Friday, March 02, 2007

"Back Alley Death" ("Physician Assisted Suicide" )

Oregon and Vermont - extremes on the map and extremes on medical ethics. But this is the first time that I've heard that doctors should give patients a deadly prescription to prevent a "back alley" death.

How many of us really want our Family Doctor to be proficient in killing? Or, in over-riding his or her conscience?

The Vermont Legislature is once again considering legalized, intentional death by medication and physician prescription.

From the Burlington Free Press:

Is it suicide? That's at heart of Statehouse debate

Published: Thursday, March 1, 2007
By Terri Hallenbeck
Free Press Staff Writer

MONTPELIER -- Dr. Robert Orr read the Webster's Dictionary definition of suicide: "The act or an instance of taking one's own life voluntarily and intentionally especially by a person of years of discretion and of sound mind."

How, he asked, is that different from proposed legislation that the House Human Services Committee is considering that would allow a terminally ill patient to hasten dying with a lethal dose of medication?

We're trying to change the dictionary definition we've been working with for years," he said.

Dick Walters, an ardent supporter of the legislation, sees the two -- suicide and physician-assisted dying -- as entirely different things. "Suicide is a desperate act," he said. "It's done in a back alley, a barn. It destroys families.

"What we're talking about in H. 44 is something totally different," he said. "They're doing this under care, with loved ones around them. They're saying goodbye in a way supportive of their own values."

(emphasis mine)


HT to Bioethicsnews.com

Thursday, March 01, 2007

Free Access Nature Reviews Molecular Cell Biology

If you'd like to learn how little you know (except you, Rebecca of Mary Meets Dolly), Nature Reviews Molecular Cell Biology is offering free access this month, with free registration.

The free registration itself is valuable - because you'll be able to access some of the news@nature items and receive Tables of Contents of many of the Nature Group of journals each month.

The titles this month include "Stem cells: Fledglings escape from the niche," "Post-translational modification: A smooth handover," and a review of "Research Highlight: In the News: A distinct human signature". Some of which I think I understand.

Edited March 6, 2007 for the wrong name of the owner of "Mary Meets Dolly," which I tried to change from Rebecca to Rachel.

Embryonic SC researchers claim doubtful "first"

Beware of Press Release science reporting - the job of the news release or public affairs department of an institution is to get publicity, not to promote scientific knowledge. There's no peer review until after the fact, and the goal is to catch our attention, rather to educate.

A case in point was the announcement yesterday from the the University of Texas at Houston Brown Foundation's Institute of Molecular Medicine researchers' Press Release that begins:

UT Scientists Develop Promising New Procedure To Differentiate Human Embryonic Stem Cells

HOUSTON – (Feb. 26, 2007)—Molecular scientists at the Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases (IMM) – which is part of the University of Texas Health Science Center at Houston – have developed a new procedure for the differentiation of human embryonic stem cells, with which they have created the first transplantable source of lung epithelial cells.

The process, created in the laboratory of Rick A. Wetsel, Ph.D., a professor of molecular medicine at the IMM, is described in this week’s edition of the Proceedings of the National Academy of Sciences (PNAS). Research scientist Dachun Wang, M.D., is lead author of the article, “A pure population of lung alveolar epithelial type II cells derived from human embryonic stem cells.”

“We have developed a reliable molecular procedure which facilitates, via genetic selection, the differentiation of human embryonic stem cells into an essentially pure population of lung epithelial cells,” said Wetsel, noting the procedure also can be used to create other types of highly-specialized cells.


The word that seems to carry the most weight in that first paragraph is "transplantable." And a lot depends on how they define that word.

Since I can't find any mention of the article on the internet, except in the press releases, I'm not sure exactly what "transplantable" cells means to these guys.

However, I am convinced that they are not the only ones to derive alveolar II lung epithelial cells from stem cells.

