Embryonic stem cell research is older than it looks

Here's a ready answer the next time you hear the talking point that embryonic stem cells were only discovered in 1998, and so we should just get out of the way and let the poor researchers play with their new toy.

From the Wisconsin Technology Network:

In challenging the WARF patent, the Public Patent Foundation submitted what it said was unseen "art" or evidence that the previous work of other scientists made the derivation of human embryonic stem cells "obvious and therefore unpatentable."

Dr. Jeanne Loring, a stem cell scientist with the Burnham Institute for Medical Research, said the real invention was made 25 years ago, when embryonic stem cells first were discovered. Loring said Thomson "just followed a recipe written by other scientists, and there's nothing patentable about that."

Loring has provided the USPTO with more than 30 pages of information chronicling previous stem cell discoveries. (emphasis is mine)

Embryos, Dickeys, WARFs, and "rat poison."

Maybe I should have called this column "I smell a rat."

All this fuss and bother that Sam Berger is making in today's blog.bioethics.net "Guest Column" over the lack of federal funding of embryonic stem cells had me following links and searching Google half the night in an effort to decide whether or not Berger's political bias as a research assistant for the Progressive Bioethics Initiative at the Center for American Progress who seems to base his essays on his objection to the Bush Administration had anything to with his spin. The more I read,the more convinced I became that Berger is bound to know better than to claim that the only thing holding American "progress" back is the lack of our federal tax money.

For one thing, in vitro fertilization has done just fine and dandy without Federal funds or regulations for 30 years. How else do you explain the big business of assisted reproduction and those 400,000 "spare" human embryos that Berger wants to tear into?

George Q. Daley, MD, PhD, who (when he's not trying to clone human embryos) makes his living creating and disassembling human embryos at Harvard, absolutely contradicted Berger's assertion in his 2003 article for The New England Journal of Medicine. Three years ago, Daley outlined his conviction that the limit on federal funds wasn't really the biggest problem facing researchers (sorry, the NEJM is subscription only):

An even more restrictive element of government policy prohibits the use of funds for "the creation of a human embryo or embryos for research purposes; or . . . research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death." Proposed in 1996 by Representative Jay Dickey (R-Ark.) as a rider on the appropriations bill for the Department of Health and Human Services and renewed every year since, the Dickey Amendment prohibits federal engagement in a field of research pertaining to the nature of the human embryo, its disorders of development, and the derivation of new human embryonic stem-cell lines.(elipses in original, bold is mine.)

(Daley failed to mention who was the President in 1996 and indulged a little political bias by mentioning that the challenger in the 2004 Presidential election had promised to over turn the Bush policy.)


The biggest hurdle for researchers may not even be law and the limits of federal funding:

In 1998, University of Wisconsin researcher James A. Thomson received the first embryonic stem cell patent in the United States, after claiming he had a recipe for extracting the cells from primate embryos.

Thomson received additional stem cell patents on the process in 2001 and last April.

Under the patents, a researcher in the United States who uses embryonic stem cells in any way must pay a licensing fee to WARF, the university's licensing arm.

“Outside of the (U.S.) government, the No. 1 hindrance to stem cell research is the WARF patents because of how they try to enforce their licenses,” said Mahendra Rao, the former head of the National Institutes of Health's stem cell efforts.(emphasis is mine)

"WARF," the Wisconsin Alumni Research Foundation and its subsidiary, Wicell, hold and manage the patents and licenses on embyronic stem cells, pretty much however, whenever and whereever they're derived or used. WARF and WiCell constitute the monopoly that controls embryonic stem cell research in the US and much of the world, through an agreement with the NIH to distribute cell lines, by selling near-mandatory stem-cell-how-to-courses at the University of Wisconsin and by collecting royalties and license fees on their patents. Some of those licensing rights have been assigned to a WiCell start-up, Geron. (The interconnection of the most visible US bioethicists with each other and with WiCell, Geron, and the generator of press releases for "ethical" embryonic stem cells, ACT, was the subject of my "Ethicists for Hire?" last week.)

Not everyone is happy about the monopoly.:

Rights held by Geron, a San Francisco Bay Area biotech company, represent another expensive hurdle. WARF gave it exclusive commercial rights for the use of embryonic stem cells in treating cardiac, nervous system and pancreatic diseases.

If a company wants to develop therapies in these areas, it must negotiate a licensing fee and royalties with Geron.

and,

Recently, the California institute's board decided that if a grant-receiving organization made a discovery with Proposition 71 dollars that could be patented and sold, a portion of the profits would be returned to the taxpayers.

The board debated this policy at length, because it was looking for a balance between getting a return on the investment of taxpayers and not hindering scientific development.

WARF has decided it is entitled to a cut of the state's royalties.

“They are building a program using our patent. You can't build a program on our patents and pay us nothing,” Donley said. “Who has dollar signs in their eyes now?”

Which reminded me that "WARF" also owns the rights to "warfarin," the blood thinner that was originally developed in the late 1940's as the main ingredient in rat poison.

Reflection on an anniversary (9-11, Katrina)

Lots of news and reviews this week and last due to the anniversaries of the aftermath of Katrina and the 5th anniversary of the attacks on our Nation on September 11, 2001. The ethics of the responses to the grief and impact on our lives could (and should, in my opinion) be part of our discussions.

The Bioethics Discussion Blog, by Maurice Bernstein, M.D., has a post that quotes "Janet" who lists some of the many causes of pain and suffering in the world and says,

These things are happening each and every day, causing a total of death and suffering far greater than September 11, but they don't make the headlines. Enough people who cared and who opened their hearts in the same way they did to the September 11 victims could make an unbelievable difference to many of these situations. I don't mean to make light of September 11 or the victims' suffering, but I freely admit it makes me angry that events like this are considered the epitome of tragedy against which all else is supposed to pale into insignificance. The real tragedy to me is the number of horrors in this world about which people don't care.

Why do we mark the deaths and loss of a finite number of people due to a given event, while death and loss are daily occurances all over the world and throughout history? What makes the death of less than 3000 people in a few hours on "9-11" worthy of days of media coverage and conversation? On the other hand, how is it that we remember the flooding and its aftermath in New Orleans more than that in Mississippi due to the same hurricane or the tsunami, which happened in January of 2005, and which resulted in a huge outporing of charity and relief aide on the part of people around the world?

People aren't totally logical when it comes to weighing the "value" of pain and suffering. We think and react in our linear time and often out of the degree of empathy with the victims.

We react one way to the deaths of nearly 3000 people in a few hours from a deliberate act that was intended to make us feel threatened, another way to the horrors of slavery ongoing all over the world, and yet another to possibly billions of women being ritually mutilated, confined to the home, denied education and decent healthcare, and treated as non-persons.

But then, even in our own communities, we react in different ways when we hear that a young mother from our neighborhood died in a car wreck on the highway that we use to get to work and when we hear that a great-grandmother died after a long illness.

I guess it's sort of like the difference between the treatment of an acute trauma from a car wreck that shuts down several organ systems, a burst appendix in a teenager and Type II diabetes. All are life-threatening and will leave permanent scars and other effects, but the first is more directly threatening to us, making us remember that we could die the same way. The causes and results of the first seem completely out of our control unless we're the trauma surgeon, while the others require a quick burst of emergency response or a chronic titration of treatment, but we hope we can control or at least moderate the effects and even the cause of the latter two, bit by bit.

(Note, edited at 16:42 to clean up some of the language and make the title more readable.)

Answer to Embryonic Stem Cell Proponents

The Alliance for Medical Research is one of the embryonic stem cell advocacy groups active in my State, Texas. They're circulating a flyer around Austin titled, "What Makes Early (A.K.A. "Embryonic") Stem Cells Different From Adult Stem Cells?" Most of the points in the document are pure spin. Some are incomplete. A few are false.

You can read TAMR's talking points here.

Regenerative Medicine: WHAT MAKES EARLY (A.K.A. "EMBRYONIC") STEM CELLS DIFFERENT FROM ADULT STEM CELLS?

1. Adult stem cells have been studied for over 40 years and have been successful in treating diseases of the blood and bone marrow, like leukemia, and lymphomas.

