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.

"The View" goes down slippery slope on Plan B

Not really, Barbara Walters goes straight to claiming that the pill blocks implantation. (Mistaken, in my view.)

The video is available, here.

Elizabeth is passionate and fairly clear about her reasoning to protect all human life, rather than just some who are "wanted." However, the discussion slides on down to rape, incest and 12 year old girls, as though any of these can affect the humanity of any child, born or unborn.

Thanks to Prolife Blogs and Catholic Fire blog for the alert.

John Leo, columnist, on the "slippery slope" of embryonic stem cell research

"Just when you think the debate over embryonic stem cells can't get any more degraded, an outfit called the Campaign to Defend the Constitution comes along and proves you wrong. The group took out two vitriolic full-page ads in The New York Times (at $200,000 a pop) lashing out at religious conservatives as extremists and ideologues for opposing federal funding of embryonic stem-cell research (ESCR)."

John Leo's latest column on TownHall.com reviews bad journalism and thinking concerning the slippery slope of embryonic stem cell research. It's worth a read in full at the link above.

Here's a bit more:

The Campaign to Defend the Constitution bills itself as an online grassroots group of 90,000 people. It would be more accurate to call it a well-heeled creation of the Tides Foundation and its stepchild, the Tides Center, both of which concentrate on funding left causes, sometimes extreme left causes.

Stem-cell funding is a great issue for Democrats and the left this year because it's a rare instance of substantial numbers of traditionalists willing to oppose a traditional value, in this case, that human life, even infinitesimal forms of human life, must not be destroyed for research purposes. The traditional value at stake holds that slippery-slope concerns are valid -- once softened up by the distant prospect of great cures, the public may be willing to move from tiny embryos to larger ones, and then perhaps to the destruction of small children with defects, which Princeton ethicist Peter Singer already favors.

Slippery-slope fears also apply to the possible impact of embryonic stem-cell funding on the abortion wars. In 2001, columnist and author Anna Quindlen said she thinks that the stem-cell issue will decrease opposition to abortion. Once the killing of embryos is routine and government-financed, will size matter?

Futile care and when to "let go."

The idea that "we should do it because we can do it," is poor reasoning in destructive embryonic research. It is also poor reasoning in the face of death by natural causes. Good medicine and science allows non-maleficence to inform beneficence:

Heal when possible, but first, do no harm.

Here are two items that deal with the issue of "futile care" that are outside the realm of the usual.

I've posted links to the "Cheerful Oncologist," before. That blog, written by an always thoughtful, sometimes cheerful oncologist has moved to Scienceblogs.com. He discusses the dilemma of when to stop aggressive chemotherapy, etc. and change the focus to comfort and paliation in patients with cancer in, "Letting Go."

Another dilemma at the end of life is whether "first responders" other than paramedics (policemen, sheriff's departments and Emergency Medical Technicians, etc.) should initiate attempts to revive patients with intubation, electrical shocks, and CPR in the field and transport all those found without a heart rate to the ER. A study out of Canada is published in the New England Journal of Medicine (full content by subscription, only).

From an article on Reuters reviewing the report (emphasis is mine):

The assessment of 1,240 cardiac arrest rescue runs over two years in Ontario, Canada, found that only 1 in 500 people survived to be discharged from the hospital if EMTs could not restart the circulation, automatic defibrillators did not shock the heart, and rescue workers were not present when the heart stopped beating effectively.

The University of Toronto team led by Laurie Morrison said new guidelines letting EMTs know when to give up "would result in a decrease in the rate of transportation from 100 percent of patients to 37.4 percent," a reduction she characterized as "pretty phenomenal."

"These findings suggest that it is possible to identify a subgroup of patients ... in whom resuscitative efforts can be discontinued and the patient pronounced dead in the field," Gordon Ewy of the University of Arizona Health Sciences Center added in an editorial.

* * * *

Nor do they apply to paramedics, who can use various medicines and intubation to try to restart the heart and keep patients alive. Paramedics already have similar standards.

