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.

Long Term Acute Care

I've never had any experience with admitting patients to Long Term Acute Care (LTAC) hospitals, such as the one that Ruthie Webster is admitted to, so I did some research.

I was wrong about the Medicare payment rules for Long Term Acute Care. The patient pays a copay for the middle part of the stay, and is responsible for full payment after 90 or 100 days. (I found conflicting reports.)

Patients at these hospitals have been transferred from another hospital, after treatment in the ICU for problems such as ventilator treatment, seizures, and pressure sores. When the patient is stable, or like Mrs. Webster, has been weaned from the ventilator, they must be transferred to a lower level of care.
From the Regency Hospital Company's website:

Typical Patients Admitted

• Long term IV therapies (three weeks or longer)
• Ventilator/Pulmonary Care
• Hemodialysis or Peritoneal Dialysis
• Post CVA
• Post Surgical
• Low Tolerance Rehabilitation
• Wound Care (Stage III & IV Decubitus)
• Complications of Infectious Process

Long Term Acute Care (LTAC) hospitals are designed to provide acute care to medically complex patients who require critical care for an extended period of time.

LTAC hospitals fill the gap between short-term acute care hospitals and subacute care nursing facilities, acute rehab or home. By focusing solely on LTAC, we help short term acute care hospitals address the economic and clinical challenges created when treating long term, acutely ill patients. Above all, Regency is your partner in providing the best possible care for your patients

Admissions
Regency Hospital accepts patients who:

• Require 8-12 hours of direct nursing care per day.
• Are expected to require acute care for an extended period of time.
• Are medically stable for transfer.
• Have an ability to improve their health status.
• Will benefit from the involvement of an interdisciplinary team.
• Require daily physician visits.

There are several different companies that run LTAC facilities. One, Kindred Health Care, has a great website that explains more about these specialty hospitals.

Not a Texas "Futile Care" Case?

I think our heart strings are being pulled for the wrong reasons in the case of a Dallas woman. I don't believe that the case is covered by the Texas Advanced Care Act.

I wonder whether the doc was forced to admit that Mrs. Webster is a "long term care patient" that has a chronic condition and that further hospitalization - and therefore dialysis at that hospital - is not "medically necessary" under Medicare guidelines?

If so, this isn't a Texas Advance Directive Act case at all. It's just a case where the patient needs to go home and receive outpatient dialysis. Medicare will pay for the latter, but will not pay for "long term care."

From the little I can find about Ruthie Webster, it doesn't sound like this woman needs to be in a hospital at all now that she's off the ventilator. She now needs "long term care," which is not covered by most insurance, including Medicare. All patients who are diagnosed with end stage renal disease automatically become Medicare eligible.

And that's where things really get complicated.

As I understand it, Mrs. Webster had some sort of complication that caused seizures while on kidney dialysis early this summer. There is very little chance that the dialysis was done at the hospital where she is now, since most dialysis is done at out patient, dedicated dialysis centers. Mrs. Webster was taken to the hospital, and required a time on the ventilator. She is now off the ventilator, but seems to be in a coma and still has end stage renal failure, requiring dialysis.

From The Dallas Morning News, August 18, 2006 (free subscription required):

Children fight to save mom

Carrollton: Hospital seeks to end care of woman with brain injury

08:18 AM CDT on Friday, August 18, 2006

By EMILY RAMSHAW / The Dallas Morning News

The children of a North Texas woman with a severe brain injury are fighting to keep her alive, after a Carrollton hospital ruled it would discontinue life-saving treatments.

And the family's attorneys are waging a legal battle to prove that a Texas statute allowing hospitals to end treatment against the family's will is unconstitutional.

Lacresia Webster and her siblings say their mother, Ruthie Webster, is deeply religious and believes only God should give and take life. While Ruthie Webster has been largely unresponsive since early this summer, when a bad reaction to a kidney dialysis treatment sent her into seizures, her kids say she has shown signs of improvement. The 61-year-old is now breathing without a ventilator.

"My mom spent her life in the church. She always felt like, 'Who are we to decide? God decides,' " Lacresia Webster said Thursday. "If this is the way she's going to be, she's still my mom. I'm not giving up on her."

But documents signed by officials at Regency Hospital of North Dallas, where Ruthie Webster has been since late June, indicate that Mrs. Webster is not expected to recover and that continuing the treatments would be futile.

Mrs. Webster has not been declared brain dead, and hospital officials wouldn't say whether she's in a vegetative state. But family members said she appears to be in a coma: She opens her eyes and moves her feet and hands slightly but doesn't speak.

****


Mr. Bennett said that so far, Regency has taken great care of Mrs. Webster. All of her bedsores healed, he said. And in letters to family members since the decision to remove Mrs. Webster's treatment, hospital officials offered to help them seek another facility for her. The hospital has informally agreed to cover the costs of the move, Mr. Bennett said.

But for the Webster children, who are considering moving their mother to facilities in Atlanta or Indiana, it's the principle that matters. They don't want to be forced to move their mother. And they certainly don't want anyone outside of the family deciding when it's time to end treatments.

"My mother, she's breathing on her own, just like you and I are today," said Helena Webster Hill, who lives in Atlanta. "As long as she's fighting to live, we believe we ought to stand with her and fight with her."

I wonder whether the doc was forced to admit that Mrs. Webster has a chronic condition and that further hospitalization - and therefore dialysis at that hospital - is not "medically necessary" under Medicare guidelines.

