David Scadden, M.D.
Co-Director, Harvard Stem Cell Institute
Monday, March 9, 2009 2:30 PM
President Obama lifted restrictions on funding for human embryonic stem cell research this morning and issued a presidential memorandum aimed at insulating scientific decisions across the federal government from political influence.
Obama took care to emphasize that the order would not "open the door" to allow human cloning, which he said is "dangerous, profoundly wrong and has no place in our society, or any society." But the president said stem cell research has enormous potential to further understanding and treatment of many devastating diseases and conditions. America, he said, should play a leading role in exploring the stem-cell research frontier.
David Scadden, M.D., co-director of the Harvard Stem Cell Insitute, was online Monday, March 9, at 2:30 p.m. ET to discuss what today's executive order means to the scientific, medical and research communities, and ultimately to the individual.
A transcript follows.
David Scadden: I am Dr. David Scadden, a professor at Harvard focusing on stem cell research and I am here to discuss President Obama's signing of the Executive Order to lift the restriction on federal funding for human embryonic stem cell research.
Washington, D.C.: How would undifferentiated stem cells lead to medications or treatments for transplanted organs? Regarding the latter, can organs or tissues be made from stem cells, and then transplanted into the patient needing that surgery?
David Scadden: Using stem cells to create organs for transplantation is an active area of research, but as you might imagine, one that will take a long period of time and a great deal of work. The hope is that damage to some of the organs that are often transplanted (kidney, liver, heart) may be mitigated by stem cells and therefore reduce the need from transplant. Creating an entire new organ though is a daunting challenge.
Fort Collins, Colo.: It's nice to see that science means something again. Why doesn't Obama/Congress push for legislative approval of a bill to permit/fund stem cell research permanently so that the policy cannot easily be undone by future executive orders? With the current makeup of Congress and the broad support for stem cell research, I would think that passage would be a slam dunk.
David Scadden: You raise an important point for medical research broadly. Should we fund programs that will take years of investment on a year-by-year basis? The kind of research that stem cells represent is research that has great potential, but long time-lines. It would draw the best people to the field to let them know that the nation has decided to provide it more durable, reliable funding. We need help from you in speaking to Congress about that.
Fairfax, Va.: How can we be sure that "strict guidelines," as President Obama said, will be followed so this ban will no encourage human cloning?
David Scadden: Reproductive cloning takes many steps, much research and much money. By putting barriers in the way in each of these areas and at each step, the government will virtually assure this cannot be done. Might some group of rogue individuals attempt it somewhere? They might, but the difficulty getting all the expertise and pieces in place makes it extremely unlikely.
Pickerington, Ohio: Shouldn't we call this the Scientists' Full Employment Act and be done with it? If human embryonic stem cell research worked, there would be significant private research dollars involved already.
David Scadden: Private research dollars of the scale needed could only from major corporations, likely pharmaceutical companies. They generally only invest in areas with short time horizons. This is very early stage research. The kind of thing that only the government usually funds and the kind of research that then generates companies that provide the products, hires people and makes the nation better. It was true in biotechnology (think of cancer drugs), vaccines and drugs that you may even take now like cholesterol lowering agents. We have government funded research to thank for those.
San Francisco, Calif.: Hello -- I'm interested in your take on investing in companies involved in Stem Cell Research. Is this a good place to put some money because of the lifted restrictions? There is a company called Stem Cells Inc. (STEM) that is selling for $2/share for example. Any thoughts? Thanks for doing this important chat.
David Scadden: I would not feel comfortable commenting on any investments. I will say that I am investing my professional life in this field because I think he has enormous promise to transform medicine and our nation's health. How any individual company will participate and thrive in this field is not something my expertise can address.
Brookline, Mass.: What does today's lifting of the Bush Executive Order mean for the Harvard Stem Cell Institute, of which you are co-director?
David Scadden: We are tremendously heartened by this action. It means a great deal for the day-to-day conduct of the research and perhaps more importantly, it indicates that this administration is open to having science, not ideology guide scientific issues of importance to our nation.
Washington, D.C.: Who will do the overseeing on the research?
David Scadden: All research that is federally funded is overseen by the agency that funds it. All research involving human subjects has additional layers of oversight (institutional review boards) acting according to guidelines issued by the government. We anticipate that the same will apply to stem cell research and understand that the National Institutes of Health has been asked to formulate specific guidelines in this area within the next 120 days. That interval would be before any funding would likely occur.
Chantilly, Va.: Where will this work begin? And can you give an example of a case in which stem cells were needed and what we might expect and how long things might take?
David Scadden: Major universities around the country have life science research programs that may now take up this field. At present, only a small number of universities like ours have taken on the challenge of raising private money, going through the policy and accounting steps to enable the work and setting up distinctive work spaces for the work to move forward. With the lifting of the ban, we are optimistic that other institutions and the minds that they foster will now become engaged.
Adelphi, Md.: If Christopher Reeve were alive, what would this mean to him and his individual condition?
David Scadden: There is a clinical trial using embryonic stem cell derived cells that is to begin for acute spinal cord injury patients this summer. Christopher Reeve had a longstanding injury and this first trial is only for acute injury and is really intended to determine the safety of the cells. However, it is a start. With the lifting of the ban, we hope that progress will now move faster.
Washington, D.C.: If you truly believed that an embryo was a human being with a right to life, would you be against embryonic stem cell research? I understand the research potential, but am very uncomfortable with the source. I know many of these embryos would otherwise be discarded, but to be fair, I also have moral disagreements with IVF and the creation of an embryo through such a method.
