A High-Profile Proponent of Embryonic Stem Cell Research Sharply Criticizes Obama’s Policy

When President Obama signed the Executive Order last week which overturned President Bush’s policy on stem cell research, the White House extended a warm invitation to the noted Dr. Charles Krauthammer, among other distinguished guests, to attend the official signing ceremony. Dr. Krauthammer declined the invitation, and vehemently refused to attend the ceremony. In his op-ed article in The Washington Post today, entitled “Obama’s ‘Science’ Fiction”, Dr. Krauthammer explains precisely why, and in no uncertain terms.

During the 5 years that Dr. Krauthammer served on President Bush’s President’s Council on Bioethics, and despite the fact that he had been personally appointed to the council by President Bush himself, Dr. Krauthammer consistently argued, as he explains, “that, contrary to the Bush policy, federal funding should be extended to research on embryonic stem cell lines derived from discarded embryos in fertility clinics.” The words, “derived from discarded embryos in fertility clinics” constitute the key point in Dr. Krauthammer’s stance under the Bush administration, which is precisely why he refused to accept President Obama’s invitation. “I declined to attend,” Dr. Krauthammer states. “Once you show your face at these things, you become a tacit endorser of whatever they spring. My caution was vindicated.” Dr. Krauthammer has now made it perfectly clear that he certainly does not endorse President Obama’s policy on stem cells, and far from remaining tacit on the subject, Dr. Krauthammer has authored an eye-opening and blunt assessment of President Obama’s mistakes in this matter.

Dr. Krauthammer begins his Washington Post op-ed piece by reminding the reader of the context within which the new administration’s actions have taken place. “President Bush had restricted federal funding for embryonic stem cell research to cells derived from embryos that had already been destroyed (as of his speech of August 9, 2001),” Dr. Krauthammer explains. “While I favor moving that moral line to additionally permit the use of spare fertility clinic embryos,” he continues, “President Obama replaced it with no line at all. He pointedly left open the creation of cloned – and noncloned sperm-and-egg-derived – human embryos solely for the purpose of dismemberment and use for parts.”

Lest anyone misunderstand Dr. Krauthammer, he further clarifies his stance by adding, “I am not religious. I do not believe that personhood is conferred upon conception. But I also do not believe that a human embryo is the moral equivalent of a hangnail and deserves no more respect than an appendix. Moreover, given the protean power of embryonic manipulation, the temptation it presents to science and the well-recorded propensity for evil even in the pursuit of good, lines must be drawn. I suggested the bright line prohibiting the deliberate creation of human embryos solely for the instrumental purpose of research – a clear violation of the categorical imperative not to make a human life (even if only a potential human life) a means rather than an end. On this, Obama has nothing to say. He leaves it entirely to the scientists. This is more than moral abdication. It is acquiescence to the mystique of ‘science’ and its inherent moral benevolence. How anyone as sophisticated as Obama can believe this within living memory of Mengele and Tuskegee and the fake (and coercive) South Korean stem cell research is hard to fathom.”

Dr. Krauthammer echoes the sentiments of many other scientists and doctors, few of whom enjoy the distinction, as Dr. Krauthammer does, of having won a Pulitzer Prize and of having been a former U.S. Presidential Science Advisor and of having their views and opinions deemed to be so insightful and valuable that they are regularly featured in the nation’s, and indeed the world’s, leading newspapers. Nor are there many scientists and doctors who personally received invitations from the White House to attend Obama’s signing ceremony, as Dr. Krauthammer did; perhaps even fewer would have had the courage and integrity to decline such an invitation, if they had been invited. Additionally, Dr. Krauthammer does not hesitate to make the point that, even if he had somehow managed to convince himself to go to the White House for the ceremony, he would not have stayed long.

As Dr. Krauthammer continues, “That part of the ceremony, watched from the safe distance of my office, made me uneasy. The other part – the ostentatious issuance of a memorandum on ‘restoring scientific integrity to government decision-making’ – would have made me walk out. Restoring? The implication, of course, is that while Obama is guided solely by science, Bush was driven by dogma, ideology and politics. What an outrage. Bush’s nationally televised stem cell speech was the most morally serious address on medical ethics ever given by an American president. It was so scrupulous in presenting the best case for both his view AND THE CONTRARY VIEW that until the last few minutes, the listener had no idea where Bush would come out. Obama’s address was morally unserious in the extreme. It was populated, as his didactic discourses always are, with a forest of straw men. Such as his admonition that we must resist the ‘false choice between sound science and moral values.’ Yet, exactly 2 minutes and 12 seconds later he went on to declare that he would never open the door to the ‘use of cloning for human reproduction.’ Does he not think that a cloned human would be of extraordinary scientific interest? And yet he banned it. Is he so obtuse as not to see that he had just made a choice of ethics over science? Yet, unlike Bush, who painstakingly explained the balance of ethical and scientific goods he was trying to achieve, Obama did not even pretend to make the case why some practices are morally permissible and others are not.”

The outrage that Dr. Krauthammer expresses so eloquently is mild in comparison to that which many other people feel, such as, for example, the numerous distinguished scientists and doctors who work exclusively with adult stem cells, not embryonic stem cells, and to whom Obama’s new policy, not to mention his insulting and confrontational remarks, are a direct and blatant affront. Most scientists and doctors, however, even those who work only with adult stem cells, stop just short of engaging in ethical debate. Dr. Krauthammer, however, is not so timid, and fortunately for the rest of us he is unafraid to call a spade a spade. As Dr. Krauthammer puts it, in regard to Obama’s actions, “This is not just intellectual laziness. It is the moral arrogance of a man who continuously dismisses his critics as ideological while he is guided exclusively by pragmatism (in economics, social policy, foreign policy) and science in medical ethics. Science has everything to say about what is possible. Science has nothing to say about what is permissible. Obama’s pretense that he will ‘restore science to its rightful place’ and make science, not ideology, dispositive in moral debates is yet more rhetorical sleight of hand – this time to abdicate decision-making and color his own ideological preferences as authentically ‘scientific’.”

Dr. Krauthammer’s words for Obama are not to be taken lightly, nor is Dr. Krauthammer’s stance on stem cell research. Having been paralyzed in an automobile accident in 1972 during his first year in medical school, Dr. Krauthammer has been a paraplegic and confined to a wheelchair for nearly 4 decades. If anyone could benefit from stem cell therapies, it would be Dr. Krauthammer. Despite the automobile accident, however, and despite the resulting year-long hospitalization and his permanent paraplegia, Dr. Krauthammer graduated with the rest of his class from Harvard Medical School in 1975 and went on to become a leading psychiatrist at the prestigious Massachusetts General Hospital in Boston. His seminal work, discoveries and publications during these years are still repeatedly cited today in the leading textbooks of the field. Although he is board certified by the American Board of Psychiatry and Neurology, he chose to leave medical practice in 1978 when he was appointed Presidential Science Advisor to President Carter. Since then, his views and analyses on a variety of national and international issues have been widely respected and specifically sought by presidential administrations of both parties; indeed, his views and analyses have helped to shape the very structure of formal U.S. national and international policy over the years.

In 2006, Charles Krauthammer, M.D., was named the “most influential commentator in America” by the Financial Times, which wrote: “Krauthammer has influenced U.S. foreign policy for more than two decades. He coined and developed ‘The Reagan Doctrine’ in 1985 and he defined the U.S. role as sole superpower in his essay, ‘The Unipolar Moment’, published shortly after the fall of the Berlin Wall. Krauthammer’s 2004 speech ‘Democratic Realism’ set out a framework for tackling the post 9/11 world, focusing on the promotion of democracy in the Middle East.”

In 1987 Dr. Krauthammer was awarded the Pulitzer Prize for his “distinguished commentary” and highly influential work at The Washington Post. To this day, his weekly column still appears in The Washington Post and is syndicated in more than 200 newspapers and media outlets around the world.

Even as a member of the President’s Council on Bioethics under President George W. Bush, Dr. Krauthammer did not hesitate to oppose President Bush’s stance on stem cell policy, even though he respected President Bush’s attempts to balance opposing views of the argument. Now, however, through Obama’s pretentious and grossly ill-advised statements on this gravely serious matter, the new president has not only disappointed but directly offended many people who had higher hopes for him, especially within the scientific and medical communities.

