Showing posts with label embryonic stem cells. Show all posts
Showing posts with label embryonic stem cells. Show all posts

Monday, October 15, 2012

Ethical Science is Good Science

A Nobel Prize for Ethics
By Michael Cook


Two stem cell researchers have shared the Nobel Prize in Medicine for 2012, an elderly Briton, Sir John B. Gurdon, and a younger Japanese, Shinya Yamanaka. By a serendipitous coincidence, Sir John made his discovery in 1962 -- the year of Yamanaka's birth.

Fifty years of stem cell research have brought cures for intractable diseases within reach but they have also generated firestorms of controversy. Between 2001 and 2008, stem cell research vied with climate change as the most contentious issue in science. But since then, the firestorm died down -- basically because of Yamanaka’s achievements. In fact, Tom Douglas, of the Uehiro Centre for Practical Ethics, at Oxford University, describes Yamanaka's work as “a rare example of a scientific discovery that may solve more ethical problems than it creates".

So what happened in these 50 years? (Click here for a graphic explanation from the Nobel Committee.)

In his classic experiment at the University of Cambridge, Sir John discovered that cell development is reversible. The conventional wisdom was that cells could never change once they had specialized as nerve, skin, or muscle cells. He proved that this was wrong by replacing the nucleus of a frog egg cell with a nucleus from a mature intestinal cell. This modified cell developed into a normal tadpole.

This astonishing development eventually led to the cloning of the first mammal, Dolly the sheep, in 1996 and subsequent attempts by rogue scientists to clone human beings.

But while the technique clearly worked, no one really understood how cell development worked. The obvious target for research was the embryo. From this ball of undifferentiated cells come each of the body's specialized cells -- more than 200 of them in humans. Surely the answer must lie there. In 1998 an American scientist, James Thomson, of the University of Wisconsin-Madison, isolated and cultivated human embryonic stem cells.

But a one-eyed focus on embryos left stem cell science hostage to ethics. Despite scientists’ bravado, everyone had some qualms about destroying embryos for their stem cells. Even Thomson admitted to the New York Times that "if human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough”.

Still, it seemed the only way forward. Desperate patient advocates, backed by a supporting chorus of bioethicists, scientists and doctors, argued tearfully that the possibility of miracle cures had to trump ethics.

But, in 2006, there came astonishing news from the University of Kyoto. An orthopaedic surgeon turned stem cell scientist, Shinya Yamanaka, had discovered that skin cells from mature mice could be reprogrammed to become immature stem cells. It was an amazingly imaginative step. Instead of mimicking natural development from embryo to adult, why not wind back the clock from adult to embryo?

Yamanaka found that by introducing only a few genes, specialized skin cells could become pluripotent stem cells, i.e. immature cells that can develop into all types of cells in the body. Until then, creating pluripotent cells without resorting to cloning seemed unlikely. Like Gurdon, for whom he has an immense respect, Yamanaka had skittled the conventional wisdom.

This was electrifying news for biologists. It was as if commuters on the pot-holed, terrorist-infested road from Baghdad airport to the Green Zone could suddenly detour down a six-lane autobahn at 200km. Many famous scientists dropped human embryonic stem cells and began work on what Yamanaka had termed "induced pluripotent stem cells". A year later, in November 2007, both he and James Thomson, in separate papers, confirmed that human cells could also be reprogrammed.

The rest is history.

As the Nobel Committee says about Gurdon and Yamanaka's research, "Textbooks have been rewritten and new research fields have been established. By reprogramming human cells, scientists have created new opportunities to study diseases and develop methods for diagnosis and therapy."

What turned Yamanaka away from the group-think which goaded his colleagues into the swamp of human embryonic stem cell research? Nowadays, the feverish excitement over human embryonic stem cells in the early Noughties seems ridiculous. Leading scientific and medical journals launched a crusade of Enlightenment heroes against prejudiced troglodytes. In one memorable endorsement of embryo research, the New England Journal of Medicine -- the world's leading medical journal -- published an editorial which concluded with this cringeworthy hyperbole: "The Promethean prospect of eternal regeneration awaits us, while time's vulture looks on." It never mentioned cell reprogramming.

