Tuesday, April 22, 2008

Oklahoma abortion Bill survives Governor's veto

The Oklahoma State Legislature has overturned Governor Henry's veto of an "omnibus" bill containing abortion regulations. (The veto is explained at the United Kingdom site of Medical News Today. Besides gives the best definition of human embryo that I've seen in legislation:

“Human embryo” means a human organism that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.


Pro-abortion groups are concerned that the bill requires the facility doctor to perform an ultrasound before every abortion, that the girl or woman be allowed to see it, and that the results be explained to her. Not only is there a requirement to post a notice in the facility informing the women and girls that it is "against the law for anyone, regardless of his or her relationship to you, to force you to have an abortion" and the abortionist evidently must actually speak the words out loud before each abortion!

Called the "Freedom of Conscience Act," (The text is here, in a Word document) the bill offers protection to any medical professional who refuses to act in a way that goes against his or her conscience.


The best news article that I've found is here, at the "Daily Women's Health Policy Report" of the National Partnership for Women and Families, a group I'd never heard of before. It appears that the main focus has been legislation to protect women in the workplace.
Robert Cole, an Oklahoma native, writing for Associated Content, has explained the bill in this article. Here's an article from The Feminist Majority, with good links.

Ironically, Democratic Presidential Candidate, Barack Obama, used the objection to abortion by the Senator from Oklahoma, Senator and Obstetrician Tom Coburn, to justify his relationship with the Weatherman bomb-building conspirator and now-college professor, William Ayers. (Ayers is the man who was quoted in the New York Times on September 11, 2001 as regretting that he did not do enough bombing and fighting the US government in the early '70's.)

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Friday, December 07, 2007

Colorado's Human Life Amendment

Although Time Magazine, the Denver Post and the blogs insist on calling it the "fertilized egg rights" law, Colorado's State Supreme Court has approved the wording for a proposed "Human Life Amendment." The proponents of the amendment need 76,000 signatures in order to get the initiative on the November, 2008 ballot.

The Chicago Tribune reporter at least understands that after fertilization we are talking about an "embryo." The Trib even found three ethicists who agree that the human embryo is alive. Which puts them in opposition Justice Blackburn’s opinion ( which medical school did he go to, anyway?) in Roe v. Wade that no one knows when life begins.

Unfortunately all three of those ethicists are much more worried about the definition and description of the qualities and abilities of those living humans they deem worthy of “personhood” than whether or not it is acceptable to discriminate between which humans are persons or not. Their main objection seems to be that protection of the inalienable right not to be killed, enslaved or treated as research material “would cause a lot of problems." (I'll bet that they disagree with the Dred Scot opinion, though. Overturning that one sure caused a lot of problems.)

U.S. law, based as it is on “unalienable rights” mentioned in the Declaration of Independence, should absolutely prevent courts, laws and ethicists from infringement of the right not to be killed or enslaved. Ethicists – of all people – shouldn’t need a lawyer to understand that the full exercise of unalienable rights affects infants, children, the mentally disabled and the mentally ill. Parents have special duties to their children and children can't claim the same expression of liberty (drinking, driving, entering into contracts) that their parents do. There are legal precedents for dealing with the “problems” posed by the varying abilities of the mentally ill and disabled as well as for minors – including very young infants who can legally be restrained against their will (in a crib, playpen or car seat).

The “ethicists” in the Tribune article, as well as readers' comments in both papers and in blogs all over the internet, bring out every pro-abortion objection except the coat hanger. They warn us that fertile women will be “monitored,” that women who miscarry or who drink a glass of wine will be prosecuted. They insist that if State law recognizes the human being as a person from fertilization, we’ll have to decide whether to try to save every child at miscarriage and ectopic pregnancy or fail to enforce the law. Elective intentional abortions and manipulation that is intended to end the organization of an embryo - are acts which may be prohibited under law and the State Medical regulations. Spontaneous abortions (miscarriages), and stillbirths, like so many natural deaths, are impossible to prevent and cannot be prohibited.

Since US Supreme Court rulings (Roe v. Wade and Casey, among others) all base the “right” to an abortion on the autonomy of the mother and while affirming the right of the State to protect the child in certain cases, the “extracorporeal” embryo should be protected, somehow, even in current law.

It might be worth noting that the law requires determination of the cause of death of everyone who dies, and that Texas requires a special review of children under 6 and those of any age who die within 24 hours of admission to the hospital. Texas also names a “person” as living human individual from fertilization to natural death through our Penal Code. The 2003 Prenatal Protection Act allows criminal charges when a third party causes the death of an unborn child while exempting the actions of the mother or deaths due to legal medical procedures with the consent of the mother.

In fact, 3 men have been convicted of capital murder under our 2003 Prenatal Protection Act. The convicted men were abusive, the father, and intended to kill the child(ren). One killed twins at 5 months gestation but not the mother, the other two each killed mother and child. One man received the death penalty for killing a teenaged girl he'd gotten pregnant. There are charges pending in at least one more case, a drive-by shooting that caused the death of a pregnant woman.

Last month, the Texas Court of Criminal Appeals ruled in favor of the conviction of a man who killed one of two women he was sleeping with after the first told him she was pregnant. He told his second girlfriend that he would take care of the pregnancy of the first, and shot the first woman 3 times with a shotgun, once in the face.

As for "monitoring the actions of women:" a couple of county District Attorneys in Texas have tried to turn the law into an excuse to lock up mothers for endangering their unborn children. The outcome was similar to the cases in South Carolina a few years ago, when women were arrested after being tested as part of their pregnancy screening, required by that State’s Medicaid regulations. One lawyer made a speech to a group of lawyers that the Act could be coordinated with our State's Consent Laws to charge doctors with capital crimes. Texas State Attorney General has given an official statement on the intent of the Legislature that exempts mothers and doctors.

The handling of an ectopic pregnancy is well established under the doctrine of self-defense. With our current medical technology, the child cannot be saved and he or she is a direct danger to his mother’s life.

While we can’t verify the soul, we can verify which embryos are organisms: techs do it all the time in labs. The embryo, unlike the sperm, egg, and transplanted organs, is an organized organism. It's easy to tell within a day whether the oocyte is fertilized and which are not. It's also easy to tell the difference between embryonic stem cells and an embryo.

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Monday, October 15, 2007

AMA editorial on Partial Birth Abortion Ban

I would like to respond to the Commentary by Lawrence O. Gostin, JD, “Abortion Politics: Clinical Freedom, Trust in the Judiciary, and the Autonomy of Women.” in the Journal of the American Medical Association, October 3, 2007.(behind a pay wall)

Declaring that the Supreme Court's consideration of the “respect for the dignity of human life” in their ruling on the Partial Birth Abortion Ban Act (Gonzales vs. Carhart, 2007) is “Congress’ overtly political discourse,” he neatly sums up his position in this sentence from his last paragraph:

“Morality alone is an insufficient justification for the government to intrude on the private lives of women and the clinical freedom of physicians.”