Dr. Krauthammer concludes his Washington Post op-ed article by quoting none other than Dr. James Thomson, the mild-mannered developmental biologist who suddenly skyrocketed to international fame when he became the first person to isolate a human embryonic stem cell in the laboratory in 1998, and who is now revered throughout the world as the “father” of embryonic stem cell science. As Dr. Krauthammer writes, “Dr. James Thomson, the pioneer of embryonic stem cells, said ‘if human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough.’ Obama clearly has not.”

As someone whose keen insights have been so indispensable to so many U.S. presidents for so many years, on so many of the most pressing domestic and foreign policy issues of the day, Dr. Krauthammer has long been seen and valued by both political parties as someone whose expertise, and whose extraordinary breadth and depth of understanding on a wide range of issues, are invaluable. Today, especially on the topic of stem cells, Dr. Krauthammer’s analyses are particularly relevant not just because they come from someone who has been a prominent political advisor to U.S. presidents for nearly 40 years, but also because of Dr. Krauthammer’s accomplishments as a physician, as a medical researcher at one of the leading research hospitals in the world, and as a paraplegic. The current, new U.S. president, however, would seem to be the first U.S. president, ever, since prior to the Carter administration in the 1970s, who has chosen to ignore entirely what Dr. Krauthammer has to say.

Geron Seen as Scientifically and Financially Risky

During a conference call for institutional investors held Monday by Summer Street Research Partners, an independent health care research firm, a spinal surgeon and stem cell researcher offered a negative and cautionary view of Geron’s research. Subsequently, TheStreet.com decided not to disclose the doctor’s name due to privacy concerns, “since the call was not intended for public dissemination.” The doctor stated, however, that he has no financial ties to Geron, nor does he own, nor has he shorted, any of Geron’s stock. Nevertheless, the doctor pointed out that the highly publicized upcoming clinical trial for which Geron recently received FDA approval is clinically dubious because the entire rationale for the study is “based on a single experiment in 8 rats.”

In a highly controversial ruling, the FDA granted approval to Geron in January of this year to begin the first clinical trials ever to be conducted in the U.S. with human embryonic stem cells. The clinical trial will administer human embryonic stem cells to patients who have been paralyzed from the waist down with spinal cord injury. Since the primary objective of Phase I clinical trials is to test safety, efficacy will not be tested until years later – assuming, that is, that safety can be proven, although this remains the subject of widespread speculation. Without concrete evidence of safety, the proposed therapy cannot advance to further clinical trials.

In the days immediately following the FDA’s announcement, Geron’s stock soared from $5 a share to more than $48 a share, but such dramatic gains were quickly sold and the stock has steadily fallen ever since then, plummetting to a low of $3.79 on March 5th. According to Adam Feuerstein of TheStreet.com, “Even President Obama’s lifting of the federal research ban on stem cell research Monday failed to provide more than a marginal lift to Geron’s stock price, which closed Tuesday at $4.27”, up a mere 1.4%.

As Mr. Feuerstein further explains, “Wall Street’s health care investors, most notably biotech-focused hedge funds, have been more inclined to steer clear of Geron or short the company’s stock. Geron’s short interest has risen from 8 million shares to 17 million shares over the first two months of the year. Conference calls for Wall Street health care investors with experts critical of Geron’s research, like those held by Summer Street Research on Monday, explain why. The doctor on the Summer Street conference call, a spinal cord injury expert who has also conducted stem cell research, was skeptical about Geron’s study because there is very little animal data to support the theory that a therapy derived from [embryonic] stem cells will benefit patients with severe spinal cord injury.”

Indeed, as the doctor stated, “The fact that Geron’s entire study hinges on this one experiment in eight moderately injured rats is tenuous in terms of efficacy.”

This laboratory experiment upon which Geron’s upcoming clinical trial is based, was conducted by Dr. Hans Keirstead of the University of California at Irvine, using 8 rats in whom spinal cord injury had been deliberately inflicted in order to induce hind-leg paralysis. Rats that were treated with Geron’s human embryonic stem cell product saw a partial return of some function to their paralyzed legs after 7 days, but all of the rats were considered to have “moderate” spinal cord injury. However, when the start of treatment was delayed for more than a week, and also when the experiment was conducted on rats with severe spinal cord injuries, Geron’s therapy had no effect. The human patients who will participate in Geron’s clinical trial will not have moderate spinal cord injury, but instead they will have been chosen for the clinical trial because they suffer from severe spinal cord injury.

According to the doctor who spoke during the conference call, “We don’t know what will happen when these cells are placed into a human, which is the reason immune suppression is required. The risk is that these are not patients you would otherwise want to have on immune suppressants because the severity of their spinal cord injuries, the trauma they’ve suffered, their surgery and wounds make them more susceptible to infection.”

In Geron’s upcoming Phase I clinical trial, human embryonic stem cells will be injected directly into the spinal cords of the human patients. Ordinarily, after undergoing any type of transplantation, immune suppression is required for the remainder of the patient’s life, but the patients in Geron’s clinical trial will be removed from immunosuppressive drugs after 42 days, at which time there is a high risk of immune rejection by the patients’ bodies to the stem cells. In and of itself, this type of immune rejection has the potential to be life-threatening. As Mr. Feuerstein adds, “Another safety concern is the risk that the cells in Geron’s therapy may grow uncontrollably and form tumors on the spinal cord,” to which the doctor from the conference call further adds, “If one patient gets a tumor from the Geron therapy, it will be catastrophic.”

While the CEO of Geron, Tom Okarma, has tried to downplay expectations of efficacy by reminding the public that none of the patients are expected to be instantly cured from the Phase I clinical trial, it is a bit more difficult to dispel concerns about safety.

Despite the fact that Geron’s preclinical data is based upon only one experiment with only 8 rats, Geron’s FDA application nevertheless included a staggering 22,000 pages of data. Although such an unwieldy number might impress those who are uninitiated in “the scientific method”, Mr. Feuerstein points out that such an enormous FDA application “has not stopped some experts from questioning Geron’s science.” One such expert is Dr. Evan Snyder of the California- and Florida-based Burnham Institute for Medical Research, who wrote in an article that was published in the January 30th issue of the journal Science that, “There’s a lot of debate among spinal cord researchers that the preclinical data itself doesn’t justify the clinical trial.” Similarly, in the January 23rd edition of The New York Times, Dr. John Kessler, a neurologist and director of the Stem Cell Institute at Northwestern University, wrote, “We really want the best trial to be done for this first trial, and this might not be it.”

As every investor knows, financial markets are forward-looking, and the price of any particular stock at any particular time is a measure of confidence in that company. In Geron’s case, as with all other biotechs, the financial details are inextricably tied to the scientific details. Precisely for that reason, therefore, at least at this particular moment in history, institutional investors are growing increasingly wary of Geron because of the serious words of caution that are echoed throughout the medical and scientific communities.

Obama Signs Law Restricting Federal Funding of Embryonic Stem Cell Research

A mere two days after supposedly reversing President Bush’s restrictions on the federal funding of human embryonic stem cell research, President Obama today signed into law a ban on the use of federal funding for human embryonic stem cell research. Contrary to popular misunderstanding, therefore, legislative restrictions have not been reversed.

Without any publicity or fanfare whatsoever, and in a move that counteracts and contradicts his highly publicized action a mere two days earlier, President Obama today signed a law that bans the federal funding of any procedure that involves either the creation or the destruction of a human embryo for research purposes. Since the process by which embryonic stem cells are extracted from an embryo results in the immediate destruction of that embryo, such a law makes the federal funding of embryonic stem cell research on human embryos, and the derivation of new human embryonic stem cell lines from those embryos, illegal.

The specific piece of legislation under consideration is the Dickey-Wicker Amendment, which was first signed into law in 1995 under the Clinton Administration. It is this Amendment which remains the primary legislative “obstacle” to embryonic stem cell research – not the comparatively trivial funding restraints which Obama overturned two days earlier and which were mistakenly interpreted by many to represent a grand, sweeping change in national policy; in actuality, the only policy that Obama was able to change two days ago was an increase in the applicability of federal funds to a few hundred human embryonic stem cell lines, instead of to the approximately 21 human embryonic stem cell lines that were already created prior to President Bush’s Executive Order on August 9th of 2001.

