Functional Livers, Non-Functional Media

As Wesley Smith has reported on his blog, Second Hand Smoke, and in the Weekly Standard, the media is ignoring the spectacular news that UK scientists have developed "miniature livers" that can be used for testing drugs and, hopefully, for transplants in the future. It appears that umbilical cord blood stem cells are not news.

As of 2:30 PM Central Standard Time, the UPI is the only US national news bureau that is reporting on the story, according to Google News Search. In fact, Google News Sci-Tech doesn't headline the story at all (there is coverage about elephants who like mirrors) and the Google Health News list has the story at number 5, below the news that sleeping alone affects hormone levels, which has fewer references.

Ethical Guidelines for Unethical Research

Oxymoron time at the National Academies of Science.

Election day, November 7th, is the also the first day of the two day Public Symposium of the National Academies of Science on their "Guidelines" for Human Embryonic Stem Cell Research. How can there be ethical guidelines for a basically unethical enterprise?

I see that Shinya Yamanaka, MD, PhD, is going to be there. Dr. Yamanaka was the lead researcher for the team that reported inducing adult somatic cells to turn back to (dedifferentiate) embryonic-like cells, or "induced pluripotent cells." Laurie Zoloth,PhD., at the American Society of Bioethics and Humanities last week, during the session on the International Society of Stem Cell Researchers' Guidelines for the Conduct of Human Embryonic Stem Cell Research (pdf here) was quick to tell the audience that Yamanaka had made statements to the effect that his cells were years away from being used in research. I worry that he might be under pressure from the pro-embryo-destruction team.

Insoo Hyun, the moderator for the oocyte donation session, was the chair for the ISSCR subcommittee on obtaining "materials." and led that session at ASBH.

They said that there's a lot of pressure from the international community, as well as some in the US, for Wisconsin to stop regulating their patents. There were also strong remarks about the lack of a call to share intellectual property and materials in those NAS guidelines.

(Edited 11-1-06 to correct Dr. Zoloth's first name.)

Texas, UK, ethical stem cells, "artificial" livers and biased reporting

I cannot imagine why anyone would take the news that livers have been grown from umbilical cord blood cells and turn it into a story on human embryonic stem cells. But, someone did.

Last year, we learned that UK scientists, in collaboration with researchers from the University of Texas Medical Branch at Galveston used NASA technology to produce embryonic-like cells from umbilical cord blood cells. Later, Dr Nico Forraz and Professor Colin McGuckin of the UK announced that they had been able to induce these cells to differentiate into liver cells. Now, they've been able to grow the cells into "tiny livers."

From the Scotsman.com in the UK,

Using some of the skills they obtained at NASA they were able to produce the miniature livers. These can now be used for drug and pharmaceutical testing, eradicating the need to test on animals and humans.

Professor McGuckin said the transplant of a section of liver - grown from cord blood - could be possible within the next ten to 15 years.

However, he said a full transplant using a liver grown in a laboratory is decades away.

Professor McGuckin said the use of mini-livers could prevent another Northwick Park Hospital disaster, where six human guinea pigs almost died after taking an experimental drug.

"We take the stem cells from the umbilical cord blood and make small mini-livers. We then give them to pharmaceutical companies and they can use them to test new drugs on", he said.

"It could prevent the situation that happened earlier this year when those six patients had a massive reaction to the drugs they were testing."

Professor McGuckin said this development could also mean the end of animal testing.

The ability to grow these cells into functional tissue is fantastic news. It will make Dr.Forraz and Professor McGuckin wealthy, even if it's only used for testing drugs. If the tissues are developed into transplant-able organs, the wealth will be spread to the thousands across the world who suffer from liver disease.

I believe that the time estimate is far too conservative. Scientists have not learned what Ray Kurzweil has urged them to learn: the time from one discovery to the maturation of its use in human medicine and homes is much shorter than it used to be. These men and women need to learn to think in terms of months to years instead of decades.

However, for some reason, the last third of the article in the Scotsman went off on a tangent, lauding embryonic stem cell research. The article flatly states that embryonic stem cells can be differentiated into tissues and organs.

It's not happening as fast as in non-destructive "adult stem cell" research.

International Oocyte Trafficking Has Begun

The British Journal of Obstetrics and Gynaecology has an article by BC Heng (abstract is here) detailing the practice of obtaining oocytes ("eggs") from women in developing countries. Heng supposes that not only the women more susceptible to financial pressures to "donate" their eggs, but the fact that the drugs to induce superovulation are cheaper in these countries. Since eggs don't freeze and thaw as well as embryos do, the sperm of the intended father is shipped to the foreign country, the egg is fertilized and the embryo is frozen and shipped to the intended mother.

The "need" for human eggs may make all past human trafficking look benign, with camps of imprisoned young women and girls, all undergoing hormonal manipulation and surgery.

ASBH Final Day: Hurricanes, Feminists, and more Public Health Ethics

"Religion and Reproductive Freedom" was presented from a feminist bioethics view on Sunday, the final day of the American Society of Bioethics and Humanities annual conference. I'm fairly sure that no one else noticed the irony. The predictable results are discussed below.

Throughout the conference, I tried to attend presentations by Texans, in order to get to know other bioethicists in my State. I followed through on Sunday morning even though there were so many sessions that I wanted to attend, from ""Genetics," to "Rethinking Rights in Bioethics." Choosing between "Donation after Cardiac Death: Revisiting Ethical Uncertainty in the Face of Public Acceptance," and "Bedside Meets Boardroom: Organizational and Professional Dilemmas When Admitting and Discharging Patients with Inadequate Psychosocial and Financial Resources" was the toughest. However, the latter covered immediate, real-time work in which I can affect policy and I know at least one of the presenters.

Representatives from the M.D. Anderson Cancer Center (in Houston) reported about the conditions in that facility after Katrina and during the evacuations of New Orleans and Houston a year ago were both encouraging and alarming.

Far too much of the Houston medical complex is at sea level and in the flood plain. We were urged to join efforts to coordinate emergency response efforts on local, State and Federal levels and to be honest with the public about the limits and realities that we might all face in times of disaster.

One speaker warned that we should be prepared - and warn others to be prepared - for large-scale emergencies. It is necessary to strengthen and adapt homes, hospitals and other structures to withstand and survive floods, extremes of weather and, as much as possible, crises brought on by terrorism. The speaker is convinced that in the case of the more catastrophic events - such as level 5 hurricanes, an influenza pandemic on the scale of 1918, or the successful deployment of bioterrorism or weapons of mass destruction, there may come a time when each family will need to care for ourselves for a few days or weeks, and for the possibility that "no one is coming."

(From me: At the least, be familiar with such advice as is available online. Take a look at the Red Cross Family Disaster Planning information. You might also consider beginning to store up water and food that doesn't require gas or electric power or much water to prepare, etc., and keep the supplies current. All those solar chargers bought before "Y2K" don't seem such a waste anymore.)

The "Religion and Reproductive Freedom" session was typical of the major problem of the conference: too little time for the material presented and for the Q & A. That, and I was unable to get my questions in the public discussion, due to the fact that the men were more assertive and were recognized almost exclusively (I think only one woman was recognized) by the speakers. (More irony)

I wasn't surprised by most of the content of this session, but I was surprised that - like my Rhode Island friend - at least 2 of the presenters seem to have never actually had a conversation with someone who is pro-life. (Or, as they called us, "the religious right." As in contrast to the "progressives" and the "religious progressives.")

Every one of us who has had an actual discussion - or read one on the internet - between "pro-choice" and "pro-life" advocates could have predicted the stereotypical content and direction of the presentations by Carolyn McLeod, Ph.D. and Laura M. Purdy, Ph.D.:(summarized, by me, from my own perception) "Abortion must be allowed, those ignorant, oppressive and oppressed religious people don't want us to have abortion, they are dangerous, we are enlightened, the doctors and pharmacists could have chosen a different career," etc.

