Big questions stem from research

A ruling delays a threat to embryonic stem cell projects and controversy deters donors, despite surveys showing most Americans acknowledge the primacy of a sick child over a tiny ball of cells.

War of the words

Last month, scientists exhaled. A federal court postponed an order from a lower court judge, which had banned the use of public funds for embryonic stem cell research. Twenty-two American stem cells projects that depended on receiving cheques in September might otherwise have been suspended or halted.

The standoff goes back to 1996, when Congress first attached some flashpoint language to annual bills that authorise medical spending. The key words, known as the Dickey-Wicker Amendment, prohibit federal funding for “research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death”.

Both the Bush and Obama administrations have applied a narrow interpretation of Dickey-Wicker, arguing that researchers are merely using (“deriving”) cells from embryos that have already been destroyed. Imagine, by analogy, drilling for oil. First the oil is extracted from the ground, then subsequently sent to a refinery to be processed into petroleum for cars. Suppose the government were not allowed to pay for making a hole in the earth, but could subsidise refining activities. (article continues below)

In August, Judge Royce Lamberth ruled that previous interpretations for harvesting embryonic cells constituted a distinction without a difference. In other words, the hypothetical refinery and hole in the earth should be part of one integrated process. “It was a misinterpretation of the law, and simply isn’t how science works,” says Michael Werner, a partner at Holland & Knight, a law firm based in Washington DC. “The setback creates a cloud over the field and puts investment on hold. The longer the delay, the harder to make up for lost time,” he adds.

Josephine Johnston, a research scholar at the Hastings Center, outlines two alternatives: either Congress could “tweak” the Dickey-Wicker language, which it passes each year, or it could enact new, freestanding legislation to remove or modify the provision. Although it did just that in 2005 and again in 2007, President Bush vetoed those efforts.

Now, public opinion polls, bipartisan political support, and a more liberal administration all suggest that a third attempt might fly.

A cloudy investment

The American biomedical system offers a robust, peer-reviewed model for basic research. Since the initial return on investment for such research is generally not sufficient to attract private investment, the government provides seed money, with scientific competition ensuring that the most promising ideas prevail. If those ideas lead toward a therapeutic product, private funding steps in. No one, however, can accurately measure the split between private and public stem cell investment. “Many private donors choose to be anonymous,” Johnston points out, and companies rarely detail their research budgets.

The ongoing cultural/political controversy muddies the climate. “Many large pharmaceutical firms hesitate to commit resources, because of the bad name,” says Timothy Kamp, co-director of the Stem Cell and Regenerative Medicine Center at the University of Wisconsin Medical School. “Politics is driving research more than scientific rationale.”

Since adult stem cells are less controversial, why do scientists not follow that route? There are reasons. Only embryonic stem cells are ’pluripotent’, meaning they can become any type of tissue; furthermore, embryonic cells can easily be grown in culture, whereas adult cells are more challenging to extract. One consequence of casting a pall is that “capital markets and Wall Street don’t always distinguish between embryonic and adult cells, so if one area takes a hit, the other is also affected,” Werner says.

Only one American firm, Geron, is conducting a clinical trial, specifically on spinal cord injuries. Eventually, other potential therapies include type one diabetes and Parkinson’s, says Sean Tipton of the American Society for Reproductive Medicine. He notes that another “under recognised application” is using stem cell tissue for research models. For example, if scientists can isolate a cell line created from an embryo that expresses, say, cystic fibrosis, they may be able to use that line to test new treatments for the condition.

1000 fathers

A vocal minority insists that sacrosanct life begins with gestation. Most Americans do, however, distinguish between an eight-month old foetus and an egg not yet implanted, which contains about 100 cells at a three to five-day stage. Researchers need to use tissue from “a clump of cells, which is like a bowl of grapes, with no neural network, no advanced organisation, and is smaller than the tip of a pencil,” as Dr Kamp describes.

The crux comes down to moral status. A broad swathe of opinion polls resoundingly show that most Americans do see a stark difference between the moral status of a nine-year old child with type one diabetes, and a fertilised egg in a Petri dish. They are willing to grant that child higher status.

The Gallup organisation has conducted polls on the subject for years, asking respondents whether it is “morally wrong” for medical research to use stem cells from human embryos. In 2003, the public split 52/39 in favour of using the cells; numbers slightly diverged 64/30 by 2007; and as of 2010, they have settled at 59/32.

On October 7, 2010, a Harris Interactive/HealthDay poll showed almost 72% of adults surveyed saying scientists should be allowed to use embryonic stem cells, left over from in vitro fertilisation procedures, “to search for penitential treatments, or ways to prevent diseases such as Parkinson’s.” Interestingly, 58% of Republicans, 69% of Catholics and 58% of born-again Christians all support such research.

Regarding the recent ban, in a September 2010 poll conducted by the Coalition for the Advancement of Medical Research, 68% responded that Congress should do what it can to reinstate federal funding.

Media attention has highlighted the IVF breakthroughs of Robert Edwards, the winner of this year’s Nobel prize for medicine, who also worked with embryonic stems. Technologies like IVF, which initially frighten people, tend to gain acceptability once the benefits are seen as concrete. In that vein, “if the Geron spinal injury trial pans out and produces treatments, the stem cell debate basically goes away,” Tipton predicts. Victory has 1,000 fathers, but defeat is an orphan.