Wesley Smith reviews "The Great Stem Cell Coverup"

The review/editorial by Wesley Smith on the realities of stem cell research, the attacks on opponents of unethical research, and the lack of coverage of advances in the adult stem cell realm is now free on line at The Weekly Standard.

Progesterone, infertility, and early pregnancy

I spent the evening researching progesterone in early pregnancy and the FDA debate concerning the risk after ovulation and/or fertilization to any embryo that might be present when a woman or girl takes Plan B, which contains the progesterone, levonorgestrel.

More evidence that the Plan B formulation should not be a risk to the early pregnancy (after fertilization, before or after implantation) includes:

1. The statement by Dr. Linda C. Guidice, MD, PhD, then-Chair of the Advisory Committee on Reproductive Health Drugs (approximately page 202 of 314 of the document) to the joint meeting of FDA advisory committees concerning changing the status of Plan B to Over the counter:

DR. GIUDICE: Actually I have two comments. One is that a five-day window can be interpreted with the sperm being in the reproductive tract for 72 to 96 hours with a very late ovulation and with an effect of the levonorgestrel on a decreased release of the sperm in the cervical mucous or in the crypts of the fallopian tubes.
Secondly, for fertility therapy we commonly begin progesterone administration on post ovulatory day 2, and for infertility therapy with embryo transfer, we commonly begin supplemental progestin or progesterone one day before embryo transfer.
So I just want to make it very clear that administration of progesterone clinically early and periovulatory has no significant impact upon implantation rates.

2. Statement in the review of evidence (on p. 13)in the Government Accounting Office investigation into the circumstances surrounding the refusal to change the status, with footnotes:

ECPs have not been shown to cause a postfertilization event—a change in the uterus that could interfere with implantation of a fertilized egg.29 Some researchers argue that an interference with the implantation of a fertilized egg is unlikely to happen because progestins, whether natural or synthetic, help to sustain pregnancy.30 In addition, there is no evidence that one burst of levonorgestrel without estrogen can prevent implantation. However, researchers have concluded that the possibility of a postfertilization event cannot be ruled out, noting that it would be unethical and logistically difficult to conduct the necessary research.31 ECPs, including Plan B, do not interfere with an established pregnancy.

29Implantation is the embedding of the fertilized egg in the uterus six or seven days after fertilization. See A.L. Muller and others, “Postcoital Treatment with Levonorgestrel Does Not Disrupt Postfertilization Events in the Rat,” Contraception, vol. 67 (2003): 415-419.
30Horacio B. Croxatto, Maria E. Ortiz, and Andres L. Muller, “Mechanisms of Action of Emergency Contraception,” Steroids, vol. 68 (2003):1095-1098.
31It has not been possible to identify groups of women who had taken ECPs after fertilization so as to assess their effect on the establishment of a pregnancy. Therefore, there is no direct evidence, either for or against, the hypothesis that ECPs prevent pregnancy by affecting postfertilization events. See Croxatto, Ortiz, and Muller, “Mechanisms of Action of Emergency Contraception,” 1096.

3. Progesterone levels in early pregnancy, with graphs showing increase in progesteron after ovulation

4. Use of Progesterone in therapy for treatment of infertility and recurrent early pregnancy loss

Ms. (R)agazine and "We had abortions" campaign

Ms. Magazine is repeating their 1972 campaign - in their first issue, just so we all know/knew what the actual mission of the publication is/was - to encourage women to brag about their abortions, as shocking as that is to some of us.


At the Bioethics and Politics conference last month, I heard a well known lawyer/"bioethicist" chide the panel and audience for discussing the difficulty and emotionality of abortion.

Hers, too, was the best thing for her. She was in school, hadn't planned on having a child at that time and, "besides, I had no intention of marrying the father."

I was stunned.

