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Michigan Plans to Expand hESC Research After Referendum Overturns Restrictions

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Michigan life-science leaders have begun planning how to expand human embryonic stem-cell research in the state, days after a narrow majority of voters passed a state constitutional amendment that ended restrictions on the work.
 
By a 52.6-percent to 42.4-percent margin, voters approved Proposal 2, which amends Michigan’s state constitution by declaring that, in mid-December, “any research permitted under federal law on human embryos may be conducted in Michigan,” subject to federal law and four stipulations. [See text below].
 
Whether Michigan can use the victory to elevate its place among other states that have relatively liberal stem cell-research laws remains to be seen, according to Stephen Rapundalo, executive director of MichBio, the state’s life-sciences industry group.
 
Saying the state has “lost a lot of momentum” in this kind of research to other states, Rapundalo told BRN last week that “it’s going to be hard to play catch-up and distinguish ourselves.” He added that it won’t be “in the cards in the near term.”
 
The Stem Cell Research Ballot Question Committee, or CureMichigan, a coalition of academic, business, and political leaders that sought the end of restrictions on stem-cell research, argued that Prop 2 was needed because the state’s most advanced research centers have struggled to attract top-tier researchers, and that current laws had discouraged stem-cell startups from growing in the state [BRN, July 14].
 
Until now, embryonic stem cell research has been technically legal in Michigan, but it was all but precluded because the state banned the destruction of embryos for “non-therapeutic” research purposes. According to the state’s Public Health Code, available here: “A person shall not use a live human embryo, fetus, or neonate for non-therapeutic research, if… the research substantially jeopardizes the life or health of the embryo, fetus or neonate” without having any therapeutic benefits for that embryo.
 
The results marked a victory for CureMichigan. The group prevailed over a coalition of amendment opponents, known as Michigan Citizens Against Unrestricted Science and Experimentation, or MiCAUSE.
 
“Michigan will be able to join the other 45 states in the 21st century of embryonic stem-cell research,” Chris DeWitt, a spokesman for CureMichigan, told BioRegion News last week.
 
Just how that will come about — through new laws, or a revival of existing legislative proposals — has yet to be decided, DeWitt said. “What other changes, if any, will be needed as far as any statutory action, that I know is being reviewed right now.”
 
Michigan’s House of Representatives has in the past approved one bill designed to facilitate hESC research and two others that sought to impose harsher penalties for “human cloning.” The measures — all of which have died in the state Senate — include:
  • House Bill 4616 and companion Senate Bill No. 52, which would allow researchers to use embryos for “nontherapeutic” scientific research.
  • House Bill 4617, which would bar researchers from “intentionally engage[ing] in or attempt[ing] to engage in human cloning,” and raised from 10 to 15 the number of years in prison to which violators could be sentenced.
  • House Bill 4618, which would elevate human cloning from a class D felony to a class C felony.
“I doubt if those will need to go forward, given the passage of the ballot initiative,” Rapundalo told BRN.
 
“I do, however, anticipate that there might be some legislation put forward to attempt to chip away at what was just derived from the voters, and perhaps even pre-empt federal regulations,” Rapundalo added. He was referring to the federal government’s ban on using taxpayer dollars to fund research that uses stem-cell lines created after Aug. 9, 2001. President-elect Barack Obama is expected to lift this ban, which was enacted through an executive order by President George W. Bush.
 
David Doyle, a spokesman for MiCAUSE, told BRN he could neither say if hESC opponents are crafting any such legislation, nor confirm published reports that there were no such plans. “MiCAUSE and my role are done,” he said. “Whether individual representatives and senators try and do anything, that remains to be seen.”
 
Countered Rapundalo: “I don’t know that we necessarily believe that, but time will tell. We’ll see what happens.”
 
Rapundalo said he did not know if Michigan life-sci leaders would pursue efforts to enable public funding to support hESC research in the state, or to create a state agency to dispense such cash akin to the California Institute for Regenerative Medicine. However, he cautioned that if these measures are pursued, neither will likely happen any time soon.
 

“We’ve already lost a lot of momentum in this regard relative to other states that have gotten ahead in this area. …. It’s going to be hard to play catch-up and distinguish ourselves from some of these other states.”

