medical ethics

Journal of Neurotrauma Paper on Withdrawal of Treatment in Severe Traumatic Brain Injury

nancyvalko advance directives, brain injury, disability, futility, Living wills, medical ethics, pro-life, Simon's Law, ventilators/life support

Just before Drs. Jennet and Plum invented the term “persistent vegetative state” in 1972,  I started working with many comatose patients as a young ICU nurse. Despite the skepticism of my colleagues, I talked to these patients as if they were awake because I believed it was worth doing, especially if it is true that hearing is the last sense to go. And why not do it to respect the patient as a person?

Then one day a 17 year old young man I will call “Mike” was admitted to our ICU in a coma and on a ventilator after a horrific car accident. The neurosurgeon who examined him predicted he would be dead by morning or become a “vegetable.” The doctor recommended that he not be resuscitated if his heart stopped.

But “Mike” didn’t die and almost 2 years later returned to our ICU fully recovered and told us that he would only respond to me at first and refused to respond to the doctor because he was angry when heard the doctor call him a “vegetable” when the doctor assumed ‘Mike” was comatose!

After that, every nurse was told to treat all our coma patients as if they were fully awake. We were rewarded when several other coma patients later woke up.

Over the years, I’ve written about several other patients like “Jack”, “Katie” and “Chris” in comas or “persistent vegetative states” who regained full or some consciousness with verbal and physical stimulation. I have also recommended Jane Hoyt’s wonderful 1994 pamphlet “A Gentle Approach-Interacting with a Person who is Semi-Conscious  or Presumed in Coma” to help families and others stimulate consciousness. Personally, I have only seen one person who did not improve from the so-called “vegetative” state during the approximately two years I saw him

Since then, I have written several blogs on unexpected recoveries from severe brain injuries, most recently the 2018 blog “Medical Experts Now Agree that Severely Brain-injured Patients are Often Misdiagnosed and May Recover” and my 2020 blog “Surprising New Test for Predicting Recovery after Coma

However, there is now a new article in the Journal of Neurotrauma titled “Prognostication and Goals of Care Decisions in Severe Traumatic Brain Injury: A Survey of The Seattle International Severe Traumatic Brain Injury Consensus Conference Working Group” about a panel of 42 physicians and surgeons recognized for their expertise of traumatic brain injury that states:

“Overall, panelists felt that it would be beneficial for physicians to improve consensus on what constitutes an acceptable neurological outcome and what chance of achieving that outcome is acceptable. “Over 50% of panelists felt that if it was certain to be enduring, a vegetative state or lower severe disability would justify a withdrawal of care decision.” (Emphasis added)

In addition:

“92.7% of respondents somewhat or strongly agreed that there is a lack of consensus among physicians as to what constitutes a good or bad neurological outcome (Fig. 3A). Similarly, 95.1% of respondents somewhat or strongly agreed that there is a lack of consensus among physicians as to what constitutes an acceptable chance of achieving a good neurological outcome.” (All emphasis added)

RESPONSIBILITY FOR WITHDRAWAL OF CARE DECISIONS

As the article states:

“Although many would report that decision making following devastating TBI is the responsibility of well-informed substitute decision makers familiar with the wishes of a patient,12,25 our survey confirms that the relationship between clinicians and decision makers is complex. As our panelists recognize the marked influence that physicians have on aggressiveness of care, it would seem that in many cases physicians are actually the decision makers and that substitute decision makers are limited by the perceptions (communicated to them. (Emphasis added)

CONCLUSION

Legally, the issue of who makes the decision when treatment or care can be withdrawn as “medically futile” varies.

Often ethics committees are called in to review a situation. Sometimes, as in the Simon Crosier case, families can be unaware that treatment is being withdrawn.

For years, Texas has had a controversial “futile care” law that allows treatment to be withdrawn with the patient or family having only 10 days to find another facility willing to provide care. This was challenged in court and was successful in the Baby Tinslee Lewis’ case . Tinslee eventually went home.

Now a new bill H B3162 has passed in the Texas legislature and is headed to the Governor to be signed and Texas Right to Life states that:

“HB 3162 modifies several aspects of the Texas Advance Directives Act, including the 10-Day Rule. The bill by Representative Klick offers more protections to patients, such as:

  • Requiring the hospital to perform a procedure necessary to facilitate a transfer before the countdown may begin, 
  • Specifying that the process cannot be imposed on competent patients, 
  • Prohibiting decisions from being based on perceived “quality of life” judgments, and 
  • Giving the family more notice of the ethics committee meeting and more days to secure a transfer.”

