In what was widely seen as a needless politicization of science, President George W. Bush announced early in his presidency that he was forbidding federal funding for research on human embryonic stem cells (with certain exceptions). This episode, and the way he sold his decision to the public, is the prime example in Chris Mooney’s excellent The Republican War on Science. In particular, he oversold the exceptions, claiming that up to 60 lines of usable stem cells existed, when only 21 were viable, and when those were contaminated in various ways, and could not be used to research certain questions. Critics noted that the restrictions were arbitrary and overly limiting, and that they seemed to have been devised with no input from the researchers who were beginning to understand how stem cells could help us understand and even treat some of the most horrific illnesses we face.

While President Obama campaigned on a promise to reverse this and other abuses of science, he was slow to reverse Bush’s order with his own executive order. The problem with Bush’s order was not just with the restriction on stem cell research, but that it was sold based on misrepresentations of science, and implemented without any understanding of how science was using stem cells.

i-fb2c30d525b3f97518eefaf7e53e816d-200903091554.jpgIn a Nobel-studded White House ceremony today (note Energy Secretary Stephen Chu amidst his fellow Nobelists in the background), President Obama overturned these limits, and did so in a way that does not repeat Bush’s mistakes. The order does not set forth specific rules for the use of stem cells, but says that the HHS Secretary (Kansas Governor Kathleen Sebelius, when she is confirmed) “may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.” The Secretary, through the Director of the NIH, is required “Within 120 days from the date of this order? [to] review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance on such research that is consistent with this order. The Secretary, through NIH, shall review and update such guidance periodically, as appropriate.”
By referring the implementation details not to political officers, but to scientific leadership at the NIH, the President avoided major pitfalls of his predecessor’s approach. The decision which belongs in the realm of politics is whether to allow research on human embryonic stem cells, how much funding to provide, and, to some extent, how those cells can be obtained. The details of how those cells are used and how they may be obtained has to be settled by scientists, based on the guidance offered by the political leadership. This is the tricky balance of making science policy. Scientific questions which touch on complex moral issues, or which might compel broader social policy (as with global warming), can’t be completely isolated from the political realm, but allowing politics to dictate what research is or isn’t conducted is a very dangerous course.

Bush breached that wall, mixing scientific-sounding claims amidst moral or philosophical claims, obscuring what aspects of his policy were dictated by moral aversions and which parts were motivated by a clear view of what scientific research required.

Obama’s decision, and his speech announcing it, show a clear separation of his hopes, his take on the broader moral questions, and the state of our scientific knowledge. He closed the speech with a clear warning about the timeline for the therapeutic applications from this research. Noting that Christopher Reeve, a passionate advocate for stem cell research, passed away three years ago last Friday and could not fulfill his hopes of walking again within ten years, Obama said:

Christopher did not get that chance. But if we pursue this research, maybe one day ? maybe not in our lifetime, or even in our children?s lifetime ? but maybe one day, others like him might.

There is no finish line in the work of science. The race is always with us ? the urgent work of giving substance to hope and answering those many bedside prayers, of seeking a day when words like “terminal” and “incurable” are finally retired from our vocabulary.

Today, using every resource at our disposal, with renewed determination to lead the world in the discoveries of this new century, we rededicate ourselves to this work.

At the opening, he reminded his audience that “At this moment, the full promise of stem cell research remains unknown,” and “that potential will not reveal itself on its own. Medical miracles do not happen simply by accident. They result from painstaking and costly research ? from years of lonely trial and error, much of which never bears fruit ? and from a government willing to support that work.”

Recognizing that uncertainty is vital to effective use of science in policymaking, or in effective policymaking for science. So it is only fitting that Obama’s stem cell decision was accompanied by an order to his Science Advisor (John Holdren, who still awaits confirmation) “to develop a strategy for restoring scientific integrity to government decision making. To ensure that in this new Administration, we base our public policies on the soundest science; that we appoint scientific advisors based on their credentials and experience, not their politics or ideology; and that we are open and honest with the American people about the science behind our decisions. That is how we will harness the power of science to achieve our goals ? to preserve our environment and protect our national security; to create the jobs of the future, and live longer, healthier lives.”

That order, sent to all heads of departments, gives Holdren broad power to work with departments to ensure the integrity of scientific advice, and to ensure that scientific information is disseminated to the public rapidly. These changes will reverse a worrying trend from the Bush years, when political hacks who hadn’t even graduated from college were instructing NASA scientists’ to refer to the Big Bang “not [as] proven fact; it is opinion,” and forbidding NASA climatologist James Hansen from speaking publicly about global climate change.

