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Happy days are here again for the embryonic stem cell (ESC) research community, or at least they should be. The day after Barack Obama was inaugurated as president in January, the U.S. Food and Drug Administration green-lighted an application from Geron Corporation to pursue the first phase I clinical trial of an ESC-based therapy (in this case, for spinal cord injury).
President Obama, who ran on a pro-ESC research platform, cannot take credit for that regulatory first, which was largely a coincidence of timing. But he has already made good on his promise to lift the burdensome restrictions on federally funded ESC studies imposed by his predecessor in 2001. Laboratories receiving federal money are once again free to work on the cell lines of their choice (with some important restrictions).
So scientists at last mostly have what they have been asking for. And the public should now prepare to be disappointed.
Perhaps “disappointed” is an overstatement, but a realistic recalibration of expectations is surely in order. The problem with turning a scientific issue into a political football is that the passionate rough-and-tumble of the game can leave the science itself rather scuffed. When opponents of ESC research likened it to genocide and Nazi concentration camp experiments, its proponents countered by emphasizing how irreplaceable ESCs were and how miraculous the cures arising from them could be. Whether or not those claims wandered into rhetorical excess, at least a few false hopes and misimpressions have probably been left behind.
To address the most obvious one first: practicable ESC-based therapies are years away. The upcoming tests of Geron’s paralysis treatment, for example, will look only at how safely it is tolerated by patients; tests of its effectiveness are further off. The therapeutic cells helped mice to partially recover from spinal injuries, but in humans they might fail to do the same or, worse, might induce tumors. It will take time to find out. New drugs often take five to nine years to progress from phase I testing to market.
Moreover, many if not most of those future therapies based on ESC research may not actually involve ESCs. Patients, after all, will not be able to supply embryonic cells directly from their own body. Therapeutic ESCs would either have to come from immunologically matched stockpiles (the equivalent of blood banks) or be cloned for each patient individually. Both solutions would involve technological and legal headaches. Using adult stem cells or others reprogrammed for versatility from a patient’s own tissues may therefore prove much easier. (Adult stem cells are indeed already used to treat some blood-related and orthopedic disorders.)
Opponents of ESC research may howl that these facts only vindicate their long-standing position that it would be better simply to concentrate on adult stem cell therapies. But the hard-fought campaign against restricting ESC research was well worth it: ESCs will most likely be essential for developing sophisticated stem cell therapies of any kind because they offer the best clues to how the body naturally grows, repairs and regenerates demandingly intricate tissues.
Anyone who thinks that the public debate over ESCs is nearing an end is also in for a rude awakening. In March, 10 out of 18 members of former president George W. Bush’s Council on Bioethics issued a press release criticizing the Obama administration’s policy as unethical. Days after the president’s executive order, the Georgia State Senate approved the Ethical Treatment of Human Embryos Act, which would bar the deliberate creation of embryos for ESCs. Expect more of the same.
Stem cell research continues to be a pawn in a larger political game being fought over abortion, women’s reproductive autonomy, and the tension between individual rights and notions of public morality. And that fact, however inescapable, may be the most disappointing one of all.
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21 Comments
Add CommentThe purpose of this editotial is a puzzle. You have done the the same thing as the other Obama opponents: You cant't ignore his talent, so all you can do is to give him a backhanded compliment.
Reply | Report Abuse | Link to thisPrivate companies sometimes shy away from the basic research if the results are uncertain. That's why the federal funding is so important for the embryonic stem cell research (ESC). If your idea is followed - asking for immediate benefits - then there would be no basic research at all.
As a medical oncologist with three decades of experience, I can tell you this: Many expensive clinical trials are failures, and some are abandoned in the middle of the studies because of unexpected complications. Would you, then, advocate against clinical trials?
Your philosophy is like the animal-advocate zealots, who want to prohibit vivisection or animal experiments. They ask to get answers through computer modeling. Would they or for thet matter the editors, voulteer to be the first patients to receive a new cancer chemotherapy that has not gone through animal studies?
I have no connection to Geron. But I believe they are doing a pioneering work. And it's admirable that they are looking for safety first - that's how science is supposed to work.
Your comment about the adult stem cell is preamature as well. It's in no better shape than the ESC. It's pioneer, Shinya Yamanaka of Kyoto University in Japan, maintains an ESC lab at University of California at San Francisco, to compare the properties of ESC versus adult stem cell; they may be similiar but not identical. Even he concedes that, "There is no way to get around some use of embryos ..."
In vitro fertilization (IVF) is legal and ethical, and in IVF many more blastocysts are produced than needed. So rather than discarding them, use them for human good. What dignity the embryos get in the trash can? And how does the use of these embryos differ from the use of the organs of the unfortunate children who die of accidents? Do these children have any say to their organ donations?
