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Georgia Senate OKs Bill Limiting Use of hESCs for IVF; House, Governor Must Still Approve

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This article has been updated from a previous version that was posted on March 13

Georgia's state Senate late last week approved a bill barring research institutes and businesses from creating their own human embryonic stem cell lines within the state, just four days after President Obama lifted federal funding restrictions designed to stoke more hESC research in the nation.

The bill, called the "Ethical Treatment of Human Embryos Act," must still be approved by the Georgia House and signed by the governor, who is believed to support it.

By a strict party-line vote of 34 to 22, the Republican-controlled Georgia state Senate passed the measure, also known as Senate Bill 169, to limit the purposes for creating in vitro human embryos "solely for … initiating a human pregnancy … or cryopreservation for such treatment in the future."

State Sen. Ralph Hudgens (R-Hull), who introduced the bill last month, told BioRegion News last week that the measure "does not impede, inhibit, [or] restrict research with embryonic stem-cell lines, the existing stem-cell lines, or stem-cell lines that are created outside of Georgia."

There are three things the bill "would prevent:" cloning, the creation of animal-human hybrids, and the creation of new embryonic stem-cell lines in Georgia, Hudgens said. "You’re just not going to be able to take a human embryo and kill it to create a new stem-cell line."

"Nothing in this article shall prohibit or otherwise impede the use of induced pluripotent stem cells," according to the version of the bill that passed the state Senate. iPSCs, which are typically derived from adult stem cells and can be produced without embryos, are capable of creating all types of cells with the exception of extra embryonic tissue.

Citing that provision, Hudgens said he rejects the argument that SB 169 would end stem-cell research in the state. "It will allow for any research, adult or embryonic."

Not so, countered Charles Craig, president and CEO of GeorgiaBio. "As far as we're concerned, this bill is not a good bill, whether it has that [iPS] language in there or not," Craig said. "SB 169 would be devastating to the state of Georgia, and undermine its life-sciences economic-development effort. There's no question of that."

He also noted the bill does not address the issue of stem-cell lines created outside Georgia — and would negate for Georgia researchers the benefit Obama conferred on them with his March 9 executive order allowing the National Institutes of Health to fund all manner of hESC research.

"It's not clear that new embryonic stem cells could be made in South Carolina, for instance, and shipped over to Georgia, even though that's what the bill supporters say," Craig said. "There's no reason why Georgia's scientists should not be able to make new embryonic stem-cell lines from embryos that are donated by IVF clinic patients."

"We will certainly urge the [state] House to defeat Senate Bill 169 very aggressively," Craig added.

Hudgens said the Peachtree state has the right to develop its own rules governing stem-cell research: "If the federal government wants to send money down here to the various research universities and other entities that are studying stem-cell research, then we welcome their money."

Craig said SB 169 would hurt a segment of Georgia's economy that has grown in recent years. He cited figures from a forthcoming revised edition of the group's annual review of the life-sci industry, Shaping Infinity, to be released at the Biotechnology Industry Organization's 2009 International Convention, to be held in Atlanta May 18-21.

• Georgia's life-sci industry is responsible for more than 62,000 direct and indirect jobs statewide;
• The sector's annual economic impact is $16 billion; and
• Academic research in the state generated some 15,000 jobs and another $1.3 billion in economic impact in 2007.

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The figures will be included in the first-ever economic impact study of the state's life-sci sector, conducted by Jeffrey Humphreys, director of the Selig Center for Economic Growth at the University of Georgia's Terry College of Business. Selig and GaBio partner to produce the annual Shaping Infinity reports.

These and future economic benefits are outweighed by what supporters of SB 169 say is the moral wrong of destroying embryos for research.

Craig noted that GaBio had found allies in opposing SB 169 in the Board of Regents of the University System of Georgia and three statewide professional groups, including the chambers of commerce of Gwinnett County and Greater Athens.

The Medical Association of Georgia has not taken a position on SB 169, spokesman Tom Kornegay told BRN, adding. "We understand that the bill was still being amended late last week, and we haven’t had a chance to review the measure in any detailed way in its most current form."

Supporters of SB 169 have lined up support from other statewide groups, including Georgia Right to Life, the Georgia Baptist Convention, and the Georgia Catholic Conference.

On its web site, Georgia Right to Life said it "supports research that can save lives of human beings without causing harm to other lives. The GRTL has said it supports stem-cell research in which adult stem cells, cord blood, or other sources are used.

"We oppose all forms of research where living human embryos are destroyed; this includes destructive embryonic stem-cell research, as well as fetal tissue research," GRTL added.

The success of those opponents in the state Senate last week marked the second defeat in the past three weeks for life-sciences interests in Georgia's legislature, formally known as the General Assembly. Last month, the state Senate Economic Development Committee defeated Senate Bill 101, which would have shielded biopharma and medical device companies from tort claims if their products were approved for use by the US Food and Drug Administration.

The bill also would have forced plaintiffs to pay legal fees in cases dismissed soon after being filed, and for those who sue life-sci companies and lose to pay the defendants [BRN, Feb. 2].

The bill would have applied to companies that either "base [their] corporate headquarters in Georgia" or "either employ over 200 workers in manufacturing or research and development, or have [their] principal place of research and development in Georgia."

"You can't say that what happened on that bill is a vote against the life-sciences industry, because there were many other issues involved there," Craig said.

Gov. Sonny Perdue, a Republican in his second term, and top aides argued that the bills were needed to demonstrate the state's friendliness to its life-sci employers as Atlanta gears up to host BIO 2009, the industry's largest annual event, which is expected to draw some 20,000 attendees to the Georgia World Congress Center.

“With this proposed legislation, we will cement our position as a leader in the biotech industry," Perdue declared in a press release. SB 101 "will make Georgia an even more attractive environment for biotechnology companies.”