In contrast, the other two presenters have evidently met some religious people that aren't dangerous, although unfortunately, (again, in my own opinion) their perceptions are based on the degree of acceptance of abortion by those who identify as religious.

Neither of the two women named above were amused by my comment that I had been "grandmothered" into a world where I am a doctor faced with the constant challenges to my belief that human life begins at the beginning of biological development: the single-celled zygote.

I was surprised to hear Dr. Purdy refer to the Bible, while repeatedly noting that she is not very familiar with it. As I told her, I would be embarrassed to use a reference that I had not studied enough to (at least in my own mind) understand.

Dr. McLeod, who questioned the "Value of Conscience," when medical professionals refuse to participate in abortion, was not happy with my objection that I have an informed and educated conscience, and that I have faced the challenges through the years by educating myself and thinking them through. It was at this point that she began to say something about "Bush, . . ." I interrupted her to make my point (again) that I make my decisions and choices, that I have been a doctor longer than George Bush has been President, and that I, and no one else, have made my "choices."

I regret the interruption now, I wish I knew how Dr. McLeod would have continued. As I told her, I'm "comfortable with dichotomy," and prefer to research each of my positions and to make informed decisions, and that I attempt to make sure that these decisions are guided by science and empirical evidence. Unfortunately, she needed to catch her plane.

It's a shame when caring, passionate people cannot discuss such vital issues without stereotypes, name calling, and with no possibility of empathy toward the other's viewpoint. I believe that Drs. McLeod and Purdy and I truly wish to protect women from harm. We have very different conclusions about abortion and the children who are placed at risk by so many "reproductive healthcare" practices. We probably can't change the minds of our opposites. However, I do believe that we could find common ground on the protection of women, children, and the more helpless around us.

Did anyone else notice how much of the conference dealt with Public Health Ethics and disasters that threaten lives? It's time to consider that bioethics covers more than abortion, euthanasia, and embryonic stem cells.

Day 3 ASBH: Chimeras, Public Health, and Bioethics Bloggers

We also had the annual Member's meeting, where our new President, the bioethicist for Planned Parenthood and NASA, Paul Root Wolpe,Ph.D., gave his first official speech. Unfortunately, this speech (like many talks this week) was full of political and ethical bias. I'm not sure how to take the President wondering why there are so few members from the right, immediately following a tacky, political remark about the motives and tactics of the right.

One of the most interesting and concerning sessions today covered the pros and cons of chimeras of humans and other animals, using human embryonic stem cells in "nonhuman primate blastocysts and embryos." My biggest concern is the risk of infectious diseases that result from the mix, but there is the ethical problem of creating feeling creatures that share DNA and possibly some physical or mental characteristics of humans. The latter is slim within the near future, but it's just a matter of time if science fiction and human history proves true. I am not afraid of new sub-humans so much as I of the old subhumans who currently exploit, enslave and hurt humans and who, history teaches us, would do the same to the new creatures that might be created. I was glad to hear a question from the floor that was similar to mine.

We also heard a "Work in Progress" discussion about planning for pandemics or limited epidemics, similar to that in Canada, where about 170 people had SARS. The particular point of the researchers is how to compensate/reward those who must be "constrained" or quarantined because of their disease or exposure to the disease, in order to control the spread. A novel way of looking at each of us and all of us as "embedded" in an ecology of microorganisms was used to demonstrate that we may be vectors of disease as well as victims. I did like the point that the presenter made that it is important to discuss these scenarios not just as though other people will get sick, but to remember that we might, too. We need to call on the personal: how would we want to be treated?

At the end of the day, about 10 bioethics bloggers and would-be bloggers sat down to talk about what we are doing and the impact we hope to have. The consensus is that we bloggers are the cutting edge of information about bioethics and science. Watch this page!

Texas T-cells trained to kill viruses

Texas scientists have developed a method to extract virus-killing "T-cells" and induce them to attack 3 types of viruses, cytomegalovirus, Epstein-Barr virus, and adenovirus. The cells can then be placed back in the body of the original patient.

This technique is useful in the care for patients after bone marrow transplants, when the patient is especially susceptible to infection. T-cells are a group of white blood cells that help fight infection, especially viral infections. Most of us would never notice these infections or become only slightly ill with "Mono," a "stomach bug," cold symptoms, or "pink eye" before our own T-cells learned to attack and control the multiplication of the virus. In transplant patients, however the infections are life-threatening.

(In fact, the next time you donate blood, look at the report you get back: most adults are "CMV positive." Their blood will not be used to transfuse CMV negative pregnant women, immunocompromised patients or sick children, but is not a problem in most adults.)


Science Daily reports on the success of researchers at Baylor College of Medicine, The Methodist Hospital, and Texas Children's Hospital in Houston, Texas in developing the technique resulting in Trivirus-specific cytotoxic T lymphocytes (CTLs).

"Not only were patients prevented from getting these infections after transplant, but those patients who had infections responded to the T-cell therapy and did not require any other treatment," said senior author Dr. Catherine Bollard, assistant professor of pediatrics, immunology, and medicine at BCM and a researcher at the Center for Cell and Gene Therapy at BCM, Methodist and Texas Children's. "To make dramatic recoveries like these was really quite something."

The research team drew cells from bone marrow donors and "trained" T-cells to target the three viruses before injecting them into transplant recipients.

"Drugs only control the virus. They don't cure the underlying problem," said Bollard. "Whereas by introducing these specialized T-cells, we are fixing the underlying problem. Using your own immune system is preferable to chemical agents, which can have toxic side effects."

Although the CTLs must undergo further testing, the early results suggest the combination therapy to be more, cost-effective, and safe than traditional therapies and more practical than cell-based therapies that target EBV and CMV separately, both of which are carried in roughly 80 percent of all people. Adenoviruses are common viruses carried in all populations.

"There is no safe and effective therapy for patients with adenovirus infections at the moment, so if you get an infection after a transplant it becomes very problematic," said first author Dr. Ann Leen, BCM instructor of pediatrics at the Center for Cell and Gene Therapy. "So we trained certain T-cells to target this virus."

Bollard envisions one day extending the application of CTLs to other people with compromised immune systems, such as cancer patients undergoing chemotherapy. The therapy could also potentially be used in babies, who are more susceptible to adenovirus infections than other age groups.

ASBH day 2: Human rights and Public Health Ethics

Ever been the only conservative in the room? I can go one better: a woman from Rhode Island responded to my confession that I'm a conservative by saying that we should talk, since she'd never had a conversation with a conservative before and she wanted to understand how we think.

BTW, before I go on, I need help: I was told by one of the speakers that some proponents of human dignity defend the "dignity" of "stem cells" in the same way that they defend the dignity of "the impaired." Supposedly, in the discussion about the ethics of research on human tissue banking, some focus on the dignity of the tissue as separate from the infringement on the dignity of the original donor of the tissue. She could not give me a reference, but seems a bright young woman, so I wonder if anyone can explain where this idea could come from.


I guess I ought to explain how the conference is set up. Most of the day, there are 1 to 1 1/2 hour sessions with 5 or 6 different groups, consisting of 2 or 3 (up to 5) panelists who present a paper (or summarize a paper, if time seems short) on a given theme. The presentations are followed by a question and answer period. There's never enough time for the Q and A, so I end up asking my questions after the conference.

Today, I attended sessions on "Bioethics and Public Health Ethics" and "Human Rights and Human Dignity: Curb your enthusiasm." Each of the sessions touched on the basic idea of human rights. And each seemed to get the most bang out of political points: the Bush administration is abusive and against the bioethics Powers That Be.

In the first, we were asked to consider the proposition that Public Health Ethics should be more concerned with the good of the community, rather than attentive to individual rights. After all, public health and most health care systems are public, community enterprises, and an activity of the State that relies on pooled resources and interdependence.

