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CGS issues biotech policy brief for President Obama

Posted by Jesse Reynolds on January 20th, 2009

CGS has released an eight-page brief of biotechnology policy recommendations for the new presidential administration of Barack Obama.

"Responsible Federal Oversight of the New Human Biotechnologies: Opportunities for the New Administration" [PDF] includes

1) Immediate opportunities for policy action;

2) How the Obama administration can reshape the public discussion of human about human biotechnologies to reflect widely shared values; and

3) Human biotech issues that the administration will likely face over the next four years.

A new tune for CAMR? Hopefully so.

Posted by Jesse Reynolds on January 16th, 2009

We here at CGS often call for depolarization of the discourse around human embryonic stem cell research (hESCR) so that concerns unrelated to the status of embryos can be addressed. Yet even when there have been openings for cooling the stem cell wars, some have tried to keep them alive. In the past week, the Coalition for the Advancement of Medical Research (CAMR), the leading national organization for greater hESCR funding, seems to be trying to do both.

Now with President-elect Obama poised to remove his predecessor's restrictions on the federal funding of hESCR, CAMR may be making tentative moves in a new direction. Its president recently made a welcome call for tempering expectations:

A new Obama policy relaxing controls on ES cells should help foster more realistic attitudes about the promise of stem cell therapies, says Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research in Washington, D.C. At a recent meeting, she said, "There's been a shift in understanding" on the part of people in the patient community--they are less inclined to blame all obstacles on the restrictions imposed by Bush and recognize that in any case "the field has an awfully long way to go."

Rick’s remarks can be read as acknowledging the exaggerated claims that have marred stem cell advocacy. However, CAMR has been a key player in fostering less realistic attitudes about the promise of stem cell therapies, both in the past and presently.

It has regularly exaggerated their near-term potential, sponsoring biased surveys (1, 2), and backing many of the pro-hESCR legislative campaigns (1, 2). It was a key partner in opposing even modest reforms at California's stem cell research program, and its then-president Daniel Perry complained that our well-documented report [PDF] on the first year of that program "poisons the atmosphere" because it was "unfair." CAMR vehemently opposed a compromise on cloning-based stem cell research, and downplayed the technical – and thus policy – relationship between this technique and reproductive cloning .

Furthermore, in its 2004 public sign-on letter to President George W. Bush, Perry claimed that "In the past three years since the policy was announced, more than 4 million Americans have died from diseases that embryonic stem cell research has the potential to help." My back-of-the-envelope calculations show that he is claiming that the majority of deaths in the US are from such diseases. I remain skeptical.

Nevertheless, I would welcome CAMR's new tune, if it came from both sides of its mouth. Unfortunately, its just-released white paper [PDF] for the incoming presidential administration is basically the same old song and dance. Here are four of its most overt exaggerations and misrepresentations:

First, the paper obfuscates the various forms of stem cell research, by implying that a recent major development using cellular reprogramming was done with hESCR. In only its third paragraph, the white paper states:

With the knowledge gained in the past decade, stem cell research is more promising than ever. Researchers at U.S. universities, medical centers, and in industry are moving toward safer and speedier drug development and devising hES cell-based treatments. These efforts may move the study of disease from people to Petri dishes. They are growing the cell types that are damaged or die in various forms of disease, such as Lou Gehrig’s disease (amyotrophic lateral sclerosis) and using them for drug discovery.

Second, CAMR plays the race card by asserting that Bush's funding limitations are shortchanging minorities:

Federal restrictions on hES cell lines are a social justice issue. The Federal lines do not represent the diversity in our society. If hES cells have the potential to change the future of medicine, our Federal government has imposed restrictions that might lead to minorities being left out of that future. The same Federal government that insists on enrolling diverse patients in any clinical trial to ensure that new medicines work in everyone, insists that researchers do all work on hES cells that are from a small number of sources.

There is an argument that the twenty or so federally-approved human embryonic stem cell lines do not contain enough genetic diversity to represent the world's population. But there is much more genetic diversity among people of the same racial or ethnic group than there is between such groups. So while some people may be underserved by the current lines, there is not much reason to believe that they will be significantly correlated with race.

Third, CAMR goes on to misrepresent cloning-based stem cell research (a.k.a. SCNT):

“SCNT is the only known procedure for completely and normally reprogramming a cell,” says John Gearhart, University of Pennsylvania. Because SCNT is more efficient than iPS cell technology for reprogramming cells, and can be done without inserting new genes, continued studies of SCNT could help scientists find the linchpin to make reprogramming factors more efficient and effective. SCNT will also provide fundamental insights into how an egg reprograms that will teach a great deal about basic biology.

Calling cloning-based stem cell research a "known procedure" that “normally reprogram[s]” a cell in an “efficient” way is a stretch, considering that the technique has failed to produce human stem cells despite almost a decade of work. Meanwhile, cellular reprogramming is producing disease-specific pluripotent lines after just a couple years.

Finally, the tone of the document is captured by a highlighted pull quote from Hans Kierstead: "10 years ago, human embryonic stem cells offered hope. Today they offer solutions." I am unsure to what solutions he refers, considering that the first clinical trials for human embryonic stem cells, planned by him and his biotech patron Geron, have been promised "next year" for at least five years ago (1, 2). Nevertheless, the paper cites these impending trials at least four times.