She became Medicare eligible - whether she signed up or not - when she was diagnosed with end stage renal failure. I can't imagine that any private insurance would allow her to *not* sign up, as so many retired people who had insurance as part of their benefits have found.

Medicare is a stickler about proper diagnosis, coding, and standard of care. Her doctors and the hospital are at risk of felony charges if they don't treat her the same way as every other long-term care patient, eligible for Medicare.

I'm not even sure whether the family is allowed to pay for her to stay in the hospital, without the hospital and docs becoming ineligible for Medicare and all Federal and State funds.


Medicare will not pay for indefinite stays in the hospital - or, more specifically, it pays a set price for any given diagnosis, regardless of the course of the patient. They also watch for "fraud and abuse" in diagnosis, length of stay and treatments. Medicare defines "long-term care" patients as patients with chronic diseases - those who are stable and whose status is not changing. From Medicare.gov:

Long-term care is a variety of services that includes medical and non-medical care to people who have a chronic illness or disability. Long-term care helps meet health or personal needs. Most long-term care is to assist people with support services such as activities of daily living like dressing, bathing, and using the bathroom. Long-term care can be provided at home, in the community, in assisted living or in nursing homes.
****
Medicare doesn’t pay for this type of care called "custodial care". Custodial care (non-skilled care) is care that helps you with activities of daily living. It may also include care that most people do for themselves, for example, diabetes monitoring.(emphasis in the original)

Again, if she's a Medicare patient, the docs and hospital are at risk for jail and triple fines or losing all ability to take care of any Medicare, Medicaid, TriCare, or Workman's Comp - and most insurances - if they try to work around the Medicare definitions, diagnoses and codes.


Medicare will pay for outpatient dialysis. In fact, all end stage kidney patients are automatically covered for dialysis.

But most dialysis facilities are *out patient* - away from the hospital - and aren't set up for comatose patients.

So, the woman needs a nursing home with the ability to dialyze her or one that can transfer her by stretcher to an outpatient dialysis center that can handle a comatose patient. Payment for her dialysis needs to be changed to private pay or Medicaid, with Medicare Part A, B and/or Medicare/Medicaid.

What I wonder is why don't her children want her near them and why did lawyers and courts get involved?

Exciting (Ignored) Adult Stem Cell Stories

There's better things to do than to arguing about whether Advanced Cell Technology really made embryonic stem cells and whether it's worth millions of dollars if they did: how about learning about knee regeneration and finding a key to making adult stem cells work they way we want them to work, where they're needed? And the University of Minnesota wants us to know that they're recruiting patients for phase II and III in their stem cell transplant treatment for children with inborn errors of metabolism.


The Houston Chronicle reports that doctors in Houston, Texas are doing actual research on growing knee cartilege from a patient's own bone marrow stem cells, the mesenchymal stem cells.

And the University of Pennsylvania announced two days ago that they have discovered additional information about how stem cells differentiate appropriately: they sense their physical as well as their chemical environment.

The the first clinical trials using mesenchymal stem cells from the patient's own bone marrow to heal knee cartilege are underway, and the preliminary results are due in October. 800,000 people per year have part of their meniscus removed due to injury. In this study, 55 patients who have under-gone surgery to remove part of the meniscus - that half-moon-shaped cartilege in the knee - have been assigned to one of two legs of a controlled, double-blinded study. Half are injected with their own mesenchymal cells (harvested from their bone marrow) and half are subjected to "dummy" operations. All of the patients are being followed by MRI.

("Dummy" means that the doc is sticking a needle into the knee joint, but neither they nor the doc know until later whether the needle had any stem cells in it.

The double blind is the golden standard of research, so that the expectations or wants and wishes of the patient or the doc will not affect the outcome. Ethically, the ability to do "dummy" procedures is acceptable if the risk of harm is slight or if the potential gains are substantial. The justification leans more on the autonomy of a patient who gives his consent and the expectation of a greater good for many with a slight risk for some, than on the "First, do no harm," school of thought. It depends heavily on informed consent and following the patients closely and closing the "blinded" part of the experiment if significant good or bad effects are observed. Normally, at the end, the researchers open the envelopes, or virtual envelopes, to know how to interpret what has already happened and been measured.)

The second story reinforces the importance of the environment for stem cell differentiation, which, Wesley Smith notes was a twist in the ACT experiment. It also may explain some of the low yields, such as in spinal cord trauma and heart attacks.

The physical, as well as the chemical environment of the stem cells is vital. Mesenchymal cells react to the force needed The key will be in finding ways to "prime" (or train?) stem cells to work in diseased or injured tissue.

The big fuss earlier this year about phase I fetal neural stem cell treatment for Batten's disease overshadowed any attention given to the trial for several similar diseases, started in 1995. That series is evidently now entering further testing and recruiting more patients.

And this is just yucky

Warning - yucky (adult) topic follows.

Supposedly to raise funds and awareness about HIV/AIDS, several "Masturbate-A-Thons" have been held in England, and San Francisco.

The real purpose - at least for the reporters - seems to be a chance to comment on the prude-ish-ness of Americans and our insistence that the best policy to prevent sexually transmitted disease and teen pregnancy is abstinence.

But, seriously, any event that needs 200 rolls of toilet paper should not be public or a morality lesson for anyone.

Now, this is politics

I've posted before that I'm inclined to believe (while I'm not ready to advocate its use for several reasons) that Plan B is not an abortifacient.

(See here and here. Or look here for a posting of one of the research articles that convinced me to reconsider my earlier rejection of post-coital contraception.)

