Science Policy

My colleague wrote yesterday about the two candidates for chair of the California Institute for Regenerative Medicine. The votes are in, and investment banker Jonathan Thomas, PhD, was selected. The New York Times’ Prescriptions has the story.

Previously: New chair to be selected for the California Institute for Regenerative Medicine

The governing board of the California Institute for Regenerative Medicine is scheduled to decide this evening between two candidates for chairman: bond financier Jonathan Thomas, PhD, and cardiologist and business man Frank Litvack, MD. Litvack was nominated by California State controller John Chiang, while Thomas was nominated by California treasurer Bill Lockyer, lieutenant governor Gavin Newson, and governor Jerry Brown.

The two men are very different in terms of both background and expectations as to what role the chair should play in CIRM’s overall governance and mission. Thomas feels the job would require a substantial time commitment and involvement in the day-to-day workings of the agency, whereas Litvack views the job as more of a supervisory position with less hands-on governing. The men are reportedly also seeking vastly different salaries–from about $137,000 for Litvack versus about $400,000 or more for Thomas.

I could list lots of links for background, but David Jensen of the California Stem Cell Report has already done that legwork for me by compiling a thorough reading list that includes links to statements from the candidates, recent news reports about the selection process and a memo from current chairman Robert Klein detailing his opinion as to the role of the chair in CIRM’s future. He also includes a link to a recent Nature report describing the ‘stark choice’ the agency faces with their vote tonight.

The meeting, which starts at 4 pm PST will be webcast to the public. Candidate statements are estimated to begin at around 5 pm. However, I’m thinking much of the juicy discussion will likely be reserved for the governing board’s closed session this evening. Le sigh. That won’t stop me from listening to the public portion of the meeting. If you care about the future of California’s stem cell agency, you should too.

Jonathan Moreno, PhD, makes the case for a “bioprogressive America,” in which the left and right join together to support the advance of human knowledge:

Since the nation’s founding, progress in the Enlightenment sense has been key to the idea of America. A corollary belief has been an exceptional level of investment in creating a political, legal, and financial environment that encouraged scientific innovation. Jefferson’s patent statute, for example, gives particular latitude to inventors, as the founders (who were themselves remarkably keen on natural philosophy and numbered several world-class thinkers), sought to make the new nation a welcoming home for the brightest and most creative minds.

Loved this entry.

Via Krista Conger

As reported here and elsewhere, a federal injunction banning federal funding for human embryonic stem cell research was overturned last Friday. For those of you interested in the legal details behind this development, Stanford law professor Hank Greely, JD, has written a lengthy and informative entry on the Law and Biosciences Blog. Greely’s conclusion?

April 29 was a good day for embryonic stem cell research. It has no immediate effect, as the injunction had been stayed, but it helps eliminate some of the legal uncertainty around this funding. It is not the end of the legal wrangling, but I think it greatly weakens the most serious legal challenge to this research.

Previously: Stem cell funding injunction overturned by federal court , Judge Lamberth’s stem cell opinion is disappointingly bad, More concern over US judge’s stem cell ruling and Stanford stem cell expert weighs in on district court ruling

American adults are scoring higher than they did 20 years ago on a widely used index of civic scientific literacy – but there is still room for improvement, according to a recent report from the American Academy of Arts and Sciences.

Overall, the report (.pdf) showed that 28 percent of U.S. adults in 2008 had a sufficient enough understanding of basic scientific ideas to be able to read the New York Times‘ science section, up from 10 percent in 1988.

Among the other findings were:

• Approximately 44 percent of American adults can define DNA correctly, but only 20 percent can define the meaning of a stem cell.
• While 85 percent of adults recognize that all plants and animals have DNA, only 27 percent of Americans think that more than half of human genes are identical to those of mice.
• American adults who are able to define the meaning of a scientific study has increased from 22 percent to 34 percent.
• The proportion of adults who understand that antibiotics do not kill viruses has increased from 31 percent to 55 percent.

In their conclusion, authors underscored the need to strengthen science literacy:

Scientific literacy has become an essential component of the skills that every adult needs to thrive in the twenty-first century … Looking to the future, we must increase the proportion of scientifically literate adults in our society. As the survey results presented here demonstrate, formal education and informal science learning are partners in the process of advancing scientific literacy. Without a solid foundation of basic scientific constructs, even the best science journalism and communication will fall on deaf ears. Scientific literacy is not a cure or antidote in and of itself. It is, however, a prerequisite for preserving a society that values science and is able to sustain its democratic values and traditions.

