We've heard this (stem cell) story before

Stanford scientists are working on a "stem cell treatment" to cure hearing loss due to lost nerves.

The Science Guy at the Houston Chronicle references a Wired News article, that links to the American Association for the Advancement of Science and the San Francisco Gate and an interview with Stefan Heller.

Here's a slightly better review from Medical News Today.

I believe that reading about the evolution of Heller's research will give us some indication about future treatments that result from "stem cell treatments."

Dr. Heller found stem cells in the hearing and balance systems in the ear of humans and mice.

He found that the hearing, inner-ear adult stem cells of mice don't grow and divide much after birth, but that the balance nerve cells, the vestibular hair cells are "pluripotent" ("can give rise to a variety of cell types in vitro and in vivo, including cells representative of ectodermal, endodermal and mesodermal lineages") and can be induced to form either the vestibular, balance cells or the hearing sensory cells.

Then, Heller's team discovered (free abstract, here)that human bone marrow stem cells can become progenitor cells - or the dedicated adult stem cells - that can repair damaged hearing sensory nerve cells.

[Editing note: I had the url of that abstract wrong. Also, I many have the timeline wrong, since a closer look at the abstract shows that it was only published in January, 2007.]

However, Heller and his team ignored the bone marrow cell findings and began focusing on embryonic stem cells. Why would he leave a field of inquiry that would allow each of us to have access to genetically matched cells to repair our own hearing?

Nevertheless, it turns out that the goal is to regenerate the patient's own stem cells to repair damage where it's needed in the body, when it's needed.

From the January 29, 2007 San Francisco Gate article:

On this day he is finally starting his first experiment -- growing inner ear cells in a culture dish, to test the new equipment -- and already people in the medical school are asking, "When are the first transplantations taking place?" he says. "I'm a little careful of that, because we have to do animals first."

He wouldn't be here answering this question at all if he hadn't found stem cells in the vestibular organ, which controls balance. Both balance and hearing are controlled by hair cells. When the hearing cells are damaged by illness or noise, they die off and don't come back. A University of Virginia study 15 years ago found that cells in the vestibule have shown a small and limited ability to regenerate. Heller took that further and within these cells was able to isolate stem cells that continuously multiply. In culture dishes, these regenerative balance cells can be engineered to produce hearing cells.

The logical next step would be to transplant these into the auditory canal. "The problem with any surgical approach to the ear is you have the potential of doing more damage than you can do any good," he says. "So I don't think this will be successful any time soon."

That means 10 years and 10,000 mice, maybe more of each. The immediate future is drugs.

They can be tested directly on embryonic inner ear cells to see if any lead to over-production of hair cells. If a drug could be found that stimulates enough productivity within the damaged ear, this drug could be applied to a deaf ear. These can then be tested on animals, starting in a year or so.

More on HPV, mandates, and tax money

All State Medicaid programs must offer the vaccines recommended by the (Federal) Advisory Committee on Immunization Practices, under the Vaccines for Children program. The States don't have to mandate the vaccine, however.

Some of the docs I've talked to are convinced that Medicaid and uninsured patients will have an easier time accessing and affording Gardasil than insured patients - unless the insurance companies are forced to cover it somehow.

I predict that within just 2 or 3 years, the private insurers will see that the girls who receive the vaccine don't have to have nearly as many repeat paps, fewer colposcopies and biopsies. Eventually, in 5 or 6 years, there will be fewer freezing and laser therapy treatments. Somewhere in there, they will begin to cover and strongly encourage the vaccine, without being forced.

It turns out that the transition from infection with the more virulent strains to a precancerous or even carcinoma intraepithelial neoplasm (cancerous cells in the surface layer - the kind that leads to repeat pap smears, colposcopy and biopsies and then freezing or laser ablation or removal of the surface layer of the cervix. The pathology-reported names given to these spots on the cervix include "Low Grade Squamous Intraepithelial Lesions, High Grade SIL, Carcinoma in Situ ) can occur within 2 to 3 years, although most take 10 years or so.

From an article available here, free on line,

The traditional view has been that this process takes years, if not decades, to occur after initial HPV infection. Recent studies suggest that these changes may develop more quickly than previously thought. Winer et al followed women after initial HPV infection for the development of CIN 2/3.

As shown in Figure 3, approximately 27% of women with an initial HPV 16 or 18 infection progressed to CIN 2/3 within 36 months [20]. A second study of a large health maintenance cohort found that approximately 20% of women 30 years of age or older who were initially infected with HPV 16 developed CIN 3 or cervical cancer within 120 months.

Women who had an initial HPV 18 infection had approximately a 15% risk of developing CIN 3 or cervical cancer at 120 months [21].

The strong correlation between infection with high-risk types of HPV and LSIL, HSIL, and cervical cancer suggests that HPV DNA testing would be a useful tool for the management of women with abnormal Pap test results, especially in the case of those with equivocal test results. In the case of an equivocal Pap test result, HPV DNA testing can help determine whether the individual should be referred for colposcopic assessment [22].

(Ault, Kevin. "Epidemiology and Natural History of Human Papillomavirus Infections in the Female Genital Tract." Infect Dis Obstet Gynecol. 2006; 2006: 40470. Published online 2006 January 30. doi: 10.1155/IDOG/2006/40470. Copyright © 2006 Kevin A. Ault.)


The biggest financial gain to the Medicaid program and then the insureres - as well as the biggest gain in decreased worry and actual pain and suffering of women - will not be from a decrease in diagnoses of the cancer, itself. It will be from the decrease in the visible warts, as well as precancerous changes from the occult infections that can't be seen with the naked eye and the repeat testing and biopsies, along with the cervical damage from excisions, lasers and freezing which can lead to infertility and premature births.

More information at this summary of another research paper. And this paper reports on 2 year risk of developing CIN.

Debate On Ethics

After several days of discussion about a baby that Texas lawyer Jerri Ward asked Wesley Smith to blog about on Secondhand Smoke, I have been asked "How can you be a doctor and not know this about what passes for ethics nowadays?"

Because I have a different understanding "about what passes for ethics nowadays."

I do not agree that euthanasia is practiced in Texas medicine or that utilitarian arguments prevail in medical ethics, especially in Texas. I am a pro-life family doctor who has been studying and practicing medicine, and now, bioethics in Texas. My activism and biggest motivator has been focused on the manipulation and dehumanizing of humans at the beginning of life, because of the advocacy for abortion and destructive embryonic research. I am repeatedly reassured that our Texas physicians do not support euthanasia at the end of life by what I know of them and by what I witness at our medical association meetings and at the meetings where we have been debating the amendment of the Texas Advance Directive Act.

I know what is said in the literature, in the media, in the blogs, and what is said between doctors. I've experienced being the patient, the daughter, wife and mother of a patient, and the doctor in some tough ethical situations.

The elite "ethicists" across the world voice and publish all sorts of utilitarian ideas, including the feminist bioethicists at the American Society of Bioethics and Humanities who discounted conscience as a legitimate guide for physician's actions. I oppose this sort of "ethics" every chance I get.

However, the doctors in Texas do not advocate or encourage such drivel. The very rare doc who is unwise enough to voice the opinion that some lives are not worth living is immediately countered and out-numbered and out-reasoned by his or her professional and compassionate colleagues.

In contrast to my own experiences and education, in the one-sided reports on the blogs and in the media, I hear a story that never quite fits what I know about medical facts, much less about the way I see practical clinical ethics being practiced and taught in Texas. Unlike the other posters at Secondhand Smoke, it is not at all "obvious" to me what happened in this case.

Concerning the bit we know about the case in question, it's not at all "obvious" to me that any pediatrician would have argued to an ethics committee that there are not enough resources to go around or that a child would be better off dead than to have a safe tracheostomy and feeding tube placement in order to continue the current level of technology and in anticipation of transfer to the proper step down care.

On the other hand, if, as I suspected, there had been concerns about imminent death or about a crisis due to the mitochondrial defect flaring after stress of surgery, then it would have been appropriate to object to treatment that could hasten death while causing pain and (surgically) separating the child from her/his mother.

I spent several hours over the last two days watching and listening to the hearings last August 9 on the TADA. I couldn't attend them because my mother was in the hospital - she died August 14. I was reassured by the testimony of the doctors and hospital representatives.