Every state should consider having such protections for vulnerable patients and their families.

Is Donation after Circulatory Death a “Game Changer” for Heart Transplant?

nancyvalko assisted suicide, brain death, brain injury, culture, disability, end-of-life, euthanasia, futility, law, medical ethics, organ donation, suicide, ventilators/life support

In 2002, I wrote a paper titled “Ethical Implications of Non-Heart-Beating Organ Donation” (NHBD) and presented it at Trinity College at a medical ethics conference. At that time, brain death organ donation was well-known, but NHBD was virtually unknown to the public although it comprised about 2% of organ donations at that time.

As I wrote then:

“It is now apparent that the number of organs from people declared brain dead will never be enough to treat all patients who need new organs. ” and “doctors and ethicists have turned to a new source of organs — patients who are not brain dead but who are on ventilators and considered “hopeless”. In these patients, the ventilator is withdrawn and organs are quickly taken when cardiac death (DCD) rather than brain death is pronounced.”

Now, the term “Donation after Circulatory Death” (DCD) is used instead and means:

“Circulatory death occurs when the heart has irreversibly stopped beating and when circulation and oxygenation to the tissues irreversibly stops.” (Emphasis added)

However, with heart transplantation, the heart will be restarted as explained in a March 24, 2023 Medscape article “A ‘Game Changer’ for Heart Transplant: Donation After Circulatory Death Explained”.

In the article, Adam D. DeVore, MD, MHS is interviewed by Ileana L. Piña, MD, MPH and explains how this works and why he is excited:

“Adam D. DeVore, MD, MHS: In the field of heart transplant, DCD or donation after circulatory death is really a game changer. For decades now, we’ve been doing heart transplants from donors who die or have been declared brain dead.

There’s a whole population of potential donors who have very similar neurologic injuries — they’re just not technically declared brain dead — whose organs the family would like to donate. We didn’t have a way before.”

“There are two mechanisms. The family would withdraw care. Somebody affiliated with the hospital would declare that the donor has died. There’s usually a standoff period. That is a little variable, but it’s around 5 minutes.” (All emphasis added)

and added that then:

“…There are then two ways where that heart could be resuscitated or revived, outside the body on the organ care system. Or it could remain in the body through normothermic regional perfusion (NRP), or they’ll go on cardiopulmonary bypass and re-perfuse the heart in the room, and then look at the heart and try to evaluate it before donation. The rest of that donation looks just like every other brain-dead donation.”

…I remember when we were first starting this, I was thinking of how we would explain this to potential recipients and what would this look like. It turns out that something terrible has happened, and families that want to donate organs are relatively enthusiastic and less focused on the details.” (All emphasis added)

ETHICAL CONCERNS

In another March 23, 2023 Medscape article titled “Does New Heart Transplant Method Challenge Definition of Death?, Sue Hughes, a journalist on Medscape Neurology, writes:

“The difficulty with this approach, however, is that because the heart has been stopped, it has been deprived of oxygen, potentially causing injury. While DCD has been practiced for several years to retrieve organs such as the kidney, liver, lungs, and pancreas, the heart is more difficult as it is more susceptible to oxygen deprivation. And for the heart to be assessed for transplant suitability, it should ideally be beating, so it has to be reperfused and restarted quickly after death has been declared.” (Emphasis added)

When the NRP technique was first used in the US, these ethical questions were raised by several groups, including the American College of Physicians (ACP).

“The difficulty with this approach, however, is that because the heart has been stopped, it has been deprived of oxygen, potentially causing injury. While DCD has been practiced for several years to retrieve organs such as the kidney, liver, lungs, and pancreas, the heart is more difficult as it is more susceptible to oxygen deprivation. And for the heart to be assessed for transplant suitability, it should ideally be beating, so it has to be reperfused and restarted quickly after death has been declared.” (Emphasis added)

Harry Peled, MD, Providence St Jude Medical Center, Fullerton, California, co-author of a recent Viewpoint on the issue said that:

“There are two ethical problems with NRP, he said. The first is whether by restarting the circulation, the NRP process violates the US definition of death, and retrieval of organs would therefore violate the dead donor rule.

