A colony of undifferentiated embryonic stem cells.

University of Wisconsin-Madison

Rick Weiss outlines a framework for a new federal policy that supports funding human embryonic stem cell research over on the CAP website. He writes that within the first week of taking office, President Obama “should call upon the Department of Health and Human Services and the National Institutes of Health to devise a plan for dismantling the current, overly restrictive Bush administration policy on the funding of human embryonic stem cell research.”

Within 90 days, he argues, NIH and HHS should have regulations in place for federal support of research involving ethically derived hESCs with these restrictions:

• The cells must have been derived from embryos produced for reproductive purposes.
• Those embryos must have been deemed in excess of medical need, were no longer being considered for transfer to a womb, and were slated for destruction.
• The embryos were freely donated by both of the adults who contributed genetic material to create them, as evidenced by proper written informed consent.
• No financial inducements were offered to donors, and the donors expressed through an informed consent process their understanding that any resulting cell lines will be used for research and not for the development of therapeutic benefits for the donors.
• All federally funded research on human embryonic stem cells must be conducted under the review of a Stem Cell Research Oversight committee that adheres to the standards put forth in the guidelines of either the National Academies or the International Society for Stem Cell Research.

Read the full outline for the policy recommendation here.

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What kinds of change can we expect the new president to make? In the short term, Obama can immediately repeal President Bush’s executive order restricting federal funds for embryonic stem cell research to those stem cell lines derived from embryos left over at fertility clinics at the exact time of his edict (9 P.M. on August 9, 2001). But Congress will have to appropriate money and achieving adequate government funding in these perilous economic times will probably be a tough sell for two reasons. The return on this investment through therapies and cures cannot be guaranteed. And convincing  politicians and the public that funding this research is ethically sound will bring out the special interest groups that for decades have stymied any embryo related research.

When Bush effectively pushed the research into the private sector, he argued that he wasn’t against claimed to be against science, just concerned about “crossing any moral boundaries.” His comments were really about the elephant in the room:  the abortion debate masquerading as a discussion about the ethics of embryonic stem cell research.

Presidents since Richard Nixon have had to deal with the far-reaching ramifications of Roe v. Wade (1973), especially the basic flashpoint: When does life begin? The justices categorically refused to answer the question until a time when scientists have a more complete understanding of human development. Although they rejected the idea of a legal or scientific conclusion, they noted that for some theologies and philosophies, the answer is more definitive. So opponents of abortion have relentlessly tried to enshrine the idea that life begins at conception and, therefore, an embryo should have all the rights bestowed on any human being.  As a result of their efforts, religious dogma, and pumped up fears about what “brave new world” results could stem from scientific advances, there are significant historical precedents for restricting federal funding for embryonic research going back to the limitations on  in vitro fertilization (IVF) in the late ‘70s that forced the research overseas.

Make no mistake. This has not been a strictly Republican versus Democratic argument. In late1994, President Clinton rejected the NIH Human Embryo Research Panel’s recommendation that federal funds be used for creating embryos to study different diseases and human development. Congress went even further, banning the use of federal funds for any experiment in which a human embryo is destroyed or physically harmed for research purposes. Known as the Dickey-Wicker Amendment (1995), the ban passed as a rider attached to the appropriations bill for the Department of Health and Human Services. And Congress has actively renewed that ban each year since its inception.
Such was the state of affairs when, in 1998, using-by necessity-private funds, James Thomson of the University of Wisconsin successfully created the first human embryonic stem cell lines. After the publication of the historic research, NIH director Harold Varmus said he would draft guidelines regulating the use of embryonic cells. He testified at a Senate hearing that “This research has the potential to revolutionize the practice of medicine.”  Again the Dickey-Wicker Amendment stood squarely in the way, . according to Harriet Rabb, the top lawyer at the Department of Health and Human Services.

Once we questioned the ethics of mixing an egg and sperm in a petri dish to form an embryo and alleviate infertility. Today in vitro fertilization is readily accepted.  Still the mystique of the embryo remains and scientists remain unable to procure federal funding to work with microscopic balls of cells, invisible to the human eye, in order  to study different diseases and safely develop drug therapies . The power of embryonic stem cells to mitigate human suffering is yet to be unlocked?