Yamanaka's originality may have sprung from his ethical sensitivities. Even Julian Savulescu, the director of the Oxford Uehiro Centre for Practical Ethics, who has no objections to embryo research, recognises this. "Yamanaka has taken people’s ethical concerns seriously about embryo research and modified the trajectory of research into a path that is acceptable for all. He deserves not only a Nobel Prize for Medicine, but a Nobel Prize for Ethics."

In an interview with the New York Times in 2007, Yamanaka remembered one day years before when he paid a social visit to a friend's IVF clinic. There, he peered through a microscope. "When I saw the embryo, I suddenly realised there was such a small difference between it and my daughters," said the father of two. "I thought, we can’t keep destroying embryos for our research. There must be another way."

Nor does he believe that scientists should put progress above ethics. In another 2007 interview, with New Scientist, he spoke about the firestorms. "These are very difficult decisions, and I think that society should make them," he said. "It should not be scientists. They can find it difficult to think like the person on the street, and instead may see it simply as a good opportunity. We scientists can be involved in the decision-making process, but I think unless society is comfortable with the therapy it should not go ahead."

Once again, experience shows that that ethical science is good science.

Michael Cook is editor of MercatorNet.

Tuesday, April 19, 2011

Embryonic Stem Cell Research "Overhyped"

It's difficult to think of bioethicists who differ on more issues than Robert P. George, of Princeton (yes, there is a bioethicist at Princeton who is not Peter Singer) and Arthur Caplan of the University of Pennsylvania. George, a former member of President Bush's Council on Bioethics, is a leading conservative who opposes embryonic stem cell research and abortion. Caplan is the unofficial dean of progressive bioethics and perhaps the most quoted bioethicist in the American media. But at a meeting organised by the Witherspoon Institute, a think tank at Princeton, they agreed on one thing: stem cell scientists told porkies about the promise of their research.

Caplan complained:

"Embryonic stem-cell research was completely overhyped, in terms of its promise. And people knew it at the time. I tried to say so myself at different times myself, even though I support embryonic stem-cell research. But this notion that people would be out of their wheelchairs within a year if we could just get embryonic stem-cell research funded was just ludicrous...

"Here's an assertion that you hear all the time: 'Stem-cell research will help Alzheimer's.' But stem cell research has no possibility of helping Alzheimer's. Alzheimer's is a gunk-up-the-brain disease, where every cell is affected. You can't fix it by any sort of stem cell research. Model it? Maybe. Cure it? Never."

Twisting the truth could backfire, George warned:

"...that's the kind of dishonesty that threatens to alienate the public from science. Because even if the public buys it in the beginning, and the scientists win the political debate, when they can't deliver on the promises they made, people's faith in scientists--crucial for the funding of science--is placed in jeopardy."

The key point on which the two celebrity bioethicists agreed was that facts do not speak for themselves and that science is not ethics. Ethical norms have to govern scientific inquiry and medical practice. As Caplan put it, "You can pile up evidence to the size of the Jungfrau, but if you don't have norms, evidence does you no good. But some out there believe that the evidence speaks for itself."

The dialogue between the two men is fascinating reading. It is a great contribution to the bioethics debate by Public Discourse, the Witherspoon Institute's online journal. ~ Public Discourse, April 13

Saturday, October 16, 2010

First Human Test of Stem Cell Therapy

A Menlo Park biotech firm said Friday that federal regulators will let it proceed with the world's first human test of a treatment made from embryonic stem cells, a much-anticipated but controversial study of patients with spinal cord injuries that had been placed on hold for nearly a year because of safety concerns.

If the treatment from Geron works, it "would be revolutionary," said Dr. Richard Fessler, a neurological surgeon at Northwestern University, who will lead the study of a stem-cell treatment designed to be injected into patients with spinal injuries to restore their motor function. "The therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."