As I said, part of what the lawyer who reported this case experiences is most likely ("obviously") the result of her previously publicized comments in the media that doctors and hospitals kill patients and bury their mistakes.

Healing wounds and regrowing tissue

Doctors at the Brooks Army Medical Center in San Antonio, Texas take care of soldiers (and sometimes civilians) who have been severely wounded or burned. I did 3 or 4 rotations at the old BAMC during medical school and residency and I was always impressed with the enthusiasm and care for the patients that all the staff and doctors displayed. The Burn Center at that hospital has always been on the cutting edge. And, now the BAMC docs are leading, again.

We've used special powders and cloths or tissues to speed wound healing or to give wounds more strength while the tissues grow back. There's a wound treatment that seems to encourage the growth of healthy tissue rather than scar tissue.

First, a little about the healing process. Think of the repairing cells as a crew that works best under water. The body first covers the wound to keep out infection and to provide a scaffold for the new tissues to grow on. The immediate repair is replaced over a couple months' time after the first healing. The workers that build the scaffold that the new skin will grow on need to swim into place. The new skin cells themselves - actually the stem cells that divide and develop into the new skins - must swim in. That's probably one reason that wounds which are dressed with wet coverings or an ointment that holds in the body's tissues heal so much faster.

The powder or tissue, ACell Powder Wound Dressing, is approved for use in wounds as a scaffold or matrix for the new skin to grow on. It appears that in some cases, the wounds grow back better, with more normal tissue and less scarring than in wounds without the powder.
The plan is to try the substance on men who have had their fingers amputated, leaving no tissue appendages that allow us all to grasp a pencil or a fork, to close buttons or a zipper. The hope is that even the smallest improvement will allow grasping.

There's (Still) No "Futile Care Act" in Texas

I keep running across news articles like this one in the Dallas Morning News (free subscription required) which claim that Texas has some sort of "futile care" law. There is no such thing as a "Futile Care Law" in Texas and never has been. (Previous LifeEthics posts include several in April, 2006.)

There is a law called the Texas Advance Directive Act (TADA). (Here at the Texas Statutes website in pdf, and an excerpt with my comments, here.) The law was written by a coalition of doctors, lawyers, patient advocates, disability rights groups, and pro-life groups such as Texas Right to Life, National Right to Life, and Texas Alliance for Life.

In that DMN article above, please note that Dr. Fine was interviewed without knowledge that he would be quoted in an article about a very sad case, one which had not come to the point of being subject to TADA at the time of the interview.

I am concerned that Texas Right to Life is not speaking up about why they found the law acceptible in 1999, but feel that they can condemn it - and all doctors and hospitals - now.

We never stop treating the patient. The TADA has never been invoked in order to withhold food or water from patients or from a patient who only needs artificial food and water. The Texas Advance Directive Act does, however, allow doctors to refuse to use medicine and technology that is not in our patient's best interest, treatment that is harmful or futile.

There are no futile patients, and no "futile care law," there is only futile medicine and technology.

If my patient suffers organ failure after organ failure, some medicines and technology can become harmful -- sometimes by causing side effects and more organ failure, often by prolonging the patient's dying.

In fact the TADA coalition has been trying to come to a consensus on making sure that the Act cannot be invoked if the only intervention needed is food and water. It has also been agreed that the Coalition will support a longer period of notice before the ethics committee meeting is held, that medical records need to be offered in a timely manner and that the family should have two weeks in order to find another doctor or facility.


The cases in Texas which have been cited to criticize the TADA include:

• A woman who had been in the ICU for 4 or 5 months after heart surgery, who had had a stroke and was on a ventilator. Her doctors had suggested to her family that perhaps they should not begin dialysis when her kidneys failed. The family rejected the suggestion and the patient had to have continuous, then intermittent dialysis. She then needed increasing doses of medicines to raise her blood pressure. After a while, the attending doctor again suggested stopping or withholding the addition of new treatments because of the risk of pain and complications that each treatment added on top of the previous complications. Again, the family refused. The doctor decided that he couldn't continue to escalate the interventions and asked for an ethics committee meeting under 166.046. The family members postponed several times, putting off the meeting. Somewhere in this time, the family threatened legal action, picketing, and raising as much bad publicity for the family as they could muster. Finally, the hospital set a meeting for a firm time and refused to budge. The ethics committee members agreed with the doctor and began the process to help the family find a new doctor or a new facility for the patient. The family began protests that became news nation-wide. A new doctor was found and additional treatments and invasive interventions were performed on the patient. Finally, the doctor reported that the patient had had a heart attack, and the ventilator was stopped without verifying brain death.
• In another case, the patient was brain dead, but the family members sued to prevent the doctor - who had been the woman's family doctor for years - from turning off the ventilator. A new doctor came in, did an additional test, and confirmed that the patient was brain dead.
• A third case involved a woman who had a stroke, was unconscious and required a ventilator and dialysis. The patient's daughter was an ER doctor in that hospital. There are no Texas long term facilities that offer dialysis to an unconscious patient on a ventilator. The patient was sent home with home dialysis and ventilator.
• A fourth case involved another woman who had had a stroke, was unconscious and required dialysis. There is still no facility in Texas that offers dialysis for a comatose patient on a ventilator. Her family objected to the hospital's "forcing" them to move her to another facility. Eventually, she was moved to another state, where there is a long term facility that could provide the treatment she needed.

Unfortunately, a repeating theme from some of the lawyers at the meetings is an objection that doctors are protected from malpractice if they follow the Act.

Two identical Bills before the Texas Legislature, SB 439 and HB 1094 not only remove the current protection from risk of malpractice for doctors who follow their consciences and would require doctors to use ever escalationg "life saving treatment" until (as in the case of Andrea Clark) the family decides to remove it or until transfer to another doctor or facility is arranged, without a time limit.


Do we really want to override doctors' consciences? Remember the NEJM article from last week.

Concerning abortion due to failure of contraception and prescribing contraceptives to 14 to 16 year olds when parents object, the Chicago Tribune reports that some believe this is the case:

That approach doesn't even give a patient the option to access other physicians," said R. Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison who was not involved in the study. "It's a raw imposition of your personal beliefs on all those who come to you for professional services."

Texas researchers discover key to heart repair

Texas research team has published a report on the fusion of adult stem cells to damaged heart cells which enables healing of damage. In this case, the stem cells are from peripheral blood - the blood that circulates every day. Presumably, the origin of these cells is the bone marrow.

The review at Physorg.com. includes a discription of the current knowledge on heart repair and stem cells. Quoted is T.H.Yeh, M.D. one of the team from M. D. Anderson, the Texas Heart Institute at St. Luke's Episcopal Hospital and The University of Texas Health Science Center at Houston.

Because many of the drugs and therapies used to treat cancer can cause heart damage, M. D. Anderson, a world-renowned cancer therapy and research center, also invests in the study of heart disease.

Cardiac adult stem cells seem to do two different things: they divide to form blood vessels and they fuse to injured heart muscle cells or "cardiomyocytes" to cause the muscle cells to demonstrate "stemness." The original fused cells are now like very special stem cells that are cardiomyocytes that can divide and multiply for months, in order to repair the damage in the heart. Until recently, we were taught that heart muscle cells did not replicate and replace themselves in adults.

Yeh and his co-workers report on adult heart stem cells, three specific proteins, the mechanisms that stimulate their production, and evidence as to how these proteins and stem cells work after heart muscle damage. Two of the proteins, described as "sticky" similar to the two tapes in Velcro, are newly discovered by the team. Another protein, vascular endothelial growth factor or VEGF, was previously known to aid in the development of new blood vessels. In hearts, VEGF causes some of the stem cells to produce blood vessels rather than fuse to the damaged muscle cells. By a series of experiments using antibodies against the proteins in immune deficient mice with induced heart damage, the team has demonstrated one way the heart repairs itself and that the same adult stem cells can lead to new heart blood vessels and new heart muscle cells. The hope is that this discovery will allow us to increase the amount of repair in heart attack patients.

The abstract of the original article published in Circulation Research OnLine First, is available for free, here. The supplemental data and some figures are also available free, here.