As reported, here and very few other places, last November 1, 2006 - you know, just before the Midterm election and Missouri's disaster with the clone and kill bill - researchers at the University of Minnesota Medical School at Minneapolis published a report in Cytotherapy on their production of functioning alveolar II epithelial lung cells, capable of producing surfactant, from a certain population of umbilical cord blood stem cells:
BackgroundUmbilical cord blood (UCB) has been examined for the presence of stem cells capable of differentiating into cell types of all three embryonic layers (i.e. endo-, ecto- and mesoderm). The few groups reporting success have typically confirmed endodermal potential using hepatic differentiation. We report differentiation of human UCB-derived multipotent stem cells, termed multilineage progenitor cells (MLPC),into respiratory epithelial cells (i.e. type II alveolar cells).
Methods Using a cell separation medium (PrepaCyte-MLPC; BioE Inc.) and plastic adherence, MLPC were isolated from four of 16 UCB units (American Red Cross) and expanded. Cultures were grown to 80% confluence in mesenchymal stromal cell growth medium (MSCGM; Cambrex BioScience) prior to addition of small airway growth medium (SAGM; Cambrex BioScience), an airway maintenance medium. Following a 3-8-day culture, cells were characterized by lightt microscopy, transmission electron microscopy, immunofluorescence and reverse transcriptase (RT)-PCR.
Results MLPC were successfully differentiated into type II alveolar cells (four of four mixed lines; two of two clonal lines). Differentiated cells were characterized by epithelioid morphology with lamellar bodies. Both immunofluorescence and RT-PCR confirmed the presence of surfactant protein C, a protein highly specific for type II cells.
Discussion MLPC were isolated, expanded and then differentiated into respiratory epithelial cells using an off-the-shelf medium designed for maintenance of fully differentiated respiratory epithelial cells. To the best of our knowledge, this is the first time human non-embryonic multipotent stem cells have been differentiated into type II alveolar cells. Further studies to evaluate the possibilities for both research and therapeutic applications are necessary.


Unfortunately, most of the sites that are picking up the PR are just publishing it whole, without evaluation or editing.

For instance, ScienceDaily, one of my favorite science news sites, published the intact, clearly labeled "Press Release", although that site also published the press release on the earlier, UCB stem cell derivation of alveolar II cells.

So far, I've only seen one note on the UT announcement that distills the info available to the news, without the hype. LongevityMeme, a blog devoted to technology and science showing promise for the extension of the human lifespan, has not duplicated the silly "transplantable" or "first" claims. The post explains the pertinent points very well (click to the original for the embedded links):
Examples of continually improving control over stem cells have been rolling in of late; here is one from the University of Texas: "We have developed a reliable molecular procedure which facilitates, via genetic selection, the differentiation of human embryonic stem cells into an essentially pure population of lung epithelial cells ... the procedure also can be used to create other types of highly-specialized cells. ... The method involves the use of protein markers under the control of cell-specific promoters to convert undifferentiated human embryonic stem cells into highly-specialized cells. The human embryonic stem cells were cultured on specially coated dishes and transfected with a lung epithelial gene regulator of a drug selection gene. ... It is a general technology for developing select cells from human embryonic stem cells. The technology has allowed us to develop a platform that could potentially be useful in the development of spinal cord cells, heart cells, nerve cells and others. ... transplantable alveolar epithelial type II cells can be explored as treatments for pulmonary genetic diseases, acquired lung disease, as well as lung trauma caused by car accidents, gunshot wounds and sports injuries. ... These are the cells that can potentially be used for regenerative lung repair."
(emphasis is mine)

The "transfected gene" treatment used to induce the embryonic stem cells to develop along the desired line appears to me to be a step that will complicate the testing and approval of the use of these cells in humans. I'm not convinced that surgery will be the optimum use of the outcome of stem cell regenerative medicine. I'm convinced that we will use what we learn to induce, stimulate and and recruit the body's own regenerative stem cells in place, as we need them

If the transfected gene is safe, then, perhaps it will be the treatment in the future. Or, perhaps the UT lab and the UM lab can collaborate on truly transplantable cells, if necessary.

Wednesday, February 28, 2007

MIT adult stem cell research soap opera?

Yesterday's Massachusetts Institute of Technology press release ("MIT bioengineer advances survival, promise of adult stem cells")led to the story behind the story and and maybe more.

Behind them all, of course is the truth that human embryos are, indeed human, and that there is not any difference between the embryo in the petri dish and the one that each of us once was.

The February 27, 2007 Press Release concerns an article published on line in the January 18, 2007 online edition of Stem Cell Express Online. The Abstract is available here. According to the website, the paper, "Tethered EGF Provides a Survival Advantage to Mesenchymal Stem Cells" was submitted last year, on May 26, 2006 and accepted for publication January 9, 2007. The research supports that stem cells develop in reaction to and influenced by their environment and details a way to manipulate the growth factor EGF on an implanted scaffolding to encourage bone marrow mesenchymal cells to develop bone and encourage healing after surgery or severe wounds.