However, why do the articles in the mainstream press still focus on the "politics" of the Bush administration and the decision to change the status of a prescription drug, but don't seem to even notice the blatant politicization of the Senate confirmation of an Executive Branch appointee?

In the meantime, I have to sign for a federally limited supply of pseudoephedrine, a decongestant!

Art mimics life ("Day By Day")

I've linked to the cartoon by Chris Muir on this blog for months and enjoy watching the wry political humor.

I haven't been happy with the personal relationships depicted, with the implication that the 2 unmarried couples featured in the cartoon are intimate. (I even wrote the author suggesting that they marry - the granma in me couldn't resist. He reasured me that they weren't at risk for health consequences.)

One of the couples, conservative Damon and liberal Jan, may "be" (in cartoon world "being") pregnant. Today, despite the fact that both characters are depicted as being in love and happy at the idea of having a child, the differing attitudes about abortion are confronted.

1 +1 = 2, not 1

Ignoring the real breakthrough concerning embryonic stem cells from adult cells, the media is all over the announcement (of old news, at that)that embryonic stem cells can be derived from cells removed from embryos. In fact, all of those embryos used in the experiment were destroyed.

The ethics questions are, (1) were 16 embryos or 16 embryos plus many of their twins destroyed and (2) if the original embryos had not been purposefully destroyed as in this experiment, would they have been harmed?

Pre-Implantation Genetic Diagnosis (PGD) is a near-routine procedure for those in vitro fertilization procedures where parents do not want to have children with certain diseases or wish to choose the characteristics of the children they do have. We know that there doesn't seem to be an effect on the implantation and gestation of those children who are chosen. There are concerns about weight gain and birth defects and objections about the ethics of experimenting on children - and their children into the future - without their consent.

So the question is whether or not the blastomeres from the 8 to 10 cell embryo are in fact single cell embryos or twins of the original embryo, themselves. I'm still not convinced, but will watch with interest further research (preferably on animals).

According to the letter (a semi-peer reviewed method of reporting research - it doesn't take as long as the usual submission process, usually is not as thorough, and not subjected to the same review and critique) in Nature, August 24, 2006 (subscription only)

Concerns have been raised as to whether individual eight-cell-stage blastomeres, such as those used in the current study, are totipotent and could potentially generate a human being. A recent report shows the localization of cell fate determinants (Cdx2) in the late-dividing blastomeres of the two-cell-stage mouse embryo17. Other studies show that at the four-cell stage, blastomeres have different developmental properties18, and that individual human blastomeres have differential Oct-4 expression that seems to direct cells towards inner cell mass or trophoectoderm lineages19. Notably, individual morula (8–16-cell)-stage blastomeres have never been shown to have the intrinsic capacity to generate a complete organism in any mammalian species.

More debate on status of the human embryo

"Think of the way that you might speak to a child who asks 'is this how I began?' And the simple answer from a parent is 'yes, this is how you began, how I began'.

"That is a fundamental intuition. An embryo can't be separated from our development as a human being, can't just be seen as a mass of cells. There is something deeply wrong with that view."

The Age, a publication out of Australia, covers the current debate in that Nation, in "Cells of Division, Cells of Hope," by Jo Chandler and Karen Kissane.

(There's a glaring error: Utah's Senator Orrin Hatch is called a Catholic.)

Bioethics lessons in life (and they hurt)

I mentioned last week that my Mama was ill. My family and I were dealing with very real, very painful real-life bioethics questions.

Mama passed away Monday night, while in or on the way back from Magnetic Resonance Arteriography. I was with her, and I'm not sure whether she stopped breathing in the MRA and had some rigorous breaths after we took her off the table or whether she died over the next few minutes. Hopefully, the report on the MRA will shed some light on the strokes she'd had over the last 2 weeks and answer my questions about the immediate cause of her death. But, even this incredibly high-tech test may not give us all the answers we need.

Thankfully, I am sure that she had been unconscious and unaware for a few hours prior to the test.

My mother has been in pain for most of the last 2 years, since just before she was diagnosed with thymic carcinoma. The cancer is very rare - two or three a year in the US. It's also usually virulent and most patients are diagnosed after local invasion by the tumor.

Mama was diagnosed after the tumor was found during evaluation of a respiratory crisis,when she became unconscious. The loss of consciousness and severe muscle weakness that caused it were most likely due to the antibodies her body made to fight the cancer. While it looked as though this response had saved her life, the side effects of weakness, pain, and personality changes weren't ended by complete removal of the cancer (proven by a ton of tests in the last two weeks), radiation and steroids.

Medicine today is a combination of fantastic tests and medicines, protocols from best experience and insurance guidelines, and the experience, prejudices and guesses of the doctors. Tests that can show blood flow to regenerating bone, glucose uptake in cells, and images of the brain and other organs that look like photographs of the actual tissue cannot tell the doctor what to do next or what will happen if he or she follows a given pathway.

If you ever find yourself making the decision between making a loved one pain free (when she experiences a draft as a pain at a level of 10 out of 10) or doctors who don't seem to be listening to your questions, much less be able to answer those questions, remember that there are times when no one can give us all those answers.

More on the Texas Advance Directive Act (NOT "Futile")

Jerri Lynn Ward and I have been discussing the Act, here.

I found out that Dr. Findley has done some good deeds, too. Here's a story about a patient he helped.

Middleton said she wasn't thinking of an aneurysm when she scheduled her September physical. She just wanted to get checked out before switching jobs and, consequently, her health insurance.

But an aneurysm is something she's worried about, and been tested for, in the past. Her mother, Ginny, has had surgery on two aneurysms, including one that ruptured. An aneurysm caused one aunt's death and possibly another aunt's death as well, she said.