“American law states that death is the irreversible cessation of brain function or of circulatory function. But with NRP, the circulation is artificially restored, so the cessation of circulatory function is not irreversible,” Peled points out.

The second ethical problem with NRP is concern about whether, during the process, there would be any circulation to the brain, and if so, would this be enough to restore some brain function? Before NRP is started, the main arch vessel arteries to the head are clamped to prevent flow to the brain, but there are worries that some blood flow may still be possible through small collateral vessels.” (Emphasis added)

Nader Moazami, MD, professor of cardiovascular surgery, NYU Langone Health, New York City, is one of the more vocal proponents of NRP, stating that:

“”Our position is that death has already been declared based on the lack of circulatory function for over 5 minutes and this has been with the full agreement of the family, knowing that the patient has no chance of a meaningful life. No one is thinking of trying to resuscitate the patient. It has already been established that any future efforts to resuscitate are futile. In this case, we are not resuscitating the patient by restarting the circulation. It is just regional perfusion of the organs.” and “We are arguing that the patient has already been declared dead as they have a circulatory death. You cannot die twice.” (Emphasis added)

CONCLUSION

Ms. Hughes also wrote in her article that:

“Heart transplantation after circulatory death has now become a routine part of the transplant program in many countries, including the United States, Spain, Belgium, the Netherlands, and Austria.”

And in the US, “348 DCD heart transplants were performed in 2022, with numbers expected to reach 700 to 800 this year as more centers come online.” And “It is expected that most countries with heart transplant programs will follow suit and the number of donor hearts will increase by up to 30% worldwide because of DCD. ”

So how important is it to have strict medical ethics standards in organ donations?

In a February 9, 2023 Transplant International article titled “Organ Donation After Euthanasia in Patients Suffering From Psychiatric Disorders: 10-Years of Preliminary Experiences in the Netherlands“, it was reported that:

“Over the ten-year study period 2012–2021 59,546 patients underwent euthanasia of whom 58,912 suffered from a somatic (physical) disorder. The number of patients that underwent euthanasia for an underlying psychiatric disorder was 634 (1.1%). An estimated 10% (5955) of patients who undergo euthanasia in general are medically eligible to donate one or more organs (11).” (Emphasis added)

Organ transplants can be wonderful and lifesaving, but we must know all the facts, be able to trust our healthcare providers, and especially not allow the “slippery slope” of legalized assisted suicide/euthanasia to get any steeper.

Potentially Lethal Problems with the Uniform Determination of Death (UDDA) and Its Proposed Revision

nancyvalko brain death, law, medical ethics, organ donation, ventilators/life support

In a December, 2022 Wall Street Journal article “Doctors and Lawyers Debate Meaning of Death as Families Challenge Practices-Changing the determination of brain death potentially affects organ donation”, law and ethics Professor Thaddeus Pope stated that:

“Without brain death, most of the U.S. organ transplant system goes away,” (Emphasis added)

Ironically and on March 16, 2023, the Wilkes Journal-Patriot newspaper in North Carolina published an article “‘Clinically dead’ pastor recovering about Ryan Marlow, a father of three young children who was pronounced *“clinically deceased” and brain dead” after “a severe case of Listeriosis impacted Ryan’s neurological system, causing abscesses on his brain stem and leaving him in a deep coma” in August, 2022. 

“The hospital recorded his time of death but he remained on life support to keep his organs live before removing them since he was an organ donor.” The wife insisted on further testing and that showed he had blood flow to his brain.

According to the news article, “On Oct. 6, 2022, he awoke from a coma by indicating yes to a simple question from a therapist”,  Ryan is now home and making more progress with rehab.

MY JOURNEY TO DISCOVER THE FACTS ABOUT BRAIN DEATH

Back in the early 1970s when I was a young intensive care unit nurse, no one questioned the new innovation of brain death organ transplantation. We trusted the experts.

However, as the doctors diagnosed brain death in our unit and I cared for these patients until their organs were harvested, I started to ask questions. For example, doctors assured us that these patients would die anyway within two weeks even if the ventilator to support breathing was continued, but no studies were cited. I also asked if we were making a brain-injured patient worse by removing the ventilator for several minutes for the apnea test to see if he or she would breathe since we knew that brain cells start to die when breathing stops for more than a few minutes.

I was told not to worry because greater minds than mine had it all figured out.

