Wednesday, December 20, 2006

One more thing on errors

That letter mentioned above actually noted nine, not seven, treatments.

Here's the opening paragraphs from the letter (Sorry, subscription only) (Note the uses of "treat," "cure" and "phases"),



Originally published in Science Express on 13 July 2006
Science 28 July 2006:
Vol. 313. no. 5786, p. 439
DOI: 10.1126/science.1129987

Letters
Adult Stem Cell Treatments for Diseases?
Opponents of research with embryonic stem (ES) cells often claim that adult stem cells provide treatments for 65 human illnesses. The apparent origin of those claims is a list created by David A. Prentice, an employee of the Family Research Council who advises U.S. Senator Sam Brownback (R-KS) and other opponents of ES cell research (1).

Prentice has said, "Adult stem cells have now helped patients with at least 65 different human diseases. It's real help for real patients" (2). On 4 May, Senator Brownback stated, "I ask unanimous consent to have printed in the Record the listing of 69 different human illnesses being treated by adult and cord blood stem cells" (3).

In fact, adult stem cell treatments fully tested in all required phases of clinical trials and approved by the U.S. Food and Drug Administration are available to treat only nine of the conditions on the Prentice list, not 65 [or 72 (4)]. In particular, allogeneic stem cell therapy has proven useful in treating hematological malignancies and in ameliorating the side effects of chemotherapy and radiation. Contrary to what Prentice implies, however, most of his cited treatments remain unproven and await clinical validation. Other claims, such as those for Parkinson's or spinal cord injury, are simply untenable.


And here's the references that are noted,
1. Posted at the Web site of DoNoHarm, The Coalition of Americans for Research Ethics (accessed 8 May 2006 at www.stemcellresearch.org/facts/treatments.htm).
2. D. Prentice, Christianity Today 49 (no. 10), 71 (17 Oct. 2005) (accessed 8 May 2006 at www.christianitytoday.com/ct/2005/010/24.71.html).
3. S. Brownback, "Stem cells," Congressional Record, 4 May 2006 (Senate) (page S4005-S4006) (accessed 8 May 2006 at http://frwebgate6.access.gpo.gov/cgi-bin/wais-gate.cgi?WAISdocID=122359256098+2+2+0&WAISaction=retrieve).
4. According the latest version of the list, accessed 12 July 2006.

False information propagated by stem cell news reports

What's new, right?

In an article spread by the Associated Press, "Public misinformed about stem cell issue," (found in the Houston Chronicle, USA Today, and others, there is a blatant factual error.

A July 2006 article in the journal Science refuted claims that there were 65 treatments that utilize adult stem cells. In truth, the article stated, there are seven.


The Science "article" was actually a letter, and opened with the statement concerning treatments that were "fully tested in all required phases of clinical trials and approved by the U.S. Food and Drug Administration."

This letter led columnist Michael Fumento to dub the Journal, "PseudoScience."

For more information, see the editorial by Robert P. George and Eric Cohen at Ethics and Public Policy, "Science gets duped again," Or see my blurbs here and here.

In fact, there are more than 70 diseases in which stem cells are "utilized," many in FDA approved and NIH funded studies.

Monday, December 18, 2006

Human Reproduction: Definition of Human Embryo

Y'all didn't seriously think a little thing like my husband's left hip surgery would stop me, did you?

Human Reproduction, a peer-reviewed, high impact journal of research and opinion concerning "the scientific and medical aspects of reproductive physiology and pathology, endocrinology, andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues" (free, full text online in advance of pulishing) has published the following definition of a human embryo:

The following biological definition of ‘human embryo’ is proposed.

A human embryo is a discrete entity that has arisen from either:
(i) the first mitotic division when fertilization of a human oocyte by a human sperm is complete or
(ii) any other process that initiates organized development of a biological entity with a human nuclear genome or
altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive
streak appears,
and has not yet reached 8 weeks of development since the first mitotic division.


There is "insufficient information whether the entities derived by parthenogenesis, gametogenesis using pronuclear DNA from two parents, and several SCNT and Chimera scenarios which - prior to their creation - have had the ability to implant removed from the genome. However, the entity would be covered by the definition if the manipulation can be said to have "the potential to develop up to, or beyond, the stage at which the primitive streak appears."

I would think that this definition would cover most of the most troublesome aspects involving regenerative medicine or destructive human embryo technique. The uncertain cases would need to be proven to not be human embryos, through animal models, or for the more unethical, actual experiments using human DNA.

Let's hear no more about "early" stem cells, or "there's no sperm(!)" or "there's no potential to form a human baby/person/be implanted in a uterus," etc.

Thank you Human Reproduction, for making this article available free. The tables, showing the need for human oocytes and the sources of DNA and cytoplasmic (oocyte) material necessary for the production of each class, are invaluable.

A new left hip!

My husband had a hip replacement today after years of worsening hip due to aseptic necrosis. I may not be a busy blogger until he's home.

Saturday, December 16, 2006

Same story, new spin

It's (she's) an embryo. What part of "I'm all for stem cell research, but don't kill a human embryo" don't they get?

Harvard's George Q. Daley is in the news again. This time his research group has produced parthenogenetic mouse embryos, that were used to harvest stem cells. The original article has been published online (Free abstract) before going to print, in Science Express, a feature of the journal, Science. Another well-written review from a slightly different is available online at "ThisisLondon.com," a feature of the UK's Evening Standard. Here's another from Scientific American. Frequent mention of "virgin birth" in the articles is telling.

The method used chemical treatments to prompt the egg to develop into an embryo, a process known as parthenogenesis, and then extracted stem cells from it.

The embryo could not have otherwise developed into a baby mouse, so, even in humans, the strategy is unlikely to raise as serious ethical objections as other methods that destroy a viable human embryo.


I don't think so. The only reason that the "embryo could not have otherwise developed into a baby mouse" is because the researchers intended to destroy it in order to harvest those stem cells. If the embryo had been human, the creation of an embryo in such a situation (that carries a high level of risk for the embryo) can not be ethical.

Parthenogenetic mouse embryos have been developed before, as the Boston Globe artical notes. In 2004, an article in Nature (free abstract online) reported that one of these embryos was implanted and grew to birth, grew to adulthood, became pregnant herself and gave birth to normal mouse babies. This was one of 10 who survived nearly to birth of 23 embryos that were implanted.

Why shouldn't we assume that if the hurdles of parthenogenesis in humans is overcome that the problem with implantation and gestation to whatever stage of developement will seem useful to researchers?

At least, this Boston Globe article doesn't use the term "virgin birth" and it is more honest than some mass media stories on cloning and destructive embryonic stem cell production. The author, Cary Goldberg calls the embryos "embryos" and mentions the worries about tumor formation and other abnormalities of stem cells derived from embryomnic stem cells, as well as the risk of tumor production:

The immediate benefit of the technique is for researchers; it still has many hurdles to overcome before it will be clear whether it is safe for use in humans, said George Q. Daley of Children's Hospital Boston, senior author of the paper published online in the journal Science. There is concern, for example, that such cells could become cancerous.

But, he said, the technique may be closer to working in humans than somatic cell nuclear transfer, the conventional approach in animals for generating customized embryonic stem cells.

In that method, a nucleus from a regular cell such as a skin cell is inserted into an egg and induced to develop.

Also known as therapeutic cloning, it is highly inefficient in animals and has yet to be mastered in humans, though two Harvard teams, including Daley's, are trying.

"This is a much more workable approach to generating patient-specific and tissue-matched embryonic stem cells," Daley said. "But the trade-off is that these cells may not prove to be normal and functional."

If the egg technique works in humans, women would be their own immediate beneficiaries, but the effects could be wider, Daley said. It could also lead to the broader production of stem cells that have only half the usual set of immune system genes -- perhaps even whole banks of such cells -- and that therefore would be compatible with many patients who need to grow new tissue.


Professor Daley needs to Google umbilical cord blood cells.

Friday, December 15, 2006

Texas in Front on Ethical Stem Cells, Again

Here's evidence of private funds backing adult stem cell therapy.

Dr. James Willerson will lead a team investigating a special technique to isolate a special population of bone marrow stem cells. The stem cells will be used to attempt to increase the circulation in the legs of patients with "Critical Limb Ischemia," or very low blood flow to the legs.