On the contrary: morality, especially the laws concerning the killing of one human being by another is the basis for all law:
“What makes killing morally wrong, then, when it is wrong, is that a human life, the one killed, is treated as a life that has little or no worth rather than as a life of incalculable worth and as one having a right to be treated accordingly. If laws were permitted to embody the idea that in some circumstances life loses its worth, or that some people lack sufficient worth to have their lives protected, individuals would no longer enjoy equal protection of the law so far as their lives are concerned. Furthermore, some principled basis for protecting human life other than its sanctity would have to be provided to justify what would constitute violations of the unquestioned worth of every individual human life.Arthur J. Dyck When Killing is Wrong (Cleveland, Ohio: Pilgrim Press, 2001), p. 77. Emphasis mine)


However, the Court did not review the "right to abortion" in Gonzales vs. Carhart. It only ruled on the Constitutionality of the regulation of medical practice in one narrow procedure, which Gostin admits "does not save a single fetus because physicians could instead use a standard D&E method."

Gostin objects to the Supreme Court of the United States over-ruling lower Federal courts and to State governments who dare to regulate medical practice as though he Founding Fathers wrote the Constitution so that only the Federal Judiciary decides the really, really important issues and the representatives of the People are only allowed to decide the inconsequential. He forgets or ignores that Blackburn’s 1973 Court intervened between State legislators and their rightful power to regulate the practice of medicine in Roe vs. Wade, and invented State’s rights that gradually phase in based on trimesters.

Moreover, he seems unaware of the precedent set and precedents reviewed in Washington vs Glucksberg (1997), or Vacco vs. Quill, (1997) when that Court ruled in favor of laws from Washington and New York that served to criminalize “physician assisted suicide.”

Concerning the 1993 Planned Parenthood vs. Casey ruling to which Mr. Gostin frequently refers,
"At the heart of liberty is the right to define one's own concept of existence, of meaning, of the universe, and of the mystery of human life. Beliefs about these matters could not define the attributes of personhood were they formed under compulsion of the State." (Casey, 505 U. S., at 851.)


the Court has stated,

“[A]lthough Casey recognized that many of the rights and liberties protected by the Due Process Clause sound in personal autonomy, 505 U. S., at 852, it does not follow that any and all important, intimate, and personal decisions are so protected” (Washington vs. Glucksberg, 1997)

I suggest that it’s important to share at least some perceptions about reality within the Universe. Otherwise we would not be able to discern the difference between sanity and insanity, much less between ethical and unethical medical practice.

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Thursday, October 11, 2007

Privacy, politics, and medical records

The editors and pseudoeditors of the American Journal of Bioethics blog are talking about all the people who accessed the hospital records of George Clooney after his motorcycle accident.

Somehow, according to the author of the post, it's all President Bush's fault.

In light of the news and comments on the latest iteration of SCHIP and Hillary Clinton's health care plan, I've been doing a little research. We ought to learn and remember the history of the privacy laws, the push for electronic records. But we certainly can't claim that the problem began in January 2001.

HIPAA began the whole electronic record push and originated in 1996. It's about anything but "privacy." See the records available on line, here.

The Privacy Rule, a later part of the Act (the Summary is 25 pages), specifically mandates full disclosure to the Secretary of Health and Human Services, or any agent of the Secretary, of all information in any facility that participates in any way (or ever hopes to do so) with Medicare. It also allowed those entities to make copies to take out of the office and to write their own subpoenas that need to be vetted by a judge after the fact. Attorney General Janet Reno advocated the use of the technology to track down Medicare fraud and abuse back in 2000.

The first big influences toward electronic medical records (EMR) and digital imaging are even older. Back in the late '80's, when I was in medical school, the Veterans Administration pioneered the EMR. (I used to practice diagnosing patients from their list of medications and procedures, the first elements of the record, before our notes could be entered.)In the early '90's, radiologists discovered the benefit of taking call from home while being able to read emergency head CT's and other images.

The electronic medical record and digital storage of images is a good thing - but like all tools needs to be used properly.

The whole coding and reporting of medical care has grown into the usual government "leviathan" (to use Ira Magaziner's defense to the lawsuit against him and Hillary Clinton for the unknown status of the consultants on their 1993 Health Care Task Force).

We still hope that the EMR will help us do better than we have in the past. Although I believe that most clinicians will disagree with the the "quality" markers used, see today's NEJM article about child health care.

However, I don't think that the incident involving Mr. Clooney's records proved anything about electronic records other than the hospital had the ability to monitor who accessed the records - and that human beings are curious about celebrities.

In the meantime, Texas seems to be volunteering to be a lab for privacy issues with the correlation of drivers, insurance, and cars as well as photographing and surveying the people who use US IH 35. Car 54 can run your license plate at a red light or while you're driving down the highway and then cite you if you're uninsured. My taxes should definitely go down if these tactics can be used to generate revenue.

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Wednesday, June 06, 2007

Non-destructive embryonic stem cells

It's all over the web (here and here, at the "news@nature.com" site,for instance), three separate labs have been able to reproduce embryonic stem cells by "reprogramming" adult cells from skin.

Much of the commentary is like Art Caplan's comments quoted in the first (Blog.bioethics.net) link above. Paraphrased, the bulk of the "mainstream remarks include, "It's only in mice, and they had to used viral vectors." Well, if you will look at all the much-hyped embryonic "break-throughs," you will see that they are "only in mice" and many of them "used viral vectors."


Caplan, who notes the coincidental timing with legislation in Washington and who chronically sees bioethics through a political lens, couldn't pass up the chance for a rant on "embryos are not people." When I was an embryo, it was close enough for me - and my Mama. I actually agree with Art Caplan's comment that ". . . ditching embryos and jumping to fund alternatives is not the right response to this fascinating news about mouse cells." The reason we won't fund embryonic stem cell research requiring the distruction of human embryos is not because we have an alternative source. It's because we won't fund research that depends on the destruction of embryonic humans.

The abstracts for two of the articles are published on the Nature advance publication online page. (I don't yet have access to the third, in Cell's Stem Cell journal.


Nature
advance online publication 6 June 2007 | doi:10.1038/nature05934; Received 6 February 2007; Accepted 22 May 2007; Published online 6 June 2007

Generation of germline-competent induced pluripotent stem cells
Keisuke Okita1, Tomoko Ichisaka1,2 & Shinya Yamanaka1,2
1. Department of Stem Cell Biology, Institute for Frontier Medical Sciences, Kyoto University, Kyoto 606-8507, Japan
2. CREST, Japan Science and Technology Agency, Kawaguchi 332-0012, Japan
Correspondence to: Shinya Yamanaka1,2 Correspondence and requests for materials should be addressed to S.Y. (Email: yamanaka@frontier.kyoto-u.ac.jp).

