something contained in stem cells, those magical entities at the heart of recent debate, that would help her, I'd try to remove my own to give to her.

Care for the living

Thus, my question for those who criticize President George W. Bush's decision to allow federal funds to be used for research on existing embryonic stem cells is: Whose side are you on?

If these living entities are being used to extend or improve someone's life instead of being thrown away like garbage, I would expect shouts of "Amen!" from right-to-life corners that progress is being made, that embryos are not being wasted. Shouldn't they be glad that they're not being treated like last week's Chinese food and, instead, are helping other lives?

But instead, those who seek an end to abortion argue that if a use can be found for the embryos, it makes their fight harder. They call them "ill-gotten goods."

But abortion opponents can't have it both ways. Goods or living things? And would it be better for those living things to help people rather than be pawns in the unsuccessful effort to convince America that abortion is wrong? Meanwhile, as people play God on both sides of the debate, scientists will continue their work, no matter what, going as far as God will allow.

Leon Kass, the scientist and philosopher who will head Bush's commission on biomedical ethics, said in the Washington Post that "our self-conception, if not also our very being, lies upon the table science -- biology, medicine, psychology -- has prepared."

The table that science prepared is the one that God built. He determines who sits where and how much they get to eat.

The truth in the gray

Now that the president has set some moral ground rules, at least for federal funding, the bigger issue is whether he's set ground rules for future debate. Right now, opposing sides are focused on philosophical argument instead of life's myriad possibilities.

We cannot stop stem cell research. All we can do is shape its parameters. Sometimes, we're so busy fighting and making sure we repeat the same black-and-white arguments over and over that we skip over the gray. The truth lies in the gray.

Some embryonic stem cells already exist, from in vitro fertilization blastocysts that help couples conceive, umbilical cords, aborted fetuses or certain adult tissues.

Bush's most important question during his announcement of funding last week was this: "...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?"

Bush asked that we go forward, "guided by both intellect and heart, by both our capabilities and our conscience." Now scientists can make progress in a realm whose limits are known only to God, the same God I see in my mother's smile.

And that's the way it should be.

Contact ROCHELLE RILEY at 313-223-4473 or e-mail riley@freepress.com.


Utah, in Poll, Backs Stem Cell Money

http://www.nytimes.com/2001/08/17/politics/17UTAH.html?pagewanted=print

AUG 17, 2001
By MICHAEL JANOFSKY

ST. GEORGE, Utah, Aug. 16 — Ever since Senator Orrin G. Hatch of Utah expressed support for federal financing of human stem cell research, some of his strongest backers, conservative Republicans, have been accusing him of betrayal.

Equating the scientific use of embryonic cells with abortion, they said his position violated his long-standing opposition to abortions.

"We're extremely disappointed in him," said Gail Ruzyka, president of the Utah chapter of Eagle Forum, a powerful and politically active conservative group in the state.

But while Mr. Hatch's position has dismayed many on the right, a recent poll shows it appears to reflect the views of the majority in Utah, one of the most conservative states.

Mr. Hatch revealed his support for the research in the spring. And last week, after President Bush said he would allow federal money to be used for research only on existing stem cell lines and not on new embryos, Mr. Hatch said he would have "gone further in some areas."

At a news conference in Salt Lake City, Mr. Hatch, who won a fifth term last year, said he "would not arbitrarily limit the number of cell lines" to the 60 or so cited by Mr. Bush.

A survey in July showed that 62 percent of Utah voters favored stem cell research and 27 percent opposed it. The poll, for a Salt Lake City newspaper, The Deseret News, and KSL television, had a margin of error of five percentage points.

Those results "caught me off guard," said the pollster, Dan Jones, who has been conducting surveys in Utah for 40 years.
The sentiments were relatively consistent, Mr. Jones said, even among those who identified themselves as "very conservative," with 47 percent saying they favored the research and 35 percent saying they opposed it. Among Mormons, who make up 70 percent of Utah residents, 56 percent of those polled favored the research and 30 percent opposed it.

So what is going on in Utah?

"We're diversifying," Gov. Michael O. Leavitt, a Republican, said in an interview this week.

Governor Leavitt's observation is supported by 2000 census figures, which showed that as Utah grew by 29 percent, the percentage of whites fell to 89.2 percent in 2000 from 93.7 percent in 1990.

But more than population shifts may be involved, interviews here in St. George, one of the most conservative areas of the state, suggest. The Mormon Church, to which both Utah senators, Mr. Hatch and Robert F. Bennett, also a Republican, belong, said last month that it had taken no position on stem cell research. By recommending only that the research "merits cautious scrutiny," the church sidestepped the more sensitive question of whether body and spirit merge at conception or later in the development of the fetus.

In general, the church opposes abortion except in cases of rape, incest or when the health of the pregnant woman or fetus is at risk.

Mr. Jones called the church's pronouncement on stem cells "a roar of silence." And it may explain, in part, why the five senators who are Mormon — the two from Utah; Michael D. Crapo of Idaho; Gordon H. Smith of Oregon; and Harry Reid of Nevada, the lone Democrat — are supporting federal spending on the research, as are Utah's three House members. Like Mr. Hatch, they have drawn a distinction between embryos outside the womb that might have scientific value in fighting disease and embryos destroyed by abortion.

Likewise, voters said the church's stance allowed them to form their own opinions.

"I assume that it's O.K. as long as the church doesn't say it's wrong," said Richard Mower, 65, a retired accountant, who was eating out with two friends here on Wednesday.

All three men said they were Mormons and would abide by the church's teachings.

Mr. Mower, who is losing his sight because his optic nerve is deteriorating, said he was told that stem cell research might lead to help for him. He was uncomfortable with the notion that he might benefit at the expense of an unborn child, he said. "I'd hate to believe I'd deprive someone life for my own selfish reasons."

One of the other two men, Joe Belliston, 67, a real estate agent, said he would trust "leaders of our faith" to guide his thinking, but the third man, Jim Christensen, 72, a retired human resources director, said he fully supported Mr. Hatch's approach, asserting: "I tend to agree with Hatch, taking the more aggressive approach. Dick is one of my closest friends. If something good comes out of the research, the opportunity is there to take advantage of."

Two friends, Shannon Wallick and Amy Bird, disagreed on stem cell research. Ms. Wallick, 32, said the potential benefits in fighting multiple sclerosis and Parkinson's, Alzheimer's and other diseases outweighed her concerns over the use of embryo cells in the research. Ms. Bird, 26, said she opposed the research, even though one of her grandmothers had Alzheimer's disease.

"She's 80, and she has led a good life," Ms. Bird said.

But Ms. Wallick conceded that any objections by the Mormon Church would change her outlook.

She said that if her bishop or the church president, Gordon B. Hinckley, opposed the research, "there would be no second thinking on my part. I would do what I was told."

Still, a segment of Utah voters believes that Mr. Hatch has gone too far. By some estimates, 10 percent to 15 percent of Republican voters in the state are deeply conservative, and Mr. Jones, the pollster, said, "They show up at conventions; they're well-organized; and they have computer communications with each other that would make the military envious."

And they are angry. Shelley Buckley, 49, an interior designer, said of Mr. Hatch: "I'm conservative, and I'm surprised he took the stand he did. I don't think he's representing us properly."

Ms. Buckley added that if Mr. Hatch was running for re-election this year, "I wouldn't vote for him." Her daughters, Mykin, 27, and Kirsten, 25, nodded in agreement.

In a June interview just after Mr. Hatch revealed his support for stem cell research, he conceded that "there are some who would say that I've fallen off the truck."

"But," he added, "I think those are the ones who very sincerely believe that anything involving any aspect of life is part of the abortion issue."

That is how Ms. Ruzyka said she saw it, and she vowed that her supporters would do everything they could to make Mr. Hatch squirm in his next Senate race or if he was nominated for the Supreme Court, as some of his admirers are urging.

"The pro-life community was excited before that he could be considered for the Supreme Court," she said. "Now, we have a different attitude about him. He has redefined where life begins, based on his own philosophy, which leaves us shocked, appalled and disappointed."

Copyright 2001 The New York Times Company


Stem Cells: Now for the Hard Part

http://www.wired.com/news/medtech/0,1286,46017,00.html

2:00 a.m. Aug. 13, 2001 PDT
By Kristen Philipkoski

President Bush will allow the government to fund research on stem cell lines that already exist. Although that's not as good a deal as many researchers hoped for, they're not going to sit around and mope.

They'll take what they can get and they're eager the take the next step.

Research on embryonic stem cells using federal funds could begin before the end of this year under Bush's new guidelines.

Writing grant proposals will be daunting enough with patents and potential lawsuits complicating the process. But the science ahead is even more challenging.

Stem cells are taken from embryos, which are destroyed in the process, hence the opposition from those who believe that human life begins at conception. An embryonic stem cell has the ability to turn into almost any type of human cell. Researchers are trying to find ways to control this differentiation process so they can create cells to replace, for example, patients' damaged neurons or muscle cells.

At least scientists know how to write a research grant proposal. But no one is really sure how stem cells might eventually work to treat a disease such as diabetes, or if they will at all.

"This science is in it's infancy, so those are the questions that need to be answered," said Sean Tipton, a spokesman for the American Society for Reproductive Medicine.
Even if they see success, as Johns Hopkins researchers did recently in mice, they might not know how they did it.

John Gearhart, a stem cell researcher at Johns Hopkins University, led a group that injected stem cells (taken from voluntarily aborted fetuses in this case) into mice with induced spinal cord injury, rendering their back legs useless.

The mice regained some, but not all, movement in their hind legs. The problem is, the researchers have no idea how or why it worked.

"We don't always know what's going on," Gearhart said earlier this year.

But the hope is that undifferentiated stem cells will change into the type of stem cells they are surrounded by.

"In a mammalian embryo, a cell's fate is determined by its environment," Gearhart said.

When injected in to an injured site, such as a pancreas or heart, researchers hope the stem cells direct themselves to the injured area and replace the damaged tissue.

"We don't want them to migrate, which stem cells love to do," Gearhart said.

At this point in the research, Gearhart estimates that scientists can control the differentiation of the cells about 10 percent of the time.

Before the research comes the red tape, which could prove to be almost as complicated. But Tipton said the powers that be are doing what they can to make the process easier.

"The National Institutes of Health will have a registry of approved stem cell lines that meet the criteria the President laid out, and investigators will submit a grant proposal the same way as they submit one on anything else," said Tipton, who met with the two groups on Friday.

The final proof is The Great Stem Cell Compromise. "This is way beyond politics," said George W. Bush while pondering his verdict. What's more, he told the nation, he had found a solution to please everyone. His plan will at once "lead to breakthrough therapies and cures" and do so "without crossing a fundamental moral line."

Bush said on Thursday that researchers, to be approved for a grant, must use one of 60 existing stem cell "lines" (a number disputed as a high estimate by some scietists). Stem cells can replicate themselves indefinitely, and millions of stem cells can be derived from just one embryo, creating one stem cell line.