Scientific research must be bound by the ethical principles, while at the same time, it must free itself from religious dogmatism. Father James Martin of the "American Magazine" has said it best: "...Life begins at conception. Unfortunately, for some it ends there."
(I will be glad to send you a 750 to 1000 word essay on this if you allow me to do so.)
Fazlur Rahman, MD, FACP
3555 Knickerbocker Road
San Angelo, Texas 76904.
E-mail: frahman@wtmedical.com
Dr. Fazlur, three decades of experience is a lot of experience. I know nothing of either Stem Cell research or Gene modification research. So, I ask these two questions from a layman's point of view. In your opinion has Stem Cell research produce anything useful and I ask the same question about Gene modification research. From my point of view, it appears to me that Gene modification is already producing useful results and Stem Cell research has produced nothing. Without getting into politics or funding can you set me straight on these two questions?
Reply | Report Abuse | Link to thisI believe that's the point who knows if ESC will produce results sooner, later or ever since it's a new arena in research and is dealing with a much more complex area of knowledge. What you are proposing in your questioning the results of ESC is the equivalent of saying Columbus knew everything about the new world by his discovery of a small island chain. He had the knowledge of merely a few grains of sand.
Reply | Report Abuse | Link to thisDEAR EDITORS,
Reply | Report Abuse | Link to thisReading this article on ESCs the Editors of Scientific American reminded me the political fight over abortion is also the reason many newly diagnosed meningioma primary brain tumor patients, approximately 14,500 diagnosed each
year in the US, will not be offered an alternative safe daily oral drug therapy called Mifepristone
or RU-486 an antiprogesterone agent, and early option pill before they must decide to take the risks of brain surgery or brain radiation, while they monitor their tumor with MRI head scans and wait with their doctor's approval if their tumor is small, less than 1 or 2 cms to see if it grows, or if they have no serious symptoms including depression from the low grade tumors.
80% of low grade meningioma tumors have high levels of progesterone growth regulating receptors that are
blocked by this drug which contains no actual hormones and may actually reduce their depressive symptoms.
And it already successfully completed SWOG Phase 1 and Phase 2 human clinical trials, although the Phase 3 was
closed in 1999 because of some unnamed members of a NCI Data and Safety Monitoring Committee, said it
was no more effective than placebo, while further 2007 research by Dr Steven M. Grunberg in Vermont continues to show it has real benefits and few disadvantages compared to the risks of surgery or radiation to the brain for these patients.
The lives of these adult people with a primary brain tumor, many women beyond their childbearing years, are not being
counted equal in value or as important to protect from harm as potential new life in the first trimester in the eyes
of some powerful people with false self righteous notions of their absolute right to control all women's individual
health care issues even though they are not medical professionals or doctors. We do not know how many
men and women in the prime of life might be able to add more productive years to their lives from other safe documented medical uses of this generic drug.
I have taken it safely with no serious side effects for a total of seven years 200mg daily and have managed to continue
to postpone radiation and any eventual longterm cognitive or physical decline from brain radiation since 1992.
If I can speak up to power and President Obama loud enough, every year it will help thousands of other people avoid the medical risks of invasive brain surgeries and total hysterectomies for fibroids that I endured because of low grade 2 abnormal tumor cells and the overbearing arrogance of the conservative right.
"The lives of these adult people with a primary brain tumor, many women beyond their childbearing years, are not being
Reply | Report Abuse | Link to thiscounted equal in value or as important to protect from harm as potential new life in the first trimester"
No--opponents of ESCR want to treat all human life as equal. We went through this debate after WWII and determined that it is unethical to kill people in order to cure (or research cures for) others. No one says that white people suffering from syphilis were counted as less equal in value than the black men used as human guinea pigs in the Tuskegee experiment after the outcry was raised against it. No one would consider non-Jews "less important" than the Jews who were experimented on and killed by Nazi doctors, even though their experiments may have resulted in cures. Those opposing ESCR simply say we cannot kill one human being (for embryos are human--if they weren't, we wouldn't be having this debate) to save another.
"In vitro fertilization (IVF) is legal and ethical, and in IVF many more blastocysts are produced than needed. So rather than discarding them, use them for human good. " Perhaps you were not aware that IVF is not considered ethical by many (primarily Catholics, but other groups as well). Secondly, the problem of "spare embryos" can be corrected, as has been done in Europe--only create enough to implant, and implant them Thirdly, please reconsider what you are saying. Essentially, this argument states that embryos created through IVF are not as human as we are--that they are things to be used "for human good". They must not be human, then, for I fail to see how killing them advances their own good.