Granted, CAMR's new white paper emphasizes hESCR's potential for better drug testing and "disease in a dish" studies over cellular replacement. But coming on the heels of promise after promise of “personal repair kits.” Keep your eye on the stem cell ball, indeed (1, 2).

It’s not clear how much CAMR is committed to the more responsible tone its new president has adopted, and the “more realistic attitudes about the promise of stem cell therapies” she recommends. Let’s hope the hyperbole of the white paper represents a relapse rather than a road map.

Previously on Biopolitical Times:

Synthetic biology hackers announce "self-imposed moratorium"

Posted by Marcy Darnovsky on January 14th, 2009

An article in the current issue of New Scientist opens with the story of a woman in Cambridge, Massachusetts "who works as a synthetic biologist for a biotech company by day" and in her spare time at home, in a small closet, "recently concocted vials of an entirely new genetically modified organism."

According to "Rise of the garage genome hackers," scientists including George Church - the Harvard geneticist and biotech / synthetic biology entrepreneur - are encouraging these sorts of do-it-yourself adventures. So is the group DIYbio, which describes itself as an "Institution for the Amateur," along with the science fiction website, which is sponsoring a contest for "mad scientists with homebrew closet labs, grassroots geneticists, and garage genome hackers."

New Scientist has the sense to ask whether this is such a good idea. Richard Ebright, a biochemist at Rutgers University in Piscataway, New Jersey, notes:

Without any oversight from an institution, colleagues or peers, the probability that a cataclysmic entity might be constructed by someone unaware of known cautions is significant.
But not to worry. DIYbio says that it has called for "a self-imposed moratorium" on homebrew synthetic biology experiments, "until researchers can show that what they are doing is safe."

Jim Thomas of ETC Group, which has been tracking developments in synthetic biology, is not reassured. His comment:
I nominate this as the lamest piece of voluntary governance so far this year.

Looking Ahead to 2009

Posted by Jesse Reynolds on January 12th, 2009

In the final part of our trilogy of new year's posts (1, 2), the Biopolitical Times bloggers make some predictions for 2009.

Direct-to-Consumer (DTC) genetic testing companies should brace themselves for the inevitable media backlash after a year of adoring publicity. More reporters are likely to pick up the idea that "genetic information today is essentially meaningless at the individual level." Combine that with increasing concerns about genetic privacy in "a world in which our DNA can be screened by anybody at anytime," and with likely complaints about conspicuous consumption during a depression, and there could be some bad publicity ahead. They'll probably weather the storm.

There's little doubt about who will be Biologist of the Year: Charles Darwin. His 200th birthday is on February 12th, followed on November 24th by the 150th anniversary of the publication of The Origin of Species. The British Natural History Museum is in the thick of its Darwin 200 celebrations, and lists events all year all over Britain. Darwin Day Celebration has more of a North American focus. There's talk of a movie and maybe two.

In the realm of wild, uninformed speculation, 2009 may be the year that scientists agree (again) on what a gene is. The word "gene" (as, essentially, "unit of heredity") is 100 years old this year, but late 20th-century definitions have been increasingly hobbled by anomalies. The ENCODE Project showed in 2007 that "non-gene" sequences have vital functions, leading some to ask, "What is a gene, post-ENCODE?" and others to say that the gene is having an "identity crisis." Even if that gets resolved, however, we probably won't have a definitive answer this year to the grand old question: how many genes do humans have?

Although criticism is mounting, expect the expansion of DNA databases to include the genetic profiles of arrestees to continue. Currently, only a handful of states permit including DNA profiles from people arrested but not convicted of felonies (otherwise known as "innocent people") in their criminal database. With California and the federal government shifting policies this month to include arrestees’ DNA, expect more states and localities to follow suit. 

Our grandparents sold apples on the street, and lined up outside soup kitchens. Will we be telling our grandchildren stories about young women vying to sell their eggs and land contracts to carry pregnancies for affluent couples? As the economy gets worse, it will be a buyers' market for eggs and surrogates (1, 2, 3). Will the hard-to-miss lessons of inadequate regulation of financial markets be applied to the markets for eggs and wombs?

After an initial flurry of media coverage surrounding the new president lifting Bush's  funding restrictions, human embryonic stem cell research will fade as a relevant political issue. Cellular reprogramming will continue to make strides, and cloning-based work will stagnate, with researchers continuing to abandon the field.

Synthetic biology will be heralded by the media as the "next big thing," much like nanotechnology was a few years ago. The big question is if, and when, scientists led by Craig Venter will successfully transplant their synthesized bacterial genome into an existing bacterium, and have it function. My money is on the eventual success of this endeavor, but not this year. There's a decent chance that a synthetic biology "hacker" will accidentally cook up a deadly microbe in a bathtub sooner.

Discussion of "second generation PGD" will gather steam in academic and quasi-academic publications. In this, traditional PGD is coupled with wider genome scans - whose price is plummeting - to allow prospective parents to select among embryos based upon multiple genetic characteristics. Furthermore, the role of prenatal scanning will begin to change, as more tests become available that analyze fetal DNA in the prospective mother's blood at five or six weeks of pregnancy.

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