“Every type of stem cell may be useful for injuries but are unlikely to cure most diseases, as underlying causes of uncured diseases are often not known. Stem cells may alleviate the symptoms for several years but not affect the disease process.” (“Adult cells are behind much of stem cell success so far” Jean Peduzzi-Nelson Milwaukee Journal Sentinel Online. Posted: Sept. 2, 2006 Accessed September 6, 2006 http://www.jsonline.com/story/index.aspx?id=489953)

70 Plus diseases are being treated and are in early trials and recruitment of human patients in brain trauma (Dr. Baumgartner in Houston), spinal cord trauma (Dr. Carlos Lima in Portugal), genetic defects in metabolism (Phase II and III patient recruiting under Federally funded research on Kostmann’s Syndrome or Congenital neutropenia as in my granddaughter's case, Batten’s disease, etc.)

More on the success and treatment in Michael Fumento’s July 18, 2006 rebuttal of the Letter to the Editors at Science Magazine in National Review “Science’s Stem-Cell Scam: It should change its name to Pseudoscience.”

“An article from the May 2006 issue of Current Opinion in Hematology notes that “there is presently no curative therapy” for sickle-cell anemia other than allogeneic hematopoietic stem cell transplantation. “Hematopoietic” means from marrow or blood; “allogeneic” means the cells are from another person. Seminars in Hematology (2004) states, “. . . curative allogeneic stem cell transplantation therapy” has “been developed for sickle cell anemia.” Meanwhile, “. . . curative allogeneic stem cell transplantation therapy [has] been developed for” sickle-cell anemia according to Current Opinions in Molecular Therapy (2003), while “hematopoietic stem cells for allogeneic transplantation” are “currently the only curative approach for sickle cell anemia” observes the journal Blood (2002).”

Parkinson’s has been treated with the patient's own adult brain neural stem cells in at least one human.

Corneal transplants grown from patient’s own stem cells.

"Researchers in the U.S. and Taiwan used corneal adult stem cells to grow new corneas for patients with previously untreatable eye damage. Adult stem cells were taken from the patients themselves in 16 cases, or a family member for 4 other patients. The cells were then grown in culture before transplantation onto the damaged eyes. Sixteen of the 20 patients had improved vision." Schwab IR et al. “Successful transplantation of bioengineered tissue replacements in patients with ocular surface disease.” Cornea 19 (2000): 421-426.

2. Early, or embryonic, stem cells were discovered in the United States in 1998. In the few short years since that time, animal studies with human embryonic stem cells have demonstrated their potential by reversing diseases and conditions like diabetes, Parkinson’s, and spinal cord injury.

ESC have been known and used in experiments for much longer, but no human embryonic stem cell **lines** were obtained until Thompson's work in 1998:

"Embryonic stem (ES) cells were first derived from the inner cell masses of mouse blastocysts in the early 1980s (1, 2). More recently, primordial germ cell cultures were found to give rise to cells with characteristics of ES cells and were designated EG (embryonic germ) to distinguish their tissue of origin (3, 4). ES and EG cells have now been derived from embryos of other mammals, including primates (5-10). Now on page 1145 of this issue, Thomson et al. (11) report the derivation of ES cell lines from human blastocysts." Science 6 November 1998: Vol. 282. no. 5391, pp. 1061 - 1062

Embryonic stem cells have only been used in animal models and have proven difficult to control. Parkinson’s was treated in an animal model – embryonic/fetal stem cells in mice cause teratomas in 1 in 5 of the animals.

3. Beyond therapeutic uses of early, or embryonic, stem cells, these cells also teach researchers:
1) how to make adult stem cells behave in a more useful way, 2) how particular diseases develop and progress and might be reversed, and 3) how drugs work on disease at a cellular level.
Animal models and non-destructive human stem cell techniques are being used in all of these ways.

4. Adult stem cells are found in some - but not all - body tissues. They have not been identified for every organ system and tissue. Adult stem cells can only become cell types from their own particular organ system. Therefore, adult stem cells can be used to cure only some – but not all – degenerative diseases and conditions.

In fact, most tissues have been found to contain stem cells or to be regenerated by stem cells from the bone marrow and other depositories. We are discovering the stimulating and recruiting factors, as well as other conditions that can induce adult and umbilical cord cells to reprogram. See number 5, below.

5. Unlike adult stem cells, early, or embryonic, stem cells have the potential to become any cell type of the human body. They have the potential to replace any cell damaged by disease or injury.
ESC are hard to control, causing teratomas, differentiating into other cell lines, or developing genetic mutations as they divide.

The research on guiding the development of all types of stem cells toward the desired cells requires specific environments, nutrients and stimulating factors. The research and use in therapy is farther along in animal models and human non-embryonic stem cells. Here's some examples:
a) Texas researchers at the UT Medical Branch at Galveston worked with NASA and British Researchers to turn umbilical cords into “embryonic-like stem cells.”

b) Researchers in Japan have published results showing how to induce adult mouse cells to reprogram into embryonic-like stem cells, without using oocytes or destroying embryos.

6. The term "embryonic" means that the cells are primitive or early. "Embryonic" describes the fact that these cells have not yet been committed, or programmed, to become a particular type of cell. They have the potential to become any cell type -- scientists call this characteristic "pluripotent."

Embryonic-like stem cells can be derived from non-embryonic sources. See #5 and the "Glossary," below.

7. Scientists acquire early, or embryonic, stem cells from two sources. They are derived from leftover fertilized eggs at in vitro fertilization clinics -- these eggs are either imperfect or excess and will otherwise be discarded. Early, or embryonic, stem cells also come from a laboratory procedure called Somatic Cell Nuclear Transfer (SCNT) -- which does not involve a fertilized egg.
There have been no human embryonic stem cell lines derived by SCNT or cloning. There are reports of stem cell lines from parthenogenesis.
See #5
Human embryonic stem cells require the destruction of an embryo, whether that embryo began by in vitro fertilization, parthenogenesis, or SCNT. All will require perpetual donation of endless numbers of oocytes that must be derived from women, with the hazards of superovulation.

Definition of embryo from the International Society for Stem Cell Research Guidelines (Draft, Summer, 2006),

Definition and use of the term “Embryo”
Embryo: The term “embryo” has been defined and used differently in different biological contexts. Classical embryology has used the term embryo to connote different stages of post-implantation stages of development (e.g. the primitive streak and onwards to fetal stages). Dorland’s Illustrated Medical Dictionary (27th edition,1988 edition, W. B. Saunders Company) provides the definition: “in animals, those derivatives of the fertilized ovum that eventually become the offspring, during their period of most rapid development, i.e., after the long axis appears until all major structures are represented. In man, the developing organism is an embryo from about 2 weeks after fertilization to the end of seventh or eighth week.” An entry in Random House Webster’s College Dictionary reads: “in humans, the stage approximately from attachment of the fertilized egg to the uterine wall until about the eighth week of pregnancy.” However, the nomenclature has now been used generically by modern embryologists to also include the stage of first cleavage of the fertilized ovum onwards to nine weeks of gestation in the human and to term in the mouse. Two, four, and eight cell stages, the compacting morula, and the blastocyst are all more precise terms for pre-implantation embryos. Prior to implantation, the embryo represents a simple cellular structure with minimal cellular specialization, but soon after implantation a defined axis of development called the primitive streak begins to form. After this time twinning of the embryo can no longer occur as there is irreversible commitment to the development of more complex and specialized tissues and organs.(Emphasis is mine)

And, actually, there is an axis that tends to be present from the penetration of zona pellucida by the sperm. If one or two cells are removed, as in PGD, the remaining cells reassemble in the same axes if the embryo remains intact and functioning:

“Other researchers suspect that the sperm's entry on one side triggers a complete re-organization of the egg's internal skeleton that then makes cells at different positions in the embryo divide at slightly different times.” (“Your Destiny From Day One,” Nature 418, 14-15 (4 July 2002))

McGee: Embryo research equals physician assisted suicide

Glenn McGee, one of the editors, pseudoeditors and bloggers over at the American Journal of Bioethics blog, Blog.Bioethics.net, posted a portion of his column, "The Kavorkianization of Dolly" for The Scientist.
Subscription is required for The Scientist, but you can read part of the snide column on the blog.bioethics.net site (or here). It may be worth subscribing just to have access to a complete copy of McGee's own words on why "physicians should kill dying patients" and "scientists should kill embryos" are pretty much the same subject.

In the blog, McGee daydreams about what he believes that Richard Doerflinger might be thinking. (We all do that, don't we?) McGee also manages to pack in a high ratio of insults per paragraph against "neocons," and others who might not agree with his own "progressive" and political views.

