Washington
Seventeen months after President Obama bolstered stem-cell research on university campuses by allowing federal support for studies involving a broad range of cells derived from human embryos, a federal judge has ordered the policy suspended, alarming academic scientists who warn of slower progress in studies seeking treatments for a variety of devastating diseases.
The judge, Royce C. Lamberth of the U.S. District Court for the District of Columbia, said Mr. Obama's executive order of March 2009 violated a provision that has existed in federal law since 1996, known as the Dickey-Wicker Amendment, that prohibits the use of federal money for the creation or destruction of human embryos for research purposes. Embryos are destroyed when embryonic stem cells are obtained from them.
Mr. Obama's action largely overturned the policy announced in August 2001 by then-President George W. Bush that barred the use of federal money for any projects using embryonic stem cells created after that date, but allowed work to continue with cells derived from a limited number of stem-cell lines already existing. The idea, Mr. Bush said, was that the life-or-death decision had already been made for those embryos.
The Obama policy, by contrast, would allow federal support for studies involving new lines of cells derived from embryos created by in vitro fertilization and donated by couples who no longer wanted them for the purposes of creating a child. The policy, as set forth in guidelines issued by the National Institutes of Health last year, was intended to avoid any conflict with the Dickey-Wicker restrictions by stipulating that the actual extraction of stem cells from embryos would occur without federal money.
The guidelines' distinction between deriving stem cells and studying them, however, wasn't sufficient for Judge Lamberth. In a 15-page ruling, he declared that any embryonic-stem-cell research "is clearly research in which an embryo is destroyed."
Question of Harm
Judge Lamberth issued his decision in a case whose plaintiffs include two private researchers who study stem cells obtained from adults. They argued that Mr. Obama's policy unfairly deprived them of federal money for their own studies by increasing the competition for NIH funds. The judge agreed that the increased competition they faced was "an actual, imminent injury."
Although the plaintiffs needed to show a financial harm in order to bring their case, Judge Lamberth's ruling deals with issues far more important than money, said William B. Hurlbut, a bioethicist and physician at the Stanford University Medical Center.
Mr. Obama's policy shift raised many questions at the intersection of ethics and medical research, said Dr. Hurlbut, a consulting professor in neurology and neurological sciences who served on President Bush's Council on Bioethics. "We've barely given them any thoughtful reflection," he said.
Many other medical experts, however, were mourning Judge Lamberth's decision, saying it once again squelches the hopes of millions of people suffering from a range of ailments that include cancers, diabetes, and heart disease.
Because Mr. Bush's restrictions made so few stem-cell lines eligible for federal research support, universities either avoided the field or engaged in elaborate and costly procedures to establish privately financed laboratories and keep that work strictly quarantined from their larger government-financed activities.
"It's a shame," said George Q. Daley, an associate professor of biological chemistry and molecular pharmacology at Harvard Medical School and a pediatric clinician who treats children with blood disorders.
"Our lab will have to return to the old mode of keeping human-embryonic-stem-cell research separate from everything else, which means slower progress," Dr. Daley said. The problem is made even worse by the continuing financial crisis, which is making private research money harder to find, he said.
"Just when the dark shadow of political ideology seemed to be lifting from stem-cell research, this news puts us back under the pall," said David T. Scadden, co-director of the Harvard Stem Cell Institute.
It wasn't immediately clear what the Obama administration would do in response. Spokesmen for the White House and the National Institutes of Health referred questions to the Justice Department, where a spokesman, Charles S. Miller, said lawyers were reviewing the case.
At an earlier stage of the case, Judge Lamberth refused to hear the matter, saying an original plaintiff, an adoption agency that argued that Mr. Obama's new policy reduced the availability of fertilized human eggs for adoption, didn't have sufficient legal standing to challenge the president's executive order. On appeal, however, the U.S. Court of Appeals in Washington ordered the judge to consider the financial-loss argument raised by the researchers.
Hopes for a Reversal
The case could yet be overturned on the grounds that those researchers don't have a credible claim to have lost any federal money, said Richard O. Hynes, a professor of biology at the Massachusetts Institute of Technology.
"If the plaintiffs' research applications have merit," Mr. Hynes said, "they will be able to apply for funding and to reapply even if their first application is not funded." One of the plaintiffs, James L. Sherley of the Boston Biomedical Research Institute, served from 1998 to 2007 as a professor of biological engineering at MIT.
