A ban on somatic cell nuclear transfer (SCNT), a technique used in some forms of stem cell research, passed the House and Senate floors on Tuesday evening in a pair of higher education budget bills. The bills would prohibit state or federal funding from going toward SCNT stem cell research. The two bills are headed to conference committee, where the two bodies will hash out the parts of the bills that differ. Gov. Mark Dayton indicated in a letter to legislators that he would veto a bill that contained the stem cell bans, citing them as policy issues that don’t belong in budget bills.

In the House, Rep, King Banaian (R-St. Cloud) moved to amend the higher education bill with language banning SCNT, calling it “human cloning.”

“This is simply concerned with the funding of research into this. It is not an outright ban,” he said on the floor. “It does not ban a state institution doing it if it was able to find private funding to do so.”

In the Senate, the higher education bill was similarly amended in committee by Sen. Michelle Fischbach (R-Paynesville), whose husband, Scott Fischbach is executive director of Minnesota Citizens Concerned for Life, which has lobbied for the ban.

DFLers on the Senate floor objected to the provision saying it would prevent important therapeutic research from happening in Minnesota.

“The effect of that would be very significant for our economy and jobs, and very significant for the potential to control or cure very sign diseases that affect all of our families,” said Sen. Ron Latz (DFL-St. Louis Park).

He said proponents of the bill weren’t being completely honest about its true motivations.

“It’s the agenda of [Minnesota Citizens Concerned for Life] and the pro-life movement to move the line of where human conception begins,” said Latz. “I respect those who sincerely hold those beliefs, but we ought to be having it on terms that we understand that it’s not hiding behind scientific language when that’s not really what it’s doing.”

DFLers moved to amend the bill to have it ban the creation of human clones and to allow for therapeutic research.

Sen. John Marty (DFL-Roseville) said, “If you want to ban cloning but don’t want to stop the medical research, vote for the amendment, but don’t be pretending you want to do it because you want to ban human cloning.”

Those amendments were defeated.

Gov. Dayton wrote Senate Majority Leader Amy Koch on Tuesday stating that like his predecessor, Republican Tim Pawlenty, he would likely send back bills that contained “extraneous policy” proposals that didn’t relate to the budget.

And Dayton’s commissioner of higher education, Sheila Wright, specifically called out the stem cell ban in a letter to Republican leadership.

“Language regarding Human Cloning is moving in a separate bill and should continue to do so,” wrote Wright. “Any policy provisions not tied to the budget should be removed so we can focus on the budget.”

Sen. Michelle Fischbach, R-Paynesville, is adamant that a certain kind of stem cell research be banned. Her bill to criminalize somatic cell nuclear transfer was included in the health and human services omnibus bill currently under debate in the Senate, and she was successful in getting a weaker ban included in the higher education omnibus bill. The proposal has sparked a heated debate about whether the bill — and the testimony surrounding it — is misleading to the public on the topic of embryonic stem cell research. Republicans, however, have rejected an effort to clarify the debate.

A common refrain at a Senate Higher Education Committee hearing last week was “I’m not a scientist” as members debated Fischbach’s amendment to the higher education budget bill that would prohibit taxpayer funds for somatic cell nuclear transfer (SCNT), a technique involved in some kinds of stem cell research. The amendment calls SCNT “human cloning,” which some members of the committee found problematic.

There are two kinds of cloning, committee members discussed. “Reproductive cloning” would involve the creation of a new human being — limbs, hair and all. “Therapeutic cloning” involves the creation of eight or so cells to be used to treat disease. The amendment, perhaps purposefully, does not make a distinction between these types:

No state funds or federal funds the state receives for state programs may be used to either support human cloning or to pay for any expenses incidental to human cloning. For purposes of this section, “cloning” means generating a genetically identical copy of an organism at any stage of development by combining an enucleated egg and the nucleus of a somatic cell to make an embryo.

