What We've Been Reading This Past Week

~ Stem-cell ‘tourists’ travel to where they have access to controversial stem-
cell therapies/ treatments.

~ Every baby born a decade from now will have its genetic code mapped at
birth predicts head of genomics company. Just because we can, does that
mean we should?

~ More docs tell pharma reps to keep out. Does this mean no more free post-
its?

~ Comprehensive reform bill that would have banned pharma gifts to docs voted
down in Colorado.

~ Experts say consumers should have more facts in drug ads so they can make informed decisions.

~ Glaxo to cut prices on drugs sold in poor countries. They will also invest
profits in building clinics in those countries.

~ The U.S. drug industry has shifted most of its clinical trials to overseas
sites raises serious ethical concerns.

~ U.S. court: No link between vaccines and autism.

~ Pfizer owes damages for bilking Wisconsin Medicaid.

~ EU governments have no right to conceal the location of field trials of genetically modified (GM) crops.

~ Men may be their own worst enemy when it comes to their health.

~ Women on the other hand …: Coffee drinking lowers women’s stroke risk. Ooooh, imagine a Starbucks ‘pharmacy’ on every corner …

~ BUT, too much soda can kill a girl’s kidneys.

~ Deadly bacteria defy drugs, alarming doctors. Is this an argument for or against anti-bacterial soap? You decide!

~ Llama’s have unique antibodies that one day might be used to treat immune system diseases in humans.

~ Scientists have unraveled the genetic code of the common cold. Spectacular!

~ Decoy molecules drive cancer cells to suicide.

~Altered virus effectively delivers new gene to replace faulty one that causes CF and completely rids the lung of disease. I wonder if these researchers have seen I Am Legend?

~ Researchers have discovered that the good bacteria found in dairy products might also be an effective vehicle for an oral vaccine that can provide immunity to anthrax exposure.

~ A new study indicates that a pneumonia vaccine can significantly cut the risk of heart disease.

~ Oh, Baby: A prenatal link to Alzheimer's?

~ Doctors have identified two genetic mutations that control the growth and
development of malignant gliomas; maybe good news for brain tumor patients.

~ Cotton candy as a substrate to re-grow vascular tissue.

~ Biotechnology's potential barely exploited.

~ Stimulus package includes funds for comparison of the effectiveness of
medical treatments.

~ President Obama to lift ban on embryonic stem cell research soon.

~ Scientists and doctors try to qualm public fears about vaccines and autism.

~ Scientists preparing to storm Capitol Hill on March 25 (a.k.a. the million
scientist march?). Registration ends Feb. 23.

~ No European stem cell patent for spinal cord repair.

~ Retired nurse invents cough, sneeze cover. Maybe she can convince the
airlines to make these standard issue …

~ FDA approves new and improved treatment for gout (the first in 40 ~years!).

~ But agency second guessing another …Savient gout drug faces approval delay.

~ FDA orders Bayer to correct earlier claims in Yaz birth control ad.

~ FDA deliberately backed off of "Good Laboratory Practice" requirements for
medical device makers.

~FDA wants one strain changed for next flu vaccine.

~ Orphaned baby chimpanzees cared for by humans in a loving, attentive manner have been found to be more cognitively advanced than some human infants. But, then, is this really that weird? They do share over 99% of our DNA.

~ Parody: FDA Approves Depressant Drug For The Annoyingly Cheerful.

[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is partially taken and edited. BioBlurb is a weekly electronic publication of the American Bar Association's Committee on Biotechnology, Section of Science & Technology Law. Archived issues of the BioBlurb, as well as further information about the Committee on Biotechnology, are available here.]

the lawful frame of the banks of stem cells in France

The conservation of the stem cells is an essential question born with the increase of the samplings of stem cells of the umbilical cord especially but equally placenta. In France, specific and strict rules exist in case of samplings of organs or of fabrics. To be able to reflect on the nature and the lawful system of the banks of stem cells, it is necessary to ask himself the question of the nature of the stem cells themselves.

The stem cell is an integral part of the human body because it is unity. It is unavailable, as the human body in his entire one, and cannot do the object of a bill of sale or the object of a contract of property right. The possible lonely act is the donation of stem cells.

