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Michigan Academics, Pols, Life-Sci Leaders Campaign to Lift Stem-Cell Research Limits

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Life-science, academic, and political leaders in Michigan last week launched a  campaign to win votes in November for a state constitutional amendment ending restrictions on human embryonic stem-cell research, a goal that would position the issue as a referendum on the future of the state’s life-sciences cluster.
 
The leaders and their allies argue that the proposed amendment will benefit Michigan’s life-sci industry as much as the lives of patients. Not so, counters a coalition of amendment opponents. Michigan Citizens Against Unrestricted Science and Experimentation, or MiCAUSE, contends the amendment will lead to unrestricted experimentation on human embryos, end legal hurdles to their destruction, and legalize human cloning, now banned by state law.
 
MiCAUSE’s arguments have drawn fire from amendment backers, who are represented by their own coalition, the Stem Cell Research Ballot Question Committee, also known as CureMichigan.
 
CureMichigan cites the wording of the measure, specifically that it requires research on hESCs to be conducted “safely and ethically;” that it prohibits taking stem cells from embryos more than 14 days after cell division begins (not counting the time embryos have stayed frozen); and requires that embryos used for research “were not suitable for implantation and would otherwise be discarded.”
 
CureMichigan leaders on July 7 moved last week to place the stem-cell issue into the hands of state voters when they submitted to the office of Michigan Secretary of State Terri Lynn Land 570,373 signatures — 50 percent more signatures than the minimum 380,126 needed by the group to hold the referendum.
 
Land’s office last week began checking the validity of the petition signatures. It will submit a staff report to the state Board of State Canvassers, which is also checking signatures for a proposed government-reform ballot question. The board is expected to decide the issue at its next meeting, which has yet to be scheduled.
 
“It probably won’t be until mid- to late-August,” Land spokesman Ken Silvfen told BioRegion News.
 
Even if it survives the canvassers board, the amendment’s fate with voters will be uncertain at best, said Bill Ballenger, editor and publisher of Inside Michigan Politics.
 
In an interview last week, Ballenger recalled how the birth of Scotland’s Dolly the sheep in 1996 prompted Michigan in June 1998 to become the nation’s first state to ban human cloning. Later that year, Michigan voters trounced Proposition B, which would have allowed physician-assisted suicide. That measure began with majority support in opinion polls that disappeared once Michigan Catholic Conference and Right to Life of Michigan countered the arguments of Jack Kevorkian and other right-to-die advocates to beat back the ballot question.
 
“That could happen again, because the same two groups are going to be opposed to [the stem cell referendum],” Ballenger said.
 

The hESC restrictions also have a “spillover effect on other disciplines, just because the image of the state is one of being antagonistic toward cutting-edge scientific research.”

A defeat, if it happens, would appear to be at odds with the state’s current political calculus. Michigan is governed by a Democrat, Jennifer Granholm, who is in her second and final term of office. Democrats, who traditionally favor lighter restrictions on hESC research, control the state House of Representatives by a 58-52 seat margin, while Republicans, who typically favor tighter controls, hold the majority in the state Senate by 21-17.
 
Additionally, both Michigan’s senators are Democrats, and no Republican presidential candidate has carried the state since 1988, when George H. W. Bush topped Michael Dukakis.
 
Larry Owen, who chairs the stem-cell ballot question committee board, told BRN that stem cell-amendment backers in his state have learned from last year’s defeat in New Jersey of a stem-cell referendum by positioning the Michigan ballot question as a constitutional amendment rather than a bond issue.
 
New Jersey’s proposed bond — which critics feared would have raised taxes — drove critics of higher state spending to the polls, stunning Gov. Jon Corzine and life-sciences leaders by sinking a stem-cell question that a poll by state-funded Rutgers University had predicted would sail to approval [BRN, Nov. 12, 2007].
 
“[The bond] was a good feature, but it also made it more difficult to pass,” Owen said. “The opposition took them down by saying they were going to raise taxes to do this.”
 
But results in California were different in 2004 when 59 percent of votes approved the 10-year, $3 billion Proposition 71. The measure later withstood a two-and-a-half year court challenge by opponents that ended last year [BRN, May 28, 2007].
 