But two Republicans on the economic-development panel — Sens. Seth Harp Jr. (R-Midland) and Jeff Mullis (R-Chickamauga) — crossed party lines, joining the panel's Democratic minority to defeat SB 101, 7-to-4 [BRN, March 2]. Bill opponents contended that FDA approval is far from a guarantee that a drug or medical product is safe, citing the agency's failure to prevent the recent outbreak of salmonella-tainted peanut butter that has resulted in nine deaths nationwide. The tainted products have been connected to peanut products at a Peanut Corp. of America plant located in South Georgia.

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Craig rejected the view that the defeat of the tort bill and the Senate approval of SB 169 demonstrate legislative hostility toward the life-sci industry. Craig said his group now considers the tort shield bill moot since it would have conflicted with the US Supreme Court's decision in Wyeth v. Levine, in which a 6-to-3 majority ruled on March 4 that Wyeth could not cite FDA approval of its Phenergan as a defense to avoid liability under state laws for damages resulting from use of the anti-nausea drug.

As for SB 169, "the Senate is sending a clear signal that it is anti-science and anti-technology, and hostile to the life sciences industry," Craig added. "It doesn’t follow that the prohibition against embryonic stem-cell research is reflective that the state is hostile to the life-sciences industry."

But the industry hasn't won the support it sought from the state's highest elected official. Perdue's administration has not voiced an opinion on SB 169; a spokeswoman for Georgia's Department of Economic Development did not make officials available to discuss the bill with BRN.

Perdue has fueled speculation that he may sign SB 169 because of a statement he issued opposing Obama's executive order. "I think that there are other issues that we have demonstrated in the last few years, that if we will aggressively pursue the science in those areas I think we can absolutely do more to find a cure as rapidly through those methods as we can sacrificing human embryos for the sake of science," he said.

And speaking to reporters earlier this month, Perdue went beyond the president's action, saying he is "absolutely opposed to creating embryos to cure a disease."

Protecting embryos was less the issue behind SB 169 when Hudgens introduced the bill on Feb. 18, with tighter regulation of fertility clinics in mind. He said the original bill was written to prevent allowing anyone in Georgia to give birth to multiple babies through in vitro fertilization, as so-called "Octomom" Nadya Suleman did earlier this year in California.

The bill's original version limited the number of embryos fertility centers could create for their patients. These provisions, which do not appear in the current version, would have allowed:

• Up to two embryos for women under age 40 using their own eggs or embryos created using their own eggs, whether fresh or frozen;
• Up to two embryos for women of any age to receive treatment using donated eggs or adopted embryos; and
• Up to three embryos for women age 40 or over using their own eggs or embryos created using their own eggs, whether fresh or frozen.

Opposition by fertility clinics and mothers whose children were conceived in vitro prompted a subcommittee of the state Senate's Health and Human Services Committee to drop the proposed clinic regulations.

"Those restrictions would have essentially shut down IVF clinics in Georgia," Craig said.

In return for accepting those changes, Hudgens and supporters of SB 169 — including state Senate President Pro Tem Tommie Williams (R-Lyons) — won approval of the bill through Health and Human Services, in a 7-to-6 vote.

"I didn’t really have any option but to go along with it or just pull the bill," Hudgens told BRN.

Hudgens had to accept another key change to the bill shortly before it passed the Senate on March 12 — namely the deletion of language declaring that "a living in vitro human embryo is a biological human being who is not the property of any person or entity. The fertility physician and the medical facility that employs the physician owe a high duty of care to the living in vitro human embryo."

The discarded provision of the bill added that "any contractual provision identifying the living in vitro embryo as the property of any party shall be null and void. The in vitro human embryo shall not be intentionally destroyed for any purpose by any person or entity or through the actions of such person or entity."

The changes were made to win the support of seven Republican state Senators who initially voted with Democrats to table a vote on the bill: Bill Cowsert (R-Athens), John Crosby (R-Tifton), John Douglas (R-Social Circle), Greg Goggans (R-Douglas), Johnny Grant (R-Milledgeville), Seth Harp (R-Midland), Bill Jackson (R-Appling), and Dan Weber (R-Dunwoody).

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Defining an embryo as a person "would have enormous legal and constitutional implications. And it also means that for the IVF patient, they would lose control of their embryos because they're no longer the property of the people who created them with their tissues," Craig told BRN.

Craig said GaBio had worked with IVF doctors, patients, and patient-advocacy groups, who have urged their members to contact health and human services committee members urging them to reject SB 169, a course of action he said GaBio and allies will pursue with House members.

The Senate approval of SB 169 came on "crossover day," the last day bills from the Senate could have been advanced to the House of Representatives for consideration, after being voted out to the full Senate by its Rules Committee.

Georgia is one of several states in which opponents of unfettered stem-cell research have sought to maintain state restrictions. In Montana and North Dakota, for instance, one chamber of their state legislatures had passed legislation defining human embryos as "persons."

And in Missouri, state Sen. Jim Lembke (R-St. Louis County) has filed Senate Joint Resolution 17, seeking a November 2010 referendum on a state constitutional amendment barring the use of public funds for "abortion services, human cloning, or prohibited human research."

The proposal has the support of the Missouri Roundtable for Life, a group formed to oppose Constitutional Amendment 2 — the Missouri Stem Cell Research and Cures Initiative, approved in 2006 — which says the measure could allow state funding of human cloning research, even though it declares that "no person may clone or attempt to clone a human being." The amendment also sets a felony penalty for violations of up to 15 years in prison and a $250,000 fine.

Roundtable is being opposed by the Missouri Coalition for Lifesaving Cures, which backed Amendment 2.

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