Search results for ""stem cell""

D.C. Circuit Upholds Stem Cell Research Funding, Again

The D.C. Circuit today upheld, for the second time in 16 months, President Obama’s Executive Order permitting the National Institutes of Health to fund human embryonic stem cell (hESC) research. The same issue was before the court last year on an appeal of a preliminary injunction that would have halted all federal funding of hESC research. After the Circuit found that the Executive Order was not contrary to law and thus overturned the preliminary injunction, the District Court reluctantly granted summary judgment on the merits of the case for the government. It is the appeal of that ruling that the Circuit decided today. The outcome was somewhat anti-climactic given the four month delay between oral argument and the opinion in a case that had already been decided: all three judges on the panel agreed that the last year’s decision constituted the law of the case and thus reaffirmed that holding.

The most interesting of today’s three separate opinions – one for the court by Judge Sentelle and concurring opinions by Judges Henderson and Rogers – was Henderson’s. Henderson was on last year’s panel (with Judges Ginsburg and Griffith) and she wrote a strongly worded dissent then. She concurred in today’s judgment on the basis of the “law of the case” reasoning, but took the opportunity to again attack last year’s majority opinion. Her legal theory of why the majority was wrong, however, apparently has changed in the last year.

To review briefly, the basis for the challenge the Obama Executive Order is the Dickey-Wicker Amendment, passed by Congress as a rider to appropriations bills every year since 1976, which prohibits federal funding of “research in which a human embryo or human embryos are destroyed, discarded, or knowingly subjected to risk of injury or death….” The plaintiffs in the litigation claimed [...]

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Paying People for Bone-Marrow-Derived Stem Cells Extracted from Blood (Not Bone) Is Legal, Rules the Ninth Circuit

Two years ago, Jeff Rowes of the Institute for Justice blogged about a case they were bringing seeking to establish the legality of paying people for bone marrow cells, notwithstanding the National Organ Transplant Act. Today, the Ninth Circuit just handed down a decision in the case, Flynn v. Holder.

The Circuit rejected IJ’s constitutional claim that the ban on paying people for providing bone marrow cells extracted from hip bones is so irrational as to violate the Due Process Clause, concluding:

[Congress’s] reasons [for the ban] are in some respects vague, in some speculative, and in some arguably misplaced. There are strong arguments for contrary views [citing Virginia Postrel, who is know to many of our readers -EV]. But these policy and philosophical choices are for Congress to make, not us. The distinctions made by Congress must have a rational basis, but do not need to fit perfectly with that rational basis, and the basis need merely be rational, not persuasive to all. Here, Congress made a distinction between body material that is compensable and body material that is not. The distinction has a rational basis, so the prohibition on compensation for bone marrow donations by the aspiration method does not violate the Equal Protection Clause.

But it accepted IJ’s statutory claim — which the government disputed — that the statute does not ban paying people for providing bone-marrow-derived stem cells extracted from their blood. From the Conclusion:

[W]hen the “peripheral blood stem cell apheresis” method of “bone marrow transplantation” is used, it is not a transfer of a “human organ” or a “subpart thereof” as defined by the statute and regulation, so the statute does not criminalize compensating the donor.

Congratulations to my friend at the Institute for Justice for this victory, which I expect will [...]

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Judge Lamberth Yields to D.C. Circuit in Stem Cell Case

Judge Royce Lamberth of the U.S. District Court for the District of Columbia issued a final ruling today in Sherley v. Sebelius, upholding federal funding of human embryonic stem cell research eleven months after creating an uproar in the medical research community by issuing a preliminary injunction halting the funding. The decision came three months after the D.C. Circuit reversed his preliminary injunction on the ground that a federal appropriations statute (often known as the Dickey-Wicker Amendment) does not prohibit funding of research using the embryonic stem cells. Lamberth today held that the Circuit Court’s decision required him to resolve the underlying merits of the case in favor of the government and against two scientists who conduct research on adult stem cells and were earlier found by the D.C. Circuit to have “competitor standing” to challenge the Obama Administration’s expansion of the pool of research projects eligible for federal support. Lamberth also denied two arguments made by the plaintiffs that were not directly addressed in by the D.C. Circuit’s April ruling: that the Administration’s new policy of funding embryonic stem cell research violated the Dickey-Wicker Amendment by providing an incentive for scientists to destroy embryos (not using federal funds) in order to create new cell lines, and that the Administration violated the Administrative Procedure Act when promulgating the new funding regulations.