We have previously shown that pluripotent stem cells can be induced from mouse fibroblasts by retroviral introduction of Oct3/4 (also called Pou5f1), Sox2, c-Myc and Klf4, and subsequent selection for Fbx15 (also called Fbxo15) expression. These induced pluripotent stem (iPS) cells (hereafter called Fbx15 iPS cells) are similar to embryonic stem (ES) cells in morphology, proliferation and teratoma formation; however, they are different with regards to gene expression and DNA methylation patterns, and fail to produce adult chimaeras. Here we show that selection for Nanog expression results in germline-competent iPS cells with increased ES-cell-like gene expression and DNA methylation patterns compared with Fbx15 iPS cells. The four transgenes (Oct3/4, Sox2, c-myc and Klf4) were strongly silenced in Nanog iPS cells. We obtained adult chimaeras from seven Nanog iPS cell clones, with one clone being transmitted through the germ line to the next generation. Approximately 20% of the offspring developed tumours attributable to reactivation of the c-myc transgene. Thus, iPS cells competent for germline chimaeras can be obtained from fibroblasts, but retroviral introduction of c-Myc should be avoided for clinical application.
Although ES cells are promising donor sources in cell transplantation therapies1, they face immune rejection after transplantation and there are ethical issues regarding the usage of human embryos. These concerns may be overcome if pluripotent stem cells can be directly derived from patients' somatic cells2. We have previously shown that iPS cells can be generated from mouse fibroblasts by retrovirus-mediated introduction of four transcription factors (Oct3/4 (refs 3, 4), Sox2 (ref. 5), c-Myc (ref. 6) and Klf4 (ref. 7)) and by selection for Fbx15 expression8. Fbx15 iPS cells, however, have different gene expression and DNA methylation patterns compared with ES cells and do not contribute to adult chimaeras. We proposed that the incomplete reprogramming might be due to the selection for Fbx15 expression, and that by using better selection markers, we might be able to generate more ES-cell-like iPS cells. We decided to use Nanog as a candidate of such markers.
Although both Fbx15 and Nanog are targets of Oct3/4 and Sox2 (refs 9–11), Nanog is more tightly associated with pluripotency. In contrast to Fbx15-null mice and ES cells that barely show abnormal phenotypes9, disruption of Nanog in mice results in loss of the pluripotent epiblast12. Nanog-null ES cells can be established, but they tend to differentiate spontaneously12. Forced expression of Nanog renders ES cells independent of leukaemia inhibitory factor (LIF) for self-renewal12, 13 and confers increased reprogramming efficiency after fusion with somatic cells14. These results prompted us to propose that if we use Nanog as a selection marker, we might be able to obtain iPS cells displaying a greater similarity to ES cells.


and

Article Nature advance online publication 6 June 2007 | doi:10.1038/nature05944; Received 27 February 2007; Accepted 22 May 2007; Published online 6 June 2007

In vitro reprogramming of fibroblasts into a pluripotent ES-cell-like state


Marius Wernig1,6, Alexander Meissner1,6, Ruth Foreman1,2,6, Tobias Brambrink1,6, Manching Ku3,6, Konrad Hochedlinger1,7, Bradley E. Bernstein3,4,5 & Rudolf Jaenisch1,2
1. Whitehead Institute for Biomedical Research and,
2. Department of Biology, Massachusetts Institute of Technology, Cambridge, Massachusetts 02142, USA
3. Molecular Pathology Unit and Center for Cancer Research, Massachusetts General Hospital, Charlestown, Massachusetts 02129, USA
4. Broad Institute of Harvard and MIT, Cambridge, Massachusetts 02142, USA
5. Department of Pathology, Harvard Medical School, Boston, Massachusetts 02115, USA
6. These authors contributed equally to this work.
7. Present address: Center for Regenerative Medicine and Cancer Center, Massachusetts General Hospital, Harvard Medical School and Harvard Stem Cell Institute, Boston, Massachusetts 02414, USA.
Correspondence to: Rudolf Jaenisch1,2 Correspondence and requests for materials should be addressed to R.J. (Email: jaenisch@wi.mit.edu).

Nuclear transplantation can reprogramme a somatic genome back into an embryonic epigenetic state, and the reprogrammed nucleus can create a cloned animal or produce pluripotent embryonic stem cells. One potential use of the nuclear cloning approach is the derivation of 'customized' embryonic stem (ES) cells for patient-specific cell treatment, but technical and ethical considerations impede the therapeutic application of this technology. Reprogramming of fibroblasts to a pluripotent state can be induced in vitro through ectopic expression of the four transcription factors Oct4 (also called Oct3/4 or Pou5f1), Sox2, c-Myc and Klf4. Here we show that DNA methylation, gene expression and chromatin state of such induced reprogrammed stem cells are similar to those of ES cells. Notably, the cells—derived from mouse fibroblasts—can form viable chimaeras, can contribute to the germ line and can generate live late-term embryos when injected into tetraploid blastocysts. Our results show that the biological potency and epigenetic state of in-vitro-reprogrammed induced pluripotent stem cells are indistinguishable from those of ES cells.

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Monday, May 07, 2007

AMA on Texas Advance Directive (Futile Treatment)

The AMANews magazine, a weekly print newspaper for the members of the American Medical Association, has an article in the May 14 edition, available on line now. The excerpt is free here, but full content is only available to members and paid subscribers. Since LifeEthics readers have been following the progress of the legislation and know about the most recent action in the Senate Health and Human Services Committee, here's the portion that's not available for free:

Texas hospitals have used their state's advance directives law 27 times to withdraw treatment over family objections, said Robert L. Fine, MD, one of the 1999 law's architects.

Supporters of the status quo say the process normally extends far beyond 10 days.

"This law is usually invoked after days, weeks or even months of negotiation with families," said Tom Mayo, a health law professor at Southern Methodist University in Dallas who has helped evaluate more than a dozen medical futility cases on various hospital ethics committees.

Those seeking to abolish the time limit, however, allege that hospitals are most concerned about the estimated $10,000 a day it costs to provide intensive-care unit life support in these cases.

"The current statute, effectively allowing euthanasia with a polite and perfunctory 10-day notice, is misapplied and rips families away from the bedsides of their loved ones," said Bob Deuell, MD, author of a Senate treat-until-transfer bill, in an April letter to The Dallas Morning News. Dr. Deuell did not respond to AMNews' interview requests by deadline.

Bob Kafka, a Texas organizer for Not Dead Yet -- a disability rights group that opposes the advance directives law -- said in a statement that "the ability of a doctor to overrule both the patient and their surrogate in withdrawing life-sustaining treatment is in violation of the principle of patient autonomy."

But physicians argue that their obligation is principally to the terminally ill patient, not the family.

