Saletan on Prolife Contraception (Almost)

William Saletan has a basic problem when he begins to discuss prolife vs. abortion: while he's not pro-abortion, he's not anti-abortion, either. I'm glad that he's trying and take it as a major victory that Democrats and pro-choicers will even discuss limiting abortion in the public square at all.

I'm afraid that it's difficult for men and women who consider themselves "moderate" when it comes to abortion to understand that the rest of us actually consider life to begin at the biological marker of fertilization. We won't accept the loss of an early pregnancy before implantation that is caused by our intentional actions.

Mr. Saletan would do better to stress the evidence against loss of pregnancy due to the morning after pill and some other contraception, rather than say that what he considers an acceptable risk of early embryo loss will cut interventional and intentional surgical and medical abortions.

On the other hand, I come from a tradition that is accepting of contraception that prevents conception in the first place, including barrier methods, the true contraceptive medications and sterilization. We expect couples to only have sex within marriage (and, I'll admit, when they've convinced themselves that they expect to marry). We also expect them to welcome any pregnancy that occurs - whether planned or unplanned. I know lots of good couples who live this way in the Baptist, Church of Christ, Methodist and other non-Catholic traditions. And lots of born people who started life this way. (Some of those groups don't consider themselves to be "Protestant" or "Evangelical." I grew up hearing that the Baptists - or ana-Baptists - were always around, and so they never broke away from the Catholics, at all. But, that's another blog.)

Mr. Saletan does point out a problem that my parents ran into back before Roe v. Wade and that we've had ever since: how to get prolife activists to work well together. Conversations on ending abortion tend to break down when our own groups divide over true contraception and when and where abortion will be regulated.

I'm a lumper from the school of "if he's not against us, he's for us," "the enemy of my enemy is my friend," or even the "even a stopped clock is right twice a day." My motto: look for the common ground.

I'll never forget the email that I received after South Dakota bravely banned abortion on demand. Rather than celebrating the law against 99.7% of all elective abortions, at least one group was condemning them, claiming that South Dakota had passed legislation allowing abortion in the case of rape and incest (which I believe would be much more easily addressed as a "hearts and minds" issue.)

And I fully expect to be told that I'm not really prolife after this essay.
(Edited 10-01-06 for spelling of "really.")

New Orleans doctor and nurses deny euthanasia

I would like to hear more about an investigation into the failure to evacuate the hospitals in New Orleans after hurricane Katrina last year. I'd also like to hear about a medical review of the care of the patients - the medical review should come before any criminal charges, in fact.

Instead, the Louisiana Attorney General is trying to convince a grand jury to charge two nurses and a doctor with second degree murder for their actions after the patients had been abandoned for days, with only a few staff members remaining. And the AG has reportedly accused the doctor of murder and playing God, when talking about the case in a press conference.

If the doctor and the two nurses conspired to intentionally cause the death of patients, it is murder, and can never be excused. It is never acceptable to relieve suffering by killing the human being who is suffering.

On the other hand, these patients had been left in the heat without ventilators, dialysis, cardiac monitors and finely tuned IV medications or the personnel to administer all these things. Other patients had already died from dehydration. It would have been ethical to use what medications were available to relieve the respiratory distress and pain of the patients, even if that relief had a known risk of precipitating death due to the underlying disease. I'm not a critical care doctor, but versed and morphine would have been my choice, also.

The doctor firmly states that she is innocent. The nurses also say that they are all innocent. From the September 21 NO Times Picayune:

The 317-bed hospital had swallowed 10 feet of water, the electricity had failed and temperatures had spiked to over 100 degrees.

At least 34 people died at the hospital, many succumbing to dehydration as they waited for four days for boats to arrive.

"I do not believe in euthanasia," said Pou. "I have spent my entire life taking care of patients. I have no history of doing anything other than good for my patients. ... Why would I suddenly start murdering people?"

The medical community has aggressively defended the doctor and the nurses, pointing out that morphine and Versed, the two drugs allegedly injected into the patients, are commonly used in combination to reduce pain.

It's a point Pou makes, saying that her goal was to "ensure they do not suffer in pain."

According to state investigators, tissue samples from the dead, who ranged in age from 61 to 90, tested positive for both morphine and Versed, and the amount of Versed was found to be higher than the usual therapeutic dose.

