AMERICA’S STEM CELL PROGRAM THREATENED BY LAWSUIT
By Don C. Reed
A lawsuit is being brought against the National Institutes of Health (NIH) Director Dr. Francis Collins, and Health and Human Services (HHS) Secretary Kathleen Sebelius, as well as the NIH and HHS as public agencies.
The suit attempts to block the new stem cell research Guidelines, and to end federal funding of embryonic stem cell research.
Here is my layman’s understanding of the case.
First, the Plaintiffs, and why they feel they have “suffered irreparable damage” by the new Guidelines, and claim standing in the case:
Dr. James L. Sherley and Dr. Theresa Deisher are adult stem cell researchers, who allege they will be injured financially if limited federal dollars are diverted to embryonic stem cell research, resulting in less funding for their area of specialization.
Nightlight Christian Adoptions describes itself as a non-profit which “protects human embryos conceived through In Vitro Fertility procedure”. They claim injury through decreased number of embryos available for “adoption” from the new stem cell guidelines; they claim guardianship of Plaintiff Embryos, (some portion of roughly 440,000 in storage at present, plus more in future), describing said blastocysts as “minor persons”.
Shayne and Tina Nelson, William and Patricia Flynn, are clients of Nightlight; guidelines would allegedly jeopardize the likelihood of embryos being available for their adoption.
The Christian Medical Association is a group “opposed to federal funding of human embryonic stem cell research and (which) expends approximately $300,000 a year…”(opposing the research). They claim potential financial injury, that the Guidelines would require them to spend “significant resources” to continue their efforts to oppose “illegal public funding of embryo research.”
Behind the suit are various conservative religious lobbying organizations, including the Alliance Defense Fund.
Plaintiff’s law firms include: GIBSON, DUNN & CRUTCHER LLP, Los Angeles, California, and Law of Life Project, Advocates International, Springfield, Virginia.
Defendants: Health and Human Services (HHS) Secretary Kathleen Sebelius, and the HHS: National Institutes of Health (NIH) Director Dr. Francis Collins, and the NIH.
Personal Opinion: Among the unnamed defendants should be every American family with a child or adult suffering a disease or disability the research might alleviate.*
Claim: Plaintiffs allege that the NIH embryonic stem cell research guidelines should be blocked, and federal funding denied, because, in their view:
1. The Guidelines violate the Dickey Wicker Amendment because the research “requires the destruction of living embryos.” The Dickey-Wicker Amendment is found in the Omnibus Appropriations Act 2009, an annually attached rider.
2. Violations are claimed of the Administrations Procedures Act, charging prejudicial treatment of issues involved during the public comment period for the new Guidelines; plaintiffs claim insufficient time allowed for comment; further, their belief that neither consideration for, nor adequate response to, said comments was provided. They claim the NIH “abdicated its duty to exercise reasoned decision making and issue fair and informed rules.”
3. Plaintiffs charge “arbitrary and capricious action”, because they feel the NIH dismissed the value of research which claimed superiority of adult stem cells (ASC) and induced Pluripotent Stem Cells (iPSCs) over human embryonic stem cells (HESCs). ”
4. Plaintiffs feel the guidelines fail to properly inform potential blastocyst donors of the alleged superiority of non-embryonic stem cell research, nor of the opportunities to put un-needed blastocysts up for “adoption”, nor of the states which oppose embryonic stem cell research, (which may place donors in violation of the law) and how these laws may be undermined by the new regulations. Plaintiffs question whether donors may have the legal right donate blastocysts to “hazardous biomedical experiments.”
5. Plaintiffs claim conflict of interest between fertility clinics and scientists, stating the latter may be able to manipulate the donation process by encouraging a donor to have more eggs fertilized than necessary, thereby benefiting the researcher.
Goal of Lawsuit: Plaintiffs seek an order declaring: the new guidelines are contrary to law, were promulgated without proper legal procedures, and constitute arbitrary and capricious agency action. They seek to block the promulgation of the Guidelines—and prevent the United States government from funding embryonic stem cell research.**
*For example, my paralyzed son Roman Reed and I are among the many millions of families directly affected by the outcome of this suit. If research which could alleviate my son’s condition is delayed, he suffers; and as someone who helps provide my son’s home health care needs, I am also affected. We would both suffer irreparable damage if research toward a potential cure for paralysis was blocked.
**Section VII, PRAYER FOR RELIEF, Paragraph 79, section c: “Enjoining Defendants and their officers, employees, and agents from implementing, applying, or taking any action whatsoever pursuant to the Guidelines, or otherwise funding research involving human embryonic stem cells…” (emphasis added—DR)
There it is, folks. As you can imagine, this will be vigorously contested. With an estimated one hundred million Americans suffering chronic illness or injury, what may well be the greatest medical advance in history is not going to casually be denied research funding.
I am not responding to the suit yet, other than to raise awareness of its existence, because I hope to be allowed to provide testimony in the case. There are answers to every charge the plaintiffs make, but the timing of the answers may be important. If I can help within the case, I will be glad. If not, I will do as I have always done, and report on the action to you, the family of advocates, through this small column.
By for now, and don’t forget—September 23rd is Stem Cell Awareness Day! (Read earlier weblog entry for details.)
Hugs to all, and I hope to see some new friends and old at the World Stem Cell Summit, one week from today!
Don C. Reed