"It can be hard for patients' families to wrap their heads around the dying process," said Hanoch Patt, MD, an Austin, Texas, pediatric cardiologist who has served on hospital ethics committees and testified against the treat-until-transfer legislation. His patients often require invasive procedures if there is any hope for recovery, "but when a treatment can cause only more pain and suffering without any hope of benefit, then we're just prolonging the dying process, and I'm obligated to stop the treatment."
Compromise in the works

As this story went to press in late April, a compromise bill authored by House Public Health Committee Chair Dianne Delisi that would give families 21 days' notice to secure a transfer before the withdrawal of life support gained backing from the Texas Hospital Assn. and the Texas Medical Assn. The bill also would not apply to cases in which the only life support provided is artificial hydration and nutrition.

Such a compromise is not ideal, said Mark Casanova, MD, an internist at Baylor University Medical Center in Dallas.

"Physicians are going to live within the legal confines that we are forced to live within," he said, "but morally and based on medical ethical principles that are centuries old, we don't feel that it's necessarily appropriate. It's just 11 more days of suffering and pain for these patients that will not result in a single saved life."

AMA policy on futile care says hospitals should develop policies on how to handle such cases, refer them to ethics committees, involve families to the greatest extent possible and attempt to negotiate settlements. If the committee sides with the attending physician, the ethical opinion states, the hospital should seek a transfer, and if no transfer can be arranged, care should be withdrawn.

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Thursday, May 03, 2007

Do No Harm 101 (Wesley Smith, Catholic Bishops and Futile Care)

Wesley Smith is covering Texas' legislature's debate over our Advance Directive Act. Yesterday, he accused the 24 Bishops of Texas of practicing "Futile Care Theory," which he defines as the decision to limit care by anyone other than a family member or patient. (In other words, here, he says that Terri Schiavo was not a "Futile Care Theory" case.)

Patient autonomy is not the first principle of medicine - that should be non maleficence guiding beneficence over-rides autonomy. "Heal when possible, but first, do no harm."

If you want to get to basics, the right to life means the right not to be killed, not the right to some one else's actions to maintain your life to the standard that you want and as long as you want. The doctor also has the right to life and the right to liberty.

Those rights intersect in medicine with/by a fiduciary duty of the doctor to place the patient's interests above his own and society has agreed that medicine is a good that we will provide for our community.

These interactions have to be guided by a respect for life and health and the medical knowledge and skills of the doctor. The medical knowledge and skills are the element that is measurable, licensed and verifiable by observers outside the patient-physician relationship. The practice of applying medical knowledge and skills requires medical judgment. Acquiring medical judgment - even if it's just the ability to understand statistics and not a growth of our actual wisdom - is how we learn to do surgery and chemotherapy when it's obvious that there's at least a short term harm.


I certainly don't practice medicine at what Wesley Smith has called "at the macro level." The closest I come to "macro level" thinking is that extra ankle xray to rule out fracture and ward off lawsuits. And I don't dare touch a pregnant woman after 20 weeks without all kinds of informed consent forms that ensures we understand that I'm taking care of the cold or sprained ankle (no xray here, without the Obstetrician's permission), because I'm not insured for OB care.

Nevertheless, money is a factor - society has a duty to the entire community, but the doctor's fiduciary duty has been to the patient in front of him. We've pretty much held that line over the last 20 years despite the push to make us "gatekeepers" and "managers." (read that, "bean counters." However, a doctor can't afford to financially bankrupt himself to devote care to one patient or to provide free or deeply discounted treatment for so many other patients that he can't provide for his family. (and pay his staff, taxes, rent, etc.)

Every day, our ability to offer increasing levels of technology and pharmaceutical interventions that can serve to keep a body alive longer and as more cells and organ systems fail. It was reported this week that new techniques of resuscitation after cardiac arrest that may benefit - and may harm - thousands of patients.

Each new ability to keep patients alive when they would have died "naturally" puts more stress on the medical judgment element. And puts the doctor in the position of increased likelyhood that he will have to determine the benefit to his patient for more and more invasive treatment. A side effect is that some patients and families may demand that he act against his judgment.

Carried to the extreme, the doctor could become the slave of any family - unable to withdraw from the care of a patient for months or years, forced to change IV's and IV settings, to maintain and adjust the ventilator and dialysis settings, or even to maintain the heart-lung assistance device that slows cell death, even after the heart has died.

When so many doctors agree that the demands to use medical technology on a patient is inappropriate, that's not "Futile care theory," no matter how finely some define it. That's the practice of medicine. For the Bishops to back the doctors in the practice of medicine is not "futile care theory," either.

Where are the doctors stepping up to cast doubt on specific decisions and doctors in the cases that have become so celebrated in Texas? We hear rumors, but I don't see action.

Last year, a good man, a skilled and compassionate doctor, ended up treating Andrea Clark's family while doing his best to treat the patient, herself, but his actions were definitely futile, proved to be of no medical benefit. By treating the family's concerns, he enabled them to agree to stop increasing Mrs. Clarke's level of intervention. He showed wisdom in addition to knowledge, skills and judgment. However, my medical skills and judgment wouldn't have allowed me to go so far as to drain the gallbladder as he did.

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Tuesday, April 17, 2007

More Complaints About Texas Legislator

A blogger over at the Daily Kos is complaining about the Texas State Affairs meeting on HB 225. The complaint is that people with disabilities had to wait until the early morning to testify.

There's more comments at the South Texas Chisme: Sneaky Republicans ban stem cell research funding" (See the problem with the headline? Nothing has been banned, other than funding for a certain type of stem cell research that carries restrictions from the NIH, as well as being unethical.)

More at "Brains and Eggs," and Texas Freedom Network (self-defined as "A Mainstream Voice to Counter the Religious Right") has an article and a petition.

Perhaps I should tell them some of the realities about testifying in front of the Texas State House Affairs Committee.

1. First, Chairman Swinford believes that everyone should have their say. He never puts time constraints on witnesses, unlike some of the other Chairs, who have lights and buzzers and 3 minute limits. We all mutter, but we're all grateful when it's our turn.

2.The Chairman always lets kids go first. The other bill had children as witnesses, none of us there to testify on HB 225 had brought children.

3. Those early morning meetings are always interrupted by the House meeting and resume when the house adjourns for the day.

4. We should just be thankful that only two bills came before the Committee the other night -- they might all still be there.

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"Sneaky" Texas Legislator

Perhaps this article, written by an Associated Press writer, should be receive the Yellow Brick Award. (Should I put "copyrighted" here? No, there's others, although most - like the award for finishing the obstacle course at Quantico - are awards for achieving the impossible, not for misdirection.)

Someone is practicing distraction and projection by calling a vote in the Texas House State Affairs Committee a "Sneak attack."

Friday's vote came after a committee meeting that began Thursday and lasted through the night. Critics said the vote came hours after testimony concluded and while the committee was focused on an unrelated bill.