Sen. Michelle Fischbach

Sen. Sandy Pappas (DFL-St. Paul) expressed the concern that it was misleading. “I think it would be helpful if we could all come to a consensus that we oppose reproductive cloning,” she said. “We can’t send the message out that we are anti-research in Minnesota, and by passing these laws that don’t have enough thoughtfulness. Why do we want to ban therapeutic cloning? The therapeutic use of cells to treat disease?”

She added, “Let’s come up with a clear definition for human cloning.”

Sen. Kathy Sheran (DFL-Mankato) tried to do that with an amendment to Fischbach’s amendment to make clear that the law would ban both therapeutic cloning and reproductive cloning, but Fischbach and the panel’s Republicans were having none of it.

“I think we are really in danger of confusing the public about the difference between human cloning using stem cells for the creation of another human being and stem cells used for therapeutic purposes,” said Sheran. “They are very different and very separate, and this rolls them all in together and confuses the public into thinking this is all about human cloning when it isn’t.”

Fischbach said, “I think ‘human cloning’ is pretty clear.”

Sheran responded, “I know from your perspective it is, but we have heard testimony that there is a distinct difference between reproductive cloning and therapeutic cloning. It ought to be clear that your intent is to prohibit both, otherwise you will serve to create confusion in the public.”

Despite that plea, the amendment failed.

No scientists in the room

The science of SCNT was clearly an obstacle for just about everyone at the hearing. Pappas advised Fischbach, “You have to explain the biology here of what’s going on.”

But Fischbach couldn’t. “I will have to look that up. That’s beyond my scientific ability.”

Pappas shot back, “Mr. Chair, that’s our problem here today.”

Sen. Ron Latz (DFL-St. Louis Park) complained, “If we had a scientist here, if we had proper notice, some of these questions could be answered directly.”

With that the committee turned to Jordan Bauer of Minnesota Citizens Concerned for Life, which is pushing for the ban. “I am, unfortunately, not a scientist,” she said.

She did accurately explain the process of SCNT, however — something that didn’t happen in earlier committee hearings. In the Health and Human Services committee on Mar. 15, MCCL representative Andrea Rau discussed SCNT:

What they were trying to get at with human cloning research was to be able to create various tissues and they have new found others ways to do that without cloning. Now, what this language [in the bill] talks about, it’s very specific, it refers to only the cloning of human embryos. Once you have a human embryo, you know, if you were going to try to derive some kind of tissue, you would have to grow that embryo. If you wanted to grow a heart then, you’d have to grow the embryo and have the whole thing grow, the whole body and then harvest the heart, now I don’t think anyone here would think that was appropriate, but that’s the only thing you could do with it if you were trying to get a heart from it.

The Minnesota Independent ran that statement by several researchers, none of whom had heard of such a process, let alone of anyone attempting it.

“No one is trying to do that,” Don Gibbons, spokesman for the California Institute for Regenerative Medicine, told the Minnesota Independent. “I’ve never heard of anything like that. All organizations that support SCNT strongly oppose anything that would result in the implantation in a uterus,” the only way an embryo could grow large enough to harvest organs.

“SCNT is used to create new stem cells,” he added.

MCCL responded to a question by the Minnesota Independent asking for clarification. The spokesperson asked not to be quoted, but stood by the organization’s statement.

Pro-life versus science?

“The fact that it’s the MCCL that’s here testifying on this bill tells us a lot about the motivation of this bill. This is the pro-life movement trying to move the envelope based in large part on religious belief,” said Sen. Latz. “I think it’s a broader debate than we’ve had. I think we ought to be honest and candid about what’s on the table here and not pretend what’s going on here despite testimony that doesn’t specify that.”

He continued, “I respect that religious belief, but ennobling it in state statute is a different question, and doing it without notice and opportunity to be heard by everyone who might be concerned about this… that’s terrible.”

Dr. John Wagner

MCCL hasn’t been shy about its opposition to “human cloning,” but the motivation appears to be the fact that an eight-cell unfertilized embryo is created in SCNT research and that the group considers such an eight-cell embryo human life and worth protecting from destruction.