Middleton's general practitioner, Dr. Michael Findley, said he felt compelled by Middleton's history to order the test in September.

"The family history was very overwhelming," he said Wednesday. "It's not always clear what to do, but in something that is this strong of a family history, I just thought it was prudent to take the next step."

It's Official: Adult Stem Cells to Embryonic (ethical)

The good news is that scientists are closer to being able to produce true patient-specific stem cells from non-embryonic adult somatic cells. But, we still need to stress that the research is still in its early stages.

Let's wait (but don't hold your breath) to see whether the media plays this one up as much as all the hullabaloo on unethical stem cells and the Korean veterinarian, Hwang Wu Suk's faked cloned embryonic stem cells.

Cell, one of the most respectable peer-reviewed journal covering molecular biology of the cell, has published the report of Japanese researchers who claim to have induced adult mouse fibroblast cells to revert to the embryonic stem cell stage. It's currently available at a link on this page.

Embryonic stem (ES) cells, which are derived from the inner cell mass of mammalian blastocysts, have the ability to grow indefinitely while maintaining pluripotency and the ability to differentiate into cells of all three germ layers (Evans et al., 1981; Martin, 1981). Human ES cells might be used to treat a host of diseases, such as Parkinson's disease, spinal cord injury, and diabetes (Thomson et al., 1998). However, there are ethical difficulties regarding the use of human embryos, as well as the problem of tissue rejection following transplantation in patients. One way to circumvent these issues is the generation of pluripotent cells directly from the patients' own cells.

Somatic cells can be reprogrammed by transferring their nuclear contents into oocytes (Wilmut et al., 1997) or by fusion with ES cells (Cowan et al., 2005; Tada et al., 2001), indicating that unfertilized eggs and ES cells contain factors that can confer totipotency or pluripotency to somatic cells. We hypothesized that the factors that play important roles in the maintenance of ES cell identity also play pivotal roles in the induction of pluripotency in somatic cells.

Several transcription factors, including Oct3/4 (Nichols et al., 1998; Niwa et al., 2000), Sox2 (Avilion et al., 2003), and Nanog (Chambers et al., 2003; Mitsui et al., 2003), function in the maintenance of pluripotency in both early embryos and ES cells. Several genes that are frequently upregulated in tumors, such as Stat3 (Matsuda et al., 1999; Niwa et al., 1998), E-Ras (Takahashi et al., 2003), c-myc (Cartwright et al., 2005), Klf4 (Li et al., 2005), and β-catenin (Kielman et al., 2002; Sato et al., 2004), have been shown to contribute to the long-term maintenance of the ES cell phenotype and the rapid proliferation of ES cells in culture. In addition, we have identified several other genes that are specifically expressed in ES cells (Maruyama et al., 2005; Mitsui et al., 2003).

In this study, we examined whether these factors could induce pluripotency in somatic cells. By combining four selected factors, we were able to generate pluripotent cells, which we call induced pluripotent stem (iPS) cells, directly from mouse embryonic or adult fibroblast cultures.

The researchers did not use human cells. However, other researchers have done the basic work of induction in human cells. These researchers have narrowed down the requirements, the factors for culture, for future work on human non-embryonic cells.

The stem cells form embryoid bodies in the lab and teratomas - tumors with all three of the main stem cell lines - when injected into live mice. They do not appear to be toti-potent. In other words, the scientists haven't found a way to make single celled cloned embryos.

Breast Milk: a source of stem cells

Here's a link to a (free) commentary (in pdf) on stem cells that are passed back and forth between mothers and their children.

From the Journal of Human Lactation, by James A McGregor, MD, CM and Lisa J. Rogo,

Research shows that breastfeeding provides multiple lifelong biologic advantages to children, including increased survival and improved neurocognitive and immune functioning. These and other advantages have been linked to breast milk components, including longchain fatty acids, epithelial growth factor, immunestimulating cells, and live maternal immune cells (lymphocytes and plasma cells), which survive gastrointestinal
transport and implant in neonatal tissues. Previous research related to stem cells and breastfeeding has focused on the identification of mammary gland stem cells rather than their biologic functions. Gudjonnson and colleagues demonstrated that stemlike cells exist in mammary epithelial cells in humans,
mice, and rats.1 However, these investigators did not evaluate inclusion of stem cells in the cellular components of breast milk, passage to the newborn, or establishment of lactation-derived stem cells in infant tissues. Newer research attempts to characterize the biological activity of mammary stem cells. Boulanger
and colleagues suggested mammary stem cells play roles in mammary epithelial regeneration and hormone responsiveness.2 We propose that maternal stem cells secreted in milk and suckled by the infant may be an important but so far unappreciated live, functional component of breast milk.

Perinatal stem cell research suggests that humans
potentially contain persisting stem cell–like cells derived from perinatal placental cell transfer. Recent research establishes the extent and potential significance of physiologic bi-directional cell transport across the placenta. Differentiated XY chromosomal
cells (presumably fetal) have been found in maternalblood and organs up to 30 years after birth.3,4 Such cells are hypothesized both to provide comparative survival advantages for mothers and to be involved in the pathogenesis of immune-mediated disease such as
scleroderma and thyroiditis. Less well-studied is the reverse, whereby maternal cells cross the placenta and implant in perinatal tissues. Support for this hypothesis is provided by the findings that undifferentiated or pluripotent maternal stem cells have been found in human fetal cord blood,5 and differentiated maternal
cells have been found in human newborn tissues and organs including the liver.6 The physiologic roles and responses to such nonself (maternal) engrafted stem cells remain uncharacterized. We suggest that the mother-to-perinatal engraftment continues postnatally
by way of lactation. We suggest that future research should examine breastfeeding as a physiologic pathway by which the suckling infant receives maternal stem cells. Transportation of maternal stem cells to the breastfeeding infant may be associated with possible benefits (increased populations of progenitor cells that assist with repair of damaged tissues) or cause disease (graft versus host reactions, autoimmune processes, or stem cell–derived neoplasia).