It was years before I realized that these doctors did not have the answers to my concerns either. After more investigation, I found that my questions were valid.

I also discovered that some mothers declared “brain dead” were able to gestate their babies for weeks or months to a successful delivery and that there were cases of “brain dead” people who lived for months or years.

In my 2021 blog “Rethinking Brain Death and Organ Donation“, I wrote:

“I have been writing for many years about the implications of brain death, the lesser known “donation after cardiac/circulatory death”, diagnosed brain death cases like the supposedly “impossible” prolonged survival and maturation of Jahi McMath, and the unexpected recoveries like Zack Dunlap’s.

Last August, I wrote about the World Brain Death Project and the effort to establish a worldwide consensus on brain death criteria and testing to develop the “minimum clinical standards for determination of brain death”. (Emphasis added)

I also wrote about the current effort “to revise the (US) Uniform Determination of Death Act (UDDA) to assure a consistent nationwide approach to consent for brain death testing” that could otherwise lead to a situation where ”a patient might be legally dead in Nevada, New York, or Virginia (where consent is not required). But that same patient might not be legally dead in California, Kansas, or Montana (where consent is required and might be refused)”. (All emphasis added)”

In 2021, 107 experts in medicine, bioethics, philosophy, and law, are challenging the proposed revisions to the UDDA. While they admit that they “do not necessarily agree with each other on all aspects of the brain-death debate or on fundamental ethical principles”, they do object to three aspects of the revision to:

“(1) specify the Guidelines (the adult and pediatric diagnostic guidelines) as the legally recognized “medical standard,” (2) to exclude hypothalamic function from the category of “brain function,” and (3) to authorize physicians to conduct an apnea test without consent and even over a proxy’s objection.” (All emphasis added)

These experts’ objections to those proposed revisions are that:

” (1) the Guidelines have a non-negligible risk of false-positive error, (2) hypothalamic function (a small but essential part of the brain helps control the pituitary gland and regulates many body functions) is more relevant to the organism as a whole than any brainstem reflex, and (3) the apnea test carries a risk of precipitating BD (brain death) in a non-BD patient….provides no benefit to the patient, does not reliably accomplish its intended purpose”… and “should at the very least require informed consent, as do many procedures that are much more beneficial and less risky.” (All emphasis added)

And these experts further state that:

“People have a right to not have a concept of death that experts vigorously debate imposed upon them against their judgment and conscience; any revision of the UDDA should therefore contain an opt-out clause for those who accept only a circulatory-respiratory criterion.”

AUTOMATED ORGAN DONOR REFERRAL

In the January 2023 United Network for Organ Sharing (UNOS) document “Actions to strengthen the U.S. organ donation and transplant system” has several suggestions such as:

“Seek authorization for the OPTN (Organ Procurement and Transplantation Network) to collect or receive data on ICU deaths for patients under age 70 for faster and more accurate monitoring of organ procurement organization (OPO) performance”

and

“The OPTN will continue to advocate for a national investment in the automation of donor referral” that “would ensure every
potential donor is referred every time. Every hospital with the ability to ventilate patients would need to participate, a requirement that is beyond the authority of UNOS or the OPTN. Automated donor referral would be a significant innovation. Our nation has the technology to automate this important step, but it will not occur without a national commitment.” (All emphasis added)

CONCLUSION

Many years ago, I served on a hospital ethics committee when a doctor complained that he could not arrange an organ transplantation from an elderly woman in a coma caused by a stroke because she “failed” one of the hospital’s mandated tests for brain death. He said he felt like he was “burying two good kidneys”.

Although I already knew that the medical criteria used to determine brain death vary — often widely — from one hospital to another, one young doctor checked our area hospitals and came back elated after he found a hospital that did not include the test the elderly woman “failed”. He suggested that our hospital adopt the other hospital’s criteria to allow more organ donations.

When I pointed out that the public could lose trust in the ethics of organ donations if they knew we would change our rules just to get more organ transplants, I was told that I being hard-hearted to people who desperately needed such organs.

Unfortunately, now some countries’ healthcare ethics have degenerated to the point where euthanasia by organ donation is legally allowed.

Personally, I am all for the ethical donation of organs and tissues. Years ago, I volunteered to donate a kidney to a friend and one of our grandsons was saved in 2013 by an adult stem cell transplant.