The Dickey-Wicker Amendment was included today in the 465-page Omnibus spending bill that will fund government agencies through September 30th of this year, which is the end of the fourth quarter of the 2009 fiscal year (FY09). As the Amendment specifically states, “None of the funds made available in this Act may be used for: 1/ the creation of a human embryo or embryos for research purposes, or 2/ research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death.” Since the extraction of embryonic stem cells from an embryo results in the immediate destruction of that embryo, as already explained, such language pertains directly to the creation of new human embryonic stem cell lines.

It is the creation of new human embryonic stem cell lines, however, that embryonic stem cell scientists covet the most, not the authorization to spend federally awarded grant money on already existing human embryonic stem cell lines. In regard to the creation of new human embryonic stem cell lines, President Obama has changed nothing, nor does he have the power to change this law by himself since only Congress, not the president, can overturn such an Amendment. Not surprisingly, some members of Congress are actively mobilizing their efforts to do exactly that. Nevertheless, the Dickey-Wicker Amendment only applies to the use of federal money, not to the use of private (non-taxpayer) money, so it is still perfectly legal, as it has always been, to create and destroy as many human embryos as one wants, as long as it is done with private (non-taxpayer-derived) funding.

Named after its authors, Representatives Jay Dickey of Arkansas and Roger Wicker of Mississippi, the Dickey-Wicker Amendment was originally passed in 1995 under the Clinton Administration as a rider attached to the appropriations bill for the Department of Health and Human Services, and Congress has actively voted to renew the Amendment every year since then, although that could change by the end of this year. To reiterate, it was President Bill Clinton who signed this Amendment into law, not President George W. Bush, who merely inherited it.

At least until September 30th of this year, therefore, it will still be illegal to spend federal funding (i.e., NIH grant money, which comes directly from the U.S. taxpayer) on any human embryonic stem cell research that involves newly created human embryonic stem cell lines, since, by necessity, the creation of such stem cell lines requires the destruction of the human embryos from which the cells are derived.

Democratic Representative Diana DeGette of Colorado and Republican Representative Mike Castle of Delaware, who twice failed to overturn Bush’s funding restrictions, are now trying to pass legislation to repeal the Dickey-Wicker Amendment. Similarly, an editorial in The New York Times on Tuesday called for Congress to repeal the Dickey-Wicker Amendment, but opposition still remains strong.

According to Douglas Johnson, spokeman for the National Right to Life Committee, “This sets the stage for an attack on the Dickey-Wicker law. Any member of Congress who votes for legislation to repeal this law is voting to allow federal funding of human embryo farms, created through the use of human cloning.” In his highly publicized and widely applauded though generally misunderstood speech on Monday, Obama assured people who have ethical concerns about embryonic stem cell research that his policy is designed so that it “never opens the door to the use of cloning for human reproduction”, which he described as “dangerous, profoundly wrong, and has no place in our society or any society.” However, the overturning of the Dickey-Wicker Amendment would be seen by many as a slippery slope that would inevitably lead not only to cloning but also to a number of other consequences that would be “dangerous” and “profoundly wrong”, to use Obama’s own words.

Nevertheless, only Congress, not the president, can overturn the Dickey-Wicker Amendment, which still remains in effect as the law, at least until September 30th of this year. Contrary to popular misconception, therefore, President Obama has not entirely reversed the legislative policies that he seems to be credited with reversing, and which he inherited from his predecessor – who, in turn, inherited the Dickey-Wicker Amendment from his predecessor, President Bill Clinton.

One can only marvel at how and why Obama happened to legalize the federal funding of human embryonic stem cell research on Monday, while surrounded by carefully orchestrated applause and fanfare, and then immediately perform an about-face a mere 2 days later and ban human embryonic stem cell research on Wednesday, without any reporters or television cameras present and with no fanfare whatsoever.

(Please see the related news article on this website, entitled, “Obama Decrees Changes in Embryonic Stem Cell Research, Though Not What One Might Expect”, dated March 9, 2009).

How to Mend a Broken Heart

Former heart patients such as Howard Lindeman and Dick Dufala are strong advocates of adult stem cell therapy, and their enthusiasm is the result of personal experience. Along with many other people who share similar stories, Mr. Lindeman and Mr. Dufala have adult stem cell therapy to thank for the fact that they are no longer in danger from the life-threatening heart conditions with which they had previously suffered.

According to Mr. Lindeman, who chose to undergo adult stem cell therapy follwing a heart attack, “It’s the most amazing thing I’ve ever been through. I had the procedure done and since then, I’ve just been getting better and better and better. I’m going to be 58 years old in May and I’m on my way to being 35 again.”

Similarly, according to Mr. Dufala, who used to suffer from congestive heart failure before receiving adult stem cell therapy, “I think it’s improved my life and my life will be extended as a result of having the procedure. I feel like I don’t have congestive heart failure. I feel quite good.”

Both men underwent their adult stem cell therapies from the cardiologist Dr. Zannos Grekos, who uses autologous (in which the donor and recipient are the same person) adult stem cells derived from each patient. Speaking at a seminar recently in Naples, Florida, Dr. Zannos explained, “Because it is coming from the patient, there’s no [immune] rejection and there’s no risk of cancer because we’ve been using adult stem cells for about 40 years in treating cancers. We know that adult stem cells are effective.”

By stating that “there’s no risk of cancer”, Dr. Zannos is referring to the fact that embryonic stem cells are defined by their ability to form teratomas (tumors), which is the formal scientific definition of pluripotency, whereas adult stem cells are not capable of forming such tumors for the simple reason that adult stem cells are not pluripotent. Similarly, in his statement that “we’ve been using adult stem cells for about 40 years in treating cancers”, Dr. Zannos is referring to the fact that bone marrow transplants have been conducted for several decades now, and the mechanism-of-action by which bone marrow transplantation is effective is through the adult stem cells that are present in the bone marrow. More specifically, the first bone marrow transplant was performed in 1956, which was over 5 decades – over half a century – ago. It was Dr. E. Donnal Thomas of Cooperstown, New York, who performed this first successful bone marrow transplant that resulted in the long-term survival of the patient who subsequently enjoyed a complete remission of leukemia after being given a bone marrow transplant from an identical twin. For this first, pioneering medical procedure, Dr. Thomas was awarded the Nobel Prize in Physiology or Medicine, along with Dr. Joseph E. Murray, “for their discoveries concerning organ and cell transplantation in the treatment of human disease.” This revolutionary transplantation paved the way for numerous other transplants of a similar nature, which in turn were followed in 1968 by the first bone marrow transplant from a related donor in the treatment of a non-cancerous condition, namely, in the treatment of a four-month-old boy who had inherited severe combined immunodeficiency syndrome. This procedure in turn opened the door for numerous other bone marrow transplantations for non-cancerous conditions, which in turn were also followed in 1973 by the first bone marrow transplant using an unrelated donor, which was performed at Memorial Sloan-Kettering Cancer Center in New York City and which likewise paved the way for numerous other procedures of a similar nature. It has therefore been for over the past 50 years that bone marrow transplantation has demonstrated the safety and efficacy of the adult stem cells that are present in bone marrow. If one were to trace the history of umbilical cord blood therapies, one would find that these therapies extend back even farther in time and predate World War II by at least a decade, and for over the past 70 years the various uses of the adult stem cells that are present in umbilical cord blood have been documented in the medical literature for the treatment of a vast number of people for a variety of conditions, without adverse side effects. Although the concept of a human stem cell, per se, was not yet understood at these times, prior to World War II nor even in 1956 when the first bone marrow transplant was performed, today it is well known and understood that bone marrow transplants and umbilical cord blood work as effective treatments because of the adult stem cells that they contain. By contrast, the first human embryonic stem cell was only isolated in the laboratory in 1998, so embryonic stem cell science is barely a decade old, and in that short decade embryonic stem cells have never been used to treat anyone for anything. A clinical history, therefore, does not exist, at all, for embryonic stem cells, which thus far can be said to have a 0% success rate, which is the equivalent of a 100% failure rate. Since embryonic stem cells carry a number of inherent risks, not the least of which is their strong natural ability to form teratomas (tumors), even the most ardent of embryonic stem cell proponents has cautioned that an actual therapy based upon embryonic, not adult, stem cells is at least another decade away, if such a goal is attainable at all. Meanwhile, there are many patients who cannot wait that long for treatment, and fortunately adult stem cells are already being used as clinical therapies to help such people.