Well, ladies and gentleman, I am proud to say that I never had an elective medical or surgical procedure that was designed and intended to kill my own child. And I never slept with anyone but my husband. I firmly believe that the facts are connected and strongly urge others to only have sex when they could bear up under - even unexpected - pregnancies and only with their spouses.

At the very least don't sleep with people you flat out know you wouldn't marry, even to save a life!

Truly the "best stem cell debate ever!"

blog.bioethics.net has posted the embryonic stem cell debate between Stephen (red tie) Colbert and Stephen (blue tie) Colbert.

Worth the wait, so give it a chance, even if you have to watch it on a slower dial-up.

More info on British experience with OTC EC

More on the lack of effect on the abortion rates in the UK after emergency contraception went over the counter in that nation. (And a rare chance to post the word, "whilst.")

From the responses (reader's letters) to that British Medical Journal Article posted earlier:

Whilst Marston et al make interesting observations , it only comments in passing on the failure of OTC emergency contraception to reduce unwanted pregnancy. OTC emergency contraception was introduced to try and reduce unwanted pregnancies by improving access. However the latest abortion statistics from the DoH sadly show a further increase in abortions for 2004 (up to 184,000), and in this respect the introduction of OTC emergency contraception can be said to have failed in its purpose.

Plan B Not Abortifacient, But Doesn't Change Much, Either

As the news that the FDA may soon make Plan B , the progesterone only protocol that is often called "Emergency Contraception" or the "morning after pill," available without prescription, we'll probably hear all sorts of opinions about whether or not it is an abortifacient or will lower the abortion rate.

The answer is probably "no" for both.

There is good news about the Plan B protocols, the progesterone-only formulations. The evidence is not conclusive, but I am fairly convinced that the protocols only work before ovulation and any effect after ovulation would serve to slow the sperm so that it's less likely to get to the oocyte in the fallopian tube, where fertilization takes place and to actually *encourage* implantation if there is fertilization.

This latter makes sense when we remember that one of the reasons for miscarriage is low progesterone and fertility docs often give
progesterone to women early in pregnancy.

It is very important to spread the news that if the pill only works by blocking ovulation, it will only work - and is only useful- during the 5 days or so before ovulation. (Fortunately, that's the most fertile period of the cycle, too.)


The most significant information about the mechanism by which the Levonorgestrel-only medicines function are the studies from Brazil by Croxatto and his group (H.B. Croxatto et al. Contraception 70 (2004) 442–450), which was a blind study, cycling women who were otherwise unable to get pregnant (sterilized or with - what I consider unethical and potentially abortifacient - IUD's) through 3 courses - placebo, and two forms of progesterone-only pills. The researchers followed the women with serial ultrasound and hormonal blood essays of hormone levels. The levonorgestrel interupted ovulation, so there could be no fertilization and no lost pregnancies.

There is a supporting study by Durand, et.al. (M. Durand et al. Contraception 71 (2005) 451– 457), from 2001 which tested surgically sterilized women given 2 doses of Levonorgestrel, 12 hours apart. These women were studied by serial ultrasounds and women who ovulated also underwent endometrial biopsy. There was no difference in their uterine lining function or anatomy although there was a difference in the expression ofglycodelin-A. This protein prevents binding of the sperm to the zona pellucida of the oocyte and so, prevents fertilization. (There is some speculation that the protein acts to help implantation, too.)

The conclusions from the data are still controversial. I am not one to risk causing death until I am certain, so I hope that Croxatto and Durand will continue their research and that others will replicate it.

On the other hand, results from other countries indicate that the abortion rate will not come down with increased access to Plan B. In fact, women and girls who were provided with the morning after pill in advance were no more likely to use the medication than before and were no more and no less likely to have unprotected sex.

From the British Medical Journal:

After emergency hormonal contraception was made available over the counter, levels of use of different types of contraception by women aged 16-49 remained similar. No significant change occurred in the proportion of women using emergency hormonal contraception (8.4% in 2000, 7.9% in 2001, 7.2% in 2002) or having unprotected sex. A change did, however, occur in where women obtained emergency hormonal contraception; a smaller proportion of women obtained emergency hormonal contraception from physicians and a greater proportion bought it over the counter. No significant change occurred in the proportion of women using more reliable methods of contraception, such as the oral contraceptive pill, or in the proportion of women using emergency hormonal contraception more than once during a year.