The group, which is run by Sen. Fischbach’s husband, Scott, distorted the position of leading stem cell researchers to make their case. In every committee where MCCL representatives have testified, they’ve cited world-renowned stem cell researchers Drs. Rudolf Jaenisch and Ian Wilmut.

“Leading researchers and scientists, including Ian Wilmut who cloned Dolly the sheep, and many others have turned away and against human cloning even for so called therapeutic purposes,” said MCCL’s Bauer at one committee meeting. “Ten years ago there was a lot of discussion about human cloning,” MCCL’s Rau said at another committee meeting. “They’ve tried that and, like Jaenisch and like others, they are continually turning away from that.”

But that’s not the whole story.

Dr. John Wagner of the University of Minnesota Stem Cell Institute talked directly to the researchers about their positions.

He told the committee, “When [Jaenisch and Wilcut] make statements that they are against cloning, they are talking about reproductive cloning not SCNT.”

“I am sure that it is no one’s intention to speak incorrectly about the science,” said Wagner. “I did call Dr. Wilmut on Saturday and Dr. Jaenisch, who was brought up, and they support my position entirely despite what you have heard. It’s misunderstanding what they are saying. They agree with the ban on reproductive cloning but not SCNT. There is certainly no question that there should be a ban on reproductive cloning.”

Sen. Fischbach and MCCL have cited a United Nations declaration numerous times in committee hearings as an example of international agreement on banning “human cloning,” but the UN declaration is nonbinding and the international body working on changing its position to allow the very research that Fischbach wants banned in Minnesota.

A bill in the Minnesota Legislature that would ban some forms of stem cell research could have unintended consequences for patients and researchers if it becomes law. The Human Cloning Prohibition Act could cost the Minnesota biotech industry millions in lost research dollars and sales, and the bill could potentially turn certain stem cell patients into criminals if they return to Minnesota after receiving certain treatments outside the state.

Dr. Hans Keirstead of the University of California Irvine is in negotiations with the Food and Drug Administration to conduct the first ever trials using embryonic stem cells to improve function in people with spinal cord injuries. While the therapy is promising, patients will also have to take anti-rejection drugs to prevent the body from attacking the stem cells. But Keirstead has another plan: Use somatic cell nuclear transfer (SCNT) to create stem cells out of the patients’ own cells, ensuring that their bodies won’t reject them. In California such research is legal even though human cloning is expressly banned; legislators in Minnesota want to make that research a crime along with human cloning.

Keirstad and his research teams are pioneers in the field of stem cell research. They found a way several years ago to program stem cells to replicate as neural cells — the kind damaged in spinal cord injuries — at a high rate of purity. The embryonic stem cells his lab created are from existing stem cell lines which were created from discarded embryos from fertility clinics.

Those stem cells won’t match spinal cord injury patients’ own cells, and their bodies will reject the cells unless they take long-term courses of drugs to prevent their own immune system from attacking what could be an effective treatment.

Using SCNT, Keirstad hopes to create stem cells that match each individual patient. By taking cells from the patient’s skin or other part of the body and injecting them into a human egg, researchers can create stem cells that match the patient perfectly.

That’s what Minnesota’s proposed bill would criminalize, and it’s what the anti-abortion rights group Minnesota Citizens Concerned for Life calls “human cloning.”

But the bill goes even further as Sen. Ron Latz (DFL-St. Louis Park) noted in Monday’s Higher Education Committee meeting.

Criminalizing patients?

“This bill makes it a crime not only to engage in that particular form of scientific conduct, but also to ship or receive or import any aggregation of cells that would meet this definition including, I suppose, if a person were to travel out of state and receive therapy that was created… created using this method of science and attempt to return to the state would be guilty of importing those cells and committing a crime simply by coming to Minnesota,” he said.

The Minnesota Independent spoke with several experts to ascertain if that would indeed be the case.

“Laws have been interpreted that way, but it’s a matter of opinion the courts will have to decide,” said Don Gibbons of the California Institute for Regenerative Medicine. He added that it’s hard to say for sure, since it’s up to law enforcement and the court system to determine application of the law.