This statute has a direct consequence on the nature of the banks of stem cells. They must have a public character and cannot be considered as vulgar stores of stem cells

Seen the lawful current French texts, a last question must be put concerning the appearance of new forms of banks of conservation: the mixed bank as the Virgin Health Bank creates by Sir Richard Branson. Can such a bank be established in France? We reply by the negative one.



In French;

La conservation des cellules souches est une question essentielle née avec la multiplication des prélèvements de cellules souches du cordon ombilical surtout mais également du placenta.
En France, des règles spécifiques et strictes existent en cas de prélèvements d'organes ou de tissus. Pour pouvoir réfléchir sur la nature et le régime juridique des banques de cellules souches, il faut se poser la question de la nature des cellules souches elles-mêmes.

La cellule souche fait partie intégrante du corps humain car elle en est l'unité.
Elle est indisponible, comme le corps humain en son entier, et ne peut faire ni l'objet d'un acte de vente ni l'objet d'un contrat à caractère patrimonial.
L'acte unique possible est le don.

Ce statut a une conséquence directe sur la nature des banques de cellules souches.
Elles doivent avoir un caractère public et ne peuvent pas être considérées comme des vulgaires magasins de cellules souches.

Vu les textes juridiques français actuels, une dernière question doit être posée concernant l'apparition de nouvelles formes de banques de conservation: la banque mixte comme la Virgin Health Bank crée par Sir Richard Branson.
Une telle banque peut-elle être implantée en France? Nous répondons par la négative.


To read the article completely, click on the title. Good reading to all!

The position of France regarding stem cells

France is a country that has come in a bit late into bioethics discussions, specially in the matter of new therapies. Regarding stem cells, whether adult, embryonic or other, France's position has not been all that clear.

The adult stem cells
While the debate about origin of the stem is not a major problem, (whether placenta, umbilical cord, or adult stem cells), we think, nevertheless, that it would be important to store the collection of adults stem cells (whether placenta, umbilical cord, or our fabrics) for easy availability, while preserving their multipotency and respecting autonomy of individuals. Their effectiveness is being newly revealed every day, whether by transplant, cell therapy or cotton candy .

The embryonic stem cells
A law passed in August 6 2004 relating to bioethics prohibits the research on the embryo. Consequently, it prevents the possibility of sampling of embryonic stem cells (stadium morula, blastocyste). The policies of France are contradictory, our lawmakers have chose not recognize or reconcile the laws for fear of accusations of hypocrisy (In fact, we think they wished not to go against the strong scientific lobbies fighting to obtain the authorization of the research on the embryo); for it is this same law that allows the importation of lines of embryonic stem cells into French territory, and such was the case after the entry in force of the law.

Otherwise says, the legislation of 2004 gives themselves good conscience close to landa citizens and inquiring doctors. It forbids the research on the embryo to satisfy the one and it satisfies the others for not to prevent them from do their work in importation of the lines of stem cells. The research ban on the embryo in France does not hold for the legislator of 2004 recommends it in the other countries and in end on his territory in importation of the lines of embryonic stem cells obtained by this legally forbidden bias.

Which lack of courage? Which hypocrisy? We are sad to see to which not at all the legislator denies himself to work on important bioethics problems.

Seen the current state of the French lawful texts, we think that research authorization on the embryo will have to be given, after reflection, that when the legislator will have done « the housework » in its texts. What it will have given again coherence and moderation to his legislation. It is necessary to add that France has not any clear position concerning the embryo statute, which does not reduce the problem.


In conclusion, we think that regarding stem cells, France must not be afraid of there to reflect as all the others imminent bioethics problems, as euthanasia or gene therapy...




In French

La France est un pays un peu en retard et en retrait dans le domaine de la bioéthique, spécialement en matière de nouvelles thérapies. Concernant les cellules souches, bases de la thérapie cellulaire, la France a une position qui n’est pas toujours claire.

Les cellules souches adultes
Il n’y a pas de problèmes majeurs les concernant vu leur origine de prélèvement (placenta, cordon ombilical tissus adultes)
Nous pensons, toutefois, qu’il serait important de généraliser la collecte de cellules souches de cordon ombilical ou de placenta, en respectant des règles d’hygiènes et de respect des individus stricts. Leur efficacité est révélée à chaque nouvelle greffe par thérapie cellulaire.

