How Obama's Stem-Cell Order Will Change Research

Stem-cell researchers around the country are celebrating President Obama's decision to reverse restrictions on embyronic stem-cell research, a move they say could lead to dramatic advances in the understanding and treatment of conditions like diabetes, heart disease and Alzheimer's. For years, scientists have been frustrated by the restrictions imposed by President George W. Bush in 2001. Bush's policy was intended to be a compromise: it banned the use of federal funds for the creation of new embryonic stem-cell lines while allowing scientists to study 21 lines that had already been created. But researchers say those lines aren't diverse enough and they have been eager to study hundreds of other lines, some of which contain specific genetic mutations for diseases like Parkinson's. There have been practical challenges as well. The restrictions forced scientists to use different lab equipment for privately funded and government-funded research; some even built entirely separate lab space. One of the most disconcerting aspects, researchers say, has been the negative effect on collaboration, a hallmark of the scientific process. Researchers supported by private money haven't been able to team up with scientists funded by the government, potentially holding back new insights and advances. (Article continued below...)

 All that is likely to change under Obama's executive order, issued Monday. Already, major progress has been made: earlier this year, the FDA approved the first clinical trial of embryonic stem cells in the United States. The biotech company Geron will test embryonic stem cells, derived from a government-approved line, against spinal-cord injuries. Now, scientists say they can build on the work they've accomplished during the Bush-policy era, take it in different directions and learn from one another in whole new ways. None of this, however, will put an end to the controversy. Longstanding critics deride the use of embryos for medical research, and they're letting the administration know that they're unhappy. House Republican leader John Boehner put it this way: "The question is whether taxpayer dollars should be used to subsidize the destruction of precious human life. Millions of Americans strongly oppose that, and rightfully so."

Claudia Kalb talked to Amy Comstock Rick, CEO of the Parkinson's Action Network and president of the Coalition for the Advancement of Medical Research (CAMR), a group formed in 2001 to advocate for embryonic stem-cell research. Excerpts:

NEWSWEEK: How are you feeling?
Amy Comstock Rick: I am very excited, very happy and very grateful to all the patient advocates and researchers who've kept this issue in the forefront for the last eight years. That is why it's a priority issue for this administration—because people kept the issue going. I'm grateful to the researchers who have continued to do research in this field even though it's been tough. The field could have floundered after the Bush policy. While it didn't move as quickly as it could have, it did move forward.

Take us back to Bush in 2001. 

At the time, it seemed like a compromise position, but pretty soon it became clear that it wasn't going to be enough to allow promising research. There has been some commitment of private funds and state funds since then, but not enough.

What kind of restrictions have scientists been up against?
If you talk to some of the scientists, you hear absurd stories. One guy has green dots on the things in his lab that are federally funded and red dots on the privately funded equipment. That shows you how crazy it is. You have post docs or young researchers in a lab next door who could benefit by learning what's going on, but they can't if they're on federal training grants and that's how they're paid. So it's been holding science back.

How will Obama's executive order change the way stem-cell research is done?
The [Bush-approved] stem-cell lines aren't ethnically or genetically diverse. Researchers are chomping at the bit to do research with nongovernment lines. It will allow research projects to be eligible for federal funding and it will also bring this research under NIH [National Institutes of Health] oversight. Currently, privately funded embryonic stem-cell research is not subject to any government oversight. The vast majority of research is still conducted in a very ethical manner and complies with guidelines from private organizations, but the best research in this country is funded by NIH and benefits from the accountability to NIH.

Talk about the science. What can embryonic stem cells do?
Early on, there was a lot of excitement about the idea of replacement therapy—using embryonic stem cells to make replacement cells, almost like organ replacement. That is still certainly exciting. But there are two other really exciting things that have happened over the last 10 years. One is creating disease in a dish. The idea is that you create Parkinson's or ALS [amyotrophic lateral sclerosis, or Lou Gehrig's disease] in a dish so that you can watch and understand the process of the disease. Stem cells hold huge promise in that way. Another area that's really cool is creating healthy liver cells or heart cells in a dish so that you can test drugs in the lab before you test them in a person to find out if they're dangerous. Imagine if they'd been able to test Vioxx in a dish before they actually gave it to humans? Or if you could find out that a chemotherapy is toxic before you give it to a cancer patient? The last personalized medicine hope, and we're not there yet, is to create an individual's cells in a dish—create Amy's liver or your liver so that you can test a drug in the lab before you give it to me or you. That's a dream, but it is a possibility.

What about critics who say embryonic stem cells are no longer necessary?
We're talking about three different kinds of stem cells: adult stem cells, induced pluripotent cells (iPS) and embryonic stem cells. Embryonic stem cells have the potential to turn into any kind of cell and appear to the have the greatest hope of being differentiated. iPS cells [adult skin cells that have been reprogrammed to an embyronic-stem-cell-like state] are very exciting. But all three forms of research are absolutely necessary to go forward. We have hundreds of diseases in this world that could benefit from one of these three kinds of cells and all deserve to be pursued.

How do you respond to people who are opposed to the destruction of embryos for medical research?
We have to always remember that the largest source of embryonic stem cells are embryos in IVF clinics that are going to be discarded and end up in the Dumpster. Personally, I have trouble with the ethical argument that it is inappropriate to use these embryos to save lives, but somehow it's appropriate to throw them in the Dumpster. I don't understand that.

What are you hearing from others about Obama's order?
Absolute excitement, enthusiasm, real hope for the future. The years of hard work of keeping this issue alive were worth it. There's a genuine sincere happiness. People are saying, "we've worked so long," and "I've waited for this day for so long." There's great potential for health benefits in so many ways. This has been an issue where researchers and patients have been so closely aligned—two groups that don't tend to work together or communicate very much. It's so heartwarming to see that the emotion is just as great on the researchers' side as it is on the patients' side.

Some patients today believe there will be embryonic-stem-cell treatments in their lifetime. Is that realistic?
That is one of the most difficult realities that I've had to accept in this job. I think most patients understand that more research needs to be done. Breakthroughs happen but no one can give a timeline. I have such respect for patient advocates. They understand that even if it doesn't help them, they want to help the next person.

Now that CAMR has achieved its goal, what will you do?
Aside from sleep? Our primary focus was the executive order. Now, NIH will begin working on guidelines for research, so we'll be focused on that. And there's been consistent conversation about legislation to make sure this form of research will continue to remain eligible for federal funding. When that happens, maybe our coalition will go away. That's what should happen when a single-mission organization has succeeded. It would be a wonderful thing.

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