JLVernonPhD presents "American SciCo"

It is highly likely that our current representatives in Congress struggled with science in high school and college.  I say this because in the current Congress, only 17 House members and no senators are scientists (PhDs).  Well, yesterday’s ruling by Judge Royce Lamberth, which places an injunction on federal funding for embryonic stem cells, tells me that they continue to struggle with science.  It’s not that I feel they need to be experts on embryonic stem cell research.  It is that if they understood science, they might have seen this case coming. 
You see, the ruling in this case is based on interpretation of a single word in the Dickey-Wicker Amendment, a “rider” attached to the Labor, HHS and Education appropriations act. 

That word?  “Research.”  The word “research” appears in the rider multiple times as follows:

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).

The definition of the word “research” has been interpreted by Judge Lamberth to include all studies that rely on cells derived from the original embryo.  According to Lamberth’s ruling all subsequent research using embryonic stem cells falls under the jurisdiction of this law and shall not be funded.  This interpretation of the word “research” is perplexing to me.

To explain my consternation I’ll use a personal example.  Since I work in a cell biology lab, I have access to several human cell lines including HEK293 cells, HCT116 cells, K562 cells and the now MORE famous HeLa cells.  Each of these cell lines was derived from a human who likely died of cancer.  The cells are immortal so they continually divide as long as I provide proper nutrients for them to grow.  Now, since I work with cancer cells, you might think that I study cancer, right?  Wrong.  I study something completely unrelated to cancer.  I study gene targeting in human cells.  There is a chance that the results of my research could someday be used to treat or even cure cancer, but no reasonably knowledgeable scientist would say that I study cancer.  In fact, as was well-characterized in Rebecca Skloot’s book, we, scientists, put only brief thought into the actual origin of the cells we use for our experiments.  Odd, but true. We feel that we are distantly removed from the original “research” that gave rise to the cells in the first place.  Similarly, stem cells that derive from an embryo will be used in hundreds, maybe thousands, of research disciplines and I would venture to guess that the scientists using these cells would rarely say that they are doing “embryonic stem cell research.”  They might say that they are doing cancer research, Parkinson’s research or even HIV research, but not specifically embryonic stem cell research. 

So as you can see, it is confusing for me to read that all “research” that incorporates embryonic stem cells shall fall under the guidelines of the Dickey-Wicker Amendment, which is designed to regulate “research in which a human embryo or embryos are destroyed.”  Further, I think I have demonstrated that there is a reasonable argument to be made that the word “research” as it appears in the amendment is subject to multiple interpretations.  Based on this point, I suggest that Judge Lamberth made a critical error in this case by suggesting that there is no ambiguity in the word “research.”  Lamberth is ignoring the fact that the NIH has repeatedly relied on the ambiguity of this word to justify lifting the ban on funding for embryonic stem cell research.

Lamberth has rejected the NIH’s argument that the ambiguity that exists in the term “research” is sufficient to force the judge to follow the U.S. Chevron deference rule.  This rule of deference basically states if a statute administered by an agency is ambiguous with respect to the specific issue, the courts will defer to the agency’s reasonable interpretation of the statute.  This would give the NIH authority to interpret the meaning of the word “research.”  According to President Obama’s executive order, the term “research” in the Dickey-Wicker amendment should not include experiments downstream of the isolation and preparation of the embryonic stem cells.  It is on this argument that I believe the NIH will win the case.

Returning to my original point, all of this could have been prevented if Congress had a better grasp of the process of scientific research.  If they did understand the process, they might have passed a law to change or replace the Dickey-Wicker Amendment and remove any ambiguity about the word “research” and about the intention of this law to fund research that involves the use of embryonic stem cells.  That law might go a little something like this:

SEC. 498D. HUMAN EMBRYONIC STEM CELL RESEARCH.

(a) In General- Notwithstanding any other provision of law (including any regulation or guidance), the Secretary shall conduct and support research that utilizes human embryonic stem cells in accordance with this section (regardless of the date on which the stem cells were derived from a human embryo).

(b) Ethical Requirements- Human embryonic stem cells shall be eligible for use in any research conducted or supported by the Secretary if the cells meet each of the following:

(1) The stem cells were derived from human embryos that have been donated from in vitro fertilization clinics, were created for the purposes of fertility treatment, and were in excess of the clinical need of the individuals seeking such treatment.

(2) Prior to the consideration of embryo donation and through consultation with the individuals seeking fertility treatment, it was determined that the embryos would never be implanted in a woman and would otherwise be discarded.

(3) The individuals seeking fertility treatment donated the embryos with written informed consent and without receiving any financial or other inducements to make the donation.

(c) Guidelines- Not later than 60 days after the date of the enactment of this section, the Secretary, in consultation with the Director of NIH, shall issue final guidelines to carry out this section.

(d) Reporting Requirements- The Secretary shall annually prepare and submit to the appropriate committees of the Congress a report describing the activities carried out under this section during the preceding fiscal year, and including a description of whether and to what extent research under subsection (a) has been conducted in accordance with this section.

Well, the fact of the matter is that this legislation has been written.  It is H.R. 873: Stem Cell Research Enhancement Act of 2009 and it currently sits in committee, as it has since February 4, 2009, without sufficient action to get it to the floor of the House.  The bill was written by Diana DeGette [D-CO] and Michael Castle [R-DE] and submitted with a host of co-sponsors.  Despite the existence of this bill, we are now stuck in what will surely be a costly and ugly court battle that may or may not fall based on the arguments that I have proposed above.  So, once again, Congress has failed stem cell science.

Additional arguments:

I also believe the implications of this ruling conflict with current funding norms and shall not be upheld in higher courts.  The plaintiffs arguments basically state that funding for embryonic stem cells will negatively impact their chances of receiving funding for their research on adult stem cells.  I’d like to know when Congress became responsible for deciding which lawful areas of research are to be funded.  My experience has been that once an area of research has been shown to be protected under the law, the funding decision falls under the jurisdiction of the NIH, which funds grants that are most consistent with the NIH research mission.  If scientists are now allowed to sue the government in order to bypass the normal competitive procedures for receiving research funds, I know a few people who should be hiring lawyers.   

Stay tuned…