In reference to the natural regenerative ability of the body’s own adult stem cells, even in full-grown adults, Howard Lindeman adds, “The people who doubt it should stop doubting because it is a fact that our body can heal itself. If it didn’t, I’d be dead right now.”

Obama Rescinds Bush-Era Executive Order Pushing for More Ethical Stem Cell Research

The Executive Order which Obama signed yesterday formally and specifically rescinded Executive Order 13435, which President Bush signed into law on June 20th of 2007, and which was an initiative pushing the Secretary of Health and Human Services to “conduct and support research” on stem cells that “may result in improved understanding for treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus” – such as, for example, therapies developed from research conducted on adult stem cells and on iPS (induced pluripotent stem) cells. Consequently, in response to President Bush’s 2007 Executive Order, the NIH (the National Institutes of Health) drew up a plan at that time for implementing President Bush’s order, in which the NIH authors stated that, “Adult stem cells, such as blood-forming stem cells in bone marrow … are currently the only type of stem cell commonly used to treat human diseases.” Indeed, the only type of stem cell research that has ever yielded an actual treatment for anything is adult stem cell research, which is already being used in clinics around the world for a wide variety of diseases and injuries. By sharp contrast, embryonic stem cells have never resulted in any therapies for anything.

President Obama is not without his critics, especially in his decision to rescind this particular Executive Order of President Bush, which did not prohibit anything but instead specifically encouraged further research with adult stem cells and other non-embryonic sources of adult stem cells, such as iPS cells. One such critic of Obama, the bioethicist Wesley Smith, points out that Obama is putting politics and ideology above science – the very thing that Obama accuses his predecessor of doing. According to Wesley Smith, “I can think of only two reasons for this action, for which I saw no advocacy either in the election or during the first weeks of the Administration: first, vindictiveness against all things ‘Bush’ or policies considered by the Left to be ‘pro-life’; and second, a desire to get the public to see unborn human life as a mere corn crop ripe for the harvest. So much for taking the politics out of science!”

The precise reasons why Mr. Obama decided to overturn an Executive Order that sought to attain stem cell therapies from non-embryonic sources such as adult stem cells and iPS cells, is anyone’s guess. One would think that “a man of faith”, as President Obama describes himself, would be in favor of such research and development purely on ethical grounds, if not also on scientific grounds, which are considerably more compelling for adult stem cells than for embryonic stem cells. To the contrary, however, yesterday’s actions by Obama demonstrate not only that he is strongly pro-embryonic stem cell research, at all costs, but also that he is strongly anti-adult stem cell research.

According to House Minority Leader John Boehner of Ohio, “Advancements in science and research have moved faster than the debates among politicians in Washington, D.C., and breakthroughs announced in recent years confirm that the full potential of stem cell research can be realized without the destruction of human embryos.”

As Republican Senator Richard Shelby of Alabama also adds, “My basic tenet here is I don’t think we should create life to enhance life and to do research and so forth. I know that people argue there are other ways. I think we should continue our biomedical research everywhere we can, but we should have some ethics about it.”

(Please see the related article on this website, entitled, “Obama Decrees Changes in Embryonic Stem Cell Research, Though Not What One Might Expect”, dated March 9, 2009).

Obama Decrees Changes in Embryonic Stem Cell Research, Though Not What One Might Expect

President Obama accomplished three major goals of his today: 1/ the signing of an Executive Order that reversed President Bush’s restrictions on federal funding for some, but not all, types of human embryonic stem cell research, 2/ the overturning of one of President Bush’s Executive Orders which encouraged stem cell research beyond embryos, such as with adult stem cells and iPS cells, and 3/ the issuing of a “presidential memorandum” calling for “scientific integrity in government decision-making”.

Perhaps just as important as what he did today is what he did not do today, since President Obama did not change any of the laws that prohibit the use of federal dollars for the destruction of human embryos. In fact, he is unable to change such laws, since such changes require more than a presidential Executive Order, namely, they require Congressional approval. Consequently, these laws remain unchanged, and it is still illegal to use federal funds to extract embryonic stem cells, and thereby to create new embryonic stem cell lines, from a human embryo.

In order to understand the significance of these actions, and inactions, it is important to review the background and context in which they took place. Described below, therefore, is a brief review of each the aforementioned 3 actions.

1/ In regard to President Obama’s Executive Order overturning President Bush’s restrictions on federal funding for some, but not all, types of human embryonic stem cell research:

As every stem cell scientist remembers, August 9th of 2001 was the date when President George W. Bush made his speech to the nation in which he announced that the use of federal money for embryonic stem cell research would be limited to those embryonic stem cell lines that were already in existence prior to that date, August 9th of 2001. Contrary to widespread misunderstanding among the general public, President Bush did not prohibit embryonic stem cell research, but instead, he only prohibited the use of federal money – in other words, taxpayer dollars – for the funding of research conducted on embryonic stem cell lines that were created after August 9th of 2001. He did not prohibit the use of federal money for research conducted on embryonic stem cell lines that already existed prior to August 9th of 2001, nor did he prohibit the use of private funding (non-taxpayer dollars) for research on embryonic stem cell lines created at any time, whether before or after that date. As The New York Times reported the following day, on August 10th of 2001, “Research in the private sector is unaffected by Mr. Bush’s statement.” Indeed, embryonic stem cell research has been conducted throughout the U.S. over the past 8 years, during the entire Bush administration, in a perfectly legal manner, either through private funding or through the use of federal funding on the research of embryonic stem cell lines that already existed prior to August 9th of 2001. In fact, even though he was personally opposed to embryonic stem cell research on ethical grounds, President George W. Bush nevertheless became the first U.S. president ever to allow the use of federal funds for human embryonic stem cell research, at all. Compared to President Clinton, President Bush actually expanded the federally funded embryonic stem cell research program, merely by creating it, since it did not exist at all under Clinton, and the main legislative restrictions that are erroneously associated with President Bush were, in actuality, already in place under the Clinton administration. (Please see the section below on the Dickey-Wicker Amendment). Prior to President Bush, no federal funds were available, at all, for any type of human embryonic stem cell research. When Bush gave his historic speech on August 9th, 2001, which was his first formal address to the nation since his inauguration, the main point of significance was not that he was restricting the use of federal funds to exclude only a certain subset of all types of stem cells, but rather the main point of his speech was that he was allowing, for the first time in history, the use of federal funds for any type of human embryonic stem cell research at all, since he was the first U.S. president ever to permit such a thing.

Be that as it may, today, in keeping with one of his campaign promises, Barack Obama has overturned President Bush’s restriction on the use of federal funding for research conducted on human embryonic stem cell lines that have been created after the date of August 9th, 2001. The precise implications of this, however, are not, in general, well understood.

What President Obama did, specifically, by issuing a new Executive Order, is that he has now made it possible for federal funding – taxpayer dollars, i.e. – to be spent on research conducted on human embryonic stem cell lines that have been created both before and after August 9th of 2001. In other words, this new policy now makes it possible for NIH (the National Institutes of Health) to award grants to scientists, most of whom are primarily in academia, who wish to conduct research on human embryonic stem cell lines that have, somehow, already been created up to the present time, now and into the future. “Somehow” is the key word, however, since there’s a “catch-22” in Obama’s new Executive Order, which conceals the fact that it is still illegal to create such human embryonic stem cell lines, at least with federal funds, because it is the mere process of establishing a new embryonic stem cell line that destroys the embryo from which the embryonic stem cells are extracted. As of today, it is now legal to perform research on those cell lines that already exist, but it is still not legal to create new cell lines – because it is still illegal to destroy human embryos, at least with federal tax dollars, and no one can create a new embryonic stem cell line without also destroying the embryo from which the stem cells were extracted. These restrictions are specifically stated in something called the Dickey-Wicker Amendment, which Obama renewed by signing into law a mere 2 days after overturning President Bush’s Executive Order today. But we’re jumping ahead in time, and we’ll come back to that point later.