Pou acknowledges the drugs could have caused harm, but stresses: "Anytime you provide pain medicine to anybody, there is a risk. But as I said, my role is to help them through the pain."

And, now, the Louisiana State Medical Society is backing the doctor.

La. medical group supports doctor accused of killing patients
9/27/2006, 6:50 p.m. CT
By MARY FOSTER
The Associated Press

NEW ORLEANS (AP) — A state medical organization on Wednesday came out strongly in support of the Louisiana physician accused of killing four critically ill patients at Memorial Medical Center in the aftermath of Hurricane Katrina.

Dr. Anna Pou and nurses Cheri Landry and Lori Budo, were arrested and booked on second-degree murder after an investigation by Louisiana Attorney General Charles Foti, who said the trio injected a lethal cocktail of sedatives into the four bedridden patients, after determining they were too ill to be moved.

"The Louisiana State Medical Society is confident that Dr. Pou performed courageously under the most challenging and horrific conditions and made decisions in the best interest of her patients," said a statement from LSMS President Dr. Floyd A. Buras. The statement was released Wednesday.

The statement came on the same day Memorial reopened its New Orleans Heart and Surgery Institute. But the main building remains closed.

The doctor and two nurses have not been formally charged, pending the outcome of a New Orleans grand jury investigation.

Speaking Sunday night on the television show "60 Minutes," Pou emphatically denied killing the patients.

"No, I did not murder those patients," said Pou, who's been practicing medicine for more than 15 years. "I've spent my entire life taking care of patients. I have no history of doing anything other than good for my patients. I do the best of my ability. Why, would I suddenly start murdering people? It doesn't make sense."

The LSMS statement said that Pou has a long and distinguished career as a "talented surgeon and dedicated educator" which should not be tarnished by the accusations against her.

"Her recent statements regarding the events clearly show her dedication to providing care and hope to her patients when all hope seemed abandoned," the statement said.

On Monday the American Medical Association issued a statement saying it would continue to monitor the case closely.

"The facts of this case appear complex, remain under investigation, and based on media reports, are sharply contested," the statement said.

The AMA said it has a policy on several of the issues in the investigation, including encouragement of physician involvement in disaster preparedness and a doctor's obligation to relieve pain and suffering.

The organization also opposes the "criminalization of medical judgment," the statement said.

Foti released a statement late Wednesday detailing the scope of the investigation and pointing out that many hospitals were in trouble after the hurricane.

"However, this is the only hospital where doctors, nurses and other health care professionals and witnesses on the scene reported suspicious deaths of patients," Foti's statement said. "Many came forward and reported to us after witnessing events they believed were wrong and against ethical and legal standards."

Foti said he believes in the presumption of innocence, and does not want the case tried in the media "where the defense seems to want it argued."

Pou's attorney, Rick Simmons, said he has only been trying to counter Foti's comments at a news conference in which Foti called Pou a murderer and said she was playing God.

"When the prosecutor makes those type of comments it's appropriate for the defense to respond," Simmons said. "I was only responding to his effort to prejudice the public through the media."

Stem cell hearing: Houston Chronicle "coverage"

The Houston Chronicle's Todd Ackerman is the only reporter who sent out an article on yesterday's hearing on stem cells in Houston. It seems that my 20 minutes or so of being grilled by Rep. Cook was seen as a "clash.":

The hearing was marked by a minor clash between Dr. Beverly Nuckols, a New Braunfels bioethicist who opposes embryonic stem cell research, and Rep. Byron Cook, R-Corsicana. He repeatedly challenged her on whether the embryo is a life, why she's out of step with eminent scientists and whether women will sell their eggs for research purposes.

Adult cells
Nuckols and other opponents of embryonic stem cells at the hearing touted adult stem cells.

The versatility of adult stem cells has surprised scientists in experiments in recent years, but it is not thought to have the potential of embryonic stem cells.

The hearing drew about 150 people. Swinford, who visited the Texas Heart Institute earlier in the day to learn about the treatment of diseased hearts with adult stem cells, said the hearing was in Houston because the city is renowned for cutting-edge medical treatment.