Les cellules souches embryonnaires
La loi du 6 août 2004 relative à la bioéthique interdit la recherche sur l’embryon. Par voie de conséquence, elle empêche la possibilité de prélèvement de cellules souches embryonnaires (stade morula, blastocyste).
La position de la France est hypocrite, nous n’avons pas peur de le reconnaître et de le dire.
Car cette même loi permet l’importation de lignées de cellules souches embryonnaires sur le territoire français, et tel a été le cas après l’entrée en vigueur de la loi.

Autrement dit, le législateur de 2004 se donne bonne conscience vis à vis des citoyens landa et des médecins chercheurs.
Il interdit la recherche sur l’embryon pour contenter les uns et il satisfait les autres pour ne pas les empêcher de faire leur travail en important des lignées de cellules souches.
L’interdiction de la recherche sur l’embryon en France ne tient pas car le législateur de 2004 la préconise dans les autres pays et in fine sur son territoire en important des lignées de cellules souches embryonnaires obtenu par ce biais légalement interdit.

Quelle frilosité? Quelle hypocrisie?
Nous sommes triste de voir à quel point le législateur se refuse de travailler sur des problèmes bioéthiques importants.

Vu l’état actuel des textes juridiques français, nous pensons que l’autorisation de la recherche sur l’embryon devra être donnée, après réflexion, que lorsque le législateur aura fait le ménage dans ses textes. Qu’il aura redonné cohérence et pondération à sa législation.
Il faut ajouter que la France n’a pas de position claire concernant le statut de l’embryon, ce qui n’allège pas le problème.


En conclusion, nous pensons qu’en matière de cellules souches, la France ne doit pas avoir peur d’y réfléchir comme tous les autres problèmes bioéthiques imminents, comme l’euthanasie ou la thérapie génique...





Special Thanks to Linda MacDonald Glenn for the collaboration in the writing of this text.

The Week in Review

Embryo adoption reopens controversy. Back to the question of when does human life begin, and so what are our responsibilities toward all those frozen embryos out there.

Sports gene test available for little kids. So little Johnny has the genes to be a sprinter, push him in that direction (whether he enjoys it or not)? One can also think of more disturbing uses, like using such a test for embryo election (excuse me, I’ve been in a reproductive rights course this semester, so these issues are top of mind!).

Overseas clinical trials under the microscope—concern whether medical and ethical practices are being adhered to in developing countries. Out of sight, out of mind?

Studies show arrogance and abusive behavior by doctors contributes to
medical mistakes, preventable complications, and even death.

More fallout from the economic crisis—rising stress levels, linked to increases in vulnerability to a long list of illnesses and viruses.

Acupuncture beats aspirin for chronic headache. OK, ancient biotech in
this one!

Computer technology can cut into personalized patient care. Need to enter that data before giving that injection! Admittedly, tech can bring efficiencies, but during an actual patient visit, the tech can interfere in a range of ways. Some inconvenient, yet somewhat comical, like the doctor and nurse huddled over the PC trying to find the code for FluMist before giving it to me. Some rather dehumanizing, like the doctor using up half the precious visit time staring at the computer screen and reading aloud the prior entries before even casting an eye or ear in my direction for the day’s visit.

U.S. study weighs lifetime cancer risks from CT scans.

Fibroid growth differs by race and age.

Gene silencing drug shown to block heart failure in mice (targets a
particular strand of RNA).

British team leads stem cell heart surgery that could end need for
transplants. Patch and rebuild that heart!

Stem cells injected into the brain help stroke patient. Incredible.

Bipartisan report finds U.S. vulnerable to bioterrorism attack. Scary stuff.

FDA sets “safe” levels for melamine in baby formula, despite not being able to say what level is really safe. Does that sentence disturb you as much as it does me? Hey, the levels are significantly lower than the Chinese formula, so that is something.

FDA staff says Solvay’s enzyme pill carries pig virus risks. Comforting.

The more incompetent your boss, the greater your risk for heart attack. Probably not a big surprise, but here you go, study results to back up that gut feeling!

And on a positive note, study shows that happiness is contagious! Spread the joy!

[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is partially taken and edited. BioBlurb is a weekly electronic publication of the American Bar Association's Committee on Biotechnology, Section of Science & Technology Law. Archived issues of the BioBlurb, as well as further information about the Committee on Biotechnology, are available here.]