DURHAM, N.C., Dec. 15 /PRNewswire/ -- Aldagen, Inc. today announced that the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston, Texas will be the first site for its clinical trial using Aldagen's ALDESORT(R) product to isolate a unique stem cell population as therapy for critical limb ischemia (CLI) patients. The co-lead investigators at Texas Heart Institute on the study will be Dr. Emerson Perin and Dr. James Willerson.
"We are very excited to begin this study as it represents the first clinical study in the United States to use purified stem cells for the treatment of critical limb ischemia. We believe that these cells have the potential to offer CLI patients a new therapeutic option," said Drs. Willerson and Perin. Dr. James Willerson is president-elect and medical director of the Texas Heart Institute at St. Luke's and President of The University of Texas Health Sciences Center at Houston. Dr. Perin is director of New Cardiovascular Interventional Technology and director of the Stem Cell Center at the Texas Heart Institute at St. Luke's.

About the Study

Aldagen's clinical trial will involve 20 patients, all of which will have bone marrow extracted. Ten patients will receive multiple injections of the bone marrow directly into muscle in the ischemic leg and ten patients will receive multiple injections of stem cells isolated from the bone marrow using Aldagen's ALDESORT product. The patients will be monitored for up to six months with a primary endpoint at three months. Endpoints will include safety and the ability of therapy to reduce rest pain, increase skin surface oxygen pressure and improve ulcer healing.

ALDESORT isolates a highly potent population of stem cells taken from the patient's own bone marrow. These stem cells have the potential to build new blood vessels (angiogenesis) in ischemic legs which could ultimately lead to improved functionality for CLI patients.

For more information on the study, call the Texas Heart Institute's Stem Cell Center at 832-355-9404, visit online at http://www.texasheart.org/stemcell or e-mail directly to plea@heart.thi.tmc.edu.

About Critical Limb Ischemia

Critical limb ischemia is a severe form of peripheral vascular disease (PVD). It is estimated that between eight to 12 million Americans suffer from PVD, which is a disease of the blood vessels characterized by narrowing and hardening of the arteries that supply the legs and feet. This causes a decrease in blood flow that can injure nerves and other tissues. CLI can lead to gangrene or tissue death, often necessitating amputation of the affected limb. Currently, there are no suitable alternatives to either percutaneous or surgical revascularization in patients with CLI. Despite some success of limb salvage with leg bypass, the condition remains associated with a substantial rate of morbidity and mortality and the need for subsequent surgery and hospitalization for wound complications is as high as 50%. There is a pressing need for the development of techniques to improve the vascular supply to ischemic leg by less invasive means.

Thursday, December 14, 2006

Reports on kidney repair by (ethical) stem cells (and more!)

You may not have read it in the New York Times, but there's exciting news supporting the hope that ethical - non-embryonic - stem cells may be used to treat not only diabetes, but to repair kidney damage.

The most significant article is from The Procedings of the National Academies of Science, which, although largely ignored by the mainstream press, was summarized in a November report in the National Geographic online:

In a study published in November in the journal Proceedings of the National Academy of Sciences, researchers reported that stem cells derived from human bone marrow and transplanted into diabetic mice stimulated the animals' pancreases to produce insulin, repairing damage caused by diabetes.

"This fits with a large body of evidence that these cells have this remarkable ability to go to injured tissues and repair them," said the study's lead author, Darwin Prockop, the director of the Center for Gene Therapy at the Tulane University Health Sciences Center in New Orleans, Louisiana.

In the future, Prockop said, "the therapeutic idea would be to take small amounts of marrow from patients, then grow a large number of these cells, and give them back to the same patient to heal tissue."


From The Procedings of the National Academies of Science article:
The observations here do not rigorously rule out the possibility that the improvements in the glomeruli were secondary to the lower blood glucose levels in the treated diabetic mice. However, it was striking that the human cells were found exclusively in the glomeruli and that some the cells apparently differentiated into endothelial cells. Therefore, the simplest interpretation of the data are that the engrafted hMSCs either prevented the pathological changes in the glomeruli or enhanced their regeneration.



Support for the belief that treatment for kidney damage and disease will come from ethical sources is reinforced by a report from this week's 48th Annual Meeting of the American Society of Hematology (ASH(TM)). Hematologists are the specialists in treating blood disorders, but their field overlaps with Oncologists in the treatment of cancers and, because of the work with bone marrow stem cell transplants, many are also involved in stem cell research.

Three of the papers presented at the ASH conference were on ethical stem cells, including one that dealt with damage from Graft vs. Host Disease in transplant patients using bone marrow stem cells, treatment for one type of "SCID" (popularly known as "bubble boy syndrome," a genetic defect that causes an almost total lack of ability to fight off infection) and the one dealing with stem cell treatment for kidney failure.

As if these two sources were not enough evidence there's a research article in The Journal of the American Society of Nephrology (free abstract) that reports on the isolation of stem cells from the kidneys, themselves.


These reports are exciting news - and should have received much more media coverage - due to the shear numbers of patients who experience acute and chronic renal or kidney failure and disease due to infections, drug reactions, high blood pressure, heart disease and diabetes.

Wednesday, December 13, 2006

Fetal vs. umbilical cord neural stem cells

The news about "Stem Cells, Inc.'s" phase I trials of fetal neural stem cells in the treatment of Batten disease reports improvement in the condition of the first patient.

I'm a little shocked at how matter-of-fact the article treats the use of brain cells from aborted infants.

Why is there not more questioning about the process and methods involved in harvesting these cells? Where is the open scientific communication?

And why, in the reports about this trial, are there no discussion about - seemingly no consideration of - ethical stem cells from umbilical cords and adult tissues?

Of course, there have never been any human trials using embryonic stem cells. The tissues transplanted into Daniel Kerner's brain are fetal stem cells - the babies killed in the abortions before their brains were collected and then processed for the transplant were at least 8 weeks along, and probably a bit more. However, there's not much info on the "purification" process that resulted in the volume of "purified neural stem cells."

There is quite a bit of research showing that neural stem cells are available from the cells harvested from umbilical cords and even adult sources, such as bone marrow and neural tissue in the mature body.

Wharton's jelly cells have been "easily" ( Free abstract online) induced to transform into neural stem cells and to proliferate in the lab - at least 80 doublings. In animal models, the cells are being evaluated for use in treating Parkinson's and other neurological disease.

There are also reports of development of stem cell lines from bone marrow cells, brain, and even skin cells.


Perhaps, now that "Stem Cells, Inc." researchers believe that they know the specific markers that are to be found on the cells they believe to be useful, they can turn their efforts to more ethical research. And more accessible stem cell sources, especially umbilical cord cells. Even with 1 out of 3 babies aborted in this country, most are aborted at the embryonic stage (1st trimester), and so there are many, many more opportunities to harvest ethical stem cells from umbilical cords.

Monday, December 11, 2006

Hypothetical end of life dilemma

Suppose there was a patient, Mr. B., with adenocarcinoma, a fast growing malignancy that begins in the liver, the pancreas, or another intestinal organ. Although the patient has lived twice the predicted 3 month life expectancy, the cancer has finally spread throughout the body - to the liver, the lungs, the intestines, and, now, the brain.

Mr. B. is a 50 year old engineer, divorced and has no children. When he found out about his cancer, he spent some time "getting his affairs in order." This month, he moved back to the town he grew up in, to live with his older sister, Mrs. S. Unfortunately, he has not seen a doctor in town, since he had planned to continue seeing the oncologist 50 miles away. The day after he arrived, Mrs. S. found him passed out on the floor of his room and called the ambulance.

On admission to the Emergency Room, Mr. B. is not conscious, can't swallow, and his liver and colon are not functional. The CT scan of the head shows a small mass, but the doctors explain that the problem is probably the loss of liver and kidney function.

The liver has completely shut down, causing the loss of the blood plasma protein normally made by the liver. The fluid from his blood moves from the veins and arteries into the body tissues by osmosis. The liver can't clean toxins from the body, so he is yellow, his blood vessels are losing the ability to hold blood pressure, and his kidneys are shutting down.

Mrs. S. refuses to hear of transferring Mr. B. to the big hospital 50 miles away where his oncologist practices. She insists that Mr. B. is a fighter and has already fooled the doctors by living so much longer than they predicted, and demands that he be given "everything possible" to prolong his life.