A similar hearing by the Senate Health and Human Services Committee was held Sept. 19 in Austin.

Swinford said the committee would produce a report from the testimony but make no recommendation.

todd.ackerman@chron.com

Back in med school, we had a term for repetitive questioning designed to make the one being questioned show off/learn something/be humiliated (depending on the "benign" or "malignant" nature of the one doing the questioning). We called it being "pimped." However, it is necessary for the questioner to know more than the one he's "pimping." Rep. Cook failed, miserably, if his intention was to pimp me.It never works for someone with a lesser knowledge to attempt to pimp someone who actually understands the science and who can quote the latest literature.

As I told the Representative Cook: "Science informs us that human beings begin as the single-celled zygote. Any other point is arbitrary."

Texas House State Affairs Committee meeting

Today the Texas House State Affairs Committee met in Houston to hear invited testimony on their interim charge on following stem cell research. The proponents of embryonic stem cell research are still claiming that "only" 9 or so diseases are being treated with adult stem cells and that we've had 40 years on adult stem cell research and only 8 with the embryonic.

In fact, the number of diseases treated is greater than the number being cured. We heard from a representative from the Texas State Cord Blood Bank who told us that over 500 people have received cord blood stem cell transplants. (My grand daughter was one of the early ones. Her congenital neutropenia was treated if not cured, at Cooks' Children's Hospital in Fort Worth in December, 2001. And, of course, she's superduper.)

I was kind enough not to read my 2700 word written testimony to the Representatives present. But, then,during the question and answer period, I got the idea that none of them had read it prior to the meeting. I will recite every darn word out loud, next time. Plus the three-inch thick set of references to go with them.

One Rep was really hung up on cloning, which he thinks is just fine. I heard "there's no sperm!" lots of times, today. Of course there was sperm: the donor's daddy.

I did finally open my notebook and read the definition of somatic cell nuclear transplant or cloning to the Reps.

We had some very good and some not so good testimony, today.

I am always impressed when the proponents of what I consider an unethical act seem to try to be as honest as possible. I was glad to hear that the blastocyst is an embryo from a couple of them. We heard a lot about 'losing' scientists and little about the ones who are moving in. But, I was saddened by the lack of response to the idea of cord blood banking and the wonders of the new discoveries on adult stem cells. The last speaker, a PhD molecular biologist, did the best job on wrapping up what a waste embryonic stem cell research is, and where adult stem cell research is going. He was very clear about the fact that we have pleuripotent stem cells created from adult stem cells.

No one seems to care as much as I do about the patents and licensing fees from our Texas taxpayers to the University of Wisconsin.

Oh, well, "An embryo is a human being, Representative."

The man with the patent on humans

James Thomson, the lead researcher on the team that grew the first embryonic stem cell line, and who has the patent on all human embryonic stem cell lines, has given an interview to the Wisconsin State Journal. There is a partial transcript and an audio slide show at the website.

Dr. Thomson agrees with me: embryonic stem cells and even those from cloned embryos are not likely to be transplanted. He believes that the embryonic stem cells will be useful for "basic research."

He does complain about the lack of money.

If his research does not have funding, then where is the money going that the University of Wisconsin collects via WARF, Wi-Cell and all those patent and royalty fees from the patents?

If there's no money from patents, then why does the Juvenile Diabetes Foundation spend their money on embryonic stem cell research in countries that do not honor US laws and patent regulations, claiming that their money goes farther where no one has to pay fees to WARF?
(More information on the patents at the link above)

From the Sign On San Diego Website:

According to the Foundation for Consumer and Taxpayer Rights, which filed the July 18 challenge to the WARF patent, licensing fees can go as high as $250,000.

And that does not include annual maintenance fees of about $40,000 and potential royalty payments, Wetherell said.

Donley, the WARF lawyer, would not talk about the high end of the foundation's scale of licensing fees.

But she said a commercial license could be as low as $75,000, broken into three annual installments. WARF has also been willing to take a stake in a company in lieu of fees, she said.

“If a company can't afford our $25,000 yearly fee, then it cannot afford the growth factors it needs to grow the cells,” Donley said.

(Read more, here.)

If the U of W will not invest those royalty and licensing fees in Thomson's labs, then why should we US taxpayers?

