The past months have been filled with disputes, protests and discussions of education funding. A divided Michigan legislature has debated what to cut and where to cut it. The legislature must allocate funding for Michigan’s public colleges and universities. As expected, this funding plan has strings attached, perhaps the most notable of which is a rider which could affect stem cell research in Michigan.
The chairman of the house appropriations committee, Representative Robert Genetski, introduced the proposed funding for public colleges and universities to the state legislature on February 16th of this year. In addition to a breakdown of budget numbers, house resolution 4275 contains a rider that would modify the state’s existing policy towards stem cell research.
Section 473 of the appropriations bill would require universities doing research using embryonic stem cells to create a yearly report for the Michigan Department of Community Health detailing “(a) The number of human embryos and the number of human embryo stem cell lines received by the university during fiscal year 2010-2011 (b) The number of human embryos utilized for research purposes during fiscal year 2010-2011 (c) The number of human embryo stem cell lines created from the embryos received during fiscal year 2010-2011 (d) The number of donated human embryos being held in storage by the university as of September 30, 2011 (e) The number of research projects using human embryonic stem cells derived from donated embryos being conducted by the university.”
Proposal 2 and Embryonic Stem Cell Research
This proposal follows three years after Proposal 2, which amended the state constitution to scale back restrictions regarding embryonic stem cell research in 2008. Although this is not the first challenge to the amendment since its passage, a hectic political climate, in which economic problems take precedent, has prevented this issue from garnering significant attention.
Proposal 2, as a constitutional amendment, required passage by popular vote. It passed by a slim 53%-47% margin and allowed researchers to use embryos donated from fertility clinics that would otherwise have been destroyed. This move changed Michigan’s policy to complement regulations put in place by the federal government and the systems of most other states. The bill has led to the creation of three stem cell lines at the University of Michigan that have provided new opportunities for research.
Dr. Eva Feldman, a professor of Neurology at the University of Michigan, has used these stem cells for research both as a model for disease and as a possible treatment for neurological, degenerative diseases such as Lou Gehrig’s Disease, also called ALS, that affects as many as 30,000 Americans according to the ALS Association. “What we use our stem cells for is twofold. The first thing we do is to model a disease. Specifically what we’re interested in is neurological diseases like ALS and Alzheimer’s…The second thing we’re doing is developing cellular therapies,” said Simon Lunn, a postdoctoral fellow at the University of Michigan’s Taubman Institute who works with Feldman.
Feldman is leading the first human trial using stem cells to treat ALS. So far it has proven effective on twelve patients, and fifteen more will be tested before the treatment is cleared to move to the next level of FDA screening.
“The good thing about stem cells is they can become any type of cell you want and we make them into neurons, but we don’t think those neurons can get all the way down to your little toe. What we think we can do in the spinal cord is patch. Basically [the stem cells] sit next to the cells that you already have and act like first aid… When we put stem cells in our systems, we’re getting the patching effect of touching and communicating with other cells, but we also get the production of factors like IGF-1 that act as first aid, so basically we put a band aid on the disease,” said Lunn.
Proponents of the rider argue the information it requires is necessary to ensure that research like Feldman’s is being done carefully and legally. “It is important to know where the human embryonic stem cells are coming from and where they’re being generated,” said Genetski to the Holland Sentinel last month. “It’s really about accountability.The reason that we feel that this is necessary as a form of accountability is because the number of embryos is very limited, and there will evolve a black market for them,” said Ed Rivet, Legislative Director of Right to Life of Michigan.
The Support of Right to Life
Right to Life of Michigan has been an ardent supporter of this bill since its proposal in February. The group has long spoken out against the use of stem cells derived from embryos and ran a $7 million dollar campaign in 2008 in an effort to prevent the passage of Proposal 2.
Rivet said Right to Life’s goal is to be able to answer simple questions about the research currently being done in Michigan. “There is no accountability. And they, apparently, in opposing this rider, this reporting language, don’t feel that they are accountable to anybody…You can ask me how many embryos are there frozen in Michigan in storage that could possibly be donated some day and I don’t know the answer to that either, because nobody knows. We don’t have that basic information and that’s what the rider’s about: basic information.”
Rivet also argues that the bill will tie up loose ends not resolved by the 2008 constitutional amendment, and if universities are complying with state and federal regulations they will simply be providing several small pieces of information. “Right now there are certain provisions of Proposal 2 that are in the Constitution that say you cannot sell embryos, you must donate them. The embryos cannot be researched on after 14 days of development and a whole other series of requirements that are in the constitutional amendment. Now here’s the problem: they didn’t put any penalties into it. We don’t have penalties. We don’t have definitions for terms so those are the kind of things the legislature has to go back and clean up afterwards,” he said.