But before the researchers can even apply for a grant, they must deal with a patent issue. In 1998 when University of Wisconsin researcher James Thompson isolated the first stem cells from an embryo, he also garnered an exclusive patent on how he did it for the university.

Since a company in Menlo Park, California, called Geron donated millions of dollars to Thompson's research, it was granted an exclusive license to this patent.

Since it wouldn't be fair to keep all of the goods to themselves, the Wisconsin Alumni Research Foundation set up the WiCell Research Institute to dole out the precious cells for a fee of $5,000 per cell line.

About 30 research centers have taken them up on their offer to date, and 100 more applications are being reviewed.

Some companies such as Bresagen of Athens, Georgia, have developed their own stem cells and say the Wisconsin patent is too broad. A patent dispute is likely to ensue, although no one has sued anyone yet.

Once the researcher could show that she had access to a line of stem cells, she could then apply for a grant from the government.

Grant writing is a daunting task in itself, but the good news is the NIH plans to allow researchers to append existing grants.

For example, a diabetes researcher might be using "adult" stem cells, which are taken from bone marrow, placentas, or skin (but thought to be less flexible than embryonic) to figure out how to create new pancreatic cells that would produce insulin.

He could simply resubmit his existing grant application and add a request for funds to use one of the 60 approved stem cell lines to pursue in tandem with his adult stem cell research.

"We are concerned about some of the restrictions, but on the other hand this may actually be a quicker way to get the work started," Tipton said.
 

Copyright © 2001 Wired Digital Inc., a Lycos Network site.


The Genius of George W. Bush

http://www.nytimes.com/2001/08/18/opinion/18RICH.html?todaysheadlines

August 18, 2001
JOURNAL
By FRANK RICH

After months of deriding the president as an idiot, Democrats have to face the fact that he is at the very least an idiot savant — and just possibly a genius.

The final proof is The Great Stem Cell Compromise. "This is way beyond politics," said George W. Bush while pondering his verdict. What's more, he told the nation, he had found a solution to please everyone. His plan will at once "lead to breakthrough therapies and cures" and do so "without crossing a fundamental moral line."

In fact, everything Mr. Bush said is false. His decision was completely about politics. It will slow the progress to breakthrough therapies and cures. It did force the pro-life movement he ostensibly endorses to cross a fundamental moral line. And yet the politics were so brilliantly handled — and exquisitely timed, for the August dog days — that few vacationing Americans bothered to examine the fine print, which didn't arrive until the final seconds of an 11- minute speech. Few have noticed, at least not yet, that the only certain beneficiary of this compromise is George W. Bush.

Denigrated as a lightweight and a slacker, he seized on the stem cell debate to transform his image into that of our philosopher king — grappling mightily with the science and ethics of an issue he and his handlers hyped as "one of the most profound of our time" — even as he induced religious-right political leaders to sell out their principles and sent Alzheimer's, Parkinson's and juvenile diabetes patients to the back of the medical research bus. As an act of self-serving political Houdinism, this is a feat worthy of Mr. Bush's predecessor, another master at buying time when caught in a political corner with no apparent way out.

If you spend a week talking to scientists actively involved with stem cells, which I did, the most enthusiasm you can find for Mr. Bush's compromise is lukewarm. "It could have been better, it could have been worse," as Sloan Kettering's Harold Varmus, the former head of the National Institutes of Health, puts it. Jerome Groopman, a Harvard Medical School professor who has worked on bone marrow stem cells, calls the president's decision "unprecedented" in the way "it ignores the fundamental needs and process of experimental medicine" by "holding research hostage to private companies" that own many of the 60 stem cell lines that Mr. Bush has approved for federal study. "No company has the kind of resources that can match the N.I.H. for the kind of free scientific inquiry that might bear fruit," says Dr. Groopman. Besides, he adds: "There isn't a soul alive who can testify that these 60 lines can give us what we need. The success of science depends on a string of failures, and no one can work at a laboratory bench with his hands shackled behind him."

"Where are those lines? Are they any good? Are they available?" asks Doug Melton, a leading stem cell scientist who had a 45-minute meeting with the president, Karl Rove and other political operatives in July. It's not enough, Dr. Melton says, "to say there are cells at Singapore at this phone number and go get them." Since there has been no firsthand scientific investigation of the quality of these far-flung lines, some of them could prove stale, unstable or insufficiently varied for research purposes.

But even if by some miracle they're all just what the doctors ordered, Dr. Melton fears delays of many months for all the lawyering required to sort out the intellectual property rights of the Bush-blessed cells before their private owners ("who have now been given a mini- monopoly") will transfer them to academic researchers. It was only four days after Mr. Bush's speech that the Wisconsin Alumni Research Foundation, allied with the pioneering stem cell scientist James Thomson, sued its biotech partner, the Geron Corporation, over who controls which commercial rights. Evan Snyder, another prominent stem cell researcher at Harvard, fears that some owners of Bush-approved stem cells could restrict their intellectual property as zealously as "Coca-Cola and its secret formula or a computer company that won't give out the secrets of its latest chip."

Dr. Snyder also points out that the administration is "scientifically naïve," since some of its approved cells may have been extracted by already outdated mid- 1990's technology. "We can now get stem cell lines that are more efficacious and heartier," he says. "Would we fight new infections only with penicillin and sulfa and not the new antibiotics?" He also worries about a potential brain drain beyond the well-publicized decision by Dr. Roger Pedersen of the University of California to decamp to Cambridge University in pursuit of scientific freedom. It's possible that "new intellects and talents we'd like to see jump into the game" will go into other fields, given the roadblocks to stem cell work.

As if these barriers to the expeditious pursuit of life-and-death research weren't enough, the Bush administration has also yet to appoint its new director of the N.I.H. — the person needed to run all the bureaucratic and legal gantlets separating researchers from the approved stem cell lines. Will that appointee have to pass an ideological litmus test, and if so, will there be a lengthy Senate confirmation fight?

The president's new council on stem cells, headed by the bioethicist Leon Kass, may add further confusion and delays. No one seems to know its precise role, including the White House, which has yet to delineate any of its specific stem cell duties. If the panel's point is to rule on the ethical questions, didn't the president already do that? If it's to add another layer of guidelines as to how the research can proceed, "it could add another year to the process," says Harold Varmus.

Yet if scientists — not to mention patients desperately hoping for stem-cell therapies — got at best a half-loaf out of the Bush compromise, the anti-abortion absolutists got snookered.

The pro-life cause (and the Republican platform that parrots it) has staked its moral rectitude on the belief that life begins at conception. As Douglas Johnson of the National Right to Life Committee said in July, "We're opposed to federal funding of research if it kills embryos, whether the killing took place yesterday or today."

Well, that was yesterday. By the time the president gave his go-ahead for federal funds to underwrite research on previously killed embryos, the White House had smartly romanced the National Right to Life Committee to the point where it declared itself "delighted" with the news. A few spoilsports who disagreed with this retreat — such as the U.S. Conference of Catholic Bishops — were drowned out and marginalized by pro-life politicos like James Dobson of Focus on the Family and Jerry Falwell, who also enthusiastically endorsed the Bush speech. Pat Robertson went so far as to dismiss "ethical dilemmas" as secondary to the "practical reality" of a "very useful science."

Pro-choicers should welcome all these former pro-lifers into the fold. Their position — that it's O.K. to sacrifice embryos to the greater good of potentially ending the suffering of living juvenile diabetes and Alzheimer's patients — is at one with the pro-choice view that in pregnancy embryos sometimes must be sacrificed for the health of the mother.

What gives the scientists I spoke with some guarded hope despite the strictures placed on their work by the president's policy is that Mr. Bush moved just enough to convince them that the policy isn't permanent. Though Mr. Bush said he wouldn't change his mind, they predict that if the 60 stem cell lines aren't accessible or scientifically useful, the political pressure from patients' advocacy groups and Congress will force inevitable concessions from the White House. And now they have the added boon that not just pro-life senators like Orrin Hatch and Bill Frist but also the nation's loudest pro-life leaders will be in the president's pocket when he next capitulates.

Thanks to the sudden national fixation on stem cells, the entire country now knows that there are between 100,000 and 200,000 frozen embryos currently in storage at fertilization clinics, most of them slated to be killed anyway, most of them with greater potential for saving lives than becoming lives. As Christopher Reeve has noted, long before anyone had heard of stem cells there was never any "outrage that these unwanted fertilized embryos are being thrown in the garbage." When Mr. Bush inevitably finds another ingenious "compromise" to make more of them available to medical research, there won't be outrage either — only votes.

Copyright 2001 The New York Times Company 


Bush's Stem Cell Policy May Streamline Research

http://www.nytimes.com/2001/08/18/health/18CELL.html?pagewanted=print

AUG 18, 2001
By NICHOLAS WADE

Biologists may find there are fewer restrictions on research with embryonic stem cells under the Bush administration than they would have faced under the Clinton administration, whose guidelines have been scrapped, officials at the White House and the National Institutes of Health said.

The abolition of the guidelines means that researchers can now use, among other sources, the embryonic stem cells first derived in 1998 by Dr. James A. Thomson of the University of Wisconsin, which did not comply with the Clinton administration guidelines in two technical respects. And the foundation that handles the university's patents has said there was nothing in the way of researchers gaining access to the cells and doing any research they please except for cloning a human or inserting the cells into other embryos.

Dr. Lana R. Skirboll, director of the Office of Science Policy at the health institutes, said the guidelines governing embryonic stem cell research would be replaced by the four conditions specified by President Bush in his Aug. 9 speech: that the cells were derived before that date, that donors gave informed consent, that the cells must come from excess embryos created solely for reproductive purposes and that donors were not offered financial inducement.

Scientists applying for federal grants from the health institutes need only list which of the approved embryonic cell lines they intend to use, and there will be no further scrutiny other than the usual review of grants by outside experts. The agency is developing the registry and will publish it soon on the Internet, Dr. Skirboll said.

Along with the guidelines, a supervisory panel of the health institutes called the Human Pluripotent Stem Cell Review Group has been abolished.

"We see a much more streamlined process," Dr. Skirboll said. "Once the registry is up, if your grant application lists a cell line on the registry, there is no secondary review."

The guidelines drawn up under the Clinton administration "no longer pertain," she said, because the criteria specified by President Bush "capture the essential elements of the guidelines and supplant them."

The four straightforward principles described by Mr. Bush replace many pages of federal regulations specifying the conditions under which the cells must have been obtained. The reason is that with research now confined to existing cell lines, the guidelines are unnecessary, a White House official said.

The new Council on Bioethics, to be led by Dr. Leon Richard Kass of the University of Chicago, will provide general ethical guidance, and it will not, as many scientists had expected, revise the health institutes' guidelines on stem cell research or draw up new ones of its own. The Kass council "will not be developing specific regulations," the White House official said.

Dr. Skirboll said the full registry of up to 60 lines of human embryonic stem lines would be published as soon as permission had been obtained from those who derived them to use their names.

