The Genetizen

Genetizen

Advances in genetics and biotechnology are impacting society in provocative ways. The Genetizen is written by a select group of scientists, bioethicists, and healthcare professionals who provide you with expert analysis and commentary on many important issues.

Disclaimer: Opinions expressed in blog postings may or may not reflect the opinions of Geneforum. In addition, the content provided here is purely informational and not a substitute for advice from your personal physician.



Survey set 3

A number of arguments have been made in the embryonic stem cell debate. Please indicate if you strongly agree, agree, disagree, or strongly disagree with the following. Q20. It is really important to find cures for diabetes, heart disease, and Parkinsons as quickly as possible, even if it means destroying embryos to do so. Strongly agree Agree Disagree Strongly disagree Q21. It would be terrible if cures were delayed because of policies that make embryonic stem cell research difficult. Strongly agree Agree Disagree Strongly disagree Q22. It would be terrible if embryos were destroyed because of policies that promote embryonic stem cell research. Strongly agree Agree Disagree Strongly disagree Q23. It is really important to protect human embryos, even if it will delay the development of new medicines. Strongly agree Agree Disagree Strongly disagree Q24. Using embryos for research is dehumanizing and turns embryos into commodities. Strongly agree Agree Disagree Strongly disagree Q25. All in all, which is more important to you, conducting embryonic stem cell research that might result in new medical cures OR not destroying the human embryos involved in this research? Q26. Would you be willing to delay progress in medical research in order to find sources of stem cells that do not involve embryo destruction? Yes No Q27. If so, for how long? One year Five years. Ten years Twenty five years Forever Q28. In addition to embryos donated by couples after infertility treatment with IVF, it is possible for people to donate sperm and eggs specifically to create embryos to be used to make embryonic stem cells. Some scientists believe that stem cells from these embryos would be particularly useful in research. Some people oppose creating embryos specifically to be used to make stem cells because they believe it is wrong to create embryos only to destroy them. In general, do you strongly approve, approve, disapprove or strongly disapprove of using embryos specifically created to be used to make embryonic stem cells in which the embryo will necessarily be destroyed? Strongly approve Approve Disapprove Strongly disapprove Q29. In your view, is there a moral difference between creating embryos specifically for research and using embryos remaining after IVF for research? Yes No Q30. Is creating embryos specifically for research morally more or less acceptable than using embryos donated by couples after IVF for research? LESS acceptable MORE acceptable
Genetizen's blog

More survey questions

This is the second set of questions in the Johns Hopkins Stem Cell Survey. Your answers are for your own use only. I'll post the summary of the survey results when the questions are finished. Oh, by the way, in the previous set of questions, the abbreviation IVF should have been defined as in vitro fertilization.

There is a public debate about embryonic stem cell research and disagreement about the public policies that should be put in place regarding this research. Some believe embryonic stem cell research is morally acceptable because research to find cures for diseases is extremely important. Others believe embryonic stem cell research is morally unacceptable because it requires the destruction of human embryos. A number of proposals have been put forward for embryonic stem cell research policy. The current policy of the US government has three components: 1) it allows federal funding of research using a limited number of embryonic stem cells that were created before August 2001 (because those IVF embryos had already been destroyed); 2) it prohibits federal funding to create new embryonic stem cells or to study new embryonic stem cells created with private funds; and 3) it permits private funds to be used to create and study new embryonic stem cells. Some feel the current policy is a good compromise because of the controversy about destroying embryos. Others feel that federal funding is essential to spur important medical research.

Q 15. Please review the following possible policies the government could adopt about research on embryonic stem cells. Select the one that you think is the best government policy.

  1. The government should prohibit all research to create or study embryonic stem cells.
  2. The government should keep the current policy that allows federal funding for research to study a small number of embryonic stem cells created before August 2001.
  3. The government should not fund research to create new embryonic stem cells, but if private funding is used to create new embryonic stem cells then the government should fund research to study these cells.
  4. The government should fund research to BOTH create and study new embryonic stem cells.

Please pick one above, or select one of the last two options. 5. Don’t know   6. No opinion

Q16.  Imagine that in a year from now scientists report results from new research showing that embryonic stem cells are an effective treatment for a serious disease like diabetes. Would such a development change your views about government policy about embryonic stem cell research? Yes ….No.

Q 17. What would your policy preference be based on this new information?

  1. The government should prohibit all research to create or study embryonic stem cells.
  2. The government should keep the current policy that allows federal funding for research tostudy a small number of embryonic stem cells created before August 2001.
  3. The government should not fund research to create new embryonic stem cells, but if privatefunding is used to create new embryonic stem cells then the government should fundresearch to study these new cells.
  4. The government should fund research to BOTH create and study new embryonic stem cells.