From Medical News Today, a fairly reliable source for medicine news, is this story from December 2004;

Morning after pill fails to reduce abortion rates
04 Dec 2004

The decision to provide women with the morning after pill over the counter has failed to reduce the UK's abortion rate, new figures reveal.

Researchers from Dundee, Edinburgh and Oxford universities found that a 28-month scheme by Lothian Health Board had no effect on women who were not already using family planning services.

Nearly 18,000 women aged from 16 to 29 were given packs of the morning-after pill to keep at home under the scheme.

However, the study concluded that many people were "too embarrassed" to ask for the advance emergency contraception.

More than 4,500 of the women gave at least one course to a friend and 45 per cent of the women used at least one of the courses themselves during the study, but admitted that they rarely asked for advance supplies of emergency contraception due to embarrassment and concern about being judged by health professionals as morally inadequate.

(Please note the fact that women gave these pills to other women and girls.)

What will change is that there will be less of a chance for a woman or a girl to have personalized medical advice or any sort of examination for the other problems that come from unprotected sex.

Imagine! Editorial On President's Veto

This is one of the best editorials I've read about the veto of HR 810, thanks to a Mr. Don Ehler and the Fort Worth Star Telegram (Free registration required for some content):

Posted on Tue, Jul. 25, 2006


Imagine all the aspects

By Don Erler
Special to the Star-Telegram

Imagine there's no heaven

It's easy if you try

No hell below us

Above us only sky

Imagine all the people

Living for today ...

-- John Lennon, Sept. 9, 1971

Add to the former Beatle's (perhaps drug-enhanced) imagination a pair of soberly unimaginative laws of life: All slopes get slippery when wet, and we traverse slopes daily. Preventing our slide into oblivion are the legal (therefore, political and moral) footholds that we establish on the hillsides of our collective life.

Maybe you know that last Wednesday, President Bush directed the National Institutes of Health to proceed with stem cell research that would not require the destruction of human embryos.

You didn't know that?

Oh, that's probably because most of the news stories touching on this controversial subject mentioned only Bush's first veto of his presidency.

He stopped federal funding for research using "spare embryos" from fertility clinics, which would otherwise be destroyed. White House press secretary Tony Snow said the president is one of those who abhor public funding of "something many people consider murder."

You might have seen pictures of Bush hoisting 15-month-old Trey Jones, once a frozen embryo who was adopted. Said the president of Trey and similar children: "These boys and girls are not spare parts."

At least seven points need to be made:

First: Even if Lennon's imagination happens to be correct, the embryos in question are human life (not "potential" or "building blocks"). Each contains unique DNA, making each a unique member of the human species. There is nothing religious about this biological fact.

Second: Our constitutional system protects "persons," not necessarily all human life. For example, the Fifth Amendment states that "No person shall ... be deprived of life ... without due process of law." Article II requires the president to be a "natural born" citizen. And the 14th Amendment confers citizenship only on "persons born or naturalized in the United States."

In short, embryos (and, for that matter, even late-term fetuses) cannot be citizens here. But they can, if we choose, be treated as "persons," just as fetuses should be protected when they begin to resemble "normal" people.

Third: Although the fact that embryos constitute early human life is biologically incontestable, the moral status of such life remains problematical. Columnist Chuck Colson has claimed that the "supporters of embryo-destructive research ... are seeking not only to destroy human life made in God's image but also to manufacture life made in man's image."

Fourth: Some loonies have referred to Bush's veto as politically inspired. If so, given opinion polling depicting a substantial majority opposing his veto, he is an inept politician. But Democrats have vowed to make this a political issue in the fall elections.