The 60 lines were all derived independently, from different human embryos, and are not clones of one another, she said. Some of the derivers have expressed interest in taking DNA fingerprints of their cells, similar to those used in forensic cases, to keep track of who is using them. Dr. Skirboll said that the idea was being considered for that purpose, and not as a method of policing the Aug. 9 cut-off date.

Though some of the 60 cell lines may prove unsuitable on further study, researchers should have a much wider choice than many had expected would be the case.

A second respect in which stem cell research has been made easier is that the elimination of the agency's guidelines resolves a difficulty faced by the Wisconsin Alumni Research Foundation, or WARF, which owns the patent on the human embryonic stem cells derived by Dr. Thomson.

The problem is that Dr. Thomson's cells, which he derived before the agency's guidelines were written, did not fully comply with the guidelines. The donor's informed consent was obtained before the embryos were created, not afterward, as the guidelines required. Also, the guidelines required the embryos to have been already frozen for storage. Dr. Thomson used embryos from two sources. One was a United States in vitro fertilization clinic, in which the embryos were frozen; the other was a clinic in Israel, which may have supplied fresh embryos. "We could not certify that they were frozen and Jamie is not in a position to say," said Andrew Cohn, a spokesman for WARF.

Frozen embryos lose viability over time and fresh embryos would be better starting material for making embryonic stem cells, which some scientists speculate may have been one of the several factors behind Dr. Thomson's success in being the first to establish lines of the cells.

Mr. Cohn said WARF was eager to get its embryonic cell lines into researchers' hands with minimal restrictions. "We want to push this research forward as fast as we can," Mr. Cohn said. All distribution of the cells to academic researchers is handled by WARF, not by the Geron Corporation, the biotechnology company that holds a major license to the cells.

WARF will make the cells available to academic biologists for a subsidized fee of $5,000, and they may do whatever research they wish, Mr. Cohn said.

"Any researcher who gets our cells and makes a patentable discovery will own that patent," Mr. Cohn said. But, as is routine practice, if researchers wish to commercialize any discovery they make on the basis of WARF's patent, they must negotiate a license with WARF, or with Geron for anything that falls in the scope of Geron's license. Geron financed Dr. Thomson's research and has commercial rights to six types of human cell that can be derived from the stem cells.

Mr. Cohn said he was baffled by some researchers' belief that WARF's conditions on use of the cells turned them into employees of Geron. Geron would negotiate an agreement in the usual way, he said, and was hardly likely to block any invention covered by its license.

In the event agreement could not be reached, Geron as licensee had no right to go to federal court to enforce its patent, Mr. Cohn said. "They have to come to WARF because we are the patent holder. Who would you rather have as an arbitrator, a nonprofit, university-affiliated entity or a private company?"

Biology has made rapid progress over the last quarter century, with several pioneering discoveries that seemed to place their authors in a monopoly position, like the recombinant DNA technique for moving genes between organisms. In that case the patent holders profited without holding researchers to ransom.

"On broad pioneering-type inventions like these it inevitably works out that all the stake-holders are satisfied," said Todd Dickinson, a former director of the United States Patent and Trademark Office. Mr. Dickinson, now at Howrey Simon Arnold & White, a Washington law firm, said he expected the same would prove true of embryonic stem cells, without the need for legislation.

"The system has almost inevitably self-corrected and access to the technology has been made available. I would expect that WARF would be fairly likely to take a positive approach to making this technology widely available," he said, noting WARF's role as the patent portfolio manager of a leading research university.

Copyright 2001 The New York Times Company


Cloning Capsized?

After the House of Representatives votes to ban cloning, biopharmaceutical researchers ponder their alternatives

http://www.the-scientist.com/yr2001/aug/agres_p1_010820.html

The Scientist 15[16]:1, Aug. 20, 2001
By Ted Agres

Biopharmaceutical researchers fear how pending federal legislation outlawing the cloning of human cells will restrict their abilities to find cures for major degenerative diseases.1,2 Some also see lawmakers impinging on established nonhuman cloning techniques essential for the discovery of new drugs and therapies.

The source of all this worry? The US House of Representatives passed July 31 by a wide margin a bill (H.R. 2505) sponsored by Reps. David Weldon (R-Fla.) and Bart Stupak (D-Mich.) that would ban the cloning of human cells for reproduction as well as for research. Of particular concern to scientists, the bill outlaws somatic cell nuclear transfer (SCNT) using human cells, a mechanism required in the new field of regenerative medicine. Potential uses for such therapeutic cloning include creating immune-compatible replacement tissue for diseased organs, such as the heart and pancreas, and treatments for neurodegenerative diseases, such as Parkinson's and Alzheimer's.

Scientists, ethicists, and politicians agree that human reproductive cloning should not be permitted. Therapeutic cloning is another matter, however. While most researchers in the field argue that human therapeutic cloning through SCNT will result in medical breakthroughs, some ethicists assert it must be banned because it will inevitably lead to reproductive cloning.

President George W. Bush, who opposes human cloning, praised the House anti-cloning legislation. He recently decided to allow federal funding for research on human embryonic stem cells (ESCs) but limited it to 60 preexisting cell lines. The stem cell decision "allows us to explore the promise and potential of stem cell research without crossing a fundamental moral line," because the embryos were previously destroyed, Bush said.

While technically distinct, the cloning issue has become intertwined with the human ESC research because both involve the discarding of human embryos. Current federal law prohibits the government from directly or indirectly financing research that results in the destruction of human embryonic material. The House bill would make human SCNT research a crime punishable by fines and imprisonment whether done with private or public funding. The bill "is completely antithetical to two decades of US policy to support biomedical research," says Michael Werner, director of government relations for the Biotechnology Industry Organization (BIO), a Washington-based trade group representing more than 950 biotech companies.

The new legislation from Congress and regulatory guidance from the administration may not be directed at established cloning techniques, but scientists still fear the consequences. Some researchers have contemplated moving their work abroad to Europe or Asia. A day after the House voted, a Japanese Cabinet panel authorized human stem cell research. "Obviously, we are watching this whole cloning debate very carefully and very closely," says Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America, a Washington-based trade association for major pharmaceutical and biotechnology companies. "There's a lot at stake for us."

Biotechs Skirt Ethical Logjam

While Congress legislates and Bush deliberates, many biopharmaceutical companies and institutions may be wor-rying, but they have not been waiting. Using private funds to forge ahead with stem cell research and with cloning involving both human and animal cells, the firms hope to create breakthroughs in drugs and therapies. "The potential for the field of regenerative medicine is enormous," says Werner. "It's a new paradigm in medicine that could lead to treating currently untreatable conditions, including heart attack, stroke, and conditions like that. Stem cell technologies are integral to the development of this field, which we feel could change the nature of medicine in the coming decade."

PPL Therapeutics, the Scottish firm that worked with the Roslin Institute to produce Dolly, the first cloned sheep, estimates that the market for transplantable cellular therapies, such as for treating diabetes, and for solid organs derived from animals (e.g., pigs) using xenotransplantation can reach $12 billion. Therapeutic cloning also could be used to develop tools for drug testing, says Carl B. Feldbaum, president of BIO. Cloned normal human liver cells could be used to safely test toxic metabolites in drugs under development, he explained in testimony before a Senate commerce subcommittee in May. "This process could both safeguard and streamline the drug development process," he said, "bringing drugs to patients sooner and safely."

Biopharmaceutical companies such as Geron Corp. in Menlo Park, Calif., plan to develop therapeutic and diagnostic products for drug discovery, regenerative medicine, and pharmaceutical protein production. Geron obtains frozen human embryos left over from in vitro fertilization clinics and breaks them open to harvest the ESCs for research. "We are learning how to turn undifferentiated human pluripotent stem cells into neurons, liver cells, and heart muscles," explained Thomas B. Okarma, president and CEO of Geron in testimony before a House judiciary subcommittee in June. Therapeutic cloning is essential, he maintains, because it is the only way to produce adequate replacement cells for clinical treatment.

Advanced Cell Technology Inc. (ACT), a private biotech company in Worcester, Mass., last month confirmed press reports that it planned to use SCNT to fertilize human eggs obtained from paid donors and destroy the resulting embryos to derive stem cells for research, the first US public acknowledgement of the procedure. Robert P. Lanza, ACT's vice president of medical and scientific development, says the work is continuing but the company has not yet created human embryos. "All we are able to say is that when we have appropriate data we will present it through the appropriate channels, through a scientific peer reviewed publication."

The House bill, if it were to become law, could force ACT officials to rethink at least where the company will continue its research, according to spokesman Tom Tureen. "I think it's unfortunate that a matter concerning the health of so many people was based on so little information and decided in just two hours," he says. ACT would have no choice but abide by any final decision. "We obey the law. Any research that was banned, we would not conduct in the United States. We would move to someplace where it was legal."

In addition to Geron and ACT, only a handful of small US biotech companies employ SCNT using animal or nonembryonic human stem cells: Stemron in Rockville, Md., StemCells Inc. in Palo Alto, Calif., and VistaGen Inc. in Burlingame, Calif., among others. "The importance of the debate on cloning and stem cells is greater than the specific number of companies using these technologies," says Werner. If Congress bars or restricts SCNT, he says, "it would be the first time that a government has shut down a legitimate area of scientific inquiry," and it would set a dangerous precedent. Adds Rudolf Jaenisch, biology professor at the Massachusetts Institute of Technology and the Whitehead Institute in Cambridge, "It is premature to ban a technique that is still in the process of evolving."

About the same time ACT announced its intention to investigate therapeutic human cloning, the Jones Institute for Reproductive Medicine of the Eastern Virginia Medical School in Norfolk, Va., published a research study declaring it already had created human embryos for research by using eggs and sperm obtained from paid, consenting anonymous donors.3 While pro-life advocates deplored the development, others saw ethical merit to the Jones approach. The Jones researchers "make a pretty good case that there may be some ethical advantages to doing it this way," says Sean Tipton, spokesman for the American Society of Reproductive Medicine, which published the Jones Institute report. "It's cleaner if you approach the donors from the beginning saying, 'we want to user your sperm or your egg in order to make embryos for research purposes,' than it is to deal with infertility patients," he says.

The Federal Role

Not surprisingly, the blockbuster announcements on cloning for profit further fueled the debate on Capitol Hill. No fewer than seven bills had been pending in the House and Senate to regulate human cloning, ranging from minimalist legislation by James Greenwood (R-Pa.) that would allow therapeutic cloning, to the more restrictive Weldon and Stupak bill that the House finally passed. "Proposals to criminalize laboratory techniques that otherwise might help us find cures for diseases such as cancer and Alzheimer's would cast a pall over the conduct of academic science," claimed Daniel Perry, executive director of the Alliance of Aging Research, in House testimony in June.

The Food and Drug Administration (FDA) since 1993 has claimed legal authority over "products" developed through human somatic cell therapy and gene therapy activities by defining a cloned human embryo as a biological product and drug.4 Numerous legal experts and congressmen say FDA's claim of statutory authority over human cloning will not stand up in court.