The Week in Review

1. Sex bias in control of cancer pain. Women get less meds, more pain. Sounds like a Raw Deal.

2. AAAS comments on human subject protection training.

3. Gardasil requirement for immigrants stirs backlash.

4. Paxil suit settled by Glaxo for $40M.

5. Inspire Pharmaceuticals reaches deal with SEC in investigation related to clinical trial of experimental dry-eye treatment.

6. Chinese parents file tainted milk lawsuit.

7. Personalized medicine: new predictive tool can help determine treatment for breast cancer patients (identifies those most at risk of relapse, potentially avoiding chemo).

8. Doctors urge the FDA to ban OTC cough and cold medicines for children until they are found safe and effective. Not safe and effective? Perhaps we should resort to that cherry-flavored placebo elixir reported on in these very pages a few weeks back, eh?

9. Impact of expanded newborn screening in the US.

10. "Friendly" bacteria protect against Type 1 diabetes. Ah, friendly, protective bacteria. Such a nice change from those drug-resistant ne'er-do-wells.

11. Secrets revealed! Penicillin bug genome unraveled.

12. Scientists find gene pathway that triggers the spread of melanoma.

13. Researchers find yet another new source of multipotent stem cells—in the walls of blood vessels.

14. How best to schedule downtime for ERMs (Electronic Medical Record Systems) . *Is* there any good time for the records to be unavailable?

15. No more excuses! Health clubs gear programs for those with ailments.

16. Faster genetic test for flu virus approved in the US.

17. Genentech warns about PML (progressive multifocal leukoencephalopathy—a rare brain infection) death in a patient taking Raptiva for psoriasis.

18. European drug makers urge regulators to impose price controls. I know, this sounds counterintuitive, but you'll see, it's not (seriously).

19. NIH announces funding for new epigenomics initiative.

20. FDA grants 510(k) clearance to I-Flow for topical wound dressing that controls oxygen and moisture. I'd like to see this thing. How does it manage all that? I'm thinking of robo-bandage here.

AND in the category of "Weird News":

21. Tainted candy from China found in US: White Rabbit Creamy Candy. Yes, that's the actual name of the candy. Is it me, or does it sound oddly sinister? Or perhaps I read "Alice in Wonderland" one too many times as a kid. Darn, now I have Jefferson Airplane's song "Go Ask Alice" stuck in my head.

22. If bioterrorists strike, letter carriers might deliver antibiotics. Neither rain, nor snow, nor anthrax spore . . . Wait a minute, weren't these the guys who were targeted with the anthrax in the first place?

23. Experts call for warning labels on energy drinks. Apparently, these things are so chock full o' caffeine that they deliver quite a blast, and people aren't really aware of just how much caffeine they're loading up with. Gives me the shakes just thinking about it.

[Thank you to Lisa von Biela, JD candidate, 2009, UMN, Editor of the BioBlurb, from which this content is taken and edited. BioBlurb is a weekly electronic publication of the American Bar Association's Committee on Biotechnology, Section of Science & Technology Law. Archived issues of the BioBlurb, as well as further information about the Committee on Biotechnology, are available here.]

Shrinky Dinks All Grown Up

Do you remember Shrinky Dinks? Chances are, if you're around my age or have a child around my age, you do. We loved them when I was a kid; we had the kits, of course, not the newfangled Shrinky Dinks for ink jet printers and other fancy stuff.

Little would I have ever thought that I'd run across Shrinky Dinks again, outside of crafts with my niece. But Michelle Kkine and her students, of University of California, Merced, have continued with their DIY biotech projects, using their imagination and the toy isle to use Shrinky Dinks to create tiny rubber plates of cell wells that can nestle embryoid bodies and allow for rapid growth medium change with minimum hassle. So it's cheap, it's fast, it's easier than before - it's kind of hard to find a downside. They published their results in Journal of Visualized Experiments, which gives you a detailed video how-to, as well as written protocols for reproducung the stem cell growth yourself. Unfortunately, I can't figure out how to get that particular video embedded in our site, but it's definitely worth the click-through to watch if you find this sort of thing interesting.

