Tuesday, August 24, 2010

The meaning of research

The case Sherley v. Sebelius on federal funding of embryonic stem cells is getting some publicity.

One legal gambit in the case was the attempt by the defendants to enter into the "Chevron two step":

The defendants argued that the term “research” is ambiguous, and that, as a result, their interpretation of research
should be entitled to Chevron deference. See Chevron U.S.A., Inc., v. Natural Resources Defense
Counsel, Inc., 467 U.S. 837, 843 (1984).

The Court's answer:

Congress has spoken to the precise question at issue—whether federal funds may be used
for research in which an embryo is destroyed. The Dickey-Wicker Amendment provides that no
federal funds shall be used for “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 C.F.R. § 46.204(b) and section 498(b) of the Public Health Service
Act (42 U.S.C. 289g(b)).” Pub. L. No. 111-8, § 509(a)(2). Thus, as demonstrated by the plain
language of the statute, the unambiguous intent of Congress is to prohibit the expenditure of
federal funds on “research in which a human embryo or embryos are destroyed.” Id.

Contrary to defendants’ argument, the term “research” as used in the Dickey-Wicker
Amendment has only one meaning, i.e., “a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable
knowledge.” 45 C.F.R. § 46.102(d); see also Random House Dict. (listing the first definition of
research as “diligent and systematic inquiry or investigation into a subject in order to discover or
revise facts, theories, applications, etc.”). This is the most common definition of research, and
no other definition of research is supported by the language of the statute.
The language of the statute does not support defendants’ alternative definition of research
as “a piece of research.” (Def.’s Opp’n [22] at 31 (citing RANDOM HOUSE DICT. (2009).)
Indeed, the Dickey-Wicker Amendment does not contain any language to support such a limited
definition of research. Rather, the language of the statute reflects the unambiguous intent of
Congress to enact a broad prohibition of funding research in which a human embryo is destroyed.

The bottom line:

This prohibition encompasses all “research in which” an embryo is destroyed, not just the “piece
of research” in which the embryo is destroyed. Had Congress intended to limit the Dickey-
Wicker to only those discrete acts that result in the destruction of an embryo, like the derivation
of ESCs, or to research on the embryo itself, Congress could have written the statute that way.
Congress, however, has not written the statute that way, and this Court is bound to apply the law
as it is written. Accordingly, this Court must “give effect to the unambiguously expressed intent
of Congress” to prohibit federal funding of research in which a human embryo is destroyed.
Chevron, 467 U.S. at 843.

One must remember the basis for standing here concerned FUNDING.
Of irreparable injury, the Court noted:

Plaintiffs are researchers who work exclusively with ASCs. They seek funds for their
research projects from defendants and allege “that obtaining NIH funding is necessary for their
continued research.” (...)There is no after-the-fact remedy for this injury because the Court cannot
compensate plaintiffs for their lost opportunity to receive funds. See Bracco Diagnostics, Inc. v.
Shalala, 963 F. Supp. 20, 29 (D.D.C. 1997) (quoting Hoffman-Laroche Inc. v. Califano, 453 F.
Supp. 900, 903 (D.D.C. 1978) (stating that even if an injury is economic in nature, the injury may
be irreparable if “there is ‘no adequate compensatory or other corrective relief’ that can be
provided at a later date”). Accordingly, plaintiffs would suffer irreparable injury in the absence
of the injunction.

Yes, the status quo and private funding are mentioned:

The balance of hardships weighs in favor of an injunction. Defendants argue that two
interested parties would be injured if the Court issues an injunction: ESC researchers and
individuals who suffer from diseases that may be treatable in the future as a result of ESC
research. The Guidelines give ESC researchers, like plaintiffs, the opportunity to compete for
NIH funding. The injunction, however, would not seriously harm ESC researchers because the
injunction would simply preserve the status quo and would not interfere with their ability to
obtain private funding for their research.

And, just as californiastemcellreport didn't publish LBE's comment about the case, the
decision does not mention CIRM.

The Lamberth opinion does talk about speculative:

In addition, the harm to individuals who suffer from
diseases that one day may be treatable as a result of ESC research is speculative. It is not certain
whether ESC research will result in new and successful treatments for diseases such as
Alzheimer’s and Parkinson’s disease.

***An article by Carol Cratty of CNN titled Government will appeal injunction against stem cell funding has some problematic points:

--> Monday's ruling involved a lawsuit against the NIH filed by researchers opposed to use of embryonic stem cells, a group that seeks adoptive parents for human embryos created through in vitro fertilization, the nonprofit Christian Medical Association and others.

[The only plaintiffs in the case on 23 Aug 2010 were adult stem workers, who had standing because they were adversely affected as to funding]

-->In his ruling, Lamberth said he was granting the injunction because of the likelihood that the lawsuit will succeed.

[In the "conclusion," Lamberth wrote:

Plaintiffs have established that the preliminary injunction factors—the likelihood of
success on the merits, irreparable injury, the balance of hardships, and the public interest—weigh
in favor of a preliminary injunction. Accordingly, the Court will GRANT plaintiffs’ motion [3]
for a preliminary injunction.

Sloppy reporting by Cratty.


see Stem Cells Are Back! Is It All Semantics?


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