Asked if the bill would criminalize travel into the state by patients participating in SCNT research, Michael Werner of the Washington, D.C.–based Alliance for Regenerative Medicine, said, “Well, it certainly could. This type of bill doesn’t account for a number of variables.”

“We don’t know where the next scientific discovery is going to come from whether it’s induced pluripotent stem cells, embryonic stem cells, umbilical cord cells or SCNT.”

He gave a scenario where a researcher might use SCNT to develop a certain kind of cell, and then that cell was altered or refined to create a treatment for a specific disease.

“Would that treatment still be a considered a product of SCNT?” Warner asked. “How many steps removed does the product stop being SCNT-derived? What if this technology led to other discoveries would treatments devired from those discoveries be available?”

He added, “The process of scientific discovery builds on itself.”

Lost research dollars

Dr. John Wagner of the University of Minnesota’s Stem Cell Institute told members of the Senate Higher Education Committee that the bill could cost the state in lost research funding.

“I think that, to be conservative, on the cheap end, would be hundreds of millions of dollars. There is a lot of work to get there, but the potential is massive,” he said.

Those numbers are in line with what market experts estimate. In one study in the publication Regenerative Medicine Cell Therapies, cell-based research alone generated millions in 2010. “We estimate from the cumulative numbers of units manufactured and patients treated as well as from discussions with senior industry experts, that the current value of the regenerative medicine cell therapy market is presently in the order of $100–200 million per annum,” the report’s authors wrote.

A 2010 memo from MaRS Advisory Services, a market research company based in Canada, stated that “2009 estimates approximate that the stem cell market (including blood cord banking and drug development tools) will achieve an annual growth of 29.2% resulting in sales of $11 billion by 2020.”

None of the organizations contacted by the Minnesota Independent would offer an estimate of how much a ban on SCNT would cost Minnesota in the long-term.

If passed into law, the ban could also mean top researchers leave the state to work at universities where such research is permitted. “I’ve been approached by Stanford,” Wagner said. “The California Institute for Regenerative Medicine is putting out an RFA to recruit people from other states.”

Sen. Latz asked him if that was before or after the bill was introduced.

Wagner responded, “Both.”

Huge potential

SCNT has not yet been successful in the lab, but there’s a consensus among stem cell researchers that it has huge potential.

A working group of stem cell researchers from around the world met last summer to discuss the future of the technique and they concluded that the research is vital:

Given that our knowledge of reprogramming is in its infancy, it is still possible that hSCNT will emerge as the technology of choice for specific human stem cell therapies or for developing particular disease models. A further reason to continue hSCNT research rests in its potential to shed light on the earliest stages of human development. Even the first few events after fertilization differ among species (Haaf, 2006), and increasing evidence suggests that subtle defects in these early stages of development can have serious repercussions on health and viability (Reefhuis, et al., 2009). Although some of these events can be studied using other in vitro models, hSCNT could be particularly useful for understanding the influence of genetic background on early development and help us understand environmental and genetic contributions to developmental disorders.

Because of that potential, the Minnesota Medical Association and the University of Minnesota have come out strongly against the proposed bill.

The bill — sponsored by 31 House Republicans and three House DFLers and five Senate Republicans — passed through key committees in both chambers within the past week and currently awaits a vote on the Senate floor.

Committees in both the Minnesota Senate and House passed a bill this week that would criminalize the somatic cell nuclear transfer (SCNT) process in embryonic stem cell research as well as prohibit the products of that research from entering the state of Minnesota. Despite expert testimony that the bill would hamper medical research in Minnesota, it passed three key committees this week.

The Senate’s Committee on Judiciary and Public Safety heard the bill on Thursday.

John Wagner, professor of pediatrics at the University of Minnesota and the Stem Cell Institute, said the bill would harm research at the university. He also implied that the bill’s title, The Human Cloning Prohibition Act of 2011, was misleading.

There are two kinds of uses for SCNT, he told the committee: one is to create a living, breathing human clone, also called “reproductive cloning,” and another is to use SCNT for “therapeutic cloning” to create stem cell treatments for treating disease. Wagner said that no one is trying to create whole human beings with the reproductive cloning, but many researchers are using SCNT to create stem cells for medical purposes.