The family doctor who is assigned as Mr. B's new Dr. by the ER "on call list" has asked both of the kidney specialist groups in town to evaluate the patient for dialysis and each has separately advised him that the dialysis is not appropriate and declined the consult. For one thing, the veins in his arms and legs are not big enough to handle the amount of fluids necessary for dialysis, and he would need a surgical procedure to place a larger central IV line than the one that was placed in the ER.

The sister, Mrs. S, who is acting as the patient's surrogate for making medical decisions, is furious with the new doctor. Although by th day after admission, Mr. B.'s legs are swollen to the point that the skin has begun cracking and draining, she is certain that the patient is thirsty and hungry. Convinced that the doctor is "killing" and "starving" her brother, she calls a lawyer who takes the family doctor to court. The judge grants an emergency hearing and then orders the doctor to begin dialysis and provide adequate artificial nutrition and hydration.

The family doctor, who is board certified in Family Medicine, which requires continuing medical education and repeat certification each 7 years - in fact, he just passed his boards for the 3rd time - has never written the orders for dialysis, hasn't written orders for "total parenteral nutrition" (TPN) since he was in medical school, and hasn't placed a central line since residency 21 years ago. Besides, his hospital privileges don't include supervising dialysis. He's already explained all of this to the judge.

The doc, just looks at the judge and says, "Tell me, your honor, will you assist me in placing the central line and then dictate the exact orders you want me to write? What rate of filtration and how much pressure should I use in the dialysis? How much fluid can I safely remove, and how fast?"

Medicare fees tied to reporting

"Pay for Performance" (P4P, sometimes called "Pay for Play" by some of us who aren't fond of the scheme) just got a huge boost from Congress. Expect to see more docs carrying computers equiped to run an "electronic medical record" (EMR) around the office.

And don't be surprised to see more solo and small group practices withdraw from participation with Medicare and insurance companies, merge with ever-bigger groups or close down completely as the docs find other ways to make a living.

The current lines of EMR cost $50,000 per doc or "provider" to start, and can cost $8000 or so each year for up keep. (I have no idea why, but that's what I hear.) And EMR's will be necessary in order to charge for the work that the doc does in the near future.

Initially, the scheme will measure the doc's ability to report data, more than any health benefits. From today's Wall Street Journal, subscription only:

This is clearest in Medicare, the federal health program that covers more than 40 million elderly and disabled people. Congress agreed to erase a scheduled reduction in payments to physicians, but it made a 1.5% bonus payment available only to physicians who report to Medicare how they perform on certain specified barometers of health-care quality. Initially, the payments will be based on whether the physician reports the data, but the system lays the groundwork for higher payments to better-performing physicians.

Among the information Medicare officials will collect: whether doctors provide aspirin and beta blockers to patients having heart attacks, and whether elderly patients are screened for their risk of falls. These practices are considered indicators of good patient care.

Thursday, December 07, 2006

More on End of Life - Family Dilemmas

Increased medical technology creates a burden on family decision makers and loved ones as well as doctors, nurses and pharmacists. Listen to the (free) National Public Radio interview with journalist Stephen Kiernan on medical care at the end of life, from December 4, 2006.

It’s not surprising that there would be misunderstandings between doctors and patients and families during high stress crises. The end of life is, of course, potentially one of the worst times in life of the individual who is dying and all the loved ones around him. The doctors are speaking their own language. The patient and family members not only have to learn new skills and evaluate technology and weigh risks versus benefits. They are each bringing their own perspective, emotions and world views to the bedside. The experiences of everyone will even differ by the time of day and the “baggage” that they bring to each meeting.

And each time we add a new "routine" or "experimental" therapy or protocol - whether it's the ventilator, a new thousand-dollar-per treatment drug, or deciding on dialysis or feeding tubes, the questions become harder.

I’m concerned that end of life care too often becomes care of the families’ fears and pain, rather than being focused on the actual last days of life of the patient herself. We stop treating Moma or Daddy in his or her own best interest and begin to intervene in an attempt to ease our own psychological and spiritual pain. I’m reminded of the natural childbirth literature of the ‘70’s, that accused us of ignoring and adding to the baby’s pain and shock because we are all holding our breath, waiting for his first breath. Labor and delivery is hurried with chemicals and surgery, the lights are overly bright, and we suction, rub and – in the past – slap the baby’s behind for our benefit, not his. It’s as though we can’t breathe until we are reassured that he is alive, even if he is screaming in pain.

Mr. Kiernan reviews the dilemmas that he and his family endured during the illnesses and deaths of his parents. His mother and siblings didn’t realize until after the fact that have a tracheostomy performed on his father was not “progress.”

Mr. Kiernan also speaks of what he calls the “tradeoffs” that go along with hospice coverage. If I understand it properly, however, Medicare does not require a patient to give up dialysis or other treatments. What happens is the hospice contracts with Medicare for a given fee per patient. If a patient needs dialysis, there’s no extra money. On the other hand, Medicare will pay all the costs for outpatient dialysis, but the patient will not have access to the specialized care and services available through hospice.

I thought my “Advance Directive” covered everything. But Mr. Kienan adds a point that I hadn’t considered: he wouldn’t mind being kept alive “by any means necessary” for up to 48 hours in order for his family to gather and say good bye. Then, he wants all the life support stopped and to be placed in the sun.

(Mine was amended after Terry Schiavo’s death. Essentially, I’ve always said, “don’t wake me up to ask me!” There’s a new note that asks for ice chips and for someone to place chocolate on my lips.)

Agreement: no euthanasia for children

Art Caplan, the pseudoeditor at blog.bioethics.net, head of the Center for Bioethics at Pennsylvania University, and a columnist for MSNBC, has posted a note at the bioethics.net blog that calls for an end of the suggestion that sick babies should be killed by their doctors.

Good going, Art!

Wednesday, December 06, 2006

Human enough to think about

Watching the changing definitions and necessary and sufficient conditions for any of us to be deemed human enough to be afforded the protection against infringement of the right not to be killed , an observant being would just about have to assume we're dealing with a fairly significant group of entities.

The Supreme Court went so far as to allowing an infinite number of meanings of the universe, in order to justify affirming abortion in the Planned Parenthood vs. Casey decision.

And now, people are increasingly willing to make life with the express intent to take it. (Nigel Cameron HT)

It might be that all of us who have this conversation, and all the members of our species are "human enough" just because we're one of us.

At the very least, as I say at the top of the page, we're the only ones having this conversation.

On stem cells and media bias

I report frequently on the media and its bias against reporting successes in adult stem cell research. Sometimes, what appears to bias is just early results and sometimes I'm wrong - there is no bias. JivinJehosaphat mentioned my blog from yesterday comparing the reports on non-embryonic stem cells and embryonic stem cells in Parkinson's, and noted that the numbers of articles were more even, a little later in the day. Monsters and Critics and the UPI even reported on the breakthrough from Georgia researchers who transplanted non-embryonic (adult) human neural stem cells into animal models to study their effects as treatment for Parkinson's disease. As of this morning (about 5 AM CST), the count on Google news is 11:11. (I am glad to be wrong in this case.)

In another example where I might have been wrong about bias, back in February of this year, I posted about a report on bone marrow cells used to treat humans with Diabetes type II. As an anonymous poster has pointed out in the comments, there's not much evidence of this research protocol other than news articles, whether in a Google or Pub Med search. Formal publication in peer-reviewed journals takes a long time, and that sort of delay may explain the lack of corroboration of human stem cell transplants for diabetes. However, 10 months should be long enough to find other, reliable reports of what the original article called "the most important step in Diabetes research since 1929."

The good news, though, is that animal models are demonstrating that the report from Argentina's Dr Fernadez Vina may become a prediction that comes true.

One of the most exciting reports comes from the Procedings of the National Academies of Science, "Multipotent stromal cells from human marrow home to and promote repair of pancreatic islets and renal glomeruli in diabetic NOD/scid mice." The article, available free online, describes the surprising effects of bone marrow stromal cells on not only the pancreas, but the kidneys.

It also has a number of links to research along the same line - many available free online, also. For instance, there's this article from Stem Cells, "Human Cord Blood–Derived Cells Generate Insulin-Producing Cells In Vivo." Which led me to this review of the literature on umbilical cord stem cells in the treatment of diabetes.