NASA and Planned Parenthood Share Bioethicist

As a science fiction reader, I'm concerned that the bioethicist for NASA can't even tell which humans are human enough to have their rights protected.

What's going to happen when he runs into another species somewhere "out there"?

Paul Root Wolpe, Ph.D. has been the NASA bioethicist for a few years, but I wasn't aware until this Philadelphia Inquirer article. I did know that he's the bioethicist for Planned Parenthood and the President-Elect of the American Society for Bioethics and Humanities. I should have known all of this, since it's on his University of Pennsylvania biography page. He's a senior fellow at the Center for Bioethics at U Penn, working with Art Caplan.

It's a shame that the major names in bioethics are not prolife. Instead, they discriminate among which humans are human-enough for protection and which are not. And the definition seems to change and grow narrower with each year.

Discrimination is ugly and anti-life.

That's where each of us can make a difference. When we see the name of a non-ethical, "pro-choice" person who has been appointed or hired to work with an agency, bureacracy, or institution that is funded with our tax money, we should complain. We can let our Legislators know that it is not acceptable to pay for any activity that runs the risk of encouraging abortion, euthanasia, or destructive research.

If we want our voice to be heard, we must ensure that our elected and appointed officials and the bureaucrats know what motivates us to spend our extra dollars on elections and politics and what gets us out to vote.

Watch your professional associations and memberships, too. Step up, attend meetings and make your voice heard.

A few years ago, I resigned from the American Medical Association over their support for making Plan B over the counter. This may have been the one and only time that the AMA ever endorsed taking any activity from the exclusive control of physicians. (And we certainly did not have the excellent research that's been done since, by Durand, et. al.)

However, it soon became clear that if people like me left the AMA, the membership would have nothing but pro-abortion, pro-euthanasia, and pro-utilitarian research advocates. Then, a friend pointed out to me that a wise Teacher once told us to be "salt and light" in the world.

So, I went back to school and started crashing attending every committee and council meeting I could. My letters to the editors became more focused and regular. And I started Life Ethics.org.

Y'all write your legislators and friends, and let's ask NASA to ask Dr. Wolpe to reconsider his concurrent association with Planned Parenthood. Or ask them to find a bioethicist who actually believes that all humans are human enough.

More on dead embryos and stem cells.

A couple of corrections and some comments on the original article, from the journal, Stem Cells.

The authors did not achieve any stem cell lines ("hESCs")from the early (2-10) cell lines. So I was wrong about their having done what Lanza and Advanced Cell Technology claimed to have done.

Also, the Nature article by Alison Abbott has at least one glaring mistake that I did not pick up on when I wrote my earlier post. (A poster at FReeRepublic.com alerted me).

Ms. Abbott repeated the myth that the US does not allow the development of hESC lines if they come from destroyed embryos. LifeEthics readers know that the government limits where it will spend the tax-payers' money. Only the lines derived from embryos destroyed prior to August 9, 2001 are eligible for Federal funds. There are no restrictions on private money, on destruction of embryos, or on the research itself.

Please take a moment to email Nature at news@nature.com (this is the "Feedback" email address, as well as the url) and let them know that they need to hire better reporters. Their "news" is not reliable and people like me can make mistakes on our blogs in the middle of the night if we rely on it.

Nancy Valko forwarded the link to a better review on the report from the Mercury News newsfeed. Which leads to the journal and the actual report.

The journal, Stem Cells, has graciously made the article about stem cells derived from cells removed from arrested - or dead - embryos an "Open Access" article, available in full and for free. Bravo, Stem Cells!!

I've read the report only once and still need to digest some of the information. However, I would like to note a few points.

First, please note the discussion about the organization of the embryo from the first division into dedicated trophoblast and inner cell mass on page 6. (My "sound bite" on this is "Embryos are organized, embryos are organisms." I use it to counter the "clump of cells" comments.) I don't see any comments about the capacity of the embryo for twinning at the earliest stages - meaning that the cells are not irreversibly dedicated and are still totipotent or capable of developing twins or multiples.


