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Massachusetts Panel Eyes October Repeal Of Embryonic Stem Cell Research Limits

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BOSTON – Massachusetts stands poised as early as next month to repeal restrictions on embryonic stem cell research enacted under former governor Mitt Romney, a state health official told BioRegion News.
 
The state Public Health Council, a 15-member panel that includes healthcare providers and the state’s top health official, is set to vote at its next meeting Oct. 10 on a change to the state’s biotechnology regulations that would allow businesses and institutions to use embryonic stem cells in research. The penalty for reproductive cloning of humans would also be repealed under the proposed amendment to Chapter 27 of the Acts of 2005, An Act Enhancing Regenerative Medicine in the Commonwealth
 
The Public Health Council will accept comments for and against the stem-cell proposal through Sept. 21. Comments can be e-mailed to the state Department of Public Health at [email protected]. Those comments will be posted on the department’s website, said Melissa Lopes, deputy general counsel for the public health department.
 
“It will be discussed internally and with [state health commissioner John Auerbach], then go back to the Public Health Council for a determination. It could be as soon as October,” Lopes said in an interview. “[The proposed amendment] will be presented to the council along with all the comments we have received.”
 
Lopes spoke to BioRegion News minutes after the ending of a public hearing on the measure, held at the public health department’s main offices downtown on Washington Street. The hearing was the first of two held last week.
 
The second took place in Worcester, Mass., where Gov. Deval Patrick wants to locate, on the campus of University of Massachusetts Medical School, a research center or “bank” that would make available for public and private research stem cell lines held by eight institutions. UMass is one of the eight, as are Boston University, Brigham & Women's Hospital, Children's Hospital, Harvard University, Massachusetts General Hospital, Massachusetts Institute of Technology, and Partners HealthCare.
 
Both hearings were devoted to a series of key changes in the state’s stem-cell law. One would delete a clause stating: “No person shall knowingly create embryos or pre-implantation embryo, if created by the method of fertilization, was not knowingly created with the sole intent of donating the resultant embryo for research.”
 
The second change would lift the state’s ban on using embryos in research, while retaining the ban on donation of embryos for research. The third change would remove the penalty for human reproductive cloning, which is now punishable by five to 10 years in prison, or a fine of up to $1 million. Judges can also force doctors who clone humans to pay the state all or part of their profit from such activity.
 
The restrictions were shepherded into law by Romney, a Republican who angered leaders of biotech businesses, universities, and research institutions in the state by aligning his policies with opponents of embryonic stem-cell research. Romney has cited his stem-cell stance, as well as his reversal from supporter to opponent of abortion rights, during his current campaign for his party’s presidential nomination.
 
Speaking Against
 
Lopes and Donna Levin, general counsel to the public health department, heard testimony at the hearing from only two people — both supporters of the current restrictions.
 
Tadeusz Pacholczyk, director of education for the National Catholic Bioethics Center in Philadelphia, and Evelyn Reilly, director of public policy for the Massachusetts Family Institute in Woburn, Mass., said the social benefit of cures for disease the research may reap was outweighed by what they contended was the moral wrong of destroying human embryos.
 
“The ultimate criterion of future [policy] direction should not be raw financial success. It has to be, ‘Is the moral line respected in the way that we’re going about making financial gain?’” said Pacholczyk, a neuroscientist who received his doctorate at Yale University and carried out postdoctoral work at Massachusetts General Hospital and Harvard Medical School before his ordination as a Roman Catholic priest in 1999. “There are certain things that are so evil you don’t build an economy on them in the first place.”
 
Patrick, a Democrat who succeeded Romney in January, has echoed arguments by biotechs, universities, and research institutions that the embryonic stem-cell research limits hindered the growth of the state’s life science industry at a time of increased competition among states. At least one company, Advanced Cell Therapies, publicly blamed the Romney-era limits for its decision to move its headquarters from Worcester to the San Francisco suburb of Alameda, Calif., though it retains some research in Worcester.
 