There are no quick fixes to finding cures for 100 million Americans who suffer from devastating diseases -like Parkinson’s, Alzheimer’s Stroke, heart disease cancer, macular degeneration-the list goes on.

A repeal of that 2001 order is a welcome first step. The next important hurdle is educating the public and politicians. Clearing up misinformation and misconceptions -especially in the halls of Congress- is vital if science is to move forward. Real change, especially in healthcare, means teaching the people and their political representatives what embryonic stem cell research is about. Real change means revoking the Dickey-Wicker Amendment and articulating a meaningful policy to end the rhetoric that has demonized the issues involved in stem cell research.

By Brian Vastag, Special to The Washington Post | Tuesday, September 2, 2008; HE01

A vast human experiment is afoot. And no one is taking good notes.

Fueled by demand from desperate patients, dozens of companies around the globe are peddling stem cell injections for $15,000 to $50,000 and more. Based merely on the claims made by these companies, at least a few thousand patients from the United States have paid for stem cells overseas.

Patients dart across the border to Mexico or jet to the Caribbean, India, China and elsewhere for injections of stem cells from embryos, fetuses, umbilical cords and the patients’ own fat, blood and bone marrow. These shots would be illegal in the United States, where the Food and Drug Administration has yet to approve any such treatments.

Online ads promoting this therapy target people with spinal injuries, Lou Gehrig’s disease, heart failure and other tough-to-treat conditions, promising improvements and even cures.

“Diseases and conditions such as diabetes, multiple sclerosis, cerebral palsy . . . are all being successfully treated,” claims one site, returninghope.com. When asked to support the claims, Brian Dardzinksi, who operates the site from Bangkok and Hong Kong, provided one medical journal article describing the treatment of incontinence with muscle stem cells, an Austrian study now under investigation for possible ethics problems.

Dardzinski has no medical background and acts as a broker, matching U.S. patients with stem cell providers overseas. “Several hundred patient inquiries a month is not uncommon,” he said. “I’m just a businessman trying to do some good.”

Because the companies operate offshore, they are not subject to the FDA’s strict safety regulations. And because they collect little, if any, data, it’s impossible to assess whether their treatments work.

The business is drawing sharp concern from academic researchers.

“It’s almost evil, because it preys on the fears and the hopes of the most vulnerable people,” said Evan Snyder, a stem cell researcher at the Burnham Institute in La Jolla, Calif.

“There are a lot of scams out there,” said Wise Young, a spinal cord injury researcher at Rutgers, the state university of New Jersey. “People should be very careful.”

Barbara Hanson and Jeannine Richardson discovered the risks after a trip to a stem cell clinic in Tijuana, Mexico, last year.

The women, who met in an online support forum for people with chronic obstructive pulmonary disease, learned of a company called Stem Cell Biotherapy, which has offices in Agoura Hills, Calif., and advertised online. Hanson says one of the company’s doctors, Burton Feinerman, told her he had taken 10 COPD patients to Tijuana and all had improved enough to discard their portable oxygen tanks.

Because Hanson and Richardson helped recruit patients for Stem Cell Biotherapy from the online forum, the company dropped its price from $25,000 to about $17,000 for each of them, the women said. Hanson borrowed the money from her mother, and Richardson took cash advances on her credit cards.

But a week after traveling to Tijuana at Feinerman’s direction and getting injections, both women spiked fevers and developed flulike symptoms. Richardson was hospitalized for eight days after returning home to New Hampshire.

“It was like the worst pneumonia I’d ever had,” said Hanson, who lives near Denver. “It was so bad I honestly thought I was going to die.” Hanson believes the injections made her and Richardson sick; Richardson isn’t sure.

Feinerman did not return calls asking for comment. But Casey Navabi, Stem Cell Biotherapy’s chief executive, said Hanson and Richardson grew embittered after he decided not to use the women’s printing business. (Hanson says that the company still owes her money.)