Geron has spent 15 years and more than $150 million to develop the treatment, and "getting it into a clinical trial, just by itself, is a big deal," added Fessler, who has no financial ties to the company.

Many people hope that human embryonic stem cells, which can turn into any type of tissue in the body, could prove useful for everything from generating organs for transplants to helping test drugs on numerous diseases. But because the cells are derived from discarded 3- to-5-day-old embryos, their use by researchers has sparked ethical concerns and a highly contentious national debate.

The Food and Drug Administration had put the study on hold last year after a few animals the company was testing with its treatment.

Read more here.

Friday, October 8, 2010

Harvard: Breakthrough in Somatic Cell Reprogramming

Scientists at Harvard Medical School have developed an even better way of producing alternatives to human embryonic stem cells (hESCs). The new technique, which appears to be a huge improvement over induced pluripotent stem (iPS) cells, is being described as a major advance.


While iPS cells are very promising, they have significant drawbacks. The process for generating them is very inefficient and they can cause cancer. The new method, developed by a team headed by Derrick Rossi and published in the journal Cell Stem Cell, does not require risky genetic modification and holds great promise for making the reprogramming process more therapeutically relevant. Synthetic modified messenger RNA molecules encode the appropriate proteins but without integrating into the cell's DNA.

"All I can say is 'wow' - this is a game changer," said Robert Lanza, a stem cell researcher at Advanced Cell Technology told the Washington Post. "It would solve some of the most important problems in the field."

"Our technology represents a safe, efficient strategy for somatic cell reprogramming and directing cell fate that has wide ranging applicability for basic research, disease modeling and regenerative medicine," says Dr Rossi. "We believe that our approach has the potential to become a major and perhaps even central enabling technology for cell-based therapies."

What are the ethical implications?

Richard M. Doerflinger of the US Conference of Catholic Bishops told the Post: "With each new study it becomes more and more implausible to claim that scientists must rely on destruction of human embryos to achieve rapid progress in regenerative medicine."

However, the director of the National Institutes of Health, Francis S. Collins, insisted that research on hESCs must continue as they are a gold standard. "Previous research has shown that iPS cells retain some memory of their tissue of origin, which may have important implications for their use in therapeutics," he said. "To explore these important potential differences, iPS research must continue to be conducted side by side with human embryonic cell research." ~ Eurekalert, Sept 30, Harvard, Sept 30

Saturday, August 28, 2010

Court Injunction on Obama Executive Stem Cell Order

WASHINGTON — The federal government has vowed a quick appeal of a temporary court order that halts federal funding of human embryonic stem-cell research using new stem-cell lines.

The injunction, granted by Washington, D.C., federal Judge Royce Lamberth in response to an action launched by several pro-life groups and two Christian adult stem cell researchers, might even stop research using lines approved by President George W. Bush in 2001.

Judge Lamberth found on Aug. 23 that the National Institutes of Health’s approval of 75 human embryonic stem-cell lines for federal funding violated the Dickey-Wicker Amendment prohibiting federal research that is lethal to embryos.

The NIH action lead to the implementation of a 2009 order from President Barack Obama, and his administration wasted no time promising to appeal the injunction.

Department of Justice spokeswoman Tracy Schmaler told the Politico news website that “the appeal should be filed by the end of the week.”

The same site reports deputy White House press secretary Bill Burton saying that the president “thinks that we need to do [human embryonic] stem-cell research, and he thinks his policy is the right one.”

But Cardinal Daniel DiNardo of Galveston-Houston, Texas, chairman of the Committee on Pro-Life Activities of the U.S. Conference of Catholic Bishops, welcomed the federal court injunction against the Obama administration’s policy, calling the ruling a “victory for common sense and sound medical ethics.”

The lawsuit was brought last year on behalf of a Christian adoption agency, two stem-cell scientists, James Sherley and Theresa Deisher, embryos and others. The court found that only the two scientists had “standing” to bring what amounted to an emergency lawsuit because the other plaintiffs would suffer no immediate or “irreparable” injury by having to wait until the lawsuit goes to trial.