Second, 8 of the 9 cell lines were not derived from arrested embryos. The source of these were embryos that had been discarded because they were poor quality, with uneven or fragmented cells at division. These would not be dead. It's not ethical to intentionally destroy living human beings, even those who are abnormal, defective or of poor quality. Only 1 of the cell lines in the (beautiful) tables and photos is from an ethical source.

Third, the efficiency is still poor. However, for the living embryos, the derivation approached 33%. If it is ethical to use cadaveric tissue or tissue from dead human beings, the efficiency is not quite as important, ethically.


Fourth, the cell lines are grown on human fetal lung tissue cultures. I'm uncomfortable with this medium. There's the problem of the possibility of contamination with human-infective viruses and prions, as well as human proteins that would persist in any culture or product of the research. These can then be passed on to any future subjects. (Of course, this is the distant future.) There is also the problem of the ethics of using cadaveric tissue that was obtained by illicit means - i.e., if the lung tissue was collected after an elective abortion and if there will be a need for new lines and new breaches of the First, do no harm principle.

Which, brings us to the ethics of in vitro fertilization. With care and for the purpose of bringing to birth of a child, IVF can be ethical. However, only those embryos destined for implantation should be created in the first place and the parents, doctors and technicians have a duty to these children to ensure that they are given the best chance at life.

And that brings me back to another sound bite: "Whenever possible, use original container."

(Edit at 1:30 PM to get rid of bad Latin. ??"Use first language"??)

Naturally dead embryos for stem cell research.

Okay, first: there's a problem with the idea that in vitro embryos can be called "natural." However, the rest is ethical.

news@nature.com carries a report that does what Lanza did not: shows that single cells (blastomeres) from embryos can grow to yield embryonic stem cells without the intentional killing of an embryo.

The embryos were observed for 2 days, if there was no cell division, the embryos were deemed to be "dead."

If the finding is confirmed, and the cells are pleuripotent (will give rise to embryonic stem cells, but no to the trophoblast or placenta cells, and so is no longer an embryo developing into a fetus, then a neonate, etc.), then the use of the cells would be ethical. Just as it's ethical to "use" cadavers for medical research or teaching, with the informed consent of the surrogate decision makers (i.e., parents.).

"Fewer than half of human eggs fertilized in vitro do not develop to the 'blastocyst' stage, which is required for implantation," says Miodrag Stojkovic, who led the project at the University of Newcastle in the UK. He is now deputy director of the Principe Felipe Research Centre in Valencia, Spain. "There are many different reasons why they don't survive."

Arrested development

Stojkovic used 161 donated embryos in his study, which is scheduled to be published in Stem Cells1. The embryos came from two local in vitro fertilization clinics. Of these, 29 were developing, 119 'arrested' (stopped dividing) 3 to 5 days after fertilization, and 13 arrested 6 to 7 days after fertilization.

There is the problem of the 29 which were still developing.

The researchers evidently overcame the problems that Lanza had with the necessity of growing the cells with the original embryo.

Unfortunately, this will probabley turn out to be a distraction, used to "prove" that the embryonic stem cell researchers were looking in the right places, to begin with.

The best article title

Couldn't pass, uh, couldn't resist this one:

Mouse Colon Takes Top Honors at Nikon's Small World

This is from a press release announcing the award for best photomicrograph in an international digital photography contest, sponsored by Nikon.

I can tell what you're thinking

Betterhumans picked up on this NewScientist.com article on a study published in Current Biology (vol 16, p 1824)that examined auditory "mirror neurons" in humans using functional Magnetic Resonance Imaging (fMRI).

Mirror neurons are the groups of nerves that are stimulated in our brains when we imagine someone else doing some action - in this case, the neurons fire when we hear a distinctive sound, like someone biting an apple or tearing a piece of paper.

The "cool" factor is not just that our motor neurons fire when we imagine doing some action. My neurons fire when I see or think about you doing something. Or when I hear a sound that I know is associated with someone else doing something.

Not only that, but the strength of the stimulation is stronger in people who test stronger on psychological tests for empathy, or the ability to identify with another person. Whether it's pain, joy or actions.

It's "cool" to find physical proof, through high tech, of a psychological phenomenon. And I love my measurements.

The "uncool"? All this technology gets smaller, more mobile, and more fine tuned. There's a worry that future scanning based on fMRI and what we learn from it will lead to machines that can read minds, or something very close to it.