Ballenger said Michigan is unlikely to replicate California’s success, let alone win the sharp support for embryonic stem cell research shown in national polls by Gallup and Harris: Members of Michigan’s majority party are more likely to be “Reagan” Democrats — less likely to favor unrestricted hESC research — than the liberal progressives more typical of the party’s national electorate.
 
The result is a sociopolitical paradox. “Michigan is viewed as being a fairly liberal-progressive state, a blue state. It has voted for Democrats in every [presidential] election beginning in 1992,” Ballenger said. “People look at Michigan like the Northeast and California, and other states in the upper Midwest. And yet there is a strain of conservative ideology in Michigan on social and cultural issues.”
 
One example: Right to Life of Michigan’s Political Action Committee has endorsed several Democrats opposed to abortion rights in state and local races. The races “are typically in more rural districts,” Owen said. “The reality in our state is that the Right to Life organization has a hammerlock on the legislature, which is why we have to go to the ballot.”
 
CureMichigan proposes amending Michigan’s state constitution with a new Article 1, Section 27, which would declare that “any research permitted under federal law on human embryos may be conducted in Michigan,” subject to federal law and four stipulations. [See text below]
 
CureMichigan has sought to minimize political resistance by naming as its leaders former pols from both major parties — Owen, an ex-Democratic gubernatorial candidate; and Joe Schwarz, a former Republican US Representative.
 
Owen told BRN the proposed constitutional amendment would address several challenges that Michigan scientists face when researching regenerative medicine. He said research centers at the University of Michigan, Michigan State University, and Wayne State University have struggled to attract top-tier researchers despite running strong research programs, and that current laws discourage stem-cell startups from growing in the state.
 
“We really believe that given the strengths that we have, that we could build really top-notch, first-rate programs if this ban is lifted,” Owen said. “We know anecdotally that the universities are having difficulty recruiting stem-cell researchers because [unrestricted] embryonic stem-cell research is banned here. It also has some spillover effect on other disciplines, just because the image of the state is one of being antagonistic toward cutting-edge scientific research.”
 
MiCAUSE spokesman David Doyle said his group doesn’t believe Michigan’s current laws impede stem-cell scientists from working in Michigan. Doyle said the number of researchers at U-M’s Michigan Center for hES Cell Research has doubled since it opened in 2002, to what the center’s web site says is “more than 40” scientists.”
 
“If things were so restrictive in Michigan, why in 2003, when NIH gave the funding for three [embryonic stem cell research] centers in the country, was Michigan one of them?” Doyle said.
 
Owen countered that the Michigan center reflects the effects of current state law, since it employs fewer researchers than comparable programs in neighboring Wisconsin and California.
 
And Sean Morrison, Director of U-M’s Center for Stem Cell Biology at the Life Sciences Institute, which carries out research using both adult and embryonic stem cells, told BRN his center has been much more able to recruit researchers for adult stem cells than for embryonic stem cells.
 
“Laws in Michigan are so restrictive that people who specialize in embryonic stem cell research generally don't even apply for jobs at the University of Michigan,” Morrison said via e-mail. “This contrasts dramatically with our ability to recruit top faculty in other areas, such as in the area of adult stem cell research.
 
“U-M is among the highest impact universities in the world in the area of adult stem cell research, yet state laws prevent us from competing in the area of embryonic stem cell research,” Morrison added.
 
Yet, he said, one of the university’s adult-stem-cell researchers, Mike Clarke, recently left U-M for Stanford University, which is known to be friendlier to stem cell research.
 
At Stanford, Clarke “is not focused on embryonic stem-cell research, but does cancer stem-cell research,” Morrison told BRN. “He has said that the better overall climate in California as a result of Proposition 71 was one of the factors that attracted him there.”
 
Morrison said he and Clarke have co-founded a startup, OncoMed Pharmaceuticals, that has flourished since relocating from Michigan to California; last year it moved from Mountain View to Redwood City.
 
Relocating to California “was not a direct result of Michigan's stem-cell laws, but does reflect the inability of Michigan to develop a strong and dynamic life-sciences sector, partly as a result of the chilling effect of its anti-stem-cell laws,” Morrison said.
 
That chill, Owen said, has forced many Michigan labs to carry out some of their research out of state. While the Center for Stem Cell Biology is not one of those institutions, Morrison said he won’t rule it out, either: “That would be one option for enhancing our ability to [conduct] embryonic stem-cell research.”
 