Fifth: In 2001, Bush approved research using 78 embryonic-stem-cell lines already in existence. Those stem cells had already been removed from the embryos and, therefore, could never develop into fetuses, toddlers or adults.

Yet at least one state (California) permits the kind of embryonic stem cell research that Bush vetoed. The president has not called for abolition of privately funded research or for laws requiring criminal proceedings against researchers who extract stem cells from -- thereby killing -- embryos.

Sixth: Not "everybody" does embryonic stem cell research. Colson noted that "Germany and France have embraced the same position President Bush has."

Seventh: Adult stem cell research has generated treatment for at least nine (possibly as many as 80) human diseases or conditions. According to National Review Online commentator Michael Fumento, "there are 1,175 clinical trials for ASCs" (adult stem cells) vs. "zero for ESCs" (embryonic stem cells).

In other words, promising research using adult stem cells is well advanced. But research requiring the destruction of very early human life has, at least thus far, proved fruitless.

Where, on this morally and politically slippery slope, we establish footholds depends largely on whether we believe in Colson's faith or Lennon's imagination.

Life, death, lawyers and ethics

LifeSite and Wesley Smith's "SecondHand Smoke" are covering the very public grief of a family facing the death of their father due to asbestos-related lung cancer.

There are accusations of euthanasia and "precipitating" death. In fact, the story does not support any of these.

From the Wall Street Journal Opinion by Pamela Winnick:

A medical resident--we called her "Dr. Death"--at the Intensive Care Unit at Long Island's North Shore Hospital chased us down the hallway.

"Your husband wants to die," she told my mother, again. Just minutes before I had asked her to leave us alone.

"He can't even talk," I reminded her.

"He motioned with his hands when we tried to put in the feeding tube," she said.

Not exactly informed consent, I pointed out as we turned our backs on her and walked down the hallway, trying to avert our eyes from the other patients in the ICU that night, each of them at various points in the so-called "twilight zone" between life and death.

Afflicted with asbestos-related lung cancer, my father, Louis Winnick, was rushed into the ICU in late May after a blood clot nearly killed him. The next day, my husband and I raced to New York from Pittsburgh. I packed enough work and knitting for what might be an extended stay, but I also put in a suit for what I was certain would be my father's imminent funeral. Still, he wasn't dead yet. And we had no intention of precipitating the inevitable.

"Dr. Death" was just one of several. A new resident appeared the next day, this one a bit more diplomatic but again urging us to allow my father to "die with dignity." And the next day came yet another, who opened with the words, "We're getting mixed messages from your family," before I shut him up. I've written extensively about practice of bioethics--which, for the most part, I do not find especially ethical--but never did I dream that our moral compass had gone this far askew. My father, 85, was heading ineluctably toward death. Though unconscious, his brain, as far as anyone could tell, had not been touched by either the cancer or the blood clot. He was not in a "persistent vegetative state" (itself a phrase subject to broad interpretation), that magic point at which family members are required to pull the plug--or risk the accusation that they are right-wing Christians.

I complained about all the death-with-dignity pressure to my father's doctor, an Orthodox Jew, who said that his religion forbids the termination of care but that he would be perfectly willing to "look the other way" if we wanted my father to die. We didn't. Then a light bulb went off in my head. We could devise a strategy to fend off the death-happy residents: We would tell them we were Orthodox Jews.

My little ruse worked. During the few days after I announced this faux fact, it was as though an invisible fence had been drawn around my mother, my sister and me. No one dared mutter that hateful phrase "death with dignity."

Though my father was born to an Orthodox Jewish family, he is an avowed atheist who long ago had rejected his parents' ways. As I sat in the ICU, blips on the various screens the only proof that my father was alive, the irony struck me: My father, who had long ago rejected Orthodox Judaism, was now under its protection.