Given that breast milk contains multiple cellular and nonnutritive components and that breast epithelium contains stem cells, we suggest that breast milk may contain stem or pluripotent cells and that these cells may implant and serve various functions in the breastfed individual, and that these cells may be identified
and characterized using newly available stem cell biomarkers. Investigation of proposed vertical stem cell transport through milk may elucidate other potentially powerful biologic benefits of human lactation.

Texas Leads (Ethical) Stem Cell Collection

The State of Texas is pioneering a cord blood bank, supported in large part by money from taxpayers. Just as we bank our blood and are very unlikely to need it, new mothers and fathers can bank their new infant's cord blood. He, too, is very unlikely to need a transfusion or treatment. But, some other child, adult, or many children and adults may benefit by the parents' generosity.

The latest news about the Texas Cord Blood Bank comes from North Texas. The Dallas, Texas "Medical City" includes the Medical City Children's Hospital.

Here are some of the stories about treatments - if not "cures," they sure look like them - from the article linked above,

Justice Hampton, a 23-year-old recent graduate of Stanford University, was diagnosed, in 1999 at age 15, with leukemia. This track and field athlete received several rounds of chemotherapy, went into remission, but then relapsed. Instead of beginning his junior year at W.T. White High School, he once again, began an aggressive treatment of chemotherapy and radiation. As a last resort and because his sister was not a bone marrow match, Justice received a cord blood transplant in January 2000. Weighing 107 lbs at age 16, Justice was the largest recipient of cord blood. Amazingly, he recovered quite well and fairly quickly. He returned to high school for his senior year and packed two years into one, graduating with honors. Currently, with a Bachelor of Arts degree in political science, Justice is an intern in the Dallas County District Attorney's office this summer, plans to take the LSAT law school entrance exam soon and attend law school in the near future.

Kristina Hill, 18, just graduated from high school in Tyler. Shortly after her 10th birthday, she was diagnosed with leukemia. She spent six months receiving chemotherapy, was in remission for nine months and then just before she began 5th grade, she relapsed. After a month of chemotherapy, her doctors told her parents about cord blood transplants. None of her family members were bone marrow matches, so she received an anonymous cord blood transplant. Although it took her a year to get back on track, she entered the 7th grade in public school. In July she and her family celebrated the sixth anniversary of her transplant. She graduated No. 10 in her high school class and plans to attend Tyler Junior College this fall, studying graphic design.

In 2002, Victoria Fulenwider's parents questioned why their 2 1/2-year-old daughter began limping. After several diagnoses, an x-ray disclosed a fractured hip. Thinking that it was "a bone thing," she was placed in a body cast. After several weeks when the bones did not begin to heal, an MRI revealed bone marrow abnormalities. She first saw Carl Lenarsky, MD, in 2003, who diagnosed her with Stage 4 neuroblastoma. She was given a 30 percent chance of survival. That summer the doctors discussed cord blood transplants, a treatment used with leukemia. Victoria was one of the first patients at Medical City with neuroblastoma to receive a cord blood transplant. Within two-to-three weeks, her blood counts began to slowly improve and she never received another blood transfusion. On August 4, she and her family celebrated the third-year anniversary of her transplant. This tiny ballerina, whose favorite character is Polly Pocket, will soon begin first grade at Victor Hector Elementary near White Rock Lake.

Testimony on Texas Advanced Directive Act

Yesterday, the House Public Health Committee in Austin, Texas met to hear invited and public testimony on the Advanced Directive Act, which includes a provision for the refusal by a physician to follow the end of life care plans of a patient or patient's surrogate when that care is medically inappropriate. The Committee heard testimony from 10:00 AM until 11:30 PM.

As I said last night, the testimony from the families who feel that the law puts too much power in the hands of doctors to decide life and death matters is heart-wrenching. I can see so many places where there truly was rudeness on the part of members of the ethics committee. I can also see where the family members are upset because they don't believe that their feelings were taken into account. I see some places where the communications broke down and others where the family members are just too demanding.

I haven't been able to watch the first 6 hours, which is evidently mostly from the Coalition members and the staff and doctors who deal with this issue most often in Texas.

(You can watch the video online at Texas Legislature Online. At the link in that last sentence, click on the broadcast icon for Human Services. Or try here. You will need "Real Play" to watch the August 9, 2006 meeting archive.)

I did watch the middle 5 hours or so. Be sure and listen to the doctor at about 6 and a half hours in until 7 hours.

This doctor does an excellent job of discussing so many of the errors and flaws in the cases he's seen and in the law, itself. He makes excellent suggestions.

I do disagree with his "all or nothing" stance - and that of so many of the doctors and ethics committees that we hear about. It is perfectly appropriate to say, "This much and no more. We will continue the ventilator, but no more dialysis." or, "If there is further deterioration or another crisis, we will not intervene, we will continue our comfort care, and even the level of treatment that we've begun, but we will not add new medicines or machines."