Research heads at Michigan State and Wayne State universities did not return e-mail and telephone messages left last week by BRN.
 
Michigan Missing
 
In an opinion column published on the web site of a nonprofit group that promotes stem-cell research within Michigan, Lee Noll, the CEO and president of BioFlow Technologies, noted that under current state law, scientists face civil penalties of $10 million or felony charges punishable by up to 10 years in prison for conducting research that is legally permissible in most other states.
 
“Without a change to Michigan's existing regulatory framework, BioFlow and other life-science firms across our state confront a difficult choice: Relocate to states with less-restrictive laws, or, at a minimum, create duplicate development facilities outside Michigan's borders,” Noll wrote in his column, available here. “Both options make the cost of operating a business in Michigan more expensive, driving away jobs and investment at a time when our state can ill-afford either outcome.”
 
Speaking last week via e-mail with BRN, Noll expressed pessimism about the amendment’s chances of passage. “Unfortunately, the majority of voters in this state, who overwhelmingly outnumber the voters opposed to embryonic stem cell research, are not well organized and I believe that it will be difficult to motivate them to get out and vote in this referendum.”
 
Even approval of the amendment may not stop his company from leaving Michigan, he said.
 
“Unfortunately, I hold little hope that the state's stance will change rapidly enough to impact my decisions,” Noll said via e-mail. “Because of the markets that my company serves, we simply need to have the ability to test our systems with relevant human embryonic stem cells. … The federally approved lines are of no value to us or most researchers.
 
“Our work requires access to frozen blastospheres that are destined for destruction because they can no longer be maintained by the families that generated them. Success with our procedures and culture tool will greatly diminish the need to go back to these early blasts for future research,” Noll added.
 
The head of the state’s life-science industry group, MichBio, agrees with CureMichigan that current state law has discouraged the growth of research in the state.
 
“When somebody’s looking at Michigan as a possible location as a biotech business or what-have-you, they look at the business-friendly landscape,” Stephen Rapundalo, MichBio’s executive director, told BRN last week. “There’s probably a negative view that perhaps Michigan is not as open in its support of basic science, and whether people accept it or not, people do make decisions on that kind of level.”
 
“We think anything that will support the pursuit of basic science, and ultimately translate those discoveries into commercializable activities, is good for the state and the industry here,” Rapundalo added.
 
Proponents have not sought to quantify the economic benefits of the amendment: How much extra federal research money could the state receive? How many additional researchers would Michigan be likely to attract?
 
Those benefits, amendment opponents say, would be more than offset by the moral cost of repealing Michigan’s current laws banning human cloning and embryo destruction.
 
Doyle said amendment supporters are disingenuous when they insist their proposal would not affect the state ban on cloning, since some supporters also wish to lift that prohibition. Senate Bill No. 52, available here, and House Bill 4616, available here, would allow the use of embryos for “nontherapeutic” scientific research.
 
The Senate bill was introduced in January 2007 by state Sen. Gretchen Whitmer (D-East Lansing), a vocal supporter of CureMichigan; the House bill, by Rep. Andrew Meisner (D-Ferndale)  and has been at the state Senate’s Committee on Health Policy ever since.
 
The proposed amendment “puts in the constitution that the law is the law. But they’re telling people they’re banning cloning. In fact, they’re not. And that’s very deceptive,” Doyle said.
 
Not so, Owen insisted. “This campaign is not about the cloning issue one way or another. That’s up to the normal political process. My political read is, it’s highly unlikely in the foreseeable future that the legislature will change that.”
 
Doyle and amendment opponents say the amendment is too broadly written because it would trump state and local laws that could “prevent, restrict, obstruct, or discourage any stem-cell research or stem-cell therapies and cures.” The clause could be applied beyond the realm of research science, he said, using as an example a hypothetical future attempt to regulate private labs or fertility clinics.
 
The amendment, Doyle added, “opens up a Pandora’s box of problems.”
 
“Even if we find out a year, two years, or five years from now that there’s a problem in this completely unregulated, unrestricted system, and the legislature and the public want to deal with it, you can’t, unless you change the constitution, which is not an easy thing to do,” Doyle said.
 
Owen denied the amendment would increase the number of embryos destroyed in research, saying instead the measure would allow additional study on embryos that otherwise would be frozen and eventually destroyed. “What’s the right moral answer? To throw them away, or to use them to try and cure deadly diseases?”
 