Professor McGee does a pretty good job of discrediting ACT and Ron Green, his old ACT ethicist-for-hire sibling:

Advanced Cell Technology people decided that the correct way to please the right to life crowd was to take IVF embryos (all together now, chant with the predictable pro-life response: "IVF=murder") that have been put through genetic diagnosis ("PGD=eugenics") and grow their cells in a way that might or might not yield good stem cell colonies but likely would produce at least a few totipotent cells as a byproduct ("cloning is evil").

To make sure the experiment aimed at pleasing pro-life would actually work, they tried it on 16 embryos first, then killed them all (Inside the mind of Richard Doerflinger: "please, please let these guys stay in the paper just one more day...") and justified the fact that none of the people who were supposed to love their experiment actually did by calling them (Lanza's words) "irrational" ("scientist=athiest or anti-catholic").

If there is a school to teach scientists how to screw up the pursuit of PR, ACT has the professors on retainer.

What is so puzzling is that the piece that reported this great innovation [well, great in the mind of William Hurlbut, though not particularly interesting to anybody who doesn't buy the science or ethics of these continuing, idiotic schemes to make "part embryos" in order to get Bush money] in Nature was interesting - at the level of a piece that merits publication in Nature - only because it was supposed to solve the ethics problem by appeasing those who seek embryonic cells created without an embryo. Hence there was no PR officer, just the ethicist, since the whole business amounts to an "ethics experiment."

So here is the ethicist and Lanza, the former constantly (and inaccurately) referred to as "unpaid" as though he spoke from a distance, defensively spinning this experiment rather than bothering to even consider the objections raised by those whom the experiment was supposed to please. It was like reading that "ask the ethicist" nonsense in The New York Times: as recently as yesterday Green was actually quoted as saying that if it weren't for all this controversy, there might be tons of new stem cell lines very soon [without any destruction of embryos] (which the experiment didn't prove), and that - my favorite - the controversy about the experiment just proves that there is lots of interest in this work.

Go team. Except, not.

The controversy proves unambiguously that ACT can cause half of the U.S., including the intended audience to be appeased, to believe that the people with whom they disagree are not so much trying to respect their beliefs as to create monstrous half-embryo things using technologies that only Frankenstein could love - and then to duck and cover when things go badly. And to sell it all with the ethicist who is "unpaid" doing PR. ACT has been through four or five cycles of scandal, depending on who is counting, each time repeating the same cycle of misbehavior. It's time to stop blessing these guys with ethics PR. Please, Ron, give it up before ACT becomes the undoing of embryonic stem cell research.

I've already read five commentaries by major conservatives comparing ACT to Hwang. It is awful and irresponsible but you guys are asking for it. Can't we just be honest and say that we favor embryonic stem cell research, at least for now, since that's what happens at ACT (and since it is true), even though the research destroys embryos? Can't we just say that the Bush policy is idiotic and that the new "alternatives fund" is worse yet? Must you pander to the neocons?

I continue to be amazed at the degree to which this company manages to do more harm to the battle to get embryonic stem cell research funded than could any concerted right wing campaign against the research. ACT is the Kevorkian of stem cell research.

About half of my comments make it through their moderator these days, especially when I respond to the name calling and flight of ideas over there, at the American Journal of Bioethics Blog.

So, I'll post my thoughts here, as well:

You missed one of the possible thoughts going through Richard Doerflinger's head: "Please, please let these guys continue to compare embryonic stem cell research to physician assisted suicide."

By the way, why isn't PGD one aspect of eugenics? Do you actually object to eugenics?

Plan B - Does it work?

Ales Rarus comments on new notes at the LTI Blog citing evidence that Plan B is not very effective.
As Serge summarizes on the LTI Blog,

"As it was, the group who had to go to the pharmacy to get EC used it 197 times, while the group who had direct access used it 309 times. The result on pregnancy: absolutely nothing! The pregnancy rate for the first group was identical despite the fact that they used EC one third more often."

(Warning! Statistics Alert! The following may contain too much information for some people. You may just want to skip to my brilliant insights at the end. But, I do love my references.)

The Journal of the Americal Medical Association article that is used to show that women with advance access to Plan B don't engage in any more risky behavior than those who have to go to the pharmacy, even when the pills are free to each group (but which didn't note that they don't become any less likely, either) notes that those who have advance access and those who don't have similar pregnancy rates at 7.7%

There were no significant differences in frequency of unprotected intercourse by study group; 37.5% of study participants reported having unprotected intercourse (Table 2). Only half (46.7%) of study participants who had unprotected sex reported using EC 1 or more times over the study period; 54.9% of women who had unprotected intercourse in the advance provision group used EC. There were no significant differences in patterns of oral contraceptive use or the proportion of women switching their regular contraceptive method by study group (Table 2). Sexual risk behaviors, including frequency of intercourse or number of partners, were also the same across study groups (Table 3). While a significantly lower proportion of participants in the advance provision group (47%) reported condom use at last intercourse than in the clinic access group (54%), this difference was not significant after adjusting for race/ethnicity and clinic site (OR , 0.79; 95% CI, 0.60-1.04, P = .09). There were no differences in frequency of condom use or proportion of women who reported consistent condom use across study groups (Table 3). . . .The pregnancy rate correlated with self-reported measures of risk; the pregnancy rate increased as the reported frequency of unprotected intercourse increased.
* * *
We did not observe a difference in pregnancy rates in women with either pharmacy access or advance provision; the adjusted risk of pregnancy for both treatment groups was not significantly less than 1. Previous studies also failed to show significant differences in pregnancy or abortion rates among women with advance provisions of EC.6-7,19 It is possible that the effect of increased access on pregnancy rates is truly negligible because EC is not as effective as found in the single-use clinical trials, or because women at highest risk do not use EC frequently enough or at all. Indeed, almost half of women in the advance provision group who reported having unprotected sex did not use EC. Thus, it is not surprising that the vast majority of pregnancies (73%) occurred in the women who reported having unprotected intercourse rather than in women experiencing method failures.

Emphases are mine. The "Duh!" statements are in bold.

Could that be why none of the pro-abortion crowd is eager to spread the word that the protocol is not abortifacient?
It's not a simple matter of using the controversy to make pro-life advocates look extreme or fight among ourselves.
Its not just that conceding that the protocol does not cause the loss of embryos, making themselves look extreme because they don't care about those losses anymore than the losses due to interventional and intentional abortions.
It's not even to strengthen the new definition of pregnancy as beginning at implantation and dependent on the effects on the mother than the baby, a definition based not on what happens in nature, but on what happens in in vitro pregnancies and embryo freezing and research.

Perhaps the main reason is that they don't care how it works or how it doesn't, because they have a back up "plan C," abortion, and the political, cultural, and financial (including fund raising) benefits are more important than the efficacy of the contraceptive, itself.

Otherwise, why isn't their more acknowledgement that Plan B can only work in the narrow period of time when a woman is fertile and that the great majority of uses through the month are unnecessary and wasted?

At the very least, good medicine and public policy would require medical care for women who have unprotected intercourse when they don't want to become pregnanct. For those who use Plan B, they should have an opportunity to receive education and skills to allow them to be more aware of their cycle and the signs and symptoms of their fertile vs. non-fertile times.

Do all doctors need to be bean counters?

The New England Journal of Medicine (subscription only, but it should be available at your local library) has an article recommending changes in pre-med (college) requirements, medical school curriculum, and the changes the editors see in the future practice of medicine.

The article suggests trading the current premed requirement of calculus for statistics (how will we understand statistics and tolerances if we haven't learned to find the area under the curve?) and physics for a general ethics course (yeah, right, as though that's possible in a post-post-modern world? Maybe if we all believe we can do it and are willing to accept the results as neither right nor wrong).

What's the part that I really objected to is this:

Whether administering a practice, a laboratory, a department, or a hospital, physicians need to know how to account for resources. They need to know how to assess performance and quality, and how to change organizations to improve the delivery of care. It is not sufficient to have a handful of medical students who will become investment bankers, corporate executives, or hospital administrators who earn masters of business administration degrees. Every physician needs to know the essentials of management sciences, including negotiations, leadership, personnel management, accounting, strategic planning, and performance assessment. These can no longer be considered incidental skills, but are integral to optimal functioning of clinicians, researchers, and administrators; and each of them can be taught.

What if I had just wanted to practice medicine, one on one with the patient in the exam room and the hospital bed?