One patient that I helped care for did not want CPR, IV's or a permanent feeding tube, but did not mind a trial of a temporary feeding tube and any treatment that we could give that way. Another wanted chest compressions, oxygen by mouth and even shocking, but refused any and all IV's or shots for medications in the event that his heart stopped.

It took me a while to get around to the point of understanding this way of thinking, but I can see the wisdom in it now. The interventions and invasions were unwanted after a certain point. The patient did not want to die, he did not want to refuse intervention, but he did not want invasion of his body or prolonged intervention and manipulation. We did not kill Mrs. X because we didn't give her IV's. Her disease killed her when the antibiotics by the nasogastric tube were no longer absorbed well enough to fight her kidney infection.


"This much, and no more."

From the testimony of Andrea Clark's sister, the primary doctor did suggest just this plan, while offering to continuing the ventilator. Evidently, when the family insisted on doing everything, he decided to go to the ethics committee.

Any law may be abused by the people who are charged to carry out that law. However, I have not (so far) heard testimony on decisions to withhold or withdraw care that I might not have agreed to at the time. However, I do find that some of the reports of individual behavior and attitudes are rude, high-handed and/or unwise in a law-suit-happy society. If half of the behavior of one of the members of the Andrea Clark ethics committee is true, that man needs to at least take a break from the committee, if not resign completely. I can't imagine his peers tolerating either his lists of qualifications for quality of life or his body language.

Yes, there are miracles and I am thrilled to hear about them. But, I believe that I heard about the withholding of care, by "Hospital B," even in the case of one of those miracles. In this case, dialysis was not begun because of low blood pressure. In the case of Andrea Clark, dialysis was begun and continued, even as ever higher medicines were necessary to maintain her blood pressure in order to do so.

But, for some reason, the family members of the miracle lady do not react to the withholding of dialysis by Hospital B as though it's wrong.

I'm afraid that most of the problems that I heard about were "acts of God" (the woman who was found with her ventilator tube dislodged) or angry people reacting poorly. I keep wanting to talk back to the screen (probably why the Lord decided to keep me away from the meeting) and ask, "Where were the nurses during all this?" In my experience, a good nurse who could liaison between the different parties woud have just about fixed all the problems.

Texas Advance Directive Act Hearing

I had to work yesterday and couldn't attend the hearing before the Human Services Committee of the Texas State House of Representatives, in Austin. I wasn't even able to watch on the internet until about 5:30 PM. But, I still saw some of the most interesting testimony, and am very impressed that the meeting continued until about 11 PM.

The testimony that I saw was heart-wrenching. It convinced me that we need to teach our doctors how to communicate better and to look more closely at the make up of the hospital ethics committees. There was at least one story about a miracle recovery, too.

I am concerned that any amendment of the Act will be used as evidence against "conscience clauses." The portion in dispute, 166.046, appears to be a way for the physician to follow his or her conscience and professional judgement as to what is medically appropriate care. If the patient or surrogate is demanding that the doctor intervene to cause death, this law would protect the physician.

However, the (highly) publicized effect of the law is to allow doctors to refuse to provide interventional care that the patient or surrogate wants. All of the disputed cased that I heard about yesterday involved technological procedures in patients with multiple organ failure and who appeared to be within the last week or so of life.

Among those testifying were the sister and son of Andrea Clark, the doctor who took over her care and prevented the necessity of moving her to another hospital, and the families of others who have been affected by the Advance Directive Act.

As I listened to the families' stories, I believe that I could see where there was a breakdown of communication between the family and the doctors. I wish that I could fix that. Far too often it sounded as though both doctors and family members both become defensive and/or angry.

Sometimes, it appeared that families were, indeed, expecting miracles. And, in one case of a 91 year old woman, it looks like they got it: without dialysis and the immediate placement of a permanent feeding tube, the patient is recovering. (And "firing" nurses who don't behave!)

Also, from the testimony, some of the hospitals in question do need to reevaluate the members of their ethics committees. There can be no excuse for some of the behavior that I heard about.

More on this, later. (Gotta go to work!)

There's still no "Texas Futile Care Act"

While Wesley Smith and I agree on 99.9999% of ethics issues, we disagree on the Texas Advance Directive law. One portion of that law, 166.046 covers cases where the doctor refuses to carry out the end of life decisions of a patient and/or his or her surrogate.

Mr. Smith is predicting the "repeal" of what he calls the Texas Futile Care Act.

For more on the law, here's commentary from Houston Lawyer.com.


Please note, the word "futile" isn't in the law. The same clause could be used where the doctor refused to end artificial hydration and nutrition, with simultaneous withholding of oral fluids and food.


A very sad case in Houston this week, ended after a judge intervened in what sounds like brain death, as there was no blood flow to the brain:
Beaumont Enterprise.

Hospitals don't practice medicine. Lawyers and judges shouldn't. But sometimes the law is needed when there are disagreements.

The doctor determines what he or she can do in good conscience. The committee agrees whether or not the doctor's decision is medically appropriate.

However, the law recognizes the fact that doctors may disagree on the point of "medically appropriate" in a few cases. It's rare to find such a disagreement, since doctors actually try not to fail (and we consider even the contemplation of the death of a patient as failure - see the "Cheerful Oncologist," here ), and we know that the course of system, organ, tissue and cell breakdown follow a certain course.

Just as in this last, sad, case at Hermann Memorial, in the case of Andrea Clarke, another doctor stepped in and took over her care in the same hospital. A gallbladder procedure done on Mrs. Clark did not find the speculated stones or localized infection, and the poor woman died soon after of her disease by way of the overwhelming infection. Unfortunately, it appears that the signs of sepsis were mistaken as signs of improvement by the family at the time.