“Human cloning should be prohibited. Everyone is in complete agreement with that,” Wagner told the committee. “However, there is language in here that could be construed that this is also prohibiting embryonic stem cell research. And that’s the part that I think we need to make very clear.”

Sen. John Marty (DFL-Roseville) asked Fischbach if she would approve an amendment to protect the medical research uses of SCNT. “I’m willing to work on an amendment to try and limit it to banning reproductive cloning and to protect stem cell cloning,” he said. “If that’s not the intent I’d just be wasting time.”

“The intent off the bill is to ban human cloning,” Fishbach responded. “I think what the doctor was describing in very scientific terms was either you clone a human to make a baby and implant it into a women or you clone a baby to use it in experiments”

She added, “I think what we are trying to do here is to prevent a human from being created for experiments and reproduction.”

Dr. Wagner indicated that that was not quite accurate. “None of us are creating a baby. Once you insert a nucleus in to that oocyte you get an embryo,” he said. “The intent is not to create a baby, the intent is to create an embryo. I think it comes down to what you think an embryo is. We are talking about eight cells here.”

Wagner added that the University of Minnesota currently does not use the SCNT technique and does not create new embryos; instead researchers use embryonic stem cell lines created in different states and countries. He said there was concern, however, that the bill would ban the importation of cells and products created by SCNT in Minnesota and that it would impact the university’s research.

But according to testimony by Andrea Rau of Minnesota Citizens Concerned for Life, much of the bill may not matter because the type of research the group is trying to ban is already illegal.

“It is already not allowed under Minnesota law,” said Rau, citing laws related to “human conceptus.”

“If it’s already unlawful then I don’t see why we need this legislation,” Marty said. “Then this is not to stop a cloned human being, this is to stop research into cures for Parkinsons, ALS and other diseases.”

The University of Minnesota provided legislators with a fact sheet that calls the bill a “law to make stem cell research a crime.” The university also created a website to oppose the bill.

Its author, Sen. Michelle Fischbach, said the penalties for such research under the bill have been reduced from a felony charge to a misdemeanor. Fischbach is the wife of Scott Fischbach, the executive director of Minnesota Citizens Concerned for Life, a group that is working to draft and pass the bill.

The bill passed the committee by a 8-5 vote on Thursday. And on Tuesday, the bill passed the Senate Health and Human Services Committee. The House Committee on Judiciary and Public Safety passed it by a voice vote on Tuesday as well.

Source: Wikipedia

Minnesota Citizens Concerned for Life, the state’s largest anti-abortion group, says the University of Minnesota is trying to clone human beings and is in violation of the law. The university says its research is legal and that the group is engaging in a “disinformation campaign” designed to halt stem cell research.

MCCL is going after the university in the wake of a new law passed by the Minnesota Legislature — at Gov. Tim Pawlenty’s demand — that bans taxpayer funding for human cloning.

MCCL called on the university to “cease its pursuit of human cloning and to end its violation of state law through its ongoing destruction of human embryos.”

The university says it does not engage in human cloning and that all stem cell research is legal and done with private dollars.

In a letter to MCCL, Wendy Burt, director of public and community affairs for the Academic Health Center, directed the group to “remove false statements” about the university and “issue a retraction visible to your members and the community containing the truth” about the university’s research.

MCCL shot back. “MCCL’s statements regarding the University of Minnesota’s pursuit of human cloning and its embryo-destructive research have always been accurate,” said MCCL executive director Scott Fischbach. “The university’s letter only serves to highlight its own dishonest portrayal of its efforts to clone human beings.”

But Burt says that MCCL is working to quash all stem cell research at the university. “Your characterization is irresponsible,” Burt wrote to the group. “Stem cell research is regulated by stringent federal oversight and is carried out within the strict guidelines of federal law and the National Institutes of Health.”

Burt added, “I ask that in the future you commit to ensuring any information about the university is responsible and accurate.”