From the Executive Director: Stem Cell Program Does Not Win Key Ruling

The Island of Robert Klein?

Contrary to what you may have read in the print media in November 2005 about LLDF’s litigation related to the stem cell program in California, and in particular the San Francisco Chronicle, the stem cell institute did not win a key ruling in opposition to the litigation challenging the constitutionality of the operations of the Independent Citizen’s Oversight Committee (ICOC), the governing arm of the California Institute for Regenerative Medicine (CIRM). (1)

Due to the media coverage about the outcome of the hearings in this case, LLDF was the recipient of many calls by unnecessarily discouraged California residents who oppose taxpayer funding of the CIRM. This brings to mind the adage that you cannot believe everything you hear or read in the media. This case also demonstrates that the media either cannot understand, or will not understand, the issues in this case.

What did happen? Life Legal Defense Foundation brought a motion for judgment on the pleadings on behalf of its clients, the People’s Advocate and the National Tax Limitation Foundation, two taxpayer advocacy groups, asking the court to rule as a matter of law that the ICOC cannot spend three billion dollars in taxpayer funding on scientific research because the ICOC is not an entity under the exclusive management and control of the State of California, as required by Article 16, section 3 of the California Constitution. Another plaintiff in the case, California Family Bioethics Council, brought a motion for judgment on the pleadings, as did the Attorney General’s office on behalf of the ICOC. All three motions were denied, which means as a matter of law the court declined to make a ruling and we now go to trial on the matter.

According to Robert Klein, chairman of the ICOC and chief proponent of Proposition 71, the court’s ruling was a resounding victory for the ICOC. Perhaps this was just wishful thinking on his part, but the more likely explanation appeared in his statement to the media that “This opinion should be extremely helpful in providing broad support for the Bond Anticipation Note program of the CIRM.” In other words, he needs to build investor confidence in order to sell bond anticipation notes to keep the institute afloat while the litigation proceeds. These notes will only be redeemable if the ICOC prevails and can sell the planned $3 billion in general obligation bonds. If the ICOC loses, buyers get nothing back. Needless to say, savvy investors aren’t champing at the bit to get a share of such a risky scheme.

A deputy Attorney General who appeared at case management conference on December 6, 2005 also suggested that the court’s decision regarding the Motion for Judgment on the Pleadings was a victory for the ICOC, and, on that basis sought to have the court narrow discovery issues. The judge declined to narrow the issues as suggested, stating to the Attorney General that the issues would not be narrowed during discovery because no party won motion for judgment.

Admittedly it would have been ideal for the People’s Advocate and the National Tax Limitation Foundation to prevail on their motion for judgment. However, a trial leaves the ICOC exposed to the fact-finding discovery process. And brother, do they need to be exposed. Here is why:

In support of People’s Advocate and the National Tax Limitation Foundation’s motion for judgment, a friend-of-the-court brief was filed by five “pro-choice” individuals (Amici) who support our position in this case for a number of very noteworthy reasons. (2)

According to Amici, “Proposition 71 provides that the members of the ICOC are all potential grantees. Therefore, since the ICOC is ‘independent’ of government control, Prop 71 entrusts $3 billion of public funds in the autonomous hands of the grantees, all of whom have impermissible conflicts of interest.” Amici goes on to explain that ICOC procedure has departed from the federal model used by the National Institutes of Health (NIH), which protects against such conflicts of interest.

Amici also pointed out that NIH procedures protect human subjects from unsafe research. In that regard, the importance of the ICOC’s departure from such procedures is obvious, and in light of the following, may be dangerous to human research subjects.

According to Amici, “some of the same scientists from the field of gene delivery research, having made millions of dollars from university faculty start-up companies, are now the entrepreneurs of hESC [human Embryonic Stem Cell] research.” (3)

This means that scientists who were also “touting miracle cures of single-gene, single-disease cures, including [a] cure for diabetes through insulin gene delivery” are now touting another miracle cure resulting from hESC research. Keep in mind that “In 2002 the FSDA [U.S. Food and Drug Administration] halted several gene therapy trials after a boy in France developed a leukemia-like disease three years after receiving gene therapy bringing this line of research to a virtual dead end.” Perhaps the recent reports of Hwang Woo-suk, the Korean stem cell research scientist, whose recent confessions about his hESC research will result in a similar outcome for hESC research in the U.S. should the FDA take a second look at hESCR in California. (4)

Last, and perhaps the most striking example that Amici point to in their brief is what hESC opponents have been saying all along—“The truth is that hESC create human chimeras, and the long-term implications are wholly unknown… Prop 71 promoted hESC research, but promised there would be no funding of human cloning. However, Prop 71 used confusing and obscure terminology to mislead and conceal permitted forms of research. For example, Prop 71 permitted ‘somatic cell nuclear transfer’ (SCNT), which is a ‘softer’ term for ‘embryo cloning’ and ‘cloned embryo.’ The same technology was used to produce the cloned sheep, Dolly, and the cloned dog, Snuppy. In fact, that is the same necessary research for perfecting the means for producing cloned human beings.”

Amici go on to expose and document draft CIRM Guidelines which provide for the introduction of human embryonic stem cells into animals to produce “quasi-human chimeras.” That this type of “research” is being considered was never mentioned during the campaign by proponents of Proposition 71, and understandably so since the reaction to such a possibility would have been astonishing, not to mention detrimental to the Proposition 71 campaign.

As this issue of Lifeline goes to print we are beginning the discovery process in People’s Advocate, et al. vs. the Independent Citizens’ Oversight Committee, et al. The trial on this matter is set for February 27, 2006. The trial may be underway by the time this issue of Lifeline has been published. However, no matter what the outcome of the trial, what the CIRM and ICOC have planned with your tax dollars will still need to be exposed.

1. San Francisco Chronicle, Nov. 30, 2005, Stem Cell Program Wins Key Court Ruling (Carl Hall).

2. You can read the excellent brief in its entirety by downloading it from the Alameda Superior Court website: Select “Brief Amici in Support of Motions Filed.” (Case no. HG05206766 [“People’s Advocate and Nationa VS Independent Citizens’ Overs”])

3. The Associated Press reported on December 15, 2005, that Hwang Woo-suk admitted that most of the stem cells produced for a key research paper Hwang co-authored on the subject were faked. Just the month before confessing to the fake stem cell lines, he admitted and apologized for using eggs donated by two junior female scientists in his lab, a violation of international ethics guidelines.

4. Section 100010

(e) All protocols involving the combination of hES cells with nonhuman embryos, fetuses, or adult animals shall be submitted to the local IACUCfor review of animal welfare issues and to the ESCRO[Embryonic Stem Cell Research Oversight] committee for consideration of the consequences of the human contributions to the resulting chimeras.

(f) Experiments in which hES cells, their derivatives, or other pluripotent cells are introduced into nonhuman fetuses and allowed to develop into adult chimeras shall be carefully reviewed, including consideration of any major functional contributions to the brain.

(g) Introduction of hES cells into nonhuman mammalian blastocytes shall be considered only under circumstances in which no other experiment can provide the information needed.

Excerpts from brief of Amici, citing Draft CIRM Interim Guidelines, accessed week of September 26, 2005.