But the agency has been responding, in part, to widely publicized statements by Severino Antinori, an Italian infertility specialist, Panos Zavos, an American physician, and Brigitte Boisselier, a leader of a group called the Raelians, which endorses the use of eugenics to create a world without crime. These three people claim to have both the ability and intention of cloning a human being in the near future.

"Whatever Bush decides doesn't matter," says Glenn McGee, professor of bioethics at the University of Pennsylvania. "The research will continue." If public support for this research is not available, the research will move from universities and institutes to the private sector, where biotech companies stand to make a windfall, he says. Adds BIO's Werner, "Private sector research has led the way so far, and we would expect it to continue." But if the federal government pumps money into this area, "that will really accelerate the pace of discovery and ultimately bring products to patients faster and sooner."

Ted Agres (tagres@usa.net) is a freelance writer based in Washington, D.C.

References

1. T. Agres, "On the brink," The Scientist, 15[11]:1, May 28, 2001.

2. T. Agres, "New stem cell legislation introduced," The Scientist, 15[14]:15, July 9, 2001.

3. S. Lanzendorf et al, "Use of human gametes obtained from anonymous donors for the production of human embryonic stem cell lines," Fertility and Sterility, 76:132-37, July 2001.

4. H.I. Miller, "FDA clones misguided regulatory policy," The Scientist, 15[14]:39, July 9, 2001.

Ethicists, Company Clash on Cloning

As lawmakers in the nation's capital try to craft a national consensus on the morality of human cloning and stem cell research, two University of Pennsylvania bioethicists express dismay over their experiences at a US company that aims to use the research for commercial drug development and therapeutics.

Ethicists Glenn McGee and Arthur Caplan resigned from advisory boards of Advanced Cell Technology Inc. (ACT), a Worcester, Mass., biotechnology company that intends to clone human embryos to derive stem cells for research. The resignations not only focused scrutiny on ethical issues; the actions also raised questions about how the controversial research can be regulated in the private sector.

"There has been no systematic effort by the company to keep its ethics advisory board informed or to bring us into any of the various important decisions that would properly have input from any ethics scholar," wrote McGee, a professor of bioethics at Penn, when he resigned last fall. For small biotech companies, "it's all too easy for the ethics advisory board to become a kind of rubber stamp," McGee now says.

McGee's resignation followed that of colleague Caplan, who quit ACT's scientific advisory board last summer. "I started to see my name flying around as being one of their advisers and I was not happy about the fact that they hadn't used us," he says. The company's cloning of an Asian gaur, an endangered ox-like animal, without consulting the science board, particularly disturbed Caplan, director of Penn's Center for Bioethics. The creature died two days after birth.

Robert P. Lanza, ACT's vice president of medical and scientific development, says he blames Caplan's frustrations on the company's hectic start-up. "We were trying to get the company organized and were trying to put together a scientific advisory board.... We hadn't even assembled the entire scientific board before he left. So it wasn't simply because we didn't want [the board's] advice. We certainly would have wanted their advice."

Ronald M. Green, chairman of the ACT ethics board, says McGee's resignation puzzled him because the corporation had never withheld information. McGee's resignation "had little or nothing to do with the research" they were overseeing, adds Green, director of Dartmouth College's Institute for the Study of Applied and Professional Ethics.

The ethical clash at ACT mirrors the atmosphere in Congress, where the fashioning of regulations for human embryonic cloning, somatic cell nuclear transfer (SCNT), and stem-cell research has eluded lawmakers since 1996 when Scottish scientists created Dolly, the first sheep clone. Proponents and opponents of embryonic stem cell (ESC) research debate when human life begins, whether destroying embryos amounts to murder, and whether the moral good of deriving medical breakthroughs outweighs the ethical injunctions. "It is critical that in our enthusiasm to prevent reproductive cloning, we not ban vital research, turning wholly legitimate biomedical researchers into outlaws and thus squelching the hope of relief for millions of suffering individuals," Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO), a Washington trade group that represents 950 biotech companies, testified in May.

Some ethicists warn that human reproductive cloning is so alluring that any human cloning, such as therapeutic cloning to develop drugs, diagnostics, and tissues for regenerative medicine, should be avoided lest researchers start down a slippery slope that will inevitably lead to reproductive cloning. "Anyone truly serious about preventing human reproductive cloning must seek to stop the process from the beginning," Leon Kass, professor of social thought at the University of Chicago, said before a House judiciary subcommittee in June.

For many scientists, the ethical debate remains theoretical; human embryo researchers must rely on private funding because the law bans federal support. The Bush administration has yet to offer an opinion. Ethicist McGee says the whole controversy has made him rather testy. "I'm having to be the spoiler here, because I'm in favor of stem cell research," he complains. "My concern is just about the nature of oversight. I think we have got to find a way to work with companies responsibly. But the right way is probably not ethics advisory boards."

--Ted Agres

Scientists Clone Solutions to Stem Cell Debate

Scientists quietly advance their understanding of human cloning and embryonic stem cell (ESC) research even as the public debates the ethics of the procedures. Over the past few months, researchers who have used stem cells to produce neurons and insulin-secreting cells in mice have demonstrated the potential of cloning for therapy development and disease research; others have raised questions about the constancy of cloned embryonic cells.

Work by Rudolf Jaenisch at the Whitehead Institute for Biomedical Research in Cambridge, Mass., and Ryuzo Yanagimachi at the University of Hawaii have demonstrated that ESCs in culture are extremely genetically unstable.1 This instability--in cells cloned through somatic cell nuclear transfer (SCNT)--helps explain why most animal clones die before birth and survivors often have respiratory and circulatory problems and growth abnormalities. While reproductive cloning is inefficient and dangerous, the researchers emphasize that therapeutic cloning does not appear to be similarly negatively affected by genetic instabilities.

Jaenisch and Yanagimachi cloned mice from the nuclei of ESCs and monitored activity of imprinted genes--developmental genes controlled by special tags that do not affect the DNA base sequence of the genes themselves. They found donor ESCs lost tags that would instruct an imprinted gene to be turned on or off during development. Despite this instability, many embryos survived to adulthood.

The researchers examined imprinted genes in the placenta, kidney, heart, and liver in about 40 cloned mice and found to their surprise that in none of the mice did all work correctly. The differences in genetic expression appeared to be random, with wide variations between different ESC lines, between individual colonies of cells or subclones, and even between individual cells within each colony. These differences in gene activation may or may not trigger abnormalities later in development, and it may only be the cumulative action of many abnormally expressed genes that produces the excessive growth typical in clones, the researchers reported.

While some opponents of human embryo research latched onto the findings as supporting their position, members of the research team emphasized that the genetic instability of cultured ESCs does not interfere with their in vitro differentiation into different tissue types, a hallmark of therapeutic cloning. "We see a good future in ESC research, and we shouldn't abandon this potential," says Yanagimachi. Nevertheless, "we should be more cautious for future therapeutic purposes."

In therapeutic or research cloning, nuclear material from a donor somatic cell is transferred into an enucleated egg cell and ESCs are harvested from the resulting blastocyst. If the ESCs can be coaxed to differentiate into functioning tissues, the new cells might be reintroduced into the donor to regenerate diseased tissue and even organs.

New research suggests progress in this area. In one study,2 researchers at Rockefeller University and the Sloan-Kettering Institute, the basic research unit of Memorial Sloan-Kettering Cancer Center, in New York derived 35 ESC lines using a cell from a mouse tail in SCNT. After about four days, they harvested the cells from the mouse blastocyst and chemically induced them to differentiate into dopamine-secreting neurons. The next step is to introduce the neurons back into mice with a Parkinson's-like condition to see if damaged nerve tissue can be regenerated without triggering an immune system rejection. Two of the scientists, Teruhiko Wakayama and Anthony Perry, plan to continue this research at Advanced Cell Technology Inc. (ACT) of Worcester, Mass., a biotech company.

In a separate approach showing potential, researchers at PPL Therapeutics Inc. in Blacksburg, Va., took adult skin cells from cattle and reprogrammed them into multipotent stem cells without first producing an embryo. They then transformed these stem cells into heart cell tissue. If the non-embryonic approach proves applicable to humans, the approach could sidestep some ethical and legal objections to human SCNT research.

--Ted Agres

References

1. D. Humpherys et al, "Epigenetic instability in ES cells and cloned mice," Science, 293:95-97, July 6, 2001.

2. T. Wakayama et al, "Differentiation of embryonic stem cells lines generated from adult somatic cells by nuclear transfer," Science, 292:740-43, April 27, 2001.

© Copyright 2001, The Scientist, Inc.


In Cloning, Will One Person Really Make a Difference?

After the House of Representatives votes to ban cloning, biopharmaceutical researchers ponder their alternatives

http://www.the-scientist.com/yr2001/aug/agres_p1_010820.html

The Scientist 15[16]:51, Aug. 20, 2001
OPINION
By Arlene Judith Klotzko

Biopharmaceutical researchers fear how pending federal legislation outlawing the cloning of human cells will restrict their abilities to find cures for major degenerative diseases.1,2 Some also see lawmakers impinging on established nonhuman cloning techniques essential for the discovery of new drugs and therapies.

The source of all this worry? The US House of Representatives passed July 31 by a wide margin a bill (H.R. 2505) sponsored by Reps. David Weldon (R-Fla.) and Bart Stupak (D-Mich.) that would ban the cloning of human cells for reproduction as well as for research. Of particular concern to scientists, the bill outlaws somatic cell nuclear transfer (SCNT) using human cells, a mechanism required in the new field of regenerative medicine. Potential uses for such therapeutic cloning include creating immune-compatible replacement tissue for diseased organs, such as the heart and pancreas, and treatments for neurodegenerative diseases, such as Parkinson's and Alzheimer's.

In just a week, two developments in Washington restored cloning to the very top of the policy agenda in the United States, knocking stem cell research off the perch it had enjoyed--or just endured--for months. On July 31, by a vote of 265 to 162, the House of Representatives passed the Human Cloning Prohibition Act of 2001, a ban on all human cloning, including therapeutic cloning to derive immunologically compatible embryonic stem cells. And on August 7, Severino Antinori, an infertility specialist from Rome, announced he was going to clone a human by November. It seems as if an awful lot of people want to be cloned. Out of the many who applied, two hundred couples were selected. They made their way to a clinic in Rome from all over the world--Japan, Britain, and the United States included. Antinori's patients are infertile men. Because of accident or disease, they cannot produce a genetically related child either naturally or through conventional assisted reproduction techniques. They have rejected artificial insemination using donor sperm and decided, instead, to undergo a procedure that, if successful, will result in their wives giving birth to a clone--a later-born identical twin--of their husbands. So, if these reproductive tourists get their wish, the women will return home married to one twin and the mother of the other.

