::Edit:: The injunction that was the subject of this post was reversed on appeal by the D.C. Circuit in Sherley v. Sebelius, 644 F.3d 388 (D.C. Cir. 2011).
On Monday, a federal court issued an injunction against NIH funding of embryonic stem cell research. This decision has severe impacts on ongoing and proposed research projects. Although labs that received grants and their disbursements for embryonic stem cell research will be able to spend the money they’ve already gotten, new grant application review has ceased, and annual renewals of existing awards have also been suspended. Additionally, NIH is still figuring out whether “no cost extensions”, a common request to spend disbursed money beyond the proposed project years, will be allowed. This injuction should never have been granted.
In 1996, Congress passed the Balanced Budget Downpayment Act, which contained a rider, the Dickey-Wicker Amendment, which prohibited the use of federal money in projects involving the creation of embryos for research, or research in which a human embryo is destroyed or discarded. From then on, the Amendment was included in every major appropriations bill involving the Department of Health and Human Services, most recently in 2009.
- SEC. 509. (a) None of the funds made available in this Act 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 Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)) (Title 42, Section 289g(b), United States Code).
- (b) For purposes of this section, the term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 (the Human Subject Protection regulations) . . . that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes (sperm or egg) or human diploid cells (cells that have two sets of chromosomes, such as somatic cells).
Fortunately and unfortunately for scientists, Congress has a very limited understanding of scientific research. Embryonic stem cells are not taken from embryos each time an experiment is to be performed, just as cancer cells do not need to be freshly taken from a tumor every time they are studied in a lab. HeLa cells, for example, are the predominant cells used for study of human cell biology. The HeLa cells used in labs today around the world are all descended from a sample taken in 1951 from a patient with an aggressive cervical adenocarcinoma–Henrietta Lacks. Those cancer cells now constitute an immortal “cell line”, and can replicate indefinitely in vitro. Embryonic stem cells are similarly immortal. Once the original cell lines were established from embryos, no future embryos will be needed to replenish the stock of those cell lines. This was a loophole to the Amendment. Stem cell lines were created by private companies who destroyed embryos, but the researchers with government grants only used stock cell lines. It’s important to note that even after this loophole was established and basically continued as precedent, Congress took no steps to modify the language of their Amendment to remove this loophole. It’s also interesting to remember that even though HeLa cells were procured (basically stolen) from Henrietta Lacks in what would today be seen as a clearly unethical manner, no one argues that the use of HeLa cells (which is vitally important to biology research) should be discontinued as a sort of fruit of the poisonous tree.
In 2001, George W. Bush announced a policy of limited funding for stem cell research, in which embryonic stem cell lines created prior to 2001 could be funded. In 2009, Barack Obama lifted all limitations on embryonic stem cell research. The embryos used for creation of new cell lines would be sourced from only embryos created for in vitro fertilization reproductive purposes and were no longer needed, and were donated by individuals who gave voluntary written consent.
Like many interested parties, I do not believe this injunction should have been granted. As D.C. District Court Chief Judge Royce Lamberth writes in his opinion:
A preliminary injunction is “an extraordinary remedy that should be granted only when the party seeking the relief, by a clear showing, carries the burden of persuasion. Cobell v. Norton, 391 F.3d (251, 258 (D.C. Cir. 2004). A party carries this burden of persuasion by establishing: (1) that there is a substantial likelihood of success on the merits; (2) that the plaintiff would suffer irreparable injury absent an injunction; (3) that an injunction would not substantially injure other interested parties; and (4) that an injunction would further public interest.
The Court found that each of these weighed in favor of the plaintiff doctors. I want to skip 3 and 4 (because I think scientists and society have both clearly suffered from this injuction) and focus on 1 and 2.
I do not believe there was a substantial likelihood of success based on the merits. As quoted, the language of the Dickey-Wicker Amendment bans federal funding for projects involving “the creation of a human embryo or embryos for research purposes; or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death.” As I stated above, most of the embryonic stem cells used in labs today have been derived from existing immortal cell lines created by other labs. There is simply not a need to destroy new embryos for the use of established cell lines, and so at a minimum an injunction should not apply to projects where there is no destruction of an embryo, simply the use of an old stem cell line, but only blocking the funding of new embryonic cell lines/destruction of new embryos. The embryonic stem cell lines approved by George Bush, for example, should continue to receive research funding. The Court writes that “ESC research is clearly research in which an embryo is destroyed. To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo.” On the contrary, embryos had been destroyed and once depended on the destruction of a human embryo. It is entirely possible and most often the case that embryonic stem cell research may continue in which no human embryo is destroyed, by a private company or a federally funded actor.
Next we have the “irreparable injury absent an injunction.” The two plaintiffs in this case were Dr. James Sherley and Dr. Theresa Deisher. They are researchers of adult stem cells who claimed competitor standing; they were eligible to sue because the embryonic stem cell policy would “result in increased competition for limited federal funding.” To put it simply, I doubt these fine researchers will get NIH funding after this. Peer review of grant applications is already not only highly difficult to pass with many researchers struggling to receive funding–according to Science, “The NIH typically receives between 35,000 and 40,000 proposals a year, while the NSF gets roughly half that number. Only a quarter to a third of these proposals are ever funded”–but also highly political. The NIH review committee use five core review criteria: significance, investigators, innovation, approach, and environment. The reputation of the investigators plays a role in the grant review, as does it in peer review for scientific journals. Grant proposals must include a “Biosketch” with the CVs of the PI and other key personnel. I can’t think these plaintiffs helped their cases before the NIH review committee, especially when there is plausible deniability given the high rate of unapproved grant proposals, and given the past grant history of one of the plaintiffs, revealed below.