The annually-enacted Dickey-Wicker Amendment to federal appropriations prohibits federal funding of “research in which a human embryo or embryos are …knowing subjected to risk of injury or death.” Last year Lamberth ruled that the word “research” in the Amendment refers not just to the particular project for which a grant recipient seeks federal funding (such as studying whether and how embryonic stem cells can be used to fight disease) but also the earlier steps in the chain of [...]

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Stalemate in Stem Cell Battle

Last Friday, the D.C. Circuit voted 2-1 in Sherley v. Sebelius to reverse the preliminary injunction against federal funding of embryonic stem cell research granted by Judge Royce Lamberth of the federal District Court for the District of Columbia. While this seems on its face like a victory for proponents of the research, and was largely reported as such, I view its likely impact as prolonging the stalemate.

A quick recap of the issues (which I blogged about in greater detail last August here and here): Every year Congress includes a provision, known as the Dickey-Wicker Amendment, in its appropriation of funds for medical research that prohibits federal funding of “research in which” human embryos are destroyed. Three presidential administrations have interpreted this language as permitting funding of research on cultures of embryonic stem cell, as long as no federal funds are used to create such cultures in the first place (which requires the destruction of an embryo). Judge Lamberth enjoined such funding based on (a) his interpretation of the Dickey-Wicker Amendment as unambigiously prohibiting funding of any research involving embryonic stem cells and (b) his determination that the plaintiffs (researchers applying for federal funds for non-embryonic stem cell research) would suffer “irreparable harm” if funding were to continue before a final ruling on the merits. The D.C. Circuit quickly stayed the prelimary injunction pending its resolution of the appeal.

In last week’s ruling, the majority (Judge Ginsburg, joined by Judge Griffith) held that the preliminary injunction was improperly granted because (a) the Dickey-Wicker Amendment is ambiguous, and thus the Administration’s interpretation of its reach is entitled to Chevron deference, and (b) the potential harms of a preliminary injunction were greater to embryonic stem cell researchers (whose funding would be cut off mid-stream) than to the plaintiffs (who would [...]

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D.C. Circuit Issues Second Stay Order in Stem Cell Case

Following oral argument Monday, a three-judge panel of the D.C. Circuit (Rogers, Griffith, and Kavanaugh) yesterday ordered a “stay pending appeal” of District Court Judge Royce Lamberth’s preliminary injunction of NIH grants for human embryonic stem cell research.

This is clearly good news for the federal government and supporters of embryonic stem cell research. Judge Lamberth’s order that the government must stop funding this research is still on hold, as it has been since the same D.C. Circuit panel issued an administrative stay order on September 9.

For those interested only in the policy issue, you can stop reading now. For those issued in procedure, please continue.

I’m scratching my head over whether there is any practical significance to yesterday’s order, which replaces the September 9 “administrative stay” currently in place with a “stay pending appeal,” and then orders that the appeal itself be expedited. Here’s the actual text:

Upon consideration of the government’s emergency motion to stay preliminary injunction pending appeal and for immediate administrative stay, the opposition thereto, the reply, and the argument by counsel, it is

ORDERED that the administrative stay entered September 9, 2010, be dissolved.

It is FURTHER ORDERED that the motion for stay pending appeal of the preliminary injunction entered on August 23, 2010, be granted. Appellants have satisfied the standards required for a stay pending appeal. See Metro. Area Transit Comm’n v. Holiday Tours, Inc., 559 F.2d 841, 843 (D.C. Cir. 1977); D.C. Circuit Handbook of Practice and Internal Procedures 32-33 (2010).

It is FURTHER ORDERED, on the court’s own motion, that consideration of this appeal be expedited. The parties will be notified by separate order of the briefing schedule and oral argument date.

According to the citations provided, a stay pending appeal is appropriate when the petitioner demonstrates either a strong likelihood [...]

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Judge Denies Stay on Stem Cell Research Injunction

Following the August 23 preliminary injunction issued by federal District Court Judge Royce Lamberth to block NIH funding of embryonic stem cell research, the Justice Department filed a motion requesting that the injunction be stayed pending an appeal to the D.C. Circuit. In a very short, 2-page order this afternoon, Judge Lamberth denied the stay motion.

Lamberth’s decision is not surprising, given that the issues at the root of both a motion for a preliminary injunction and a motion for a stay order are essentially the same: the court must weigh (1) the relative harm that each side would suffer if they ultimately prevail on the underlying merits of the dispute but are precluded from acting in the way desired while the underlying issue wends its way through the legal system and (2) the “irreparable” nature of such harm. I believe Lamberth’s ruling today is legally incorrect, for the same reasons articulated in my August 25 post analyzing the preliminary injunction. I won’t rehash those arguments in their entirety, but a couple of points bear noting in light of today’s order.