As a matter of fact, none of you would have heard a peep from me if I had simply been able to practice medicine without the charges of "fraud and abuse," the bundling of services (meaning I wouldn't get paid for what I did and spent beyond the lowest common denominator) and the ever-changing codes, levels of service and the notes to my patients that their tetanus shot was not "medically necessary." If the doctor's office weren't considered to be the weakest link in the government pyramid scheme where recruitment is backed by guns and prisons. I probably would have marched in a few prolife rallies and read great books on cutting edge technology. I certainly wouldn't have learned how to format web pages and enrolled in bioethics courses if I could have just practiced medicine without having to learn to out smart what I couldn't understand or influence: the bureaucracy that is today's medical policy.

If you think healthcare is expensive, now . .

" . . . Just wait until it's free."

Ending with one of my favorite quotes from P.J. O'Rourke, this article from the Washington Times is framed in political bias, but the statistics and the stories (which are verifiable elsewhere) are apolitical. They are particularly pertinent if you remember that all Medicare payments will be stopped for the last 10 days of the fiscal year, later this month. If you discover that you can't get a new doctor on Medicare or if you discover that your doctor went on vacation and closed his office the last 2 weeks of September, you may find these numbers and stories interesting:

It would be bad enough if national health care merely offered patients low-quality treatment. Even worse, Ms. Ridenour finds, it kills them.
• Breast cancer is fatal to 25 percent of its American victims. In Great Britain and New Zealand, both socialized-medicine havens, breast cancer kills 46 percent of women it strikes.
• Prostate cancer proves fatal to 19 percent of its American sufferers. In single-payer Canada, the National Center for Policy Analysis reports, this ailment kills 25 percent of such men and eradicates 57 percent of their British counterparts.
• After major surgery, a 2003 British study found, 2.5 percent of American patients died in the hospital versus nearly 10 percent of similar Britons. Seriously ill U.S. hospital patients die at one-seventh the pace of those in the U.K.
• "In usual circumstances, people over age 75 should not be accepted" for treatment of end-state renal failure, according to New Zealand's official guidelines. Unfortunately, for older Kiwis, government controls kidney dialysis.
• According to a Populus survey, 98 percent of Britons want to reduce the time between diagnosis and treatment.
Unlike America's imperfect but more market-driven health-care industry, nationalized systems usually divide patients and caregivers. In America, patients and doctors often make medical decisions and thus demand the best-available diagnostic tools, procedures and drugs. Affordability obviously plays its part, but the fact that most Americans either pay for themselves or carry various levels of insurance guarantees a market whose profits reward medical innovators.
Under socialized medicine, public officials administer a single budget and usually ration care among a population whose sole choice is to take whatever therapies the state monopoly provides.

* * *

. . . politically driven health care jeopardizes patients' lives.
• Emily Morely, 57, of Meath Park, Saskatchewan, discovered that cancer had invaded her liver, lungs, pancreas and spine. She also learned she had to wait at least three months to see an oncologist. In Canada, where private medicine is illegal, this could have meant death. However, Mrs. Morely saw a doctor after one month -- once her children alerted Canada's legislature and mounted an international publicity campaign.
• James Tyndale, 54, of Cambridge, England, wanted Velcade to stop his bone-marrow cancer. However, the government's so-called "postcode lottery" supplied this drug to some cities, but not Cambridge. The British health service finally relented after complaints from the Tories' shadow health secretary, MP Andrew Lansley.
• Edward Atkinson, 75, of Norfolk, England, was deleted from a government hospital's hip-replacement-surgery waiting list after he mailed graphic anti-abortion literature to hospital employees. "We exercised our right to decline treatment to him for anything other than life-threatening conditions," said administrator Ruth May. She claimed her employees objected to Mr. Atkinson's materials. Despite a member of Parliament's pleas, Mr. Atkinson still awaits surgery.

1 in 10: How lucky do you feel?

If you want to save your child's cord blood, there's a nine in ten chance that the sample won't be usable. That's a good reason for us all to get behind the public banking of umbilical cord blood cells.

From the San Antonio Express-News:

. . . So far, the hospital has collected 2,500 units — 800 of which actually made it to the liquid nitrogen freezers, she said.

The numbers belie a unique challenge for cord blood collection. On average, only one in 10 units of cord blood collected nationally are deemed viable, Fisk said. A top reason is volume — if enough blood is not available from the cord for whatever reason or there are problems in collection, it cannot be banked.

To build an adequate supply of cord blood for transplantations, the Institute of Medicine has said the nation needs about 100,000 donations, besides the usable 50,000 cord blood donations already in stock at public cord blood banks around the country. The Texas Cord Blood Bank needs to collect 6,000 units to be financially self-sustaining, Fisk said.

But then, just as you most likely won't need that pint of blood you donate at the more familiar blood bank, there's also very little chance that your child or anyone in your family will need a cord blood treatment:

"Advocates for banking as a public resource cite that fact and research showing that the chances your family ever will use the privately banked blood are low — from 1 in 1,400 to 1 in 200,000.

According to the National Marrow Donor Program, most people have a better chance of finding a stem cell match in the public cord blood system than in their own family."

Remember that proven research and treatments such as those that saved the little girl in today's story and my own granddaughter, who was born unable to make white blood cells. Texas scientists have even been able to make umbilical cord cells act like embryonic stem cells.

And no one has to die for these cures.

Proven research in ethical stem cells

From Human Events author James Kelly:

Faustman twice cured mice of Type I Diabetes without stem cells. She uses an inexpensive drug, called BCG, to block ongoing immune attacks on insulin producing “beta islets.” She then removes the cause of Diabetes by supplying a missing protein, which retrains the immune system to recognize the cells of the pancreas as “self.” Five other labs have confirmed that this method can allow the pancreas [in mice] to regenerate.
* * * *
Millions have already suffered, but not because of a President’s veto, or over religion, morals, or ethics. Proven research with immediate potentials for improving the lives of millions is being ignored, maligned, delayed, and blocked to protect financial strategies cloaked in the guise of ‘looking’ for cures.

The rest of the article is such an extensive review of the state of ethical vs. unethical stem cell research that I'm trying to figure out how I'm going to be able to avoid plaigerism.

Medical ethics, lawyers, bean counters and government guns

As you know, I'm studying for my Master's in Bioethics at Trinity International University, an Evangelical university in Deerfield, Chicago.

Jerri Lynn Ward, J.D., asks at her blog, Texas Advance Directives Blog, how medical ethicists are being trained today.

TIU has a Masters in Bioethics program begun by Nigel Cameron and John F. Kilner in conjunction with the Center for Bioethics and Humanities. Two of the physicians who teach there are Robert Orr and Edmund Pelligrino. We also have lawyers, such as Paige Cunningham of Americans United for Life.(Take a look at some of the wonderful work on the CBHD website on the Physician and Covenant.

Unfortunately, the great majority of "bioethicists" are not physicians and they are not trained in a setting where the Christian worldview predominates. Some, like R. Alta Charo from Wisconsin are lawyers. Art Caplan from Pennsylvania is a Ph.D. in the History of Science.

All too often, doctors who usually begin our education in order to help people are - in effect - taught that medical ethics are the way to avoid being sued or reported to the State Medical Board. We are grilled in the necessity to follow government laws and regulations and corporate insurance guidelines, such as those mentioned in Dr. Faria's article copied at Ms. Ward's blog and in this one on Cardiac rehabilitation hospitals.


The bulk of continuing medical education on "ethics" doesn't cover why we do what we do, but how to follow the law and avoid being sued or audited by Medicare (and the guns and fines of the Office of the Inspector General) and the corporate insurance bean counters.

I'm trying to do something about it by encouraging pro-life, pro-family doctors and scientists to speak out at their professional societies and to monitor our laws, regulations and traditions (especially all the changes in definitions) that risk the protection of any human, no matter how young, old, or especially how sick they are. First, do no harm.

Medicare Regulations, Chronic Care, Legal Tests

First, the good news: Mrs Ruthie Webster has been moved to a long term care facility that can offer her dialysis. The bad news, this case is still being used to test the Texas Advance Directive Act, Section 166.046.

This was not a choice between death and life. This was a choice concerning where medical care was to be given.