The last author of the original article is James Willerson, M.D., the President of the University of Texas Health Science Center at Houston, and the man who went off to Brazil in order to do one of the first studies of bone marrow stem cells used to treat heart disease. He's been mentioned on this blog, here and here.
Unfortunately, Willerson is often quoted advocating the creation of new embryonic stem cell lines, and the destruction of more and more human embryos in order to harvest those lines.

Language change alert ("Embryonic" at 8 weeks)

We were due, I guess. We went through the redefinition of pregnancy (implanted in a uterus"), embryo (after 14 days or implanted in a uterus), cloning (therapeutic cloning, then somatic cell nuclear transplantation, nuclear transplantation, patient specific stem cells, production of "early stem cells, etc.)

And now, we're supposed to move the line of "embryonic" to eight weeks of gestation.

And we should just forget all the past promises about "14 days," implantation, along with our objections to killing the youngest of our children.

Some of us have warned that embryonic stem cell research, with it's high risk of teratomas - tumors that (to paraphrase a popular slogan) "contain all the cell lines in the body," would lead to further maturation of human embryos into the fetal stage of development. Since the goal is usable tissues and stem cells, it made sense to us that researchers will eventually get around to demanding for funding to grow the embryos in human or surrogate wombs in order to "save lives," and further their grant requests.

There have been previous examples (I'm on my way to a meeting, so the references will have to wait 'till tonight) in production of "embryonic" nerve tissues being used to treat a few children with neurological metabolic diseases. In fact, the "embryonic" tissues used to harvest these cells must come from children who are aborted at 7 to 9 weeks, technically fetuses, not embryos.

Further evidence of the possible direction of stem cell research - if we allow it - comes to us this week, from the online journal, PLOS-Medicine.

Here's the press release that showed up in my Google alerts file, from Eureka News Alerts, "Human stem cell transplants mature into neurons and make contacts in rat spinal cord.":

Human stem cell transplants mature into neurons and make contacts in rat spinal cord

Human nerve stem cells transplanted into rats' damaged spinal cords have survived, grown and in some cases connected with the rats' own spinal cord cells in a Johns Hopkins laboratory, overturning the long-held notion that spinal cords won't allow nerve repair.

A report on the experiments will be published online this week at PLoS Medicine and "establishes a new doctrine for regenerative neuroscience," says Vassilis Koliatsos, M.D., associate professor of neuropathology at Johns Hopkins. "The spinal cord, a part of the nervous system that is thought of as incapable of repairing itself, can support the development of transplanted cells," he added.

"We don't yet know whether the connections we've seen can transmit nerve signals to the degree that a rat could be made to walk again," says Koliatsos, "We're still in the proof of concept stage, but we're making progress and we're encouraged."

In their experiments, the scientists gave anesthetized rats a range of spinal cord injuries to lesion or kill motor neurons or performed sham surgeries. They varied experimental conditions to see if the presence or absence of spinal cord lesions had an effect on the survival and maturation of human stem cell grafts. Two weeks after lesion or sham surgery, they injected human neural stem cells into the left side of each rat's spinal cord.

After six months, the team found more than three times the number of human cells than they injected in the damaged cords, meaning the transplanted cells not only survived but divided at least twice to form more cells. Moreover, says Koliatsos, the cells not only grew in the area around the original injection, but also migrated over a much larger spinal cord territory.

Three months after injection, the researchers found evidence that some of the transplanted cells developed into support cells rather than nerve cells, while the majority became mature nerve cells. High-powered microscopic examination showed that these nerve cells appear to have made contacts with the rat's own spinal cord cells.

###

The research was funded by the National Institute of Neurological Disorders and Stroke, the Muscular Dystrophy Association and the Robert Packard Center for ALS Research at Johns Hopkins.

Authors on the paper are Jun Yan, Leyan Xu, Annie M. Welsh, Glen Hatfield and Koliatsos, all of Hopkins, and Thomas Hazel and Karl Johe of Neuralstem of Rockville, Md.

On the Web:

http://neuroscience.jhu.edu/VassilisKoliatsos.php
http://www.plosmedicine.org
http://pathology2.jhu.edu/disease/home_files/page0003.htm

There is nothing alarming - and quite a bit that's encouraging - in that press release. However, reading the actual published articles leads to the discovery that the stem cells in question come from human fetuses. I'm afraid that I don't know of any way to harvest neural stem cells from human fetuses without harming those unborn children.
Here's the first article, "Extensive Neuronal Differentiation of Human Neural Stem Cell Grafts in Adult Rat Spinal Cord."

And the second, which explains where we are going:"Making Human Neurons from Stem Cells after Spinal Cord Injury"

Spinal cord cells were obtained from cervical and upper thoracic spinal cord of an eight-week-old human embryo and expanded in monolayer culture in defined medium with the mitogen FGF2 (a member of the fibroblast growth factor family).

(Emphasis mine)

In the future, perhaps fetal neural stem cells can be developed from cells harvested from placentas collected after the birth of children or as a by-product of amniotic fluid tests done for medical indications and then used as we use other cellular and tissue transplants of adult stem cells and specialized tissues.

Perhaps Dr. Atala and his research group could follow this line.

However, I expect to see a call for more money for fetal stem cell research and for a demand for an expansion of the time that human "extracorporeal" embryos can be maintained.

And won't it be interesting to see how these nascent human beings are grown to eight weeks or so?

Publish (destroy embryos) or perish

Professor James L. Sherley is losing weight on his hunger strike, but Fox News and Reuters are the only mainstream media outlets to take notice. It seems that racial discrimination, storming the Administration building of a university and even extreme measures of weight loss are not newsworthy if you're critical of embryonic stem cell research and cloning.

It doesn't matter that Dr. Sherley reported a break-through on the secret to inducing adult stem cells to divide and how and why these cells can form cancers (here and here). It is of no consequence whatever that he won an award from the NIH, and millions of dollars in research money to go with it. Unfortunately, he also criticized embryonic destruction and cloning in public, with letters to the editors in Science, Nature, and The Boston Globe.


Dr. Sherley has shown rare conscience and integrity by confronting and exposing the bias and prejudice within academia encountered by those who believe that human beings should not be killed in experiments, and most certainly should not be created for the purpose of killing.

He has been a vocal critic - albeit one who is rarely quoted in the media - of embryonic stem cell research, creating embryos for the purpose of killing for research, and of cloning in order to obtain embryos for research and killing in research.

He is using the tools - the legitimate, legal and ethical tools using current law and endangering no one other than himself - that have been provided by the law, the media and his own intellectual and moral adversaries. But, don't expect to see his story in the National news.

In the United States, the law protects those discriminated against because of their race and Dr. Sherley has charged that he is a victim of racial discrimination at the Massachusetts Institute of Technology. According to this article (from a conservative news service begun by Brent Bozell - one of the very few reporting at all on the story) points out that Dr. Sherley is "he first and only black faculty member of MIT's Division of Biological Engineering, and he was awarded a $2.5 million research grant last year from the National Institutes of Health." Colleagues support the conflict of interest demonstrated by the choice of the lead tenure reviewer - who is married to someone who was a prior critic of Dr. Sherley:
From the Boston Globe,

Some MIT professors are circulating a letter that asks for further investigation into the process that denied Sherley tenure. The letter states that a head of Sherley's department is married to a senior faculty member whose relationship with Sherley has been "openly contentious." That division head should have recused himself from deciding Sherley's case, rather than soliciting an internal letter from his wife to include in Sherley's tenure file, the letter said.

"We checked to see whether that influenced the decision, and we are confident that it did not," Clay said.

Of 740 tenured faculty members at MIT, 27 are African-American or Hispanic. Three minority faculty members have earned tenure since Sherley was denied, according to the school.

The mainstream media have not given Dr. Sherley the same publicity that they would if he would just advocate for the killing of a few embryos. Even his hunger strike is not very successful at gaining national attention.

Could it be that no one at UPI, any of the big 3 television networks, Time, Newsweek, or CNN cares about racial discrimination at MIT? There's nothing from any of these as of this morning - not one little note - according to my Google News search at about 7:30 AM CST.


Or could it be that no one cares about the discrimination against a man who has had a letter published in Nature criticizing embryonic stem cell research?

Med Associations Announce Position Statements on HPV Vaccine

Washington State is planning to offer the Human Papilloma Virus vaccine free to girls. New Hampshire has made the vaccine available on an "opt in" basis. Florida's Legislators are considering following Texas Governor Rick Perry in making the vaccine mandatory, with an "opt out" option, similar to the way that Hepatitis B and other mandated vaccines are regulated. (The vaccine would also have been mandatory under the bills that had been introduced in the Texas Legislature before the Governor's Executive Order.)