And of course, we have to consider the ethical implications of this. First and foremost is the simple fact that the DIY Biotech movement is growing, and will continue to grow, and become easier for the home enthusiast to pursue and do outside of a laboratory (especially with video guides), and then the more abstract concept of video documentation in general. Given the scandals that continue to rock the biotech world, including the latest from South Korea, I wonder what kind of result it would have to require video documentation as part of any journal submission.

It's interesting - I think most people are going to be more panicked by the idea of people culturing mediums in their bathroom. In a lot of ways, it's the start of the ultimate doomsday scenario. Me, I find the idea of using technology to enforce research integrity much, much more interesting.
-Kelly

News of Note

A couple of stories that have captured our interest:

From the Wisconsin Technology news:
"In the first of several decisions expected in a patent dispute involving human embryonic stem cells, the Wisconsin Alumni Research Foundation said today it has been notified that the United States Patent and Trademark Office has upheld the claims of one of the foundation's key stem cell patents.

The patent challengers, however, said they will continue their challenge of what they termed "three overreaching patents on human stem cells."

According to WARF, the licensing arm of the University of Wisconsin-Madison, the decision pertains to the patent for primate and human embryonic stem cells known as '913.'

Carl Gulbrandsen, managing director of WARF, called the decision of patent examiner Gary Kunz an affirmation. 'We're extremely pleased with this decision,' he said in a statement released by WARF. 'It affirms what WARF has believed all along, that Dr. Thomson's breakthrough discoveries are patentable inventions.' " Full story here.

From Science Daily:
New survey results show that only 29.5 percent in a sample of 1,015 adult Americans consider nanotech morally acceptable. In Europe, significantly higher percentages of people accepted the moral validity of the technology:
"In the United Kingdom, 54.1 percent found nanotechnology to be morally acceptable. In Germany, 62.7 percent had no moral qualms about nanotechnology, and in France 72.1 percent of survey respondents saw no problems with the technology.

'There seem to be distinct differences between the United States and countries that are key players in nanotech in Europe, in terms of attitudes toward nanotechnology,' says Scheufele.

Why the big difference?

The answer, Scheufele believes, is religion..." Read on here.

From the NY Times: Six Killers: America’s Leading Causes of Death: "They are the leading causes of illness and death in the United States today: heart disease, cancer, stroke, chronic obstructive pulmonary disease, diabetes and Alzheimer's disease, in that order. And they have a lot in common." Full article here. [Query: Would more Americans find nanotechnology more acceptable if they knew that it could cure these leading killers?]


From the Washington Post, a study suggesting that man's 'best friend' could be a robot? - a study by Saint Louis University that found the lovable pooch and the interactive dog robot called AIBO were about equally effective at relieving the loneliness of nursing home residents, and fostering attachments. Full story here. I agree with Sara Kiesler, professor of computer science and human-computer interaction at Carnegie Mellon University, who said "the results of the study are encouraging but not completely convincing."

Removing the need for men?

From the Daily Mail, a scientific breakthrough with a technique will help lead to new treatments for infertility, but may render the male partner obsolete in reproduction: British scientists discover how to turn women's bone marrow into sperm.

The comments to the article range from humor (But without men, who would mow the lawn?) to outrage (What is it coming to, the world has gone totally mad...) But I can think of several reasons why this won't render males obsolete -- first, I'm really rather fond of the male I'm married to, and secondly, there is nothing that indicates that the 'new' way' is more fun than the 'old way'. Also, I guess I also to like think of my life partner as something far more than a mere tool for reproduction; that our union is something that has contributed to our personal and spiritual growth.

Embryonic Stem Cells for Therapeutic Cloning in Humans

A California research team has become the first to report, and document, the cloning of a human embryo using donated oocytes (egg cells) and DNA from the cells of an adult donor.

The study has been published online by the journal "Stem Cells."

The experiments, using a technique called somatic cell nuclear transfer (SCNT), provide key steps toward the development of patient-specific embryonic stem cells for use in developing new treatments for conditions such as Alzheimer's disease, Parkinson's disease, and spinal cord injury, among others. The lead author was Andrew J. French, Ph.D., of Stemagen Corp., a private company headquartered in La Jolla, Calif.

In the experiments, the researchers removed the nuclei of mature oocytes from healthy young women who had previously donated eggs for successful infertility treatments. The SCNT technique was then used to insert DNA from an adult male donor into the oocytes. The DNA was derived from a type of cell called fibroblasts, obtained from skin biopsies.