"Those of us who rely on the hope stem cell research holds, and anyone who cares about an open public dialogue, should be outraged at the manner in which the vote was taken on Friday afternoon — without discussion and while two members opposed to the bill were absent," said Judy Haley, president of Texans for the Advancement of Medical Research.

Kathy Miller, president of the Texas Freedom Network, called the vote's timing a "sneak attack."

"It's a shameful case of putting politics ahead of science as well as patients and their families," she said.


The bill, HB 225 by Ken Paxton (R - District 70, McKinney)reads as follows:
By: Paxton, Olivo, Christian, Chisum, Parker, H.B. No. 225 et al.

A BILL TO BE ENTITLED AN ACT
relating to prohibiting the use of state money for certain
biomedical research.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle H, Title 2, Health and Safety Code, is amended by adding Chapter 169 to read as follows:

CHAPTER 169. BIOMEDICAL RESEARCH
Sec. 169.001. PROHIBITION ON USE OF STATE MONEY FOR CERTAIN BIOMEDICAL RESEARCH. A person may not use state money for biomedical research if federal law prohibits the use of federal money for that research on January 1, 2007.
SECTION 2. This Act takes effect September 1, 2007.


For those of us who object to embryonic stem cell research, the bill serves the purpose of preventing our tax dollars from being used to destroy embryos whether from existing in vitro embryos or from purposeful creation of new embryos for the purpose of research, including cloning or parthenogenesis.

And for the fiscally responsible, the bill ensures that any research we pay for will be eligible for additional Federal research funds, and/or we won't spend money on redundant labs and equipment.

The House was in session until nearly midnight last Thursday, and began hearing testimony on HB 225 about 1 AM. They were in session, hearing about stem cells and cloning, until 5:30. (I had to work on Friday, so I went home at 1, and didn't get to testify.) The Committee met again on Friday: for a few minutes at 8 AM and again after the House adjourned for the day. The Chair, Representative David Swinford (R- 87th District, Amarillo), was a little punch drunk from being up all night - the maximum amount of sleep he could have gotten if he'd stayed at the Capitol would have been about 2 hours.

Representative Swinford made an effort to make sure that the members were present, and all were at certain points. However, the Committee members came and went both Thursday night and Friday. In fact, Representative Farrar (D-148, Houston) didn't attend Thursday's meeting at all, and Chairman Swinford reminded her on Friday that she probably wanted to "vote against this bill."

It's possible to watch both Committee meetings on line.

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Saturday, March 24, 2007

Good for South Carolina

The South Carolina House of Representatives has passed a bill requiring the abortion clinic to offer to show the ultrasound of the unborn child - the fetus - to the mother before the abortion. The ultrasound is already being done and paid for by the mother, why shouldn't she be offered the opportunity to see what she's paying for?

Of course the pro-abortion delegates to the SC House and in the media and blogosphere object.

From Forbes.com on line:
Rep. Gilda Cobb-Hunter, a Democrat, said the new requirement is emotional blackmail for a woman who has already made an agonizing decision.

"You love them in the womb but once they get here, it's a different story," said Cobb-Hunter, a social worker. "You're sitting here passing judgment? Who gave you the right?"


Star Jones writes in her World Net Daily column on one pro-abortion advocate's comments:

According to NARAL Pro-Choice America President Nancy Keenan, "The women of South Carolina are fully capable of asking their doctor for information they need to make private, personal medical decisions. Politicians don't belong in the examining room."


Then, there are these from Blog.bioethics.net:

South Carolina law already requires the ultrasound, as well as doctor counseling of the age and development of the fetus, as well as alternatives to abortion. This is nothing more than a bald-faced attempt at intimidation and emotional manipulation of someone who is already in a vulnerable position.

The thing that baffles me the most is, what? You're going to suddenly see an ultrasound image and decide that no, all the reasons you have for an abortion have flown out the window, and really it's a great time to be a mother, hooray? Are we suddenly going to see social services increase in funding? Are we going to have outstanding health care, job retraining, free and good state-sponsored child-sitting services? Is South Carolina going to suddenly take away every single obstacle that exists to bearing and caring for a child, so that the only barrier remaining is whether or not a woman thinks this is the right time for her, without consideration to financial/economic concerns?


And from a comment on that last:

Isn't this really a case of the state trying to persuade based on images. Images are often misleading--they often fail to portray facts because humans associate the images with particular notions, accurate or not. In the case of abortion, the image of a partially developed fetus may resemble the outline of a newborn child. But that fact alone does not mean that it is a newborn child. Yet for many, including many under-educated, images may conjure notions that do not portray fact.



Isn't it great to hear/read the same old "love them in the whom, but once they get here . . ." and "What gave you the right?" Not to mention that abortion is justified as long as there are any poor or "under-educated."

Ms. Jones answers the NARAL argument:

An increasing number of crisis-pregnancy centers now have ultrasound equipment that allows clients to see the child developing within them. Their experience shows that there is little question that this materially impacts the decision that women make. Centers report that anywhere from 62 percent up to 95 percent of women who had intended to abort changed their minds after seeing the images.

Assuming that these statistics are accurate, the question remains whether these young women changed their minds because their perceptions of the reality with which they were dealing changed, or because they were intimidated or emotionally blackmailed.

Intimidation or blackmail implies some kind of threat. What exactly might that threat be?

You might say that a young woman with a pregnancy she did not intend is emotionally vulnerable. I would agree with that.

It's exactly why statements from the NARAL universe that portray these young women ("fully capable of asking their doctor for information they need") as cool, sober and rational, calculating the equivalent of whether or not to have a wart removed or to get a Botox injection, are so ludicrous.

As any woman can tell you, instincts and intuition are powerful. These women are stressed because they know that suddenly the decision they have to make is not casual, that it is deeply meaningful and gravely important. Chances are, if they had the tools at their disposal to make a proper decision, they would not be in the situation they are in to begin with.

In South Carolina, as in the nation as a whole, about half the abortions that are performed are on women under 24. Around 17 percent are on women under age 19.

What kind of sense can it possibly make to suggest that a young woman, who we don't think is old enough to vote or go into a liquor store and buy beer, has the resources on her own to understand the implications of aborting a child? Is there some absence of proportion here?

A woman in her 40s may not remember who taught her math in high school, but she'll never forget the abortion she had. Why?

Knowledge comes to us through different paths. We hear and read words. But visual images are something else. Why, when we realize something we had been indifferent to or unaware of, do we say our "eyes were opened"?

More eyes are opening in our country today and realizing that freedom is not tantamount to meaninglessness.

When these young women see fingers, toes and a beating heart, they understand the emerging life within them. This is a profound moment of personal growth. It's what causes their change and opens the door to their own rebirth and a life with new possibilities.


I agree. What, exactly, do all those pro-abortion women mean when they say that women and girls about to undergo abortion are "vulnerable"?