But Sherley, a Baptist and a researcher at Boston Biomedical Research Institute, and Deisher, a Catholic who runs Seattle-based AVM Biotechnology, were granted standing on the basis that their work on adult human embryonic stem cells would suffer “irreparably” unless the expansion of human embryonic stem-cell research were halted immediately.

Reasoned the court: Researchers in adult and embryonic stem-cell research were competing for the same federal dollars, but only researchers of adult stem cells relied almost entirely on public funding, while embryonic stem-cell scientists stood a chance of getting private money.

But granting the two scientists “standing” only got their legal foot in the door.

Dickey-Wicker Amendment
The meat of Lamberth’s decision is that the Obama-ordered expansion of embryonic stem-cell research violates the Dickey-Wicker Amendment.

“The language of the statute reflects the unambiguous intent of Congress to enact a broad prohibition of funding research in which a human embryo is destroyed,” wrote Lamberth, who was appointed to the federal bench by President Ronald Reagan in 1987. “ESC research is clearly research in which an embryo is destroyed.”

Reached in Seattle, Deisher declined to comment. In an e-mail she sent to friends relaying news of the victory, however, she led with two words: “Praise God.”

Deisher, whose research paradigm is to work within the life ethic of the Church, is currently studying links between autism and vaccines made by using embryonic stem cells.

In a previous interview with the Register, she said that while adult stem cells had been used for decades in successful treatment of humans, the experimental treatment of animals with embryonic stem cells produced dangerous side effects and when used with humans would end in “disaster.”
Condemnation
Nonetheless, a group of medical research foundations swiftly condemned the Lamberth injunction. Declared Lisa Hughes, president of the Washington, D.C.-based Coalition for the Advancement of Medical Research: “Today’s Federal District Court injunction halting federal funding for human embryonic stem-cell research is a blow to the hopes of millions of patients and their families suffering from fatal and chronic diseases and disorders.”

Hughes added, “CAMR, and the patients and researchers we represent, remain committed to supporting all stem-cell research and the search for cures that might be discovered from these essential research tools.”

NIH director Francis Collins said the injunction “had poured sand in the engines of discovery” by stopping $54 million in NIH research grants due to be issued in September.
Meanwhile, $131 million in NIH research grants for human embryonic stem-cell research has already been issued and won’t be taken back.

Bush’s Stem Cells
The question remains as to whether the injunction applies to research using the lines approved by President Bush in a 2001 order. Will Bowman of the Alliance Defense Fund, one of three pro-life legal organizations that acted for the plaintiffs, told the Register, “The Bush regulation from 2001 doesn’t exist anymore because it was rescinded by the Obama administration, and it is not resurrected by the preliminary injunction because the order in this case only prohibits funding ESC research under the Obama guidelines from 2009.”

The Bush order never provoked a legal action from pro-lifers because it limited research to the use of stem-cell lines derived before Aug. 9, 2001 — preventing the grants from encouraging any more embryo-killing and violation of the Dickey-Wicker Amendment.

The fact that the injunction is temporary does not mean it is necessarily short-lived. Unless it is successfully appealed, it will stand until the D.C. federal court makes a final ruling on the case for a permanent injunction, said Bowman.

Legal experts supportive of embryonic stem-cell research are also urging Congress to take action by either repealing Dickey-Wicker or passing legislation specifically enabling human embryonic stem-cell research. A poll released this week by Rasmussen Reports indicates 57% of Americans oppose public funding for embryonic stem-cell research, though only 23% believe it to be immoral. This suggests the Dickey-Wicker Amendment is safe for now.

Steve Weatherbe writes from Victoria, British Columbia.

Saturday, August 21, 2010

Human Trials of Embryonic Stem Cell Therapy Approved

MENLO PARK, Calif. — Even as a federal agency gave a California biotech firm the go-ahead to begin the first human trials of therapy employing human embryonic stem cells, a federal court approved a pro-life legal action that could lead to blocking President Obama’s promised expansion of federal funding for research using these cells.