Feldman’s team is hopeful that this use of stem cells will prove effective in combating the symptoms and slowing the decline in function characteristic of ALS. “What we do in these patients, is we actually take stem cells and we do a surgery where we transplant the stem cells directly into the spinal chord of these individuals with Lou Gehrig’s disease (ALS). If we can show safety in another fifteen patients, the next step is called a phase two trial where then you can enter patients, hopefully, and show the treatment works in terms of prolonging their lives,” she said.
Feldman spent time campaigning and educating the public about Proposal 2 and its possible effects. “For Proposal 2 I spent a lot of time educating people… The climate for stem cell research now is much more favorable since the passage of Proposal 2 in 2008. Prior to that, we were not allowed to develop or create any of our own stem cell lines in Michigan,” she said.
The 2008 amendment allowed Feldman and her colleagues increased freedom in their research, and new opportunities to study the disease process and test treatments. “[We] just created the third, what we call ‘disease specific’ stem cell line. What we’re able to do is create stem cell lines that carry specific genetic diseases. And that’s really going to allow us to better understand what causes the disease, plus allow us to screen drugs against human cells, something we’ve never been able to do. So the climate is improving, and continues to improve,” she said.
The current rider would not change the actual wording of Proposal 2, but it would mean increased paper work for those, like Feldman, conducting research. “What we need is to get to that point not to be over-regulated, or over-legislated by our own state of Michigan. That is important, so I’m very happy to comply with the federal government’s rules, and do to the letter of the law, but to have another set of rules… That makes it onerous and unnecessary. Take my word for it, the federal government legislates us very well. They regulate us very well. We don’t need another set of regulations,” said Feldman.
If this rider passes, Michigan would be the only state in the nation to request additional reports regarding human embryos beyond what federal regulations require.
Where the Information Goes
Universities have expressed frustration that this extra work would be required, but not used by the state in any way. “I can’t figure out why Michigan Department of Community Health report that says we got 100 embryos and we used five of them to create five new stem cell lines, has any meaning for anybody except maybe another scientist who says ‘oh gee, you used five, we used eight. You must have a better technique than us.’ [That is] hardly a public health issue,” said Ed Goldman, professor in the University of Michigan School of Public Health and former Attorney for the University Health System.
The fight over this rider attached to the higher education funding bill is just one facet of a national, philosophical debate which has significant ramifications. This discussion sheds light on serious questions about when life starts, how research should be done and what the government should and shouldn’t be able to regulate.
Feldman also believes that a lack of understanding may also play a part in the opposition that stem cell researchers face. “I really think that people don’t understand it. Every time I explain it people will go ‘Oh’… We always say that we’re more ‘Pro-Life’ than any other group because we’re not putting those embryos down the garbage disposal, we’re allowing them to be used. Most people don’t understand that simple explanation. They don’t understand what an embryonic stem cell is, how we obtain them, and they really do believe that we are killing babies… After I’ve had them time to talk with someone I’ve never had them be against stem cell research,” she said.
Proposal 2 only allows for researchers to use cells that have been allowed to replicate for fewer than 14 days, when the mass technically becomes an embryo. “It is completely undifferentiated cells. It does not look like a fetus. It is technically a blastocyst because it is only after 14 days that it becomes an embryo, and we’re talking about something at day five through eight, and so it is not even an embryo. [It is] a mass of undifferentiated cells smaller than the period at the end of a sentence. People have the wrong image in their minds,” said Goldman.
Those in favor of the research argue that since the cells are not technically embryos when they are harvested, and could not develop without being implanted in a human womb, it is not killing or preventing human life to use the stem cells from the inner lining of the blastocyst to create tissue or cells for research purposes. “It’s like saying an acorn is one little step away from being an oak tree. An embryo will only become a person if it is implanted in somebody’s womb and then it only takes one third of the time,” said Goldman.
Proponents of embryonic stem cell research also cite the fact that the embryos donated by fertility clinics for the purpose of research would be discarded. They have been deemed not healthy enough to be implanted in a human so they are destroyed. “In the state of Michigan, what happened before Proposal 2, is that they were literally put down the garbage disposal. There was a special garbage disposal for the embryos. And when people understand that that’s what happened to them alternatively what we can do is what we showed you in the lab we can take them and grow them in to stem cells and use them for therapies,” said Feldman.