Mr. Sherley, who attracted national attention in 2007 by going on a hunger strike after MIT denied him tenure, has championed adult-stem-cell research not only on scientific but on moral grounds, contending, as did the judge, that research involving embryonic stem cells is unavoidably linked with the destruction of embryos.
Even if Judge Lamberth's ruling is ultimately overturned, just a brief halt in embryonic-stem-cell research could mean prolonged sickness or death for many patients awaiting cures, said Amy Comstock Rick, past president of the Coalition for the Advancement of Medical Research. "We're pretty devastated by the ruling," she said.
The California Institute of Regenerative Medicine, the state stem-cell agency, has already stated that it will use its own money to support research using embryonic-stem-cell lines approved by the NIH in the past year, as well as the lines previously approved by the Bush administration.
Ironies of the case include the fact that the same essential claim of a violation of the Dickey-Wicker Amendment could have been lodged against the earlier Bush administration policy, Ms. Rick said.
Dr. Hurlbut said that argument might have been technically possible under the previous guidelines, although the Obama policy appears to have allowed clearer and more-widespread violations.
Rather than lament the loss of research involving human embryos, ethicists should consider the ruling's implications more thoroughly, he said, and researchers should take more seriously alternative methods of producing stem cells.
"The living human embryo is a human being in process," Dr. Hurlbut said, "and I think that's the correct scientific interpretation of it—the earliest stages of human life."
Comments
1. sdorley - August 24, 2010 at 09:02 am
I hope everyone who sees the two previous comments will contact the Chronicle about abuse. This is an academic paper, not a place for the invasive and annoying websites to ply their wares. This stuff should be immediately removed from any of the Chronicle's Comment sections whenever it appears.
As for the article, I am dismayed that this research venue has once again been sidelined. I find it interesting that a judge can do what science and faith have been unable to do for years--definitively determine what is and isn't life for the purposes of research.
2. tridaddy - August 24, 2010 at 09:21 am
No matter which side of this issue you happen to side with, the fact (as best I can surmise from my investigation) is that there have been more successes with NON-embryonic (i.e., adult) stem cells than embryonic stem cells. I have to question what the real motive is in pushing the embryonic stem cell aspect when compared to the successes using adult stem cells.
3. lcrandal - August 24, 2010 at 09:21 am
One suspects that this judge's disposition toward overturning current policy may have preceded the facts of the case.
4. schultzjc - August 24, 2010 at 09:38 am
The dispute that provoked the ruling is over money: scientists working on adult stem cells claimed that the competition from research on embryonic stem cells lowered their likelihood of winning funding on adult stem cells.
Once again, scientists are pefectly willing to eat their own.
5. bioinfres - August 24, 2010 at 10:29 am
tridaddy says there have been more successes with adult than empryonic stem cells. This is hardly surprising when most researchers have not been able to use embryonic stem cells in their research.
6. greeneyeshade - August 24, 2010 at 10:45 am
It floors me that a government can so easily dispense with a human life.
How was Mengele much different, in essence? Some human beings are less important than others? Really?
7. physicsprof - August 24, 2010 at 10:48 am
"They argued that Mr. Obama's policy unfairly deprived them of federal money for their own studies by increasing the competition for NIH funds. The judge agreed that the increased competition they faced was "an actual, imminent injury."
Priceless.
8. mccclib - August 24, 2010 at 11:21 am
I would just like to know what disease has been cured by stem cell research. At this point, I am unaware of any.
9. _perplexed_ - August 24, 2010 at 11:22 am
One can only hope that greeneyeshade and his/her descendants never learn first hand the difference between Mengele's "research" and stem cell science.
10. physicsprof - August 24, 2010 at 12:09 pm
mccclib (#8), are you consistently against any research that has yet to yield practical benefits?
11. 22118130 - August 24, 2010 at 12:50 pm
One has to wonder whether the judge is enshrining his own values in the decision he makes. For one thing, I have a lot of trouble seeing increased competition for grant funds as "actual, imminent injury," which is what standing was based on in this instance. If that is the standard, then anyone facing increased competition for anything would have standing to challenge a federal law or executive order. Hard to believe establishing standing could be so easy, when it is usually so difficult in federal court. If the judge's interpretation of the Dickey-Wicker Amendment is correct, perhaps that needs to be changed by Congress so this problem does not arise again. As someone with a history of Parkinson's Disease in my family, for which stem-cell research offers great promise, I find it aggravating that progress keeps getting hung up by arguments raised by the lunatic fringe, where fertilized eggs are accorded human rights. I care much more about the well-being of people already in this world, than I do about the supposed rights of a zygote. We're talking about embryoes that would be discarded anyway, so they will be destroyed in either case. If that offends your sensibilities, so be it. I care much more about my health and the health of others who would be benefited.