Meanwhile, to return to the topic of what it was exactly that Obama did overturn today, let’s look at the National Institutes of Health. NIH is an agency within the Department of Health and Human Services and it is the branch of the U.S. federal government that provides federal funding to researchers in the biomedical sciences. President Bush’s 2001 funding restrictions meant that NIH could not award grants to embryonic stem cell researchers who wanted to conduct research on human embryonic stem cell lines that were created after August 9th, 2001, even though NIH was still allowed to award grants to embryonic stem cell researchers who wanted to conduct research on human embryonic stem cell lines that had already been created prior to August 9th, 2001. But if anyone wanted to conduct research on a human embryonic stem cell line that was created after that magic date of August 9th of 2001, they would have to find private funding (non-taxpayer, non-NIH dollars, i.e.) for such research, and that is exactly what numerous scientists did. One of the major complaints about this restriction was the extra accounting work required of scientists who, for example, were already receiving NIH grants for some research, but who were disqualified from receiving NIH grants for embryonic stem cell research, and who therefore were able to find private, non-NIH funding in addition to their NIH funding, but who consequently could not intermix laboratory equipment and could not even use NIH-funded microscopes or petri dishes for non-NIH funded research. As a result, many scientists had to construct entirely separate laboratories, one for NIH-funded research and one for non-NIH-funded research, just to be able to keep the financial accounting and inventory separate, and to avoid being in violation of federal law. But despite such inconveniences, the non-NIH funded research continued anyway, just as vigorously as did the NIH-funded research. The major complaint among scientists was therefore not that President Bush’s federal funding restrictions prevented embryonic stem cell research altogether, since that is not what President Bush’s restrictions did, nor is that what President Bush intended the restrictions to do, and indeed embryonic stem cell research has thrived in the intervening years since August 9th of 2001, with private funding from such organizations as the Howard Hughes Medical Institute, for example, which has awarded much of the funding to scientists such as Dr. Douglas Melton of the Harvard Stem Cell Institute, among others. Similarly, when Dr. James Thomson at the University of Wisconsin at Madison skyrocketed to instant fame when he became the first person to isolate a human embryonic stem cell in 1998, his research had been conducted with private funding from the Geron company, not with federal government (NIH) funds. President Bush’s restrictions did not stop embryonic stem cell research from continuing, nor from flourishing, but instead his restrictions only applied to the use of federal taxpayer dollars for a specific subset of all embryonic stem cell research. It was the new complexities in laboratory inventory and accounting methods that were created by President Bush’s restrictions which scientists in academia did not appreciate, and which constituted the primary complaint against President Bush’s federal funding restrictions. (Please see the related news article on this website, entitled, “Former Director of N.I.H. Explains Why Embronic Stem Cells are Obsolete”, dated March 4, 2009, and originally reported in U.S. News and World Report, for an excellent clarification of this fact).

However, despite the publicity and fanfare that accompanied President Obama’s action in reversing President Bush’s federal restrictions today, the primary “hindrance” to embryonic stem cell research still exists, and it remains beyond President Obama’s reach since something more than a president’s signature will be required to overturn it. First enacted into law under the Clinton administration in 1995, the Dickey-Wicker Amendment specifically bans federal funding for any “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death”. Since the extraction of embryonic stem cells from an embryo results in the immediate destruction of that embryo, such language pertains directly to the creation of new embryonic stem cell lines. It is precisely the creation of new embryonic stem cell lines, however, that embryonic stem cell scientists covet the most – not the authorization to spend federally awarded grant money on already existing embryonic stem cell lines, which number very few in quantity, even after Obama increased the number to include those embryonic stem cell lines that were created after August 9th of 2001. In regard to the actual creation of new embryonic stem cell lines, President Obama has changed nothing, nor does he have the power to change anything by himself since only Congress, not the president, can overturn the Dickey-Wicker Amendment. Apparently, there are not many people in the general public who understand this point, and one wonders if even Obama and his own advisors were at all aware of it. Those who do understand the Dickey-Wicker Amendment wonder what all the hype and fuss were about, since Obama’s highly publicized overturning of President Bush’s federal restrictions have resulted in changes that are resoundingly insignificant.

To recap the key points: it is still illegal, therefore, for federal funds to be used for establishing new human embryonic stem cell lines, since such a laboratory procedure results in the destruction of the human embryo, and this is still illegal under the Dickey-Wicker Amendment – which, not surprisingly, some members of Congress are actively mobilizing their efforts to overturn. Nevertheless, the Dickey-Wicker Amendment only applies to the use of federal money, not to the use of private (non-taxpayer) money, so it is still perfectly legal, as it has always been, to create and destroy as many human embryos as one wants, as long as one uses private funding instead of federal funding to do it. Named after its authors, Representatives Jay Dickey of Arkansas and Roger Wicker of Mississippi, the Dickey-Wicker Amendment was originally passed in 1995, under the Clinton Administration, as a rider attached to the appropriations bill for the Department of Health and Human Services, and Congress has actively voted to renew the Amendment every year since then, although that could change by the end of this year. To reiterate, as should be obvious by the date on which this Amendment was created, it was President Bill Clinton who signed the Dickey-Wicker Amendment into law, not President George W. Bush, who merely inherited it.

It would seem as though at least one person in Obama’s inner circle is aware of the existence of the Dickey-Wicker Amendment, and that would be Dr. Harold Varmus, president of Memorial Sloan-Kettering Cancer Center in New York City and co-chairman of Obama’s science advisory council. In reference to President Obama’s highly publicized actions today, Dr. Varmus has cautioned that, “The president is, in effect, allowing federal funding of human embryonic stem cell research to the extent that it’s permitted by law – that is, work with stem cells themselves, not the derivation of stem cells.” But ask any embryonic stem cell scientist, and he or she will confirm that it is precisely “the derivation of stem cells” that they want, but that is not something which Obama can give them.

There are many U.S. taxpayers who object as a matter of principle to the idea that their hard-earned taxpayer dollars will now be specifically allocated for the deliberate destruction of human embryos, and there are many people who believe that such research, if it is to be legal at all, should remain within private industry. As already explained, President Bush did not ban the research itself, he only banned the use of taxpayer dollars to fund the research. According to House Republican Leader John Boehner of Ohio, “I fully support stem cell research, but I draw the line at taxpayer-funded research that requires the destruction of human embryos, and millions of Americans feel similarly.”

In reference to the hype and ostentatious fanfare surrounding Obama’s widely misunderstood actions today, House GOP Whip Eric Cantor of Virginia states, “Unfortunately, today the administration wasted an opportunity to unite our country around ethically and scientifically sound innovations by allowing the use of taxpayer money for embryo-destructive stem cell research, which millions of Americans find morally reprehensible. This divisive action will divert scarce federal resources away from innovative and proven adult stem cell research.” Indeed, regardless of the date at which an embryonic stem cell line was, or will be, created, the embryo from which the stem cells were derived is destroyed.

Nevertheless, contrary to popular misconception, Obama’s new policy still does not allow the use of federal money to destroy human embryos, and it also still does not allow the creation of new human embryos; it merely increases the number of already-established human embryonic stem cell lines on which research may be conducted. Consequently, many scientists insist that the new Executive Order is not enough, and that federal funding should also be allowed for the destruction of new embryos via the creation of new embryonic stem cell lines. In regard to overturning the Dickey-Wicker Amendment, however, Obama has not yet formally expressed an opinion on the matter, even though his opinion, alone, whatever it may be, will not be enough to overturn the Amendment since only Congress has the power to do that.

Obama’s Executive Order directs NIH (the National Institutes of Health) to develop revised guidelines on federally funded embryonic stem cell research within 120 days. Such guidelines will determine such things as, for example, how embryonic stem cell lines will be obtained for research purposes and what will constitute proper “consent” from those who donate the embryos, etc.. The nation will therefore have to wait another 4 months in order to learn exactly what it is that NIH will recommend.

2/ In regard to the overturning of one of President Bush’s Executive Orders which encouraged stem cell research on non-embryonic sources, such as with adult stem cells and iPS cells:

Among other national policies that were signed into and out of law today with the stroke of a pen, Obama also formally rescinded President Bush’s Executive Order that advocated research into non-embryonic sources of stem cells, such as adult stem cells and iPS cells.

The Executive Order which Obama signed today formally and officially rescinded Executive Order 13435, which President Bush signed into law on June 20th of 2007, and which pushed the Secretary of Health and Human Services to “conduct and support research” on stem cells that “may result in improved understanding for treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus”. In other words, President Bush’s Executive Order encouraged the development of therapies derived from research conducted on adult stem cells and on iPS (induced pluripotent stem) cells, but Obama’s Executive Order has now specifically overturned, repealed and annulled any such initiative for the promotion of research on non-embryonic sources of stem cell therapies.