Embryos that would develop with genetic diseases are not suitable for implantation but can provide valuable information if used for research. “We’ve created three lines, one was from a healthy embryo and the other two were from embryos with disease, Hemophilia B and [Charcot]-Marie-Tooth disease. Those embryos would never have been implanted anyway… So under Michigan law what the people who created them would say is ‘throw those three away.’ [It is] perfectly legal to do that. All we’re saying is you have a choice, you can throw them away or you can give them to us so we can learn more about Hemophilia B. I don’t think that’s a hard choice,” said Goldman.
The Promise of Stem Cell Research
Despite political and legal battles, stem cell research promises astounding results. “When I first started working on ALS, because it is such a very complicated disease and we don’t really know what the cause is, if you had asked me then, four years ago, if we had a treatment for ALS from stem cells I would have said ‘No. Not going to happen. Not for a long time.’ But through the persistence… of Eva and her collaborators it’s really pushed this forward really quickly in a really good, safe manner. I think we’re a lot closer,” said Lunn.
Treatments derived from stem cells have allowed Feldman and scientists like her to come the closest they ever have to a viable treatment for neurological, degenerative diseases. The unique properties of stem cells allow them to replace cells that have lost their functionality, something not allowed by previous attempts by doctors to treat diseases such as ALS. “We spent a lot of time doing growth factor trials, both in animals and in man, to see if we could get growth factors to work in many degenerative diseases… Growth factors didn’t work in phase three trials. And I know that’s because you inject the growth factors in the arms, and how do they get to the problem, which is in the spinal chord and the brain? They can’t… The way to do that is to directly inject the therapy there… We elected to use stem cells as the therapy. These stem cells make growth factors, so they make the factors we were trying to inject anyway, plus they do so much more than that. So that’s really what led us down this path,” said Feldman.
However, for some the potential benefits of research using embryonic stem cells does not justify the means. Certain religions, including Catholicism, do not believe in in vitro fertilization, and therefore, by default do not support the use of embryos created this way for any purpose, including research. Others are morally opposed; they believe that embryos, even before they are scientifically classified as such, have the potential for human life and as a result should not be used for research. “The question is whether it’s ethical, and the destruction of human beings in order to advance research is not ethical. The distinction is that they don’t see them as human beings, but we do. I’ll admit it, they’re the tiniest of all human beings, but I was once that tiny and so were you. I don’t think I’m any less human just because I got bigger and was allowed to grow. Yeah we can have the debate, they just think it’s some cellular mass. And we think it is nascent human life,” said Rivet.
Goldman agrees that there is a difference of opinion on this topic. “If you take the high road then you can argue that they have a sincere religious, personal, moral belief that says embryos have the potential for human life and so they should never be destroyed,” he said.
The Bill’s Path in the Legislature
The bill has been approved by both the house and then the senate. However, the two different versions of the bill must be reconciled. It is in this situation that the rider could be removed from the bill before it is sent to the Governor for approval. It is also possible, but unlikely, that the entire bill could be vetoed by Snyder, who has come out is opposition to the rider, saying publicly “I think the Higher Education budget should be about higher education, not stem cells.” However, this scenario is not likely because this rider is a small portion of a bill that is essential for Michigan’s colleges and universities to operate. It would be unusual for a few lines at the end of this budget to halt the entire proposal.
As of now, both houses passed section 473 of the bill. “If both chambers pass the identical language, then it just stays in there and they just negotiate the differences they had. I don’t anticipate it changing, but it’s possible. I expect it will just stay in there the way both the house and the senate pass it,” said Rivet.
Although six other proposals have been presented to the legislature regarding embryonic stem cell research since the passage of Proposal 2, none of them have passed. This time could be different. Without a campaign to raise public awareness, this issue will most likely be decided solely by the legislature. “There hasn’t been a huge public interest campaign because those take money. The problem with fighting in the legislature is that the legislature is pretty conservative. On one level you can say well what’s the worst thing that could happen. You file a report, Michigan Department of Community puts it in a file somewhere and you’re done. The problem is then Right to Life has won round one and who knows what happens in round two,” said Goldman.
While the stem cell research debate evolves in Michigan, this issue is of national importance. The government will play a roll in this issue at both the state and the national levels. The power of the federal Dickey-Wicker Amendment, which has been attached to the appropriations budget every year since 1996, is being determined by the court system.
In a time of economic instability, stem cell research would encourage biomedical innovation and research at Michigan’s public colleges and universities. The future of this research is in the hands of the legislature, and though it is difficult to determine their potential course of action, it will have an impact on medical breakthroughs and, as a result, our national health in years to come.