Geron Corp. of Menlo Park, Calif., is seeking people paralyzed by spinal injuries to be the first human test subjects for the clinical use of human embryonic stem cells, which some scientists say is dangerous, wasteful of taxpayers’ dollars and unethical.

Stem cells are undifferentiated, primitive cells that have the ability both to multiply and to differentiate into specific blood cells and other cell/tissue types. This ability allows them replace dead or defective cells and/or tissues.

Embryonic stem-cell research, which involves the killing of a unique human being in an attempt to cure different diseases, has proven not only lethal and costly, but has not produced a single cure. On the other hand, adult stem-cell research, which utilizes cells from adult tissues or umbilical cords, does not require the taking of human life. It has proven successful in treating more than 70 kinds of cancers and autoimmune diseases such as multiple sclerosis.

Read it all here.

Saturday, July 3, 2010

George Daley Abandons hESCs for iPS Cells

Amongst scientists who promoted the use of human embryonic stem cells five years ago, in the middle of passionate debates in the US, Australia and elsewhere, few were more influential in shaping the ethical debate than Harvard's George Q. Daley. "We must support the vitally important applications of embryonic stem cells to medical research," he testified to a Congressional committee in 2005.

He contended that work on hESCs was so important that it could not be delayed. It was needed for cures, drug development and genetic research. The fact that years had passed without results made no difference. "The field of human embryonic stem cell research is a mere 7 years old, so it is premature to expect successful cell therapies to have already been delivered to patients."

Now, he has transferred the same sense of urgency and excitement to an ethical non-controversial alternative to hESC research which he dismissed before the committee - induced pluripotent stem cells (iPS cells). At the time, he said, "Although this strategy is worth pursuing, it is extremely high-risk, and may take years to perfect, and may never work as well as nuclear transfer, which we know we can practice today."

However, in 2007 iPS cells were developed by Shinya Yamanaka. Professor Daley immediately stopped campaigning for hESCs. In an interview with Nature Medicine, he says, "Once Yamanaka solved the problem, I turned around virtually my entire program to take advantage of that breakthrough."

In language remarkably similar to his 2005 testimony, he now promotes iPS cells: "There's no reason in my mind to think that we're not going to have iPS cells that function as well as embryonic stem cells." Why haven't there been any cures yet? "You can't hold the field to too high a standard. It's only been two years, and a lot of this stuff is in the pipeline." And Daley is taking a wait and see attitude, as he stated: "There’s no reason in my mind to think that we’re not going to have iPS cells that function as well as embryonic stem cells, but it may be that there are fundamental limitations in the reprogrammed cells." ~ Nature Medicine, June

Sunday, November 8, 2009

Geron Cashing on People's Hopes?

Geron has announced many times that it would soon start human embryonic stem cell trials -- but so far no trials have begun. The latest announcement came last week when it announced that the trials would begin next year. Its share price rose 4.2% at the news.

Dr David Prentice, of the Family Research Council, a critic of embryo research, has been logging Geron's announcements since 2002 and found that trials were going to begin "next year" every year since 2004. He argues that "the obsession with embryonic stem cells has obscured the real hope for patients-adult stem cells. Peer-reviewed evidence of adult stem cell success for spinal cord injury patients has already been published by groups in Portugal, in Australia, in Ecuador, and in Brazil". The trials with embryonic cells have usually been delayed over safety concerns, as they could cause tumours. --Forbes, Oct 30

Monday, May 18, 2009

Induced Pluripotent Stem Cells

Research in stem cells and the origin and treatment of disease is definitely moving away from destructive embryonic stem cell research toward induced pluripotent stem cells (iPS).

A fantastic review that connects Japan's Dr. Yamanaka, San Francisco's Srivastava, the University of Texas Southwestern Medical Center in Dallas, and the Burnetts of Sulphur Springs, Texas, is published in the Japan Times. (Written by Rob Waters for Bloomberg news.)

Yamanaka, a professor at Kyoto University, developed a technology that may make the argument moot. Yamanaka, who has two daughters, started his effort 10 years ago, after peering at a tiny embryo through a microscope and reflecting that it might form a child if it wasn't used to make stem cells, he said in an interview.