It's not enough to say that seeing the fetus will cause emotional stress or trauma. She's bound to see an ultrasound ("US") of a fetus someday - either in a movie, a TV show or as part of her own or someone else's prenatal care for a future pregnancy - and she is just as likely to compare that US to the aborted fetus. If the US leads to emotional damage before the abortion, it's likely to cause emotional trauma after the abortion.

The US and the counseling are already necessary for medical reasons of improved staging and positioning which improve the care for the woman, herself. Why not use the US for the counseling while you're at it?

It's true that the pregnancy assistance centers ("anti-abortion" groups who counsel women against abortion and provide various resources related to pregnancy and motherhood) report that the women who see their fetus by US are more likely to decide against abortion. But these are women and girls who are already contemplating not aborting.

The same may or may not be true of the general population.

But if it is, then it seems to me an argument in favor of, not against, showing her the US, unless you find abortion inherently preferable to continuing the pregnancy.

The economic and social consequences are very real concerns, but should be a separate issue from the benefits of informed consent for the procedure of abortion.

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Money for Babies?

There is a gut reaction, what Dr. Leon Kass has called a "yuck" factor, to the idea that a mother would trade her child for money, however the idea is framed.

ABC news picked up another news item, this time from my hometown. Our local Chamber of Commerce owns the copyright to the title of "Texan of the Year" and makes the award at our "Legislative Conference" every spring. The event is pretty big as far as State politics go, so there are usually quite a few of our Legislators present. I do my best not to miss it, but had to work yesterday, so I missed seeing our Governor, Rick Perry honored.

I also missed my chance to hear Senator Dan Patrick make the case for his proposal to pay women $500 if they will choose to carry their babies to term and put them up for adoption rather than have an abortion.

I'm all for supporting women who have chosen life for their child, and for individual support of local charities and outreach, as well as public policy that blatantly and unequivocally favors life over abortion. However, something doesn't feel right about this cash money for babies deal.

At the very least, the proposal appears to favor adoption over keeping your own child to raise, at least as much as it favors adoption over abortion - possibly more.

I find it difficult to believe that a woman or girl will continue a pregnancy for the promise of $500 in 8 months or so, after the birth and after signing the rights of the child away. However, I can see desperate or depressed women and girls who have just given birth deciding that they can't handle motherhood and considering the right-now $500. I'm also afraid that predators will find ways to take advantage of these mommas and the would-be adoptive parents.

My feminist side - my matriarchal/sisterhood side - is stirred to thoughts of "Just like a man!" (The Libertarian/Republican side is certain that the money could be spent more wisely.)

Frankly, I'm a little insulted by the implication that $500 will override the heartache, confusion and crisis that brings a woman or girl to the point of believing she has to make a choice between her child and her life, her future, her education or (all too often) the support of the man who got her pregnant or the family who should protect her most of all. These problems are not that cheap, and the currency is not money.

First, if you're going to spend the money (sorry, Republican/Libertarian), spend it to give girls more options before they put themselves at risk of an unwanted pregnancy. Education is directly associated with delayed childbirth. Unfortunately, delayed childbirth is also related to increased infertility.

All too often, the only resources on college campuses for pregnant women are abortion-referral services. (See Feminists for Life) How would it be if we enabled and supported mothers and mothers-to-be in school, work, and the home? We could provide campus housing for married students and families, more daycare and family-centered health care and social services in the universities and colleges, where we are already investing our State tax funds.

Or, as a last resort, you could add that $500 per pregnancy to the Medicaid and TANF funds.

Added: My husband (who donates at least that much each month to life-causes, even if you just count the time I could be working instead of going to Austin and blogging) just commented: It's strange that he'd talk about how priceless human life is, and then proceed to offer $500."

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Monday, March 19, 2007

Leigh's Disease (Long post on end of life and baby Emilio Gonzales)

The mitochondria are the power plants of the cells. They take the sugar and turn it into the power that runs all the processes of the body. Leigh's disease is a defect in the genes of these mitochondria or of the body’s ability to make a protein or an enzyme that is used in the mitochondria, like pyruvate dehydrogenase.

The prognosis for individuals with Leigh's disease is poor. Individuals who lack mitochondrial complex IV activity and those with pyruvate dehydrogenase deficiency tend to have the worst prognosis and die within a few years. Those with partial deficiencies have a better prognosis, and may live to be 6 or 7 years of age. Some have survived to their mid-teenage years.


The defect can be nearly complete or it can be very mild depending on which of the many genes that can be involved are involved. The cells may be able to make energy but only very slowly - or very, very slowly. Or some cells may be able to make some power, but others can't. Some functions of the body need constant energy, others do not.

Pro-Life Blogs and other blogs carry posts about the very sad case of little Emilio Gonzales, who has been diagnosed with "Leigh's Disease." Unfortunately, they are full of implications that doctors (and even the Bishop of the diocese of Austin) are planning to "murder" the baby boy.

We do not have good tests to determine where the genes went wrong and they can go wrong in several places causing different symptoms and even different symptoms in the same child at different times. So this is a “syndrome” or a diagnosis given when we see a pattern of symptoms. AIDS is a syndrome that has only one cause -- infection with a virus instead of many different gene defects -- but it still develops differently in different people and can mimic different diseases in the early stages.

Sometimes Leigh’s disease does respond to thiamine – but only if the defect is in certain genes. Not in the vast majority of cases.

Another name for the syndrome is “Subacute Necrotising Encephalitis,” because in the late stages, areas of the brain die and break down. This little boy's nerve cells all over his body, including large areas in his brain, have died. This can be seen on his MRI.

It’s also supported by the findings on his EEG – that shows that he is having seizures one third to one half of the time. The seizures cause more cells to die.


However, the pain nerves still live: the report says he still reacts to painful stimuli as though he is in pain. He isn't able to process the pain.

Other organ systems fail as the lactic acid builds in his blood and tissues – cooking the proteins that make up the muscles, enzymes, and most structures of the body. If you’ve ever been sore the day after exercise, you know what lactic acid build up in one spot feels like and how long it takes to go away.

And, of course, growing and healing takes energy. The fastest growing cells for most of us line the intestines and make up the liver where food is processed - they die first, but can grow back sometimes - so the symptoms seem to come and go. When they are dead, it hurts the patient to give him tube feedings that must be absorbed by the gut or to give IV feedings that contain anything that must be processed by the liver.

Even the kidneys use energy. And the sphincters of the bowel and bladder do, too. If there is an imbalance between nerves, the sphincters spasm shut - so Emilio needs a catheter in his bladder.

The lungs stiffen with prolonged ventilator use. The stiff lungs and muscles mean that the pressure from the ventilator needs to be so high in order to give him enough oxygen that he is having leaks appear in his lungs as some of the airways break. The baby's lungs are repeatedly collapsing and having to be re-inflated. This means that over and over, he has a “pneumothorax.”The air goes into the sac around his lungs, squeezing the lung tissue itself down. The pressure outside the lungs is even higher than the pressure the ventilator is making inside the lungs -- each push from the ventilator pushes more air through the leak.

