August 30, 2010

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Safety Issues of Concern as First Trials Using Embryonic Stem Cells Approach; Public Opposes Federal Funding
Part One of Three

By Dave Andrusko

Editor's note. Be sure to send your comments to daveandrusko@gmail.com. Thank you!

Last Friday I was racing to make sure every last change was properly made to the August/September issue of National Right to Life News before it went into the mail-stream. I mention that both because I want you to read Part Two which talks about that edition and because it meant I missed the results of a Rasmussen Reports survey done on the attitude of likely voters to using taxpayer money to fund embryonic stem cell research (ESCR).

Almost six in ten (57%) are opposed, saying "funding for such research should be left to the private sector," according to Rasmussen Reports. Only 55% of self-identified pro-choice voters supported government funding of stem cell research, while overwhelmingly (83%) pro-lifers opposed.

In a second I'll talk about a very skittish Washington Post story that ran today, headlined "First tests for [embryonic] stem cell therapy are near." But what makes the Rasmussen Reports survey of 1,000 likely voters even more revealing is that 54% do not think ESCR is morally wrong and "69% of voters believe it is at least somewhat likely that embryonic stem cell research has the potential to lead to cures to previously incurable diseases."

So even if a majority does not find ESCR morally unacceptable and an even larger majority has bought into the propaganda line that ESCR is a medical elixir, they STILL don't want the research federally funded. That voter resistance applies to ObamaCare as well. Wherever people are on abortion, they don't want the feds using everyone's money to undergird and expand it.

The Washington Post's story, written by Rob Stein, is a cautionary tale, wrapped in qualifications, inside a plea that please-don't-let-anything-go-wrong.

In "First tests for [embryonic] stem cell therapy are near," we learn from Rob Stein that ESCR supporters are quietly about to reach a "portentous landmark." Which is? "Scientists are poised to inject cells created from embryonic stem cells into some patients with a progressive form of blindness and others with devastating spinal cord injuries." For good measure, Stein adds, "That's a welcome step for researchers eager to move from the laboratory to the clinic and for patients hoping for cures."

That's pretty much the end of the uncritical hosannas.

The very next sentence cuts to the chase. "But beyond being loathsome to those with moral objections to any research using cells from human embryos, the tests are worrying many proponents: Some argue that the experiments are premature, others question whether they are ethical, and many fear that the trials risk disaster for the field if anything goes awry."

You read assurances that "We jumped through a lot of hoops to convince a lot of audiences," in the words of Thomas B. Okarma, president and chief executive of Geron Corp. of Menlo Park, California. According to Stein "after years of delay [Geron] received a green light in July from the FDA to study patients partially paralyzed by spinal cord injuries."

There are any number of safety concerns surrounding the use of embryonic stem cells, "most prominently" that "the cells could cause tumors." These fears have been ratcheted up both by the immediate context and the nature of the trials.

As we discussed several times last week, Judge Royce C. Lamberth issued a temporary injunction to prevent the Obama Administration from continuing to fund research that requires the destruction of human embryos. Lamberth, Chief Judge of the U.S. District Court for the District of Columbia, wrote in his August 23 order that it appeared that the Administration's decision to fund embryonic stem cell research was inconsistent with a federal law known as the Dickey-Wicker Amendment. The ruling was preliminary, but the judge ordered the funding to cease while the case progresses.

ESCR proponents worried that if patients in the trial do not improve--let alone if they are injured!-- "that could be a devastating blow just as scientists are scrambling for funding from private foundations and benefactors."

But also it's the nature of this first trial. It "will involve 10 [patients] partially paralyzed by a spinal cord injury in the previous one to two weeks." The trial is supposed to show primarily that using embryonic stem cells is safe, "but researchers will look for signs that the therapy restores sensation or enables patients to regain movement."

However, spinal cord injuries are very tricky, according to Stein. "Patients can often improve on their own, for example, which will make it difficult to evaluate whether the cells had any effect," he wrote. But beyond safety issues, the most revealing part of the story is the ethical reservations raised.

Stein quotes Stanford University bioethicist David Magnus, who told him, "Think of it this way: You are a healthy young person, you have had a terrible accident, you wake up in the hospital and are told that you will never walk again, that you will paralyzed for the rest of your life." In an email Magnus added, "Then you are told that there is a Phase I stem cell clinical trial that you are eligible for, but a decision needs to be made quickly. It would be hard to imagine that would be the optimal scenario from the point of view of informed consent."

Meanwhile officials at Advanced Cell Technology in California "are hoping for the FDA's go-ahead to start possibly even sooner injecting 50,000 to 200,000 cells into the eyes of 12 patients suffering from Stargardt's macular dystrophy." You can read more about this at http://www.washingtonpost.com/wp-dyn/content/article/2010/08/29/AR2010082903888.html.

Stein's very useful story ends with the people behind the two trials again issuing loads of assurances why everything and everybody is safe. But the final paragraph speaks volumes about the dangers.

"If human embryonic stem cells are going to be useful in treating humans, someone has to be the first one to try it," said Hank Greely, a Stanford lawyer and bioethicist. "They need to have their fingers crossed and hold their lucky rabbit's foot and be really careful in their preparations, because before you try something in humans you never know what's going to happen."

Part Two
Part Three

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