"That's the moment I thought about this project," he said. "I saw that if we could make pluripotent stem cells without using human embryos, that would be ideal."

In 2006, he scored his first success. Using a virus to insert four genes into the skin cells of mice, he started a process that returned the cells to a primordial state able to form any other cell in the body. Yamanaka named them induced pluripotent stem, or iPS, cells. The next year, he repeated the feat with human cells.

Yamanaka and researchers elsewhere are now racing to find better ways to achieve the same effect. They would like to get rid of the virus, which can cause the genes to lodge permanently in the structure of the cell and may trigger the growth of tumors.

Yamanaka's technique exploits a basic fact of human biology — that every cell in a person contains the genetic instructions that set that person's traits, from hair color to inherited disease. By taking skin cells from a person with a disease and turning them into cells in the heart, brain or pancreas that are affected by a genetic disease, researchers can experiment with disorders at their earliest stages, Harvard's Melton said.

Labs are now creating iPS cells because making them is far simpler than getting cells from embryos, said Jeanne Loring, founding director of the Center for Regenerative Medicine, part of the Scripps Research Institute in La Jolla, Calif.

"Every stem-cell researcher I know has made about a dozen," Loring said.

She estimates that researchers have made 300 different so-called lines of iPS cells, a number that may double this year. Each line is a colony of cells descended from the first ones made. Scientists keep them alive in culture and the cells keep replicating.

Read it all here.

Wednesday, April 22, 2009

Ethical, Moral Disconnect in Embryonic Stem Cell Use

WASHINGTON (from CNS) -- By proposing to allow the use of federal funds for stem-cell research on embryos created for reproductive purposes at in vitro fertilization clinics and later discarded, the National Institutes of Health opens "a new chapter in divorcing biomedical research from its necessary ethical foundation," said Cardinal Justin Rigali of Philadelphia April 21.

"Without unconditional respect for the life of each and every member of the human race, research involving human subjects does not represent true progress," said the cardinal, chairman of the U.S. bishops' Committee on Pro-Life Activities.

"It becomes another way for some human beings to use and mistreat others for their own goals."

Cardinal Rigali was commenting on draft guidelines for embryonic stem-cell research issued April 17 by acting NIH director Dr. Raynard S. Kington during a news briefing by telephone.

Although Kington said he believed the draft guidelines reflect "broad support in the public and in the scientific community," he said he expected much of the public comment on them to focus on ethical concerns.

A 30-day period of public comment was to begin with publication of the draft guidelines in the Federal Register, which had not occurred by April 21.

Sunday, April 19, 2009

Pfizer to Begin Embryonic Stem Cell Trials

This week Pfizer is set to announce its financial backing of the development of an embryonic stem cell therapy to cure age-related macular degeneration (AMD). The clinical trial would begin in about two years.
Read about it here.

Friday, March 27, 2009

Doctors Alarmed by Obama's Anti-Life Stance

ROME, FEB. 17, 2009 (Zenit.org).- The World Federation of the Catholic Medical Associations is sounding an alarm about new threats to human life under the administration of U.S. President Barack Obama.

In a statement released today on the Obama presidency and the culture of life, the health care professionals note that the new president "has begun his term with actions that will undermine respect for human life, human dignity and religions freedom."

The statement recalls the ominous message already sent during Obama's political career and campaign, including his 100% approval rating from Planned Parenthood; his opposition to every limitation on abortion; his support for the Freedom of Choice Act; and "shockingly," his opposition as a senator to "any protections for infants born alive after failed abortion procedures."

The health care officials also noted Obama's promise of support for federal funding for stem cell research that destroys human life.

Now that he is president, the federation statement continued, he has already engaged in "a series of actions that indicate that he is prepared to implement his prior support for abortion." In this regard, they noted his overturning of the Mexico City policy, which denied federal funding to international agencies that promote or perform abortion as a means of birth control; and his willingness to provide financial support to the United Nations Population Fund, an organization that lost U.S. government funding after it collaborated with the Chinese government's "one child" population policy.