Subsequently, several of the reconstructed oocytes continued to develop as normal embryos, to the blastocyst stage. Extensive and carefully documented genetic tests were performed to confirm the genetic identity of the cloned embryos. In three embryos, tests showed the same DNA as the male fibroblast donor.

In one of the three cases, additional tests showed that the embryo had another type of DNA, called mitochondrial DNA, from both the female oocyte donor and the male DNA donor.

Mitochondrial DNA testing is viewed as an essential proof of successful human cloning -- particularly after previous fabricated reports from a South Korean research group.

The ability to generate stem cells using the patient's own DNA is significant in the treatment of currently incurable degenerative diseases, as well as for cell-based drug discovery. Previous studies reporting the development of cloned human embryos have used embryonic stem cells as the DNA donors.

While the study is an important step toward the development of stem cells for therapeutic cloning, much more research will be needed to confirm and extend the results.

2008 State of the States

For folks looking for a good primer on the "state of the states", Stateline.org has published their State of the States 2008 pamphlet. In this, they discuss subjects as broad as the various states both funding and banning human embryonic stem cell research, as well as state abortion laws, Romeo and Juliet laws, campus security, same sex marriage laws, and more. It's 75 pages of data, graphs, and trends - well worth reading for anyone interested in health care, policy, and federalism.

Of particular interest to me was Christine Vestal's analysis of states attempting to attract prominent stem cell researchers to grow their hESC research facilities into world class research labs. Once the fear was federal stem cell research laws would create a brain drain of science talent, as American scientists picked up and moved to countries more open to doing hESC. Now, the concern is the state next door, as California, Connecticut, Illinois, Maryland, New Jersey, New York and Wisconsin have awarded nearly $250 million in grants, which is three times more than the federal government spent in the same time frame.

While some states consider how to keep up with the funding next door (Iowa, Massachusetts and Missouri), others have simply bowed out of the stem cell race (Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota).

The State of the States 2008 document appears to be a great resource, full of interesting information. For example, did you know that 100 bills both for and against hESC research were considered in 39 states, but only three laws actually enacted? (New York State approved its hESC research funding, Iowa repealed a ban, and Illinois confirmed an executive order.)

While the ethics of the research are briefly mentioned (and Jonathan Moreno is quoted, albeit in another section of the article), overall they are given rather short shrift. That flaw aside, however, this appears to be a valuable addition to any researchers stack of pdfs.
-Kelly

Questions for Our Leaders

Yesterday, we wrote about our call for a presidential debate on science policy. When pulling together potential questions for the debate, I came across a compelling series titled “American Values and the Next President” in the Los Angeles Times (December 12, 2007, Part A; Pg. 30.) It touches on a few of the incredibly important issues our political leaders need to be prepared to address:

An excerpt from the "Life" essay:
…Last month's news that scientists in Japan and Wisconsin had modified adult skin cells to behave as embryonic stem cells seemed at first to have resolved this issue, but that's only true if you believe that the debate over stem cells, cloning and genetic modification is a subset of the debate over abortion.

It is not. It is, or could become, the central life debate of our time, and depending on your perspective, the questions it raises are either exhilarating or horrifying. If you could ensure that your children would never get melanoma, should you do that? How about nearsightedness? Should we be modifying humans in hopes of making them more fit for survival in a warming climate? How about for handling complicated technology, or space exploration?

If these ideas seem excessively science-fictional, consider that when Leon Kass, the conservative University of Chicago professor who would later serve as head of President Bush's Council on Bioethics, wrote a 1972 screed against the then-novel science of in vitro fertilization, he warned that it could someday make mothers of "single women, widows or lesbians." Yesterday's absurdity is today the mainstay of many lives.

Given the expected level of discourse in a presidential campaign, we may be lucky that the candidates are not keen to explore the frontiers of life. Still, it's a missed opportunity...

I would expand the life debate beyond reproductive technologies. Advances in nanotechnology, neuroscience, and robotics, to name a few, will also play an important part in defining "what is life."

My wish for the New Year is that we get beyond paralyzing partisanship, over the top religious rhetoric and the trivializing sideshow antics of the last year and focus the debate on how we can work together to achieve social justice, equity, human dignity and cultivate a critical optimism towards science in order to shape a better future for all.