Interestingly, the plaintiffs had separate experiences in receiving NIH funding. I used the NIH RePORTER engine to search for historical grants given to these researchers (if you try this, make sure to expand the fiscal year search to all years, and uncheck the ‘active projects’ box). I’ve never really used this before, so I tested it by looking up the grant history of a professor I worked for at Columbia University, Dr. Darcy Kelley. She had multiple grants listed, all the way back from 1986, listed on the server; so it looks like RePoRTER gives both current and historic NIH grants. A search for Theresa Deisher, however, found no grants ever awarded. Dr. Theresa Deisher, who graduated with a PhD from Stanford in 1990, has never been awarded an NIH grant. Did she really suffer competitively from any embryonic stem cell funding? After two decades of futility, I don’t think this stunt will help her in her quest for NIH money. Side note: Deisher is clearly also in this for religious, and not personal financial, reasons. She’s been trying to establish a connection between abortion, vaccines, and autism with funding from a pro-life group. On the other side of things is Dr. Sherley, who despite hunger-striking after being denied tenure by MIT, has managed to assemble a steady stream of NIH grants since 1988, including a grant in 2010. Has he really suffered from embryonic stem cell funding after Bush’s 2001 policy, and Obama’s 2009 policy? I think standing should have been denied to these plaintiffs, one of whom couldn’t get a grant before competition from ESC researchers, and one of whom got grants in spite of them. There is no evidence to show that their success or lack thereof in obtaining grants was changed in any way by Bush’s or Obama’s policies.
The U.S. Department of Justice will appeal this incorrect decision to the DC Circuit Court of Appeals, and regardless of how one feels ethically about the use of embryonic stem cells, I think the scientific fact and legal background makes the correct ruling quite clear. Hopefully there can be a speedy review and decision from the D.C. Circuit that will restore funding to embryonic stem cell researchers, and they can continue their important work in battling the diseases that plague humanity.
I implied that Chief Judge Lamberth was wrong in granting Drs. Sherley and Deisher standing, but it looks like the fault may not be his/the District Court’s. When the case originally came through his District Court in October 2009, Lamberth signed a memorandum opinion in Sherley v. Sebelius that stated:
The competitor standing doctrine is not applicable to the facts of this case. The Supreme Court has held that the competitor standing doctrine applies only “when the particular statutory provision [or regulation] invoked . . . reflect[s] a legislative purpose to protect a competitive interest.” Hardin v. Ky. Util. Co., 390 U.S. 1, 6 (1968). Here, Drs. Sherley and Deisher have not demonstrated that they have a protected competitive interest in receiving NIH funding. Their only protected interest is their opportunity to compete with other applicants for limited NIH funding. See CC Distributors Inc. v. United States, 883 F.2d 146, 150 (D.C. Cir. 1989) (stating that “a plaintiff suffers a constitutionally cognizable injury by the loss of an opportunity to pursue a benefit”). The guidelines neither prevent nor hinder either doctor’s opportunity to compete for funding. Indeed, Drs. Sherley and Deisher’s proposals for adult stem cell research can receive funding if they survive the two-tier review process that all applications undergo.
Last, even if the competitive standing doctrine did apply, Drs. Sherley and Deisher would not have standing because the guidelines will not “almost surely cause [Drs. Sherely and Deisher] to lose” funding. El Paso Natural Gas Co., 50 F.3d at 27. The application process to receive NIH funding is extremely competitive. Only about 22% of applications receive NIH funding. (Rockey Decl. ¶ 14.) Thus, even if the guidelines did not exist, Drs. Sherley and Deisher are not assured of receiving funding for adult stem cell research.
Accordingly, the Court concludes that the competitor standing doctrine does not apply and that Drs. Sherley and Deisher lack standing.
However, the District Court was reversed on appeal to the D.C. Circuit in June 2010, in which a three judge panel of Brown, Ginsburg, and Kavanaugh ruled that they did have competitor standing, and prudential standing:
The Doctors have met the basic requirement for competitor standing. This is not a situation like that in El Paso, in which it was uncertain whether a new seller would enter the market. 50 F.3d at 27. There can be no doubt the Guidelines will elicit an increase in the number of grant applications involving ESCs; indeed, the Government never suggests otherwise. Because the Guidelines have intensified the competition for a share in a fixed amount of money, the plaintiffs will have to invest more time and resources to craft a successful grant application. That is an actual, here-and- now injury.
This sent the case back to Lamberth, who then granted the preliminary injunction. What’s interesting about this, to me, is that much ado has been made about Lamberth’s possible conservative leanings given the fact that he is a Reagan appointee. This evidence suggests that he is more impartial than given credit for. Given the chance to grant standing (and a preliminary injunction) the first time, he demurred, even though, judging from the D.C. Circuit’s decision, it could have easily gone the other way.