Linda G. Griffith, Ph. D., leads the Griffith Lab at MIT, which focuses on bioengineered tissue, using adult stem cells. In fact, the MIT press release and the Science Daily adaptation both mention that Dr. Griffith has a personal interest in preferring to avoid research on embryonic stem cells.

Griffith, who does not work with human embryonic stem cells, believes that adult stem cells offer promising therapeutic possibilities.

"I'm very optimistic about the potential for adult stem cells to be useful clinically for the problems I work on, since there are already some clinical successes based on these cells" she said. "Continuing, careful, methodical work will lead to improved therapies based on adult stem cells. We are aiming to expand the range of therapies that work in the clinic." Griffith is one of several MIT biological engineering faculty members who work with adult stem cells but not human embryonic stem cells.

Griffith is also one among many scientists around the world who have at least some objections to creation of human embryonic stem cells, for a variety of reasons. She says her current focus on adult stem cells is driven largely by the interesting science and the feasibility for near-term clinical use for the types of cells she investigates. However, she also avoids research with human embryonic stem cells following a personal experience with in vitro fertilization almost 10 years ago.

"Like some other scientists I know, my personal views about creating human ES cell lines changed when confronted with the reality of doing so from my own embryos. After this experience, I was not comfortable conducting human ES cell research myself, and I have a better understanding of why some scientists object to all work with human ES cells," she said. She also said she feels her personal views, and those of others, are respected in the scientific community.

Currently, federally funded research is only allowed on certain established lines of embryonic stem cells, although a few states, including California and Connecticut, offer state funding for broader embryonic stem cell research. There are no legal restrictions on funding to study adult stem cells.


These quotes are exactly what so many of us have been saying all along. I certainly intend to use them in any testimony I give in the future, although I wish there were not quite so much stress on the theme of "personal views." I don't see much room for personal views in whether or not the embryos who are her children and those who other researchers would disaggregate for stem cells.

What's the story behind the story? We may never know all of it. But here's just a bit from an article on the MIT website about the hunger strike of Dr. James Sherley which was also covered here earlier this month:
Additionally, Sherley also outlined his main reasons for complaint, which included denial of independent lab space by then Provost Robert Brown and the conflict of interest that resulted from the spousal relationship between Lauffenburger and BE Professor Linda G. Griffith led him to believe his case for tenure was not handled fairly.

Do not look behind the curtain! (again, with the magic tricks)

I'd say the man who said this needs both a heart and a brain:

"Ultimately, human hearts, human brains, and human kidneys and human pancreas will be re-created in their entirety from human embryonic stem cells or some combination of adult and embryonic stem cells," Willerson said.


He's certainly got enough nerve.

Tell me what happens when you get a new brain, in its "entirety," Doctor.

On the other hand, there's this brilliant man who's using the brain and heart he's got:
Dr. Karel Dicke, an oncologist at the Arlington Cancer Center, uses stem cells found in patients' bone marrow to ease their recovery from high-dose chemotherapy.

Dicke, who has conducted research into adult stem cells for more than 40 years, said he opposes the use of public funds for embryonic stem-cell research because it doesn't have enough public support. He echoed statements from opponents of such research in noting that the field may not be as promising as some have predicted.

"It is not that far along yet," Dicke said. "Scientists are making political statements."


Of course, it's really all about the money. As I've said before - stem cell therapy of the future will not depend on the destruction of embryos. The goal will be to use the patients' own stem cells in site, when and where they are needed. Umbilical cord and placental cells are plentiful and have shown themselves plastic enough to provide the tissues and organs that we will need. (Where the repair cannot be made in situ. Edited, March 19, 2007. BBN)

Researchers in Minnesota
have produced beating heart muscle from stem cells taken from the hearts of rats. In humans, they say they are using muscle from the legs to heal hearts in place.

Have a look at more stem cell advances in this article.

Dr. Anthony Atala's group at Wake Forest University grew nerve stem cells that homed in to the areas of the brain where they were needed. Last year, Zurich researchers reported work to develop heart valves for babies from their amniotic stem cells, even before they were born.

We don't need the smoke and mirrors, Doctor Willerson. You and others have already shown us that we already have a future without embryonic stem cells.