According to reports, eight of the women who have sought out Antinori are from the United Kingdom. In Britain, reproductive cloning will be made illegal when legislation is introduced by the government in the next Parliament. Meanwhile, the Human Fertilisation and Embryology Authority, which licenses embryo research and storage and infertility treatment involving donated gametes, has announced that it would refuse to license any attempt at reproductive cloning. Hence the necessity for an airplane ticket.

Is there anything that can be done about this reproductive tourism? The British Royal Society has called for a worldwide moratorium on reproductive cloning, at least until the risks and possible justifications of the technique are explored fully. But the obstacles in the way of achieving such a moratorium are daunting and most likely insurmountable. There have been rumors that some unnamed Mediterranean country--clearly not his own--has agreed to host Antinori's efforts. And there have been other rumors that he might take to the sea, to become a kind of biomedical Flying Dutchman.

It could well be that such a project could be done in the United States. While it is true that the Food and Drug Administration has claimed jurisdiction over cloning, such claims might not withstand legal scrutiny. Four states (California, Michigan, Rhode Island, and Louisiana) have prohibitions of various kinds. But the US Congress has been unable, despite efforts dating back to 1997, to enact legislation to ban reproductive cloning outright--or to pass a law with a sunset clause, the course recommended by the National Bioethics Advisory Commission and endorsed by former President Bill Clinton.

So the flurry of legislative activity in the current session of Congress has been significant (See "Cloning Capsized?" Page 1). The bill that passed, which bans and criminalizes both reproductive and therapeutic cloning, enjoys the support of President George W. Bush. In early August, it seemed doubtful that Senate Majority Leader Tom Daschle would bring the Senate counterpart to the floor for a quick vote. He has said that he favors going slow on cloning while going much faster with respect to stem cell legislation, which would enjoy large bipartisan support.

But no one reckoned on Antinori, who came to town to announce the imminence of his reproductive cloning plans. What kinds of pressures will there be on members of the Senate when they go home for the summer recess to face their constituents? Will they return to Washington determined to stop Antinori, even if it means stopping, and criminalizing, therapeutic cloning in the process? They very well might. And as disappointing as such a development might be for those in favor of therapeutic cloning, it might provide very badly needed political cover for legislators from conservative districts who want to support embryonic stem cell research.

In Britain, therapeutic cloning is legal. Indeed, the stem cell policy discussion that ranged over more than two years never attempted to separate the questions, or to allow Parliament to chart a more modest course such as that set out in the National Institutes of Health Guidelines on Stem Cell Research. The British legislation, an amendment to the 1990 Human Fertilisation and Embryology Act, supplemented the permissible uses of embryo research with cell therapies. Creating embryos for research purposes has been legal here since 1990. Thus, in some ways, it was a relatively small step to allow creation of those embryos by cloning. In other respects, however, the step seemed quite large.

While stem cell research itself did not inspire much opposition in Parliament, what opposition there was involved cloning. There were fears expressed that acceptance of therapeutic cloning would send them hurtling down the proverbial slippery slope to reproductive cloning. And that is why the government has promised to ban it.

How real is the danger of the slippery slope? The idea behind a slippery slope is that if you do x, which is acceptable, you will end up doing y, which is not. Indeed, two types of slippery slopes--logical and sociological--exist. On the logical slippery slope, you slide to the bottom and embrace the morally unacceptable because there is no way to distinguish it from an acceptable practice. You can slide down the sociological slippery slope from one practice to the other--even if the two are conceptually different--just because the existence of one creates a social climate receptive to the other.

Therapeutic cloning is conceptually distinct from reproductive cloning. Although the first step is the same, the intent behind the practice is not. The former would be done to save lives by treating diseases now incurable, say, Parkinson's, ALS, and multiple sclerosis. The latter--creating a person by cloning--would be done for reasons extending from egomania, to confusion between replication and resurrection, to the understandable desire to have a biologically related child.

Will therapeutic cloning make it more likely that people come to accept reproductive cloning? I don't think so. Therapeutic cloning is intended to heal the sick. The cells created through cloning would be an extension of the patient: a means to treat him with cells generated by his own body.

In the United Kingdom a line can be drawn between therapeutic and reproductive cloning--a moral line and also a legal line. In the United States, the situation may be much more complex. It may even be impossible to enact a ban on reproductive cloning that would withstand constitutional challenge. In the United States, reproduction is a fundamental right, and, as such, it can only be restricted if the state has a compelling interest to do so. If the replication that is cloning is construed by a court as a form of reproduction--a likely interpretation--would the courts uphold a restriction on, say, an infertile couple who cannot have a biologically related child in any other way?

Allowing therapeutic cloning may subject us to a kind of legal slippery slope. Would a court be able to forbid a couple who had a cloned embryo that was created for therapeutic purposes from implanting that embryo, should they wish to do so? In the unregulated climate that is the United States, how could we ensure that cloned embryos created for therapeutic purposes were not implanted covertly? Such assurance would not be difficult in the United Kingdom. Would it even be possible in the United States?

With the Antinori effect, Congress might well surrender to the science fiction fears of cloning and enact a sweeping ban covering both types and having no sunset clause. The public's science-fiction fed unease is very strong. As a sort of busman's holiday the other evening, I watched a movie on television, Mr. Murder, an adaption of a novel by Dean Koontz. As the program was about to start, the announcer summarized the plot, saying that a famous writer was cloned after a mix-up in the lab and the result was a psychopathic mercenary. Then he paused for dramatic effect and said, "It's so annoying when that happens."

It's even more annoying when someone like Severino Antinori has a chance to set the public policy agenda of the United States.

Arlene Judith Klotzko, a bioethicist and lawyer, is writer in residence at the Science Museum, London, and visiting scholar in bioethics at the Windeyer Institute of Medical Science, University College London. She is editor of The Cloning Sourcebook, published recently by Oxford University Press.

© Copyright 2001, The Scientist, Inc.


Bush's Stem Cell Data Disputed

Scientists, Some Hill Democrats Want Proof That 60 'Lines' Exist

http://www.washingtonpost.com/wp-dyn/articles/A26831-2001Aug17.html

Saturday, August 18, 2001; Page A03
By Ceci Connolly
Washington Post Staff Writer

A leading scientific association and several members of Congress, skeptical of President Bush's assertion that at least 60 existing embryonic stem cell lines are available worldwide for research, are pressing the administration to provide evidence of the claim.

The American Association for the Advancement of Science, the world's largest group of scientists, released a statement yesterday saying that until scientists are able to study the source and makeup of the cells, it is impossible to "assess the potential values of the cells for research and potential medical advances."

Last week, Bush said that he would be willing to spend federal money on medical research of existing stem cells derived from human embryos. He put that figure at 60, although other administration officials have since said it could climb to 70. His new policy prohibits federally-funded research on any cell lines derived after the date of his announcement, Aug. 9.

"Many of our scientific colleagues have questioned that number, believing it to be much smaller," the association said. In urging the Bush administration to release detailed information on the stem cells, the organization of more than 138,000 scientists said that until then, "it is not possible to determine whether the existing collection of those lines will be sufficient to foster productive research."

The Bush policy on this controversial and politically sensitive new field of research faced congressional criticism as well for its unanswered questions.

Rep. Diana DeGette (D-Colo.) sent a letter yesterday to Health and Human Services Secretary Tommy G. Thompson outlining 10 specific questions on the condition and ownership of the cells and the potential hurdles to conducting research on them.

"I am concerned that limiting federal funding of research to 60 cell lines places arbitrary limits on innovation and is not based on sound science," she wrote. "It also potentially creates a myriad of access, availability, quality and legal problems that may have the effect of restricting the development of useful therapies."

Sen. Edward M. Kennedy (D-Mass.) raised similar concerns in a recent letter to the National Institutes of Health, requesting answers well in advance of a hearing he has scheduled for Sept. 5.

"We will certainly make every attempt to answer the senator's questions in a timely fashion," Lana Skirball, director of the NIH Office of Science Policy, said last night.

Thompson and other administration officials have said they have been unable to release that data because much of it is proprietary information that private companies control.

"We hope all of them would come forward" in the near future, Skirball added.

Scientists believe that the cells extracted from five-day-old embryos hold enormous potential in treating or curing a wide range of illnesses -- including juvenile diabetes, spinal cord injuries and Parkinson's disease -- because of their ability to grow into any type of tissue. Opponents say that because an embryo is destroyed in the process, the work is akin to murder.

Bush's decision would leave open the door opened by President Bill Clinton to federally funded basic research on the cells, but researchers worry it may not provide enough material to go beyond that initial phase of study.
 

© 2001 The Washington Post Company


Scientists Divided on Limit of Federal Stem Cell Money

http://www.nytimes.com/2001/08/16/health/16CELL.html?searchpv=day03

August 16, 2001
By NICHOLAS WADE

Scientists are divided over President Bush's decision on human embryonic stem cells, with some expressing dismay that their work has been constrained and others saying that they are lucky the door has been opened as far as it has. But many researchers agree that the onus is now on them to show that stem cell research is as promising as they have been saying.

"I personally think we are better off now than we were, though we are not where we need to be," said Dr. Irving Weissman of Stanford University, a leading student of the blood- making stem cells of the bone marrow. "We shouldn't pooh-pooh Bush for going only so far and shouldn't think that we as scientists should be the only ones to make that decision."

Dr. Harold Varmus, director of the Memorial Sloan-Kettering Cancer Institute in New York, said scientists were "in a more fortunate place than we might have been" if President Bush had vetoed stem cell research the day he came into office, just as President Clinton in his first week in office reversed a ban on fetal tissue research. As former director of the National Institutes of Health, Dr. Varmus framed the government's strategy and guidelines for research on the cells.

Other scientists said that the president's decision to confine federally financed research to the 60 cell lines or colonies already established might impede progress.

"I think it's a shame, and clearly it will give other countries the advantage over us, and there will be a brain drain," said Dr. Ben Barres, an expert on neural stem cells at Stanford University.

He then spoke of Dr. Roger Pedersen, a human embryologist who recently decided after working for 30 years at the University of California, San Francisco, to move to Cambridge University in England. "Others will inevitably follow Pedersen," Dr. Barnes said.

An article on Tuesday in the British newspaper The Guardian portrayed Dr. Pedersen as a Pilgrim in reverse, seeking the freedom of British shores to escape religious extremists in the United States who, in this latter-day case, have blocked research.

In an interview yesterday, Dr. Pedersen said, "I wouldn't be able to maximize my potential" in the United States, given the restrictions on federal financing and developing cell lines. He said he knew of several scientists who were thinking of moving to Britain for the same reason.

Other scientists see the president's decision as a mixed blessing for scientific inquiry. "I don't know if I could characterize it as either a victory or a defeat," said Dr. Evan Snyder, who works on neural stem cells at the Harvard Medical School. "What it has done is bought more time," Dr. Snyder said.

Scientists are better off than they were because the president's decision means that federal money for stem cell research will now be available to the large, skilled corps of academic scientists who depend on grants from the National Institutes of Health. Though private companies have always been free to work on human embryonic stem cells, research is at such a basic stage that progress is likely to be much slower if the nation's academic biologists cannot participate.