Two letters (via email) concerning the HPV arrived since yesterday, one from the Christian Medical and Dental Association and the other from the American Academy of Family Physicians. There is also a newspaper article that covers the Statement of the Texas Medical Association. (I'm a member of each.) Another group forwarded the statement from the Catholic Medical Association.

All encourage the voluntary use of the HPV, because of the safety and efficacy of the vaccine and the ethical practice of preventing disease. And all discourage making the vaccine mandatory.

The Catholic Medical Association (CMA) statement is available online, but in "Macromedia FlashPaper" form, which I've never seen before. The statement is well thought out, with excellent ethics and medical basis. The short statement explained by the 5 page document is:

Does the CMA Support Use of the HPV Vaccine?
The CMA supports widespread use of Gardasil for girls and women in the age range for which the vaccine has been recommended by the ACIP, because it is effective, safe and ethical to use, provided certain conditions are met.

Those conditions include continued teaching concerning abstinence outside of marriage and allowing parents to give informed consent.


The Christian Medical and Dental Association gives the following analogies:

The condom, safe-sex message is like telling your teen not to speed and then giving them a radar detector. HPV vaccination is like telling your teen not to speed, while reminding them to wear their seat belt. You want them to have protection from harm if they are in an accident – whether their fault or not.

and for the Christian philosophical basis for the vaccine:

As Jesus taught us in the story of the woman caught in adultery, Scripture teaches that we can/should show compassion by protecting others from the consequences of sin (while not endorsing sin or promoting continued sin). Facing death by stoning, Jesus protected her and offered forgiveness before calling her to a path of righteousness. He showed grace and compassion, not requiring her to commit to some standard prior to offering protection.

The American Academy of Family Physicians' (AAFP) email contained concerns about the ability to fund the vaccine and to obtain enough vaccine to administer it to all the eligible girls. The AAFP already had a provisional statement, but the move in several states, including Texas, to make the vaccine mandatory prompted the following:

"The AAFP feels it is premature to consider school entry mandates for HPV vaccine until such time as the long term safety with widespread use, stability of supply, and economic issues have been clarified."

Recently, there has been increasing state level action considering mandating HPV vaccination with proof of vaccination required for school attendance among other mandates. Upon review of the situation, the Commission on Science felt that this usage does not fit the classic public health model for infectious diseases such as measles. Several issues arise when considering a mandated school entry requirement. These include:



HPV does not adhere to the public health model for control of infectious disease in a school setting. (e.g. measles, chicken pox)

Universal school entry requirement would come at a cost of approximately $900 million per year to provide coverage for the female birth cohort (2 million girls: $120 per dose plus $25 administration fee; 3 doses). This would be a significant burden on state public health budgets.

There would have to be an assurance of supply of 6 million HPV doses per year to meet the school entry cohort. Given the recent experience with shortages of new vaccines such as the MCV4 for meningitis and Thimerosal-free influenza vaccine for three year olds, it is not clear that this new vaccine could be produced in adequate amounts to meet such demand at this time.

As with the costs for public health departments, there is concern that physician practices may not be able to afford such a large scale requirement at this time.

The Texas Medical Association leaders gave interviews to reporters concerning their reaction to the Governor's Executive order.

"We support physicians being able to provide the vaccine, but we don't support a state mandate at this time," said Dr. Bill Hinchey, a San Antonio pathologist and president-elect of the TMA, which represents 41,000 physicians. "There are issues, such as liability and cost, that need to be vetted first."

Other reasons cited by doctors in Texas and across the country include the vaccine's newness; supply and distribution considerations; the possibility opposition could snowball and lead to a reduction in other immunizations; the possibility it could lull women into not going for still-necessary cervical cancer screenings; gender-equity issues; and the tradition of vaccines starting as voluntary and becoming mandatory after a need is demonstrated.

Hinchey said that TMA leadership expressed their concerns to Perry on Tuesday. He said the TMA arrived at its position after debating the issue in committees in recent days.

A spokeswoman for Perry reiterated Tuesday that the governor stands by the order. She said he is listening to the discussion but thinks the vaccine is safe and effective.

Majority of Doctors Oppose Abortion

In that NEJM article that I blogged on earlier, there are numbers about the "Intrinsic religiosity" of physicians, based on the answers of the 1000 or so docs who answered the questionaire.

The authors seem to have no feeling for the history of bioethics as an outcome of the Holocaust or Tuskegee. Instead, the fuss and bother is over docs refusing to follow through on legal killing. (Okay, I will admit that the authors might be trying to avoid in their analysis what they seem to see as a problem: "for the doctor to describe that objection to the patient." Heaven forbid -oops- that anyone name "wrong," wrong!)

27% of responders measured moderate and 36% were high on the "Intrinsic Religiosity" scale:

"We also assessed physicians' intrinsic religiosity and religious affiliations. Intrinsic religiosity — the extent to which a person embraces his or her religion as the "master motive" that guides and gives meaning to his or her life (12) — was measured on the basis of agreement or disagreement with two statements: "I try hard to carry my religious beliefs over into all my other dealings in life" and "My whole approach to life is based on my religion." Both statements are derived from Hoge's Intrinsic Religious Motivation Scale13 and have been validated extensively in previous research.(13,14,15) Intrinsic religiosity was categorized as being low if physicians disagreed with both statements, moderate if they agreed with one but not the other, and high if they agreed with both."

10% of the docs said they had no religious affiliation, while 18% identified as Protestant, 22% as Catholic, 16% as Jewish, and 14% as "other." The surveyors defined other as "a category that included Buddhist, Hindu, Mormon, Muslim, Eastern Orthodox, and other."

52% of the docs object to abortion for failed contraception, by the way and 46% object to providing contraception to children 14 - 16 years old when their parents object.

Oddly, the authors cite a lack of consensus about these matters of conscience, and don't seem to question the moral rightness of any of the practices, only to the fact that a some few docs might actually follow through on their beliefs.

And watch out, docs! The authors suggest a need to actually observe your reaction when patients ask for abortions.

Bad, Bad Doctors (Religious, with Consciences)

The NEJM has a free on line article evaluating the results of a survey of doctors, "Religion, Conscience and Controversial Clinical Practices," which is a perfect example that far too much of the effort of "medical ethics" or "bioethics," goes into deciding who can be killed.

"In recent years, several states have passed laws that shield physicians and other health care providers from adverse consequences for refusing to participate in medical services that would violate their consciences. For example, the Illinois Health Care Right of Conscience Act protects a health care provider from all liability or discrimination that might result as a consequence of "his or her refusal to perform, assist, counsel, suggest, recommend, refer or participate in any way in any particular form of health care service which is contrary to the conscience of such physician or health care personnel." In the wake of recent controversies over emergency contraception, editorials in leading clinical journals have criticized these "conscience clauses" and challenged the idea that physicians may deny legally and medically permitted medical interventions, particularly if their objections are personal and religious. Charo, for example, suggests that the conflict about conscience clauses "represents the latest struggle with regard to religion in America," and she criticizes those medical professionals who would claim "an unfettered right to personal autonomy while holding monopolistic control over a public good." Savulescu takes a stronger stance, arguing that "a doctor's conscience has little place in the delivery of modern medical care" and that "if people are not prepared to offer legally permitted, efficient, and beneficial care to a patient because it conflicts with their values, they should not be doctors.""

"If physicians' ideas translate into their practices, then 14% of patients — more than 40 million Americans — may be cared for by physicians who do not believe they are obligated to disclose information about medically available treatments they consider objectionable. In addition, 29% of patients — or nearly 100 million Americans — may be cared for by physicians who do not believe they have an obligation to refer the patient to another provider for such treatments. The proportion of physicians who object to certain treatments is substantial. For example, 52% of the physicians in this study reported objections to abortion for failed contraception, and 42% reported objections to contraception for adolescents without parental consent."

Not surprisingly, these "controversial" "legal" practices are abortion "for failed contraception," giving "birth control to teenagers between the age of 14 and 16 if their parents do not approve," and "sedation to unconsciousness in dying patients." For some reason, the authors do not give results or even discuss the other "Controversial Issues in Medicine": Physician assisted suicide, withdrawal of artificial life support or abortion for congenital anomalies.