However, aren't Law and the Court system activities of the State, based on pooled resources and interdependence? And aren't these systems still governed by the fact that the rights of the individual are primary?

We also heard how inept the Bush administration was proved to be in the Katrina/Rita hurricane "debacle," although the panelist later stated that the basic problem was the failure to repair the levies and protect the people in the way of the flood. Somehow, the panelists believe that all political failures in public health policy began in 2001. There was no mention about the debacle that came from the redefinition of oral sex as not being "sex," for instance.

The second session was based on the deconstruction of a single term, "human dignity," and a rather confused discussion about human rights. In both cases, the presenters seem to believe that the Bush administration is responsible for attempting to foist an idea of the inalienable rights of human individuals.

Like Caulfield and Brown in this article, the presenters object to protection of human embryos and the children of the future as bearers of human dignity because the concept is not held by all and will not stand in a pluralistic society.

An interesting twist was the first presenter's statement that the proponents of human dignity include "stem cells." (see above)

Beliefs about which members of the human species are bearers of rights are not consistent throughout the world. Islamic nations do not hold that women bear full human rights: women are not protected from killing, enslavement, and are not allowed freedom of movement or ownership of property.

However, regardless of a lack of consensus, or more particularly in the case of disagreement, hasn't history shown that it is it better to support the wider classification of human rights in the case of all races, both sexes, all religious and political backgrounds?

The fact that some of the "dignitarians" and human rightists have expressed concern about the humanity of our descendents who are no longer members of our species was mentioned. I believe that this concern will complicate our efforts to protect the (negative) right to life.

Believers who hold that humans are created in the image of God base our argument for human dignity on our duty to Him for giving us life. If we are created, it's obvious that we and our children are not here because of our plan and efforts, but because of His. Those of us who are concerned about whether or not our children who are not of the human species are 'human" would do well to spend some time contemplating whether or not it is possible to divide the image of God.

Edited for typos at 11:30 PM CDT

Totalitarian bioethics and assumptions

The American Society of Bioethics and Humanities meeting is different from the medical and political meetings I'm used to. From what I can tell, the people who attend expect to participate in the Question and Answer period. They are actually more critical than doctors are at our meetings. And they don't necessarily ask questions. Sometimes they just give other viewpoints. I think I like it.

I attended one session consisting of members of one of the subgroups of the International Society of Stem Cell Researchers' Guidelines for Human Embryonic Stem Cell Research. I was surprised to hear old fallacies repeated: ESC's are immortal, Alzheimer's will be treated, "SCNT" is not cloning and appears to be the most promising line of research, etc. Unfortunately, the focus was not the actual morality of ESC research, but on the regulation and sharing of material and results.

Another session concerned "Biopolitics," a phrase coined by Michelle Foucalt to mean the possibility of science and medicine to become totalitarian tools of government. (See this post for another view) However, I believe that Professor Foucalt needs to thank Isaac Asimov and Robert Heinlein, along with many other Science Fiction authors who have explored the theme for nearly a hundred years. "Who owns your body?" One presenter discussed the effects of screening for spina bifida in the UK's government medicine when the only "treatment" was/is abortion. "Good parents will screen, good citizens will abort or recommend abortion."

If you're concerned about the assumptions of science and medicine in public policy, go to my website, LifeEthics, read my Mission and Vision and consider following the recommendations on becoming involved in bioethics, science and medicine as public policy. At the very least, take a look at the wider implications of bioethics - they go far beyond abortion and euthanasia. Let me know what you think!

American Society of Bioethics and Humanities Conference

I'm about to get on a plane in balmy San Antonio to fly to cold, snowy Denver for the American Bioethics and Humanities Conference. Hopefully, there'll be lots to write about while I'm there. At the least, I'll report on the discussions about the Missouri Amendment 2, celebrity ads and rebuttals, and what the bioethics gurus have to say.

Stand by!

"A more realistic light" on embryonic stem cell research

"Some folks are portraying this as imminently useful and it's not."

"This [experiment] shows the incredible potential of the field, but it also sheds a more realistic light on the near-future potential."

These are comments from scientists in Nature.com and the Globe and Mail of Canada that sheds "light" on the Parkinson's treatment experiment with embryonic stem cells that has been covered by JivinJehosaphat , MaryMeetsDolly, and SK at the LTI blog.

The Canton Repository mentions that this is similar to another (little publicized) report published October 11, 2006 (abstract only - does not mention the tumors) in the journal, Stem Cells, which showed similar results. In contrast, the Geron corporation (part of the Wicell/ACT/Geron stem cell connection that I wrote about here and here)representatives tell us that they have (unpublished) results using stem cells in spinal cord injury that do not cause tumors.

None of the articles on Goldman or Isacson (that I've read) mentions that adult stem cells have produced relief in human patients, without tumors, in spinal cord injuries, Parkinson's disease and Lou Gerig's disease.


News@nature.com covers the report originally published online in Nature Medicine (this is the abstract, the full article is available by subscription only) and explains the technique used to encourage the development of the dopamine-producine cells:

[Stephen Goldman, Ph.D.] and his team took human fetal midbrain tissues, in which dopamine cells are made, and extracted glial cells, whose normal role is to support and maintain the growth of neurons. They then cultured stem cells in this glia-rich environment.

"What we were really trying to do was to mimic the environment of the developing brain to increase the efficiency of dopamine-neuron generation, but also to bias the cells towards generating the type of dopamine neurons that we wanted," says Goldman.

The technique worked. When the new dopamine neurons were transplanted into the brains of rats with the symptoms of Parkinson's disease, the animals recovered almost entirely. "The positive results were really remarkably strong," Goldman says. "The animals exhibited almost a complete restoration of normal function."

But there could be alarming side effects. Each stem-cell transplant also contained cells that had failed to become neurons, and which remained undifferentiated. These cells keep dividing, and can turn into tumours, says Goldman. (The rats in the study were killed before any such tumours developed.)

The human embryonic stem cells were first grown in cultures of human fetal nerve tissues (harvested from human infants who had been aborted at 11 to 22 weeks of age), that had themselves been manipulated ("telomorase-immortalized") and selected for producing the "glial cells" that support the developemnt of the specific brain cells that produce dopamine. We knew from past experiments that transplants of fetal tissues cause tumors in the brain of experimental subjects.

The Globe and Mail's review, "A Sobering Set-back in Stem Cell Research," explains the experiment very clearly:

Twenty years worth of studies have tried treating Parkinson's with dopamine-cell transplants, in rodents, primates and people. In the 1990s, after a Swedish study found some benefit to patients who received dopamine-cell transplants from aborted fetal tissue, large human trials began in both Canada and the United States.

"These failed," Dr. Goldman said. "It made things worse; patients suffered movement abnormalities." In part, he explained, this was because the transplants contained all sorts of cells. Less than 10 per cent of the cells, and in some cases, less than 1 per cent, produced dopamine.

For this reason, Dr. Goldman, a neurologist and chief of cell and gene therapy at the University of Rochester, and many others, considered embryonic stem cells a possible source of growing only the cells that would be needed and they were right. But no one had been able to grow enough for a transplant.

In this experiment, however, Dr. Goldman and his team overcame the volume problem by tricking the embryonic stem cells into behaving like they were growing in the developing brain.

To do this, they harvested glial, or brain-support cells, from the precise brain region of an aborted fetus that would, at 11 to 22 weeks gestation, trigger the development of the dopamine neurons needed.

The researchers then used a retrovirus as a courier to deliver into the DNA of these cells a gene, known as telomerase, which would immortalize them. This way, Dr. Goldman explained, the support cells would continue to grow endlessly and continuously give off the chemical cues to keep stem cells maturing into dopamine cells.