Tuesday, December 05, 2006

Embronic stem cells: twice the coverage

Google News search on new Parkinson's stem cell research.

Reseach on adult stem cells used to treat Parkinsons: 5 citations - none of the big names. Embryonic stem cells used to treat Parkinsons: 10 news articles, including UPI, Science Daily and Monsters and Critics.

Can you study medical ethics?

I'm still working on my article on age at marriage and sexual initiation changes. I'm trying to learn to post the graphics that I think are useful. Preview, tweak, delete.

In the meantime, what about all the docs and student docs who are learning how to treat patients ethically?

Deleting their mistakes is not an option. They can't preview the results of their actions, except in a theoretical way, based on experience and guidelines built on the experience of others. The tweaking can look worse than some of my HTML mistakes.

The BBC has a fairly well written article on teaching medical ethics that I recommend.

We don't always get it right. In my experience, "medical ethics" conferences teach how to get along with Medicare and Medicaid, to avoid charges of fraud, and how not to get sued. We ought to be teaching and reviewing - and perhaps, sharing - how to deal with the truly hard questions. (See the discussions here and here.)

Saturday, December 02, 2006

Be sure and take a look at LifeEthics.org and the news commentary at the blog, Lifeethics.org Blog.

Friday, December 01, 2006

Contraception and abstinence in the news

The news today reports on a study by the Alan Guttmacher Institute that abstinence doesn't make as much difference in the overall teen pregnancy rates in the US as increased contraceptive use.

I'm still looking at the data in the report and trying to understand their methods and statistics. (Free Abstract here).


Comparing data from the National Survey of Family Growth, 1995 and 2002, the researchers found,

Our data suggest that declining adolescent pregnancy rates in the United States between 1995 and 2002 were primarily attributable to improved contraceptive use. The decline in pregnancy risk among 18- and 19-year-olds was entirely attributable to increased contraceptive use. Decreased sexual activity was responsible for about one quarter (23%) of the decline among 15- to 17-year-olds, and increased contraceptive use was responsible for
the remainder (77%). Improved contraceptive use included increases in the use of many individual methods, increases in the use of
multiple methods, and substantial declines in nonuse.



On the other hand, some of the blogs and pro-life news sites have been talking about a new study that shows strong evidence that there is protection in abstinence based sex ed.

John Jemmott, PhD
of the University of Pennsylvania Annenberg School, reported in Toronto in August, 2006 that his team had compared abstinence-only education with


The PowerPoint slides showing efficacy of the abstinence only approach, from the presentation in Toronto are here.

And here's a review of the discussion in the media, at the time:


A study of 662 African-American Grade 6 and 7 students from inner-city middle schools in Philadelphia found those taught an abstinence-only approach to sex were less likely to have had sexual intercourse at 24 months' follow-up compared to those put through a "safer sex" intervention that emphasized condom use but made no mention of abstinence.



And while Bill Clinton, the former U.S. president, told delegates to the International AIDS Conference in Toronto yesterday that abstinence programs delay sexual activity but make teens less likely to use condoms when they do start having sex, the study found the opposite to be true.


"It did not reduce intentions to use condoms, it did not reduce beliefs about the efficacy of condoms, it did not decrease consistent condom use and it did not decrease condom use at last sexual [encounter]," lead author John Jemmott, of the University of Pennsylvania, said.


The youngsters in the study ranged in age from 10 to 15; half were girls. Twenty-three per cent said they had had sexual intercourse at least once before the study began.


"There aren't any studies that show that children are less likely to use condoms as a result of an abstinence intervention. I've looked in the literature, there are no studies that show that," Mr. Jemmott said in an interview.

Thursday, November 30, 2006

Literature Search: Smoking exposure and kids

Texas will ban smoking in the homes of foster kids beginning January 1. For some reason, there are not many articles in the News on this subject. (There is this editorial from my hometown.)

I would guess there's not much media attention because the deadline is a month away and because the rationalization is supposed to be a slam dunk. I'm sure any objection won't be popular.

So, I did a Pub Med search or two, on "passive smoking ear infections," "otitis media," and some more I can't remember. Although I found quite a bit of assumptions and mention of increased risk, the data is not as conclusive as I expected, except for "wheezing." (I will have to admit that I wasn't surprised, since I remember some studies from the '80's and '90's that showed conflicting risks of cancer from second hand smoke at home in wives and in children of smokers.)

This article shows a correlation between carriage of Streptococcus pneumoniae in children whose mothers smoke, with a probability of P=0.016. I'm used to seeing numbers that show probability <0.01 or <0.05 - meaning that there's less 1% or 5% chance of being a coincidence.

Then there's this review in Pediatrics (free copy) that does show correlations, but no real data or tables.

On the other hand, I found some significant articles with no correlation or inconsistent correlation with childhood infections.

Free text and tables
"Respiratory Infections" from Norway study on over 3000 10 year olds.
Here's the table showing risk factors for ear infection, tonsilitis, and lower respiratory infections. (sorry, my skills aren't up to posting the table.)

This article shows no correlation with ear infection and passive smoke, although there is a correlation between being exposed before birth and after birth with recurrent ear infections:
Archives of Pediatrics, AMA (Free full text with free registration):

RESULTS: The cumulative incidence of ear infections was 69%. Of all participants, 38% were exposed to passive smoke, 23% were exposed to gestational smoke, and 19% were exposed to combined passive and gestational smoke. The occurrence of any ear infection was not increased by passive smoke exposure (adjusted risk ratio [RR], 1.01; 95% confidence interval [CI], 0.95-1.06), but was slightly increased by gestational (adjusted RR, 1.08; 95% CI, 1.01-1.14) and combined (adjusted RR, 1.07; 95% CI, 1.00-1.14) smoke exposures. The risk of recurrent ear infections (> or = 6 lifetime episodes) was significantly increased with combined smoke exposure (adjusted RR, 1.44; 95% CI, 1.11-1.81). Other risk factors for ear infection identified in multivariable analysis were race/ethnicity, poverty-income ratio of 2.00 or more, attendance in day care, history of asthma, and presence of allergic symptoms. CONCLUSIONS: Passive smoke exposure was not associated with an increased risk of ever developing an ear infection in this study. The increased risk found with gestational and combined smoke exposures has marginal clinical significance. For recurrent ear infections, however, combined smoke exposure had a clinically and statistically significant effect.


For those concerned about smoking risks for children, please consider reading this free article, which has been translated into English, from the Jornal de Pediatra, a fantastic review of the literature on risk factors ("RF") for recurrent and chronic ear infections.

In conclusion, although some authors declared the relation between RAOM and COME with passive smoking as established, others are totally against such affirmation. It may be said that passive smoking does not increase the chance of non-recurrent AOM (level of evidence IV). With regard to recurrent AOM and COME, passive smoking was classified as a probable RF (level of evidence II).

Wednesday, November 29, 2006

New House and Senate Revive Embryonic Stem Cell Bill

Wasn't there a Bill that promised to increase funding for (ethical) alternatives to embryonic stem cell research - using umbilical cord blood and other cells to produce embryonic-like stem cells? Will the Democratic controlled Senate and House re-examine that Bill?

Senator Harry Reid has promised long days for the first seven weeks in the new Congress. Speaker of the House to be Nancy Pelosi has laid out her priorities for her first 100 hours. Each has promised to bring back the legislation that the President vetoed in September, to use Federal funds on destructive embryonic stem cell research.

There's no mention in the news articles of the other bill, the "Alternative Pluripotent Stem Cell Therapies Enhancement Act" by Arlen Specter and Rick Santorum (current Republican Senators from Pennsylvania).

The Alternative bill, and the House versions such as the Stem Cell Therapeutic and Research Act, authored by Rep. Christopher H. Smith (R-N.J.), who was the chairman of the House Pro-Life Caucus at that time, would have increased funds for research to find new ways to produce stem cells without destroying embryos. It would have been directed to the research on umbilical cord cells conducted at Galveston University of Texas Medical Branch in cooperation with NASA and researchers from the UK to produce embryonic stem cells from cord blood. Similar work has resulted in masses of functional liver tissue the size of pennies and in lung cells that function to produce surfactant. There's also reports about blood vessels and heart valves that have been grown from cells in the amniotic fluid - so that babies who are found to have heart defects could have hope of transplants built from their own cells.