Not me. I've got my tin hat.

Seriously, the current theory is that we learn by watching and mimicking others - even if it's just in our heads. Speech is associated with the same area of the brain. Earlier studies have shown that autistic people have less mirror neuron activity than people without autism. Other studies have shown that dancers have more activity when watching steps that they have been trained to perform - things they've learned - than when they see new movements.


So, is it that sociopaths and autistic children (not equivalent, except in the inability to feel others' pain) did not learn empathy, or is it that they do not physically have the functioning mirror neurons?

Hey, maybe we could screen doctors and bioethicists - maybe politicians - for mirror neuron activity.

Looking in the right places

On Tuesday, the Texas Senate Health and Human Services Committee heard invited and public testimony on stem cell research. I was one of those invited, and brought my Granddaughter who has had an umbilical cord bone marrow stem cell transplant. (The video is here, about 6 hours in.)

One of the speakers used the old story about the drunk looking for his keys under the corner lamppost, rather than over in the dark, where he lost his keys. The speaker, a pediatrician who believes that life begins when the mother wants it to, was using the story as an analogy in favor of funding for embryonic stem cell therapy as opposed to funds for non-embryonic stem cell research.

But, look at the evidence. Every stem cell therapy actually uses *adult* stem cells and progenitor cells. The goal of all those embryonic stem cell researchers is to turn the embryonic stem cells into "every cell of the body."

So, why not go to the actual place where there are "the cells of the body"? Sure, a given adult progenitor or stem cell line may not give the full range of stem cells. But the full range of adult progenitor and stem cells will!

Adult stem cells and progenitor cells have been found for most tissues and organ systems. Those are the ones we will use - whether they come from destructive embryonic stem cell research, or from non-destructive non-embryonic stem cell research.

The studies on producing, harvesting and then implanting those cells all lead to immunogenic adult cells. The difficulties associated with identifying and controlling adult cells shouldn't be any more than those associated with obtaining and controlling embryonic stem cells that will function as normal adult cells, without causing an immune response.

How about that: we lost our keys under the lamp post!

On human nature and where babies come from

I guess it's true - you are your DNA. In fact, some children of the future will only be worth as much as the value of their DNA in their parents' eyes. Nature wins out over Nuture in planning the family of the future.

Let's all hope that human nature is strong enough to make these parents good nurturers.

Nancy Valko forwarded William Saletan's column ("If you think it's hard to explain where babies come from, try explaining where baby-making is going.") from the Washington Post (Free registration required) on the business of making babies to order that is using IVF and PGD - and a good dose of old fashioned hubris - to allow parents to accept or reject their children earlier than ever before. The siblings who are rejected never even get a chance to disappoint.

The tests aren't just for life-threatening congenital diseases like Tay-Saks any more. We aren't talking about Muscular Dystrophy or even Down's Syndrome. The testing has gone down the predictable and cliche'd slippery slope from selecting for a donor for a living brother or sister to Colon Cancer and Breast Cancer (50% chance as an adult) to arthritis (20% chance for a non-life threatening disease) to "balancing the family" by sex selection.

Mr. Saletan reports that according to a new study being released by the Genetics and Public Policy Center, 6% of clinics have already used PGD to select for children who can act as "tissue banks" for their siblings. In the example he gives, the cord blood from the baby brother was not sufficient, so the infant became a bone marrow donor. At least once.

There's no question that some of these families are faced with heart-breaking choices. Others are treating their children of the future like subjects of next month's Consumer's Reports.

Perhaps the clinics could assign "My Sister's Keeper" and "Never Let Me Go" as required reading for the "moms and dads" in question. I strongly suggest that they consider joining the "Bioethics Book Club."

Robert Lanza wrote my blog

Okay, actually Karen Kaplan wrote much of it. A news report out of California stresses the fact that the scientists are asking for more new embryos to be used in embryonic stem cell research. So, the State that's pretty much tied in to embryonic research due to their own votes has more troubles than funding. The funding to create new embryos carries the need for further regulation on how to to get the eggs to make them and the hassles with the WARF patents on embryonic stem cells.