The dopamine cells had first been grown from the limited number of human embryonic stem-cell lines that U.S. President George W. Bush made available to government-funded researchers in 2000.

Culturing the immortalized glial cells alongside the stem-cell derived dopamine neurons -- although not touching each other -- resulted in a growth of dopamine cells three to 10 times what is normally seen.

But Dr. Bhatia, who read the report, said this step might have contributed to the uncontrolled growth of the cells.

Comments on the experiment and where it went wrong focus on the known risks of transplanting fetal and embryonic stem cells and the need to isolate only those stem cells which are destined to become the exact dopamine-producing cells that were the desired results.

I keep wondering why the scientists don't approach the question from the other side: turn adult cells from the patient into precursors of the dopamine producing cells or activate the patient's own stem cells.

Umbilical Cord Cells for Retinitis Pigmentosa

From the October 19, 2006 "Stem Cell Express," early online publication of Stem Cells is more news about possible future use of umbilical cord cells for treatment of eye disease. Human stem cells from the umbilical cord and the placenta, mesenchymal stem cells, and skin fibroblasts were transplanted into,

. . . the subretinal space of the Royal College of Surgeons rat early in the progress of degeneration. Umbilical tissue-derived cells, placenta-derived cells, and mesenchymal stem cells were studied; dermal fibroblasts served as cell controls. At various ages up to 100 days, electroretinogram responses, spatial acuity and luminance threshold were measured. Both umbilical-derived and mesenchymal cells significantly reduced the degree of functional deterioration in each test. The effect of placental cells was little better than controls. Umbilical tissue-derived cells gave large areas of photoreceptor rescue; mesenchymal stem cells gave only localized rescue. Fibroblasts gave sham levels of rescue. Donor cells were confined to the subretinal space. There was no evidence of cell differentiation into neurons, of tumor formation or other untoward pathology. Since the umbilical tissue-derived cells demonstrated the best photoreceptor rescue and unlike mesenchymal stem cells were capable of sustained population doublings without karyotypic changes, it is proposed that they may provide utility as a cell source for the treatment of retinal degenerative diseases such as retinitis pigmentosa.(emphasis is mine)

Besides the significant hope that the research holds for those who are going blind from retinal degenerative disease, I noticed some other points about the report.

First, the report was received in May, 2006 and accepted October 13, 2006 and is included in the next issue. The time line seems very fast for peer-reviewed journals, but I encouraged by the trend to publish online in advance of the "dead tree" printings and hope that we will see more rapid dissemination of cutting edge research. I do wonder whether the widely publicized research by Lanza's Advanced Cell Technology influenced the timeline, however. Unfortunately, this report did not receive the same media attention given to Lanza's embryonic stem cell research on macular degeneration.

Risks of egg donation - new research

Approximately 3% of women who undergo egg stimulation and treatment will develop severe ovarian hyperstimulation syndrome. 1% will have pain that requires hospitalization.

The risks of egg donation is the subject of a newspaper article in the Kansas City Star, in anticipation of the vote in November on stem cell research.

Of course, the focus of much of the debate is on the ethics of embryonic stem cell research. Embryonic stem cell research requires that embryos be destroyed and in order to study and produce human embryonic stem cells. In order to get human embryos, you need human oocytes or eggs.

Most of us probably know at least one woman who has undergone the hormone treatments to stimulate egg production. The series of shots reset the menstrual cycle and cause the woman to produce more than the usual one or two eggs. The hormones can have side effects that can range from uncomfortable to life-threatening. Ovarian Hyperstimulation is one of the side effects and can be mild or it can cause fluid build up in the lungs and abdominal cavity, and a risk of blood clots.

Retrieval of the eggs is normally done transvaginally. A laparascopic needle is placed into the pelvic cavity through the wall of the vagina, in order to get to the ovaries where the eggs are.

Because infertility treatment and especially in vitro fertilization and embryonic research has not been federally funded - and because the whole abortion/women's rights/compassion for infertile women conversation is a touchy political issue - there is also very little oversite and even less formal reporting of side effects and complications.

Since there's little reporting, there's not much information available in the medical literature about the risks. However, there is finally information on the short term effects, even if none on the long term effects, yet.

A prospective cohort study (the patients are identified in advance and followed through the study period) of over a thousand women who underwent oocyte retrieval (OR) in Germany has been published on line at Human Reproduction, (in advance of actual printing in the dead tree version). The abstract, or outline is available for free on line. Here's the results:

RESULTS: A total of 1166 OR were performed during the study period, of which 1058 (90.7%) ORs were included prospectively. Incomplete data meant that the remaining 9.3% were excluded. No complications were caused by sedation or general anaesthesia. Vaginal bleeding was observed in 2.8% of procedures, without any cases of intra-abdominal bleeding. An injury of pelvic structures (a ureteral lesion) occurred in one case. No case of pelvic infection, but one case of unexplained fever, was observed. A severe ovarian hyperstimulation syndrome (OHSS) occurred in 2.7% of cases. Although most patients tolerated the OR well, 3% of patients experienced severe to very severe pain after the OR and 2% of patients were still suffering from severe pain 2 days after the procedure. The pain level increased with the number of oocytes retrieved. About 0.7% of patients required hospitalization for pain treatment.

Resource:
Ludwig, AK, et. al. ”Perioperative and post-operative complications of transvaginal ultrasound-guided oocyte retrieval: prospective study of greater than 1000 oocyte retrievals.” Human Reproduction, Advance Access published on July 27, 2006.

Should the US be more like France?

National Review Online gives us an editorial written by Dennis Boyles about the difference between the United States and most of Europe when it comes to abortion and stem cell research.

Abortions are limited or illegal after the first trimester in much of Europe, and there's even a discussion about pulling the UK's limit back from 24 weeks to 22 weeks or earlier. Laws in other countries forbid or limit abortion according to the weeks of gestation:

France: 12 weeks
Germany: 12 weeks
Italy: 13 weeks
Sweden: 18 weeks
US: limits after 26 weeks
Australia: No limit

While the US has no national laws that ban any sort of embryonic stem cell research or cloning by Somatic Cell Nuclear Transfer (SCNT), most nations in the world has laws to forbid any cloning at all for research and few allow destruction of embryos for research. France, in particular, forbids SCNT and only allows research on embryonic stem cells from donated embryos. The European Union actually tightened their policies this summer.

From the NRO article:

When the issue of stem cell research came up before the EU last July, Germany and Austria led the effort to impose common-sense restrictions, as the Daily Telegraph reported. Elisabeth Gehrer, Austria’s science minister, asked if the EU really wanted “300-400 fertilized human embryos to be destroyed to create stem cells? This destruction of human embryos to create stem cell lines is not something we can support. We do not want community money, which includes Austrian money, to support this.”

Gehrer’s comment was reported under a wistfully misleading headline and lead in the International Herald Tribune, which also quoted the EU’s research commissioner: “[The EU] will not pay for the destruction of embryos with EU money,” he said. This was echoed by Germany’s research minister, Annette Schavan, who told reporters, “The protection of human dignity, the right to life, need to be properly entrenched. There should be no financial incentives for the destruction and killing of embryos.”

Calorie Restriction: Living longer or it just seems that way

On a lighter note.

Betterhumans, a page devoted to research and study on making humans live longer, run by Ray Kurzweil (I think, it's hard to tell, but many of the posts are attributed to him) has another article referencing calorie restriction, with a possible explanatory mechanism.


My question, as someone who believes that an allergy to chocolate might not be compatible with life, is "why"?

However, it's worth looking at the site every so often.

The most negative campaign ad ever

There ought to be daisies.

Art Caplan posted the YouTube version of the most negative campaign ad I've ever seen, over at the blog.bioethics.net site.

The ad has three people, telling us about their future with disease.

Notice:
Each uses the phrase "stem cells," without specifying what kind of stem cells.
None of them predict that they will die.