ScienceInsider reported yesterday on a petition making the rounds of NIH-funded researchers. The aim of the document, which reportedly is supported by more than 1000 signatures, is to increase the number of times an applicant can resubmit a revised version of a grant application from one to two. As it is now, researchers whose second try is not approved for funding must then submit a substantially different proposal for consideration.

Greg Miller writes:

The petition is a response to a rule change instituted in 2009 that allows investigators to resubmit a rejected grant application only once instead of twice. After that, any subsequent submission “is expected to be substantially different in content and scope.” In a 2008 announcement of the rule change, NIH said it was intended to reduce the number of submissions per investigator and reduce delays in funding successful applications.

Those who support the petition argue that the requirement places an unfair burden on young investigators, who are likely to be less experienced and have fewer lab members to devote to starting a new project from scratch than would a more seasoned researcher:

How can a young investigator, for example, who is just starting “substantially” change their aims when they have to focus their efforts on a very limited number of projects undertaken with limited funds and staff? These investigators are often hired by senior faculty on the strength of their first proposals in intensely competitive job searches. To be told they must change their focus on the basis of applications that fail despite being ranked better than 90% of grants submitted, seems patently absurd.

The petition continues:

All of us who have sat on study section know that we cannot distinguish a 15th percentile grant from a 5th percentile grant. It is simply beyond the limit of resolution of the process. We are not after all just evaluating the impact or validity of a scientific finding or theory (as difficult as that can be), but the projected trajectory of some early findings, a process which is fraught with extraordinary uncertainties in fields as complex as ours. Therefore, this new rule will have the consequence of redirecting the science of many of our very best scientists on the basis of what will essentially be an arbitrary criterion.

Interestingly, not all researchers agree. Some side instead with the NIH and its reported goal to increase efficiency in the distribution of much-needed funds. What do you think?

Like our own Frank Longo, MD, PhD, Susan Blumenthal, MD, MPA, former U.S. assistant surgeon general, is featured in this year’s Rock Stars of Science campaign. In a Huffington Post piece, Blumenthal discusses how the campaign, which aims to support research funding and get young people interested in a career in science, draws attention to the need for the U.S. to strengthen its investment in research. She also outlines six action items – included in a recent report from the Center for the Study of the Presidency and Congress – to ensure that this happens.

It’s lengthy but worth a read.

Previously: Stanford neurologist rocks out for science and Stanford “rock doc” talks about science as a career

Members of the Association of American Medical Colleges (AAMC) are calling on Congressional leaders to pass legislation that would authorize and continue federal support for human embryonic stem cell research. A letter (.pdf) delivered on Friday and signed by more than 100 representatives of medical schools and teaching hospitals, reads in part:

The discovery of human embryonic stem cells is a significant research advance and Federal support to U.S. researchers is essential both to translate this discovery into novel therapies for a range of serious and intractable diseases, and to ensure that this research is conducted under a rigorous and credible ethical regime…

This legislation, which has received strong bipartisan support in previous Congresses, recognizes the need to authorize and continue Federal support of research on human embryonic stem cells so that the tremendous scientific and medical benefits of their use may one day become available to the millions of patients who so desperately need them.

Philip Pizzo, MD, dean of Stanford’s medical school, is among the signees.

Via @AAMCtoday
Previously: Poll shows “overwhelming support” for embryonic stem cell research, AAMC urges Congress to reinstate federal funding for human embryonic stem cell research, Congress plans quick move on stem cell bill and Third time’s the charm for stem cell legislation?

UPDATE 2: If you missed this morning’s Senate subcommittee hearing, it’s now available as an archived webcast here.

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UPDATE: Washington Post writer Rob Stein reported on what happened during the hearing in this blog entry.

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For those of you who are interested, Sen. Thomas Harkin (D-Iowa) is holding a hearing this morning on “The Promise of Human Embryonic Stem Cell Research.” It’s being webcast live beginning at 7 am PST. NIH director Francis Collins, MD, PhD, and several stem cell researchers are slated to talk.

Previously Congress plans quick move on stem cell bill

The Denver Post reported today that U.S. Rep. Diana DeGette (D-CO) wants to move forward quickly with legislation to allow federal funding of human embryonic stem cell research. DeGette hopes to have some resolution by the time Congress recesses on October 8 before the upcoming elections:

“The fact that people are running against these hard-right Tea Party
candidates really will help them because the vast majority of Americans are for stem-cell research,” said DeGette, a longtime champion of the research who has seen legislation she’s written on the issue pass twice only to be vetoed by then-President George W. Bush.

The Senate is moving forward as well; as reported by the Los Angeles Times, Arlen Specter (D-PA) spoke in support of similar legislation on Monday:

…in his statement, Specter emphasizes that Congress did not intend for the Dickey-Wicker amendment to preclude funding for human embryonic stem-cell research. Everyone agrees that the law prevents the federal government from paying scientists to create the stem cells. But once created, the cells themselves are supposed to be eligible for NIH funding, Specter says.