As though to confirm this, there came a series of miracles. Just a week after he was rushed to ICU, my father was pronounced well enough to be moved out of the unit into North Shore's long-term respiratory care unit. A day later he was off the respirator, able to breathe on his own. He still mostly slept, but then he began to awaken for minutes at a time, at first groggy, but soon he was as alert (and funny) as ever. A day later, we walked in to find him sitting upright in a chair, reading the New York Times.

(Emphasis is mine)

From a link on Euthanasia at the bottom of the LifeSite article concerning Ms. Winnick's article:

"Euthanasia is the deliberate act of putting an end to a patient’s life for the purpose of ending the patient’s suffering."

I suspect a local - meaning the treatment team including residents, fellows, and the attending - influence with a prejudice toward low/no interference in patients with a terminal condition. The upper level residents and fellows would be the place I'd look. Someone taught the resident to use the phrase, "Your father wants to die." There's also the possibility that she's had a bad experience in her professional or private life and that she's projecting or assuming too much from Mr. Winnick's fighting when the feeding tube was placed (probably a nasogastric tube - through the nose to the stomach - at this point in the story.)

However, please note the timeline in the original essay and that the doctors were not suggesting "precipitating" anyone's death. The disease is/was killing Mr. Winnick. The blood clot was symptomatic of changes due to the cancer. It is absolutely true that it was a miracle that Mr. Winnick was able to come off the ventilator and that he had no heart or brain damage due to the blood clot.

The original article told us that these conversations were in the ICU, while the author's father was still unconscious. (Later reports on LifeSite and SecondHand Smoke were not as clear cut. This one seems to contradict the description of Mr. Winnick's condition described above and to be a later report.)

If there was no advance directive, how could the treating team know how far to go with intervention in the face of a patient with terminal cancer and a blood clot (I assume in the lungs) who has very little chance of being weaned from the ventilator due to the damage from the cancer, aggravated by the clot, before the patient has regained consciousness, without asking the family?

Many people would consider death during the unconsciousness due to a pulmonary embolism or pneumonia preferable to pain and air hunger or liver failure, kidney failure, bleeding disorders as the clotting factors are used up, and the other problems that I can imagine down the line.

Especially in these days of autonomy and accusations that doctors are patronizing and have all sorts of bad motivations and worse actions, it is/was appropriate to hold a family meeting in the ICU to discuss the attitude toward accelerated treatment, if needed. The treatments to be anticipated are interventional, possibly painful and require multiple departments and people: surgical intervention for a tracheostomy tube for the ventilator, permanent placement of a gastric feeding tube, cardiac compression and/or shocking in the event of heart attack or arrhythmia, addition of pacemaker, dialysis, or parenteral feedings [high-tech IV solutions that require constant monitoring and adjusting and which cause liver damage in the long-term]. If there were recurrent admissions for emergent conditions due to more clots or infections, I would discuss the risk vs. benefit of repeated painful interventions and manipulations in the face of new complications.

The discussion just happens to be the right thing to do, as well as good risk (lawsuit risk, that is) management.

After all, if lawyers have taught us anything, it's that if we don't document, we didn't do it and that anyone can be sued for anything, right?

Now, I agree with Ms. Winnick that bioethics doesn't seem to be all that ethical, far too often. (In fact, I call it the "formalized study of who we can kill.")

On the other hand, medical Clinical Ethics, a much older discipline that is too often considered a sub-division of bioethics, does tend to be more ”ethical.”


Unfortunately, ethics training in medical school focuses more on how to avoid lawyers than on clinical ethics. We are taught to avoid malpractice, to obtain informed consent, to code properly so the Federal government won't come in with their fines and guns, and to avoid crossing personal barriers. (The latter usually means sexual barriers.)

I’ll admit that clinical ethics has come to focus more on autonomy and justice (as in fair distribution) more than on beneficence guided by non-maleficence. Rather than “Heal when possible, but First, do no harm,” medical students learn that physicians should consider all world views as equal. Lord forbid that we mention Him (the subject of the last half of that original editorial by Ms. Winnick) or that we imply that some actions are flatly wrong and others are “the right thing to do.” Some ethicists teach that doctors have no right to let their consciences influence their practice of medicine, at the risk of being "idiosyncratic," "bigoted," and "discriminatory."