First, "elective" abortion is neither mandatory nor beneficial.

Second, I guess that the first discussion must be whether or not "legal" implies that a practice is necessarily "beneficial," moral, or required.

Third, the legality of providing contraceptives to minors under the age of consent, against their parents' wishes, is questionable, except in Federally funded clinics, where it is mandated under Title X funding for Family Planning clinics.

Fourth, it is illegal in most states to participate in "Physician Assisted Suicide."

And fifth, the "monopolistic control" is distraction. Are all professionals who are licensed by the government required to do whatever is demanded of them by whomever can use their services? Let's see: architects, engineers, all those media types?

If so, I'd like to ask Alta Charo - who, after all is a licensed lawyer, working for a State University that receives Federal funds - to give me some good, solid quotes that do not advocate the taking of human life or the defamation of those of us who act on our convictions.





Take a look at the survey and the article. Take the survey.

Do you agree with the "bioethicists" quoted in the introduction?

Texas HPV Vaccine

One of my goals is to translate between the pro-life and pro-family community that has a religious background and those who do not necessarily count themselves as religious. Sometimes, it seems that's all I do.

Governor Rick Perry evidently surprised most of the world with his brave move concerning a vaccination against Human Papilloma Virus, a group of sexually transmitted viruses that cause abnormal pap smears and cervical cancer. While he follows a 2003 law, he has been criticized by the Family Policy Center, the American Association of Physicians and Surgeons and many Texas conservatives. Even the Republican Party of Texas issued a statement calling on him to rescind his Executive Order.

Although I normally agree with these groups, I think they are wrong in this case. The Christian Medical and Dental Association agrees with me. And Governor Perry, since he went so far in his EO to protect the right of parents to "opt out."


The vaccine will not interfere with our efforts to teach and encourage our children to abstain from sex outside of marriage. In fact, I hope that by giving the vaccination before 6th grade, younger children will be less likely to connect the vaccine with sexual activity and will be protected when they do have sex for the first time. The fact that the vaccine is so necessary could also be used to teach the fallacy of "safer sex."

The research showed that younger girls show stronger immune responses to the vaccine than older girls and women. And logically, vaccines only work before contracting the disease.

Studies of teen girls have shown that over 2 years, 40% to 80% of them will become positive for HPV, and over 10% of them will have the high risk virus, HPV 16, that is associated with over 50% of cervical cancers. Admittedly, the infected girls must be exposed. However, contrary to popular opinion, the viruses can be spread by the hands during heavy petting.

Besides the pain and cost of the cancers and the 400 deaths per year in Texas from cervical cancer, however, there is the cost of the early precancerous changes from the viruses. There are the every three to six month repeat paps and HPV tests, the freezing and lasers, and the weakened cervices that can result in premature labor.

Gardasil, while new, is produced the same way most insulin for diabetics is manufactured these days: by recombinant DNA. It’s not a weakened or killed virus, isn’t grown in human tissues and doesn’t contain mercury. The vaccine contains copies of antigens that are part of the outside covering of the virus, not the DNA that causes infection and cancer. Vaccinated patients make antibodies against four strains that cause the most harm.

In contrast, the last two vaccines mandated for schoolchildren in Texas are manufactured using human tissue cultures that resulted from abortions. Many parents object to the “Chicken Pox” Varicella and Hepatitis A vaccines – although the children were not aborted in order to obtain the vaccine, and there is some ethical support for accepting the vaccines because the unethical act is isolated from the intention and act of the vaccine.

(Edit: The Hepatitis B vaccine is also made by recombinant DNA, and not one of the un-ethical methods. This was added to strengthen the case for the safety of the recombinant technique, similar to the evidence due to the wide spread use of insulin from recombinant DNA. I could have added that Hepatitis B is another virus that is unlikely to be spread by casual contact in school. That fact is also true of another mandated vaccine for Tetanus - what we used to call "lock jaw.")

The vaccine against Hepatitis B, which is spread by blood and bodily fluids, has been mandated for school children in Texas since 1998.

The Texas Legislature gave the Governor the power that he exercised as the head of the Executive Branch: the power to regulate the Medical Board and the Department of State Health Services. The Legislature has passed law as recently as 2003 that allows the Department and Board to add vaccines as they deem them necessary.

The Governor's language strongly promotes the parental right to "opt out" and orders the Department to make the “opt out” provision available on the Internet. Currently, parents have to make a request in writing for an affidavit, which has to be notarized and then delivered to the Department - eventually the Department mails the exemption to the parent. (Can you imagine? There's no way we could have ever managed to get parental consent forms this complicated or the process so convoluted for abortions.) The Governor's language would make the opt out process easier.

Governor Perry’s Executive Order: here.

The Texas Education Code: here.

Gardasil prescribing information: here.

Statement from the Christian Medical And Dental Association: here.

Texas Governor pulls a fast one (HPV shot)

In all the excitement about Texas becoming the first State to mandate the vaccination against a Sexually Transmitted Disesase, no one seems to have noticed that Governor Rick Perry ordered the Health Department to make it easier on parents who wish to opt out on vaccinations for their children.

Parents' Rights. The Department of State Health Services will, in order to protect the right of parents to be the final authority on their children's health care, modify the current process in order to allow parents to submit a request for a conscientious objection affidavit form via the Internet while maintaining privacy safeguards under current law.

The current relevant law is all over the website containing Texas Statutes. I'm not at all sure that I tracked it all down, but most of it is in The Education Code, especially Chapter 38 and some is in the Health and Safety Code. The "opt out" provision is in 38.001, which was passed in 2003. I believe that this law was the first time in Texas that there was a formal way for parents to object for philosophical reasons, without having to claim health risks.


However, the law concerning the paperwork is in 161.0041 of the Health and Safety Code, and has higher requirements than the parental consent for abortion rulings!

Sec.A161.0041. IMMUNIZATION EXEMPTION AFFIDAVIT FORM.
a) A person claiming an exemption from a required immunization based on reasons of conscience, including a religious belief, under Section 161.004 of this code, Section 38.001 or 51.933, Education Code, or Section 42.043, Human Resources Code, must complete an affidavit on a form provided by the department stating the reason for the exemption.
(b)The affidavit must be signed by the person claiming the exemption or, if the person is a minor, the person ’s parent, managing conservator, or guardian, and the affidavit must be notarized.
(c)A person claiming an exemption from a required immunization under this section may only obtain the affidavit form by submitting a written request for the affidavit form to the department.
(d)The department shall develop a blank affidavit form that contains a seal or other security device to prevent reproduction of
the form. The affidavit form shall contain a statement indicating that the person or, if a minor, the person ’s parent, managing conservator, or guardian understands the benefits and risks of immunizations and the benefits and risks of not being immunized.
(e)The department shall maintain a record of the total number of affidavit forms sent out each year and shall report that information to the legislature each year. The department may not maintain a record of the names of individuals who request an affidavit under this section.

Added by Acts 2003, 78th Leg., ch. 198, Sec. 2.163, eff. Sept. 1,
2003.

In order to opt-out, the parent has to send a "written request" for the paperwork to the Department. The law actually states that the legal affadavit has to have "a seal or other security device" to prevent copying. Can this be done online?

Texas: First to Mandate STD Vaccine

That'll shock 'em on the coasts, won't it? Not to mention France and England, since the story has gone global.

Governor Rick Perry reportedly (free registration required) has signed an order mandating that teen girls in the State of Texas receive the vaccine against four strains of the Human Papilloma Virus by 12 years old and that the State pay for the vaccines that are not covered by health insurance. Two of these strains cause most cases of cervical cancer, and the other two cause most of the big, ugly genital warts that, while they don't cause cancer, can obstruct the urine or bowels and definitely cause bleeding and pain.

We all hope that our daughters and sons will meet their perfect mate, get married while they are both virgins. Then, we wouldn't have to worry about 99.7% of all cervical cancer. However, as Dr. Gene Rudd of the Christian and Dental Medical Association has said, no matter how well we raise our daughters and sons, their future husbands and wives may not have benefitted from the same background. A virginal wife can catch the virus from her husband on their wedding night(and vice versa - although he has vastly less risk of cancer of the penis in the US).