So, basically I'm asking how you'd encourage people who have a legitimate objection to embryonic stem cell research to overcome their qualms without sacrificing a basic tenet?
David Scadden: This is an extremely personal decision a person needs to make. There are at least two morally justifiable positions on this work. The first is the one you state; the other is that people are suffering from conditions that might be helped if we were to use cells that were otherwise destined for the incinerator. As a physician, I am compelled by the opportunity to relieve suffering recognizing that hundreds of thousands of stored embryos in IVF clinics will otherwise become medical waste. If and when we can move away from needing to use such cells, I assure you that scientists in the field are anxious to do so. At the moment, these are still the gold standard pluripotent cells. We hope to move away from them with more understanding of the so called iPS (induced pluripotent cells), but we are not yet at that point.
Washington, D.C.: How is cloning a human more difficult than cloning a sheep, which was accomplished in the late 1990s? Your assumption that cloning humans is difficult may be based in the belief that responsible cloning of humans is difficult. It's sort of like the difference between building a modern nuclear weapon and a simple dirty bomb. One is dependable, controlled and scientific. The other is experimental, volatile and ad-hoc. If you were morally neutral to creating ten thousand human mutants, how difficult would it be to get a near copy of a healthy human?
David Scadden: There is great variability in how easy it is to successfully accomplish nuclear transfer and have viable cells result (the first steps in cloning). Mice are easy. Sheep harder. Primates, including humans seem to be very difficult. We don't know the rules that govern these processes, but at present, even if someone wanted to clone humans, there is no evidence that it can be done.
Washington, D.C.: It's my understanding that this order would authorize "work with stem cells themselves, not the derivation of those stem cells." Can you please explain?
David Scadden: If stem cells already exist (as they do), those scientists who are working with federal funding, can now use the cells created after August 9, 2001. Previously, only the cells on the list of August 9, 2001 could be used. The cells created since that time have features that make them more desirable and therefore, this order will impact work.
The order does not allow for federal money to go to establishing new embryonic stem cell lines.
Philadelphia, Pa.: Will you please discuss the issue of when human testing should begin, especially for terminally ill patients. When you see hope that there is a cure that shows up in animals, as I see some cancers have been cured in research with dogs, or stem cell growth recovery with dogs, when can we begin testing on humans? I realize that there are no assurances that what works for one species may work for another, and I understand there are dangers and many unknown complications. Yet, when there is hope for terminally ill patients, isn't it better to provide something that holds hope instead of doing nothing?
David Scadden: This is an extremely difficult balance to strike: providing help at the earliest possible moment, without sacrificing safety. No one wants to hold back when the promise looks real, but causing harm, is an anathema to all. Scientists pass along discoveries made in animals to those who can guide converting them into a human therapy and then the steps of review begin. It is usually years of testing to shape the right dose and means of delivery and establish safety. It is very important that those involved in each step realize the urgency for the people waiting at the end. I try to make sure the people here recognize how important their effort and timeliness is to those awaiting therapy.
Alexandria, Va.: Will raising money be hard for this effort, in light of the state of the economy?
David Scadden: Absolutely. This is a time of great promise in the science and a great challenge in finding the funds to drive it to fruition. Being able to compete for federal money now is a great first step, but philanthropic money is what fuels the most innovative work. We hope that individuals of means will see the promise and the need and wish to help.
Baltimore, Md.: House Republican Whip Eric Cantor (R-Va.), said today that Obama's action "is about forcing taxpayers to fund ethically troublesome -- and unproven -- research that destroys life." Can you understand this side of the argument?
David Scadden: I do understand that people are uncomfortable with embryos being used in research. Those religious views are ones that should be respected. For others, the hundreds of thousands of embryos that are in freezers in IVF clinics and destined never to be used in reproduction, are a difficult but reasonable source of cells to be used in carefully conducted, morally responsible research for therapies to help those in need. I think the majority of Americans and members of Congress have spoken out in favor of the latter position. They have blocked by Executive Order and Presidential veto (twice) under President Bush. The majority has spoken however and in accord our mode of government, the research will now be able to continue, with oversight. If there are those who do not wish to receive any stem cell based therapy, it has been and will always be their prerogative to refuse it. For others, that religious opinion will no longer be forced upon them.
Cambridge, Mass.: Why do you suppose people expect results overnight in the stem cell field, when it took half-a-century to develop a polio vaccine, and research on AIDS vaccines has gone virtually nowhere in a quarter century?
David Scadden: There is never any guarantee on the pace of discovery or of new therapies arising from it. You raise the issue of AIDS. You may remember that HIV infection was a certain death sentence until 1996 when, because of basic research, therapies emerged. People literally on their death beds, got up and are now still thriving, contributing productively to society. This is a field in which I participated. It is what gives me confidence that medical research can result in revolutionary changes. Not always, but sometimes and I for one, prefer to push for the dream.
Washington, D.C.: You're taking stuff that isn't alive and making it into stuff that is alive. So if it's not alive, what's the difference between you and Frankenstein?
David Scadden: All cells are living. Dead cells cannot be made alive, but they can be replaced. Stem cells offer the possibility of replacing cells in our bodies that may have died from injury or disease.
Falls Church, Va.: I just read a news article with the headline "Lift on Stem Cell Ban May Lead to More Abortions." Do you have a response to that claim?
David Scadden: Stem cells have nothing to do with abortions. This is a scare tactic without basis in fact.
David Scadden: Thank you all. I need to sign-off.
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