As far as I can tell, the conflict between Mrs. Webster and the hospital began over the issue of discharge to a lower level of care. It appears that Medicare Long Term Acute Care Hospital regulations and the scarcity of facilities that could provide dialysis for a patient who could not sit up were a problem in Mrs. Webster's case. The family members did not wish to "be forced to move their mother," although the hospital had attempted to arrange the transfer from the beginning and some sort of post-acute care must have been a part of the discharge plan before admission. Mrs. Webster would never have been - in fact never was - in danger of being unable to access dialysis. She will be dialyzed at her new nursing home or she could have had home dialysis, either at her home if someone lived with her there or at the home of a relative. (See the comment from Jerri Ward, here.)

Long term acute care hospitals are required by law to have a discharge plan for any patient who is admitted to their facility, before they are admitted. The patient must meet strict criteria including an anticipation of being able to follow that discharge plan. In each case, the institutions are required to periodically review each patient's medical status and determine whether he or she meets the regulations under which the institutions work.

Reading the very few newspaper articles available on this case, all from August 18th, led me to believe that the hospital and doctor were requiring the patient's family to follow through with the discharge plan to the other hospital, rather than deciding that it was time for the patient to die. I have no idea whether 166.046 is the only law that allows doctors to do this or whether another would have been appropriate.

Tough questions must be asked about chronic care and end of life care as regulated by laws and the government. The issue goes far beyond "funding," although that is complicated enough.

In the last week, I've had conversations with several people involved in hospice care and a former hospice nurse who now works as an administrator for a Rehabilitation Facility. I asked them questions in an attempt to understand what happens when patients are no longer eligible for Medicare benefits under Medicare laws and regulations.

The consensus is that the administrators, lawyers, doctors and nurses who run and work for these institutions believe that admitting or continuing care for patients who fall outside of Medicare qualification guidelines will endanger the institutions' license and that the penalties for not following the guidelines include demands for payment of money that Medicare has paid them extrapolated to the first time they billed Medicare, fines, jailtime and the confiscation of their homes and assets for the administrators. (See Association of American Physicians and Surgeons for for more.)

The Rehab administrator said, "We can't keep them" on the Medicare plan if the patient is not making progress or otherwise becomes ineligible for Medicare. I asked about families who did not want to move the patient, especially in cases such as Mrs. Webster. He explained that the facility cannot bill Medicare any longer so the patient then becomes liable for fees of $140 for "room and board" per day plus any medical care necessary. The facility also risks its standing with Medicare, since they are supposed to only care for patients who meet Federal standards and they are required to have "compliance plans" and "compliance officers" to ensure this.


I've posted information about long term acute hospitals. Here is similar information on Rehabilitation hospitals from the Center for Medicare Advocacy, which have similar regulations.

Review: Plan B, How It Works and Doesn't Work

I'm convinced that Plan B does not block implantation. Because I keep getting emails, hearing radio personalities and reading posts on various forums claiming that Plan B is an abortifacient, here's a review of information on the medical effects of the pills and on the other effects and lack of effects.

The overwhelming evidence - from several different groups of researchers - is that Plan B, the single ingredient protocol containing a synthetic progesterone called levonorgestrel, only works - when it works - the 5 days or so before and just after ovulation. Furthermore, since few women really know when they ovulate, and only slightly more women will even use the protocol when they have the pills in their medicine cabinet, easy access doesn't change anything.

The best and most ethical research evidence, "On the Mechanisms of short term levonorgestrel administration as emergency contraception" is available online free of charge at this site.

If, as I believe, the pills only work in preventing fertilization, they are only medically justified/necessary 5 days before or one or 2 days just after ovulation, the window of fertility. The other 20 days or so of the menstrual cycle, the pills are useless and un-necessary.

The best evidence is that Plan B works to prevent ovulation or to prevent the oocyte (the "egg") from being released from the ovary and passing to the fallopian tube. This is why the pill is best (and only?) functional before ovulation. In nature, the egg only lives about 24 hours and sperm can live from 2 to 5 days. If the egg is not released, is over 24 hours old, if the sperm cannot get to the egg or if they are dead or incapacitated, there can be no fertilization.

The only post-ovulation effect that has been proven that could prevent pregnancy also prevents fertilization. Levonorgestrel causes the mucus in the cervix to be thick (so sperm have a hard time getting to the uterus and then the fallopian tube where the egg is) and by making the sperm unable to penetrate the zona pellucida, the covering and nurturing cells around the oocyte or egg.

Biopsies of the uterus of women who have ovulated in spite of taking Plan B do not show any changes that would prevent implantation of the embryo. The blood flow and lining of the uterus is normal. Support for this lack of abortifacient effect in the uterine lining is the natural increase of progesterone in women after ovulation and the treatment of some infertile women with progesterone around ovulation or around transfer of the embryo in an in vitro fertilization cycle. Levonorgestrel and the other forms of progesterone actually seem to encourage implantation.

The reason I am still wary is the evidence that the "luteal" phase of the cycle - the time from ovulation to the time the woman starts shedding her uterine lining - is shortened in some women. If the lining is shed early, I can't be sure that there could not be a loss of an embryo which is beginning to implant. (late note, October 3, 2007 - the evidence indicates that if the pill is taken before ovulation, the luteal phase is shorter, but the closer to ovulation -and the greater the chance of ovulation - the less effect on the luteal phase. So that I don't worry, any more, about losing an embryo that way.)

Women continue to get pregnant - and have abortions - at about the same rates in England and other countries where Emergency Contraception is available without prescription. Part of the reason is that even when women have the medicine in their homes and have received education, they take the pills only about 20% of the time when they have unprotected sex. This month's Contraception reports that only 11% of 706 women (ages 18 to 44 years old, who knew they were part of a study and who were at risk because they did not want to be pregnant but were using other contraceptives incorrectly) used the pills, even though the medicine is available without a prescription in that country.(H. Goulard et al./Contraception 74(2006)208-213)

And while studies have shown that women and girls don't increase risky behavior, the same studies show that there is no decrease in such behavior, either.

I do wonder whether over the counter use in the US will lead to at least a short-term burst of promiscuity and abuse of women and girls, since the studies on access have all included only women and girls who went to clinics and at least received some education (and, as I said, even those women and girls didn't change their risks).

The medicine has never before been available to men in the US. At least there has been some effort to provide education to women and girls receiving the medicine in Washington, where pharmacists could dispense the meds under certain conditions.

Anecdotal information from pharmacists and doctors in the UK, Jamaica and the Far East indicates that men buy EC at least as often as women and that that it appears that some women and girls are using EC more than once a month.



Here's some links in this blog and other pro-life writers who have come to the same conclusion.

Progesterone, infertility and early pregnancy

Plan B not Abortifacient, But Doesn't Change Much


More on British Experience with OTC EC

Plan B Doesn't Change Much (Actual article reproduced - New information on the study that is often quoted to prove that promiscuity doesn't increase - in fact, there's no change at all - But that's even after going to the clinic, etc.)

Jamaica Experience with Plan B, Jamaican Teens Opt for Abortion over EC


Good (Not Prolife) Review of Emergency Contraception

Another physician's Blog and thorough review, at "LTI":
There are at least 6 articles reviewing the facts and the scientific literature. These are the first and the sixth in the series.

A non physician who does a lot of research, "Ales Rarus"
Mangling, Mishandling, and Misrepresentation of Science in the Plan B Debate (Part II)


Another unquestionably pro-life blog, "Jivin'Jehosaphat"

Note: Edited some typos 02/15/07 BBN

Another Ethical Stem Cell Story from Texas

The Austin American Stateman August 30, 2006 article by Ashley Sanchez calls for common ground in Texas stem cell research. Ms. Sanchez describes just some of the many examples of cutting edge ethical science going on in Texas.

In contrast to private banks, parents can donate cord blood to public banks that are available to anyone needing a stem cell transplant.

Unfortunately, not many hospitals are equipped to accept these donations. The Web site nationalcordbloodprogram.org offers amazing stories of people successfully treated with donated cord blood. To date, thousands of cord blood transplants have occurred worldwide, treating at least 12 types of malignant and 59 genetic diseases.

Thanks to ongoing research, the number of conditions successfully treated with adult stem cells should continue to grow. Researchers at the University of Texas Health Science Center, Houston, are conducting a clinical trial to treat children who have had a recent traumatic brain injury with stem cells harvested from their own bone marrow.

One of the principal investigators is a pediatric neurosurgeon at Memorial-Hermann Children's Hospital. Dr. James Baumgartner explained to me that stem cells appear to be remarkably good at going to the site of a brain injury. He calls stem cell research an extraordinary and revolutionary opportunity.