Another shock will probably come when (what the Houston Chronicle and the Austin American Statesman are calling) "the Governor's base" does not rise up in revolt and rants.

There is a strong lobby in the State against mandated vaccines (largely driven by objection to mercury preservatives, the vaccinations that are grown in human cell cultures and the troubles with the pertussis [whooping cough] vaccine from the '70's and '80's.) However, while good people who probably agree with the Governor's pro-life, pro-family views on other issues, these are not quite large enough to be called the Governor's "base."

In my opinion, the Governor decided that the vaccine is too important to leave to politics - especially in a State still healing from the redistricting fight of 2003, that ended up with first the Democratic Representatives and then the Democratic Senators running away from Austin and leaving the State to stall legislation.

I wish he would go ahead and let both the boys and girls get the shot -- Take a look at this video on "herd immunity." If we're going to do this thing, we might as well eradicate as much of the virus as possible.

I am concerned that no one knows how long the vaccine's effects will last.

On the other hand, this is Texas.

We don't like the government mandating anything. We can be convinced that some things are for the good - at least for other people - if you sell it right(grin).

The Governor must make a huge effort to convince the parents of Texas that this is good for the boys and girls in Texas, and that the money spent on the vaccine ($360 per girl, for 3 shots over 6 months) will save lives and money by preventing cervical cancer, genital warts and even anal cancer in both men and women.

Feminists For Life History

I wrote about Serrin Foster's article on National Review Online, yesterday. Be sure and click through to the actual op-ed and to the Feminists for Life website. (Especially the "Covetable Stuff"!)

The actual founders of F4L were two women, Catherine Callaghan, Ph.D. and Pat Goltz. Like many of us in the '70's and '80's, these women recognized the conflict between abortion and feminism. Both were once members of the National Organization of Women. Ms. Goltz was expelled from her local chapter, and both eventually resigned from the national organization.

Feminists for Life reminds us how common it is to assume that we know all about other people and other groups. It seems that we quickly stereotype and assume division, rather than look for common ground.

I love common ground! My goal has been to offer that ground and possibly to offer my translation and peacemaking skills in order to demonstrate the logic of the prolife arguments to the domestic and sexual violence communities, non-Christians and even atheists, pro-life churches and other prolife groups who assume they have nothing in common. Unfortunately, far too many prolife organizations require members to agree to a Christian creed.

For more surprises and information on opposing abortion in the public square, take a look at Libertarians for Life and Democrats for Life. And then, check out the Atheists and Agnostics Prolife Leaque (you've got to see their url).


(For those Christians who are offended, I offer the book of Romans - I try to live so that others can see some of the insight in Romans 1 through my example. A little bit of truth can serve as a catalyst for more truth.)

Feminists For Life op-ed on National Review Online

Serrin Foster, whose latest essay is published on National Review Online, is one couragious woman. She is the President of Feminists for Life, which some people are absolutely convinced is an oxymoron.

No, it's not. At the least, half of all the human beings that are killed by abortion are female. In some of the world, many, many more of the abortions are for "sex selection" - meaning they're culling the culturally less desirable girls.

And then there are the women who, like me are convinced that women should not be pushed to "choose" as the mother of "Sophies' Choice" did: between their children (the child you're carrying now and the children of the future) or between their children and their lives, their education or their jobs. Or between being fully women (who do get pregnant and bear children, by nature) or more like the men.

Between someone else's definition of success and failure.

Ms. Foster writes about the pressures placed on college girls to abort - the only "choice" offered on too many campuses seems to be what kind of abortion to have.

(Edited above - to correct some spelling - including Ms. Foster's name and her title. See the February 2 post for more on Feminists for Life.)

Take a look at the next post on Feminists for Life History.

$17.9 Million plus for Texas: ethical stem cells

The UT Austin Daily Texan has the only report that I can find in the news about Wednesday's announcement that the University of Texas Health Center in Houston is the recipient of $17.9 million for stem cell research on treatments for heart disease.

The National Heart Lung and Blood Institute granted $17.9 million for the research of stem-cell treatments for cardiovascular disease to the UT School of Public Health Coordinated Center for Clinical Trials.

The school was established in 1967 as part of the UT Health Science Center in Houston.

The new funding will bring the institution to the forefront of stem-cell, cardiovascular research. Charged with coordinating the network's participating centers, the school will serve as the hub for the Cardiovascular Cell Therapy Research Network.

"This research will examine the promise of approved stem-cell research of cardiovascular disease," Dr. Lemuel A. Moye said.

The network's centers include the University of Florida, the Cleveland Clinic, the University of Minnesota, the Texas Heart Institute and Vanderbilt University. Dr. Lemuel A. Moye, biostatistics professor and principal investigator of the program at the UT School of Public Health, was excited that the institution was selected to coordinate the other centers.

"It was a pleasant surprise," he said.

I wonder whether this grant will help one of the Houston Health Center Hospitals begin collecting cord blood?

Or will the docs at the UT School of Public Health work with Dr. Willerson and Dr. Perin at the Texas Heart Institute, who are testing a system to select progenitor cells to repair heart tissue, using a commercial product, Aldagen?

Hopefully there's a coordinating board somewhere that's watching over the efficiency of these different research groups.

How do you say "Duh!" in French?

Il n'est pas facile!

Nanodot reports on a citizen conference consensus paper which concludes that understanding nanotechnology and evaluating the ethics of research on constructs and machines built on the molecular leve requires effort and may be too hard.

They didn't know that nanotechnology existed until someone told them and then found that they had to work at understanding.

Last week, Science Daily told us about a similar study from a Pennsylvania professor who participated in a survey of people Vermont and New Zealand.

I'll admit to a bit of worry that we're all paying for the emperor's clothes - we can't see or measure it without the tools the researchers give us or until we - someday - see the effects.

How do we know what those little machines (like these little "ratchets") are really doing down there?

Texas, Adult Stem Cells, Multiple Sclerosis

Opexa is a division of Pharmafronteirs (or it's the other way around, I'm not sure) which is based at the Woodlands, near Houston, Texas.

The company specializes in cell therapies, based on adult stem cells and the controlled manipulation and replication of adult cells.

Multiple sclerosis (MS)is a disease that causes the loss of the myelin around nerves. Think of myelin as insulation that speeds the transmission of nerve signals. When myelin is lost, nerve signals can't go where they're needed, as fast as they are needed. People end up weak, with tremors, and the lack of balance, loss of coordination and the loss of the ability for the muscles that enable us to breathe and cough to function.

We know that MS is a sort of autoimmune disease in most cases. The cells that are supposed to fight infection and keep abnormal or injured cells that can cause cancer actually decide that the myelin needs to be destroyed.

For over 4 years, Pharmafrontiers or Opexa has been running a series of experiments using T cells - the specialized white blood cells that mature in the Thymus and which are supposed to kill foreign cells, like bacteria or cancer cells.

The company has a technique for isolating the patient's specific T cells that attack their myelin, growing them in the lab until they have millions, and then treating them so they can't multiply. The treated cells are then injected under the skin of the patient, and the body really notices the cells, and uses all the immune system to attack them - and all or most of the T cells in the body that act like them. So the myelin is not destroyed anymore - or at least not as fast.


Opexa are now in Phase IIb - meaning that they know it's safe to use in people (Phase I tests) and are finding out more about how much is needed and who can be helped.

There's a great first-person story about someone who is being treated as part of the experiment at "I Have MS."

For a couple of very pretty videos that explain all this much better than I ever could - and the press release by the company about the Phase IIb trial -- take a look at the Opexa site, at this page.

Added:

Opexa is selling the treatment as "Tovaxin™" - a vaccine.

That's how vaccinations work, by the way. Our bodies are convinced to make antibodies and specialized white blood cells to kill or destroy the foreign bacteria, virus -- and someday, cancer and all sorts of cells that inappropriately make those antibodies and attacks against our own normal cells, treating them as though they are damaged or foreign. As long as our bone marrow is healthy, we seem to be able to make a nearly unlimited number of those white blood cells (there's also some "depots" or reserves out in the lymph nodes and in the liver, spleen and the gut lining where the cells lurk and wait for their chance to multiply and fight disease, evidently). And I think this is how "allergy shots" work.