In response to President Bush’s 2007 Executive Order, the NIH (the National Institutes of Health) drew up a plan at that time for implementing President Bush’s order, in which the NIH authors stated that, “Adult stem cells, such as blood-forming stem cells in bone marrow … are currently the only type of stem cell commonly used to treat human diseases.” Indeed, the only type of stem cell research that has ever yielded an actual treatment for anything is adult stem cell research, which is already being used in clinics around the world for a wide variety of diseases and injuries. By sharp contrast, embryonic stem cells have never resulted in even one therapy for anything.

President Obama is not without his critics, especially in his decision to rescind this particular Executive Order of President Bush, which did not prohibit anything but instead specifically encouraged further research with adult stem cells and with other non-embryonic sources of adult stem cells, such as iPS cells. One such critic of Obama, the bioethicist Wesley Smith, points out that Obama is putting politics and ideology above science – the very thing that Obama accuses his predecessor of doing. According to Wesley Smith, “I can think of only two reasons for this action, for which I saw no advocacy either in the election or during the first weeks of the Administration: first, vindictiveness against all things ‘Bush’ or policies considered by the Left to be ‘pro-life’; and second, a desire to get the public to see unborn human life as a mere corn crop ripe for the harvest. So much for taking the politics out of science!”

The precise reasons why Mr. Obama decided to overturn an Executive Order that sought to attain stem cell therapies from non-embryonic sources such as adult stem cells and iPS cells, remains unknown. Apparently, rather than wishing to remove restrictions on research, as he claims, Mr. Obama instead prefers to impose restrictions on research. Additionally, one would think that “a man of faith”, as President Obama describes himself, would be in favor of such research and development purely on ethical grounds, if not also on scientific grounds, which are considerably more compelling for adult stem cells than for embryonic stem cells. To the contrary, however, today’s “soaring rhetoric” by President Obama, if not his actions, demonstrates not only that he is strongly pro-embryonic stem cell research, at all costs, but also that he is strongly anti-adult stem cell research, at all costs. And despite the fact that Obama failed to remove the primary legislative “obstacle” to embryonic stem cell research, because no president has the power to do so, and therefore the legal policies have changed only negligibly since the Bush administration, nevertheless Obama is widely and mistakenly given credit for having instantly changed and improved everything.

According to House Minority Leader John Boehner of Ohio, “Advancements in science and research have moved faster than the debates among politicians in Washington, D.C., and breakthroughs announced in recent years confirm that the full potential of stem cell research can be realized without the destruction of human embryos.”

As Republican Senator Richard Shelby of Alabama adds, “My basic tenet here is I don’t think we should create life to enhance life and to do research and so forth. I know that people argue there are other ways. I think we should continue our biomedical research everywhere we can, but we should have some ethics about it.”

(Please see the related article on this website, entitled, “Obama Rescinds Bush-Era Executive Order Pushing for More Ethical Stem Cell Research”, dated March 10, 2009).

3/ Finally, in regard to the issuing of a “presidential memorandum” calling for a return of “scientific integrity to government decision-making”:

In an op-ed article published in the Washington Post and entitled “Obama’s ‘Science’ Fiction”, the Pulitzer Prize-winning syndicated columnist and commentator, Dr. Charles Krauthammer, issued a scathing rebuttal of Obama’s actions today, including the issuing of this “presidential memorandum” in which Obama pretentiously called for a return of “scientific integrity to government decision-making”. Dr. Krauthammer, who is also a former U.S. Presidential Science Advisor to the Carter Administration as well as a graduate of Harvard Medical School, and who has been a paraplegic since 1972, was personally invited by President Obama to attend the White House signing ceremony today, but he rejected the invitation. In his Washington Post op-ed article, Dr. Krauthammer writes, “…the ostentatious issuance of a memorandum on ‘restoring scientific integrity to government decision-making’ – would have made me walk out. Restoring? The implication, of course, is that while Obama is guided solely by science, Bush was driven by dogma, ideology and politics. What an outrage. Bush’s nationally televised stem cell speech was the most morally serious address on medical ethics ever given by an American president. It was so scrupulous in presenting the best case for both his view AND THE CONTRARY VIEW that until the last few minutes, the listener had no idea where Bush would come out. Obama’s address was morally unserious in the extreme. It was populated, as his didactic discourses always are, with a forest of straw men. Such as his admonition that we must resist the ‘false choice between sound science and moral values.’ Yet, exactly 2 minutes and 12 seconds later he went on to declare that he would never open the door to the ‘use of cloning for human reproduction.’ Does he not think that a cloned human would be of extraordinary scientific interest? And yet he banned it. Is he so obtuse as not to see that he had just made a choice of ethics over science? Yet, unlike Bush, who painstakingly explained the balance of ethical and scientific goods he was trying to achieve, Obama did not even pretend to make the case why some practices are morally permissible and others are not.” (Please see the related article on this website entitled, “A High-Profile Proponent of Embryonic Stem Cell Research Sharply Criticizes Obama’s Policy”, dated March 13, 2009).

Indeed, the implications extend further than merely to President Bush, as Obama is insinuating that the countless distinguished doctors and scientists who choose to work only with adult stem cells and not with embryonic stem cells, are all driven only by dogma, ideology and politics, whereas the other half of that insinuation is that anyone who advocates embryonic stem cell research (such as the many politicians and Hollywood movie stars) must be motivated only by scientific integrity. In fact, all of the evidence, including the scientific facts, strongly indicate that the exact opposite is true. And most of the doctors and scientists who choose to work exclusively with adult stem cells, and who refuse to go near embryonic stem cells, do so because of the numerous compelling scientific reasons, regardless of their own individual ethical convictions.

Additionally, to call for “scientific integrity in government decision-making” seems to be a strange contradiction of Obama’s concurrent action overturning President Bush’s Executive Order which specifically encouraged the research and development of stem cell therapies beyond embryonic stem cells, such as with adult stem cells and iPS cells. If nothing else, today President Obama made it perfectly clear that he is strongly opposed to beneficial therapies that are developed from adult stem cells and iPS cells – despite the fact that a wide variety of adult stem cell therapies already exist.

Summary:

Other than the rather mystifying and surreptitious reversal of a Bush Executive Order which did nothing other than call for the research and development of stem cell therapies from non-embryonic sources, and which limited nothing, and which only encouraged research into promising adult stem cell treatments, the only thing that Obama has managed to change today in regard to Bush-era restrictions is that scientists are now allowed to spend their NIH grant money on human embryonic stem cell lines that are somehow currently already in existence. Such stem cell lines are estimated to number in the hundreds, which is more than the approximately 21 embryonic stem cell lines that had been in existence prior to August 9th of 2001, but it is hardly enough to satisfy the research objectives of every embryonic stem cell scientist in every embryonic stem cell laboratory in the country. In order to do that, it would be necessary to legalize the use of federal funds for the destruction of embryos, which is necessary for the creation of new embryonic stem cell lines, which would require overturning the Dickey-Wicker Amendment, which Obama does not have the power to overturn since only Congress, not a president, can overturn such an Amendment.

Beyond that simple change – namely, expanding the applicability of federal funds from approximately 21 human embryonic stem cell lines to a few hundred human embryonic stem cell lines – and in addition to the momentous denial of the importance of adult stem cell and iPS cell therapy, nothing else is different from the stem cell policies that existed during the Bush administration. The main legislative restriction of primary importance, the Dickey-Wicker Amendment, which predates President Bush and which originated under the Clinton administration, and which still makes the federally funded destruction of human embryos illegal, has not been reversed, and cannot be reversed by any president. (Please see the related news article on this website, entitled, “Obama Signs Law Restricting Federal Funding of Embryonic Stem Cell Research”, dated March 11, 2009, which further addresses this issue).

Overall, the main goal that Mr. Obama accomplished today was to exhibit his own, personal vindictiveness against the previous administration. But nothing that he decreed in his ceremonial signing today had anything whatsoever to do with “scientific integrity”.

In what CNN referred to as “a thinly veiled criticism of his predecessor”, Obama made a number of claims today which left many people in his national and international audiences questioning the logic and “scientific integrity” of everything that they heard the president announce.

Former Director of N.I.H. Explains Why Embronic Stem Cells are Obsolete

Citing a number of examples which demonstrate the “markedly diminished need for expanding these cell lines for either patient therapy or basic research”, Bernardine Healy, M.D., explains in clear and logical terms why embryonic stem cells are obsolete.