12. fergbutt - August 24, 2010 at 01:00 pm
No worries. Just change the law. Assuming the electoral landslide toward more Republicans this fall doesn't get in the way of the progressive movement.
13. bmljenny - August 24, 2010 at 01:18 pm
No way are the Democrats going to spend any political capital on overturning the Dickey-Wicker amendment. If they're not willing to spend political capital on things that the voting public agrees with and understands (Energy independence? Making banks honor the provisions of the loan modification bill? All the good stuff in health reform they left on the floor?), they're certainly not going to spend it on a nuance of science that nobody understands.
14. softshellcrab - August 24, 2010 at 01:34 pm
@ lcrandal, #3
Why? You say "One suspects that this judge's disposition toward overturning current policy may have preceded the facts of the case."
But why should one suspect this? There's no evidence of it... Don't you give people the benefit of the doubt? Maybe it's you who are guilty of a predisposition.
15. softshellcrab - August 24, 2010 at 02:22 pm
Just in general, no matter how you feel about this issue, I do not believe that district court judges should be permitted to overturn government policies or to declare government actions and laws unconstitutional. If any court should have the power to do that, it should be only the Supreme Court and there should even then be a mechanism giving the President and Congress the right to override such "veto". Lest anyone accuse me of constitutional heresy, please note that the constitution does not give the power even to the Supreme Court to do this, it is something that the Court itself declared itself authorized to do, and that is widely accepted today. Not by me though. What particularly irks me is when I see small-time district judges like here declaring policies of a duly elected U.S. president, or duly passed laws of the entire U.S. congress, to be invalid. I don't see where they rate such power, and I wish the Congress would reign the courts in.
16. 11319762 - August 24, 2010 at 05:25 pm
Softshellcrab should also take note that we elect a President, not a monarch. Executive Orders are supposed to be administrative rules for those who work within the executive branch, not law by fiat. Those orders should not be in conflict with laws passed by Congress and signed by the President, which is exactly what took place here, as Judge Lamberth ruled that the executive order violated the Dickey-Wicker Amendment, passed and signed into law in 1996.
If "small-time district judges", an interesting description of a Federal Circuit Court judge, appointed for life by the President and Confirmed by the Congress, should not be ruling on the Constitutionality of federal laws and regulations, why should a President? He is not the Supreme Court either. Congress cannot "reign in" the Judiciary. There are three co-equal branches in our government. All three are reigned in by the Constitution, which as its opening line states, "We the People" do the reigning in.
17. softshellcrab - August 24, 2010 at 06:53 pm
Actually, ***9762, I think you make a good point in part, as applicable to this particular instance. You may have missed my real point a bit, however. I do agree it was appropriate for the judiciary to rule as to whether this particular policy violated another fedeal law, so in that sense what was done in the particular case is understandable.
But if you look at my post, it was a "by the way" opinion on the much more widespread practice of "small time" District Court judges holding presidential actions and laws fully passed by the congress to be unconstitutional. This was not a Circuit Court judge, but a district court judge. I know he is not really "small time", of course, as being a District Court judge is a respected and lofty position. I probably should have put it into quotes myself, but compared to the President, or to the U.S. Congress as a whole, a District Judge really is small in comparison. There are close to 700 U.S. District Court Judges. I wouldn't pretend to compare the stature of a single district court judge to the president, or to the entire U.S. congress when acting a body. It grates on me when a single, unelected, and non-removable district court judge decides to throw out the actions taken by a duly elected U.S. Congress and President.
Some of what you say is simply wrong, however. No where in the constitution is a power granted to even the Supreme Court itself (much less to just a District Court judge) to declare U.S. laws, passed by the entire 535 member Congress and signed into law by a dulty elected President, to be unconstitutional. It's just not there.