“I don’t know if there’s going to be any legislation moved to facilitate embryonic stem cell research in terms of public funding,” Rapundalo said last week in an interview. “We’ve already lost a lot of momentum in this regard relative to other states that have gotten ahead in this area, like New Jersey and California, and New York, and so forth. It’s going to be hard to play catch-up and distinguish ourselves from some of these other states. That’s not to say it might not happen someday, but I just don’t see that in the cards in the near term.”
 
The Michigan Catholic Conference, the church’s official public policy voice in Michigan and a key supporter of MiCAUSE, issued a statement after the Nov. 4 vote warning that it would oppose “any attempt within the Legislature, whether by statute or appropriation, to expand further the destruction of human life in the name of research.”
 
“Regrettably, we exist in a society that seeks immediate gratification and pleasure, with a damaging tendency to fall victim to emotional appeals that lack any notion of good public policy,” the conference said in its statement. “Enshrining in the state constitution a measure that prohibits the legislature from enacting any oversight or accountability measures related to the destruction of human embryos has unsettling consequences for the future.”
 
According to unofficial data from the Michigan Bureau of Elections, the ballot measure appeared to do best in urban areas and areas containing the state’s heaviest concentrations of life-sci employers. In Kalamazoo County, the measure won by 59 percent, while in Ann Arbor’s county of Washtenaw, Prop 2 won by 68 percent.
 
But in more conservative Grand Rapids and its home county of Kent, the presence of life-sci employers didn’t stop the measure from losing by 54 percent to 46 percent.
 
Yes, They Did
 
Rapundalo said one factor in CureMichigan’s victory was the Election Day turnout generated by Democrats and others who helped elect Obama as the nation’s 44th president. According to state Bureau of Elections data, Obama carried Michigan, a state with 17 electoral votes, with 57 percent of the vote.
 
“We can’t discount the fact that there was a coattail ride in terms of the Democratic wins here in Michigan, in all the different races,” said Rapundalo, including the 63-percent approval of a ballot question approving the medical use of marijuana.
 
Doyle of MiCAUSE agreed, invoking two of Obama’s campaign themes: “People went to the polls in droves wanting hope and change, not only for president, but for everything else.”
 
But CureMichigan’s DeWitt downplayed the Obama-coattail effect on Proposal 2: “We did better with Democrats than with Republicans, but across the state we did well with Republicans as well as Independents. It was by no means just that one factor.”
 
A longtime observer of Michigan’s political scene said the approval of Prop 2, combined with the Obama vote, reflected a change in the state’s Democratic politics — from the more conservative “Reagan” influence to a more liberal direction.
 
“The fact that the state is becoming more and more Democratic with every passing election, becoming more and more blue, is a factor in Proposal 2 having passed,” Bill Ballenger, editor and publisher of Inside Michigan Politics, told BRN.
 
Michigan’s traditional Reagan Democrat tilt, he said, explains why “most people thought it was probably going to lose, although everybody thought it would be close.”
 
Asked about an Obama coattail effect, Ballenger replied: “It’s conceivable a heavier turnout could have produced more voters, particularly younger voters who would have favored” more lenient stem cell-research laws.
 
Whatever the cause of CureMichigan’s victory, it was among the costliest for a ballot question in recent state electoral history, according to the Michigan Campaign Finance Network, which monitors election spending.
 
MCFN spokesman Rich Robinson said CureMichigan is estimated to have spent $8.3 million, not including the $2 million the coalition spent to get its measure on this year’s Election Day ballot. According to MCFN, CureMichigan was able to spend such cash in part thanks to a $5 million gift from philanthropist and shopping center magnate A. Alfred Taubman, a key benefactor for the University of Michigan.
 
On Oct. 7, Taubman announced he would donate another $22 million for the endowment of the U-M medical research institute he created last year with his first $22 million donation.
 
By comparison, MiCAUSE is estimated to have raised $6.1 million to fight the amendment, according to MCFN. Most of the money, $4.9 million, came from the Michigan Catholic Conference, though Michigan Right to Life was another key backer.
 
Doyle said of the final number, “I think will be around $6 [million] to $6.5 million, somewhere in that range.
 
“We got outspent at the end. But frankly, we knew that was coming,” Doyle said.
 
While the Michigan Catholic Conference and Michigan Right to Life have traditionally condemned hESC as the immoral destruction of human life, MiCAUSE combined moral and more pragmatic arguments in its fight.
 
The coalition against Proposal 2 challenged CureMichigan’s arguments; highlighted the advancement of research using adult stem cells, to which hESC opponents have raised no moral qualms; and played up Michigan’s fiscal problems by arguing that the amendment would inevitably lead to unaffordable state subsidies for researchers using embryonic stem cells while Michigan struggles to balance its budget.
 