Previously: Third time’s the charm for stem cell legislation?

The Nature blog The Great Beyond is reporting that the U.S. District Court judge who issued an injunction against the use of federal funding for human embryonic stem cell research has refused a government request for a temporary stay.

Judge Royce Lamberth derided the idea that the injunction could cause irreparable harm to ongoing research projects and pointed out that if, as expected, the plantiffs file for a summary judgment this week, the case could be decided within the next two months:

Defendants are incorrect about much of their “parade of horribles” that will supposedly result from this Court’s preliminary injunction. . . . Additionally, since plaintiffs anticipate filing their motion for summary judgment by September 10, (id. at 13 n.4,) the length of time this preliminary injunction will be in place should be limited.

The judge’s order seems to agree with from the plantiffs’ Saturday response to the administration’s request for a stay (also reported by The Great Beyond) in which they also criticize National Institutes of Health Director Francis Collins’ response to the injunction:

Defendants’ claims of irreparable harm absent a stay rest on speculation, misinformation, and hyperbole,” the memorandum says, adding in a footnote, “In addition, the Collins declaration is replete with exaggerations and factual mischaracterizations.

You can read the full text of Judge Lamberth’s decision here (.pdf).

Previously: Judge Lamberth’s stem cell opinion is disappointingly bad, Stem cell ruling throws Stanford researcher’s project into limbo, AAMC urges Congress to reinstate federal funding for human embryonic stem cell research, and Stanford stem cell expert weighs in on district court ruling

I was shocked last week when I learned that Judge Royce Lamberth had enjoined federal support for human embryonic stem cell (hESC) research.

This case is about the so-called Dickey-Wicker Amendment. This amendment was first added to the HHS appropriations bill in 1996. Appropriations bills are good for only one year, so every year from 1996 to the present, Congress has added essentially the same language to the relevant appropriations bill. The current version states:

(a) None of the funds made available in this Act may be used for- . . . .

(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death . . . .

For 11 years, the Clinton, Bush, and Obama administrations have agreed that this language allows funding of research using hESC lines as long as that funded research project does not itself destroy embryos. Judge Lamberth held that this language clearly and unambiguously prohibits government funding of any hESC research:

This prohibition encompasses all “research in which” an embryo is destroyed, not just the “piece of research” in which the embryo is destroyed. Had Congress intended to limit the Dickey-Wicker to only those discrete acts that result in the destruction of an embryo, like the derivation of ESCs, or to research on the embryo itself, Congress could have written the statute that way.

In 1996, this interpretation might have been reasonable, though, I believe, still wrong. In 2010, the decision is clearly and unambiguously wrong, for at least three reasons.

First, the NIH does not say, “Here’s a pool of $100 million for hESC research; come and get it.” It says “Please write us a long and complicated application for a grant to do a specific piece of research and, if we accept your grant, we’ll give you some money to do the work you said you would do.” What the NIH funds are “pieces of research,” as defined by grant applications.

Second, HHS has maintained its interpretation of Dickey-Wicker for 11 years, through three very different administrations. If his reading of the language is unambiguously right, why did three very different administrations reject it? And if the language is, in fact, unclear, then under governing administrative law, the judge has to defer to HHS’s interpretation of the statute.

Third, the version of Dickey-Wicker that Judge Lamberth was supposed to apply was passed in 2009… by a Congress that had seen three administrations interpret the language permissively. If Congress had disagreed with that interpretation, it could have changed the wording of any year’s Dickey-Wicker Amendment to make that disagreement clear. It did not. In fact, twice Congress passed new legislation to overturn President Bush’s relatively restrictive policy on use of federal funding, only to see its bills vetoed. These facts make it very odd indeed to interpret the action of Congress in passing the 2009 version of this rider as clearly rejecting federal funding for any hESC research.

As a citizen, I support federal funding for hESC research as a matter of public policy. As a law professor, I teach and support sound, logical judicial decision-making. Judge Lamberth’s opinion is disappointingly bad. I do not know Judge Lamberth and I do not know whether this decision is the result of bias or is just an example of the occasional bad opinion one must expect from even a good judge. Either way, I hope – and expect – that the District of Columbia Circuit will quickly first stay the order and then reverse the decision.

A much more detailed version of this discussion can be found here.

Hank Greely, JD, is a Stanford law professor and an expert on the legal, ethical, and social issues surrounding health law and the biosciences. He is director of the Center for Law and the Biosciences, and he chairs the steering committee of the Stanford Center for Biomedical Ethics.