According to Dr. Healy’s article in U.S. News and World Report, “Even for strong backers of embryonic stem cell research, the decision is no longer as self-evident as it was, because there is markedly diminished need for expanding these cell lines for either patient therapy or basic research. In fact, during the first six weeks of Obama’s term, several events reinforced the notion that embryonic stem cells, once thought to hold the cure for Alzheimer’s, Parkinson’s, and diabetes, are obsolete. The most sobering: a report from Israel published in PLoS Medicine in late February that shows embryonic stem cells injected into patients can cause disabling if not deadly tumors.”

As Dr. Healy further explains, “The report describes a young boy with a fatal neuromuscular disease called ataxia telangiectasia, who was treated with embryonic stem cells. Within four years, he developed headaches and was found to have multiple tumors in his brain and spinal cord that genetically matched the female embryos used in his therapy.” (Please see the related news article on this website, entitled, “Fetal Stem Cell Therapy Could Prove Fatal”, dated February 17, 2009).

Such findings should make everyone rethink, among other things, Geron’s upcoming clinical trials with human embryonic stem cells, and Dr. Healy even suggests that the U.S. FDA (Food and Drug Administration) should reconsider the wisdom of having granted such authorization in the first place. According to Dr. Healy, “His experience [the Israeli boy who developed the tumors] is neither an anomaly nor a surprise, but one feared by many scientists. These still-mysterious cell creations have been removed from the highly ordered environment of a fast-growing embryo, after all. Though they are tamed in a petri dish to be disciplined, mature cells, research in animals has shown repeatedly that sometimes the injected cells run wildly out of control – dashing hopes of tiny, human embryos benignly spinning off stem cells to save grown-ups, without risk or concern. That dream was still alive only a few weeks before this report. Within days of Obama’s inauguration, the Food and Drug Administration approved its first-ever embryonic stem cell study in humans: the biotech company Geron’s plan to inject highly purified human embryonic cells into eight to 10 patients with acute spinal cord injuries. (The cells are from a stem cell line approved by Bush because it predated his ban). The FDA should now be compelled to take another look: Are eight to 10 patients enough, or one year of monitoring sufficient, to assess safety? And doctors who participate in the trial will have to ask what every doctor must ask before performing research on a human subject: Were I this patient, would I participate? Would I encourage my loved ones to do so?”

In acknowledging the extraordinary successes that have already been accomplished with adult stem cells, Dr. Healy adds, “Even as the future of embryonic stem cells has dimmed, adult stem cell research has scored major wins evident just in the past few months. These advances involve human stem cells that are not derived from human embryos. In fact, adult stem cells, which occur in small quantities in organs throughout the body for natural growth and repair, have become stars despite great skepticism early on. … Such stem cells can be removed almost as easily as drawing a unit of blood, and they have been used successfully for years in bone marrow transplants. To date, most of the stem cell triumphs that the public hears about involve the infusion of adult stem cells. We’ve just recently seen separate research reports of patients with spinal cord injury and multiple sclerosis benefiting from adult stem cell therapy.”

Even iPS (induced pluripotent stem) cells, which are also not without their own dangers, are more promising than embryonic stem cells, and on this topic Dr. Healy cites not only the inherent medical risks of iPS cells but also the advice of the first scientist who ever isolated an embryonic stem cell, the famous Dr. James Thomson. As Dr. Healy describes, “While these cells [iPS cells] might become a choice for patient therapy in time, scientists are playing this down for now. Why? These embryonic-like cells also come with the risk of cancer. James Thomson, the stem cell pioneer from the University of Wisconsin who was the first to grow human embryonic stem cells in 1998, is an independent codiscoverer of iPS cells along with Japanese scientists. Already these reprogrammed cells have eclipsed the value of those harvested from embryos, he has said, because of significantly lower cost, ease of production, and genetic identity with the patient. They also bring unique application to medical and pharmaceutical research, because cells cultivated from patients with certain diseases readily become laboratory models for developing and testing therapy.”

Finally, Dr. Healy points out another important distinction which is often overlooked, namely, the distinction between the simple act of overturning President Bush’s restriction on the use of federal funding for human embryonic stem cell research, which President Obama has promised to do, and the far more difficult task of repealing the Dickey-Wicker Amendment, which became law under the Clinton Administration and which forbids both the creation and the destruction of embryos for scientific research. In regard to this matter, Dr. Healy has this to say: “The importance of stem cells for medical research has never been greater, and the scientific and public clamor for unimpeded research is fully understandable. But it’s important that Obama and everyone supporting a lifting of the ban be clear with the public on what is involved in this decision; it’s more complex than advertised. The more ethically charged decision – less understood by the public and one Congress has avoided – involves the ban on creating human embryos in the laboratory solely for research purposes. In fact, President Clinton is the one who balked at allowing scientists to use government money for embryo creation and research on stem cells harvested from such embryos; Bush only affirmed the Clinton ban. The scientific community has been able to attract nonfederal money for such work, and it is going on all the time in stem cell institutes. Scientists want relief from the inconvenience and expense of keeping that work and the money that supports it separate from federal dollars. Reversing the Executive Orders of 2 prior presidents on embryo creation, which even the Congress has been unwilling to tackle, is a far bigger issue than lifting the ban on the use of IVF embryos slated for destruction. Obama stands for transparency, and it’s important for him to make sure the public understands his decision, including that all stem cells are not the same or created equally.”

Dr. Bernardine Healy, a cardiologist who has spent more than 25 years practicing medicine, is currently a senior writer and health editor for U.S. News and World Report, and the author of the magazine’s “On Health” column. A graduate of Harvard Medical School, she was one of only ten women out of a class of 120 Harvard Medical School students at that time. She is a former Professor of Medicine at Johns Hopkins University School of Medicine where she was also Director of the Coronary Care Unit and Assistant Dean for Post-Doctoral Programs and Faculty Development. She has served in the capacity of Presidential Advisor under several administrations, beginning in 1984 when President Reagan appointed her as Deputy Director of the White House Office of Science and Technology Policy. In 1991, President George H.W. Bush appointed her as the first woman Director of the National Institues of Health, and in the George W. Bush administration she was appointed in 2001 to the President’s Council of Advisors on Science and Technology where she served as an advisor on bio-terrorism. Additionally, she was President of the American Heart Association from 1998 to 1999, and President and CEO of the American Red Cross from 1999 to 2001, during which time she led the response of the American Red Cross to the terrorist attacks of September 11th, 2001, which included the creation of a $200 million family grant program for the families of victims and the initiation of a stratetic blood reserve from extra blood collections, among other programs. From 1995 to 1999 she was Professor of Medicine and Dean of the College of Medicine and Public Health at Ohio State University. She has written 2 books and coauthored more than 220 peer-reviewed manuscripts on cardiovascular research and health science policy. Despite her numerous administrative, executive and Presidential appointments, from which she became known for her outspoken and innovative policy-making decisions, she has continued to treat patients throughout much of her career. She has also served as a medical correspondent for CBS news.

Japanese Company Conducts Clinical Trials with Adult Stem Cells

The Japanese biotech company, JCR Pharmaceuticals, has announced that it has begun clinical trials for the treatment of graft-versus-host disease (GVHD) with its proprietary product, known as JR-031, which consists of a patented preparation of human mesenchymal stem cells derived from bone marrow.

GVHD is a common and potentially fatal complication of allogeneic (in which the donor and recipient are not the same person) bone marrow transplantation, for which a reliable cure has not previously existed. Conventional treatments with corticosteroids which are intended to induce T-cell immune suppression carry a high risk of infection and cancer relapse. Now, however, adult stem cells offer the first actual therapy which has already been shown to halt and reverse GVHD, without imparting further dangers and risks to the patient.

JR-031 uses adult stem cell technology originally developed by the U.S. company Osiris Therapeutics, which is currently in Phase III clinical trials with its human mesenchymal stem cell products in Europe and the U.S., where the therapy has received Fast Track designation from the corresponding regulatory agencies for the treatment of GVHD. In Japan, where Phase I and II clinical trials will be conducted at more than ten hospitals, JCR Pharmaceuticals is developing the therapy in collaboration with the Mochida Pharmaceutical Company. Some patients have already been treated with JR-031, and data should be available within the next few months. If Japan’s Ministry of Health approves JR-031, as expected, this mesenchymal stem cell product will then become the first stem cell-based therapy in Japan. In anticipation of successful clinical trials in Japan, as already demonstrated by the success of clinical trials conducted by Osiris in the U.S. and Europe, JCR Pharmaceuticals and Mochida have already entered into a formal agreement in which both companies will co-develop and commercialize JR-031 for Japan.