“They wanted our business, and we didn’t give it to them,” he said. “Now they’re putting out a lot of negative comments about us. I view it as extortion.”

About 25 patients from the forum eventually visited the Tijuana clinic, Hanson says, with Stem Cell Biotherapy acting as the broker. “None of us has gotten off of oxygen,” Hanson said. She and Richardson say the injections might have slowed the course of their illnesses (they both rely on bottled oxygen less than before), but Hanson is furious. “I can’t say I didn’t get any [benefit],” she said. “But I sure didn’t get my money’s worth, and I sure didn’t get what I was promised.”
Patient Complaints

That refrain is common among those who pay for stem cells. Nine years ago, Fia Richmond of Santa Barbara, Calif., took her brain-damaged 3-year-old son, Palmer, to a clinic in the Bahamas run by William C. Rader, a psychiatrist from Malibu, Calif.

Palmer was unable to walk or talk, and Richmond said she decided to take a chance on Rader, who offered to inject Palmer with fetal stem cells for $25,000, telling her the cells might help her son.

When the pair returned home, Palmer began having seizures, Richmond said.

Rader disputes this. “The only communications from Mrs. Richmond [post-treatment] . . . were all very positive,” he wrote in an e-mail.

Now 12, Palmer is still unable to walk or talk, his mother said.

“It was devastating to come back and for my son to not do well, to have a lot of seizures where he hadn’t had seizures for years,” Richmond said. She said she “had taken a step too far with my son being a guinea pig.”

Another mother whose developmentally disabled child received Rader’s injections, Dianne Caprio of Monterey, Calif., said: “There was no follow-up at all. He never called us. He did nothing but collect money.” Caprio said her daughter Courtney received two rounds of injections, one in the Bahamas and one at Rader’s clinic in the Dominican Republic. “Initially we thought we saw some improvements, but nothing really substantial,” Caprio said. “Looking back, it might have been wishful thinking. I think he’s just preying on desperate people.” Rader provided notes that show the Caprio family originally thought they saw some initial improvement in Courtney. The notes detail several phone calls from Rader’s office to the family to arrange more cell injections.

The government of the Bahamas closed Rader’s clinic in 2000 after a critical television report. He moved to the Dominican Republic, where he meets and injects patients on weekends. In a phone interview, Rader said he gets his product from a lab in the republic of Georgia, where technicians extract stem cells from the brains and livers of aborted fetuses. Rader claimed in an interview to have injected more than 1,000 people with such cells since 1997.

Rader recruits patients from his Malibu office and via the Web site of his company, Medra Inc. Earlier in his career, he operated eating disorder clinics and reported medical news for a television station in Los Angeles.

During four hours of phone interviews, Rader described himself as a misunderstood pioneer. He said that he has tried to educate several physicians about the benefits of stem cell injections but that they refuse to accept that he has helped patients. Rader said his treatments have reversed Down syndrome, stopped intractable seizures in children, cured AIDS in at least two patients and boosted the immune systems of cancer patients undergoing chemotherapy. “If I’m telling the truth, it will change the face of medicine,” he said.

Rader is not interested in talking to the FDA about conducting fully documented clinical studies. He said that if he opens his work to scrutiny, the FDA and the pharmaceutical industry will squelch him. “I trust no one,” he said.
Short on Science?

Quackwatch, a Web site devoted to outing doctors practicing unsafe and unproven medicine, highlighted Rader and other overseas stem cell providers in 2006. “Their theories and methods are simplistic; their treatments may have adverse effects; they offer no credible outcome data; and their promises go far beyond what is now possible,” wrote the site’s founder, Stephen Barrett.

Rader dismissed the criticism, questioning Barrett’s credibility. He and other stem cell providers point to testimonials, posting videos and blogs from patients who say they’ve improved. Research from Harvard University and elsewhere on patient decision making shows this to be smart marketing: Patients pay far more attention to stories than to statistics.

But when determining whether a medical intervention really works, “testimonials mean absolutely nothing,” said Snyder, the Burnham Institute researcher. “They’re worthless.”