Immune Privileged Cord Blood Stem Cells

Pluristem is one of the companies focusing on the commercial development of stem cells. There are two or three names which have been regularly sending out press releases concerning their research and development (besides ACT, of course).

In this case, it's a company that's marketing selected umbilical cord blood cells or placental cells. If the product turns out to be what they say it is - a population of adult or fetal cells that can be harvested from the placenta after a child is safely born, isolated by the company's secret method, and transplanted to replace or supplement diseased bone marrow - then the complication of rejection may soon be a thing of the past:

Pluristem Announces Evidence That PLX-I Cells Are Immune Privileged

NEW YORK--(BUSINESS WIRE)--Jan 29, 2007 - Pluristem Life Systems, Inc. (OTCBB:PLRS), a cell therapy company dedicated to the commercialization of stem cell products, today announced evidence that its PLX-I cells have proven to be immune privileged. PLX-I cells are Pluristem's first potential product dedicated to resolving the global shortfall of matched tissue for bone marrow transplantation by improving the engraftment of umbilical cord blood. PLX-I cells are mesenchymal stems cells obtained from the placenta and expanded by using Pluristem's proprietary 3D PluriX(TM) technology.

"Immune privileged" is defined as the absence or diminution of rejection when implanted into unmatched recipients. Being immune privileged, the PLX-1 cells carry significant positive implications in the development of Company products for a variety of degenerative, malignant and immune diseases. Additionally, this immune modulating property could prove important in treating or preventing immune reactions associated with transplantation.

Ora Burger PhD. V.P. of R&D at Pluristem states: "Our PLX-I cells possess immune privileged characteristics that can be used in the future for other applications involving transplantations. PLX-I cells posses[s] these immune privileged characteristics without carrying the associated social stigmata of embryonic stem cells because PLX-I cells come from the placenta."

William R. Prather RPh, MD, Sr. V.P. Corporate Development notes: "Mesenchymal stem cells can differentiate into a range of different tissues types associated with the musculoskeletal system such as bone, cartilage, fat, muscle, tendon and ligament. Consequently, mesenchymal stem cells are considered to be multipotent. Additionally, some reports provide evidence of these cells plasticity or the ability of mesenchymal stem cells to traverse tissue boundaries and give rise to cells of a different non-musculoskeletal tissue, such as brain or liver cells. If this is the case, mesenchymal stem cells may be used to help treat a broad range of tissues affected by damage or disease. Allogeneic transplantation of mesenchymal stem cells between different individuals may also be possible as these cells appear to be immune privileged in that they are not necessarily rejected when implanted into unmatched recipients. The characteristic of these cells being immune privileged may enable Pluristem to be involved with new clinical applications with PLX-I."

Of course it's fiction!

In my review of Michael Crichton's NEXT, I missed the most obvious clue that the fake news article was, indeed, fake: There's no way that the professor would have been given so much space in a review about stem cells.
(Another "Duhhh!" moment!)

Texas leads in nanotech armor

Betterhumans ("forward thinkers discussing, celebrating and creating the future") reports that another Texas researcher is a leader in biotech.

University of Texas' nanotechnologist Ray Baughman has learned to spin a new yarn from carbon nanotubules. It appears that the yarn contracts when stimulated with electricity and is expected to be strong enough to serve as armor. he has a contract with the Pentagon to produce "exoskeletons" for soldiers. More from Spiegal Online International.

Book Review: Michael Crichton's NEXT

"Stroke Damage May Help Smokers Kick the Habit: The insula, an area of the brain largely ignored by researchers, may hold the key to breaking harmful addictions" (Scientific American Science and Technology News, January 25, 2007)

"Fresh light thrown on tragic drug trial: Animal tests may have missed danger because monkeys 'too clean'." (news@nature.com online, January 25, 2007)

"Preparing cloning for market: Ranchers are getting set, but are consumers ready?" (Boston Globe, January 26, 2007)

"Biomed firm commercializes stem-cell sales" (UPI Business Newstrack)

"New WARF Stem Cell Rules To Benefit Biotech Research" (BioWorld Headlines, AHC Media, LLC, January 25, 2007)

"Crunch time for multiple-gene tests: Sophisticated new genetic tests face an uncertain future — unless they can win clear-cut approval from regulators, insurers and, most importantly, doctors. Virginia Gewin reports." (Nature News, premium access only)

"Stem Cell Debate Rages: Effective Treatements "Decades Away" Prof. McKeown Shocks Audience" (Beaumont College Alumni News, as reported in NEXT, 2006)

Only that last headline is fictional, from Michael Crichton's newest book, NEXT.

I'm just a bit more than half-way through the book, but the fact is that I had to "Google" the fake news report to convince myself that it wasn't a very real article from some past news source. After my sureal experience of researching today's news and having to remind myself that the Google stuff was "real," I was spurred to give y'all a heads up.

Dr. Crichton is the author of The Andromeda Strain, Jurassic Park, and The Terminal Man. His science fiction is heavy on science and he has always seemed to be drawing on tomorrow's news stories - probably (I'd like to believe) because of his medical training.

This book is not very flattering to doctors. Or the media, research scientists, regulatory agencies, public policy makers or politicians. I had nearly decided that the author was stretching reality and coincidence in order to build his story, but then I opened my e-mail this morning and there were the Google News search alerts I've cited above - some of which are more fantastic than anything in the book so far.

In that "fake" news piece above, the reporter quotes a fictional professor of biology as he describes the hype that's surrounded stem cell research, including a thorough history of the human cloning scandals by Korea's Hwang Wu Suk. The "doc" continues,

". . . First, in a media-saturated world, persisitent hype lends unwarranted credulity to the wildest claims. For years the media have touted stem cell research as the coming miracle. So when somebody announced that the miracle had arrived, he was believed. Does that imply there is a danger in media hype? You bet. Because not only does it raise cruel hopes among the ill, it affects scientiest, too. They start to believe the miracle is around the corner - even thought they shourld know better.
"What can we do about media hype? It would stop in a week, if scientific institutions want that. They don't. They love the hype. They know it brings grants. So that won't change. Yale, Stanfor, and Jons Hopkins promote hype just as much as Exxon or Ford. So whenever you hear a scientist claim that his statements have been exaggerated, or taken out of context, just ask him if he has written a letter of protest to the editor. Ninety-nine times out of a hundred, he hasn't."
. . .
"Next lesson: Peer review. All of Hwang's papers in Science were peer-reviewed. If we ever needed evidence that peer review is an empty ritual, this episode provides it. Whang made extraordianry claims. He did not provide extraordinary evidence. many studies have shown that peer review does not improve the quality of scientific papers. Scientists themselves know it doesn't work. Yet the public still regards it as a sign of quality, and says, "This paper was peer-reviewed,' or 'This paper was not peer-reviewed,' as if that meant something. It doesn't.
"Next, the journals themselves. Where was the firm hand of the editor of Science? Remember that the journal Science is a big enterprise - 115 people work on that magazine. Yet gross fraud, including photographs altered with Adobe Photoshop, were not detected. And Photoshop is widely known as a major tool of scientific fraud. Yet the magazine had no way to detect it."
. . .
"The ultimate lesson is that science isn't special - at lest not anymore. Maybe back when Einstein talked to Niels Bohr, and there were only a few dozen important workers in every field. But there are now three million researchers in America. It's no longer a calling, it's a career. Science is as corruptible a human activity as any other. Its practitioners aren't saints, they're human beings, and they do what human beings do - lie, cheat, steal from one another, sue, hide data, fake data, overstate their own importance and denigrate opposing views unfairly. That's human nature. It isn't going to change."

Crichton also slams the patents on human genes and on cells that have been removed from patients in the course of medical treatment - patents that become property and make people near-property of universities and then private corporations.

(He also tweeks people like me, who love to give references in the form of urls or internet addresses in support of their points. One of the characters invents pages of "Google" references in just a few hours in order to hide her own secret. Lesson: Watch your sources, verify and then verify, again.)

Crichton is one of the writers that I recommend for what I call "ethics lessons we don't have to learn the hard way." Science fiction, which long-time Astounding Science Fiction - now Analog Science Fiction and Fact - editor John Campbell called "future fiction," often explores the "why's" and "why not's" of science, medicine and research, and the feelings that characters experience in what are (usually) novel situations that strain everyday ethics. Just as we study classical and contemporary fiction to learn more about the human condition, we can learn from science fiction authors' and their characters' reaction to what is fantastic today (but may not be tomorrow, in a few minutes, or in an "alternate history"), as well as our reaction to their reactions.