The state’s shaky fiscal situation resurfaced a day after the referendum. Michigan Gov. Jennifer Granholm, a Democrat in her second and final term of office — and a member of Obama’s transition team on the economy — warned that she would issue an executive order by year’s end to cut the state budget by an as-yet-unspecified amount to plug a budget shortfall projected at between $300 million and $600 million.
 
‘Completely Preposterous’
 
Fattening state coffers was among the benefits of Proposal 2 that CureMichigan cited as it sought voter support for the referendum. The coalition trumpeted a report by the public policy institute Michigan Prospect that said removing restrictions on hESC research would create hundreds and possibly thousands of new jobs in the state, as well as:
  • Increased worker productivity — $28 million per year, $831 million over a 30-year period, from reductions in absenteeism and death from specified diseases;
  • Lower Medicaid costs —$38.5 million annually, almost $1.2 billion over 30 years, based on projections that the state could save 0.5 percent on its $7.7 billion in vendor payments;
  • Patient savings — Almost $80 million per year, nearly $2.4 billion over 30 years, based on projections that stem-cell enhanced treatments could cut treatment costs by 1 percent; and
  • Benefits to patients — More than 770,000 Michigan residents have conditions that could be treated through regenerative medicine, the report concluded.
In the 39-page report “Michigan Stem Cell Economics Study,” authors Allen Goodman, professor of economics at Wayne State University, and Sam Berger, a Yale University School of Law student and former researcher at the progressive think tank Center for American Progress, laid out two additional policy options for promoting stem-cell research in Michigan.
 
One calls for the state to fund such research: “Because only a few states have supported stem cell research, a commitment of even $15 million could demonstrate tremendous state support for the science.”
 
That option is uncertain at best, the authors acknowledge.
 
“Of course, there are difficulties in pursuing public funding, not only in ushering such a proposal through the political process, but also in finding sufficient resources,” Goodman and Berger wrote.
 
That reality, the nature of Michigan’s current embryonic research laws, and the presence of top-tier stem-cell researchers in the state, are cited by the authors as reasons why “simply updating the laws would have a positive effect on research in Michigan.”
 
Among positive effects cited by Goodman and Berger is an increase in the state’s life-sciences workforce. The report offered two employee-growth scenarios:
  • An increase of 1 percent, which would create 443 jobs in the industry, plus another 354 jobs as a result of “induced” or indirect economic impacts, such as purchases of goods and services by life-sci companies within the state. The indirect job projection uses a multiplier of 1.80; and
  • A 5-percent increase, which would create 2,215 jobs, plus another 1,770 indirect jobs.
In a rebuttal to the report posted on its web site, MiCause said the job estimate was “completely preposterous.”
 
“There is no reason to believe changing Michigan’s law on killing human embryos would provide a 1-[percent] increase in the biotechnology jobs in Michigan,” MiCAUSE said.
 
“This is like someone claiming removing small restrictions on headlight manufacturers in Michigan would lead to a 1 [percent] increase in the number of Michigan’s automotive jobs.”
 
MiCAUSE contended the amendment would lead to unrestricted experimentation on human embryos, end legal hurdles to their destruction, and legalize human cloning, now banned by state law. CureMichigan cited 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.”
 
Meantime, CureMichigan argued that Proposal 2 was needed because the state’s most advanced research centers — U-M, Wayne State University, and Michigan State University — have struggled to attract top-tier researchers despite running strong programs, and that current laws had discouraged stem-cell startups from growing in the state.
 
CureMichigan’s argument resonated with most of the state’s news outlets, which endorsed Proposal 2 — though Doyle said it was not a key factor in the win. “Was that a big factor? No,” he said.
 
CureMichigan launched its referendum effort in July, collecting 570,373 signatures — 50 percent more than the minimum 380,126 needed to get on the November ballot.
 
The pro-hESC coalition deliberately sought voter approval for an amendment to the state constitution, rather than a bond issue — a tactic that Owen told BRN was a lesson learned from last year’s unexpected defeat of a stem-cell referendum in New Jersey, where opponents stoked anti-tax sentiment [BRN, Nov. 12, 2007]. 
 

 
The Approved Amendment
 
Following is the text of the amendment to Michigan’s constitution approved by voters last week. The amendment was 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 alter Michigan’s current prohibition on 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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