One reason: They don’t allow for the possibility of spontaneous recovery. A 2007 study in the journal Spinal Cord found that “almost all” spinal cord injury patients spontaneously regain some feeling and movement.

And then there’s the placebo effect: If the brain thinks it’s getting a treatment, the body often feels better. Medical journals are littered with descriptions of drugs and other interventions that displayed initial promise only to wilt under the rigors of placebo-controlled studies, where some patients get the intervention and some get a sugar pill or other non-treatment.

Clinical trials in Parkinson’s disease offer perhaps the most stunning demonstration of the placebo effect. In the trials, doctors transplanted fetal cells into the brains of some Parkinson’s patients, hoping the cells would make the brain messenger dopamine, which diminishes with the disease. Other patients got holes drilled in their heads but no cells. Over a year, both groups showed some improvements, according to a 2004 report in the Archives of General Psychiatry. Further, of the patients who did not receive the cells, those who thought they had fared better than those who thought they had not.

In other words, believing makes the “medicine” work.

Likewise, patients who travel for stem cells are strongly motivated to feel better, said Jamie Heywood, founder of the online support network PatientsLikeMe. “If you spend so much money and sacrifice so much to do something, it’s difficult to believe it didn’t help,” said Heywood, who tracks several offshore stem cell providers.
More Study Needed

The disease that most interests Heywood is amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig’s disease.

In 1999, after doctors diagnosed his brother Stephen with the fatal disease, Heywood organized the first human stem cell trial in the country for ALS. After Heywood won FDA approval for the safety study, his brother and two other ALS patients received spinal injections of stem cells from their own blood at Thomas Jefferson University Hospital in Philadelphia. None of the patients improved. Stephen died in 2006.

Since then, about 20 ALS patients from PatientsLikeMe have received offshore stem cell injections, Heywood said. None has shown lasting improvements, according to patient reports and surveys on the site. “The evidence to date is that the simple ‘put them in and they will heal you’ model isn’t going to work” against ALS, Heywood said.

The only way to know if the injections help patients, academics say, is to subject them to fully documented, placebo-controlled studies. That’s why the 2,500-member International Society for Stem Cell Research (ISSCR) is developing guidelines to encourage overseas stem cell companies to collect and share data. A draft of the guidelines says the society “condemns” injections of stem cells outside rigorous studies.

At the same time, a few academics voice regret about overplaying the promise of stem cells. Reams of evidence suggest various types of stem cells do possess healing properties, but figuring out how to harness that power will take years of careful human trials, they say. “There’s been extremely high levels of hope and hype” surrounding stem cells, said Laurie Zoloth, a bioethicist at Northwestern University.

“I take as much blame for creating this aura that stem cells can do anything as anyone else,” Snyder said. He and other academics offer a rule of thumb: Avoid companies asking for money.

“There’s a standard in clinical research: Patients don’t pay for it,” said George Daley, president of ISSCR and a researcher at the Harvard Stem Cell Institute. Snyder said this rule might screen out “some legitimate operations,” but it will also weed out the scams. Legitimate clinical trials are usually funded by the government or by private companies, he said.

“At the beginning you think, ‘I’m going to be cured for life, I’m going to get better every day,’ ” said Hanson, the lung patient who traveled to Tijuana. “Well, that isn’t true.”

Brian Vastag is a freelance science writer in Washington. Comments:health@washpost.com.

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By Philip Pullella |  Fri Dec 12, 2008 8:56am EST

VATICAN CITY (Reuters) – A Vatican bioethics document Friday condemned artificial fertilization and other techniques used by many couples and also said human cloning, “designer babies” and embryonic stem-cell research were immoral.

The long awaited document from the Vatican’s doctrinal body marked a big step by the Vatican into the brave new world of biotechnology, an area in which governments around the world are struggling to formulate legislation.

The document also condemned new drugs that block pregnancy from taking hold, such as the so-called “morning-after pill” and the drug RU-486, which blocks the action of hormones needed to keep a fertilized egg implanted in the uterus.