Unfortunately, what we're hearing about in the news and on the blogs, is politics as usual (just as in Texas) - the embryonic stem cell funding bill that would over ride the Dickey Amendment and the President's ruling of August 2001. It would also waste a ton of money, since so much would have to go to the Wisconsin Alumni Research Fund at the University of Wisconsin for the patent and royalty fees.

Ongoing discussion: science vs. religion

CBS' Blogophile, Melissa P. McNamara, has summarized the blogosphere comments on the Beyond Belief seminar, quoting LifeEthics and other wise and level heads (grin) (even if she did misspell my name):


Religion and science are not mutually exclusive, some suggest. "If you ask me ... a rational universe that is subject to measurements and study that yield consistant and ever sharper, more focused results in different labs and at different times does not preclude a Creator," Beverly Nuchols (sic)at LifeEthics writes.


Thanks for the pings, Ms. McNamara!

The conversation about science vs. religion is ongoing (along with the promotion of books) at Jewcy ( 4 day debate between Dennis Prager and Sam Harris on "Why are atheists so angry?" that continues in the comments, at Vox Populi (in several posts around November 27), Richard Dawkin's site (virtually all the posts - actually a good site for reading the op eds and articles around the Web dealing with this subject), BlogCritics and at The Edge (again, virtually all of the site - very high level discourse).

You can watch highlights or the entire conference at TSN, The Science Network.

Tuesday, November 28, 2006

Planned Parenthood's "Free EC Days" (for men and girls)

Planned Parenthood in Waco, Texas, Memphis, TN and Williston, Vermont, and probably a town or city near you, will host a Free EC (Emergency Contraceptive) day next week. (Waco on Dec. 8, Memphis and Williston Dec. 8. More sites can be found by searching Google or Yahoo for "Free EC Days" - including information from MySpace PP pages, and information on previous "Free EC" days before the med when over the counter.)

The Memphis Regional Planned Parenthood notice states:

We can provide EC to girls and women of any age and to men 18 or older. (emphasis mine)



The Waco Herald-Tribune
The event, billed as Free EC Day, is something Planned Parenthood affiliates are doing across the nation, said Pat Stone, education director for the local affiliate.

In general, it’s meant to raise awareness about emergency contraception.

But more specifically, it’s to remind women that the medication is now available without a prescription for people ages 18 and older.

. . .
That’s where Planned Parenthood’s event comes in, Stone said. The idea is that making the drug available for free might nudge some women into keeping a box on hand, she said. Planned Parenthood normally sells the medication for $25, but it costs up to twice that at stores around town.

Officials also are hoping the event will help remove any of the taboo or intimidation factor surrounding the medication or sexual health in general, Stone said.
Officials also are hoping the event will help remove any of the taboo or intimidation factor surrounding the medication or sexual health in general, Stone said.

For some women, all it takes is an initial visit to a health care provider for them to begin taking control of their sexual health, she said.

That’s why in addition to giving the drug away for free, Planned Parenthood officials also will be giving tours of their facility and handing out a price list for services, Stone said.

She added that men are welcome at the event and that it will be a come-and-go process to accommodate people who may have to stop by before or after work or during their lunch breaks.
(emphasis mine)


I'm very concerned that that Plan B is being given to minor girls, but especially about the promotion to men. This is the first time that hormonal contraceptives intended for women have been available to men without concern or knowledge of the women or girls who will be taking the medicine. How can there possibly be education or informed consent in the giveaways and over-the-counter sales in pharmacies, for the girl or woman who will be taking them. I'm concerned about the potential for abuse. Will men present the pill to the women as a reason to skip the condom? Will the women be faced with being forced to take the pill by their partners? And, since half of the partners of minor girls 15-17 years old who get pregnant are 2 or more years older than the girls, will the pill give license to child abusers?

As I've posted before (here and here), I don't believe EC, used as directed, will cause the loss of any embryos - there's good evidence that it does not block implantation and that it only works, when it works, to hamper ovulation and to interfer with the sperm getting to an oocyte or egg. It only has a contraceptive effect - it only needs to work - during the 5 days or so that a woman or girl is fertile - just before and the day of ovulation.

Unfortunately, JAMA (the article is reproduced on my blog), Contraception, and the British Medical Journal, reports show that even in women and girls who are part of a study and who receive education and follow-up, there is no change in unprotected sex, Sexually Transmitted Infections or pregnancy rates.

Monday, November 27, 2006

UK: Teaching children how to use condoms no help

This month, the British Medical Journal (sorry, subscription only) has published a report on a randomized controlled study on enhanced sex ed that failed to reduce the numbers of pregnancies or abortions in teen girls. Essentially, the "programme" involves education for boys and girls 13 to 15 years old, including teaching them to obtain and "handle" condoms (how to put them on), role playing and games about sexual situations. This is in contrast to "Conventional Education" in the UK, which is described this way in the report:

In the 12 control schools sex education for third and fourth years varied from seven to 12 lessons in total, primarily devoted to provision of information and discussion. Only two control schools routinely demonstrated how to handle condoms, and none systematically developed negotiation skills for sexual encounters. The cost of conventional education varied, with individual packages starting from about £20. Few teachers had more than one day’s training, which would have cost about £180 a day, and some had received none or only a few hours’ training.


Luckily, there are some good reviews online:
"Sex Education Fails to Cut Teenage Pregnancies" from the Guardian.

"Role playing sex classes fail to cut abortions," from the Telegraph.

An enhanced sex education programme for teenagers has proved no better than conventional teaching in cutting unwanted pregnancies or abortions, a detailed research study said yesterday.

The programme was based on an intensive £900 training course for teachers that was then delivered to 15-year-olds over three years.

Five years later, conception rates were measured in 20-year-olds who had been on the programme and compared with those in young people who had not.
advertisement

The teaching system, called Share — sexual health and relationships: safe, happy and responsible — included group work, role play and games. The teenagers were shown how to use condoms and access sexual health services and were given leaflets on sexual health.

The programme and research was devised and supported by the Medical Research Council (MRC) and the Education Board for Scotland, now Health Scotland.

Teachers in the schools used for comparison had less instruction or none at all.


"Sex education "only does so much'" from BBC News notes that schools are required to teach sex ed from ages 11-14 in England and Wales, but there has been no such requirement in Scotland.

And from the November 23 "Learning and Teaching Scotland" web site, we learn that the program was introduced throughout that region last week.

The UK press reports that the teen pregnancy rates under 18 are going down, from 44.3 births per 1000 girls ages 15 to 17 to 42.9 since 1998, and declared this a "success."

Edited 12/29/08 for labels.

Physicians to UK TimesOnLine: Abortion and Depression

The letter to the editors of the (UK, London) TimesOnLine one month ago from several physicians concerning the New Zealand report by New Zealand's Fergusson on the increased risk between abortion and depression (that article is online in pdf, here - and that issue is their free sample issue, here) was hard to find. So, once I found it, I thought I'd post it, with the link (I'll review it and the original article, later):


The Times October 27, 2006

Risks of abortion
Sir, Research published in The Journal of Child Psychology and Psychiatry in January has shown that even women without past mental health problems are at risk of psychological ill-effects after abortion. Women who had had abortions had twice the level of mental health problems and three times the risk of major depressive illness as those who had given birth or never been pregnant.

This research has prompted the American Psychological Association to withdraw an official statement denying a link between abortion and psychological harm.

Since women having abortions can no longer be said to have a low risk of suffering from psychiatric conditions such as depression, doctors have a duty to advise about long-term adverse psychological consequences of abortion.

We suggest that the Royal College of Obstetricians and Gynaecologists and the Royal College of Psychiatrists revise their guidance, and that future abortion notifications clearly distinguish between physical and mental health grounds for abortion.