Furthermore, the statement pointed to Obama's choice for pro-abortion staff members, including Hillary Clinton, Rahm Emanuel, Dawn Johnsen, and many others.

And in a move that particularly touches health care officials, the statement noted the president's opposition to a rule that protects the conscience rights of doctors, nurses, pharmacists and other health care workers.

Thus, the World Federation urged the president to change his support for abortion.

They added: "In addition, we offer our prayers, encouragement and appeals to Catholic physicians in the United States to educate the public and to oppose these efforts to promote abortion. Finally, we appeal to all members of [the World Federation] to be vigilant in opposing the new threats to human life and dignity that could now come from the Obama administration officials in foreign policy positions and at the United Nations."

To read the full text, go here: www.zenit.org/article-25117?l=english

Sunday, March 22, 2009

Destroying Embryos Unethical and Irreverent

From the moment President George W. Bush imposed federal funding restrictions on embryonic stem cell research, Big Biotech, patient advocacy groups, celebrities and the media have been obsessed with eviscerating the policy. Indeed, although the Bush administration funded about $175 million in grants for human embryonic stem cell research, and despite the literally billions poured into the field from public and private sources such as the California Institute for Regenerative Medicine, or CIRM, and philanthropists, the public was continually warned that embryonic stem cell research in the United States was in danger of withering on the vine due to Bush.

With such abundant funding, that wasn't true. Nor was the charge that Bush's policy was "anti-science" because it funded only research on stem cell lines in existence as of Aug. 9, 2001. But the controversy was never a science debate. It was – and remains – an ethics debate that impacts directly on the importance and meaning of human life. Indeed, the question raised by embryonic stem cell research is whether it is morally right to treat and exploit human life – even at the nascent stage – as a mere natural resource.

That concern did not start with Bush. Since 1996 with the passage of the Dickey Amendment and continuing in a bill just signed by President Barack Obama, it has been illegal for the federal government to directly fund research that destroys human embryos.

Bush's policy went a step further, preventing funding to study stem cell lines derived from destroyed embryos in anticipation of receiving federal funding – the reason for the 2001 date.
Last week, the new president kept a campaign promise to free up federal funding for all embryonic stem cell lines whenever derived. But he also told the country that ethics still matter, stating: "We will support it (embryonic stem cell research) only if it is both scientifically worthy and responsibly conducted. We will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse."

How is that different in kind from what Bush did? Are ethical constraints "anti-science" only if one disagrees with where the lines are drawn? Beyond that, as he revoked the Bush restrictions, Obama also undermined a promising field of regenerative medical research that holds tremendous potential to bridge the bitter cultural divides rending the country – pro-life vs. pro-choice, liberal vs. conservative, pro- and anti-embryonic stem cell research – the very kind of policy the president has repeatedly promised to pursue. This field involves alternative methods for obtaining pluripotent stem cells, which theoretically can become any tissue type, without destroying embryos.

One such alternative, "cell reprogramming," transforms ordinary body cells in the lab into "induced pluripotent stem cells." Science hailed the development of IPSCs as the biggest scientific breakthrough of 2008 and for good reason: They have already been used to create patient-specific, tailor-made stem cell lines for use in drug testing and research – the very benefit researchers once claimed that only therapeutic cloning could provide.

In 2007, President Bush issued an executive order requiring the government to fund research into alternatives. Inexplicably – and without discussing it in his speech – Obama revoked this Bush order, too. He claimed he wants to fund such research, but what he did was take away the existing legal requirement that it be done. We have seen this same undermining of alternatives here in California. Last year, Sen. Sheila Kuehl (D-Santa Monica) introduced a bill (SB 1565) that would have, among other provisions, made it easier for the CIRM to fund IPSC research. That proposed legal shift in emphasis was opposed adamantly by the CIRM, and despite overwhelming bipartisan support, fell to Gov. Arnold Schwarzenegger's veto.