The docs then have to place a chest tube or chest tubes – possibly in a baby, they would use the temporary insertion of large bore needles - to release the air around the lungs, and allow the lung itself to inflate.

Some of the air moves between the tissues of his body, coming to the surface in little pockets – causing “subcutaneous emphysema.” Patients tell me that the pneumothorax and the subcutaneous emphysema hurt. The chest tube does not take away the air in the tissues – that takes days or weeks to be reabsorbed.

What would I do? I would suggest that the mother and the docs adopt a strategy of "this much and no more." Give Emilio droppers of fluids by mouth, to keep his mouth moist. Hold him as much as possible. Continue the ventilator, but stop placing the chest tubes and stop changing the ventilator settings. Do not add new medicines and do not resuscitate when the heart stops.

The Ethics Committee Report has been published at the North Country Gazette.

Medical Update Since Last Ethics Committee Meeting on 2/19/07:

Dr. Alexandra Wilson, the patient’s current attending physician, states that Emilio is unable to move his arms and legs and only has abnormal posturing movements with stimulation. He rarely opens his eyes, does not gag, cannot cough and cannot breathe without use of the ventilator; his pupils are not normally responsive to light. In addition, he can not empty his bladder and has to have a catheter. He does appear to experience pain, as he grimaces in response to deep stimulation, and is now receiving pain medications. He also bites his tongue, which causes bleeding, making it necessary to place a device in his mouth to prevent further injury to his tongue. In addition, he has experienced repeated full and partial collapses of his lungs, and his physicians and the treatment team are having great difficulty keeping his lungs inflated, even with the assistance of the mechanical ventilator. Finally, he is now having seizures, some of which produce visible physical symptoms, and scans (MRIs) of his head show progressive loss of brain tissue.

Dr. Brendle Glomb, pediatric pulmonologist, then discussed Emilio’s pulmonary status, which as noted above has continued to deteriorate. He explained the current functioning and support provided by the ventilator, and then described why Emilio would no longer benefit from a tracheostomy. He also noted that the repeated collapse and reinflation of Emilio’s lungs is damaging to the lungs, and increases the risk that they will tear or even burst during attempts at re-inflation.

Dr. Jeffrey Kane, pediatric neurologist, then discussed Emilio’s current neurological status, which has continued to deteriorate since the last consultation. Overall Emilio shows no purposeful response or movement, which is evidence that the deeper functioning of the brain is absent. In addition, Emilio’s EEG suggests that Emilio is experiencing many more seizures than those at the bedside can see. Based on his review of Emilio’s most recent EEG, Dr. Kane believes Emilio’s brain may be experiencing seizures between 1/3 and ½ of the time. Dr. Kane believes that the seizure activity will continue to increase, and that continued seizures will accelerate the death of Emilio’s remaining brain tissue. In response to a question, Dr. Kane noted that the current brain damage is not reversible, even if the seizure activity for some reason should slow or stop. Instead, he believes that Emilio will continue to experience the relentless and progressive loss of his brain tissue and brain function, and that no therapy or other intervention has been identified which could stop or reverse this process.

Dr. David Anglin, a pediatric intensivist involved in Emilio’s care, then discussed Emilio’s care-setting. He noted that during the Ethics Consultation on February 19, 2007, there was some hope that Emilio might be able to be transferred to a lower-acuity care setting or discharged home, and particularly if he were to undergo a tracheostomy and receive a feeding tube. However, given Emilio’s continued deterioration, he is too ill to survive anywhere but an intensive care setting, and he certainly is not a candidate to be discharged to home.




Edit 03/19/07 at 21:30 - cleaning up grammar.

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Tuesday, March 13, 2007

Umbilical Cord Blood Saves Lives


Today, the Texas House State Affairs Committee heard from a young man who was born with sickle cell disease. Young Joseph, Jr. told the Representatives that his baby brother saved his life. And now, he doesn't have to take medicine or get shots any more. (The oblivious hero slept through the hearing.)

And of course, I told about my granddaughter who received cord blood stem cells at 15 months old from an unrelated, anonymous little boy to cure her Kostmann's nutripenia. That's her with me, last August when we testified to the Senate State Affairs Committee.

You can watch the video at the Texas Legislature Online website archived files from 3/12/07, here, beginning around 25 minutes in. (Don't miss the earlier testimony in favor of legislation to protect embryos and embryo adoption. Joseph and his family testify at 45 to 47 minutes.)

Representative Robert Puente (D- 119) presented his House Bill 709 was before the Committee and is a perfect example of the "common ground" that is possible for those of us looking for ethical ways to further (ethical, non-embryonic) stem cell research.

The Bill would require the State Department of Health Services to develop and distribute a brochure to educate expectant parents about donating and banking cord blood. We heard that there are free opportunities for all mothers and fathers to donate their child's cord blood, if they have time to make the arrangements.

We also were privileged to hear from David Harris, Ph.D., of The University of Arizona. (His testimony begins at 30 minutes on that video) Dr. Davis began the first cord blood bank, and he told us that his children were the first to have their cord blood banked at birth.

I learned quite a bit, including that there are out of State public banks that will accept cord blood stem cells from Texas, and that there is a procedure to donate blood from a private, "family" bank to the public bank.


Here's a few sites with more information:

The Texas Cord Blood Bank

The MD Anderson Cord Blood Bank

HealthBanks (a commercial health information site)

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Friday, March 02, 2007

"Back Alley Death" ("Physician Assisted Suicide" )

Oregon and Vermont - extremes on the map and extremes on medical ethics. But this is the first time that I've heard that doctors should give patients a deadly prescription to prevent a "back alley" death.

How many of us really want our Family Doctor to be proficient in killing? Or, in over-riding his or her conscience?

The Vermont Legislature is once again considering legalized, intentional death by medication and physician prescription.

From the Burlington Free Press:
Is it suicide? That's at heart of Statehouse debate

Published: Thursday, March 1, 2007
By Terri Hallenbeck
Free Press Staff Writer

MONTPELIER -- Dr. Robert Orr read the Webster's Dictionary definition of suicide: "The act or an instance of taking one's own life voluntarily and intentionally especially by a person of years of discretion and of sound mind."

How, he asked, is that different from proposed legislation that the House Human Services Committee is considering that would allow a terminally ill patient to hasten dying with a lethal dose of medication?

We're trying to change the dictionary definition we've been working with for years," he said.

Dick Walters, an ardent supporter of the legislation, sees the two -- suicide and physician-assisted dying -- as entirely different things. "Suicide is a desperate act," he said. "It's done in a back alley, a barn. It destroys families.

"What we're talking about in H. 44 is something totally different," he said. "They're doing this under care, with loved ones around them. They're saying goodbye in a way supportive of their own values."