These drugs, as well as the IUD (intrauterine device), which has been in use for decades, were deemed to fall “within the sin of abortion” and are gravely immoral.

“Dignitas Personae (dignity of a person), an Instruction of Certain Bioethical Questions,” is an attempt to bring the Church up to date with recent advances in science and medicine.

The document, the most authoritative of its kind from the Vatican in 20 years, said human life deserved respect “from the very first stages of its existence (and) can never be reduced merely to a group of cells.”
“The human embryo has, therefore, from the very beginning, the dignity proper to a person,” said the Congregation of the Doctrine of the Faith’s document, approved by Pope Benedict who headed the same office before his election in 2005.

It said most forms of artificial fertilization “are to be excluded” because “they substitute for the conjugal act … which alone is truly worthy of responsible procreation.”

Condemning in-vitro fertilization, it said the techniques “proceed as if the human embryo were simply a mass of cells to be used, selected and discarded.”

The highly technical document said only adult stem cell research was moral because embryonic stem cell research involved the destruction of embryos. It also condemned freezing embryos.

Governments Grapple

Governments in countries including the United States are grappling with legislation on embryonic stem cell research.

The outgoing administration of U.S. President George W. Bush has placed restrictions on federal funds for embryonic stem cell research but President-elect Barack Obama has promised to lift them.

The 35-page document also attacked the concept of “designer babies,” either by pre-implantation diagnosis during in vitro fertilization where embryos are selected before being transferred to a woman’s womb, or in attempts at human cloning in the future.

It branded as “shameful and utterly reprehensible” diagnosis aimed at ensuring that only embryos free from defects or having the desired sex or other particular qualities are transferred into a woman’s womb.
It condemned the concept of human cloning “to satisfy certain specific desires, for example, control over human evolution, selection of human beings with superior qualities, pre-selection of the sex of a child to be born, production of a child who is the “copy” of another, or production of a child for a couple whose infertility cannot be treated in another way.”

Saying life was sacred from the moment of conception to the moment of natural death, the document also defended the Roman Catholic Church’s right to intervene on such matters.

“There are those who say that the moral teaching of the Church contains too many prohibitions. In reality, however, her teaching is based on the recognition and promotion of all the gifts which the Creator has bestowed on man: such as life, knowledge, freedom and love,” it said.

Stem-cell medicine takes a step forward

Ms. Castillo relaxes

IN THE hierarchy of transplant surgery, replacing a bronchus (the passage from the main windpipe, the trachea, into a lung) does not sound difficult compared with, say, plumbing in a new heart. In fact, until a few months ago, it had never been attempted. The reason was not that the surgery itself would be hard, but that the tissue in question, which is the first line of defence against the bacteria and viruses that come with every lungful of air, has a remarkably active immune response. So active, indeed, that if you transferred part of an airway from one person to another, the resulting immunological conflict would probably kill the recipient. Since a weak bronchus, though debilitating, is seldom life-threatening, transplant surgeons have left well-enough alone.

In a blaze of publicity this week, that changed. A paper in the Lancet, published by a team led by Paolo Macchiarini of the Hospital Clinic in Barcelona, described such an operation, carried out in June on a patient called Claudia Castillo, whose left bronchus had been damaged by tuberculosis. The reason for the publicity, though, was not that this was the first bronchial transplant, but rather that it involved some serious bioengineering using stem cells.

Stem cells exist to replenish the supply of other cells. When a stem cell divides, it sometimes produces daughters that are different from one another. One is another stem cell. The other is the first step on the path to a particular sort of tissue such as the lining of a windpipe. The idea behind stem-cell bioengineering is to use the recipient’s own stem cells to create an artificial organ that will be recognised as part of the body by the recipient’s immune system, and thus not rejected. And this, in the case of Ms Castillo’s new bronchus, is what Dr Macchiarini and his team have done.

To make an artificial organ requires two things. One is the right sort of cells. The other is a framework on which to grow those cells so that they take up the right shape. Previous projects of this sort, which have successfully created artificial skin and artificial bladders, have relied on synthetic frameworks. A windpipe, though, is a more complicated structure than skin or a bladder. The starting point for Ms Castillo’s transplant, therefore, was a piece of trachea removed from a dead donor.