For practical purposes, the most important point in today’s order — and the one that should be the lead in tomorrow’s newspapers — is Lamberth’s surprising statement that his injunction does not prohibit the NIH from continuing to fund embryonic stem cell research that was permitted by the Bush Administration under its restrictive rules. This is a silver lining for some stem cell researchers, because it means that research projects on the 21 Bush-approved stem cell lines that has been ongoing for as long as eight years need not be shut down. But it completely undermines the reasoning of Lamberth’s decision on the merits of the case, and helps to illustrate why it should be overturned on appeal.

To [...]

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Stem Cell Shock #2: The Preliminary Injunction

In a post yesterday, I described why I think Judge Royce Lamberth’s decision on Monday that the Dickey-Wicker Amendment prohibits the federal government from funding human embryonic stem cell (hESC) research is wrong on the merits. Technically, however, the decision was not a ruling on the merits. Lamberth actually granted the plaintiffs’ motion for a preliminary injunction. Because the issue is a pure question of statutory interpretation, and because the opinion in no way suggested that it was tentative in nature, it seems almost certain that Lamberth will eventually replace the preliminary injunction with a permanent one. But the government is entitled to another day in court before this can happen.

Lamberth’s grant of the preliminary injunction is even more troubling as a legal matter than his quasi-merits determination. To win a preliminary injunction, the plaintiff must show (1) a substantial likelihood of success on the merits; (2) that the plaintiff will suffer “irreparable injury” in the absence of an injunction; (3) the injunction would not substantially harm other interested parties; and (4) that the injunction would further the public interest. The plaintiff must carry the burden of persuasion “by a clear showing.” Cobell v. Norton, 391 F.3d 251 (D.C. Cir. 2004).

Let’s take a look at Lamberth’s analysis of these four guideposts:

Although I do not agree with the judge’s analysis of merits (i.e., the meaning of the Dickey-Wicker Amendment), under his analysis, the plaintiffs would seem to have a substantial likelihood of success on the merits.

The second question is whether, if the plaintiffs were to eventually prevail on the merits of their claim, a failure to enjoin the government from funding hESC research in the intervening period would cause them irreparable harm. Judge Lamberth finds that the plaintiffs “have met this high burden.”

The plaintiffs argue that [...]

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Shocking Stem Cell Decision

Yesterday’s opinion by District Court Judge Royce Lamberth enjoining federal funding of human embryonic stem cell (hESC) research sent shockwaves throughout the medical research community. As usual in this area, the implications of the decision, rather than the legal analysis, is getting all the air time. I’ll discuss the statutory interpretation issue on which the case turns.

The legal issue is the proper interpretation of the Dickey-Wicker Amendment, an obscure provision attached by Congress to omnibus appropriation bills every year since 1996. The amendment prohibits the use of federal money for scientific “research in which … embryos are destroyed, discarded, or knowingly subject to risk of injury or death….” The Clinton, Bush, and Obama administrations have all interpreted this language to mean that the NIH may not fund the creation of embryonic stem cell lines, a procedure that destroys a 5-day old donor embryo (known as a blastocyst) by removing its inner cell mass. The conventional wisdom has always been that Dickey-Wicker does not speak to the question of federal funding of research on hESC lines themselves. These hESC lines, once created, replicate themselves, and the cells are shipped by the institutions that manage them to researchers around the world. The distinction matters a lot, because creating hESC lines isn’t all that hard or all that expensive, relatively speaking, and researchers don’t need a huge number of cell lines to work with. It is not much a problem to rely solely on private funding to create these research materials. What costs hundreds of millions of dollars, and requires substantial federal support, is funding the thousands of scientists who use hESC lines to study human development and search for cures for a range of disabling illnesses and conditions. The Bush Administration largely refused to provide this funding, but it did not [...]

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Stem Cell Advance Raises New Questions:

Two respected scientific journals today reported that Chinese researchers have created baby mice out of induced pluripotent stem cells (“iPSCs”), an advance that raises difficult ethical questions and could reignite the culture-war battles over stem cell research that have subsided over the last two years.

Many conservatives oppose human embryonic stem cell (hESC) research, and President George W. Bush severely limited its funding, because the five-day old embryos (called blastocysts) that are used are living organisms and, if implanted into a uterus, could mature into people. Although President Obama lifted the Bush funding restrictions, the NIH released new guidelines that are still solicitous of the discomfort many Americans feel about using blastocysts for medical research: the Obama administration will fund such research only if the blastocysts used are “extras” created in in vitro fertilization clinics and would otherwise be destroyed anyway. Want to create a blastocyst in a test tube in order to produce stem cells? Don’t look for federal funding, even from a Democratic administration.