The little girl will probably be old enough to vote herself before any embryonic stem cell is used in humans -- if the ever are.

Measuring a Universe without God

Richard Dawkins was the guest on the second hour of Science Friday on October 6, 2006. The Dawkins interview follows a series of interviews with United States scientists who are this year's Nobel Prize winners in Physics, Chemistry and Medicine or Physiology.

I love this stuff: the discussion of basic science, finding patterns that explain old discoveries and new discoveries that offer ever more questions. Add in brilliant people speaking clearly and I'm just like a kid with a present. (Or "in Heaven.")

I don't normally discuss religion so obviously on this blog, but they started it. . . .

I have not read it yet, but Dr. Dawkins was interviewed in order to review and discuss his most recent book, The God Delusion. The book was written with the expressed purpose of proselytizing readers to atheism - although, in the interview, he denies that atheism is or can become a religion. He does speak of what he and others call a "war" between those with faith and those without, or between those who believe in a Creator and those who do not. I would think that he would see the correlation.

During the first hour, a caller asks about what we know about the conditions or what existed before or "on the other side" of the Big Bang. Dr. Dawkins speaks of measuring the universe with a God vs. a universe without a God.

These are different versions of the truly unknowable, unanswerable question, at least until we are able to leave this universe or become super-natural to the nature we know and live in.

How could we measure the universe in such a way as to discriminate between the variable of the existence of God?

Currently, as I've said before, we're the only ones having this conversation, so our discussion is necessarily limited to observations drawn using our own tools and senses. We might be able to draw better conclusions if we found another world with other beings having the same conversations.

My capitalization of the words "God" and "Creator" reveals that I'm a believer. In fact I am a Christian, raised (as my heroine, Scarlet put it) on the Bible, especially on John 3:16 and Romans 5:12.

My study of science and bioethics as a way to use what I learn in science as informed by philosophy and ethics is founded on a further belief that Romans 1 teaches that God reveals Himself by looking at and studying the Creation. There just doesn't seem to be a better answer to questions about the conditions on the other side of the Big Bang than that given in Genesis 1:1, "In the beginning, God..."

Science is properly understood by a believer as using what He gave us to draw conclusions about His Creation from what we can measure and study.

Both believers and nonbelievers agree that those studies should be repeatable in various labs by various observers.

To extrapolate ethics from either a study of history or thought experiments, as Dr. Dawkins seems to do, seems better informed by an understanding that we're not as we're supposed to be, while observing what we're striving to be. We can tell that we have a sense that things are not as they should be, because we keep writing books about what is wrong, and telling others how to be better.

The position that we want to be better, is supported by the fact that we *are* having these discussions. Dawkins must believe that it's better to be atheist than to be a believer or else why write the book, sell it on radio shows, and risk the discrimination to which he believes atheists are subject?

(It could be just that he can sell a lot of books. But still, all those extra universes just to sell a few books?)

Dawkins says that he is passionate about what is true. I am also. And I see this passion for truth as a reason to believe in the Creator: one Who would build us so that we seek truth, love one another, and Who is the source of ultimate Truth and Love. If He does love us unconditionally, it's not so surprising that He would want to become "Immanuel," or "God among us."

It's interesting that Dawkins believes that Jesus ("Immanuel") was a good person. And that he says that if there is a God, it would be very important to know Him.

Embryonic Stem Cell Review

The ethical, political, and financial commotion has overshadowed the field's scientific progress, which researchers say is accelerating.

Opening with the comment that the policy debate has dominated the discussion of science, The Journal of Cell Biology has a review article covering the current state of embryonic stem cell research (ESC), "The action behind the words: embryonic stem cell research marches on." (free full content)

The author, Mitch Leslie, claims that lack of funding in human ESC's in the US has slowed research in the field, but that progress is still rapidly increasing (both in the US and elsewhere). But the rest of us have been too busy with noting the fraud and discussing policy and ethics to notice the successes of the researchers that are doing what we don't believe they should be doing in the first place, much less that they should be doing it on our tax dollars.

There's a neat little table about the laws regulating ESC and somatic cell nuclear transfer (SCNT, the other term for cloning) in various countries. (opens in a new page) The US has no nation-wide regulations.

While telling us about efforts to clone human embryos, the author bemoans how difficult it is to obtain the oocytes or eggs to be used. (Remember, Wu Suk Hwang used over 2200 eggs.):

Now that the lost year is over, the group is trying to pin down the problems that impede SCNT. Murdoch won't reveal what obstacles they've identified, but one limitation has loomed from the start: a shortage of eggs. SCNT works best on eggs freshly removed from a woman's body. But Murdoch and colleagues found that, even if they convinced in vitro fertilization patients to donate spare eggs, they could only garner a grand total from all the patients of about 10 eggs per month (Choudhary, et al., 2006). The Harvard team plans to solicit egg donations from young, healthy women. However, the UK body that regulates ESC research has rejected on ethical grounds Murdoch's application to tap the same source. She plans to apply again. With good eggs scarce, researchers like her who have worked with in vitro fertilization have an advantage, says Murdoch. They are adept at coaxing star performances from a single, recalcitrant egg.

Meanwhile, the parallel research on human adult stem cells is also accelerating. But that's not the subject of Leslie's article. At all.

However he confirms what we know from other sources.

Embryonic stem cells require the distruction of embryos, reqire women to donate eggs and risk ovarian hyperstimulation, and are dangerous unnecessary, and not likely to ever be used AS *embryonic* stem cells in humans.

According to John Gearhart, director of research for Johns Hopkins University’s Department of Gynecology and Obstetrics.
. . . “We are going to use the information we get out of this research to get the patient’s own cells and work with them to get them to do what we want.” (Washington Fax, Novermber 19, 2002 - from Dr.David Prentice's website presentation on stem cells at DoNoHarm.


Embryonic stem cells will not be used for treatment in humans. They are not subject to normal immunity and can't be controlled enough to pass any reasonable standard for use in human beings.

Also, stem cells, after their first flush of growth in the embryo, are slow growing to dormant. Ever so often they make "forays" out of the bone marrow or are awakened by local conditions. They make copies of themselves - some of which are identical and some of which are farther along the developmental line and some move about looking for areas to repair - becoming part of that area. Then the excess either return to dormancy or die of old age.

Besides,in "real life," the stem cell "stimulating factors" (the best influences, catalysts, or determinants of stem cells) are only found - and are easily and reliably found - in the local site where they are needed.

The goal should be to follow the line of research on recruiting, stimulating and controlling the patient's own stem cells in his own body, where and when they're needed.

An Ethicist on Who Owns Your Body

For a look at the thinking behind the debate, work your way through Alta Charo's (she's the one who called Wesley Smith on his "human-centric" views and the rest of us in the right wing and pro-life community on our "endarkenment" at the conference on Bioethics and Politics in July. She's also a founding member of the Progressive Bioethics center with Moreno and Caplan.) essay and/or the audio interview in the New England Journal of Medicine. (free, online)

My opinion? Your body belongs to you. If the tissues were not removed with full consent, including fairly specific information that the tissue would be used in research, then it cannot be used without compensation and legal permission - again with full informed consent.

More on challenge to WARF patent (on human beings)

Okay, the patent being challenged is on the products of the destruction of human beings - embryonic stem cells.

The Scientist has an article by Cathy Tran outlining the objections to the patents. If nothing else, these objections put a lie to the argument that embryonic stem cells were only discovered in 1998, so we ought to let them have our taxes to spend.

It also illuminates the way the patents are slowing research on embryonic stem cells.

My problem? My (little "l") libertarian side is rooting for the challengers, and it has occurred to me that getting rid of the patents would mean an increase in the clamor for research.

Frankenbunnies, non-brain dead organ donation, cloning, and PVS guinea pigs

Isn't it amazing how many of the most controversial news and public policy issues revolve around bioethics and medicine?