While Massachusetts restricted research on the stem cells of embryos, California officials led by Gov. Arnold Schwarzenegger persuaded voters to approve $3 billion for regenerative medicine projects, then prevailed in the state’s court system over opponents of the funding. And New Jersey voters this November will decide whether the state should borrow another $450 million for stem cell research, in addition to the $270 million that Gov. Jon Corzine and state lawmakers agreed to spend last January [BioRegion News, July 2].
 
The Massachusetts Biotechnology Council has advocated support for the proposed change in regulations among its more than 500 members, spokesman John Lacey told BRN. He cited the tighter restrictions in the current state law compared with New York law, which allows researchers to create embryos using sperm and eggs donated by families stricken with the ailment being studied.
 
“The regulations as they currently read might be interpreted in such a way that if a scientist in Massachusetts accepts stem cell lines from New York researchers, that this might be against the law and that the Massachusetts researchers could be jailed and fined. It’s also not clear if a Massachusetts researcher can consult with a New York researcher, or researchers in other states that have less restrictive policies,” said Stephen Mulloney, the council’s director of policy and public affairs, in a policy brief the organization has posted on its Web site.
 
Lacey also noted his group was one of two organizations asked by the Public Health Council to advertise last week’s meetings; the other was The New England Journal of Medicine: “MBC has briefed key members of the Public Health Council. The PHC knows the MBC interest and involvement in the issue,” Lacey said.
 

“It will be discussed internally and with [state health commissioner John Auerbach], then go back to the Public Health Council for a determination. It could be as soon as October. “[The proposed amendment] will be presented to the council along with all the comments we have received.”

Repealing the stem cell regulations in Massachusetts would dovetail with Patrick’s primary effort to grow the state’s life sciences industry. The governor in July submitted to state legislative leaders his Massachusetts Life Science Initiative, which calls for the state to spend $1 billion over the next decade for programs intended to attract and retain biotech companies, subsidize research, and train future professionals. [BioRegion News, May 14].
 
The biotech council’s new president, Robert Coughlin, helped craft the initiative in his previous job as undersecretary of housing and economic development in Patrick’s administration. Coughlin drew criticism late last month when the state Republican party filed a ethics complaint, citing an Aug. 26 Boston Globe report that he began negotiating his new position in June while still a state employee, a month before he alerted the state Ethics Commission and recused himself from state business involving the life science industry.
 
Coughlin has publicly denied wrongdoing; last week the biotech council defended Coughlin’s conduct [See Around the Regions, this issue].
 
Awaiting Legislative Action
 
Patrick’s life science measure is expected to begin legislative reviews this fall in both the state Senate and House of Representatives.
 
Among companies awaiting the outcome of the legislative review is Shire Pharmaceuticals. The British-owned company has submitted to Lexington, Mass., officials its plan for a $394 million expansion at Lexington Technology Park, consisting of 370,000 square feet in two buildings.
 
Shire spokesman Matt Cabrey told BioRegion News last week his company expects to decide within the next four to six weeks whether to continue pursuing the expansion and wait out the legislative review of Patrick’s bill, or pull the plug on the project altogether.
 
Cabrey said the tax breaks within Patrick’s life science bill will be crucial if the company is to carry out its expansion plan in Lexington.
 
“We’re concerned that the process is simply moving slower than we need it to move, based on internal timelines we have related to when we need shovels to go into the ground so that the building would be completed and we’d have medicines coming off the production line in 2011,” Cabrey said. [See this week’s BRN Interview for more of the conversation with Cabrey].
 
Shire made similar comments to the Boston Herald, and drew criticism in turn from the chair of the House’s economic development committee, Rep. Daniel Bosley, a North Adams Democrat: “You don't make a billion dollar decision overnight. They wouldn't do that in their business and we are certainly not going to do it in ours,” Bosley told the Herald.
 
Bosley did not respond to an e-mail message from BRN seeking the timetable of review by his committee and additional comment about the bill.
 

Cabrey added Patrick’s biotech initiative will not stop Shire’s previously announced plan to lease 52,000 square feet at 125 Spring St., within Lexington Technology Park. While Shire has its US headquarters in Wayne, Pa., the company is still a significant biotech employer in Massachusetts; the company bases its Human Genetic Therapies Business Unit in Cambridge, at 700 Main St., where it employs about 500 staffers.

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