ROBERT BALFOUR
Emeritus Consultant Obstetrician and Gynaecologist, Bridgend

PATRICIA CASEY
Professor of Psychiatry, University College, Dublin

MARJORY FOYLE
Consultant Psychiatrist, London

GREG GARDNER
General Practitioner, West Midlands

LIZ GUINNESS
Consultant Psychiatrist, Surrey

TONY LEWIS
Emeritus Consultant Obstetrician and Gynaecologist, Bridgend

LUKE PARSONS, QC
Barrister, Inner Temple, London

EVELYN SHARPE
Consultant in General Adult Psychiatry

ANDREW SIMS
Past President Royal College of Psychiatrists

PAM SIMS
Consultant Gynaecologist, Hexham

JOAN SMITHIES
Consultant Psychiatrist, Hampshire

TREVOR STAMMERS
General Practitioner, London

GORDON STIRRAT
Emeritus Professor of Obstetrics & Gynaecology, Bristol

ADRIAN TRELOAR
Consultant Psychiatrist, London

HANRI VOGELZANG
General Practitioner, London

Sunday, November 26, 2006

Parachutes, Abstinence, Randomized Controlled Studies

There have never been any controlled randomized trials on "Parachute use to prevent death and major trauma related to gravitational challenge," according to this review published in the British Medical Journal in December 2003. And yet, in the nearly 3 years since it was documented in a prestigious peer-reviewed journal that the evidence supporting the use of parachutes by those who jump from planes is anectotal, Federal, State and private entities continue to support the private parachute industry.

The Government Accounting Office released a review (in pdf) on the accuracy and effectiveness of abstinence sex education programs, in response to a request by several members of Congress. Editorials from the Bangor (Maine)Daily News, the Atlanta Journal Constitution and others on the review indicate that abstinence education is "scientifically invalid."

The International Herald Tribune's headline reads, " . . . no-sex-before-marriage programs forgo accuracy, are ineffective."

The GAO report actually covers several ways that an entire alphabet soup of agencies and States fund abstinence-until-marriage programs, how these programs are reviewed for accuracy and efficacy. There are also descriptions of problems that have been found and corrected. There is a mention of studies that are pending that would be equivalent to the "randomized controlled studies" that will supply "scientific validity" to measurements of evidence comparing outcomes in children who participate in abstinence-until-marriage programs to those in abstinence-plus programs and those who receive no structured sex ed according to standardized end points.

None of the sources give any references for "scientifically valid" "abstinence-plus" or "if you do it, use a condom and a back-up method of contraception" sex ed.

If I may, I'd suggest that editors learn to read reports and perhaps take a class in statistics. Or, they could follow the recommendation of Smith and Pell:

A call to (broken) arms

Only two options exist. The first is that we accept that, under exceptional circumstances, common sense might be applied when considering the potential risks and benefits of interventions. The second is that we continue our quest for the holy grail of exclusively evidence based interventions and preclude parachute use outside the context of a properly conducted trial. The dependency we have created in our population may make recruitment of the unenlightened masses to such a trial difficult. If so, we feel assured that those who advocate evidence based medicine and criticise use of interventions that lack an evidence base will not hesitate to demonstrate their commitment by volunteering for a double blind, randomised, placebo controlled, crossover trial.
(Final emphasis, mine)

Friday, November 24, 2006

Beyond Belief: the Institutional Delusion of Scientism

The New York Times reports on "Beyond belief: Science, religion, reason and survival," a symposium sponsored by the Science Network at the Salk Institute for Biological Studies, which

began to resemble the founding convention for a political party built on a single plank: in a world dangerously charged with ideology, science needs to take on an evangelical role, vying with religion as teller of the greatest story ever told.


No one should be shocked that there was a conference of scientists (put on by the self-described "CSPAN for science") who condemned religion while outlining ways to replace religion with an awe for science. After all, these guys want to launch a TV cable network and Richard Dawkins has to sell his book, The God Delusion.

But, wow, when these "Scientism"-ists (see Voegelin quote, below) let go (from the New Scientist, subscription only):

The big challenge, according to Porco, will be dealing with awareness of our own mortality. The God-concept brings a sense of immortality, something science can't offer. Instead, she suggested highlighting the fact that our atoms came from stardust and would return to the cosmos - as mass or energy - after we die. "We should teach people to find comfort in that thought. We can find comfort in knowing that everyone who has ever lived on the Earth will some day adorn the heavens."

Like many of the others at the meeting, Porco was preaching to the choir, and there was no more animated or passionate preacher than Neil deGrasse Tyson, director of the Hayden Planetarium in New York. Tyson spoke with an evangelist's zeal, and he had the heretics in his sights. Referring to a recent poll of US National Academy of Sciences members which showed 85 per cent do not believe in a personal God, he suggested that the remaining 15 per cent were a problem that needs to be addressed. "How come the number isn't zero?" he asked. "That should be the subject of everybody's investigation. That's something that we can't just sweep under the rug."

This single statistic, he said, gave the lie to claims that patiently creating a scientifically literate public would get rid of religion. "How can [the public] do better than the scientists themselves? That's unrealistic."
(Emphasis is mine.)


Other examples of public statements by scientists that the belief in God is dangerous include the comments of Robert Buckman, MD, an oncologist who gives talks concerning the correlation between right temporal lesions and “sensitivity” to religious experiences as well as violent and psychotic behavior. He cites surveys which lead him to believe that, “If you believe that there is a god, you are halfway to aggression,” because, of course, if your god told you to kill, you would have to do so. In the fall of 2005, the New York Times (available only for a fee, now - see Note 1) reported about scientist’s attitudes about religion and science, including the explicit statement concerning those working in science who believe in a Creator, by Herbert Hauptman, Ph. D., "this kind of belief is damaging to the well-being of the human race."

The late philosopher Eric Voegelin decried this attitude, describing the loss due to it:

"The transfer of [the pathos of autonomy and self-reliance that animates the advancement of science] from science to existence expresses itself concretely in the growth of the belief that human existence can be oriented in an absolute sense through the truth of science. If this belief is justified, then it becomes unnecessary to cultivate knowledge beyond science. As a consequence of this belief, the preoccupation with science and the possession of scientific knowledge has come to legitimate ignorance with regard to all problems that lie beyond a science of phenomena. The spreading of the belief has had the result that the magnificent advancement of science in Western civilization is paralleled by an unspeakable advancement of mass ignorance with regard to the problems that are existentially the important ones."


What "important" questions?

The Beyond Belief participants mentioned a few of them: aesthetics, the meaning of life, mortality, love, and "being good:"

"The axiom that values come from reason or religion is wrong... There are better ways of ensuring moral motivation than scaring the crap out of people."
Patricia Churchland, philosopher, University of California, San Diego

"What about the hundreds of millions of dollars raised just for Katrina by religions? Religions did way more than the government did, and there were no scientific groups rushing to help the victims of Katrina - that's not what science does."
Michael Shermer, editor-in-chief, Skeptic magazine

"It doesn't take away from love that we understand the biochemical basis of love."
Sam Harris, author of The End of Faith



If you ask me (or read this far in the blog), a rational universe that is subject to measurements and study that yield consistant and ever sharper, more focused results in different labs and at different times does not preclude a Creator.



Note 1. Cornelia Dean, “Scientists Speak Up on Mix of Religion and Science,” New York Times August 23, 2005. http://www.nytimes.com/2005/08/23/national/23believers.html (accessed September 29, 2005).

Thursday, November 23, 2006

Heart "master stem cells"

There's news about embryonic "master stem cells" for heart tissue, or embryonic stem cells that give rise to the 3 types of cells in the heart, which were found in mouse embryos.

I wonder how many of the articles will mention non-embryonic human cardiac precursor cells from amniotic cells (this month) and umbilical cord stem cells (reported in 2005, 2005, and this year) that have been used to produce heart valves in the lab?

Or that umbilical cord blood cells and the embryonic cells that are derived from them are less likely to be rejected than we thought in the past?

The animal research will be useful to find the markers or identifying genes of precursor cells in the human. They might lead us to the discovery of factors and conditions that will recruit and stimulate each patient's stem cells in place. But they won't treat anyone. As the article above about the embryonic stem cells explains, the local environment and stimulation are the determining factors that turn precusors in to functional tissues.

(Edited 11-24-06 for grammar.)

Wednesday, November 22, 2006

Balky Democrats, Selective Travel, Selective Signatures

Three members of the Texas House State Affairs Committee have refused to sign off on the Committee's final report on stem cell technology.

The Houston Chronicle calls them Balky Democrats.

I'm not surprised. None of them bothered to come to the Committee's hearing on the charge held in Houston in September, where I was one of many who testified.

And they were 3 of the Democrats who ran away to Ardmore, Oklahoma in 2003 to prevent the House from having a quorum for deliberation.