Jesus, embryos, research, and IVF protesters


Newsday printed an op ed by Michael D. Kerlin, "Where faith and stem cells meet: Jesus might have us use embryos - otherwise destined to be discarded - to aid the sick and dying." (That's pretty much it, except to testify to his Christianity, his alma mater, and to lay the fate of all sick and dying at the feet of President George Bush.)

As I commented at the site, Jesus taught that "self" belongs in front of "sacrifice."

The other posters and Mr. Kerlin do not seem aware of the facts about the numbers of embryos that would actually be available for research.

And a couple of the posters are horrified that I set the responsibility for ensuring the safety of the embryonic humans on the parents and the labs who created humans in harm's way. They ask whether I would forbid in vitro fertilization (IVF) and tell men and women who are unable to have children by natural intercourse, "tough luck." One poster doubts my sincerity, since there are so few picketers and protesters outside of IVF facilities. He questions whether the protests are only hypocritical abuse and harassment of poor single women, rather than rich couples seeking IVF.

There was a RAND study on the numbers of embryos available for research (Hoffman DI, Zellman GL, Fair CC, Mayer JF, Zeitz, JG, Gibbons WE, and Turner TG. May 2003. "Cryopreserved Embryos in the United States and Their Availability for Research." Fertility and Sterility 79 (5): 1063–1069.)and Art Caplan published one a few years ago, and he was surprised at how few parents would even consider research and how reluctant they and the clinics were to simply destroy the "excess" embryos. In addition, for those currently frozen, it's unlikely that the proper informed consent.

Yes, there are few protesters at IVF clinics, because most people have empathy for the parents who want children so much that they would go through all that IVF requires. Also, most people simply aren't aware of how many embryos are discarded.

However two wrongs don't make a right. Again, "self" should always precede "sacrifice."

It was our empathy that created the current situation, where the brothers and sisters of those babies who are now in the arms of the parents who wanted them so much died during the IVF process and more are frozen and at risk. We must steel ourselves to resist the temptation to help "the sick and dying," everyone from celebrities to tiny children who beg us and our legislators to sacrifice human embryos for their sake.

Who is to decide that some humans may be destroyed and dissected for research or so many spare parts for the benefit of someone else?

Because we know that embryonic stem cell research leads to a slippery slope. We know because some men and women have already fallen down that slope.


I'm sure that most of us have read about the women paid to become pregnant and have abortions for research and profit in the Ukraine and about all the full term healthy babies who mysteriously die in some of that country's hospitals. At one of these hospitals, graves of infants who had had brains and other organs have been found.(More here and here. Warning - graphic descriptions)

Tuesday, February 27, 2007

"Flawed" Adult Progenitor Cells Study

Lots in the stem cell news about the report a few years ago that certain populations of adult stem cells can become "any cell in the body."

No one doubts whether Verfaillie found the stem cells that she said she did. The problem is that there were mistakes in the reports about how she actually did it and that other labs have had a hard time duplicating her work. From the New Scientist article on the "flaws":

"In her most recent paper, Verfaillie and Irving Weissman, a stem cell biologist at Stanford University in California, showed that MAPCs can give rise to all the cell types found in blood, but it is still unclear whether MAPCs are as versatile as she claimed in the original Nature paper."


Many researchers are unable even to isolate them. “They’re very testy cells,” observes Amy Wagers of Harvard University, who spent a week in Verfaillie’s lab trying in vain to learn the technique.


The problems with the marker profiles may help explain these difficulties. “If I had been following this recipe since 2002, I’d be extremely angry,” says Jeanne Loring, a stem cell biologist at the Burnham Institute for Medical Research in La Jolla, California.



There's a much more detailed evaluation on the original report in yesterday's The Scientist:

Tim Mulcahy, vice president for research at the University of Minnesota, told The Scientist that the university asked two experts in flow cytometry to review the data, and they found "technical flaws with the paper," but said they didn't have the background to determine if the problems affected the results. The university then contacted three stem cell experts, and two agreed to review the data. One reviewer said the flawed data wouldn't affect the findings, and the other said the flaws might "weaken the conclusions," Mulcahy noted. He said the university decided to release the information to allow the scientific community to debate the impact of the panel's findings. The university is not releasing the names of the stem cell experts who reviewed the data.

Mulcahy added that Verfaillie asked the university to investigate the findings, and has been very helpful. "This was all done with her consensus and her willing cooperation."