I've noted before that all of the controversies (like those mentioned above, from the days surrounding the weekend of October 8-9, 2006) are actually only one: which humans will receive society's protection of the inalienable right not to be killed, enslaved or robbed.

Which is why it shouldn't surprise anyone that some prolife organizations are beginning to look more like bioethics centers. (See LifeNews' article on the increased focus on bioethics by one prolife group," Florida's "Respect Life.)

The entire field of bioethics has developed to make these decisions. Somehow, the most visible bioethics spokesmen and women in the mainstream media appear to agree that if it can be done, it should. The "First do no harm" ethic that has guided Western Medicine for over 2500 years has been abandoned in favor of pretending that humans are just another animal.

Because I am concerned about this change, I started "crashing" Texas Medical Association meetings, set my self a goal of one letter to the editor a week, lobbying in my State Capital and writing this blog.

I'd like to challenge every reader to write a letter to the editor of your local paper (keep it under 150 words), attend one civic or political meeting (just to get them used to seeing you there, if there's nothing concerning life issues on the agenda - but, I'll bet there's at least some infringement of liberty or the pursuit of property going on) and make it a point to attend and participate in any professional association or union you belong to, in order to make your voice heard when support for life, liberty and property is possible. Look into committees and interest groups. Join the Republican National Coalition for Life, the Democrats for Life, Libertarians for Life, Feminists for Life, or Not Dead Yet. (Wear their jewelry until we see little feet or the F4L stick figure as often as we see pink ribbons or yellow rubber bracelets!)

Now, go to work!

Plan B compared to withdrawal method

The British Medical Journal had a great editorial by Anna Glasier published earlier this month objecting to the false premise that Plan B will prevent abortions. Unfortunately, it's subscription only, but the excerpt is here. It's odd that the Brits are so interested in our Federal Food and Drug Administration.

More from that editorial:

Even if emergency contraception can work (is efficacious), the experimental evidence that it does work (is effective) is disappointing. Ten studies in different countries have shown that giving women a supply of emergency contraception to keep at home, so that they have it when they need it, increases use by twofold to threefold. In three studies that measured subsequent pregnancy rates, advance provision of emergency contraception increased its use but had no measurable effect on rates of pregnancy or abortion. When reasons for not using emergency contraception, despite having a supply at home, were documented three out of every four women said they did not realise they had put themselves at risk of pregnancy.

There's an equally great letter in response that's online, and free. The information about the emergency contraception, Preven being bought out and then removed by the manufacturers of Plan B is interesting, as is the statistic that shows that Plan B is no more likely to prevent pregnancy that the withdrawal method. Here's part of that letter:

Rapid Response

Re: Waking up to the morning-after pill

Ironically, within a couple of months the combined regimen, marketed as Preven, was voluntarily withdrawn from the U.S. market. Apparently, physicians did not appreciate that the combined regimen is twice as ineffective on an annual basis of perfect use when compared to the progestin-only regimen. With added irony, the withdrawal of Preven from the prescription use market received little attention, including from the American Medical Association, in stark contrast to the attention given to delays caused by the U.S. Food and Drug Administration concerning over-the-counter use of Plan B. The withdrawal was swept under the rug, and even the company website, www.preven.com, has now disappeared.

Yet what of the progestin-only regimen? In the United States, the prescription label for Plan B does not help us to answer this question. For, in an amazing sleight-of-hand, the label leaves doctors with nothing to compare it to! Specifically, the label presents annual use rates for traditional methods, but only the single use rate for perfect use of Plan B is included, not the annual use rate. To the unsuspecting, a single use rate of 89% may sound like a grand ("better than nothing") number. But little does one know that the relationship between single use and annual rates is exponential. For example, the 75% single use rate for Preven, when compared to the 89% rate for Plan B, implies a two-fold increase in annual rates (38 pregnancies per 100 women, versus 19). (3) So how could well-informed physicians have equated the two?

The plot thickens when we learn that the annual rate of pregnancy expectation for perfect use of Plan B, though available, was not included in the prescription label for comparison with traditional methods. It turns out that on an annual basis of pregnancy expectation, women can expect as many pregnancies from perfect use of Plan B (19 per 100 women in the first year of use) as they would from typical use of the withdrawal method! Notably, the same researcher, Princeton University professor James Trussell, had a hand in the publication of both of these statistics, and it was his work that the U.S. Food and Drug Administration had relied upon in making its decisions.

(emphasis is mine.)

Myths and Facts: Embryonic vs. Adult Stem Cells

I've been working on my previous response to The Alliance for Medical Research talking points on Embryonic Stem Cells. The new version can be printed on 2 pages, although I had to skip the references. Feel free to print and use, just be sure to send 'em to LifeEthics.org!

Regenerative Medicine Myths and Facts About Embryonic vs. Adult Stem Cells: Basic research vs. therapy that is applicable in patient treatments.

1. Myth – “Embryonic" means primitive or “early.”
Fact – Embryonic Stem Cells (ESCs) come from an embryo which is an organism in the embryonic stage of development.

2. Myth - The embryo is just a hollow ball of undifferentiated cells.
Fact - Embryos are complete organisms. The cells of an intact embryo are organized along an axis that is determined from the moment of fertilization. By the second or third division, the cells have committed to become the placenta or the body of the unborn child. ESCs are harvested from the second type of cells, and require the destruction of the embryo.

3. Myth - Adult stem cells (ASCs) have only been successful in treating diseases of the blood and bone marrow.
Fact - Over 70 diseases are being treated or are in early trials in human patients using adult stem cells. These include blood and bone marrow diseases (sickle cell anemia and other genetic blood diseases, leukemia, and lymphoma), bone marrow loss due to cancer therapy, autoimmune diseases (Rheumatoid Arthritis, Lupus and Multiple Sclerosis) and for corneal transplants grown from a patient’s own stem cells. Dr. Carlos Lima in Portugal reported improvement in patients with spinal cord injury. In the US, there are trials using ASCs to treat or cure genetic defects in metabolism and blood diseases, brain trauma in children (Dr. Baumgartner in Houston) and all of the above.

4. Myth - ESCs weren’t discovered until 1998, so scientists need more time and money to catch up with the 40 years of adult stem cell research.
Fact - James Thomson’s patent on all ESCs is being challenged on the grounds that his success in obtaining a human ESC line in 1998 was simply an outgrowth of over 25 years of research in labs all over the world.

5. Myth – Research on ESCs holds more promise than research in adult stem cells to discover the causes of disease, and to test drugs on human tissues.
Fact - Animal models and non-destructive human stem cell techniques are being used in all of these ways as well as in actual applications for therapy for human patients, without the ethical controversy.

6. Myth - ASCs offer less hope than ESCs because they are hard to find, are scarce, and can only become one type of cell.
Fact – ASCs are much easier to obtain in quantities large enough for research and therapy than ESCs. Most tissues have been found to contain stem cells or to be regenerated by stem cells from the bone marrow and other depositories. We are discovering stimulating and recruiting factors, as well as other conditions that can induce adult and umbilical cord cells to reprogram and multiply, both in the lab and in the body. Every day, the umbilical cord blood of thousands of babies is thrown away.
The research on guiding the development of all types of stem cells requires specific environments, nutrients and stimulating factors. Our knowledge and ability to obtain desired stem cell lines and the volume of cells needed for use in human patients is becoming more advanced and efficient in animal models and in human non-embryonic stem cells. Researchers have reported several ways to obtain “embryonic-like” or “pleuripotent” stem cells from a patient’s own adult stem cells and umbilical cord blood, without the need to create and destroy an embryo.

