The Real Message of Monday’s Stem Cell Ruling
The August 23, 2010, decision of Royce C. Lamberth, chief judge of U.S. District Court in Washington, D.C, in Sherley v. Sebelius has legal significance for one main reason: it reasserts the principle, occasionally lost sight of, that laws passed by the Congress and signed by the president — good, bad, or indifferent — trump both executive orders and the actions of administrative agencies. It is hardly a novel principle, and its application here was proper. Judge Lamberth issued a preliminary injunction. That was done based on a substantial likelihood that the plaintiffs would prevail at trial on the merits, that the harm done to them by not issuing a preliminary injunction would be substantial, and that no substantial harm would be done to the defendants.
As noted by Judge Lamberth, the Dickey-Wicker Amendment to the 1996 Balanced Budget Downpayment Act:
[P]rohibited the use of federal funds for “(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under” applicable federal regulations.
Presumably, subparagraph (2) was included to prohibit federal funding for the stated type of research and not to meet some requirement that statutes must have more than a specified number of words. In the present case, the embryos being used were not created for research purposes; they were a byproduct of the in vitro fertilization process. They were, however, destroyed in the process of the subsequent research.
The Dickey-Wicker rider has been included in every appropriations bill for Health and Human Services since 1996. In 1999, the Department of Health and Human Services concluded (rather oddly) that human embryonic stem cells (“ESCs”) are not covered by the Dickey-Wicker rider. As Judge Lamberth’s decision notes:
On August 9, 2001, President Bush announced a policy statement on stem cell research that limited federal funding for research on ESCs. … Specifically, the President prohibited federal funding for research on ESCs that were created after the date of the policy statement. … Federal funding remained available, however, for research on ESCs that were created by private researchers prior to his policy statement. (Id.) The President formalized this policy statement in Executive Order No. 13,435, which provided federal funding for IPSC research and left the limitations on ESC research unchanged. (emphasis added.)
Did President Bush screw up in permitting at least arguable violations of the Dickey-Wicker rider through continued federal funding of research using human embryonic stem cells created after the date of his 2001 policy statement? I don’t know. Maybe he did:
On March 9, 2009, President Obama, by executive order, removed President Bush’s limitations on ESC research in order “to expand NIH support” for human stem cell research and “to enhance the contribution of America’s scientists to important new discoveries and new therapies for the benefit of humankind.”
Important new discoveries and benefits to humankind are often good; that’s beside the point. Regulations were then adopted which “require … that research involves only ESCs that were derived from human embryos that:
[W]ere created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose” and “were donated by the individuals who sought reproductive treatment … and who gave voluntary written consent for the human embryos to be used for research purposes.”
In effect, President Obama deleted subparagraph (2) of the Dickey-Rider Amendment. That was not within his presidential powers and probably wasn’t within President Bush’s presidential power back in 2001 either.
Finally, they read the fifteen page decision; always a good idea.
Activist judge.
Judge Royce C. Lamberth again comes through. Another Ronald Reagan appointment.
who will rid me of this meddlesome (priest) judge?
What makes ANYONE think that the Obama administration has ANY intent of complying with this court decision? They have already FLAUNTED the ruling against the Obamatorium, and are clearly facing NO consequences. Why on earth do you think this will be ANY different?
You’re thinking of FLOUTING, Mark. Flaunting is the other thing.
A good informative piece.
The biggest problem with such rulings of late is the Obama crowds habit of just by-passing the judges findings. A very pointed reminder of what lays a head.
READ Lamberth’s ruling, READ the statutes (see below), READ about the plaintiffs NIH funding history (and research publications), and FOLLOW THE MONEY.
1 – Among his many flawed legal arguments, Lamberth gave short shrift to the ‘balance of hardship’ argument that one must demonstrate before issuing an injunction. In particular, he failed to take into consideration any irreparable injury that can and will result to the millions of individuals suffering from disease and injury that may potentially be treated by cells derived from hESCs. He called this only ‘speculative’. He also failed to consider the immediate harm that will be caused to any and all researchers who rely on federal funding to support hESC research in their laboratories. Some people will lose their jobs as a result of this ruling; others may lose their lives.
2 – Lamberth – of course – cited Dickey-Wicker and citations therein, specifically 45 CFR 46.208(a)(2) and 42 U.S.C. 289g(b). But 45 CFR 46.208(a)(2) and 42 U.S.C. 289g(b) have absolutely nothing to do with research on cells derived from excess frozen 5 day old preimplantation blastocyst stage EMBRYOS that were created by IVF. 45 CFR 46.208(a)(2) and 42 U.S.C. 289g(b) refer to protection of and research on human FETUSES (including aborted fetuses). In issuing his overly broad ruling, Lamberth may have also prohibited all federal funding for research on any cell lines that were derived at any point in time from any human fetus except in those rare circumstances where acquisition of the fetal cells resulted in saving the life of the fetus. Like it or not research on cells derived from human fetuses has been ongoing for decades in this country, approved by Congress and supported (to some extent) by NIH. I don’t know if this was Lamberth’s intention. He may not even realize he opened this can of worms with his flawed ruling. But if his ruling stands, then it may affect far more research in this country than simply hESC research.