Cloning seems to be interconnected with embryonic stem cell research according to the researchers in California. Since we learned from the Korean veterinarian that it takes more than 2200 oocytes to clone a human embryo, Robert Lanza, of Advanced Cell Technology, is going out of his way to remind us that, "Without eggs, there's no research."


From the LA Times (requires free registration):

UC San Francisco researcher Renee Reijo Pera has a well-equipped laboratory, generous funding and an ample staff of scientists working to create new lines of embryonic stem cells.

She has everything she needs to do cutting-edge work except one thing: fresh human eggs.

While the world debates the morality of stem cell research, scientists are grappling with a more basic issue — a shortage of eggs that they say is crippling their work.

"Without eggs, there's no research," said Dr. Robert Lanza, medical director of the biotechnology company Advanced Cell Technology Inc.

-----

Researchers have so far complied with the payment restrictions, but the shortage has become so acute that some scientists are beginning to contest the ethical underpinnings of the status quo.

"We need to make a decision: Do you want the research to proceed or not?" Lanza said.

Here's a quote from a Texas researcher from my Alma Mater, who evidently went out to California to testify:

The controversy prompted the American Society for Reproductive Medicine's ethics committee to revisit the issue. The panel concluded that if it was permissible for fertility patients to pay women for their eggs, stem cell researchers should be able to do so too.

"Regardless of the application of the eggs, the process was still the same," said the committee's chairman, Dr. Robert G. Brzyski, a reproductive endocrinologist at University of Texas Health Science Center at San Antonio.

Drug company gifts - corruption of medical judgment and education?

[Edit note April 21, 2007 - spelling in the title and "labels"]
I don't know about the rest of you, but while it's possible that I can be bought, it's not for the price of a free pen or a lunch. I pay $100 extra for my subscription to Contraception because I won't sign off on the mission statement for the Association for Reproductive Health Professionals, for pity's sake.

I guess that since doctors are such an unreliable and untrustworthy lot(who can somehow trusted with sharp objects and every personal detail about your life and body), we shouldn't permit them to accept give-ways from salesmen.

Come on! Doctors need education in ethics and practice making ethical choices. But, this is not the way to teach them: assuming that their patient's life is worth less than an ink pen bearing advertising.

However, I do hate seeing the drug samples lumped into the "free gifts" prohibition. Even the well-to-do are helped when we can give them a a day's worth of antibiotics to get them going or a week's worth of BP meds to see how they handle the new med. The poor and the working poor who live from payday to payday or have to get by on a limited formulary and limited number of scripts a month depend on my samples, at least until we can get them on the indigent program for the drug.

The "bioethicists" at the blog.bioethics.net, run by the editors of the American Journal of Bioethics, claim to have proved that we are influenced by pens, back in 2003. (In a Journal that maintains closed access to articles even 3 years after publication, and which is difficult to subscribe to, because subscriptions appear to run according to the calendar year.) The social science Ph.D.'s often seem hostile toward physicians, and this is one of the subjects that brings it out in them.

From the Kaisernetwork.org:

Tuesday, September 12, 2006

Prescription Drugs

Stanford University Medical Center Expected To Announce Policy Banning Doctors From Receiving Drug Industry Gifts

Stanford University Medical Center on Tuesday is expected to announce a policy under which physicians will no longer be allowed to accept gifts from pharmaceutical sales representatives in an effort to limit the drug industry's influence on doctors' medical choices, the New York Times reports. The policy, set to take effect Oct. 1, would prohibit doctors from accepting even small gifts such as pens or mugs from sales representatives for pharmaceutical, medical device and other companies. The policy also will prohibit doctors from accepting free drug samples and from publishing articles in medical journals that are underwritten by drug companies. Doctors who purchase medical equipment will be responsible for reporting any financial relationship they have with medical device suppliers, and, in some cases, could be excluded from the purchasing process. The new policy will not affect consulting agreements between physicians and companies that develop drugs or devices, which already are covered by an existing conflict-of-interest policy. The Times reports that the "move is part of a reaction against corporate influence on medicine at a time of growing concern over the safety and rising cost of drug and medical devices." The pharmaceutical industry spends about 90% of its $21 billion marketing budget on physicians each year, according to an article published in the Journal of the American Medical Association in January that encouraged academic medical centers to adopt no-gift policies. The article stated even small gifts can engender a sense of obligation, while free drug samples are "a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective."