Consequently, Baumgartner is dismayed by people's misunderstanding of this promising research. To wit, the parents of two of his patients wanted their children to remain anonymous for fear of having their homes picketed by opponents of stem cell research.

These parents' fears are unwarranted. Responsible opponents have been clear: They oppose only embryonic stem cell research, research that destroys a human embryo. Their position is based on the scientific fact that as soon as a human sperm and egg unite to form an embryo, a new and genetically distinct member of the human species is created. They oppose the deliberate destruction of that human being.

However, they enthusiastically support research such as Baumgartner's that relies on other sources for stem cells, such as bone marrow and nasal tissue. In fact, there is universal support for such research, as well as that using what might otherwise be considered trash — baby teeth, umbilical cord blood and (in the case of an Austin plastic surgeon who performed his own liposuction and saved the stem cells) even fat.

Baumgartner explained his fear that the highly charged political climate surrounding embryonic stem cell research is jeopardizing efforts to find cures. He cited a bill proposed during Texas' past legislative session that would have made it a criminal offense to participate in embryonic stem cell research. He believes that kind of hostility sends a chilling message and is resulting in a scientific brain drain here.

On the other hand, some supporters of embryonic stem cell research also fan the flames of hostility. In his July 31 Newsweek column, Jonathan Alter dismissively referred to a human embryo as "a piece of protoplasm," and embryonic research opponents as "anti-cure" activists.

Wesley Smith on "Why they did it."

I've already gone on record that no one considered that any of us would notice or care that the so-called ethical embryonic stem cell technique was most certainly not ethical. Wesley Smith, in an op-ed for the Center for Bioethics and Culture, suggests that the post-modern media wants us to remember that the only reason anyone cares about the ethics of stem cell research is because of President Bush's (right wing religious) prolife policies.

I keep remembering the voice of the Great Oz as he tried to maintain the illusion that he wanted Dorothy to believe. "Do not look behind the curtain." Real scientists and ethicists aren't fooled so easily. They insist on looking at facts and intentions. Even those who aren't (right wing religious) prolife won't stand for smoke and mirrors.

Stem cell non-event explained

My theory? No one even considered that anyone would care. Surely, the peer reviewers weren't in on a conspiracy. At least Lanza, et. al., got their money's worth from the press release guys!

There is no way to do justice to the blogger's post and the incredibly informative guest comment by copying and pasting it here. Brendan Mahrer, the blogger, reproduced one of the crucial tables and Katayoun Chamany, the commenter tells me more about the process than anyone else I've read (including the original article).

Here's a couple of excerpts to tempt you to click on the link.
From Mr. Mahrer:

. . . The flurry of numbers and only distant relationship between the ‘corrected’ sentence and the original left us scratching our heads as to what exactly they meant. As if sensing they hadn’t aggravated reporters enough. They issued a second correction at 4pm on a Friday afternoon (long after the UK office had likely packed up and gone home). . .

From the commenter:

. . . So whether this technique will take us any closer to meeting the ideology of the Bush Administration has yet to be seen. Without a viable and robust trophectoderm, implantation will be less likely. So like ANT and the other methods being touted in the name of pro-life, this man-made manipulation reduces the efficiency of embryo implantation and maintenance. . . .

Ethicists for hire (Revised)

A long time ago, there were some enterprising scientists and doctors who wanted to clone animals and humans and send out press releases and make money.

Since they were scientists and doctors, and very smart, they recognized the need to cover themselves in case anyone objected to the births of sick animals and the creation and destruction of human embryos (as well as terminology - these are the first to claim to achieve "therapeutic cloning").

Anyway, in an effort to prove that they were doing nothing wrong, the scientists hired some ethicists and made sure the ethicists were agreeable. Unfortunately, even smart scientists and doctors can forget how competitive and fussy those people can be even when cloning and embryo destruction are involved.

Some of (their) bioethicists, including Glenn McGee, PhD (editor of the original version of The Human Cloning Debate, Berkley Hills Books, 2000. This book is no longer in print, but it was the first book I bought that had “As Seen on Oprah” on the cover.) and Art Caplan, PhD (co-editor with Dr. McGee of the 2006 version of The Human Cloning Debate ) even resigned!

An October, 2001 article in Christianity Today, titled “Psst! Wanna buy a bioethicist?” noted:

Indeed, this year two of the nation's most prominent bioethicists resigned in protest from the Advanced Cell Technology ethics advisory board. One of them, the University of Pennsylvania's Arthur Caplan, said that while ACT was using his name (and paying dearly for it), it wasn't seeking his advice. And after he resigned, Glenn McGee, also from the University of Pennsylvania, called corporate ethics boards "rubber stamps" created to give companies an aura of acceptability.

Ronald M. Green did not resign. He is still the ACT bioethics spokesman:

"I think this will become a standard way of producing stem cell lines," said Ronald M. Green, a Dartmouth College professor of religion who is an unpaid bioethics adviser to Advanced Cell Technology.”

It's not often that technology offers a solution to an ethical dilemma, but this could be one," says bioethicist Ronald Green of Dartmouth's Ethics Institute, a member of ACT's unpaid research advisory panel.

In the world of Ethics advisory and review, “unpaid” can mean anything from $200 a day per diem plus expenses, to millions of dollars for the advisor’s institution.

The smart scientists' company, Advanced Cell Technology (ACT), has been in the news this week claiming that two embryonic stem cell lines created by removing lots of cells from 16 newly thawed and nurtured human IVF embryos (which were then destroyed) proves that embryonic stem cell lines can be produced by removing a single cell from an unharmed human embryo that can then be implanted and grow up to be a consumer of biotechnology.

ACT's leadership includes former Geron founder and owner of the patent for the use of telomerase in the cloning of Dolly the Sheep, CEO Michael West, PhD, and Robert Lanza, MD, vice president.

Few remember that Advanced Cell Technologies began life as a company that practiced agricultural animal reproduction for research and profit.

The New York Times described ACT in 1998 as a startup biotech firm wholly owned by Avian Farms, a Maine poultry genetics company. ACT currently lists three subsidiaries of its own -- Cyagra, for work with livestock; Cima Biotechnology, which focuses on avian cloning; and Em Tran (short for Embryo Transfer), which applies genetic research to the interests of cattle breeders.

Fewer still noted the repeated criticism of ACT's tactics and ethics scandal of 2001,

"However, a former member of ACT's own ethics committee called the announcement "nothing but hype" and said that "they are doing science by press release"."

and then correlate it with similar criticism in 2006,

In a rare moment of consensus on the controversial issue of embryonic stem cells, even supporters of therapeutic cloning dismissed Lanza's work. "A pitiful attempt to look morally acceptable, rather than do valuable science," sneered Glenn McGee, editor of the American Journal of Bioethics.

One of the best comments comes from an excerpt from an email said to be from Art Caplan and posted at BodyHack, a blog at Wired News: “this is not quite as much hype as the killer of jon benet ramsey but it is close!” (sic)



A deeper look into the history of bioethicists and their corporate connections reveals that not only Green, but virtually all of the usual suspects in the field have risked Carl Elliott’s charge that bioethicists are “show dogs” and that it’s “Better to buy a bioethicist now than to be attacked by one later. The only challenge is how to disguise the job so that bioethicists do not realize that they have been bought.”


(See, “Bioethicists find themselves the ones being scrutinized,” by Sheryl Gay Stohlberg, originally published in the August 2, 2001 New York Times., “And now, ethics for sale? Bioethicists and big buck. Problem city?” By Nell Boyce , originally published July, 2001 in US News., and Carl Elliott, "Pharma Buys a Conscience," The American Prospect vol. 12 no. 17, September 24, 2001 - October 8, 2001.



I’ve noted the inbred closeness of various policy making bodies in the past. (Here and here.)


However, knowing about the connection between Green, Caplan, and McGee at West's ACT, Laurie Zoloth's advisory position at West’s former company, Geron, Robin Alta Charo's advisory position at WiCell (begun with the help of Geron) and Caplan's advising position at another partner of Geron, Celera Genomics, perhaps all the criticism of Green and ACT is simply sibling rivalry.

November 20, 2007: Edited to add Labels.

November 20, 2008 repost and rewrite on the appointment of Jonathan Moreno and Alta Charo to the (newly created) Office of the President Elect transition team.

"Deja vu, all over again"

Wesley Smith supplies my title (quoting that great observer, Yogi Berra) and a synopsis of Advanced Cell Technology's history of big claim, small retraction, ignored critics, rinse and repeat.
Take a look at his recap, "Science by Press Release," at the Weekly Standard.

