Stem Cell Freeze

Tuesday's World Events — Posted on October 20, 2009

(by Daniel James Devine, WorldMag.com) – New Obama administration rules make this year the first since 2001 that federal dollars have been available for newly created embryonic stem cell lines. That means about $92 million of U.S. taxpayer dollars are budgeted for the coming year to fund scientists working with the cells of intentionally destroyed human embryos.

But one legal challenge could temporarily-or indefinitely-shut down the flow of federal cash. In the pending lawsuit, two scientists, two families, an adoption agency, and the Christian Medical Association claim that the decision of the Obama administration to expand embryonic stem cell research was illegal. The case’s defendants are the federal agencies responsible for handling science grants, the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH).

It isn’t the first such challenge. In 2001 the Bush administration found a nearly identical lawsuit on its doorstep but it never reached a conclusion (and was withdrawn once Bush issued a new policy on stem cell research). “This case raises the central question of whether Congress does or does not want to fund the destruction of human embryos,” said Samuel Casey, an attorney with Advocates International who is co-counsel for the plaintiffs. (Alliance Defense Fund and the law firm Gibson, Dunn & Crutcher are also representing the plaintiffs.) Casey, who was also co-counsel in the 2001 lawsuit, said both cases make the same legal argument: that federal grants for embryonic stem cell research violate the congressional funding ban known as the Dickey-Wicker Amendment.

The Dickey-Wicker Amendment was added to a general appropriations bill in 1995 to bar tax dollars from funding “(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.”

Later, in 1998, embryonic stem cells were isolated and cultured for the first time, and some scientists became interested in working with the resulting cell lines. Harriet Rabb, who was a top lawyer for HHS at that time, interpreted the Dickey-Wicker Amendment to mean that although federal money couldn’t be used to derive the stem cells (which killed the embryos), it could be used to experiment with the cells afterward. Funding was acceptable if someone else did the dirty work. Not everyone in Congress agreed with Rabb’s conclusion, yet by late 2000 NIH had established grant guidelines for the research.

No money ever arrived in labs. After George W. Bush became president he called for an immediate review of the government’s stem cell policy, halting grant applications. During that review in early 2001 Samuel Casey and his colleagues filed suit to stop embryonic stem cell funding permanently on the grounds that it would result in the embryo destruction the Dickey-Wicker Amendment was supposed to prohibit. But when Bush announced in August that grants for embryonic stem cell research would become available-but only for some 60 cell lines that were already in existence-law experts decided the Bush policy would provide “no incentives for the destruction of additional embryos,” and thus did not violate the amendment. Casey and the suit’s plaintiffs voluntarily dismissed their case.

But now that the Obama administration has decided to fund research on stem cells from fresh embryos-that is, from newly created cell lines-Casey believes the Dickey-Wicker problem is back on the table. “[The Obama policy] encourages you to develop an embryonic stem cell line that does not exist now,” he said. “So now we’re in court to find out what Dickey-Wicker means-again.”

That’s not the only issue. The lawsuit alleges that NIH violated administrative rules this year as it rushed to fulfill President Obama’s executive order to write new guidelines for embryonic stem cell funding. The agency allowed only 34 days for the public to offer input on its proposed guidelines, and it appears to have ignored comments (about 30,000 out of 49,000) that questioned the usefulness of the research on ethical or scientific grounds. “They had no interest in listening to the public,” said Casey.

Federal attorneys in their initial response to the plaintiffs’ claims said that NIH didn’t have to follow administrative law to the letter because it was acting on orders from the president.

“That is a startling claim of executive power. Simply amazing,” said Thomas Hungar, Casey’s colleague at Gibson, Dunn & Crutcher. Plaintiff Nightlight Christian Adoptions, along with two families who adopted embryos through the agency, believe the Obama policy will ultimately reduce the number of embryos available for adoption. In 1997 Nightlight began to pair adopting parents with IVF (in vitro fertilization) patients who were willing to give their leftover, frozen embryos to another family. Although many embryos don’t survive thawing and implantation, executive director Ronald Stoddart said 211 babies have been born through the program so far. Nightlight itself has received a federal grant to help educate the public about embryo adoption: “Most people hear about it and go, ‘Wow, embryos? I didn’t know you could do that!'”

Although only Georgia legally acknowledges embryo adoption (elsewhere the process relies on contracts between the two families, said Stoddart), many states protect embryos from wrongful death or hazardous experimentation. Parents who may decide to donate their embryos for research under the NIH guidelines could potentially find themselves in a tangle with state law.