You emphsize the point that the President is not a monarch, and that "we the people" have the final control and should be able to do the reigning in. I don't get this at all. That is exactly my point, why are you arguing with me? Whether one likes Obama or not, or the Congress or not, "we the people" ultimately control them. We can vote them out. The "monarch" today, in my opinion, is the judiciary. As you point out, these are life-appointments, and they answer to no one. Since "we the people" can vote and control the President and Congress, I prefer to see their actions and laws given more deference and not to be simply overturned by an unelected, non-removable, non-fireable, federal judge, especially a low level judge where some are good, others maybe not so good.
18. nancypiper - August 25, 2010 at 02:16 am
11319762 & Soft Shell Crab I think you both are amazing!
The Judicial system is not to change the law but to uphold it and I think this guy did.
I can't discern which of the above remarks are serious and which have a tone of sarcasm? I do notice one that is particular selfish!
I am against Government being involved in science research. Use private grants (there are plenty of $$$ out there.) Life is sacred and eternal souls are being destroyed even if they are in frozen stages. (which ethically, I think is cruel)
The umbilical cords stem cell of living infants has had as much benefits and success as any embryonic stem cells. http://www.lifenews.com/bio3145.html
19. johannaht - August 25, 2010 at 02:21 am
I think it's fair to assume that readers of the Chronicle are academics or at least educated people. That being the case, I don't expect to see orthographic errors (not mere typographic errors) committed and repeated in comments submitted for publication.
@softshellcrab and @11319762:
In your comments of August 24, you both wrote of "reigning in" the courts, the Judiciary. Clearly you meant "reining in." One reigns only if one is a monarch exercising sovereign power. A monarch, moreover, never reigns anyone in; she simply reigns. One reins in a horse that's galloping too fast by pulling taut the reins. By analogy, you might desire to rein in the Judiciary if you think it has abused its legitimate power. For the record, this correction is submitted by a mere peon lacking formal higher education, with all due respect to your terminal degreeships.
20. jaysanderson - August 25, 2010 at 10:32 am
This decision doesn't bother Obama in the least. He will use whatever means necessary to do what he wants--regardless of laws, judges, or the will of the people. If he cannot slither around the law, he will simply ignore it and label the opposition as racists.
21. 22118130 - August 25, 2010 at 02:10 pm
nancypiper, you're drinking the right-wing Kool-Ade. I have not heard of a single reputable scientist who works in the area of stem-cell research who thinks either adult stem cells or ubilical cord stem cells offer the same promise of medical breakthroughs as do embryonic stem cells. I do not see the moral dilemma here. The fertilized eggs that would be used for embryonic stem cell research are those that would be discarded by fertility clinics, and then only with the consent of their owners. The only difference is that if they are not used for research, they will most likely become medical waste. Such research offers great promise for treating spinal cord injuries, Alzheimer's and Parkinson's Disease. Those who have moral qualms about such research will always have the option of refusing treatments resulting from embryonic stem cell research. The rest of us should have the option of benefiting from such research.
22. nancypiper - August 25, 2010 at 10:51 pm
No Kool-Ade for me. But, you are the one I was referring to as being self centered. (22118130)
This is a moral and ethical dilemma. My God (and my duty to Him) comes before any scientific research! Sorry, you find that worthy of
cheap comments. The Creator (Potter) is the Owner of those frozen eternal souls. He is Sovereign. http://www.worldmag.com/webextra/17056
23. greeneyeshade - August 27, 2010 at 07:46 pm
One can only hope that # 9 _perplexed_'s descendants never learn first hand....oh, wait. These human beings who had been at the very first stage of their individual existence will never get the chance to learn anything, will they? No Kool Aid for them; not even the chance.
That these embryos would have been trashed anyway and should therefore be used for scientific experimentation begs the question. Creating them in a test tube in the first place with the knowledge aforethought that all, or nearly all of them would be destroyed is the "scruple" that bothers many of us--irrespective of the tenets of religion. To get over that scruple I guess you have to convince yourself that the biologically gifted human embryo is not worth legal protection.
I respect science tremendously; I'm alive because of it. But we all know that science advances in fits and starts--the science of today is often the nonsense of tomorrow. Mengele probably did learn some things that have been useful. Embryonic stem cell research though, is similarly flawed--killing a human being at any stage is simply unethical.
24. greeneyeshade - August 27, 2010 at 07:55 pm
Let me add the word "innocent" before "human being" in the last sentence.