Note at 11:30 AM: I'm rewriting the post originally referenced in this one.

(Deleted)Another chapter of "Ethicist for Hire"?

I'm pulling this post for a rewrite - I fell off my train of thought in the middle.

If I can keep my analogies straight, I'll republish it later.

Sorry for the inconvenience.

Obligatory Gratuitous Propaganda

I don't normally get my bioethics news from "ThisisLondon.co.uk, the entertainment guide"

In this case, however, the first notice I had about the letter from 14 leaders in charity funding for stem cell research had written to the London Times was in that prestigious publication. While cautioning against the risks of unproven stem cell experiments, the authors at "the entertainment guide" found it necessary to insert a generic, gratuitous propaganda speil selling the hype for embryonic stem cells.

It doesn't seem to matter that the actual news story concerns a serious risk to patients who travel to European clinics for treatment with umbilical cord blood.

The Times OnLine has a more complete and acurate discussion about the letter.

While stem cells offer great promise for treating many disorders, extravagant claims made for therapies costing more than £10,000 a time do not stand up to scientific scrutiny, they say.

In a letter to The Times, 14 medical charities and research funders warn patients that there is no evidence to support the benefits attributed to unorthodox stem-cell treatments, which could carry a risk of infection, immune system rejection and even cancer.

Premature use of stem cells to treat disease, before safety and effectiveness have been evaluated in clinical trials, also threatens to set back mainstream research that promises genuinely better therapies, they say.The signatories include Professor Colin Blakemore, chief executive of the Medical Research Council, Lord Patel, of the UK Stem Cell Bank, and the heads of the MS Society, the Parkinson’s Disease Society, the Juvenile Diabetes Research Foundation and the Alzheimer’s Society.

Stem cells have the capacity to form a wide variety of tissue types, and could be used to replace cells and organs that are damaged or destroyed in conditions such as MS, diabetes and Parkinson’s disease. The most powerful are found in embryos, but other less malleable types can also be extracted from the adult body and from umbilical cord blood.

Only a handful of treatments based on adult and cord blood stem cells have been licensed in the UK, principally for treating leukaemia and eye and skin disorders. But some foreign clinics offer stem-cell injections for other conditions, chiefly MS, and for cosmetic surgery.

Several dozen British MS patients have travelled to a centre in the Netherlands to receive cord blood stem cells from a Swiss company called Advanced Cell Therapeutics (ACT) at a cost of up to £13,500. The Dutch clinic is one of two under investigation by the authorities. The ACT procedure was banned in the Irish Republic this year, prompting the company to consider offering it in international waters on the Swansea to Cork ferry.

While more subtly and skillfully done,the Times OnLine has its own obligatory, gratuitous embryonic stem cell propaganda.

Please notice the name of the Swiss company doing business in the Netherlands: "ACT, Advanced Cell Therapeutics." As far as I can tell, this is not the same as "ACT, Advanced Cell Technology," the Nevada company doing business in California and Massachussetts (which is led by Drs. Robert Lanza and Michael West along with Mr. William Caldwell IV , as well as bioethicist for hire, Dr. Ronald Green) which has been in the news this week.

Eureka! Why I gain weight when I'm sick

Seriously, this is more great research from the great Republic of Texas, from scientists at UT Southwestern Immunology in Dallas. The actual report is available only by subscription in the journal, Science, but you can read a free review at Science Daily.

It turns out that our intestines protect us from infection by invasive bacteria by producing a protein that binds to the sugars on bacterial walls, destroying the bacteria in the process. People with inflammatory bowel disease may not make the protein correctly.

A note on today's cartoon

At the top of the page, the Day by Day cartoon is still playing outthe "pregnancy" of one of the characters.

Today, we find out that Damond and Jan both feel as though they have no "say in the matter."

Well, as a mother and a grandmother and a woman who had a couple of unplanned pregnancies, I can identify with this helpless feeling.

But, there is now a third person who most certainly does not have any say in the matter. And, unlike the other two, the third person never had a "choice" to change his or her actions or decisions that could have avoided the whole confusing, overwhelming situation.

There are consequences to our actions. There are consequences to just being and functioning as a human. We may not plan for those consequences or our plans may fail. And sometimes we truly can't control our bodies as completely as we like. But, we can control our intentional actions and are responsible for the consequences of those intentional actions. Just as when we have a car wreck, or if someone falls in a hole we dug in our yard, we can't avoid our own responsibility for those consequences of getting in a car or making a hole in the ground.

For more on this subject, the best source is at the Libertarians for Life Library.

Good (not prolife) review of Emergency Contraception online

Although the authors make a point to redefine pregnancy as beginning at implantation, this article contains an otherwise fair review of the "Mechanisms of Emergency Contraception Pills," from the August issue of the journal, Contraception.

Please note this paragraph:

Early treatment with ECPs containing only the progestin levonorgestrel has been shown to
impair the ovulatory process and luteal function;16,17,18,19,20 no effect on the endometrium was
found in two studies,17,18 but in another study levonorgestrel taken before the LH surge altered
the luteal phase secretory pattern of glycodelin in serum and the endometrium.21 Treatment with
ECPs containing only levonorgestrel during the peri-ovulatory phase may fail to inhibit ovulation
but nevertheless reduce the length of the luteal phase and total luteal phase LH concentrations;
this observation suggests a post-fertilization contraceptive effect.16 Levonorgestrel also interferes
with sperm migration and function at all levels of the genital tract.22 Studies in the rat and the
Cebus monkey demonstrate that levonorgestrel administered in doses that inhibit ovulation has
no post-fertilization effect that impairs fertility.13,23,24 Whether these results can be extrapolated
to women is unknown.

The articles referred to in the article mention ovulatory dysfunction and that LH change affects the release and movement of the oocyte. This function prevents fertilization, and is a true contraceptive effect, not one of those redefined definitions of contraceptive.

Please email me if the link stops working. I have the article, and will do the work, if necessary.

Thanks to Ales Rara blog for leading me to the LTI blog, which had a link to the actual editorial, saving me from a ton of formatting.

Short course (long post) on medical ethics.

Are doctors killing patients or taking life when they withdraw or withhold care? Do families who don't insist that "everything be done" kill their loved one? Do patients who refuse ventilators, dialysis, etc., commit suicide? For that matter, does a ventilator equal dialysis equal a feeding tube?

Can the patient who refuses all attempts to resuscitate and the family who demands that every effort be made to keep the patient’s body alive even if there is no hope of awareness, both be right?

There's an old saying that pneumonia is the old man's friend. If the surrogate decision maker for a patient with Alzheimer's demands that she be allowed to die while suffering from an easily treatable condition such as pneumonia, but the doctor believes that it would be medically inappropriate to withhold nutrition and hydration, who is right? What if the patient is a child?

At what point does care become medically inappropriate? Who is best qualified to make that determination? Is there a place to say, “This much, and no more?” Is there a point where we say that the last step was where we went too far? And are we doing all this for us, or as care for the patient?

How many events must happen before we "Let go, and let God?"

These are some of the questions raised by the Texas House Committee on Public Health on August 9, 2006. You can watch the full 12 1/2 hour archived video at Texas Legislature Online. (Free RealPlayer necessary) I recommend moving the cursor to 2:20/12:38 and watching until 4:10/12:38. If you only have 30 minutes, Dr. Bob Fine, MD, is very informative (3:12 to 3:40) as a physician who helped develop the practice of hospital clinical ethics in the U.S.

The only question allowed under Section 166.046 of the Texas Advance Directive Act of the Health and Safety Code should be whether or not medical treatment is "inappropriate medical care" for the patient. Section 166.046 is an attempt to allow clinical judgment by doctors carrying out Advance Directives, for oversight of doctors by hospital ethics committees and for disagreements between doctors and the patient or surrogate by allowing time for transfer to another doctor who does not believe that the treatment is medically inappropriate.

Examples of medical procedures and technology that are not medically appropriate care are sometimes clear-cut, and sometimes professional judgment or conscience is needed to make the distinction. The same medicines and procedures used to relieve pain and symptoms carry known, but unintended side effects. Something as simple as oxygen by nasal canula or face mask can sometimes blunt a patient's drive to breathe and force a decision on whether or not to use a ventilator.

At the end of life, even “life sustaining” treatment such as pacemakers, ventilators, dialysis and tube feedings may not always be medically appropriate care. Doctors and family members are faced with decisions about whether a given technology or procedure is life saving or only prolongs dying in patients.