 Please pick one from above, or select one of the last two options. 4. Don’t know 5. No opinion

Q 18. Imagine that a year from now scientists report results from new research in which new embryonic stem cells are created from embryos without harming or destroying the embryo. The embryos that provided the stem cells could still be transferred to a woman’s womb and produce healthy babies. Would such a development change your views about government policy about research using embryonic stem cells from embryos donated by couples after IVF?  Yes …No

If you answered Yes to Q 18, please answer Q19

Q19. What would your policy preference be based on this new information?

  1. I would support embryonic stem cell research only when embryos are not destroyed
  2. I would support embryonic stem cell research using embryos from both sources.

Please pick one from above, or select one of the last two options. 3. Don’t know  4. No opinion

More questions to come . . .

Marie Godfrey, PhD

Genetizen's blog

Stem cell survey

The announcement of a new survey on stem cells arrived today and some of you may have already read about it. When I read the results of a survey, I always want to know what the real questions were—not just the results. So, I went to the website for the Johns Hopkins Values in Conflict: Public Attitudes on Embryonic Stem Cell Research website and checked out the questions. I thought some of you might like to answer them for yourself. The survey is long, so I’ll post just a few at a time. What I particularly like about this survey, though it takes you longer to complete it, is the definitions and other information before some of the questions.

Q12. Before today, had you heard about embryonic stem cells? Yes     No

EMBRYONIC STEM CELL DEFINITION  Stem cells are cells that are able to give rise both to more stem cells and to specialized cell types (e.g. muscle cells, blood cells, liver cells). The next few questions will be about one type of stem cells called embryonic stem cells. For the purposes of today’s questions, here is a definition of embryonic stem cells. Embryonic stem cells are obtained from early embryos and can give rise to all cell types in the human body. When stem cells are obtained from embryos, the embryo is destroyed. Most scientists believe that human embryonic stem cell research holds great promise for understanding human disease and developing new treatments for diseases such as diabetes, heart disease and Parkinsons disease. Stem cells can be obtained from embryos that were created through IVF for couples trying to have a baby. Sometimes there are embryos remaining after IVF. Couples can donate these embryos to stem cell research in which the embryo will be destroyed. Stem cells also can be obtained from bone marrow and umbilical cord blood. These stem cells are useful in treating some diseases such as some cancers and blood diseases. However, most scientists believe that developing new treatments for many diseases from these stem cells will take longer and is less certain than using embryonic stem cells.

Q13. Over the last three months, have you read, seen, or heard a lot, a little, or nothing about issues involving embryonic stem cells?   A lot    A little    Nothing

Q14. In general, do you strongly approve, approve, disapprove or strongly disapprove of embryonic stem cell research? Strongly approve   Approve   Disapprove   Strongly disapprove

More questions tomorrow

Marie Godfrey, PhD

Genetizen's blog

No action in Senate or House

On October 6, Mr. Bayh from Indiana was added was added as a cosponsor of S. 1317, a bill to provide for the collection and maintenance of cord blood units for the treatment of patients and research, and to amend the Public Health Service Act to authorize the Bone Marrow and Cord Blood Cell Transplantation Program to increase the number of transplants for recipients suitable matched to donors of bone marrow and cord blood.

The Senate finished  its session October 7 with approval of H.R. 2863 As Amended; Department of Defense Appropriations Act, 2006. The only mention of stem cell on that day was a comment made by one person about someone else. No relevance to our interest in when stem cell research might be debated.

Now they're on a break until the 17th.

Marie Godfrey, PhD

Genetizen's blog

Ethics and stem cell research

On Tuesday morning, I hope to be interviewing Dr. Insoo Hyun of Case Western Reserve University in Ohio. Dr. Hyun, a bioethicist, spent the summer in South Korea interviewing people involved in stem cell research, including Dr. Hwang (who developed 11 new stem cell lines using nuclear transfer). He was also able to interview people opposing stem cell research and those working at regulatory agencies.

I have come up with 12 questions in about 7 different categories and am looking forward to a lively conversation. After editing and review, these questions will become part of Geneforum's resources for readers to examine at their leisure. Which reminds me--have you checked out the other interviews we have available? Check on the grey bar at the top of the page for Resources--you'll find lots of stuff to look at.  And, there are subjects other than stem cells that may be interesting to you.

Marie Godfrey, PhD

Genetizen's blog

Our focus

When we began this blog, we decided to focus on public policy and stem cells, in line with Geneforum's focus on public involvement. Right now, we're looking at the legislative actions in Washington, DC. Since things are slow there, I've been picking up Google alerts that interest me and discussing them. I've also provided a 7-part series on bone marrow tranplants so readers can learn more about adult stem cells and their use. In the next couple of weeks, I'll be posting questions and answers from a U.S. bioethicist recently immersed in the stem cell research in Korea.