7. Myth - Embryonic stem cells are better for research because they can become any cell type of the human body.
Fact - ESC are proving hard to control, cause tumors, differentiate into cell lines other than the ones desired, and developing genetic mutations more often than ASCs as they divide. ESCs have only been used in animal models because they have proven difficult to control. Embryonic/fetal stem cells in animal research cause tumors 20 to 75% of experimental animals. The California Initiative for Regenerative Medicine released its strategic plan in early October, 2006, which states that no human therapies or trials in humans using ESCs can be expected for 10 to 15 years.

8. Myth - Embryonic stem cells will only come from fertilized eggs left over from in vitro fertilization or from Somatic Cell Nuclear Transfer (SCNT), which does not involve a sperm or fertilization.
Fact - All human embryonic stem cells require the destruction of a human embryo, whether that embryo began by in vitro fertilization, parthenogenesis, or SCNT.
Some researchers are currently making new embryos for the production of ESCs by in vitro fertilization in order to study specific diseases and certain characteristics. Others are attempting to make embryos by SCNT or cloning, which no one has been able to do in spite of thousands of human eggs from hundreds of women used in the attempt. All are inefficient and will require perpetual donation of endless numbers of oocytes that must be derived from thousands or millions of women, with the hazards of superovulation.

Definition of embryo from the International Society for Stem Cell Research Guidelines (Draft, Summer, 2006):
Embryo: The term “embryo” has been defined and used differently in different biological contexts. . . . However, the nomenclature has now been used generically by modern embryologists to also include the stage of first cleavage of the fertilized ovum onwards to nine weeks of gestation in the human and to term in the mouse. Two, four, and eight cell stages, the compacting morula, and the blastocyst are all more precise terms for pre-implantation embryos.

Will they be human?

There was a discussion this weekend on FReeRepublic.com on eugenics. It always amazes me how determined some of our ancesters were to breed "fitter families," how few people know the history of eugenics in the US, and how quickly the conversation ends up at the question about the children who might be produced who are not Homo sapiens: "Will they be human?"

This is a question that can't be answered "yes" or "no" without bringing in morals, philosophy and even religion. No longer will it be sufficient to rely on species definitions, as prolife activists often do now. We should have our answers ready for those who already define "person" according to a set of qualities and abilities, that seems to become more specific each day so that more and more members of even our species are discriminated against when it comes to qualifying for protection from harm by other members of our species.

(Personally, as a Christian, I'm convinced that all of our children, both those in our arms and our children of the future, are human, even the ones who may not be Homo sapiens. For those who believe in the Creator, it should be simple: you can't divide the image of G_d.)

My husband joked about breeding the short people (his term: "squatty bodies") out of the family by marrying me back when we were teens. There's a case to be made that there is nothing wrong with looking at and considering how to help our children, as long as no one dies for it.

( As a moral issue - proven to be correct by social science - I do believe that it's best for the family and the children for procreation to take place within marriage of a man and woman. As a practical matter, isn't the fact that such a large proportion of our children are being raised outside this traditional family a form of accidental, social eugenics?)

The good news is that no one has ever been able to clone a human being that lives beyond the first few cell divisions. The bad news is that Hwang of South Korea used over 2200 human eggs, that the attempts are ongoing in the UK and at Harvard. Probably in California, Wisconsin, Pennsylvania, New Jersey and Texas, too. Who knows? The next "tweak" to the science may be the key to allowing New Jersey and California to open their cloned human embryo "greenhouses."

Each of these embryos that are created appear normal for one or two divisions. They are organized, with a top/bottom, right/left, front/back axes, just like the "naturally" generated embryo from in vitro fertilization.

Unfortunately, California's Proposition 71 mandates that $3 Billion go into "regenerative medicine," and that much of it go for cloning and embryonic stem cell research. And New Jersey law is written to allow the gestation of embryos, as long as no live person is produced. Now, let's see. What is the current definition of "person"?

The immediate, urgent, problem - is that children are being harmed at very young ages.

Beyond the life issue: we don't know what we're doing, because the basic research in animals was not done first.

Instead, scientists and doctors rushed to be the first to publish, and justified much of what they have done by appealing to our compassion. It's hard for the most pro-life mother or father to protest actions that are sold as giving other mothers and fathers the children they so desperately crave.

The result: hundreds of thousands of the brothers and children of these children who are now in their parent's arms, are themselves in frozen limbo. They were created in harm's way, and are coveted by researchers who would disassemble them for their parts.

However, there are thousands of children who were begun by IVF. They are just now beginning to have children of their own.

From time to time, we hear some debate about whether to allow research that might change the genetic inheritance that will be passed on to the children of these children. Since the research is largely unregulated - and has never been paid for with federal funds - some private labs and universities using private funds are going ahead with attempts to change the germ line of embryos. Two examples:

1. The little boys born from intracytoplasmic sperm injections, a technique that places sperm that can't swim in the cytoplasm of the egg, are turning out to have immotile sperm themselves.


2. There are at least 15 children who have two mothers: the woman who bore them had defective mitochondria in the cytoplasm, so the embryos created from her and her husband were fused with an egg that had had the nucleus removed.

PBS "Innovations:Miracle Cell" Program

Tonight in San Antonio, PBS carried the show "Innovation," Episode 6, "Miracle Cell."

It looks to be about 2 years old, before Christopher Reeve died, but after Lima had done surgery on the two women from Texas. Every story in tonight's episode was amazing coverage of adult stem cell therapy. We see mice who regain function after nerves are cut, we see human women with chronic, long term traumatic spinal cord injury who get some improvement ("You have no idea how great it is to be able to tell when you need to pee."), heart attack and patients with traumatic heart injury and lymphoma who appear to be cured.

However, the website has one page on these stories while the main page and several others push embryonic stem cell research. Someone please explain the skewed coverage.

I'm not sure when it will air in the different markets, but it's worth setting your TIVO, VCR, or searching the TV listings for.

http://www.pbs.org/wnet/innovation/about_episode6.html



--

More on Adult Stem Cells, Arthritis, Multiple Sclerosis, etc.

Metaphor warning!!! The end of this report involves simplistic analogies to explain something I barely understand.

Yesterday's blog was my attempt at understanding and "simplifying" the information in the review article in the journal, Rheumatology concerning using a patient's own bone marrow stem cells to treat Multiple Sclerosis, Scleroderma, Rheumatoid Arthritis, Lupus and other autoimmune disease (AD).

I've read the report again as well as other references from that Google search, and some of the points I didn't understand are a little more clear.

For the most part, the cells that are killed by the radiation or chemotherapy in preparation for the stem cell transplant are the cells in the body that are actively dividing cells at that time. Those cells that are not dividing, either because they are dormant (asleep or inactive) or because they are mature may not all be destroyed. The grown up, matured white blood cells in the lymph nodes may survive and can be the cause of relapse, later on.

In other words, not all of the immune system is killed or "ablated."

In fact, if all the old immune cells were killed, we wouldn't have to worry about rejection of transplants, at all -- there wouldn't be anything around to reject it.

The review article explains that some of the cells and antibodies that cause the trouble in AD are still present and measurable after the stem cell transplant. In fact, it's these factors that seem to cause a relapse in those patients who get sick again. There are lots of theories as to what is happening in the 1/3 of the patients who do not get sick again. There's probably several different mechanisms and processes going on.

I believe that the ultimate result of the research will be the identifications of some chemicals, proteins or "factors," or perhaps a certain type of (adult) stem cell that can then be manufactured or grown in the lab and given to the patient. In that case, there won't be the need for the dangerous chemotherapy, radiation or bone marrow transplant, at all.


Think of it this way: the house has some bad paint that's actually eating away the wood and letting the windows leak and we're afraid the whole thing will colapse. We sand blasted away all the paint we could see, but there is some paint in a few cracks and between the boards that may or may not affect the new coat of paint. We know those spots can cause the new paint to bubble or peel, but we don't know how to get rid of them without damaging the house beyond repair. We hope the researchers will come up with a magic paint that will let us skip the scraping, sandblasting and repainting all together. We want to be able to spray one wall of the house in order to get the old paint to look like new and protect the house from any more damage.