Grey Goo Grief Bombs Second Life (A Thanksgiving Lesson)

The virtual fantasy world, Second Life, was attacked for at least the second time this weekend . Self replicating rings bogged down the servers, disrupting players on the site, giving us a short-term virtual model of Eric Drexler's grey goo scenario wherein self-replicating nanotech machines destroy the Earth by using up the surface resources.

There's a bioethics discussion in there, somewhere. At least, we should contemplate how much our lives have changed in the last 10 years due to the Internet and the improvements in the 'Net and our access to it. (And don't get me started on Digital Video Recorders. I keep trying to re-wind the rest of my world when I realize that I missed bits and pieces - or, heaven forbid, what the bits and pieces meant.)

I've never had the patience it takes to build an avatar and personality in one of the virtuals. I did try 'way back in 1996, on e-something or the other. Instead, being a data-junky, I get lost at Google, GoogleNews, and all the blogs that I try to follow (not to mention my mini-fantasy-vacations when I use up bandwith with wishes at Travelocity or Expedia).

However, I can sympathize with the designation of the attacks as "Grief Bombs." I've suffered along with others when attacks in the form of worms, viruses, and overwhelming volumes of email have been able to slow down the Web or shut down servers for specific sites. Recently, I've had from troubles with my on-line and off-line computer activities, thanks to a not-so-helpful Internet Security Suite update from McAfee.

Over the next couple of days, many of us in the US will be traveling, away from our wi-fi access and high-speed connections in general. We will be interfacing in the real world with our families and over-stuffing our tummies, mostly without discussion about the ethics of the production, distribution and consumption. (My family might get into the discussion over at the New Scientist about whether science can replace religion, and when we do, it will make my husband and some of the other inlaws uncomfortable or bored.)(There, I knew I could work the NS' "God Question" in, somehow.)

Y'all will hear/read much more eloquent comments from others about the blessings we enjoy, but I want to remind you to be aware, be good, be safe, and enjoy.

Tuesday, November 21, 2006

More on "Illegal" 5-Way Kidney Transplant

There is more information about the 5-way kidney transplant swap at Johns Hopkins. (Here's the original Washington Post article I reported on earlier today.)

An Illinois television station called the process "illegal."

Okay, sometimes issues are illegal but not immoral or unethical. Sometimes, good things are done for motives that are both ethical and slightly less than clear. At the same time. In the same person.

It seems that Dr. Montgomery, while doing a good thing in transplanting the kidneys, is using the "domino transplant" to make a point against the long-standing law that prohibits trading organs in exchange for any thing of value, including other organs for someone else.

From the Orlando Sentinel:

Some institutions feel multiple arrangements come uncomfortably close to quid pro quo, Montgomery said. He called for a clarification of the law.

The complicated swap worked this way:

Rothstein donated her kidney to Jantzi. Jantzi was incompatible with the kidney offered by her adoptive mother, Florence Jantzi, a Christian missionary who donated her kidney to George Brooks, 52, a mechanic who was not compatible with the kidney offered by his wife, Sharon Brooks.

Sharon Brooks, 55, a telephone company maintenance administrator, donated her kidney to Gary Persell, 61, a retired film distributor. His wife, Leslie, 61, a retired history teacher, gave her kidney to Gerald Loevner, 77, a real estate developer. Loevner's wife, Sandra, gave a kidney to Sheila Thornton, a retired elementary school teacher.


I'm afraid that the 10 hour, 12 surgeon, 11 anesthesiologists procedure followed by press conferences and petitions to Congress do not lessen the appearance of ensuring that everyone involved follows through with their part of the "bargain."

On the other hand, Sally Satel, M.D., has an article published at the American Enterprise Institute website that gives reassuring answers to some of my concerns about the safety of becoming a kidney donor:
Long-term risks are also low. Typical is a 1997 study from Norway that followed 1,332 kidney donors for an average of 32 years. It found no difference in mortality rates between people who give kidneys and the general population. A 25-year follow-up of seventy donors conducted by the Cleveland Clinic found that the renal function is "well preserved" and that the overall incidence of hypertension was comparable to that of non-donors. The truth is that a normal person can get along perfectly well with one kidney. The risk a donor runs is that his single functioning kidney will become diseased or injured, and he'll need a transplant himself--a highly unlikely event.


Dr. Satel is a recipient of a non-related donor's kidney, herself. She did know her donor before the transplant, however. Unfortunately, she is championing "Organs for Sale."

(Maybe I just don't like complicated questions, but it seems that the more I have to think about the ethics of a practice, the less I like to see it codified in law.)

Ambivalence on Quintuple Kidney Transplant

The news from Johns Hopkins in Baltimore about an historic 5-kidney "marathon" transplant among 4 pairs of relatives and 2 unrelated people troubles me on several different levels. 5 people will (hopefully) have a better life now, and that's wonderful, a miracle. And, that 5th, unrelated recipient is one of the luckiest people on earth!

However, I wonder about the motives of the transplant team and the stringency of the usual transplant ethical scrutiny, especially in light of the publicity.

It seems that there were 4 patients who needed transplants, and they had 4 relatives willing to donate, but none of them matched their own relatives. There was a woman who signed up to donate one of her kidneys to anyone who needed it. And there was a 10th person, the 5th with a need for a kidney.

Someone noticed that if all of the donors were shuffled there was a match for 5 of the patients on the waiting list.

Because of tissue or blood type incompatibility, none of the relatives could donate to her specific family member. But as they traced the possible connections, officials discovered that each turned out to be a fit for someone else in the group, and the five-way match emerged.


I worry that the "marathon" was an elaborate publicity stunt on the part of the Hopkins transplant team,

Surgeon Robert Montgomery, who directs the Comprehensive Transplant Center at Hopkins, has advocated a broader system of such pairings to increase the nation's supply of organs and save more lives of desperately ill children and adults. Although more than 72,500 people are waiting for a kidney transplant in the United States, only 11,653 such operations were performed this year through August, with only about 4,400 involving living donors.


Before I go on, I want to say that I admire all the donors. I hope that I would do what they have done, if need be. In fact, I have felt disapproval for family members who will not donate to their own relatives, while understanding their fears. I lean toward the school of thought that it is not society's job to protect an adult from himself. It is vital, however, that we all discuss the ethics in advance, in order to protect the vulnerable around us from harm caused by others. I also wonder about the duty of healthy young donors to themselves and their children and whoever will care for them if they become ill due to becoming donors. What of the young mother or father who volunteers to become a donor to a stranger?

There have long been questions about the ethics of an adult submitting to the dangers of donating a kidney to a relative who is in need, but there are legitimate questions about the "consent" that is given in these cases. How much does guilt, family and societal pressure play into the decision, and how can we objectively measure consent to a harmful procedure that will not benefit the donor? No one knows the future, and what happens if the donor has kidney failure in the future? Does the donor have the right to endanger his or her health in this way? What happens if the kidney is rejected and the donation ends up being futile?

These questions are multiplied in the case of an unrelated, altruistic donor. In this case, the woman who added the wild card (kidney) that made the 5/10-way transplant possible said that she is doing this in reaction to the loss of a husband and daughter. She is only 48 years old, herself. What of her future health? Will she someday regret an action from grief, rather than simple concern for her fellow human being.

Finally, however, I wonder about the timing. Performing the operations virtually simultaneously seems to be some sort of stunt. Or where the surgeons afraid that some of the donors would back out after their relatives recieved a kidney from someone else?

I can't believe that there are "economies in scale" in kidney transplants or that it was more efficient and safe for the donors and recipients to arrange such a complicated scheme:

The undertaking required 12 surgeons and more than two dozen other doctors and nurses working for 10 hours in half a dozen operating rooms. Twice that many Hopkins staff members, including medical specialists, technicians, social workers, psychologists and pharmacists, took part in the planning and in post-operative care, officials said.

In 2003, the hospital performed what it believed was the world's first triple-swap transplant. Montgomery was in the lead then, too, calling that success "a monumental-type experience." Three years later, it became even more so.

Sunday, November 19, 2006

Massachussetts: The Healthcare Finance Lab State

(and now for something completely different)

The Country is watching to see how the new healthcare finance plan works in Massachusetts. The State had only 7%-10% of its population uninsured, unlike the regional average around 15%. (My State, Texas has a 26% uninsured population - half of those families make more than $75,000 a year, so, it seems, have decided not to spend their money on insurance. At up to a $1000 per month per person for individual buyers or small employers, it's hard to blame them.)