I haven’t figured out where “rights” and “should” come in to play if I have no conscience. Perhaps, doctors should just follow orders.

Greenberg's Frankenstein Syndrome

I'd call it the Dred Scott Syndrome.

Paul Greenberg has written an editorial arguing against destructive and manipulative embryonic stem cell research and in favor of the veto by President George Bush of HR 810.

The next ethical ridge to be crossed would then loom ahead: If it's permissible to experiment on embryos destined to be destroyed, why not on terminally ill patients, or prisoners on Death Row, or, well, the list would surely grow.


The case for embryonic experimentation isn't dubious just ethically but scientifically. To quote Robert P. George, a law professor at Princeton who served on the President's Council on Bioethics:


"Researchers know that stem cells derived from blastocyst-stage embryos are currently of no therapeutic value and may never actually be used in the treatment of diseases. . . . In fact, there is not a single embryonic stem cell therapy even in clinical trials. (By contrast, adult and umbilical cord stem cells are already being used in the treatment of 65 diseases.) All informed commentators know that embryonic stem cells cannot be used in therapies because of their tendency to generate dangerous tumors."


All of which leads Professor George to suspect that the clamor for embryonic stem cell research isn't really about using these early-stage blastocysts but exploiting more fully developed embryos, say those 16 to 18 weeks old, when the stem cells would be less likely to grow out of control.


Slate magazine's resident bioethicist, Will Saletan, outlined just such a program not long ago in his five-part series "The Organ Factory: The Case for Harvesting Older Human Embryos."

Why harvest? Why not go on to manipulate and create post-natal children of humans who are not "persons"? Why not go forward toward a C. S. Lewis' Abolition of Man in which, since we are enslaving our children of the future without their consent anyway, we create stunted, yet useful, growing and self-replicating non-person humans?

How much consciousness is necessary, and how do I measure your consciousness on my scale, Peter Singer's scale, or Genentec's scale? Where's the arbiter when we divide humans into persons and non-persons, and why should I let any creature live free if I'm smart enough to enslave them? The person begins at fertilization - any tech in any in vitro lab can discern whether or not fertilization has occured within hours. (In fact, the axes of the embryo are set at penetration of the oocyte by the sperm, and those axes are persistent throughout development.)

That same tech can tell you that if the first cell division is poisoned or if there is contamination of the blastocyst, that the embryo's functions stop and implantation will fail. Or, perhaps the embryo can be humanly modified to follow a pre-determined tack.

Why not train children to be our slaves, or use technology to grow slaves who can accept nothing more than training?

If there is action based on immediate emotional responses to empathy, I can understand that a person without time and full knowledge will make decisions that favor the more developed human over the less developed human.

However, in the case of legislation about the deliberate creation of extracorporeal human embryos, destructive or manipulative embryonic cell research, and elective abortion, the empathy should be guided by knowledge and planning.

Very soon, as this article shows, we will have to make laws to deal with whether or not our children of the future who are not Homo sapiens are actually "human." We will have to determine whether they can ever be "persons," just as Justice Taney had to decide about Dred Scott - after all those responsible for his being in the US had never intended him or his children to be persons, either.

What about the children of the children of the future? Will they be human, objects of empathy or not-human-enough? How much self-interest will there be, then? How many horrors are we to allow? Low IQ infertile sex slaves, specialized and fertile harvest models, or chattel designed for mining on earth or for life in space stations

Lois McMaster Bujold's Falling Free is a story about similar genetically modified humans. There's the old standby, Brave New World - why not Deltas and Epsilons? Or the cloned "students" in Never Let Me Go? (Also available in e-book form here.)

How, rather than human parentage will these decisions be made? Will these children of the future need to pass some test for consciousness? Will they need to be within 2 standard deviations of "person" genes, phenotype, ability to hire a lawyer?