So, certain human beings can be reclassified as things to be used by those more powerful than they, because they are smaller, more dependent, pre-rational, etc. Can we therefore experiment on "unwanted" infants? Severely handicapped children? Older people suffering from severe dementia? Who decides who is human enough to be protected and who is just spare parts? By what authority? By what standards?
As a doctor, one should know that human development is a continuum. There is no objective point at which one can say "today this is a human being but yesterday it wasn't," because there is no one event that changes everything. All the genetic information is there from fertilization onward.
What we need to do is ask ourselves if using some human beings as disposable things for the benefit of those older/more powerful is ethical. In other circumstances we have said no. What makes this different?
Finally, in stating that by not allowing us to kill unborn human beings women and others are not considered equal rights bearers is erroneous. The equality of women does not depend on denying the equality and rights of the children they carry (or conceive through IVF). The equality of one class of human beings cannot be purchased by the denial of the equality of another.
Reply | Report Abuse | Link to thisThis means that to simply be human does not mean one is a bearer of rights. No, according to the pro-ESCR (and "pro-choice") position, we have to do something else or be something "better." Only some human beings have rights. Other human beings have the right to strip certain classes of their rights by declaring them "non-persons".
The conservatives have historically prohibited scientific advances and chosen to ignore modern science research. They have disputed the facts and blocked lifesaving medical advances before, by insisting corpses must not be violated, and prefering their own illogical, magical male thinking, For example, for years as you say many catholic male leaders have strongly disapproved of medical infertility treatments because artificial conception in a tube this way they said was an unnatural immoral act without the God given sexual union between a man and a woman. Yet now they insist the test tube result of laboratory science they condemn, this man made item in a test tube, product of a lab procedure is human? How arrogant of these powerful people to assume they can have it their way both ways, according to them it isn't natural or human without the sexual act, and now they say it is human even before it is implanted in a woman's womb where I beleive it finally does have the potential to develop into a human being. Did they just forget that it still takes a woman nine months of her life to give birth to a child? Doesn't this flawed thinking make a man think he is God, and not God?
Reply | Report Abuse | Link to thisNow they insist these surplus lab items which have been discarded as medical waste for years must not be reused or recycled, now that we finally know how to use them to study and advance biomedical science that will potentially save the lives of real living people. Instead of their superficial objections to Obama speaking at Notre Dame because he is believing in science instead of tradchurch doctrine perhaps are they hiding their own racial predjudice behind their self-righteousness, because Sunday is still the most racially segregated day of the week in America. Frankly, they have very little practical experience to advise scientists or married women in daily life, instead of attempting to dominate all women and limit advances in modern biomedical science, if they would just stick to bible preaching about living like Christ from "the womb to the tomb" we might all get along more peacefully. The man made brand names, cultural icons, and old views of all religions may vary and do change, but the core principles of God stil apply whether we are Christian, Muslim or Jew, male or female he made us all equal. but it takes a woman to decide to make a child, a man can not make a human person all by himself. unless he wants to insist on having a womb transplanted into his body, and I guess there will be a man who will try to do this medically someday
As for killing humans accidently in human clinical trials, why not allow those who want to volunteer to help advance medical science do so? especially if they no longer want to be financial or emotional burden on the community if they are terminally ill and there is nothing more that can be done anyway, if they want to donate themselves to a greater good? Like in battle? when the real enemy is a human disease, the real terrorist cancer cells hiding in their own body.
Reply | Report Abuse | Link to thisWe manage to easily rationalize murder as collateral damage in battle in our militaristic attempts to dominate and control others. Why not allow a rape victim to react in self defense against a forced invasion of her own body? Are you will to pay for a surrogate mom and dad for all the millions of surplus embryos in frozen existence in this country right now? Are you thinking they can be realistically maintained indefinely as "souls on ice" ? Who has to pay for the freezer for their frozen life? Is that life or living?
Reply | Report Abuse | Link to thisHow utterly ridiculous to play the "race card" in a discussion about the murder of the most innocent of lives. These issues were being debated long before Obama was elected. As we travel down the slippery slope of deciding which lives are valuable and which aren't. I hope you remember your liberal beliefs when the government or your nursing home decides your life isn't useful any longer, and you believe differently. Perhaps then you will consider the many lives lost to ESCR, abortion, and IVF.
Reply | Report Abuse | Link to thisI would be happy to donate my aborted fetus to see my 23 year old beautiful daughter with spinal cord injury and quadriplegia dance again.
Reply | Report Abuse | Link to thisAll I can tell is I would donate gladly my aborted fetus for my 23 year old beautiful daughter with spinal cord injury and quadriplegia to walk and dance again. Stem cell transplant is her only hope. She is asking for donations to go to China to get the stem cell therapy there. It's a shame that US is so far behind in this field compared to European and Asian countries.