Scientists' reservations pertain to whether the 60 lines of stem cells sanctioned by Mr. Bush are of high enough quality to be useful. Most biologists in the field are familiar with just a handful of such lines, notably those developed by Dr. James A. Thomson of the University of Wisconsin, Dr. John Gearhart of Johns Hopkins University, and by scientists in Israel and Australia.

The 60 lines inventoried by Dr. Lana R. Skirboll of the National Institutes of Health now need to be put under rigorous scrutiny. Biologists will need to test if they descended from 60 individuals. The lines must have the ability to generate different categories of mature cells. They must have normal chromosomes. They need to have been cultivated under stringent conditions. Since many of the 60 reported lines are likely to fail these tests, scientists will have to work with fewer.

They are also concerned that the owners of the viable lines may impose restrictive agreements, such as laborious reporting requirements or "reach-through rights" that give the owner possession of any commercially important discovery a researcher may make.

These conditions on research materials are often laid out in the form of a memorandum of transfer agreement, or M.T.A. "There's no doubt that the M.T.A. being delivered to people who request these cells has provisions that most of us don't like to work with," Dr. Varmus said, referring to reporting requirements and the sharing of intellectual property rights.

The patent on the embryonic stem cells developed by Dr. Thomson is held by the Wisconsin Alumni Research Foundation, or WARF, whose best-known licensed product before this is the rat poison warfarin. Andrew Cohn, the foundation's spokesman, said it was responsible for distributing the cells to researchers and had given them to 30 institutions around the world, with 100 or so more in negotiation.

The foundation requires only a flat fee of $5,000 with no restrictions other than those already in the federal guidelines, Mr. Cohn said.

The Geron Corporation of Menlo Park, Calif., which financed Dr. Thomson's work, has an exclusive license for converting embryonic stem cells into six human cell types, those of liver, muscle, nerve, pancreas, blood and bone.

A further 12 cell types are in dispute; the foundation filed suit against Geron on Wednesday over the rights to develop them. Though the six cell types have high medical importance, there are at least 260 different types of cells in the human body, so Geron's license is far from being an exclusive lock on the human body.

Even if researchers find no serious problem in gaining access to the cells controlled by the Wisconsin foundation and others, many believe that there will soon be a need to develop more cell lines if the promise of the research is confirmed.

In an article in The Wall Street Journal on Tuesday, Dr. Varmus and Dr. Douglas Melton of Harvard University said that if the research went well, "Even 100 good lines will likely be inadequate to treat our genetically diverse population without encountering immune rejection."

Several scientists believe that Congress may act to increase the number of cell lines available to them, if medical benefits can be shown to require such a step.

But Dr. Ronald McKay, a stem cell expert at the National Institutes of Health, said, "It's a mistake to get too absolutist about what we need and whether we have enough lines."

A more fruitful focus, in his view, would be to set up stem cell centers with scientists of the many disciplines required to get the science of tissue replacement off the ground.

Copyright 2001 The New York Times Company


Stem Cell Decision Examined

Scientists Are Wondering About Its Impact on Their Work

http://www.washingtonpost.com/wp-dyn/articles/A64200-2001Aug11.html

By David Brown
Washington Post Staff Writer
Sunday, August 12, 2001; Page A08

BALTIMORE -- In his laboratory at Johns Hopkins School of Medicine, neuroscientist Jeffrey D. Rothstein is injecting stem cells from first-trimester fetuses, human cadavers, umbilical cords and bone marrow into the spinal cords of crippled mice.

Rothstein hopes the work will eventually lead to a treatment for Lou Gehrig's disease, a fatal neurological condition that is currently incurable.

Now, after President Bush's decision last week to allow federal money to be used to support a limited amount of stem cell research for the first time, Rothstein may find it easier to eventually add embryonic stem cells to the mix.

"I basically need to test a lot of cells before I know which one works. One could easily imagine that one of the embryonic stem cells that's about to be made available could be an effective line," he said.

Rothstein is one of dozens of scientists around the country who are trying to determine exactly how Bush's decision will affect them and their hot, but very young, field.

Bush decided to allow federal money to be used for the study of 60 or so existing colonies, or "lines," of embryonic stem cells that officials say they have identified around the world. No taxpayer money may be used to create embryos for research, or to study cells harvested from newly destroyed embryos.

What and where are the 60 cell lines? How valuable will they really be? Will they be enough? How much access to them will scientists really have?

Those are among the questions researchers are asking in a field that today has more questions than answers, and which probably remains a decade away from actually helping the first patients.

In truth, the availability of stem cells isn't the main impediment to medical therapies based on stem cells. Knowledge is.

"It's not like we know what to do," said Douglas A. Melton, a Harvard University researcher using embryonic stem cells to try to grow pancreatic tissue called "islets" that might eventually be used to treat juvenile diabetes. "It would be wrong to say that if only we had the cells we'd be making islets tomorrow."

Nevertheless, nobody doubts that Bush's decision, despite its limitations and uncertainties, is a significant step toward building knowledge of how to use the primitive and powerful cells. Until now, research was confined to biotech companies, where it's usually conducted in secret, and to the few academic scientists such as Melton and Rothstein who have been able to raise private funding for their work.

"The most effective and productive members of the biomedical research community are in academia, and they depend on federal funding," said Paul Berg, a Nobel laureate biochemist at Stanford University. "If they are cut out, we are deprived by a factor of 90 percent."

David Baltimore, president of the California Institute of Technology and also a Nobel laureate, believes it will be a long time before there are clinical uses for stem cells.

"That is why Bush had to go ahead with his decision," he said. "It is going to take a lot of work from a lot of different kinds of scientists focusing their expertise on these problems. It shouldn't be left to a few companies, which necessarily focus on short-term results."

Embryonic stem cells are taken from the human embryo when it consists only of hundreds of cells forming a largely hollow ball. They're commonly described as being able to develop into any tissue, a process called "differentiation." They are also said to be immortal -- to be able to replicate and divide forever.

In practice, though, they're much quirkier. Like virtually all cells grown in the laboratory, they have their own foibles, personalities and limitations.

Melton has access to a half-dozen lines of embryonic stem cells developed by a research team in Israel. He has been studying them with grants from the Howard Hughes Medical Institute and the Juvenile Diabetes Foundation, and they're presumably among the lines that could now be studied with federal money. In practice, he only uses one for most of his work.

"Only one works well," he said. "The others, they have all kinds of different problems. They either don't grow well or they differentiate spontaneously, kind of like popcorn popping before you've added heat."

Experience with mouse stem cells, which have been objects of research for more than a decade, also leads him to doubt the claims of immortality for embryonic stem cells. Between uses, all cell cultures are kept frozen and inactive. Mouse cells tend to lose their "totipotency" -- the ability to become any tissue -- the more times a batch is thawed and allowed to divide.

"In my view [human embryonic stem cells'] properties will degrade with time. Everyone is fearful that the more you grow them in the dish, the more they lose their properties."

Different personalities and a limited life span are the two main reasons many scientists view 60 cell lines as a very low ceiling that the field may bump up against long before a stem cell treatment is ready for human trials.

It's also the reason Rothstein is testing a whole stable of comers.

"Each researcher sort of believes his is the best cell -- you know, 'This is the real one,' " he said Friday afternoon as he went over a grant application in his lab at Johns Hopkins Hospital. "But I don't know what the best cell is, and I'm not willing to spend five years on just one. It's a gamble -- and it could be a waste of time."

Rothstein's solution is to set up a parallel track system that is almost industrial in its design.

Using money from the patient organization Project ALS and from a privately endowed center at Johns Hopkins, he is testing three cell lines derived from non-embryonic human tissue and one from pigs. The cells are injected into the spinal fluid of mice carrying a mutant gene that causes the equivalent of ALS, or amyotrophic lateral sclerosis, a disease in which nerve cells controlling muscle movement die.

Each cell line is being put through the same paces: a varying number of injections, with varying "doses" of stem cells, in ALS mice of varying ages.

The preliminary work is finished and under review at a scientific journal. Rothstein won't say whether any of the human stem cell lines brought improvements in the animals' condition.

The project bespeaks an urgency that arises from ALS's current untreatability, and from the fact that it appears to be a good candidate for stem cell therapies.

The second point is a surprise because ALS is a disease in which cells die in the brain and all along the spinal cord -- across distances that, in cellular terms, span millions of miles. It would seem that more localized diseases -- those confined to one organ or to one part of one organ -- would be the ones for which transplanting stem cells might be a useful therapy.

That was Rothstein's assumption until two years ago. He was at a meeting of neurologists in Toronto when another researcher showed him a photograph of a microscope slide of a mouse spinal cord. A large nerve in the animal's leg had been cut, causing severe damage to the nerve cells in the spinal cord. It was an injury that, very crudely, mimicked ALS.

The researcher had injected stem cells into a different part of the animal's cord. Over time, they migrated through the dense tissue and came to rest at the site of injury. Stained black in the microscope slide, they looked like a swarm of bees ready to take up residence and go to work.

"It was amazing. We just knew we had to start something," Rothstein said.

One of the properties of stem cells that may greatly enhance their usefulness is the ability to go to where they are needed, at least in some cases.

To do that, though, stem cells must first be nudged toward differentiating into the type of tissue they are to repair or replace. That's done by exposing the cells, in culture dishes, to signaling molecules or growth factors that start a cascade of genetic events that "commit" each cell to one identity, forsaking all others. Alternatively, one can find the relevant genes and turn them on directly.

Many signaling molecules are known, and many remain to be discovered. The same is true of the genes involved in differentiation and development. This is a major focus of stem cell research.

In addition to their homing properties, another useful trait of some stem cells is their ability to form organs that contain multiple types of cells.

Neural stem cells, for example, can form both nerve cells (called neurons) and the nurturing cells that surround them (called glial cells). In most cases of ALS, a defect in glial cells is responsible for much of the damage suffered by the neurons. Theoretically, a stem cell therapy might replace both types of cell from the same starting material.

Similarly, it's now clear that at least some of the body's most architecturally complex organs arise from a single precursor stem cell. This is true of the liver and the pancreas.

Stem cells, however, may also develop unwanted properties as they grow.

In their primitive form, stem cells lack the molecular identifiers that alert the immune system and telegraph their "foreignness" (assuming they are introduced into an animal different from the one where they arose). When the cells differentiate, however, their inborn identifiers appear.

Consequently, stem cell transplants will probably be like whole-organ transplants. Patients will have to take drugs that suppress the immune system -- drugs that can cause substantial problems themselves. Researchers are working on ways to delete immunity genes from transplanted stem cells to blunt or eliminate this problem of rejection. If this is not possible -- or even if it is -- a menu of far more than 60 lines of embryonic stem cells may be useful to accommodate the vast immunological variety of human beings.

Practically speaking, these problems lie far in the future. Most scientists doubt that embryonic stem cells will be tested in people within the next five years. Many believe the first trials are a decade away.