But I do not have an organ donor card nor encourage others to sign one because I believe that standard organ donor cards give too little information for truly informed consent. Instead, my family knows that I am willing to donate tissues like corneas, skin and bones that can be ethically donated after natural death and will only agree to that donation.

The bottom line is that what we don’t know-or allowed to know-can indeed hurt us, especially when it comes to organ donation. We need to demand transparency and accurate information for truly informed consent as well as conscience rights because good medical ethics are the foundation of a trustworthy healthcare system.

A New Medically Assisted Suicide Organization Arises

nancyvalko assisted suicide, Canada, end-of-life, hospice, law, medical ethics, nursing, palliative care

In my June, 2016 blog “Tolerating Evil” at , I wrote:

“(A) few days after California’s new assisted suicide law took effect,  one doctor immediately opened up a dedicated assisted suicide clinic in San Francisco.

Dr. Lonnie Shavelson, 64 and a long-time supporter of physician-assisted suicide, was an emergency room doctor for 29 year and then spend 7 years at an Oakland clinic for immigrants and refugees before taking a 2 year break.

His new assisted suicide business could be quite lucrative. Although Medicare will not pay for assisted suicide costs, Shavelson says he will charge $200 for an initial patient evaluation. If the patient is deemed qualified under California law, Shavelson said he would charge another $1800 for more visits, evaluations and legal forms. (Emphasis added)

Shavelson defends his business by claiming that “..the demand (for assisted suicide) is so high, that the only compassionate thing to do would be to bring it above ground and regulate it.”

Now, a new medical group called American Clinicians Academy on Medical Aid in Dying  has been formed with a Board of Directors and Advisors and chaired by the same Dr. Lonnie Shavelson.

The board of this organization includes a Nursing Coordinator, Director of End-of-Life Doula Education, a Volunteer Systems Advisor, as well as Hospice and Palliative Care Advisors including chaplains, nurses and social workers. There is also an “Aid in Dying Ethics Consultation Service”, ethicist, lawyer and pharmacists. An Investigations and Data Collection group is also included as well as State Liaisons in various states.

Also included is Resident Training and Education, Patient Liaisons and Volunteers, Chaplains and End-of-Life  Spiritual Advisors, a legal advisor/ethicist, and a member of the San Francisco/Marin Medical Society with a Master’s in Public Health degree.

The American Clinicians Academy on Medical Aid along with the older Death with Dignity organization just had their second conference February 17-18 in Portland Oregon and provided “13 continuing education units for doctors and nurses” and 10 for social workers.

The conference included presentations like “ Some Myths about Aid in Dying”, “State Differences — Present and Future Legal Considerations”, “Hospices and Aid in Dying — A land of many journeys”, “Prognostic Dilemmas in Aid in Dying”, “Medical Aid in Dying for ALS: Navigating Complexities from Prognosis to Ingestion” and “Clinician Attendance on the Aid-in-Dying day — Doctors, nurses, volunteers, end-of-life doulas, hospice staff” and “Socially-Challenging Settings and Circumstances — homeless and impoverished; family conflicts; skilled nursing and long-term care facilities” and “Medically Challenging Cases: Complex gut function; Self-administration by oral, rectal, PEG and ostomy routes” presented by Dr. Shavelson himself. (All emphasis added)

The first National Clinicians Conference on Medical Aid in Dying occurred in 2020 at UC Berkley in California. It was sponsored   by groups like UC Davis Health,  Mission Hospice and Home Care, the San Francisco Marin Medical Society and the Center for Bioethics and Humanities at the University of Colorado that promotes “Research at the Intersection of Bioethics and Policy for Persons with Disability” (emphasis added) among other groups.

Apparently, Compassion and Choice  now has some competition in the relentless campaign to legalize and normalize medically assisted suicide in every US state.