In the meantime, we'll do the hard work required to protect the wood of the house as best we can and try not to poke any permanent holes in the walls.

Revealed: No embryonic cures for 15 years

The "California Institute for Regenerative Medicine"(CIRM), the $3 Billion drive to support embryonic stem cells and cloning that the California voters were duped into voting into place under "Proposition 71," has published its proposed strategic plan (available as a pdf here).

The Mercury News (San Francisco Bay Area, California) reports that the draft plan cautions that no cures will be available for 10 years. One leader believes that it's closer to 15 years.

But the plan -- which must be approved by the institute's board -- cautions that stem cell science remains in its infancy and that much of the agency's time, energy and money will be consumed trying to understand the cells' basic biology. Consequently, the plan concludes, the institute will still be doing early-stage studies on potential treatments by the time its money runs out in about 10 years.

Zach Hall, the institute's president, said he and others who developed the plan were extremely careful about wording it so it set obtainable goals that didn't unrealistically raise the public's hopes.

``One of the points really is to try to educate people about what a long process it is to get any `therapeutic' approved,'' said Hall, who predicted it might take 15 years before the institute's research results in a medical product.

Given the political sensitivity surrounding human embryonic stem cells, which are the institute's main focus, he added, it is essential that the agency avoids rushing to commercialize a treatment that later turns out to be unsafe.

``That would set the whole field back,'' he said.(emphasis mine

Please note that the Institute's president is more concerned about the field of research than about harm to patients.

The story mentions three studies on "the feasibility" of beginning trials in humans. One study uses fetal stem cells from aborted infants and all three studies have parallel research in adult stem cell therapy that is already ongoing, two of them are being used, today, in human subjects.

Adult Stem Cells in the Treatment of Autoimmune Disease

There is a review article in the October issue of the journal Rheumatology covering successful and improving treatment of autoimmune diseases such as multiple sclerosis, Rheumatoid Arthritis, Lupus, and scleroderma. The abstract is free and (available here).

About one third of the patients have gone into remission. The original 7% mortality rate has decreased to 0 - with no deaths due to the transplants of bone marrow stem cells in the last 3 years. Most of the patients receive their own bone marrow stem cells.

[M]ultipotent mesenchymal stromal cells obtained from the bone marrow and expanded ex vivo, may exert a clinically useful immunomodulatory effect. Such cells are immune privileged and apparently of low toxicity.

In other words, the stem cells taken from the bone marrow of the patients are encouraged to multiply outside the body and then they are transfused back into the patient (the procedure looks just like a blood transfusion) after chemotherapy or radiation to kill the patient's remaining bone marrow and immune system, including the cells in the lymph nodes. The cells that are put back in are the patient's own and are not rejected, but they are able to "reset" the immune system so that it does not attack the nerves, muscles, joints and organs any more. There is real hope that the patients are cured, rather than enjoying a limited remission.

The most likely reason is that the white blood cells in the body that are making antibodies and attacking the patient's body are killed. However, the cells that are immature, the stem cells, have not learned to make those antibodies or to attack the patient's body. So the patient starts with a fresh immune system. (They probably need all new immunizations for tetanus, measles and mumps, etc, too.)

Unfortunately, we don't understand why the body turns on itself in the first place, so we can't say that these patients are cured. Perhaps the tendency is there in the new immune system and will show up at a later date. There's also a worry that if the cause is a virus, the patient will become reinfected or that some of the virus was "hiding out" (that's my own term, not a scientific one) somewhere besides the bone marrow or lymph nodes of the patient and will become active again.

Still, a treatment that slows or lessens some of the pain and organ damage for these patients is worth persuing. The lessons we learn about the immune system as we monitor them is an added bonus.

(And no human embryos had to die for the treatments!)

There is information on the Phase III trial in Europe and Australia in patients with scleroderma at http://www.astistrial.com/ There's more information through a Google search for "autologous stem cell transplant Autoimmune Disease."

Stem cell patents are in the news

The agency that holds the patents on stem cells, WARF, has made a deal with the State of Wisconsin to wave the (disputed) patent licencing fees for companies in Wisconsin. The Governor of Wisconsin announced offerings of all sorts of deals to companies that move/start up in Wisconsin.

Makes investment in embryonic stem cell research less profitable for Texas and other states unless they're willing to fight the patents or subsidize industry to the same extent by paying for the licensing fees of any company that needs it. This is more reason to go the ethical route.

(Also sounds like cheating on the part of the incumbent Wisconsin Governor, the month before the election.)

Mice get the best medical treatments

The Cheerful Oncologist is one of the wise men in blogville, and he proved it again this weekend, commenting on a study on the effects of red wine in mice prone to an Alzeimher's like disease:

"Red Wine Slows Brain Cell Damage In Mice"

Why do mice always get to receive the newest advances in medical care? Don't these scientists know that myself and probably several of my fellow ScienceBloggers would gladly volunteer for perilous experiments such as this one?

and

Well, what's so amazing about that? You give most anyone a tumbler of Chateau Margaux for seven months, then take it away for three days and he'll figure out pretty darn fast how to get out of that maze and into the nearest saloon.

(Note: forgive me while I try to finally learn how to do "trackback" with this post. Some of the links may not work until I do. Nevermind.)

Scientific American: Cloning is inefficient

Okay, that wasn't the intended point of the Scientific American news article. While it should have been, the actual point that I think the authors here wanted to make (besides pushing embryonic stem cells, in the first place) was: Adult stem cells don't do as well as fully-differentiated White Blood Cells in SCNT experiments in mice.

Not really much new:

Cloning relies on a process known as somatic cell nuclear transfer, in which the nucleus of a donor cell is transferred into a fertilized egg that has been emptied of its chromosomes.

As I said, that's not news. We have further evidence that progenitor cells and stem cells don't work as well as adult, differentiated cells which don't work as well as embryonic cells in SCNT to produce blastocyts and birth.


The experiment was done in mice: no one has been able to get to the blastocyst stage in humans, yet. And, so far, we need embryos that will grow at least 4 to 5 days to get embryonic stem cells. (Even in ACT's supposed "ethical" method, where the embryos were killed even though the researchers swear they didn't have to.)

Embryonic stem cells succeeded 49% in SCNT. But, that won't be much help in grown-up, sick humans.

I didn't do all the math. But, 1368 white blood cell nuclei were transferred to enucleated oocytes: 34% developed to blastocyst stage - only 2 were born. Both died soon after.

1368 eggs. For only one leg of this experiment. Granted, these aren't human eggs and Hwang used over 2200 actual human oocytes.

At the end of the article is the part that is the most interesting to me:

Yang's team showed that cloning from such cells succeeded in 49 percent of attempts and led to 18 mouse pups. Of course, such embryonic stem cells are not available in adult patients, so being able to create them from regular cells is an important step. But mystery still surrounds the best way to clone. "We think that adult stem cells are more quiescent; we think that it's like a locked, closed door," Yang explains. "We think that differentiation is a way that opens some doors and makes it easier for nuclear transfer programming to go back into embryonic stem cells."

"We have some very encouraging data from an ongoing study that you can modify the status of cells and increase the efficiency of cloning," he adds. "If we modify the epigenetic status," that is, turning certain genes on or off, "it could be that you could increase the efficiency. This opens the door for a lot of different studies." The odds are that Dolly's genome came from a differentiated cell, but the quest for the best way to create cloned animals continues.

Please note that the emphasis is mine and that last sentence comes from the author of this "news" piece, not from the researcher, Yang.

As James Thomson said last month, if we learn to change which genes are turned off and which ones are turned on, perhaps we can learn to make embryonic-like cells that will form the tissue lines we desire, without ever forming or risking the lives of embryonic humans.