The more immediate concern is how to get hold of the cells Bush says will now be available for taxpayer-supported research. What the mechanism will be -- as well as whether the federal government will facilitate it -- is perhaps the most immediately pressing question.

Melton, the Harvard researcher, said the process of obtaining living material from foreign sources is one that sets every biologist's teeth on edge. It requires things called "material transfer agreements" that take months, and sometimes years, to execute.

If most of the 60 embryonic stem cell lines mentioned by Bush are overseas, his decision may result in far less loosening of the bonds of research than people imagine.

"If these 60 cell lines are going to be the target of inquiry for federal support, then it behooves the government to help researchers get access to the material," Melton said. "But if it says, 'There are these 60 cells somewhere in the world at these various addresses, now you're on your own; go and get them,' then it's going to be very, very difficult."
 

© 2001 The Washington Post Company


Stem Cell Issue Causes Debate Over the Exact Moment Life Begins

http://www.nytimes.com/2001/08/15/science/15LIFE.html?searchpv=day04

August 15, 2001
By NICHOLAS WADE

When does a human life begin? Scientists' desire to study human embryonic stem cells has raised this ancient question to new prominence.

The Catholic Church says that life begins at fertilization, when egg and sperm unite and that the embryo created from this union has the same rights due any person. Because embryos must be destroyed to generate embryonic stem cells, opponents of the research say it is morally unacceptable.

But embryos have been destroyed routinely at fertility clinics for decades, long before the prospect of stem cell research came along.

For some reason, perhaps the relatively recent origin of the human species, many human embryos are imperfect and fail to develop or implant properly in the wall of the uterus. Fertility clinics typically generate eight or nine embryos per pregnancy, of which only the healthiest looking are implanted. The rest are stored, and ultimately, most are destroyed.

The number of embryos disposed of by clinics is not known because there is no national authority that gathers the statistics. In Britain, however, the Human Fertilization and Embryology Authority has reported that some 50,000 babies have been born through in vitro fertilization since 1991, and 294,584 surplus human embryos have been destroyed.

According to the American Society for Reproductive Medicine, about 100,000 children have been born in the United States by in vitro fertilization, or twice the number in Britain, implying that some 600,000 embryos would have been destroyed if American clinics followed the same five- year storage limit used in Britain. Only a small fraction of the discarded embryos would provide as many stem cells as researchers could use.

But opponents of stem cell research, who condemn scientists for destroying embryos, seem less eager to criticize the clinics and the infertile couples who seek their help.

Douglas Johnson, the legislative director of the National Right to Life Committee, said that in-vitro fertilization "is outside of our purview." His committee has not taken a position against fertility clinics, Mr. Johnson said, because "we don't get into passing judgment on the conception of any person."

Richard Doerflinger, the chief lobbyist for the National Conference of Catholic Bishops, said that the church's moral opposition to in vitro fertilization "has been pretty clear from the outset, but in terms of political action we have to choose the issues that are raised for us."

Sean Tipton, the public affairs director of the American Society for Reproductive Medicine, said, "We have not seen any opposition from the Catholic bishops to put a stop to in vitro fertilization."

Another possible answer to the question of when life begins, and one that does not imply criticism of the clinics' practices, is based on determining when the embryo can be viewed as having an identity.

In the womb, the egg occasionally splits into two separate embryos that develop as identical twins. Very rarely, a second round of splitting occurs, leading to identical quadruplets. If individual identity does not begin until after the last moment when twinning can occur, then the starting point for life can be set at around 14 days after conception, or a week after implantation.

Dr. Margaret A. Farley, a professor of Christian ethics at Yale University, said, "A lot of Catholic ethicists take seriously the finding of embryologists that prior to implantation, you don't have an individualized entity because it can twin."

In the Jewish tradition, the embryo has no status outside the mother's body, a view that also finds no fault with in vitro fertilization treatments.

A leading opponent of abortion, Senator Orrin G. Hatch, Republican of Utah, takes a similar view of the early embryos created for in vitro fertilization, but for different reasons. Senator Hatch said last month that he supported embryonic stem cell research and explained his views by referring to the practices at in vitro fertilization clinics, which he described as ethical and laudable.

"To me a frozen embryo is more akin to a fertilized egg or frozen sperm than to a fetus naturally developing in the body of a mother," he said in a letter to Tommy G. Thompson, the secretary of health and human services. He outlined the various ethical and legal difficulties with the proposition that life starts at conception.

"He's saying there is something magical about the mother's womb," Mr. Doerflinger said in criticism of Senator Hatch. "In Mormon theology there is a belief that souls are pre- existent and are inserted into bodies at some stage by way of the parent, in a way that is not common in the various Christian denominations. I can't argue Senator Hatch out of his theological beliefs, but I don't think he should make the rest of us fund this research based on them."

Though Mr. Doerflinger represents the views of the Catholic bishops, he has presented his arguments against embryonic research in ethical, not religious, terms. He caricatured Senator Hatch's view by saying that if life depended on the mother's womb, then people grown in artificial wombs, if that became possible, would be nonpersons who could be used as slaves.

Senator Hatch said there was "definitely a difference between those who believe life begins when the sperm combines with the egg and those who believe that human life begins in the womb, that you must have a mother." He said he had not based his reasoning for a post-conception beginning of life on the phenomenon of twinning.

A third response to the question of when life begins is that the "when" is impossible to pin down. That is the view of Dr. Brigid Hogan, an embryologist at Vanderbilt University. Dr. Hogan, principal author of a 1994 National Institutes of Health report on embryo research, is an expert on the mouse embryo, which is similar to the human embryo in its early stages.

In her view, conception marks not the beginning of life, since both egg and sperm are alive, but merely an increase in complexity. Many people think of the embryo as a tiny homunculus that just grows bigger. To Dr. Hogan, the building of an embryo is a process like origami, except that the sheets being bent and tucked are made of cells instead of paper.

The early embryo is "a flat little sheet that gets folded," she said. A pivotal event is when a spearhead of cells, called the node, loses contact with its neighbors and moves into the fold, sending out signals that give the embryo a polarity and structure.

The visible structure was called the "primitive streak" by early embryologists. Biologists now know that it is at this time, some 14 days after fertilization, that specific genes are switched on, like goosecoid and brachyury, cordin and noggin — fanciful names devised by those who first found their counterparts in the fruitfly. Is the true beginning of life the moment when the goosecoid gene is first transcribed?

"It's wonderful that the public is getting interested in embryology," Dr. Hogan said, in a tone suggesting a tinge of doubt that the subject's full intricacy would be appreciated.

Wherever the line defining the beginning of human life is drawn, supporters of in vitro fertilization would like to avoid equating the clinics' practice with the killing of human beings.

The anti-abortion movement "has tried to draw a clear and bright line at fertilization," said Dr. Thomas Murray, director of the Hastings Institute in Garrison, N.Y. "Until now, they have been able to avoid having the question called. Embryonic stem cell research has called the question for them. And what we are seeing is that some politicians who have strongly supported the pro-life position now acknowledge they do not accept fertilization as the clear and bright line."
 

Copyright 2001 The New York Times Company


Think Again, Mr. President

Bush Must Reconsider Stem Cell Decision

http://www.humaneventsonline.com/articles/08-20-01/jeffrey.html

By Terence P. Jeffrey
The Week of August 20, 2001

George W. Bush announced last week that he intends to make taxpayers fund research in which one human being has been killed in the hope of helping another.

The President said he decided to do this after "a great deal of thought."

Fair enough. But the President’s thought was seriously flawed. In the end, although he got the basic premise and principle right, his reasoning was illogical, and his conclusion was wrong. And considering that the question at issue was the protection of human life, the consequences of the President’s illogic may be that innocent human beings are killed.

Let’s start where the President started: in his campaign declarations.

On Nov. 21, 1999, on NBC’s "Meet the Press," then-candidate Bush affirmed the basic fact from which any discussion of this research must begin.

Tim Russert asked, "Do you believe life begins at conception?"

"I do," said Bush.

Nine months later, President Clinton proposed new regulations attempting to circumvent a federal law, enacted by the Republican Congress in 1996, that prohibits federal funding for research "in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death."

Clinton’s proposed rules, the Washington Post reported, "forbid the use of federal funds to destroy embryos directly, but they permit federal research on stem cells taken from embryos by privately financed researchers."

The response from candidate Bush was emphatic. "The governor opposes federal funding for stem cell research that involves destroying a living human embryo," said campaign spokesman Ray Sullivan. But what of Clinton’s effort to finesse the issue by funding research only after the killing was done by private money? Reported the Post: "In Bush’s view, Sullivan said, that still amounts to federal support of embryo destruction."

In October, Bush reiterated this position in a written statement to the U.S. Conference of Catholic Bishops. "Taxpayer funds," said Bush, "should not underwrite research that involves the destruction of live human embryos."

As late as May 18, Bush stood firmly by this position. "I oppose federal funding for stem cell research that involves destroying living human embryos," the President wrote in a letter to the Culture of Life Foundation.

Although Bush never published a succinct syllogism summarizing his argument, it is easy to infer what it was:

1) Human life begins at conception.

2) It is wrong to deliberately take an innocent human life.

3) Taxpayers, therefore, should not be forced by government to subsidize scientists who do research that begins with the deliberate destruction of innocent lives.

This was good logic. The fact that human life begins at conception is undisputed by human embryologists. The principle that it is wrong to deliberately take innocent human life was embraced by the Founding Fathers when they said in the Declaration of Independence that all men are endowed by the Creator with a right to life.

Given this sound premise and principle embraced by the President, it might be wondered why he did not seek to ban the killing of human embryos, period.

Instead, egged on by a public lobbying campaign, he started to question his original, logical, position.

Sen. Orrin Hath (R.-Utah) suggested that he adopt the geographical theory of human life: whether you are a human being or not depends on where you are, not who you are. An embryo in a test tube, Hatch argued, was not a human life, even if the same embryo in a fallopian tube was. According to this thinking, if someone built a large test tube, and dropped Hatch into it, he would cease to be a human life.

Sen. Bill Frist (R.-Tenn.) advanced the age theory of human value: Human life begins at conception, he conceded, therefore a human embryo is a human life even in a test tube. But the moral value of human life increases as a human being grows older, and, human beings up to a certain age have not, as yet, attained sufficient "moral significance" to have a right to life and thus may be killed to benefit other human beings—especially if they are going to be discarded and die anyway. "I believe that those first few cells are alive and that they are living and that moral significance over time may vary, and again, this is individual interpretation," Frist explained on MSNBC’s "Hardball."

The Frist Rule, rigorously applied, means a parent could "individually interpret" whether it was acceptable to discard a child at any age because he or she believed that child had not yet attained the "moral significance" of a full human being. The federal government, then, could fund research on organs carved out of full-grown babies whose parents were going to discard them anyway.

The Frist Rule is basically the same as the Peter Singer rule: The powerful can place their own value on the lives of the weak.