The outside experts agreed with Aldhous that the antigenic markers used to define the MAPCs were in question, Verfaillie said -- "as do I," she added. But these concerns don't affect the results, she noted. "As MAPCs were - and still are - not defined on the basis of a phenotype, but based on functional criteria, I believe therefore that the conclusions of the papers are still correct. Obviously that is up to the scientific community to decide."

The current debate is over a "minor point," said Diane Krause, a stem cell researcher at Yale University. The concerns about the Nature paper focus on the "antigenic profile of these cells, and not what they can do," she told The Scientist. "I certainly believe Catherine," Krause added. "I think she's got the highest amount of integrity."

Indeed, researcher Mark Clements, from Westminster University in London, UK, has had some success replicating Verfaillie's results with human cells. "The inaccuracies in Catherine's papers do cast a shadow over her work," he told The Scientist, "but I do believe the underlying premise is valid."

Clements said the errors in the paper raise questions about the definition of MAPCs in terms of cell markers, but agreed that the overall premise of the paper is intact. "Our experience of the human cells tells us that the main problem with them is that they're so fastidious to grow," he said. This would explain why other labs and indeed Catherine's lab have had difficulties replicating this work, Clements said.

Thomas Braun from the Max Planck Institute for Heart and Lung Research in Germany told The Scientist he thinks the explanation for the duplication of the figures was adequate. "Things like that happen although it is always hard to understand why such errors are not recognized at an earlier stage," he said.



A follow up study published in Journal of Experimental Medicine (I don't have link) and reported on in Science,that included doubter Irving Weissman proved multipotency, if not pleuripotency.

"The work has impressed one skeptic, Stanford blood stem cell researcher Irving Weissman, who collaborated on the new work. Weissman calls the result "remarkable." His skepticism, he adds, "makes me a perfect collaborator, because I insisted on very rigorous criteria for the experiments."

He emphasizes, as does Verfaillie, that these cells are clearly not as versatile as ES cells. But despite their limitations, they could prove to be useful therapeutically.

"A lot of people have lost interest in MAP cells by this point," says Weissman. "What our paper will help do is get everybody to look at it again." Others agree. "I'm sure it will revive interest in MAP cells," says stem cell researcher Paul Schiller of the University of Miami, Florida."



Perhaps, now that the "recipe" is corrected, more labs will confirm the original reports.



Different populations and kinds of adult stem cells are indeed very versatile, especially for producing what we really want: stable cells that will only become the exact specialized cells that are needed, where they are needed.


Adult stem cells have yielded more populations of specific progenitor and stem cells than even embryonic stem cells. The only place that embryonic stem cells work to produce "every cell in the body" is in the original container - in the intact embryo. Elsewhere, they produce embryoid bodies or teratomas, or mutate and die out unless first manipulated to become a more specialized stem cell or progenitor cell.


Which sounds like an adult stem cell or progenitor cell, to me.

Part of the problem with all stem cell research is that, as in the press coverage, scientists have also been "shotgunning" with groups of cells as though all samples stem cells are a bunch of homogeneous one size fits all entity. Slowly but surely, we're learning what markers to look for in order to find the most primitive or the exact future lineage we need, the environment, stimulating factors and the epigenetic factors involved.


If we think the progress has been fast before, I don't think it's anything like what will happen in the next 5 years.

(HT to FreeRepublic's neverdem.)

Saturday, February 24, 2007

The key to stem cell research (no one dies)

Every living cell in our bodies has the whole set of genes that it took to grow us from a one cell embryo to the beautiful blogging people that we are now. It's just that the whole set is never working at any one time. Our growth, development, abilities and repair depend on whether a certain gene or set of genes is turned on or off by (what I think of as) the addition of keys and locks and cushions.

We constantly hear about the embryonic stem cell's ability to "develop into every cell in the body" (and all those pesky tumors when they're used in animals), as well as the trouble getting adult stem cells to work fast enough to repair damage. There's also the problem of aging, which is really just when our body can't replace dying cells as fast as we lose them, added to the fact that the cells themselves seem to die sooner and more often.

Epigenetics are the influences in the cell that turn certain genes on and others off. And they are the hot topic in the serious study of stem cells, embryology and medicine.

Stem cells rely heavily on epigenetic signals. As a stem cell develops, chemical tags on the DNA or its surrounding histone proteins switch genes on or off, controlling a cell’s fate.