The order makes clear that “The selection and retention of candidates for science and technology positions in the executive branch should be based on the candidate’s knowledge, credentials, experience, and integrity.” Hopefully this will also prevent abuses like those perpetrated by Julie MacDonald, a civil engineer who overruled Department of Interior biologists on endangered species decisions and shared confidential details of upcoming endangered species rulings with the oil industry and with players in online role-playing games.

Needless to say, the proof of these changes will be in the pudding, but it’s clear that the President understands how science works, and how to insulate scientists from improper pressure, while ensuring appropriate oversight. These executive orders leave lots of room for Congress to maintain its proper role, and for the details of scientific research to be sorted out by scientists themselves.

Comments

  1. #1 Paul Browne
    March 10, 2009

    This is excellent news, and some comments by Harold Varmus in the Washington Post yesterday http://www.washingtonpost.com/wp-dyn/content/article/2009/03/08/AR2009030801476.html drive home the change.

    I only hope that this new dawn isn’t undermined by politicians such as Senator Tom Harkin who seem determined to reduce the role of science in healthcare provision.

    http://scienceblogs.com/insolence/2009/03/senator_tom_harkin.php#more

    There are interesting times ahead, now is certainly not the time for scientists to be complacent.

  2. #2 The Curmudgeon
    March 11, 2009

    This is very good news indeed. But it’s not exactly pro-science across-the-board. What happened to the superconducting super collider? When can we see some serious funding for NASA? I’d also like to see some progress when it comes to drilling for and refining oil, and building nuclear power plants.

  3. #3 buzz
    March 12, 2009

    “But if we pursue this research, maybe one day – maybe not in our lifetime,…….”

    Isn’t this being just a wee bit disingenuous? Was there not on-going research before? Wasn’t this exclusion only applied to government funded research and had no bearing on private?

    The lead in “In what was widely seen as a needless politicization of science” is a bit misleading also. Granted, you (and I) don’t agree with those who considered embryonic research as destroying human life, but doesn’t that trivialize those who do? Widely seen in what circles? And couldn’t this be structured to say this was also a “needless politicization of science” to overturn the ban? After all, should one want to research, they are free to do so, as long as they don’t take federal dollars, not to mention the fact that nearly every outlet that reports this story uses it as a club on Bush. I rarely see any mention of what sort of federally funded stem cell research there was prior to 2001.

  4. #4 Josh Rosenau
    March 13, 2009

    There was federally funded stem cell research prior to 2001, but it was in a confused state. Human embryonic stem cells were discovered in the ’90s, leaving relatively little time to sort out what should be funded, and how a law forbidding research that destroyed embryos might or might not bear on such research. Clinton didn’t move on that front in order to let his successor operate in a clear field.

    Your objections to the “if we pursue this research…” line would be more credible if it weren’t reasonable to take “we” as referring to the federal government. The old rules were onerous, and discouraged researchers from the field. There’s very little research that doesn’t have at least some public funding, and since you couldn’t use a cent of federal funds on a research project using stem cell lines generated after 2001, a lot of scientists decided it wasn’t worth hiring an accountant and a lawyer so they could pursue the research. They collaborated with researchers in countries that didn’t have arcane and bizarre research restrictions, or they pursued other research directions entirely.

    I’m skipping past your objections based on how people who see this issue very differently might interpret this. I’m writing a personal and opinionated blog, and am not responsible for representing the views of everyone who might disagree with me. Bush’s policies were denounced by broad coalitions of people, including a majority of voters in the several states that established their own research funding for stem cell projects (needlessly balkanizing the field).

    As for whether one could claim this was act was a “needless politicization of science,” no. I invested quite a few words in explaining exactly why not. Bush politicized science by claiming his decision was rooted in his scientific understanding (for instance, how many stem cell lines existed, and how much could be done with them), and because he imposed limits on scientific practice which had no scientific basis, thus masquerading personal ethical judgments as scientific fact. By contrast, Obama set out principles, acknowledging that those principles are not scientific in nature, and left the technical details to the specialists. That’s how one depoliticizes science.