Dame Warnock weighs in again

As some of you may know, the 2007 Amendments to the highly successful HFEA (Human Fertilisation and Embryology Act) of 1990 are now before Parliament for approval. The recent announcement that pluripotent stem cells could be derived from human skin cells (thus obviating the need for embryonic stem cell research) injected some side issues into the House of Lords Debate on the passage of the 2007 Amendments. On November 21, 2007, more than one member of the House of Lords voiced concerns that the 'moral status' of embryos needed to be revisited in light of the new research by Yamanaka and Thomson. See, http://www.theyworkforyou.com/lords/?id=2007-11-19a.704.4 19.

Dame Warnock, chair of the 1984 Warnock Committee of Enquiry into Human Fertilisation and Embryology which spearheaded the 1990 HFEA - perhaps fearing the injection of old arguments into the debate on the 2007 amendments - wrote a powerful essay for the November 29 issue of Nature reminding us that "there was little possibility of moral consensus" about research using live embryos when her committee recommended the 14 day rule to criminalize keeping an embryo alive in the laboratory more than 14 days after fertilization. [During her Committee's deliberations, she noted that] "the Church claimed a right to regulate science in this area, because of its superior knowledge of morality. In sharp contrast, the committee's entitlement to issue moral advice to ministers derived from its having been set up to do so and from its having a wide and non-partisan membership."

"The moral decisions that such committees have to make are essentially matters of public not private morality. We had to consider our own moral or religious scruples alongside what the consequences might be of the decisions for society as a whole. This was the reason we could not allow ourselves to be swayed by arguments derived from a particular religious dogma." "The legislation [we crafted] would govern everyone - believers and atheists - and had to take into account wider considerations such as the relief of suffering ... [Remember] that it is permissive. No one would be compelled to seek a form of infertility treatment or engage in a form of research..."

"It is essential that ignorance and prejudice should not be allowed to dictate the outcome. Everyone should be educated so as to have a broad understanding of science, and an appreciation of its potential for good. Without this, we cannot responsibly erect barriers to scientific advance." "This must be done by weighing up possible goods against possible harms. These harms do not include only the offending of religious sensibilities of a particular group."

A Sneak Peak Inside a Stem Cell Lab

On several occasions, we've blogged about how stem cell research is not an 'either-or' proposition. Today, Kathryn Hinsch pens an article at Science Progress giving us a peek inside a privately funded stem cell lab and at the motivations of stem cell researchers. One of the researchers talks poignantly about the "work became an existential commitment, a chance to do battle with public health challenges.”

The crux of the article is that "To win the battle against disease, dysfunction, and injury, stem cell research must continue on all fronts: embryonic, IPS [induced pluripotent stem cells], placental, and adult." To get a bigger view inside the lab and read the rest of the article, click here.

Induced Pluripotent stem cell lines

It is amazing to see how the Catholic Church and George Bush can hold us all in thrall regarding human embryonic stem cell research. Because of the opposition to deriving stem cells from human embryos which destroys the embryo, eminent scientists are now reduced to attempting to find stem cell alternatives and have done so - by creating induced pluripotent stem cell lines derived from human somatic cells, an advance (?) which is being heralded today in the NY Times. In other words, we can regress human skin cells to an embryonic state by introducing retroviruses including c-Myc (cancer cells) to do so. The only problem with this is that it also creates tertomas which are nasty little creatures - effectively a germ cell tumor which may contain hair, teeth, bones, eyeballs, torsos and hands. Yuk, as Leon Kass would say. Here's an idea: instead of trying to create human embryonic stem cells from someone's nose or foreskin, let us do the research on embryos as nature intended.

"Every Month Contains a Miracle" part two - The Podcast Interview with Cryo-Cell

We had posted about the new product C'elle earlier this month and we had a chance last week to interview scientist and vice president of research and development Julie Allickson and vice president of marketing Rob Doll. The interview is now available via podcast at archives.org. We discussed how the project came into existence, the potential, the costs, and a few other things.
Give a listen and let us know what you think -- are there any follow-up questions you would like us to ask?