The new federal regulations have provoked relatively little media attention, in part because most scientists have believed for the last year or two that hESCs are a transitional technology about to be overtaken by a newer one. In late 2007, scientists succeeded in reprogrammed ordinary adult skin cells (and other types of adult cells) into cells that seem to behave, for all practical purposes, like hESC cells. Scientists still aren’t sure that these new iPSCs will behave exactly the same as hESCs for purposes of medical research, but the available evidence looks good, and iPSCs have a number of advantages over hESCs. They are much easier to produce than hESCs, and unlike hESCs, iPSCs offer the potential of allowing scientists to one day use a patient’s own cells as the basis for creating a [...]

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Stem Cells and Science (Policy) Fiction:

I’ve had a busy travel and writing week, so I did not have time to comment on President Obama’s stem cell policy announcement and accompanying statement on the “restoration” of “scientific integrity to government decision-making.” Fortunately, Charles Krauthammer wrote an excellent column on the announcement (even if he overdid his praise of President Bush). Here’s a bit of it:

Obama’s address was morally unserious in the extreme. It was populated, as his didactic discourses always are, with a forest of straw men. Such as his admonition that we must resist the “false choice between sound science and moral values.” Yet, exactly 2 minutes and 12 seconds later he went on to declare that he would never open the door to the “use of cloning for human reproduction.”

Does he not think that a cloned human would be of extraordinary scientific interest? And yet he banned it.

Is he so obtuse as not to see that he had just made a choice of ethics over science? . . . Obama did not even pretend to make the case why some practices are morally permissible and others not. . . .

Science has everything to say about what is possible. Science has nothing to say about what is permissible. Obama’s pretense that he will “restore science to its rightful place” and make science, not ideology, dispositive in moral debates is yet more rhetorical sleight of hand — this time to abdicate decision-making and color his own ideological preferences as authentically “scientific.”

Whether or not one agrees with the specifics of the President’s new stem cell policy — Krauthammer, who found the Bush policy too restrictive, thinks the Obama policy too permissive with the use of federal funds — there is no defense of the accompanying science charade.

UPDATE: Scott Gotleib also has [...]

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Obama Removes Stem Cell Barriers.

In a good move today, President Obama removed Bush Administration barriers to some forms of stem cell research [funding].
Executive Order of March 9, 2009:

Sec. 1: . . . For the past 8 years, the authority of the Department of Health and Human Services, including the National Institutes of Health (NIH), to fund and conduct human embryonic stem cell research has been limited by Presidential actions. The purpose of this order is to remove these limitations on scientific inquiry, to expand NIH support for the exploration of human stem cell research, and in so doing to enhance the contribution of America’s scientists to important new discoveries and new therapies for the benefit of humankind.

Sec. 2. Research. The Secretary of Health and Human Services (Secretary), through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law.

Sec. 3. Guidance. Within 120 days from the date of this order, the Secretary, through the Director of NIH, shall 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.

Behind Obama at the signing was a group of distinguished scientists, including my wife’s mentor, Janet Rowley of the University of Chicago.

Obama gave an eloquent little speech about basing policy on science and facts. I am happy to see this remnant of what has been called the “Republican war on science” fall by the wayside. I wish he would take on the war on science being waged by many mainstream scientists (and their political acolytes) in the climate field. If scientific standards were higher in that field, I doubt that Obama would [...]

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Invitation to Nov. 28 “Stem Cell Century” panel discussion:

I want to invite all VC readers in the Boston area interested in the policy issues surrounding stem cell reserach to a panel discussion of my new book tomorrow, Wednesday, Nov. 28, from 6-7:30 p.m. The event, sponsored by the Harvard Stem Cell Institute and the Harvard Law School’s Health Policy Center, will be held at “The Meeting Room,” located at 2 Arrow Street in Cambridge, MA, about a block away from Harvard Yard. I’ll be speaking about the book, and then commentary will be provided by Professors Kevin Eggan (a well-known Harvard stem cell scientist), Frances Kamm (a philosopher at the Harvard Kennedy School of Government), and Pam Samuelson (an intellectual property expert at Boalt Hall and Harvard Law School). The event is open to the public, so please let any friends or colleagues interested in stem cell research specifically or the interface between law and biotechnology in general know. [...]