(emphasis mine)


HT to Bioethicsnews.com

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Wednesday, February 28, 2007

Jesus, embryos, research, and IVF protesters


Newsday printed an op ed by Michael D. Kerlin, "Where faith and stem cells meet: Jesus might have us use embryos - otherwise destined to be discarded - to aid the sick and dying." (That's pretty much it, except to testify to his Christianity, his alma mater, and to lay the fate of all sick and dying at the feet of President George Bush.)

As I commented at the site, Jesus taught that "self" belongs in front of "sacrifice."

The other posters and Mr. Kerlin do not seem aware of the facts about the numbers of embryos that would actually be available for research.

And a couple of the posters are horrified that I set the responsibility for ensuring the safety of the embryonic humans on the parents and the labs who created humans in harm's way. They ask whether I would forbid in vitro fertilization (IVF) and tell men and women who are unable to have children by natural intercourse, "tough luck." One poster doubts my sincerity, since there are so few picketers and protesters outside of IVF facilities. He questions whether the protests are only hypocritical abuse and harassment of poor single women, rather than rich couples seeking IVF.

There was a RAND study on the numbers of embryos available for research (Hoffman DI, Zellman GL, Fair CC, Mayer JF, Zeitz, JG, Gibbons WE, and Turner TG. May 2003. "Cryopreserved Embryos in the United States and Their Availability for Research." Fertility and Sterility 79 (5): 1063–1069.)and Art Caplan published one a few years ago, and he was surprised at how few parents would even consider research and how reluctant they and the clinics were to simply destroy the "excess" embryos. In addition, for those currently frozen, it's unlikely that the proper informed consent.

Yes, there are few protesters at IVF clinics, because most people have empathy for the parents who want children so much that they would go through all that IVF requires. Also, most people simply aren't aware of how many embryos are discarded.

However two wrongs don't make a right. Again, "self" should always precede "sacrifice."

It was our empathy that created the current situation, where the brothers and sisters of those babies who are now in the arms of the parents who wanted them so much died during the IVF process and more are frozen and at risk. We must steel ourselves to resist the temptation to help "the sick and dying," everyone from celebrities to tiny children who beg us and our legislators to sacrifice human embryos for their sake.

Who is to decide that some humans may be destroyed and dissected for research or so many spare parts for the benefit of someone else?

Because we know that embryonic stem cell research leads to a slippery slope. We know because some men and women have already fallen down that slope.


I'm sure that most of us have read about the women paid to become pregnant and have abortions for research and profit in the Ukraine and about all the full term healthy babies who mysteriously die in some of that country's hospitals. At one of these hospitals, graves of infants who had had brains and other organs have been found.(More here and here. Warning - graphic descriptions)

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Wednesday, February 21, 2007

More on HPV, mandates, and tax money

All State Medicaid programs must offer the vaccines recommended by the (Federal) Advisory Committee on Immunization Practices, under the Vaccines for Children program. The States don't have to mandate the vaccine, however.

Some of the docs I've talked to are convinced that Medicaid and uninsured patients will have an easier time accessing and affording Gardasil than insured patients - unless the insurance companies are forced to cover it somehow.

I predict that within just 2 or 3 years, the private insurers will see that the girls who receive the vaccine don't have to have nearly as many repeat paps, fewer colposcopies and biopsies. Eventually, in 5 or 6 years, there will be fewer freezing and laser therapy treatments. Somewhere in there, they will begin to cover and strongly encourage the vaccine, without being forced.

It turns out that the transition from infection with the more virulent strains to a precancerous or even carcinoma intraepithelial neoplasm (cancerous cells in the surface layer - the kind that leads to repeat pap smears, colposcopy and biopsies and then freezing or laser ablation or removal of the surface layer of the cervix. The pathology-reported names given to these spots on the cervix include "Low Grade Squamous Intraepithelial Lesions, High Grade SIL, Carcinoma in Situ ) can occur within 2 to 3 years, although most take 10 years or so.

From an article available here, free on line,
The traditional view has been that this process takes years, if not decades, to occur after initial HPV infection. Recent studies suggest that these changes may develop more quickly than previously thought. Winer et al followed women after initial HPV infection for the development of CIN 2/3.

As shown in Figure 3, approximately 27% of women with an initial HPV 16 or 18 infection progressed to CIN 2/3 within 36 months [20]. A second study of a large health maintenance cohort found that approximately 20% of women 30 years of age or older who were initially infected with HPV 16 developed CIN 3 or cervical cancer within 120 months.

Women who had an initial HPV 18 infection had approximately a 15% risk of developing CIN 3 or cervical cancer at 120 months [21].

The strong correlation between infection with high-risk types of HPV and LSIL, HSIL, and cervical cancer suggests that HPV DNA testing would be a useful tool for the management of women with abnormal Pap test results, especially in the case of those with equivocal test results. In the case of an equivocal Pap test result, HPV DNA testing can help determine whether the individual should be referred for colposcopic assessment [22]
.

(Ault, Kevin. "Epidemiology and Natural History of Human Papillomavirus Infections in the Female Genital Tract." Infect Dis Obstet Gynecol. 2006; 2006: 40470. Published online 2006 January 30. doi: 10.1155/IDOG/2006/40470. Copyright © 2006 Kevin A. Ault.)


The biggest financial gain to the Medicaid program and then the insureres - as well as the biggest gain in decreased worry and actual pain and suffering of women - will not be from a decrease in diagnoses of the cancer, itself. It will be from the decrease in the visible warts, as well as precancerous changes from the occult infections that can't be seen with the naked eye and the repeat testing and biopsies, along with the cervical damage from excisions, lasers and freezing which can lead to infertility and premature births.

More information at this summary of another research paper. And this paper reports on 2 year risk of developing CIN.

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Thursday, February 08, 2007

Med Associations Announce Position Statements on HPV Vaccine

Washington State is planning to offer the Human Papilloma Virus vaccine free to girls. New Hampshire has made the vaccine available on an "opt in" basis. Florida's Legislators are considering following Texas Governor Rick Perry in making the vaccine mandatory, with an "opt out" option, similar to the way that Hepatitis B and other mandated vaccines are regulated. (The vaccine would also have been mandatory under the bills that had been introduced in the Texas Legislature before the Governor's Executive Order.)

Two letters (via email) concerning the HPV arrived since yesterday, one from the Christian Medical and Dental Association and the other from the American Academy of Family Physicians. There is also a newspaper article that covers the Statement of the Texas Medical Association. (I'm a member of each.) Another group forwarded the statement from the Catholic Medical Association.

All encourage the voluntary use of the HPV, because of the safety and efficacy of the vaccine and the ethical practice of preventing disease. And all discourage making the vaccine mandatory.

The Catholic Medical Association (CMA) statement is available online, but in "Macromedia FlashPaper" form, which I've never seen before. The statement is well thought out, with excellent ethics and medical basis. The short statement explained by the 5 page document is:
Does the CMA