The number of stem cell blogs has been growing recently, and a number of them are advertising on Google and other search engine sites. Naturally, I don't want to lose any readers, but many of you probably also look into other stem cell blogs, so I'd like to tell you about a new one that provides clean, unbiased information and links to other articles and sites: Stem Cell Research Progress Blog, at http://www.newdrugs.com/stemcells/?g).  

Remember to ask questions when you have them. I'm eager to help.

Marie Godfrey, PhD

Genetizen's blog

Using cardiac adult stem cells to repair heart tissue

One of the strong messages from the stem cell meeting in San Francisco over the weekend was that stem cell research needs to show some new successes soon. For many reasons, embryonic stem cell research is unlikely to provide new treatments or curescat least not in humanscwithin the next couple of years. Even though some clinical trials are planned, these are generally Phase I trials, which are intended to test the safety not the efficacy of stem cell treatments.

A new federal program focused on cell-based therapies that could be ready for clinical trials testing within two years announced Sept 29 that my favorite institution Johns Hopkins is one of three centers to receive five-year funding ($12 million) from the National Heart, Lung, and Blood Institute as a Specialized Center for Cell-Based Therapy for Heart, Lung and Blood Diseases (SCCT). Hopkins is the only center dedicated to new therapies for heart problems. The SCCT initiative will focus on two major projects.

Marbin's group will study the potential of using a patient's own cardiac stem cells to repair heart tissue soon after a heart attack, or to regenerate weakened muscle resulting from heart failure. By using a persons own adult stem cells instead of those from another donor, there would be no risk of triggering an immune response that could cause rejection. Marb¡n was recently successful in replicating large numbers of cardiac stem cells in the lab within a very short time, as little as four weeks. The stem cells, extracted from healthy parts of hearts not otherwise damaged by heart attack, grew to form clusters, called cardiospheres, which contain cells that retain the ability to regenerate themselves and to develop into more specialized heart cells that can conduct electrical currents and contract like heart muscle should.

Hare's group will evaluate adult mesenchymal stem cells (the stem cells in bone marrow that do not form blood cells) as a potential therapy to heal damaged hearts. Last year, his research in animals showed that stem cells harvested from one pig's bone marrow and injected into another pig's damaged heart restored heart function and repaired damaged heart muscle by 50 percent to 75 percent after just two months of therapy. In March 2005, Hare and other researchers began a Phase I clinical trial to test the safety of injecting adult stem cells at varying doses in patients who have recently suffered a heart attack. In total, 48 patients will participate in this study, which involves several sites across the country, including Hopkins. Results are not expected until mid-2006. Because mesenchymal stem cells are in an early stage of development, they, too, avoid potential problems with immune rejection, in which every humans immune system might attack stem cells from sources other than itself.

Marie Godfrey, PhD

Genetizen's blog

Regulatory hurdles for stem cells

One of the big surprises to me from the stem cell meeting in San Francisco over the weekend was the academic's astonishment at how much work is involved in getting a treatment approved by the Food and Drug Administration (FDA). If stem cell treatments are to be patented and sold like prescription drugs which is a likely commercial goal then a very long process is involved and the steps are many. The steps are also highly regulated by authorities, including the U.S. FDA, the European Agency for the Evaluation of Medicinal Products (EMEA), and the Korean Food and Drug Administration (KFDA).

Human clinical studies can begin in another country or in a U.S. state as long as no international or interstate commerce is involved an unlikely situation given the limited sources of stem cells. To conduct studies that may eventually be used to support a marketing application, an Investigational New Drug Application (IND) is necessary and this requires extensive, highly regimented animal (preclinical) studies. Essentially, the group planning to introduce the stem cells into humans has to 1) characterize the material to be used, 2) demonstrate that the material is unlikely to cause safety problems, and 3) provide a plan for Phase I clinical studies.

A natural question to be asked here is, why hasn't this been necessary with bone marrow transplants? The issue is profit. A group, such as a particular hospital, can perform medical procedures considered beneficial for patients without all the FDA regulatory process as long as the procedure is not patented and sold for profit. That the facility performing the procedure is likely to make a profit because patients will go there rather than elsewhere is a different issue. Thus, we have bypass surgery for heart conditions as an accepted medical procedure, but balloons inserted into blood vessels to increase blood flow were patented and met FDA regulations as medical devices.

So, as we consider the future of stem cell research we also have to include the American free-market system and the need for companies to make a profit. What I don't know and perhaps a reader can tell us what regulations companies that offer fetal stem cell treatments or cord blood cell treatments have to follow.

Marie Godfrey, PhD

Genetizen's blog

Horses and humans

Here's a follow-up to my comments a couple of days ago on research with stem cells and injured horses.

Researchers who injected horses' injured tendons with bone marrow stem cells found that the horses were twice as likely to recover as those left untreated. They have suggested that the small number of uncontrolled--individual animal--studies be expanded into a full-blown study with more horses. According to the article in the U.K. Telegraph, the hope is that the results can be applied to human injuries in the future.