Nightlight is also representing the leftover IVF embryos that expanded embryonic stem cell research would affect (respectfully called “Plaintiff Embryos”).

The Christian Medical Association, representing 15,000 doctors, opposes the Obama administration policy and supports non-embryonic stem cell research. Two scientists, James Sherley and Theresa Deisher, claim that the administration’s inclusion of new stem cell lines in funding opportunities will increase competition for the grants needed to conduct research with adult stem cells.

In fact, it is adult and umbilical cord stem cells that have produced real breakthroughs for treatment for illnesses ranging from multiple sclerosis to lupus to stroke paralysis, said David Prentice of the Family Research Council: “Embryonic is frankly no further ahead than it’s been for decades.” The only existing clinical trial of embryonic stem cell therapy, intended to treat spinal cord injuries, was recently halted by the FDA for safety concerns before any patients had enrolled. Embryonic cells have been problematic in part because of their propensity to grow tumors after being implanted.

Casey and his colleagues hope the judge in the case issues a preliminary injunction as early as this month, which would force HHS and NIH to freeze any grants being issued for embryonic stem cell research until the resolution of the suit. The agencies have asked the judge to deny the injunction and dismiss the case.

Background

THE DICKEY-WICKER AMENDMENT: (excerpted from wikipedia.org)

The Dickey-Wicker Amendment is the name of an add-on to an appropriation (spending) bill passed by Congress in 1995, and signed by former President Bill Clinton.
The Dickey-Wicker Amendment prohibits the Department of Health and Human Services (HHS) from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed.
The wording of the rider is generally the same year after year. For FY2009, the wording in the spending bill (enacted March 11, 2009) prohibits HHS, including NIH, from using FY2009 appropriated funds as follows:

(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 [in the womb]

(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).

Despite the March 9, 2009 executive order from President Obama, which removed the restriction against federal funding of stem cell research, the Wicker-Dickey Amendment remains an obstacle for federally-funded researchers seeking to create their own stem cell lines.

ADULT STEM CELLS VS. EMBRYONIC STEM CELLS. (from njfpc.org/Articles/AdultStem.asp)

Adult stem cell research has been on-going for 20-30 years, is not under any government restriction, and does not require the destruction of human life. These stem cells have already been used to treat spinal cord injuries, Leukemia, and even Parkinson's disease . Adult stem cells are derived from umbilical cords, placentas, amniotic fluid, various tissues and organ systems like skin and the liver, and even fat obtained from liposuction.
In contrast, embryonic stem cells are obtained by harvesting living embryos generally 5 to 7 days old, which are destroyed in the process. Most importantly, embryonic stem cells have never yet been successfully used to help cure disease. In fact, in animals they have caused tumors and other complications. Embryonic stem cells are also being touted by some as a possible treatment for repairing the brains of Alzheimer's patients, but stem cell researchers confess that this is a distortion that is not being aggressively corrected by scientists.
A new poll, conducted by International Communications Research, reveals that once Americans understand the difference between adult and embryonic stem cells, Americans strongly prefer funding adult stem cell research that does not destroy human life, by a margin of 61% to 23%. So, what is driving the biotech industry and many government officials to press for government money to subsidize embryonic stem cell research? Free money, and research without ethical limitations.
Private industry has not been willing to put up any large sums of money on their own for embryonic stem cell research, because they are not sure it will yield the results they hope for. However, some drugmakers are getting into the field of research utilizing adult stem cells from umbilical cord blood and bone marrow. Investors are now taking notice that adult cells are actually working with human patients, and researchers are finding that these cells appear to be as flexible as the embryonic type.

APPROPRIATIONS BILLS: (excerpted from wikipedia.org)

An appropriation bill is a bill which authorizes the government to spend money. It is a bill that sets money aside for specific spending.
Appropriations are generally done on an annual basis.
According to the Constitution (Article I, Section 7, clause 1), all bills relating to revenue, generally tax bills, must originate in the House of Representatives. The Constitution also states that the "Senate may propose or concur with Amendments as on other Bills," so in practice the Senate and House traditionally proceed separately, with each body drafting and considering their own bills separately. The Senate generally will amend its version of a particular appropriations bill to the House-passed version in order to send the bill to a conference committee prior to the bill becoming law. This is why the majority of appropriations bills that are enacted contain the H.R. modifier used to identify House introduced legislation.