Today, we have the ability to keep the body alive for a few days, even after the brainstem is dead. This is not bad for the patient, because if the brainstem is dead, the part of the brain that could be aware of pain, is also dead. It is not good for the patient either, for the same reason.

If the patient is not brain dead, we can keep them alive much longer because signals from the brain help us maintain blood pressure and heart rate.

In order to keep the heart beating and the lungs breathing on the ventilator, we have to add IV feedings and do frequent blood draws, maintain arterial blood lines to follow the oxygenation, nutrition and blood pressures. Medicines to regulate blood pressure may actually decrease blood flow to the fingers and toes. The patient who is not brain dead or in a coma will require some level of sedation until we are able to create a tracheostomy. Sometimes, we have to paralyze patients and then completely sedate them to make the ventilator tube in the throat tolerable.

When dialysis is needed over months and years, we don't have the ability to prevent the side effects. Patients begin to have “pathological” fractures in their arms, legs, and ribs, simply when they are repositioned in their beds. If the patient only communicates with us to tell us that he or she is in pain, should we continue to hook the patient up to the dialysis machine three times a week because his surrogate insists that “everything” be done? What should we do when he has a heart attack, a stroke, or seizures and the family insists on chest compression, ventilator support or a surgical procedure to place a permanent feeding tube? How about when our efforts keep a patient in physical or mental pain that is uncontrollable – when the doctors cannot control pain or (as in the case of my mother)the patient can’t process stimulation as anything but excruciating pain?

Next: what can we do?

Edited November 29, 2007, to add labels.

Medicine by jury

I received two comments to my post on the case of Mrs. Ruthie Webster, from the lawyer who runs the “Texas Advanced Directive Blog,” Jerri Lynn Ward, J.D. (I have already offered Ms. Ward any help I can give in these cases.)

(Among other things) Ms. Ward said,

You will NEVER get lawyers out of this issue. This is an issue about people's lives and choices that are being overruled by doctors and hospitals.

The Texas Constitution gives people the right to have disputes concerning property and life decided in the Courts by juries. We aim to see that people have those rights protected.

If you think we will stop fighting you--you are very mistaken.

and,

Further, we have been unable to find an outpatient dialysis center (in other cases) that will take patients who can't sit up. We've had to look for nursing homes who can do the dialysis in-house. Finding such a bed has been a very difficult task. The lady in my Austin case had to be taken home to be dialyzed there.

Let me be clear: I do not believe that the doctor should have withdrawn care from Mrs. Webster under the Texas Advance Directive Act (TADA). I do not believe that the hospital ethics committee should have agreed that dialysis or other life preserving care is medically inappropriate, from what I read in the paper about the facts of the case.

I believe that Mrs. Webster's case manager and social worker should have addressed the need for a change in the level of care, rather than anyone determining whether medical treatment is appropriate or not. The newspaper article said that the hospital had been trying to transfer Mrs Webster, but that the family is resisting.

If the Advance Directive Act, specifically Section 166.046 of the Texas Health and Safety Code, was invoked in this case, I believe that it is a misuse of the Section.

From the description of her health status as told by her daughter in that August 18th article in the Dallas Morning News, I believe that Mrs. Webster no longer meets the criteria for Long Term Acute Care Hospital admission(she no longer needs 8 to 12 hours of direct nursing care each day), and that the appropriate level of care is for her to be discharged to (non-acute) long term care with outpatient dialysis.

I also tried to explain why I believe that the funding should not be an issue.

Medicare is most likely the woman’s insurance since she was on dialysis before the seizure that sent her to (the other) hospital in the first place. She should still be covered under Medicare when it comes to dialysis and certain other kinds of care. Medicare regulations allow the hospital to charge the patient after a certain period of time regardless of the diagnosis.

I did want to relate the complications including loss of license, "exclusion" from virtually all insurance billing indefinitely, jail time, and fines (RICO anti-racketeering triple fines and confiscation of assets were used quite often by the Clinton administration) that can result if Medicare determines that their regulations are broken.

However, I believe that there are times when medical procedures are not medical care. In those cases, it is inappropriate to use the medical procedure, and 166.046 is needed if the patient or surrogate disagrees with the doctor.

Perhaps by focusing on the "values" of the physician, rather than acting according to his medical judgment, we are being distracted. The question should be whether or not treatment is "inappropriate medical care" and who is best qualified to make that determination.

This morning, I watched the first 3 hours of the 12 hour archived video of the August 9th Texas House Public Health Committee hearing. (Free Real Player needed, link available at the video website) A lawyer, Burke Balch, J.D., who believes that 166.046 should be removed from TADA, talked about whether firemen would be allowed to decide that a building’s quality is worth saving when it’s on fire.

A better question would be whether firemen should do everything to save as much as possible of every building on fire, or whether they should use their professional judgment as to when the fire has gone so far that the building can’t be saved and the only thing possible is to pull back and prevent the fire from spreading.

Or perhaps, they can fight the fire while satisfying juries.

(more to follow)

News Release on Embryonic Stem Cell "Breakthrough" Changed

From the Kaiser Network Daily Reports (free, no subscription), we learn that the Washington Post and others are being forced to backtrack on an unethical press release. It shouldn't surprise anyone that scientists who have no respect for human life go along with press agents who don't mind spinning the story!

Daily Women's Health Policy
Bioethics & Science | Language Changed in News Release for Study That Reports Method of Creating Stem Cells Without Destroying Embryos
[Aug 28, 2006]

The journal Nature on Friday corrected wording in a news release it had distributed in advance of a study published in the Aug. 24 edition of the journal that describes a technique that could derive human embryonic stem cells without destroying the embryo, the Washington Post reports. The "basic facts of the report remain unchallenged," according to the Post (Weiss, Washington Post, 8/26). Robert Lanza, medical director of Worcester, Mass-based Advanced Cell Technology, and colleagues described the technique as removing a single cell -- known as a blastomere -- from a three-day-old embryo with eight to 10 cells and using a biochemical process to create embryonic stem cells from the blastomere. Researchers removed 91 blastomeres from 16 thawed embryos donated by fertility clinic patients and found that more than half of the blastomeres began to multiply and that in two cases the blastomeres became embryonic stem cells. The method of removing a cell from the embryo is based on preimplantation genetic diagnosis, or PGD, which usually is used to test the cell for genetic deficiencies. Lanza said that the research destroyed some of the embryos used but that single-cell extractions that leave the embryo unharmed should be feasible in the future. In addition, the researchers wrote that single cells taken from three-day-old embryos "have never been shown to have the intrinsic capacity to generate a complete organism in any mammalian species" (Kaiser Daily Women's Health Policy Report, 8/24).

Release Challenged
The change in the release came after Richard Doerflinger of the U.S. Conference of Catholic Bishops in an e-mail wrote that the results presented in the release were misleading. According to Doerflinger, the researchers in the release did not make it clear that the embryos used in the research did not survive in the experiments. He also said that it was deceptive for the researchers to write that single embryonic cells could grow into stem cell colonies because in the experiment the cells were fed on hormones secreted by other cells. This raises the question of whether the cell removed from the blastomere can develop into a cell colony, Doerflinger wrote. In addition, he wrote that it was deceptive to publish a photo of a mature embryo along with the study results because no embryos in the study grew to that stage of development. Lanza responded to the three points, saying that it previously has been proved that a cell can be removed from a blastomere without harming the embryo; that the need for hormones to help the cell grow can be provided from other laboratory cells or from the remaining seven-cell embryo from which the first cell was taken; and that the team did not provide data regarding the healthy embryo because that was not the focus of the paper. According to the Post, the data related to the picture on Friday was added to Nature's Web site (Washington Post, 8/26). In related news, Monsignor Elio Sgreccia, head of the Vatican's Pontifical Academy for Life, on Saturday in an interview with Vatican Radio said that Lanza's method of producing stem cells remains an in vitro form of reproduction, which the Roman Catholic Church opposes. He also said that the research is "manipulation" and that it "doesn't solve the ethical problems" regarding embryonic stem cell research (Sanminiatelli, AP/Washington Post, 8/26).

(Be sure and go to the Kaiser site, and read the "Related" stories at the bottom, too.)

More on dialysis funding

Here's more information on all the ways that kidney dialysis is funded. End Stage Renal Failure makes a patient eligible for Social Security Disability.