JCR Pharmaceuticals is focused on the R&D of human-derived bioactive substances, especially enzyme-, hormone-, and cell-based therapies for orphan diseases. The company was founded in 1975 and is based in Ashiya City, Japan. It is traded on the Osaka Stock Exchange under the symbol JCRPF.

More Canine Cures Achieved With Adult Stem Cells

Zoey, the 14-year-old American Eskimo dog, used to suffer from advanced arthritis of the hip, but found no improvement with pharmaceuticals, and hip surgery was contraindicated by his advanced age. Fortunately, however, Zoey’s owner followed the advice of Zoey’s veterinarian, and now Zoey’s hip and quality of life have both significantly improved, thanks to canine adult stem cell therapy.

According to Zoey’s owner, Raymond Walsh, “It did wonders. He is having another round. But had we not given the first shot back in August we might have had to put him under.”

Since Vet-Stem began marketing their services last year, they have now treated more than 1,500 dogs and cats with autologous adult stem cells, extracted from each animal’s own fat. The procedure is quick, simple, minimally invasive, safe, highly effective, and while it is not cheap, it is less expensive than conventional surgical and pharmaceutical therapies which may not be effective at all. The first stem cell extraction and transplant typically run between $2,500 and $3,500, although the second transplant will often cost much less since extraction is only necessary once. In Zoey’s case, additional injections of his own stem cells cost $350 each. As his owner Raymond puts it, “If it prolongs his life, it was worth it.” The entire stem cell extraction procedure consists of the approximate equivalent of 2 or 3 tablespoons of the animal’s own adipose tissue (fat) which is surgically removed under anesthesia and shipped overnight to Vet-Stem’s laboratories in southern California where the stem cells are isolated, expanded and returned two days later to the veterinarian who injects the stem cells back into the animal. Not only do the stem cells automatically target the injured tissue, but they also stimulate endogenous stem cells which in turn are mobilized into action and participate in the healing and repair process. Although improvements are usually dramatic and immediate, even after the first injection, additional injections may be necessary, depending upon the age and condition of the animal. Very few animals ever need more than a total or 2 or 3 treatments, however, before they are fully restored to their natural, pain-free state of mobility – which contrasts sharply with conventional therapies such as most prescription medications which may need to be taken indefinitely, without ever producing any tangible signs of improvement and while even possibly causing further damage to the animal through dangerous side effects and other associated risks.

Success stories are common in the field of veterinary medicine with this type of stem cell therapy, which utilizes exclusively adult stem cells, not embryonic stem cells, since embryonic stem cells are notoriously problematic and carry a number of dangerous risks, both in humans and in animals, not the least of which is the formation of teratomas (tumors).

Another success story involved the 7-year-old golden retriever named Daisy who, in the summer of last year, received the same type of autologous adult stem cell procedure as did Zoey, at which time adult stem cells derived from Daisy’s own fat were injected into both of her hind legs. Although she had previously been unable to walk at all on her left hind leg, she was restored to effortless and painless mobility following the stem cell treatment. According to her owner, Mary Benik, “She is back to what she was. Before, she had been holding her foot up, favoring it. I hope it continues to work because I have bad knees and I would do it if it could help me.”

In fact, Vet-Stem’s consistent success is becoming increasingly difficult for the human medical profession to ignore, and pioneering patients such Zoey and Daisy are now inspiring similar therapies for humans. According to the CEO of Vet-Stem, Dr. Bob Harman, “When you look at a labrador retriever with arthritis in his hips, that is the same disease that you and I have. Fractures are similar too, even though they are four-legged.”

Indeed, Vet-Stem is now working with the San Diego company Cytori Therapeutics which is harvesting adult stem cells from human adipose tissue for reconstructive breast surgery following a masectomy, by utilizing a proprietary device that has already been approved for use with breast cancer patients in Europe. According to Tom Baker, director of investor relations at Cytori, “Our first application is taking the cells out and combining them with fat to allow fat to be used as a natural filler in breast reconstruction.” Although this is just one example of a very specific application of adult stem cell technology, other applications extend throughout the vast spectrum of degenerative diseases and traumatic injuries, including those of orthopedic, cardiovascular, neurological and immunological origin, in which there is no shortage of companies that have already demonstrated impressive results in human clinical trials, such as, most notably, the adult stem cell company Osiris Therapeutics, among others.

Once again, in a symbiotic relationship that can trace its origins back throughout the millennia, it is unclear today exactly who is training whom, and who is really helping whom, in the ongoing mutual advancement and enlightenment of homo sapiens and our canine companions.

Doctors in Spain Use Adult Stem Cell Therapy for the Treatment of Crohn’s Disease

Physicians in Barcelona are using autologous adult stem cells derived from bone marrow to treat Crohn’s disease. In other countries such as the U.S. and Italy the same procedure has already obtained excellent results, with 80% of all patients still in total remission as long as 6 years after treatment, and considerable improvement also observed even in the 20% of patients who experience partial but not complete remission.

Dr. Julian Panes and Dr. Elena Ricart of the gastroenterology department at the Hospital Clinic in Barcelona have treated 6 patients thus far, 3 of whom have already completed the therapy and the other 3 of whom are still undergoing therapy. All patients are confident that they will improve.

However, the procedure in Barcelona begins with an initial treatment of chemotherapy for the specific purpose of destroying the patient’s immune system – the logic and necessity of which are being increasingly questioned. While such a procedure had previously been considered a necessary part of such therapy, even though it exposes the patient to potentially life-threatening risks, today an increasing number of doctors are questioning the medical wisdom and scientific validity of subjecting their patients to deliberate immune destruction, and in fact there is a growing body of evidence to support the idea that such dangerous immunosuppression is unnecessary. In a publication that appeared in the Journal of Translational Medicine over two years ago, in January of 2007, Dr. Neil H. Riordan et al. posed the following question: “…in patients who are not suffering from a disease that is associated with an aberrant bone marrow such as hematological malignancies or immunological dysfunctions, how is it justifiable to subject them to the high levels of morbidity and mortality associated with immune suppression?” Dr. Riordan and his team of scientists then examined compelling evidence which strongly indicates that pre-stem cell transplant immune suppression is unnecessary for many types of autologous hematopoietic cell therapies and even for some allogeneic therapies that utilize “universal donor” cells such as mesenchymal stem cells and the CD34+ stem cells that are found in umbilical cord blood, and from which immune rejection is not even a concern. As Dr. Riordan and his colleagues wrote in their 2007 paper in a section that is subtitled, “Mesenchymal stem cells do not need myeloablation for efficacy”: “Currently there are several ongoing clinical trials in Phase I-III using ‘universal donor’ mesenchymal stem cells in non-conditioned recipients of Crohn’s disease, GVHD (graft-versus-host disease) and myocardial infarction. Although these cells are bone marrow expanded mesenchymal cells, the superior proliferative potential of cord blood mesenchymal cells may allow them not only to escape immune destruction, but also to expand in vivo and mediate therapeutic effects superior to those derived from bone marrow. The fact that regulatory agencies have allowed advancement of ‘off-the-shelf’ universal donor mesenchymal stem cells supports the numerous reports of clinical efficacy in an allogeneic setting.”

Although a total remission rate of 80% is quite impressive, one can only conclude that the rate would be even higher if the patients did not have to recover from the deliberate and life-threatening destruction of their immune systems prior to receiving the stem cell therapy, and also if the stem cell therapy would utilize the “superior proliferative potential” of the “immune privileged” adult stem cells that are found in umbilical cord blood.

Crohn’s disease is a painful, inflammatory, chronic, autoimmune disease of the digestive tract for which there has previously been no known cure and which, if left untreated, is potentially fatal. Complications are numerous, conventional medical treatments are ineffective and carry a high risk of dangerous side effects, and although the precise causes are unknown there seems to be a strong genetic component associated with the disease, which afflicts approximately half a million people in the U.S. alone and over 150,000 people in Spain. Now, adult stem cells offer the first therapy that has ever actually been shown not only to reverse the course of the disease but also to heal the patient of associated physiological injury.