I recommend the NEXT to other SF fans and bioethics nuts. I also recently read and recommend Prey and I'm listening to State of Fear on Audiobooks. My favorites are still The Andromeda Strain and The Terminal Man, but Congo is worth reading, too.

The future of stem cells, Texas and politics

The Friday, January 26, 2007 Austin American Statesman editorial, “Stem cell opposition could steer research away from Texas,” flatly states that Governor Rick Perry’s $3 Billion dollar cancer research initiative won't help at all if it doesn't include funding for embryonic stem cell research. The Statesman editors doubt that there will be any scientists to spend the money on.

The editorial is ridiculous – and, as the editors admit, political - in light of daily strides in ethical stem cell research and Texas’ strong research community.

Texas hospitals were among the first in the nation to offer umbilical cord blood transplants. Cooperation between Texas universities, medical schools, NASA and foreign researchers led to technology which allowed the development of embryonic-like stem cells and liver cells from umbilical cord stem cells.

Texas is already enough of a leader in ethical stem cell research to lure the President of the International Society of Stem Cell Researchers, Paul Simmons, Ph.D., away from Australia to the University of Texas Health Sciences Center at Houston.

We also have Diego Castrillon, MD, PhD., who moved from Massachusetts to the University of Texas Southwest Medical Center. Dr. Castrillon is credited with research into the "Fox O's." These are "transcription factors," or local proteins that cause the expression of certain genes. They promote the health of adult stem cells and suppress cancer cells.

This month’s issue of the journal, Cell, will include a report on further research on FoxO’s. From a press release at "Newswise"

The FoxO1, O3, and O4 transcription factors regulate genes in the complicated cell signaling network known as PI3K-AKT, or simply PI3K. Scientists have discovered that PI3K signaling is intimately involved in fundamental cell processes such as metabolism, aging, and protecting the body against cancer. The PI3K circuit has been found to be disrupted in many forms of cancer, making it a hot topic in cancer research labs and drug company boardrooms.

Based on previous work in his laboratory, DePinho, working with Diego Castrillon, MD, PhD, (who is now at the University of Texas Southwest Medical Center), determined that the three FoxOs had redundant, overlapping functions: To uncover those functions, it would be necessary to engineer mice that lacked all three FoxO transcription factors.

To make the task even more difficult, mice lacking FoxO1 die in the womb. DePinho and Castrillon had to engineer mice whose FoxO genes would function normally during development, but would contain a mechanism allowing them to be switched off in adulthood at the scientists’ will. It took DePinho’s team about two years to get the system to work, which Gilliland hailed as a “true tour-de-force of mouse genetics.”

Mutant FoxOs have been implicated in leukemia, and for Gilliland, who studies blood cancers, the triple-knockout mice were an opportunity to dig deeper into the issue. Unexpectedly, however, deletion of FoxO1, 03, and 04 caused blood cell abnormalities but not outright leukemia. A bigger surprise was that the blood stem cells “were really in trouble without those transcription factors,” he said, dividing too rapidly, losing their ability to renew themselves, and dying out. “This means that FoxOs contribute to the longevity of stem cells, and if you take them away, you dramatically shorten stem cells’ lives.”

Looking further, Gilliland and his colleagues found that the damage was being caused by reactive oxygen species, or ROS, a toxic byproduct of cells’ energy production. When the mice were treated with anti-oxidants, the stem cells regained health and longevity. “So, the FoxOs are acting as natural antioxidants,” said Gilliland. Conceivably, he added, drugs could be developed to manipulate the FoxO pathway and extend the lives of stem cells beyond their natural limits, which could aid their use in repairing diseased body tissues.

Texas' limited research funds should be spent on supporting the State's cord blood bank system and continuing research that will give us real cures for Texas' patients.

Note: First paragraph edited for grammar at 10:25 AM CST.

Documentation of stem cell cancer link

From Science Daily, January 22:

U.S. scientists have clarified how normal stem cells become cancer stem cells, as well as how cancer stem cells can cause the formation of tumors.

Dr. Xi He and associate investigator Linheng Li, both with the Stowers Institute for Medical Research, studied the intestinal system in mice in which one of the human tumor suppressor genes, PTEN, had been deleted.

"We found that a loss of PTEN in intestinal epithelial cells accompanied by a loss of PTEN in stromal cells can lead to changes that may increase the number of stem cells and change their position or location," said Li. "These changes result in crypt fission and budding and can lead to intestinal polyposis and uncontrolled tumor growth."

"What we learned," added He, is that "cancer stem cells are a rare population in the tumor mass; that they are slow cycling, but more active than normal stem cells; and that cancer stem cells and stromal insertions initiate the process of primary tumorigenesis ..."

The study appears on the Nature Genetics journal's Web site.

WARF relaxes embryonic stem cell fees and rules

The Wisconsin Alumni Research Foundation holds the patents on virtually all embryonic stem cells that have ever been produced, that ever will be produced, and of all the technological and medical results of that research. At least according to them, and at least in the United States.

And they've been sued by other researchers because of those patents - and not only because of the money involved.

However, early this week the Foundation announced that they will relax some of their earlier restrictions and that they will not charge some researchers for licensing fees. According to the Sacramento Bee,

The Wisconsin foundation that holds patents covering U.S. embryonic stem cell research will waive some of its fees to encourage more industry-sponsored research.

The changes follow criticism from scientists who said the Wisconsin Alumni Research Foundation's fees and its licensing system were driving some investment overseas.

Scientists around the country hailed the policy changes, which will let researchers share their cells for free and allow companies to sponsor research at universities without having to obtain licenses that cost up to $400,000.

"The notion of reducing fees and sharing cell lines and enabling companies to sponsor research at academic institutions is a good thing and should help push the research forward," said Brock Reeve, executive director of the Harvard Stem Cell Institute.

The Wisconsin foundation controls three patents covering research by University of Wisconsin-Madison scientist James Thomson, who in 1998 became the first to grow and isolate human embryonic stem cells. The patents are broadly written to cover the cells and research techniques used by many American scientists.

Nevertheless, the lawsuit will not be dropped, according to SignOn San Diego, by the Union Tribune

But despite the policy changes, the patent challenge will not be dropped, said Loring and John Simpson, of the Foundation for Taxpayer and Consumer rights, one of the groups challenging the patents.

“A change in licensing policy of the human ES cell patents doesn't solve the fundamental problem that the patents should not have been issued in the first place,” Simpson said. “The right thing for WARF to do is admit that it doesn't deserve the patents and abandon them in their entirety.”

Review of Umbilical Cord Pancreas Cells

I've read the unproofed draft (their English is much better than my Korean) of "Induction of human umbilical cord blood-derived stem cells with embryonic stem cell phenotypes into insulin producing islet-like structure" by B. Sun, et. al. (Biochem. Biophys.Res. Commun. (2007), doi:10.1016/j.bbrc.2007.01.069)

The authors do not tell us how much of the insulin-secreting cells or colonies of cells they were able to obtain. However, they do report that at one stage, the cells exhibit Oct-4 and "stage-specific antigen 4"(which are characteristic of embryonic stem cells). After inducing umbilical cord cells to revert to these embryonic-like stem cells, they then followed a previously reported protocol for inducing embryonic stem cells into beta islet cells. Colonies of cells grew in islet-like structures and were positive for both insulin and C-peptide. The C-petide is indication that the insulin came from the cells, and not from an artificial source in the nutrients in which the cells were grown.

Time will tell whether the photos are real, whether the results can be replicated in other labs, whether there are enough babies born and cord blood to be obtained to match all the diabetic patients in the world, whether it's possible to transplant immune-matched islet cell structures into humans, and whether those islet cells will survive and function in the recipients. I wonder whether the manipulated cells will be genetically stable or whether they will be prone to die or mutate.

On the other hand, if as in hematopoietic stem cell umbilical cord blood transplants, the cells do not have to be as closely matched in order to be accepted by the immune system, and if these cells persist as long as maternal stem cells have been reported to do, then this report brings us the most promising news of a possible treatment if not cure for diabetes that I've seen in all these years of stem cell reports.