If pursuing the best and most ethical science were truly the goals, why deflect increased support for this promising research to which no one objects? Perhaps it is because this debate involves more than stem cells taken from embryos "left over" from in-vitro fertilization – as the argument is usually couched – which brings us back to ethics. In the wake of the Obama changes in federal policy, the New York Times editorially threw down a gauntlet, calling for both the rescission of the Dickey Amendment and federal funding of human therapeutic cloning research.

Now that the Bush restrictions are history, look for these battles – which again are not science debates – to flare in the years to come. In this sense, embryonic stem cell research threatens to become a launching pad to an ever-deepening erosion of the unique moral status of human life.

From here.

Killing Human Embryos Doesn't Bring Life

Barack Obama announced a reversal of the Bush policy that limited embryonic stem cell research, because the President said he wanted to ensure that "we make scientific decisions based on facts, not ideology," sparking applause from attending Democrats at the White House.

Actually, the reverse is true. Since President Bush took a stand against destroying embryos in order to get embryonic stem (ES) cells, Democrats pounced on the issue, fighting for unfettered ES research. That seemed reasonable even to many Republicans, and was a reason that Democrats won control of the House and Senate in 2006, and the Presidency in 2008.

The media trumpeted the Obama reversal. ABC's Lisa Stark pontificated, "The president's move will free up federal dollars for more widespread research on embryonic stem cells, the so-called master cells of the body. Supporters say it may lead to cures for diseases such as diabetes, Parkinson's and Alzheimers."

That is erroneous reporting at two levels. While $8 billion of the stimulus package was earmarked for the National Institutes of Health, a federal law has blocked federal funding of ES research and Congressional action is needed to open the federal spigot.

Second, there is NO evidence that ES research will lead to cures for major diseases.

There is not ONE disease which has been effectively treated with embryonic stem cells, not one.

Finally, "Every disease that the President mentioned which he hoped someday to treat with embryonic stem cells - there already is evidence that adult stem cells have already helped patients with those diseases," said Dr. David Prentice of the Family Research Council."

Patients with Multiple Sclerosis treated with their own adult cells have gone five years without symptoms," he said. "Thirteen patients with Type I Diabetes have become insulin free after their own adult stem cells were transplanted." Six patients with spinal cord injuries have improved functioning after an adult stem cell transplant. They have feeling in legs, and able to walk with braces.

One patient with Parkinson's Disease had the disease significantly reduced for five years reports a new study. More than 100 patients with damaged hearts, had their own stem cells injected. They can now walk and are no longer in bed.

More than 70 diseases have been successfully treated with adult stem cells. The question which must be asked of the Obama Administration is this: "Why aren't the billions being invested in clinical trials of these proven strategies, rather than in embryonic stem cells?"

In fact, the inventor of embryonic stem (ES) cell research, Dr. James Thomson, told The New York Times that he had ethical concerns about embryonic research from the outset. "If human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough." A human embryo is killed to extract a stem cell for research.

Read it all here.

Sunday, August 3, 2008

Some Stem Cell Lines Off Limits

Stanford University is to tell its researchers that around one-quarter of the human embryonic stem-cell lines eligible for US government funding are now off-limits because of ethics concerns.

The institute, in Palo Alto, California, is concerned that some of the women who donated the embryos for these stem-cell lines did not give informed consent for the lines to be used in research. Johns Hopkins University in Baltimore, Maryland, has decided to reconsider lines individually as researchers express an interest in using them.

The concerns follow an analysis by bioethicist Robert Streiffer of the University of Wisconsin, Madison, who obtained copies of the informed consent forms given to donors of the 21 lines that have been approved for federal research funding by the US National Institutes of Health (NIH). Streiffer compared these forms with guidelines set by the US National Academy of Sciences (NAS). None of the forms met the guidelines exactly, he concluded, and some deviated egregiously (R. Streiffer Hastings Cent. Rep. 38, 40–47; 2008).

Now, ethics oversight committees at universities across the United States are questioning which lines should be permissible for research — and hoping that another agency, such as the NIH or a state government, will make the decision for them.

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