The team stripped this of its cells (and thus of the antigens that provoke an immune response) by treating it with a special detergent. That left a trachea-shaped piece of cartilage. They then took samples of Ms Castillo’s other bronchus and also her bone marrow and grew them as cell cultures. The bronchial samples consisted mainly of what are known as epithelial cells, and with these it was just a question of multiplying their numbers. The bone marrow was the source of the stem cells that made the procedure newsworthy.

Most bone-marrow stem cells generate blood cells. A few, though, can produce chondrocytes, the cells that make cartilage. The team extracted these, cultured them and then used a special growth factor to persuade them to spin off chondrocytes.

Both epithelial cells and chondrocytes were applied liberally to the treated trachea and the result, when it had settled down into something that resembled a natural windpipe, was transplanted into Ms Castillo. She, as the photograph suggests, has now made a full recovery. And those who have been asking of stem-cell science, “Where’s the beef?”, have been served what is, at least, an appetiser.

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The U.S. Conference of Catholic Bishops, which held a semi-annual meeting this month in Baltimore, says lifting a ban on funding for stem cell research would alienate millions.

By Mimi Hall, USA TODAY
WASHINGTON — President-elect Barack Obama could reignite an emotional national debate over the promise and the perils of medical research using cells taken from human embryos.
The United States Conference of Catholic Bishops is warning that Obama will alienate millions, and abortion opponents are bracing for a fight. Medical researchers, meanwhile, are rejoicing at the prospect of freedom from a government policy they say has stymied efforts to develop life-saving treatments.

Like previous presidents, Obama is expected to issue a flurry of executive orders after he takes office Jan. 20. Some could reverse Bush administration policies; others could promote his own.

Ending a ban on government funding for research using embryonic stem cells would be among the most controversial.

“The question is, does the Bush policy get replaced with the law of the jungle” where scientists can create and clone human embryos for the sole purpose of studying their cells and then destroying them, asks Richard Doerflinger, the bishops conference’s associate director of the Secretariat for Pro-Life Activities. “We are very concerned about it as a moral issue.”

Samuel Casey of Advocates International, a Christian law firm that opposes abortion rights, says a change in the Bush policy “would give a green light to the kind of eugenic human experiments that people think of when they talk about cloning.”

Scientists say cells taken from human embryos offer the most promise of being used to develop therapies for Parkinson’s, diabetes and other diseases. Some scientists have found cells taken from adults also have lifesaving potential.

“Current policy has depressed the field” of research and caused an exodus of scientists from the United States to other countries where such research is flourishing, University of Iowa researcher Nicholas Zavazava says. But “we are a big country; we ought to be able to roll things back.”

States such as California have gone ahead and funded stem cell research on their own in the absence of federal money.

Obama’s campaign promised broad support for stem cell research. His website says he “believes we owe it to the American public to explore the potential of stem cells.”

After the election, John Podesta, chief of Obama’s transition team, said aides are reviewing a host of areas where Obama might act fast, including on federal funding for research using embryonic stem cells.

Controversy surrounding the research has simmered since 2001. That’s when President Bush imposed the funding ban during his first prime-time televised address to the nation. His decision, a month before the 9/11 attacks, was regarded at the time as likely to be one of the most important of his presidency.

Abortion opponents, Catholics and many political conservatives were elated. Others, including former first lady Nancy Reagan and California’s Republican governor, Arnold Schwarzenegger, support the research and have pushed for it ever since.

Twice during his presidency, Bush has vetoed bills passed by Congress that would have lifted restrictions on stem cell research.

If Obama issues an order reversing the ban, Congress will have to act again — and House Speaker Nancy Pelosi has suggested it will. A law on the books since 1996 bans funding of research that harms embryos and would prevent funding for research even on cells from embryos slated to be discarded by fertility clinics.

Opponents of the research have no recourse against an executive order from the White House aimed at releasing tens of millions of dollars. But they can do battle on Capitol Hill.

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