The Massachusetts State insurance plan is to increase participation in insurance coverage by requiring all employers to either provide insurance or pay the State $295 per year, per employee.

Unfortunately, it appears that the program is costing more than expected, according to the Washington Times:

Full coverage is the lynchpin of the plan. Yet it's hard to see how the state will get even close to 100 percent participation, the whole point of the expensive exercise. On the subsidized plans, families will be expected to spend up to 7.7 percent of their income on health coverage. If eligible residents say "no thanks" to this new monthly bill, people are supposed to pay penalties under the individual mandate. This could lead to the absurd result of confiscating a person's earned income tax credit -- a government handout -- because one refused to accept a health care subsidy.
Officials haven't even started designing the private plans -- the plans that non-poor individuals must purchase by July of 2007 or face fines.


The theory is that if more of the low risk young and healthy people buy in, even at a low rate, the extra money added to the pool will cut the costs for everyone else and will save the State money in funding for indigent care and Medicaid. And Massachusetts does have a State Income Tax that can be dinged if penalties are needed. However, the insurance plans aren't allowed to charge different fees for different risk groups and ages. And there are a lot of other mandated benefits required by law. Also, the cutoff point for subsidies is 300 percent of the Federal poverty level, the plans will cost $300 per individual and $600 for each family. It's estimated that many of those eligible for subsidies and most likely to use their insurance are already insured at higher rates. (From a subscription only article in the Sept-Oct 2006 Hastings Center Report.)

According to another commentary in Hasting Center Report there are more than the obvious dollar costs (free registration required for this article),

Third, the legislation promises that the Connector will help the uninsured find comprehensive and affordable private health plans, but that’s like promising delicious chocolate chip cookies with no fat, sugar, or calories. While officials have projected that the mandatory policy will cost only $300 per month for an individual plan and $600 for a family, the only way to get private plans that cheap is to strip down the coverage:boost copayments and deductibles and exclude important services from coverage altogether. Such stripped-down coverage may let politicians claim they’ve done something
useful, but it provides neither adequate access to care nor real
financial protection. In the RAND Health Insurance Experiment (the only randomized controlled trial comparing highdeductible plans to comprehensive coverage), high deductibles caused a 17 percent fall in toddler immunizations and swelled the number of children failing to see a doctor in the course of a year from 15 percent to 32 percent among school-aged children and from 5 percent to 18 percent among infants and toddlers.2 While high deductibles reduced children’s use of “rarely effective care” by 33 percent, they also reduced “highly effective care” by 28 percent. Adults in the
RAND Experiment also used less preventive and primary care, and had higher blood pressure and higher risks of dying, when high deductibles were placed on their insurance coverage. Stripped-down plans like those that the Massachusetts uninsured will be forced to buy also do little to protect people against financial catastrophe due to illness. In our own work on medical bankruptcy, 76 percent of those bankrupted by medical problems had insurance at the onset of the illness that bankrupted them; many were ruined by copayments, deductibles, and uncovered expenses such as physical therapy.


Somehow, we've got to convince both the insurers and the insured that preventive care will pay off. It's discouraging to have patients "forget" their wallets so that they can't pay their co-pays (forcing me to bill them or be liable for Federal insurance fraud felonies), and it's very discouraging to have them trade "Primary Care Providers" for a $10 increase in co-pays.

That felony risk for failure to charge the patient a co-pay is not the only problem with copays and deductibles for Medicare docs. Medicare patients who have an HMO that I don't accept or who have a high deductible "Health Savings Account" type of insurance cost docs when we are required to bill Medicare before billing the patient. Not many people realize that the Social Security Act was amended in the late '90's to force any doctor who sees Medicare to treat all Medicare-eligible patients the same, no matter the patient's actual financial status: we must file for the patient, limit our fees to 125% of Medicare, and we must never, ever charge anyone less than Medicare allows. And then, our patient will get a letter telling him that the tetanus shot he received in our office after he stepped on a rusty nail was not "medically necessary."

Confirmation of Chinese Prisoner Organ Harvests

Art Caplan, PhD, a pseudoeditor of the blog at the American Journal of Bioethics, reports on an admission from a Chinese official that confirms the rumor that prisoners are killed for their organs, which are then sold. US residents are among those that pay for these organs.

Speaking at a conference of surgeons in the southern city of Guangzhou, Deputy Health Minister Huang Jiefu called for a strict code of conduct and better record-keeping to stem China's thriving illegal organ trade, state media reported.

"Apart from a small portion of traffic victims, most of the organs from cadavers are from executed prisoners," said Huang, reported the English-language China Daily newspaper Thursday. "The current organ donation shortfall can't meet demand."


(From an article in the Houston Chronicle, originally published in the Los Angeles Times). Both require free subscription.

(Accidentally posted the first paste-and-cut version. )

Friday, November 17, 2006

Anti-Religion "Declaration in Defense of Science and Secularism"

These groups are not simply against religion, of course. They object to what they call "religious fanaticism:"

Unfortunately, not only do too many well-meaning people base their conceptions of the universe on ancient books—such as the Bible and the Koran—rather than scientific inquiry, but politicians of all parties encourage and abet this scientific ignorance.


Their idea of ignorance is to advocate against embryonic stem cell research and for abstinence in order to limit Sexually Transmitted Diseases.

The joint statement of the Center for Inquiry (CFI)and the Council for Secular Humanism (CSH) "Declaration in Defense of Science and Secularism," (as published at the Institute for Ethics and Emerging Technologies) is signed by about 45 people: fellows and staff of the two organizations, (retired) editors, Nobel Laureates, and professors at major universities. You might recognize the Chair of the Department of Medical Ethics at the University of Pennsylvania, Arthur Caplan, PhD, and Peter Singer, the notorious "ethicist" from Princeton. For some reason, it seems especially odd to me that one of the signers is Edward O. Wilson, PhD, of Harvard University.

Mixing information from polls concerning beliefs and scientific knowledge and confusing religion and education, the Declaration opens with

The Center for Inquiry, affiliated with the Council for Secular Humanism, has organized this petition in defense of secular and scientific public policy:

We are deeply concerned about the ability of the United States to confront the many challenges it faces, both at home and abroad. Our concern has been compounded by the failure exhibited by far too many Americans, including influential decision-makers, to understand the nature of scientific inquiry and the integrity of empirical research. This disdain for science is aggravated by the excessive influence of religious doctrine on our public policies.

We are concerned with the resurgence of fundamentalist religions across the nation, and their alliance with political-ideological movements to block science. We are troubled by the persistence of paranormal and occult beliefs, and by the denial of the findings of scientific research. This retreat into mysticism is reinforced by the emergence in universities of “post-modernism,” which undermines the objectivity of science.


The Center for Inquiry dedicates its international resouces to counter any and all expression of religious moral grounding in the public conversation on science and ethics. CFI projects include the Committee for Scientific Examination of Religion and conferences like "Scripture and Skepticism, the Uses of Doubt in Biblical and Qu'aranic Studies" conference.

The Council for Secular Humanism publishes the journal "Free Inquiry" and objects to baptism of children and moral education that includes religious worldviews. They reject authoritarian beliefs(except their own).


The advocacy for "humanist" ethics and a "Cosmic World View" appears every bit as religious as the worldview to which the CFI objects. (I will admit that I am confused by the notion of "humanist ethics" and advocates for human enhancement in partnership with CFI, an organization that supposedly objects to the notion that "that the Earth has been given to the human species as its dominion."


The motto of the Institute for Ethics and Emerging Technologies (where I first found the Declaration which is also published at CFI) is "Promoting ethical technology for expanding human capacities." They "work closely with the World Transhumanist Association," which has the same motto. Both organizations ask why we can't be "better than well" through enhancement with technology. Since it seems that I'm almost attached to my own laptop and smartphone, I could agree with them except for their authoriatarian way of rejecting religion and proselytising in favor of moving beyond being human. At least they do admit that transhumanism might be a substitute for religion, "however, transhumanists seek to make their dreams come true in this world, by relying not on supernatural powers or divine intervention but on rational thinking and empiricism, through continued scientific, technological, economic, and human development."