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Exciting Stem Cell News:

Two publications (Science and Cell) published papers today showing that scientists have succeeded in reprogramming human adult cells to behave much like human embryonic stem cells (hESCs). Following on findings published several months using mouse rather than human cells, the researchers responsible for today’s results were able to spur the reprogramming by inserting four genes into the adult cells.

The big question is whether this new technique will quell the stem cell research controversy, which arises largely from the fact that the stem cells scientists believe have the greatest medical potential are today derived from 5-day old embryos. The answer is “maybe.” Scientists interviewed in today’s New York Times article were ebullient about the results, but it is worth remembering that there have been two major scientific discoveries in the last 18 months that promised to end the debate and then quickly faded from public view. In the summer of 2006, scientist Robert Lanza showed that it was possible to produce hESC lines without destroying embryos by carefully removing single cells from many 8-cell embryos. Although long term effects are unknown, we know that removing a single cell from an embryo at that stage does not prevent it from developing. This technique is routinely used to obtain genetic material for preimplantation genetic testing, and the embryos (less one cell) are successfully used for implantation by in vitro fertility clinics. In January of this year, scientists from Harvard and Wake Forest Universities reported that they had discovered stem cells in amniotic fluid that possessed many traits of hESCs.

I am optimistic about today’s discovery, but three questions remained to be answered, two scientific and one philosophical.

The scientific questions: First, will further research show that these reprogrammed cells actually have all the features of hESCs that make the latter [...]

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Stem Cell Vote in New Jersey:

[In conjunction with the release this month of my new book, Stem Cell Century: Law and Policy for a Breakthrough Technology” (more info here), I’ll be blogging about policy issues related to stem cell research and regenerative medicine occasionally over the next several weeks.]

Election season in the 21st Century seems to inevitably bring a battle over stem cell research, and 2007 is no different. Tomorrow, New Jersey residents will vote on a proposal to issue $450 million dollars in bonds over the next 10 years to fund stem cell research, a plan quite similar in design to California’s Proposition 71, the enactment of which in 2004 provided $3 billion in state funding over a decade. (Although frivolous legal challenges delayed the implementation of Prop. 71, appeals were exhausted in May and California’s stem cell agency is now providing funding in earnest.) Along with $270 million that New Jersey has already authorized to build five stem cell research facilities, tomorrow’s initiative, if passed, would make that state’s financial commitment to stem cell science second only to California’s in size, putting the Garden State’s effort comfortably ahead of New York’s and increasing the distance between it and far smaller financial commitments made by handful of other states including Connecticut, Maryland, and Illinois.

The race among states to publicly fund stem cell research is a response, of course, to President Bush’s prohibition on the use of federal funds to support research on any human embryonic stem cell lines derived from embryos after August 9, 2001. But even assuming that it is not immoral to destroy 5-day old embryos in the cause of medical research, that embryonic stem cells have particularly valuable therapeutic potential, and that the Bush funding policy is internally illogical (future posts will explain why all three of [...]

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President Bush’s Stem Cell Veto and Separation of Chruch and State:

Chicago lawprof Geof Stone criticizes the veto on church-state grounds, saying that it shows “a reckless disregard for the fundamental American aspiration to keep church and state separate.” Paul Horwitz (PrawfsBlawg) responds. Larry Solum (Legal Theory) passes along his own view.

My view is very close to Paul Horwitz’s, for the reasons I expressed in my 2005 debate with Geof Stone on the subject of religious reasons for government decisionmaking:

Geof Stone makes a forceful argument, but it seems to me that there are two quite different strands to it — strands that need to be separated.

At times, Geof is asking whether a “law [is] based on faith,” whether a “law [is] based solely on sectarian religious belief,” whether it “serves no legitimate public purpose.” This category, he suggests, does not include laws that are “perfectly sensible law without regard to anyone’s religious faith” or that have “a religious as well as a secular purpose,” which would include a “moral-based reason” as well a “faith-based reason.” Note that so far we’re talking about the law. [EV: I should add here that the ban on stem-cell research funding can have obvious “moral-based” justifications, albeit ones I disagree with, just as a ban on experimentation on animals or a ban on killing endangered species would have “moral-based” justifications, even if some may disagree with them.]

At other times, though, he asks whether a person (including a political leader) backs a law “based entirely on his own sectarian religious beliefs,” whether a person is “imposing [his] faith on others.” That is a very different inquiry, an inquiry into the subjective motivations of a law’s backers rather than whether the law in fact serves some public or moral purpose. For instance, I take it that all of us would agree that abolition

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