You may hear of "methylation" or "imprinting" of genes. These chemical processes are how the DNA program within the nucleus of the cell - the blueprint and instructions for what the cell will do today or for the rest of its life - is set. They are the "epigenetic" conditions that fold away some genes and expose some others so they can be read.

One of the cushions is the telomere. After Dolly the sheep was cloned, we heard about telomeres - the repeating tags on genes that make the difference between a gene being young or old. I think of the string of telomeres as a roll of postage stamps. Each time you send a letter, you use a stamp, and eventually you don't have any.

In the same way, genes lose telomere segments when they are copied. Eventually, there are not enough telomeres to make the gene copying system kick in. But, sometimes, telomeres can be added by the cell's system and sometimes they aren't lost at all during copying.

What if you could go to the telomere office and buy a new roll or, better yet, if you could just make the ones you need in your own cells, when and where you need them?

Public Cord Blood Banks

Georgia Senator Shafer has introduced a bill that would make that State the first to dedicate funds to a public bank for both cord blood and placental and umbilical cord tissues. This follows a move across the country to begin public, rather than private, cord blood banking for therapy and research.

MD Anderson (MDA), our big cancer research and therapy center in Houston, Texas, has announced that it has received $9 million from the Federal Health Resources and Services Administration to support their Cord Blood Bank. MDA is already collecting units at two hospitals in the area.
The Texas Cord Blood Bank has been growing since a push by then Representative, now State Comptroller, Elizabeth Ames Jones and our Governor Rick Perry led the move to dedicate State funds. The first $1 million dollars in Federal money was matched by State money and again by private donations. In 2005, Governor Perry awarded a grant of an additional $1.2 million in matching funds (meaning that the grant will match each dollar donated from private donors). TCCB is currently collecting cord blood at 4 hospitals, one in North Dallas, one in San Antonio, and at hospitals in two cities in the Rio Grande Valley. (See the video on the Cord Blood Bank at Jones' campaign website.)

I'm convinced that cord tissues contain the stem cells that will offer all the therapies and hope that we hear about from the advocates of destructive embryonic stem cells. And we're throwing them away, every day.

Friday, February 23, 2007

Cow-Monkey blastocyst research

The truth about the goal of researchers seeking to make chimeras and clones is in the news, today. (A big "yuk" factor, here.)

I'm convinced that the future is in stimulating and recruiting the patient's own stem cells and regenerative potential, in site, where and when it's needed.

Animal research is acceptable, but once they start manipulating human DNA, we're dealing with humans until proven differently.

The (South) Korean Times reports on work in the lab of Koo Deog-bon:

The team, headed by Koo Deog-bon at the Korea Research Institute of Bioscience and Biotechnology, said Friday they had established a monkey blastocyst, the source of stem cells, last month via interspecies nuclear transfer.

``We started the task of infusing monkey somatic cells into cow ova, from which the nuclei had been removed, last November. After hundreds of failures, we made a blastocyst in January,'' Koo said.

``It failed to thrive. But we became sure of the potential of interspecies research _ creating a blastocyst and extracting stem cell batches from it,'' the 41-year-old senior researcher said.

A blastocyst is an embryonic form at a stage where it consists of 128 cells. With its inner cells still undifferentiated, the blastocyst is the most important source of embryonic stem cells.

Scientists have made monkey blastocysts through intra-species nuclear transfer _ implanting monkey somatic cells into enucleated monkey ova. But this is the first time that a blastocyst has been established while using non-monkey ova.

``We will generate more monkey blastocysts to achieve our goals of culturing stem cell lines with them earlier than our competitors,'' said Koo at the state-backed institute.

Developing cloned non-human primate stem cells is significant in speeding up futuristic therapy by evaluating the pre-clinical safety and immune-tolerance of stem cell transplantation.

``If we are successful, we will be able to apply the technologies to humans _ making stem cells with animal ova _ if society allows such an idea,'' Koo said.

As Koo pointed out, the interspecies experiments can in part solve some of the ethical debates surrounding the making of cloned human embryonic stem cells because they don't use human eggs.

Thursday, February 22, 2007

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.

Wednesday, February 21, 2007

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.

Tuesday, February 20, 2007

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.

Sunday, February 18, 2007

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.

Friday, February 16, 2007

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."

Thursday, February 15, 2007

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.

Wednesday, February 14, 2007

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?

Thursday, February 08, 2007

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.

Wednesday, February 07, 2007

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.