Previously: Stem cell ruling throws Stanford researcher’s project into limbo, A legal perspective on the human embryonic stem cell ruling, More concern over US judge’s stem cell ruling and Stanford stem cell expert weighs in on district court ruling

The New Yorker magazine has a fantastic profile of National Institutes of Health Director Francis Collins, MD, PhD, in their upcoming Sept. 6 issue.

The piece, written by Peter Boyer, discusses Collins’ childhood on a Virginia farm, his conversion to Christianity, his thoughts on the promise of personalized medicine and – most interestingly to me – his take on the current injunction on human embryonic stem cell research:

…Francis Collins’s bureaucratic skills will be severely tested in the coming struggle. Last week, his resolve was evident. “This goes beyond politics,” he declared. As he put it to me, “Patients and their families are counting on us to do everything in our power, ethically and responsibly, to learn how to transform these cells into entirely new therapies. It’s time to accelerate human-embryonic-stem-cell research, not throw on the brakes.

Boyer also doesn’t shy away from pointing a journalistic finger at administrative missteps leading to the recent legislative mess:

Blame for this new crisis in stem-cell research can, in large measure, be placed on the attenuated way that Congress, and even the White House, has dealt with the inherent politics of the issue.

He includes quotes from stem cell proponent and congresswoman Diana DeGette (D-CO) who urged president Obama to codify his executive order of March 2009 into law:

DeGette said that after the announcement of Obama’s new policy, which she welcomed, she wanted to press ahead one more time with her bill, which would have effectively made the Obama rules law. It seemed the perfect opportunity – Republicans were in retreat, Obama’s approval ratings were at their highest, and the Democrats, who controlled both branches of Congress, were feeling expansive. “I was all ready to go at that moment with the legislation,” she says.

Unfortunately, DeGette explains, the bill fell by the wayside in the face of other, more seemingly pressing matters.

Read the whole piece. You’ll like it. If you want to engage with the author, he’ll be live chatting with readers tomorrow, Sept. 1, at noon Pacific.

Previously: The NIH’s Francis Collins’ to do list, Collins dishes on God, (medical) drugs, and rock and roll, and Stem cell guidelines under fire

Photo by IU School of Medicine

The work of researchers across the country has been thrown into limbo because of a recent injunction that suspended federal funding for human embryonic stem cell research. In a release today, my colleague discusses how the ruling affects one Stanford investigator:

For [Joanna Wysocka, PhD,] an assistant professor of chemical and systems biology and of developmental biology, the injunction puts in doubt the NIH funding that seemed sure to come this year. Wysocka had applied for a large RO1 grant from the NIH to continue [her work on CHARGE syndrome], and was delighted when the NIH rated her proposed project as more worthy than 99 percent of the proposals received.

“With my new-investigator status and the grant proposal score, I was confident that the application would be funded,” Wysocka said.

Then she heard about the Lamberth ruling, and the trajectory of her skyrocketing research took a steep dive. Her initial work was funded by a seed grant from the California Institute for Regenerative Medicine, but that grant has ended. “I am currently funding this project largely from leftovers of my start-up funds and relatively unrestricted junior investigator awards, but we need more money to continue,” Wysocka said.

What will happen with Wysocka and others? Stay tuned. “I’m sure the Department of Justice and the NIH are trying to figure this all out,” Stanford law professor Hank Greely, JD, commented.

Previously: NIH intramural human embryonic stem cell research halted, Stanford stem cell expert weighs in on district court ruling and More concern over US judge’s stem cell ruling

In response to a judge’s order last week, the National Institutes of Health today ordered an immediate halt to all human embryonic stem cell research conducted on the NIH campus. Jocelyn Kaiser of Science Insider calls the move “unprecedented:”

The shutdown is the first immediate halt to research since Lamberth issued the preliminary injunction. NIH Director Francis Collins has said that extramural researchers can continue their projects for now and that the injunction will affect only future grant payments. (“Intramural” means researchers in labs on the NIH campus; “extramural” refers to researchers at universities and other outside institutions who receive NIH grants.) But some biomedical research lobbyists worry that that interpretation of the ruling may have been too optimistic, and a shutdown of all ongoing NIH-funded hESC research could be imminent.

Although the decision today doesn’t directly affect Stanford scientists, it is a reminder of the tenuousness of federal funding for human embryonic stem cell research. Philip Pizzo, MD, the medical school dean, says:

Once again the politics of stem cell research has the prospect of entering center stage – just when it seemed that we had moved into a new theater.

Previously: Stanford stem cell expert weighs on on district court ruling, Stumbling stem-cell policy regains footing, First human embryonic stem cell lines approved for funding under new guidelines and Stem cell guidelines under fire