Harvesting of embryonic stem cell
In a move the Food and Drug Administration denies has anything to do with the new presidency, the federal agency granted permission this week to begin the country’s first embryonic stem cell treatments on human subjects.
The FDA approved an application from Geron Corporation, based in Menlo Park, Calif., to inject stem cells derived from human embryos into 10 people paralyzed from the chest down by spinal cord injuries.
“This marks the beginning of what is potentially a new chapter in medical therapeutics,” said the company’s president, Tom Okarma, in a statement, “one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells.”
Stem cells can replicate and develop into other body cells and are therefore capable, many scientists hope, of treating disease and injury by replacing damaged tissue. Research on stem cells derived from human embryos, however, has remained controversial because extracting the stem cells requires destruction of the embryos.
Former President George W. Bush, for example, signed an executive order in 2001 restricting federally-funded research to adult stem cells, animal stem cells and only those embryonic stem cells that originate from already derived cell lines and do not require the deaths of additional embryos.
Barack Obama’s presidential campaign, on the other hand, promised the group Science Debate 2008 last summer that he would overturn Bush’s policy.
“I strongly support expanding research on stem cells,” reads an Obama statement reported by ABC News. “As president, I will lift the current administration’s ban on federal funding of research on embryonic stem cell lines.”
And even though the FDA’s first approval for embryonic stem cell research in human trials reportedly came by telephone the day after Obama’s inauguration, the organization told WND it’s merely a coincidence.
Karen Riley, a spokeswoman at the FDA, told WND that approval does not reflect any Obama administration reversal of President Bush’s executive order, since the Geron application uses stem cells from lines already established before Bush’s moratorium on creating new lines.
“Politics did not enter into the decision,” Riley insisted. “The timing of the decision was driven by the date Geron submitted a response to the prior FDA request for additional information regarding the proposed trial and on statutory time frames for the review of that request.”
The difference between the two presidents’ opinions is reflected in a society divided over weighing the potential benefits of the experiments against the ethics of human life.
In recent interviews, House Speaker Nancy Pelosi, D-Calif., expressed enthusiasm over the potential for discovery should Obama lift the Bush administration-imposed restrictions.
“Science is a gift from God to all of us,” Pelosi recently told the Stanford University News Service. “Scientists have been given an almost biblical power to cure advances in embryonic stem cell research.”
“A repeal of the ban is critical so that we may take advantage of the opportunity to save lives, find cures and give hope to those who are suffering,” Pelosi said. “It is an opportunity that we cannot miss.”
Steven Ertelt of LifeNews.com, however, reports in a recent article that the potential for cures may not justify the means of finding them.
“Embryonic stem cell research has never cured or helped any patients to this point,” writes Ertelt. “Only the use of adult stem cells and treatments derived from them have cured or reduced the effects of any diseases or conditions afflicting patients.”
Ertelt notes that many in the pro-life movement oppose experimentation with human embryonic stem cells, labeling the practice “destruction of more human lives to advance science.”
According to New Scientist, the FDA has withheld permission for experimentation on humans for years over concerns that the stem cell injections could trigger immunity rejection, cause nerve damage or form cancerous tumors, but that Geron’s 20,000-page application was able to finally break through and alleviate those worries.
The Geron trial will involve injections in the spine at the point of injury and a low dose of anti-rejection drugs for about two months. After that, Okarma told the AP, the medications shouldn’t be needed.
Scientists will then observe the patients for 15 years. The goal will be do demonstrate that the treatments do not trigger prolonged rejection or cancerous growth, though researchers hope to also see the cells help repair a sheath around the nerves called myelin, restoring the injured spine’s ability to carry nerve signals.
The goal is “not to make somebody … get up and dance the next day,” Okarma said, but to observe some recovery of function and movement in the lower body.
Robert Lanza of Advanced Cell Technology in Worcester, Mass., which plans to seek FDA approval for experiments using embryonic stem cells to treat blindness, told the Washington Post that a great deal is riding on Geron’s study.
“The field desperately needs a big clinical success,” Lanza said. “It’s very important to show the naysayers that this is very real and hopefully it will start helping people.”
On the flip side, Lanza expressed nervousness over the stakes of the study.
“When you’re the first, the whole world’s eyes are on you,” he said. “We all have our fingers crossed that everything goes smoothly and nothing happens.”
John Sinden, chief scientist at the British company ReNeuron, which this week received clearance to begin human trials injecting embryonic stem cells into the brains of stroke patients, sees the almost simultaneous approval on both sides of the Atlantic as fortuitous.
“It’s great news all round,” he told New Scientist. “It’s like London buses, with two arriving together.”
Sinden also doubts on any role Obama’s election may have played in the sudden loosening of government restrictions on research, but did suggest that the new president may influence the FDA in the coming months.
“The FDA will change,” Sinden said, “and the new management will be very much aligned with Obama’s views on stem cells.”
Obama’s plans for embryonic stem cell research aren’t yet certain. Though the president is in favor of freeing government funding, he told CNN last week he’d rather invite Congress to act than issue an executive order.
“I like the idea of the American people’s representatives expressing their views on an issue like this,” Obama said.
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