3 – The plaintiffs argument that they were harmed by federal funding for hESC was based on their assertion that any NIH funding for hESC research decreased their chances of receiving funding for research on adult stem cells (i.e. they were awarded legal standing as ‘competitors’). This is specious – at best. NIH grant applications are scored on the basis of SCIENTIFIC MERIT FIRST and only then is a determination made about the availability of funds based on spending priorities established by Congress. NIH changes funding priorities as a result of new scientific findings and results. It would be imprudent, fiscally unsound and downright silly for NIH to continue spending vast sums of taxpayer’s dollars to support research on finding a cure for polio when a cure for polio was discovered decades ago.
4 – One of the two plaintiffs in this case has NEVER applied for a grant from NIH. The courts clearly erred in awarding her legal standing as a ‘competitor’. How can she justifiably claim she was harmed by being denied grant funding when she NEVER submitted a grant application? That is akin to me (a white person) claiming I had been denied admission to a law school because of a quota system that favored black applicants EVEN IF I NEVER APPLIED FOR ADMISSION TO THAT LAW SCHOOL.
5 – The other plaintiff, James L. Sherley, was awarded a 5 year, ~$5 million grant from NIH in 2006 to conduct research on adult stem cells. The focus of his grant application was to develop methods to turn adult stem cells into cells that were more ‘embryonic stem’ like. Thus, in spite of the fact that he claims he was harmed, he has – in fact – received federal funding from NIH for his research. Furthermore, he acknowledges in his grant application that adult stem cells do NOT have the same ability to differentiate into all other cell types (i.e. adult stem cells are NOT pluripotent). What did James L. Sherley do with the $5 million in taxpayers funds he received from NIH? Essentially nothing. His publication record from 2006 to the present consists of commentaries on others research and review articles – but very little actual scientific research of his own – that amount to nothing more that a series of increasing shrill screeds about the use of hESCs. James L. Sherley is just ticked off that he was denied tenure at MIT and wants to blame someone (anyone) for his own failings. When he was denied tenure at MIT he tried to claim it was because he had been discriminated against because he is a black man.
6 – Sherley’s legal bills are being paid by a group of anti-science, right wing evangelical christians whose stated goal is to protect the life of the innocent unborn. But you know what they say about the evangelical right wing christian mantra – LIFE BEGINS AT CONCEPTION BUT ENDS AT BIRTH. Their argument is that taxpayers dollars should not be used to fund anything that they find morally reprehensible. They rely on the ‘separation of church and state’ doctrine. I’m all in favor of separation of church and state, but recognize that separation of church and state is a two-way street. They don’t want my government interfering with their religion. Fine! I don’t want their religion interfering with my government. If their taxpayer’s dollars can’t be used to provide grants for hESC research, then why are my taxpayer’s dollars being used to provide grants to their religious organizations? For that matter, why are their religious organizations even granted tax exempt status?
________________________________________________________________
Dickey-Wicker:
SEC. 128. None of the funds made available by Public 25 Law 104–91 may be used for—
(1) the creation of a human embryo or embryos for research purposes; or
(2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and 42 U.S.C. 289g(b).
For purposes of this section, the phrase ‘‘human embryo or embryos’’ shall include any organism, not protected as a human subject under 45 CFR 46 as of the date of enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes.
45 CFR 46.208:
TITLE 45–PUBLIC WELFARE AND HUMAN SERVICES
PART 46–PROTECTION OF HUMAN SUBJECTS-
Subpart B–Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human In Vitro Fertilization
Sec. 46.208
Activities directed toward fetuses in utero as subjects.
(a) No fetus in utero may be involved as a subject in any activity covered by this subpart unless:
(1) The purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or
(2) the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means.
(b) An activity permitted under paragraph (a) of this section may be conducted only if the mother and father are legally competent and have given their informed consent, except that the father’s consent need not be secured if:
(1) His identity or whereabouts cannot reasonably be ascertained,
(2) he is not reasonably available, or
(3) the pregnancy resulted from rape.
42 U.S.C. 289g:
§ 289g. Fetal research
(a) Conduct or support by Secretary; restrictions
The Secretary may not conduct or support any research or experimentation, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation—
(1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or
(2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
(b) Risk standard for fetuses intended to be aborted and fetuses intended to be carried to term to be same
In administering the regulations for the protection of human research subjects which—
(1) apply to research conducted or supported by the Secretary;
(2) involve living human fetuses in utero; and
(3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations;
or any successor to such regulations, the Secretary shall require that the risk standard (published in section 46.102(g) of such part 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.
I’m going to design my very own activity since there aren’t any reliable jobs out there.
Could any individual provide any ideas or online resources about how to get government grant money to set up my own business? I’ve been looking over the internet but each and every web-site demands for money and I have been previously told by the unemployment office to stay away from the sites that ask for cash for grant info because they’re rip-offs. I’d be really grateful for any support.