Stem Cells May Reverse Alzheimers' symptoms

From the UK's Daily Mail in London, November 7 : Scientists at the University of California in Irvine have for the first time used stem cells to reverse memory problems associated with strokes, Alzheimer's, and degenerative brain disease in mice. The researchers say that the cells repaired damaged parts of the brain and restored lost memory. They believe that their technique may also work on humans. Full article here.

Good news, but I am curious as to why the scientists used newborns' neuronal stem cells as opposed to embryonic or adult stem cells?

"Every Month Contains a Miracle"

Today, Cryo-Cell announced its discovery of a new, unique type of stem cell found in menstrual blood that may one day have the potential to treat a number of diseases. With the slogan, "Every Month Contains a Miracle", Cryo-Cell also launched an exclusive and proprietary new service, called C’elle, to enable women to collect and cryopreserve their menstrual stem cells. Some more info from the media press kit:

Menstrual Stem Cells

• Cryo-Cell has discovered unique stem cells in menstrual blood that express multipotent markers of both adult and embryonic stem cells. These menstrual stem cells multiply quickly and can differentiate into other types of cells, including heart, nerve, bone, cartilage and fat, according to early research.
• The menstrual stem cells appear to have characteristics similar to those derived from the uterus (human endometrial stem cells), but they can be easily harvested in a non-invasive manner from menstrual fluid.
• This is the first time researchers have found an adult stem cell that is highly prolific and multipotent (able to differentiate into other cell types), and can also be easily harvested in a painless, non-invasive manner as compared to other stem cell sources such as bone marrow, fat or adult peripheral blood.
• Several leading stem cell researchers have launched preclinical studies to evaluate the potential of these unique menstrual stem cells to treat heart disease, Type 1 diabetes and spinal cord injury.
• Researchers believe that these menstrual stem cells could someday be used treat other serious illnesses, such as osteoporosis, stroke, Alzheimer’s and Parkinson’s disease, and that the cells may even be used for customized anti-aging or sports medicine treatments. However, current research is very preliminary and it may take years to develop widely available clinical therapies.
• Menstrual stem cells’ unique properties, combined with their ease of collection and isolation, mean they could become a breakthrough source of multipotent cells. The need for regenerative therapies incorporating cells that have the ability to engraft and differentiate is vast. The ideal cell would also have the ability to be used in an allogeneic manner, meaning it could be used to treat others with whom there is a genetic match. These cells appear to have all of these properties.
• A summary of research related to the menstrual stem cell can be found at http://www.celle.com/mediaKit.aspx

We've contacted Cryo-Cell to arrange for an interview with one of their experts about the ethical implications, and hope to hear back from them shortly. Stay tuned!

Stem Cell and MS: What's at Stake?

Embryonic stem cell transplants show promise for multiple sclerosis patients. Some reports even suggest that the procedure can halt the disease's progression and, in some cases, lessen its severity. Women's Bioethics Project scholar Linda MacDonald Glenn, JD, LLM will be interviewed today by Trevis L. Gleason, HealthTalk host and MS patient, on the ethical debate waging in the political world which threatens to hinder U.S. involvement in this important research.

You can listen in here.

AFS Cells: A Non-controversial source of pluripotent cells?

There is a new report out today that suggests there is a new, non-controversial and "ethically sound" source of pluripotent stem cells: amniotic-fluid stem cells, which, as the name indicates, are stem cells found free-floating in the amniotic fluid. They are also apparently present in the placenta.

According to Dr. Anthony Atala, the specialist at Wake Forest University who led the research team, these cells are neither embryonic stem cells nor are they adult stem cells. They're something in between, fully flexible like embryonic stem cells, but non-controversial. And this is where I take issue. Dr. Atala is saying, and I quote from the above article,

the amniotic cells can be taken easily and harmlessly from the placenta or from pregnant women by amniocentesis

while David Prentice, a senior fellow in life sciences at the Family Research Council, (who strongly oppose embryonic stem cells) says that the AFS cells come with "little ethical baggage". But anyone who's been through amniocentesis knows that there is actually a risk of miscarriage with every insertion of a needle into the womb; according to the CDC, it's a risk of one in 200 to one in 400 women will miscarry, depending on the skill of the person performing the procedure.

This is not harmless. This is not easy. This is not little ethical baggage. If it's so bad, so wrong, to create embyronic stem cells because of the loss of potential life, how can anyone justify the potential miscarriage of a developing, in utero fetus?