Doyle and other amendment opponents say Michigan cannot gauge how many if any fewer embryos would be destroyed, since the state does not track the number of embryos stored or how many are discarded by labs and fertility centers.
 
Amendment critics also argue scientists stand a better chance of curing disease, without the moral issues wrought by embryonic stem-cell use by focusing more of their research on adult stem cells.
 
In November, two teams of researchers — one led by Shinya Yamanaka of Kyoto University; the other by Junying Yu, a researcher in the lab of stem-cell pioneer James Thomson of the University of Wisconsin-Madison — announced independently that they had discovered a way to reprogram adult stem cells whose regenerative properties mirror hESCs’.
 
Supporters caution that the discoveries are preliminary and will require additional research, using both embryonic and adult stem cells. “It may be that one avenue of research proves productive for one set of diseases, and another avenue for a different set of diseases. We don’t know, and we won’t know, unless we pursue all the avenues,” Owen said.
 
He added that the amendment would allow Michigan to reap millions of dollars in additional research funding from the federal government that is expected to be available after next year. Both presumptive major-party presidential candidates, Sens. John McCain (R-Ariz.) and Barack Obama (D-Ill.), have promised to lift restrictions on embryonic stem-cell research imposed by President Bush in 2001.
 
Those restrictions have reduced to 21 the available number of independent, fully developed stem-cell lines available to researchers, Owen said. “We put ourselves in a backwards position. We have the skills and the talents, and we have a legal impediment to them doing their best. We ought to be at the head of the line,” he said.
 
Both sides of the stem-cell-amendment debate agree this year’s presidential contest will bring more Michigan voters to the polls; each side has said they think they can benefit.
 
To draw those voters, Doyle said MiCAUSE will announce endorsements from doctors; the group has trumpeted a switch of opinion, from pro-amendment to neutral, by the Michigan State Medical Society, which represents more than 14,000 physicians statewide.
 
Owen said CureMichigan will rely on TV ads as well as its endorsements and public outreach. Local news reports earlier this year quoted the group as planning to raise as much as $20 million.
 
“It’s going to be interesting to see what develops,” Ballenger said.
 

 
The Proposed Amendment
 
Following is the text of the amendment to Michigan’s constitution proposed by The Stem Cell Research Ballot Question Committee, also known as CureMichigan, which is a coalition of life-science, academic, and political leaders.
 
A PROPOSED AMENDMENT TO THE MICHIGAN CONSTITUTION TO PERMIT CERTAIN EMBRYONIC STEM CELL RESEARCH. THE AMENDMENT WOULD CREATE A NEW ARTICLE I, SECTION 27
 
ARTICLE 1, 27:
 
Ethical stem cell research
 
Sec. 27 (1) Nothing in this section shall be interpreted to alter or abrogate Michigan laws prohibiting or criminalizing human cloning.
 
(2) To ensure that Michigan citizens have access to stem cell therapies and cures, and to ensure that physicians and researchers can conduct the most promising forms of medical research in this state, and that all such research is conducted safely and ethically, any research permitted under federal law on human embryos may be conducted in Michigan, subject to the requirements of federal law and only the following additional limitations and requirements:
(a) No stem cells may be taken from a human embryo more than fourteen days after cell division begins; provided, however, that time during which an embryo is frozen does not count against this fourteen day limit.
(b) The human embryos were created for the purpose of fertility treatment and, with voluntary and informed consent, documented in writing, the person seeking fertility treatment chose to donate the embryos for research; and
(i) the embryos were in excess of the clinical need of the person seeking the fertility treatment and would otherwise be discarded unless they are used for research; or
(ii) the embryos were not suitable for implantation and would otherwise be discarded unless they are used for research.
(c) No person may, for valuable consideration, purchase or sell human embryos for stem cell research or stem cell therapies and cures.
(d) All stem cell research and all stem cell therapies and cures must be conducted and provided in accordance with state and local laws of general applicability, including but not limited to laws concerning scientific and medical practices and patient safety and privacy, to the extent that any such laws do not:
(i) prevent, restrict, obstruct, or discourage any stem cell research or stem cell therapies and cures that are permitted by the provisions of this section; or
(ii) create disincentives for any person to engage in or otherwise associate with such research or therapies or cures.
(3) Any provision of this section held invalid shall be severable from the remaining portions of this section.

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