  5. #5 Dan
    March 28, 2009

    Over 100 years ago, a Russian histologist suggested stem cells be applied for scientific research. They are the human body’s equivalent of a generator, as they can renew, regenerate, and replicate under the right conditions.
    The apex of cellular therapy and regenerative/reparative medicine has been reborn after an 8 year moratorium that basically halted federal funding for stem cell research with most states in the U.S.
    Now the NIH can award grants to scientists involved with biomedical research involving stem cell therapy.
    While never banned, stem cell research had limited funding during this time. And this was unfortunate, because there are several likely uses of stem cells.
    These uses include the replacement of tissues in the human body, as well as repairing cell types that are defective. Also, stem cells can deliver genetic therapies that are needed.
    ESCs are totiplotent if obtained from the morula which is a pre-blastocyst stage. Normally, the stem cells are acquired from the blastocyst itself. From this source, the stem cells can be any cell in the human body except for the placenta.

    Embryonic stem cells are obtained from a 4 day old embryo called a blastocyst, and are pluripotent from this source. The blastocyst contains about 100 cells, and is not suitable at this stage for implantation into the uterine wall.
    The inner core of the blastocyst has about 20 cells, and this is where stem cells are obtained.
    These cells are unspecialized cells that can be developed or morphed into the over 200 cells available in the human body through differentiation, as ESCs are undifferentiated by nature.
    As such, they can become any human cell, as long as they are prevented from clumping or crowding together when explanted into cultures as they are propagated. After stem cells are cultured, they are moved to what are called stem lines.
    Positive results from stem cell therapy are seen usually within a month, and patients can request another treatment about 6 months after the first treatment presently. This stem cell paradigm of therapy addresses the etiology of a disease state, instead of focusing on the symptoms only.
    Until recently, ESCs were believed to be most beneficial instead of the adult stem cell alternative (ASC). However ASCs (somatic stem cells) now can be coerced into differentiation through plasticity (trans-differentiation).
    Thanks to molecular biology, four transcription factors control the transfer of genetic information from DNA to RNAS to regulate gene expression. So ASCs can have the same beneficial qualities as ESCs.
    In the past, viral vectors and exotic genes interfered with the purity of ASCs. Now ASCs are re-programmed using plasmids instead of viruses and oncogenes that can become detrimental for the patient treated.
    So now, ASCs can safely become induced pluripotent cells with the same potential as ESCs. As a result, the ASCs are free of genetic artifacts that potentially can interfere with transgene sequences.
    They are capable of, and are able to renew and reproduce with minimal effort. Human blood can be reproduced with stem cells under the right conditions.
    SCT can also be used to investigate disease states for better treatment options. Disease-specific stem cell lines, which are those cells that are pluripotent and are created with the same genetic errors of certain diseases, are studied for this reason.
    So there clearly is a huge potential for stem cell-based therapies. The first FDA approved clinical trial occurred early in 2009. This human trial will involve evaluating primarily the safety of ESCs designed to be used as treatment for spinal cord injury patients. The trial was submitted by Geron Corp.
    Pfizer, the largest drug company, has implemented stem cell research, as they are an asset to drug discovery by creating within the organization a regenerative medicine unit. Other large pharma companies are implemented similar research protocols for the same reasons.
    Geron Corp. in California is the world’s leading esc developer, and financed researchers at Univ. of Wisconsin, who isolated the first human esc in 1998.
    Some believe ethical restraints are needed regarding the use of ESCs for therapeutic reasons. Yet they improve the quality of life of those with devastating diseases which involves suffering without any relief.
    So stem cell therapy and research may be the most right and ethical thing to do for such patients.
    Embryos are acquired from fertility clinics (IVFs) that have thousands routinely stored and are abnormally fertilized. This means that they could never go on to become a human, and would be destroyed otherwise.
    Ironically, one could argue it is inappropriate to discard what may be valuable and ethical for others, potentially.
    Most couples with frozen embryos would gladly give them to such research, surveys have concluded.
    These embryos are believed by many to not be morally equivalent to human life, but only have the potential for life. And they are used for therapeutic cloning, known as somatic cell nuclear transfer, and not reproductive cloning.
    Ten states have banned this cloning out of ignorance, it seems. Bioethic principles, which are beneficience, or physician-centered decisions, as well as non-maleficence, which is first do no harm, are not corrupted.
    Furthermore, autonomy, which is the patient’s right to determine their health, and justice or fairness remain intact.
    Stem cells should be utilized for those terminally ill as well, many believe. Many are seeking stem cell therapy overseas due to restrictions in the U.S. presently.
    Dan Abshear

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