Lives Depend on It

President Bush could have accepted the false premise of either Hatch or Frist and still have concluded that the taxpayers in a constitutional republic should not be forced to fund research that involves killing a human embryo—no matter what value or rights or humanity the national elite in Washington, D.C., had determined it was willing to concede to that embryo.

But that is not what Bush decided.

In announcing his decision, Bush posed the obvious question: "[A]re these frozen embryos human life, and therefore something precious and to be protected?" But, then, he did not clearly answer this question—despite having answered it directly for Tim Russert only 20 months before.

"I have concluded that we should allow federal funds to be used for research on these existing stem-cell lines, where a life-and-death decision has already been made," he said. "Leading scientists tell me research on these 60 cell lines has great promise that can 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."

This was not an argument, it was an evasion. It implied that after months of thought, Bush had abandoned the basic objective fact on which any defense of the unborn must rest—that life begins at conception—and adopted the theory that only "potential life" begins at conception.

It implied he had become Orrin Hatch.

Claire Shipman of ABC News challenged Bush on this the next day. "There are a couple of questions you posed last night that you said guided you through this process," said Shipman. "One [was] the fundamental question, when does life begin."

"I think life begins at conception," said Bush.

"Even in a petri dish. Even with a few cells," said Shipman.

"Yes, yes, I believe that," said Bush.

So, he was not Orrin Hatch.

But, then, Bush seemed to be arguing: 1) Life begins at conception, 2) embryonic stem cell research thus starts by destroying a human life, 3) but I believe the government should force taxpayers to fund that research as long as the government funding arrives after the killing has taken place.

This argument would actually be worse than the one Clinton made last year—the one Bush thought "still amounts to federal support of embryo destruction." Clinton never conceded that life begins at conception.

In a New York Times op-ed last Sunday, the President clarified his reasoning. It was right in the principle, right in the premise, but horribly wrong in the conclusion. "There is at least one bright line: We do not end some lives for the medical benefit of others," said Bush, stating an unimpeachable principle. "For me," he continued, "this is a matter of conviction: a belief that life, including early life, is biologically human, genetically distinct and valuable." So, he had not abandoned the basic fact.

And, yet, he concluded, "While it is unethical to end life in medical research, it is ethical to benefit from research where life and death decisions have already been made."

Surely, the President must not understand it this way, but, given his own stated premise and principle, this conclusion is precisely as if he had said: OK, doctor, we are not going to pay for research on the human beings you kill today, or tomorrow, but we will pay for research on the human beings you killed last week.

What if the embryos some scientist kills ten months, or ten years, from now with private money yield a therapy that arguably could cure cancer? What if hundreds or thousands or millions of additional embryos are needed to test the theory or to put the therapy in practice? Would Bush’s conclusion—"it is ethical to benefit from research where life and death decisions have already been made"—protect the taxpayers from funding the slaughter as long as the federal money arrived after the actual killing was done?

No.

President Bush has shown he has an open mind on this issue. He should open his mind now, and think again. Lives depend on it.
 

© Human Events, 2001


The Great Stem Cell Hoax

The research promises results—about a half century from now.

http://www.weeklystandard.com/magazine/mag_6_46_01/krauthammer_art_6_46_01.asp

August 20, 2001/Vol 6, Number 46
By Charles Krauthammer

Sanity and prudence combined to produce a great victory on July 31 when the House of Representatives overwhelmingly defeated—the margin was over 100 votes—the legalization of early human embryonic cloning. But the fight is not over. The Senate needs to act as well.

Before it does, however, it is worth preparing oneself for the gale-force hype that Senate advocates will unleash in defense of the indefensible. One has only to look at the debate on the floor of the House to see the extraordinary lengths to which the biotech industry and its allies in Congress will go to sell the deliberate creation of embryo factories for the sole purpose of exploiting and then destroying them.

While the media have been snooping under Gary Condit's bed, they have missed the real scandal of the season, the unconscionable deployment of fantasy and false hopes by advocates of "therapeutic" cloning for the production of stem cells. The basic premise—cure of the incurable—was stated by a Newsweek cover a month ago: "There's Hope for Alzheimer's, Heart Disease, Parkinson's and Diabetes. But Will Bush Cut Off the Money?" The theme has been echoed and reechoed nowhere more than in Congress.

The cosponsor of a permissive cloning bill, Peter Deutsch (D-FL), said this about the opposing bill totally banning cloning: "No one knows who is going to get Alzheimer's or Parkinson's or cancer. . . . What this legislation would do would be to stop the research . . . so that you could survive, so that someone who is a quadriplegic could walk, so that someone who has Alzheimer's . . ." He trailed away. You get the drift. The lion will lie down with the lamb.

Nancy Pelosi (D-CA), with characteristic subtlety: "Mr. Speaker, the National Institutes of Health and Science hold the biblical power of a cure for us."

Zoe Lofgren (D-CA): "If your religious beliefs will not let you accept a cure for your child's cancer, so be it. But do not expect the rest of America to let their loved ones suffer without cure."

Jerrold Nadler (D-NY): "We must not say to millions of sick or injured human beings, 'go ahead and die, stay paralyzed, because we believe the blastocyst, the clump of cells, is more important than you are.' . . . It is a sentence of death to millions of Americans."

Anna Eshoo (D-CA): "As we stand on the brink of finding the cures to diseases that have plagued so many millions of Americans, unfortunately, the Congress today in my view is on the brink of prohibiting this critical research."

Eshoo gets the prize. The brink? The claim that cloning, and the stem cells it might produce, is on the verge of bringing a cure to your sick father with Alzheimer's or your debilitated mother with Parkinson's is a scandal. It is a cruel deception perpetrated by cynical scientists and ignorant politicians. Its purpose is clear: to exploit the desperation of the sick to garner political support for ethically problematic biotechnology.

The brink? Cloning animals, let alone humans, is so imperfect and difficult that it took 277 attempts before Dolly the sheep was cloned. Scientists estimate that the overall failure rate for cloning farm animals is 95 percent or greater. New experiments with cloned mice have shown gross deformities. And here is the worst part. We have no idea why. We understand little about how reprogrammed genes work. Scientists don't even know how to screen with any test for epigenetic abnormality.

In other words: Even if you could grow embryonic stem cells out of grandma's skin cells, we have no idea yet how to regulate and control these cells in a way to effect a cure. Just growing them in tissue culture is difficult enough. Then you have to tweak them to make precisely the kind of cells grandma needs. Then you have to inject them and hope to God that you don't kill her.

We have already had one such experience, a human stem cell experiment in China. Embryonic stem cells were injected into a suffering Parkinson's patient. The results were horrific. Because we don't yet know how to control stem cells, they grew wildly and developed into one of the most primitive and terrifying cancers, a "teratoma." When finally autopsied—the cure killed the poor soul—they found at the brain site of the injection a tumor full of hair, bone and skin.

Let's have a little honesty in both the cloning and stem cell debates. Stem cell research does hold promise for clinical cures in the far future. But right now we're at the stage of basic science: We don't understand how these cells work, and we don't know how to control them. Because their power is so extraordinary, they are very dangerous. Elementary considerations of safety make the prospect of real clinical application distant.

Stem cells are the cure of the mid 21st century. Stem cell research deserves support because the basic research needs to be done and we might as well get started now. But the cure is for future generations. The cynical appeal to curing grandma is raw exploitation of misery. Nothing of the sort is about to happen. Those who claim it ought to be ashamed.

But rather than exhibit shame, the scientific community is rallying—in the name of retaining their autonomy from the ignorant dictates of lay society—to sugarcoat the news. Most notorious is the case of the research article on embryonic stem cells published in July in the journal Science, one of the most respected scientific publications in the world. The research showed that embryonic stem cells of mice are genetically unstable. Yes, you can make them grow over and over again, but we don't know how or why some genes are turned on and off. You can make a million copies of a stem cell. They may be genetically identical. But if different genes are turned on in the various cells, the results—the properties of the tissue or organism they develop into—can be wildly different.

Now the really bad news. The authors of that study initially had a sentence at the end of the paper stating the obvious conclusion that this research might put in question the clinical applicability of stem cell research.

But that cannot be said publicly. In a highly unusual move, the authors withdrew the phrase that the genetic instability of stem cells "might limit their use in clinical applications" just a few days before publication. They instead emphasized that this mouse study ought not hold back stem cell research.

This change in text represents a corruption of science that mirrors the corruption of language in the congressional debate. It is corrupting because this study might have helped to undermine the extravagant claims made by stem cell advocates that a cure for Parkinson's or spinal cord injury or Alzheimer's is in the laboratory and just around the corner, if only those right-wing, antiabortion nuts would let it go forward.

In reviewing a book on Parkinson's disease, Nina King, associate editor of Washington Post Book World, noted that when she was diagnosed with the disease 15 years ago, she was told that a cure was 5 or 10 years away. She has heard that ever since. A cure in 5 to 10 years "is like a mirage on the horizon, glowing with promise but ever receding."

The other scandalous myth being perpetrated, besides imminence, is inevitability. It goes like this:

The march of science will go on. Legislators can try to contain the growth of knowledge, but it is futile. Somebody somewhere will work on stem cells or cloning. So let us at least take it out of the closet and keep it in the public eye.

What this mantra does not take into account is the radical effect a ban on anything in science has on the quality and quantity of people working on it. Cloning has not even been banned, but because it is societally disapproved of, it is generally shunned by serious researchers. Look at the cloning conference called by the National Academy of Sciences on August 7 in Washington. A vast majority of researchers there view with horror the cloning of a human child—except for three researchers who declared their determination to do it. Three in the whole world.

One looked less stable than the other. Dr. Boisselier recently closed her "Clonaid" laboratory in the United States and is supposedly opening one offshore. When she spoke to the gathered about the right to do what one wants with one's genes, she did not inspire great confidence, possibly because she is a member of the Raelian sect, a cult founded by a former French race car driver after being visited by aliens in 1973. Seeing how marginalized cloning researchers are today even before a legal ban, one can imagine how much more marginalized they will be after one.

A ban works by robbing outlawed research of the best and the brightest. They are not going to devote their lives to a career where they must work in the shadows, ostracized, and under threat of arrest. That ought to encourage legislators to believe that society can indeed influence the direction of science.

Yes, in the very long run some science will break through. But one must not underestimate the efficacy of political restraint. If you can restrain for decades something that promises a cure, imagine how many other, less morally repulsive, substitute cures will present themselves in the meantime. You cannot stop evil science, but you can delay it, and thus possibly supplant it.

That is why the House action banning all cloning was so important. The Senate must demonstrate its seriousness, too. Now that the president has permitted only research from existing stem cell lines, the Democratic Senate is sure to try to loosen that standard and permit stem cell research from discarded fertility clinic embryos as well. But until Congress has demonstrated its seriousness about preventing the creation of embryo factories for exploitation by banning cloning completely, it cannot be trusted on any question regarding human manufacture.

© COPYRIGHT 2001, NEWS CORPORATION, WEEKLYSTANDARD