Reply | Report Abuse | Link to thisI spoke with the person who fixed his finger with stem cells. Quite an amazing experience. Check out the photos. Time the research community got off it's collective behind and did something like this.. btw he has sensation in the new one as well!
Reply | Report Abuse | Link to thishttp://www.indianahorserescue.com/research/stemsubject1.htm
I spoke with the person who fixed his finger with stem cells. Quite an amazing experience. Check out the photos. Time the research community got off it's collective behind and did something like this.. btw he has sensation in the new one as well!
Reply | Report Abuse | Link to thishttp://www.indianahorserescue.com/research/stemsubject1.htm
The delay in jumping headlong into the ESC 'pool' has forced science and medicine to slow down, use a more thoughtful approach to the situation. So often science tends to say "It works, let's do it!" before fully exploring the question(s) of "Is it right? Is it best?". In the intervening years, scientists have HAD to concentrate on Adult Stem Cells, and manipulating their properties to do the things they were looking to accomplish. Abortion issues aside, is this not the better approach, potentially manipulating one's own cells to work as they should, rather than using cells from a donor - along with the attendant issues of rejection, etc? Honestly, I see trying to use ESC's as a stop-gap measure, to get past our current inabilities to achieve an 'empty canvas' on which to impress our desired outcomes. Science and medicine will have achieved the real solution when it can make (sometimes force) our bodies to do as they should with minimal 'foreign' invasion. Should that not be the goal, the prize our eyes are set on? I tend to think the ESC issue is - or at least should be - a red herring, at least long term.
Reply | Report Abuse | Link to thisArwen: All people that read this forum need to understand what parents are going through when they have a family member with a spinal cord injury. I too, have a daughter, 23 yrs. old with a spinal cord injury. Stem cell clinical trials (Fall 2010) in Texas will help her recover some of her day to day functions as an able bodied person that may no longer have to depend on attendants to help her dress or do other simple tasks all of us do.
Reply | Report Abuse | Link to thisjhorn4012
Texas
The first few comments to this editorial seemed thoughtful, and I think the authors seemed genuinely interested in discussion and learning.
Reply | Report Abuse | Link to thisHow quickly they degenerated into postings attempting to promote agendas. And how sad.
Please disregard my previous post -- I did not notice the more recent ones, which seem more heart-felt and less "preachy."
Reply | Report Abuse | Link to thisI've read through the analogies and justifications for both sides of this issue for good reason...I am dying of Multiple System Atrophy. There is no cure but possibly stem cell research will one day yield one - probably not in time for me, however. I'm wondering whose moral compass is so inerrant that they can decide that people like me should die rather than allow researchers to utilize discarded embryos to find possible cures. Maybe if these pillars of morality had not interfered with medical science in 2001 there would be a cure for MSA, Parkinson's, etc.
Reply | Report Abuse | Link to thisI guess that first, we'll have to cure ignorance.
grandachica,
Reply | Report Abuse | Link to thisI think your argument against using embryos is flawed. You claim that IVF is not ethical. But it is currently legal. So unless you advocate making it illegal, prospective parents in this country will continue to use it for children.
In Europe, you say, they only create enough to implant, then implant them? There are issues in IVF -- many of the implantations do not take, so in America we harvest a large number once (since harvesting is not without risk), fertilize a number (since not all successfully fertilize), and implant a few. At the next stage, the doctors monitor the implantation and may try again with some of the other ones; if "too many" implant, they sometimes have to remove some (because of the risks associated with multiple births, etc.).
I do not know of the European technique, but if Europe has a more successful fertilization method, American doctors should be made aware of it.
But until that happens or until there is a legal challenge to IVF, the fact remains that these embryos will sit in a lab until they are disposed of. Whether it is ethical to allow them to be created is moot -- they are there.
So... given the current situation, what is the right thing to do? They can't agree to be donors, since they are not by any stretch of the imagination cognitive enough to do so. In organ donor cases involving children, the parents typically have the final say. Why not ask the parents in the IVF case whether they agree to donate embryonic stem cells?
It may not make you comfortable, but why? Unless you object to organ donation, why would you object to allowing parents to decide here? It is reasonable to press the medical industry to make the process safer and less "wasteful" in terms of embryos lost, but if you consider these embryos human, then they are clearly the children of the prospective parents. So instead of tossing them out in the trash, let the parents decide. It seems reasonable and morally sound to me.
"Perhaps then you will consider the many lives lost to ESCR, abortion, and IVF."
Reply | Report Abuse | Link to thisI'm still steamed at the number of innocent lives lost to spontaneous miscarriages. Are we doing God's will by letting them go? We should really try to save these embryos and reimplant them.