"First, do no harm." The physician must weigh the good against the harm. Our wish to "do something" must be tempered by non-maleficence, or the duty to do no harm. Eventually, the procedures we do only prolong dying while increasing the times we - or the nurses and techs, because of our orders - hurt and manipulate a patient.

Instead of being a conspiracy or even a "gentleman's agreement," it's evidence that our experience and knowledge of the usual consequences are consistent. Doctors aren't so easy to intimidate - if there were disagreement on the benefit to the patient, there'd be more than one doctor on this list.

Miracles do happen

Wesley Smith and the editors and pseudoeditors at blog.bioethics.net agree on something!

"Letting go" vs. protecting embryonic human life

A reader asks,

If it is reasonable to stop life-prolonging treatment for fully alert, self-aware (but dying) adults, why would it possibly not be reasonable to perform research on a ball of a hundred or so cells with virtually no physical organizaion or life processes beyond mere cellular metabolism, let alone consciousness, self-awareness, and personhood, as well as values, goals, interests, and desires? Or to look at it the other way, if we're so obsessed with mere biological life at any cost that we're willing to protect blastulas under any and all circumstances, how can you justify ending life support, or denying resuscitation, to actual people?

First, I do not advocate stopping treatment. I advocate appropriate treatment. Sometimes it's appropriate to use high-risk, -tech and toxic interventional treatment. At other times, it is more appropriate to provide paliative care and/or comfort only care.

It is never right to kill one human for the benefit of another. It is also never appropriate to re-define which humans are "persons" or human enough for protection from killing -- even if we have found some utilitarian reason to do so.

Simply put, the difference is in the intention to cause death by an intentional act rather than allow death due to the patient's illness.

By changing from intensive technological treatment to palliative care, we do not inject poison or smother the patient with the intention to cause death. In fact, if the body heals or the patient changes his mind, we can reassess and possibly resume the higher level of intervention.

There is no such option to "reassess" in the case of destructive embryonic research.

(Jamaica) Teens opt for abortion over emergency pill

The other side of the Emergency Contraception (EC) story.

In Jamaica, the protocol sold under the name of "Postinor 2" is available Over the Counter (OTC). There is concern that the OTC EC is being over used in this country with a high HIV/AIDs infection rate.

And then, we find out that the girls in Jamaica would rather have an abortion, even a self induced abortion, than to use the EC.

From the June 26, 2006 Jamaica Observer:

Kingston (Panos) - Despite the introduction of the Emergency Contraceptive Pill (ECP) Postinor 2 in Jamaica three years ago, research has shown that the demand for the drug is low, as some women prefer induced abortions.

The findings emerged from a recent study on the demand for emergency contraception among adolescents prepared for the Ministry of Health's Family Health Services by Hope Enterprises Limited. It suggested that abortions among adolescents range from a conservative 1,350 to a possible maximum of 4,912 per year. It also revealed that young women aged 15 to 19 and particularly those aged 15 to 16, have a relatively high incidence of abortions compared to older teens and adults.

The study forms part of a joint programme in sexual and reproductive health established by the government, the European Council and the United Nations Population Fund.
In presenting the study at a seminar recently, Maxine Wedderburn from Hope, a research-based organisation, noted that although Postinor 2 was readily available and accessible, adolescents refused to take the drug.

She pointed out that they opted to undergo induced abortions, which is illegal in Jamaica. "What is interesting to note is that although 62 per cent of the adolescents interviewed during our research have heard of Postinor 2 and 90 per cent know where to access it, they still see it as an 'abortion agent' and stigmatises those who use it," said Wedderburn. This could be one reason for its under-usage in Jamaica. Postinor 2 was gazetted by the government as an over-the-counter alternative to abortion.


She further noted that the current use of the ECP is under 20 per cent. She added that the statistics clearly indicated the need for the drug especially among adolescents 15 to 19 years old who are most likely to be involved in casual sex or coerced into sex which result in unwanted pregnancies.

"There is usually a significant amount of money involved and it can be very stressful for the young mother. There is, therefore, an obvious need for aggressive marketing of ECP to the target group most likely to need it as an alternative to abortion," added Wedderburn.

It has also been noted that some adolescents, who feared going to medical facilities, opted for risky, self-induced abortions using a number of methods, such as Pepsi and Excedrin, coat hangers and jumping from high places.

Wedderburn said that these occurrences were very worrying, especially in view of the fact that ECP is available at no cost at health centres.

"The Ministry of Health has been using the media to spread the news about Postinor 2, but obviously more marketing of the drug needs to be done. "Based on our own findings at the Family Planning Board, we realise that pharmacies are concerned about the abuse of Postinor 2 and so they do not encourage print materials on the drug near their dispensary counters," she explained.

Plan B doesn't change much

If a medication doesn't offer a significant improvement in health risks, why risk the complications of changing laws, much less side effects of medication?

Plan B is supposed to decrease pregnancies due to unprotected intercourse. Easy access to Plan B is supposed to work better to decrease pregnancy.

But, it doesn't work that way.

You may have heard the statement that easier access to Plan B does not increase risky sexual practices and that it does not affect the use of other forms of contraception. How often do you hear that the same study proved that there is no difference in the number of pregnancies either? In spite of the extra education given to all participants, there was no difference in the groups who had to obtain EC from clinics or pharmacies when they needed it, and in those who had the medication in advance.