An interesting side note was that the discovery of the marrow cells capacity to form tendon cells was fortuitous--like the fabled discovery of penicillin:

It was thought that a combination of mechanical, physical and chemical cues are required to turn stem cells into tendon cells. But a chance discovery came when Prof Smith left a syringe of stem cells in an incubator.

After three weeks, a student wanted to throw the syringe away, since it contained what she thought was fungus.

But, the syringe contained tendon cells.

This illustrates one of the key results researchers at San Francisco also mentioned: stem cells (embryonic or adult) tend to differentiate rather than reproduce in culture. What we need to learn is what the switch is that tells the cell which to do.

Marie Godfrey, PhD

Genetizen's blog

Stem cell meeting San Francisco

I just finished watching several hours of a meeting at the California Institute of Regenerative Medicine on stem cells. Unfortunately, I missed much of the scientific presentations--just getting in while the speaker was discussing oligodendrocytes--what a mouthful, but musical. This was the research where mice with spinal cord injuries were injected with stem cells and regained much of their ability to walk.

The program was broadcast by The Science Network, whose goal is to provide science "beyond sound bites".

One very strong message I heard was that everyone needs to be involved in learning about stem cell research and providing their personal expertise as part of the cooperative venture to help the public understand what is happening and what can realistically happen in the future.

By the time the Senate or the House starts debating stem cells--such as next January or February--decisions made will be political and influenced more by the upcoming primaries for the 2006 election than by science, patients, or the general public.

Now is the time to contact your representative and voice your opinion on stem cell research. Be specific; use the information provided in this blog to help you formulate an informed letter--yes, a real letter is best--and make your opinion known.

Marie Godfrey, PhD

Genetizen's blog

No stem cell action in legislature

My daily searches of the Congressional Record for instances of "stem cell" continues to come up negative.  No action in the legislature on stem celll research.

Marie Godfrey, PhD

Genetizen's blog

It's not all about humans

A trend I've often noticed is that we humans tend to think we're the top of the heap and focus on our needs and concerns almost exclusively. So it is with the stem cell issue. We are using mice for experiments, but don't much care about the injuring of a spinal cord so a scientist can test stem cells for their ability to reverse the damage. We argue about when human life begins and pay attention to cloning of sheep, pigs, cats, and dogs mostly because they imply humans could be next.

Meanwhile, research is going on with animals for the sake of the animals. The article I received today focuses on stem cell treatment of horses and gives an excellent summary of stem cell research and how it works: http://www.horseandhound.co.uk/care/402/69097.html

The irony, of course, is that the horse treated in this story is a thoroughbred--created, cared for, and stem cell treated by and for humans.

Marie Godfrey, PhD

Genetizen's blog

Hwang, ethics, regulations

Korean stem cell pioneer Dr. Hwang Woo-suk is visiting conferences around the world and discussing joint research projects. But, he notes in Germany that Germany must first revise its restrictions on stem cell research.

Current German law bans the production of embryonic stem cells within the country, and allows imports of only those cells created before January 1, 2002.

Hmmm, sound familiar?

Marie Godfrey, PhD

Genetizen's blog

Profit vs. politics

There's been an interesting shift in the subject matter of my Google stem cell alerts--they suddenly seem to focus on stem cell companies, the very entity that people were quoting as a reason not to increase federal funding of stem cell research. Many have suggested that stem cell research in the U.S. doesn't need federal funding because U.S. companies are not investing in it, so it's not a practical venture. Whether it's the time of year or the change in focus of the people at Google, companies investing in stem cell research--both adult and embryonic--are making the news.

Two issues are being discussed:

  • Will companies that have international ties, perhaps to one of those institutions that does research on "non-approved" stem cell lines, prosper?
  • Will big pharma have to do its stem cell research outside of the U.S. to overcome the current political and moral  restrictions?

Given the current demands on federal funding, including the costs of Katrina and Rita, and the new go-to-the-moon-again project, perhaps Congress and the President could simply release the restrictions on federal funding for stem cell research. Doing this without actually funding anything would acknowledge the current support for this research but not further drain the country's funds.

Marie Godfrey, PhD

Genetizen's blog

Ethics and Korean stem cell bank

On October 19, Korea's latest leading scientist and embryonic stem cell research leader plans to open Korea's World Stem Cell Bank. Geneforum will be posting questions to the ethicist for this program in the coming weeks and also posting his responses. As the one responsible for gathering the questions, I would very much appreciate help.

Please post your questions related to the ethics of stem cell research and the Korean world stem cell bank as a comment to this blog entry. If you wish to pose a question and not be identified, send it to me directly at Marie_Godfrey_PhD (at) myway.com.

Marie Godfrey, PhD

Genetizen's blog