Comments
Stanford School of Medicine Dean Philip Pizzo said, "We want to secure the public trust to value what happens in academic medicine," adding that the policy would cost the institution millions of dollars per year. "Many faculty members and departments have become dependent on sponsored meals from industry in order to run seminars," Pizzo said. David Mangus, director of the Stanford Center for Biomedical Ethics and a contributor to the new policy, said it would lead to "a pretty major change in our culture." Scott Lassman, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America, said the new policy is a "disservice to patients and physicians," adding, "The company sales representatives, in our point of view, have a lot of useful information on drug products and how to use them, and how not to use them" (Pollack, New York Times, 9/12).

Tom Burnett, Flight 93 Hero

I'm late, and not official. But, the 2996 group (the link is not working as I write) is posting information on our fellow humans who were lost when hating men hijacked airplanes to use as weapons against the United States and the world on September 11, 2001. I chose Tom Burnett, because, although I'm completely unaware of any relationship, "Burnett" is my maiden name.

From what I've heard and read, I would be proud to call Tom kin. He loved his family, impressed those with whom he worked, and left a legacy of courage and self-sacrifice in the face of certain death. He and his fellow passengers died, but they denied a weapon to our enemies.


God bless Tom Burnett, his wife, three daughters, and his family and loved ones. God bless America.

ACT and $13 million dollars

The "Better Humans" blog has a link to an article from UPI outlining the financial gain of Advanced Cell Technology after their false claims about "ethical" embryonic stem cells.

Notice that ACT does not tell us the origin of the stem cells that they plan to use. But, Better Humans assumes that the money is a sign that the rest of are getting used to the idea of cloning.

Redefining the terms alert

Just as the terms "pregnancy," "embryo," "cloning" and so many other terms have been the subject of repeated efforts to redefine and misdirect, watch out for a shift in the mainstream and scientific literature from "embryonic stem cells" to "early stem cells."

Supposedly, there are disagreements as to what an embryo is, so the advocates for embryo destruction have begun writing about "early" stem cells. In appears that someone noticed that the public's awareness that the embryo is the first stage of development of us all is obstructing such research, so it's time for a new word. (See last week's "Answer to Embryonic Stem Cell Proponents." The talking points of The Alliance for Medical Research awkwardly introduce the term in each bullet.

Be alert to this term when searching the news, literature and speech. I'm reading and hearing it more often, since I noticed it being used at the Politics and Bioethics Conference in Albany last July.

Most likey the writer or speaker is giving you a clue that he or she doesn't care whether the entity disassembled to yeild cell lines is a human individual or not. Just as we began to read "pre-embryo" a few years ago and "SCNT" became "NT" then "patient specific" stem cell lines. (Well, they didn't. But it wasn't for lack of trying or oocytes.)

In fact, the International Society of Stem Cell Researchers has published their draft guidelines, including a Glossary with a definition of embryo:

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

Embryonic stem cell research is older than it looks

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

From the Wisconsin Technology Network:

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

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

Not everyone is happy about the monopoly.:

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

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

and,

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

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

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

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

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

Reflection on an anniversary (9-11, Katrina)

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

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

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

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

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

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

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

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

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

Answer to Embryonic Stem Cell Proponents

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

You can read TAMR's talking points here.

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

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

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

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

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

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

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

Corneal transplants grown from patient’s own stem cells.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

McGee: Embryo research equals physician assisted suicide

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

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

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

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

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

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

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

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

Go team. Except, not.

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

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

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

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

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

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

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

Plan B - Does it work?

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

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

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

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

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

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

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

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

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

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

Do all doctors need to be bean counters?

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

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

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

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

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

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

If you think healthcare is expensive, now . .

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

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

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

* * *

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

1 in 10: How lucky do you feel?

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

From the San Antonio Express-News:

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

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

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

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

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

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

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

And no one has to die for these cures.

Proven research in ethical stem cells

From Human Events author James Kelly:

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

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

Medical ethics, lawyers, bean counters and government guns

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

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

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

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

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


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

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

Medicare Regulations, Chronic Care, Legal Tests

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

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

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

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

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

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

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

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

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


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