Here is an excerpt from the January 5, 2005 issue of the Journal of the American Medical Association (subscription only):

Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs

A Randomized Controlled Trial

Tina R. Raine, MD, MPH; Cynthia C. Harper, PhD; Corinne H. Rocca, MPH; Richard Fischer, MD; Nancy Padian, PhD; Jeffrey D. Klausner, MD, MPH; Philip D. Darney, MD, MSc

JAMA. 2005;293:54-62.

ABSTRACT


Context It is estimated that half of unintended pregnancies could be averted if emergency contraception (EC) were easily accessible and used.

Objective To evaluate the effect of direct access to EC through pharmacies and advance provision on reproductive health outcomes.

Design, Setting, and Participants A randomized, single-blind, controlled trial (July 2001-June 2003) of 2117 women, ages 15 to 24 years, attending 4 California clinics providing family planning services, who were not desiring pregnancy, using long-term hormonal contraception or requesting EC.

Intervention Participants were assigned to 1 of the following groups: (1) pharmacy access to EC; (2) advance provision of 3 packs of levonorgestrel EC; or (3) clinic access (control).

Main Outcome Measures Primary outcomes were use of EC, pregnancies, and sexually transmitted infections (STIs) assessed at 6 months; secondary outcomes were changes in contraceptive and condom use and sexual behavior.

Results Women in the pharmacy access group were no more likely to use EC (24.2%) than controls (21.0%) (P = .25). Women in the advance provision group (37.4%) were almost twice as likely to use EC than controls (21.0%) (P<.001) even though the frequency of unprotected intercourse was similar (39.8% vs 41.0%, respectively, P = .46). Only half (46.7%) of study participants who had unprotected intercourse used EC over the study period. Eight percent of participants became pregnant and 12% acquired an STI; compared with controls, women in the pharmacy access and advance provision groups did not experience a significant reduction in pregnancy rate (pharmacy access group: adjusted odds ratio [OR], 0.98; 95% confidence interval [CI], 0.58-1.64; P = .93; advance provision group: OR, 1.10; 95% CI, 0.66-1.84, P = .71) or increase in STIs (pharmacy access group: adjusted OR, 1.08, 95% CI, 0.71-1.63, P = .73; advance provision group: OR, 0.94, 95% CI, 0.62-1.44, P = .79). There were no differences in patterns of contraceptive or condom use or sexual behaviors by study group.

Conclusions While removing the requirement to go through pharmacists or clinics to obtain EC increases use, the public health impact may be negligible because of high rates of unprotected intercourse and relative underutilization of the method. Given that there is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to EC to clinics.

* * * *

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. We would not expect the pregnancy rate to be lower in the pharmacy access group given the similar EC use rate as the control group; however, EC use was increased in the advance provision group. An alternative explanation for the lack of observed difference in pregnancy rates is that women in the advance provision group used EC more because they were using it "unnecessarily," ie, as a backup to a regular method. We think this is unlikely since the proportion of women reporting using EC because of condom mishaps or using no birth control method the last time they used EC was similar for women in the advance provision group and the control group (94.9% vs 96.9%, P = .74).

Our sample size calculations were based on equally sized groups; however, with our unequal group sizes, we had an 80% power to detect a 50% difference in pregnancy rates. It is possible that with a larger sample or widespread increased public access that a smaller, yet meaningful reduction in pregnancy rates would be observed. While we set out to demonstrate a large reduction in pregnancy rates, even a 10% or 20% reduction in unintended pregnancy rates would be a significant and desirable public health achievement. Access to EC did not have a detrimental effect on contraceptive use or sexual behavior. While women who used condoms or other less effective forms of contraception were more likely to become pregnant than women who used hormonal contraception, women with advance provision or pharmacy access were not more likely to abandon contraception or switch to less effective methods. Given this finding, it is unlikely that increased access to EC would lead to higher pregnancy rates, even though our risk estimates indicate that the true effect may also be greater than 1.

Our study supports the hypothesis that behavior is not influenced by access to EC and that women who have increased access to EC do not have more unprotected intercourse. There were no significant differences in self-reported frequency of unprotected intercourse. One might argue that self-report is not an accurate measure of actual behavior, ie, there is underreporting.

Pregnancy is an outcome that is less susceptible to recall bias and was assessed by several measures in our study, including biological markers. We demonstrate that baseline self-report of unprotected intercourse, as well as contraceptive method, correlated directly with pregnancy rates at follow-up, adding validity to our self-report measures.

Across all measures, we also found similar rates of sexual risk behaviors in all study groups. The finding of similar STI acquisition rates among study groups seems plausible given the lack of difference in self-reported measures of risk. Using the combined STI variable including test results, self-report, and medical chart review, we had 90% power to detect an increase in STIs from 12% to 18%. It is possible that we failed to detect a smaller yet clinically meaningful increase in STIs; however, given our increased power to detect small differences in self-reported measures of risk, like number of sex partners, this seems less plausible. The FDA’s decision to reject over-the-counter sale of EC was based on concerns that increased access to EC could lead to unsafe sexual practices and the spread of STIs and HIV/AIDS, a notion that is contrary to the findings of our current study and the published literature.4-7,13, 20-22

Our study has limitations. There was cross over of treatment groups as participants could obtain EC through any of the 3 methods. The majority of participants (67%) reported obtaining EC at last use consistent with the study group to which they were assigned. Thirty percent of women in the pharmacy access group and 26% of women in the advance provision group reported obtaining EC through clinics and 12% of women in the clinic access group reported obtaining EC directly from pharmacies without speaking with a provider. This cross over may have diminished our ability to demonstrate a difference in reproductive health outcomes in treatment groups.