COMPASSION AND CHOICES

Now, Compassion and Choices has a new “Federal Advocacy and Policy-Bringing the voice of the terminally ill to Capitol Hill“ that:

“advances federal legislation and regulatory change focused on:

  • Strengthening and expanding the full spectrum of end-of-life care such as advance care planning, hospice care, and palliative care, while protecting end-of-life options and patient autonomy from federal efforts to weaken or overturn federal and state laws.
  • Addressing disparities in end-of-life care for historically disadvantaged populations and advancing healthcare equity at life’s end.
  • Expanding professional end-of-life care education, training and development for all healthcare professionals.
  • Preventing healthcare entities from disregarding patient values and preferences by refusing care due to their ethical directives and policy-based restrictions. (All emphasis added)”

Compassion and Choices strongly opposes the “Assisted Suicide Funding Restrictions Act (ASFRA) (seeking repeal)” that:

“Prohibits the use of federal funds to provide or pay for any healthcare item or service or health benefit coverage for the purpose of causing, or assisting to cause, the death of any individual.” as well as “Seeking to permanently vacate the proposed rule, “Protecting Statutory Conscience Rights In Health Care (83 FR 3880),” from the U.S. Department of Health and Human Services, which attempted to allow medical providers expanded exemptions from critical healthcare services beyond what the law currently allows.”

Compassion also supports effort to “Establish Comprehensive Telehealth Reform” and also ominously, the Palliative Care and Hospice Education Act (PCHETA)

CONCLUSION

In 2018, I wrote the blog “Beware the New Palliative Care and Hospice Education and Training Act” (PCHETA)” about Senate Bill 693. 

A similar bill had already passed in the House and this Senate bill was also expected.

As I wrote then:

“As an RN with decades of nursing experience in hospice, oncology (cancer) and critical care, I have been involved with many end-of-life situations. I am an enthusiastic supporter of ethical palliative and hospice care which is indeed wonderful for patients of any age and their families.

Unfortunately, there is a growing trend towards calling unethical practices ‘palliative’ or ‘hospice’ care.”

And we certainly should not be allocating federal dollars for this.

But, despite the enormous push for the PCHETA, it never passed.

There was great opposition by American Association of Physicians and Surgeons, the National Association of Pro-life Nurses  , Sara Buscher, a retired attorney and CPA on the board of the Euthanasia Prevention Coalition – USA. who advocates for the elderly and disabled , the Healthcare Advocacy and Leadership Organization (HALO) and others.

Now, Compassion and Choices is working hard again to get PCHETA passed to “ increase the number of faculty at accredited healthcare programs” and “promote increased education and research in Palliative Care and Hospice care.” (All emphasis added)

If groups promoting medically assisted suicide throughout the US are successful in taking over the ethics education of our health care professionals, eliminating conscience rights for healthcare providers and institutions, continue to dismantle so-called legal safeguards called “obstacles” and allow the same poor oversight and documentation found in Oregon, the first state to legalize assisted suicide, we will see the inevitable and inexorable expansion of medically assisted suicide  that we are now seeing in Canada.

We need to demand the highest ethical standards in healthcare to protect ourselves, our healthcare institutions and the most vulnerable among us who need hope and help-not medically assisted suicide.

 

 

“Safer Than Tylenol” is Deliberate Medical Abortion Disinformation

nancyvalko abortion, culture, medical ethics, Planned Parenthood, pro-life

February 23, 2023, the Attorney General of Connecticut issued a press release “Attorney General Tong Sues FDA Over Unlawful, Unnecessary Restrictions on Medication Abortion Drug”, stating that:

“Attorney General William Tong today joined a multistate federal lawsuit against the U.S. Food & Drug Administration (FDA) accusing it of singling out one of the two drugs used for medication abortions for excessively burdensome regulation, despite ample evidence that the drug is safer than Tylenol.” (Emphasis added)

In April, 2021, the Federal Drug Administration (FDA) lifted a requirement for women to have in-person visits with their doctors before receiving medication abortions. and a February 17, 2022 Bloomberg article titled “The Abortion Pill Is Safer Than Tylenol and Almost Impossible to Get” argued for medication abortion pills by mail.

As Dr. Christina Francis, a board-certified OB/GYN and chair of the board of the American Association of Pro-life Obstetricians and Gynecologists (AAPLOG), wrote in a 5/21/2021 article titled “The government’s abortion pill policy puts mothers’ lives at risk-As an OB-GYN, I know that allowing women to access abortion drugs through telemedicine is the wrong move“, stating:

“The medication regime for these abortions has real risks. When Mifepristone,
the first-stage medication in a chemical abortion, was first approved in 2000, it was
only approved with safety regulations in place (later known as REMS) that would
minimize the significant risk of hemorrhage, retained fetal tissue and infection.
These REMS were then relaxed in 2016 by the FDA absent any further safety testing
and despite mounting evidence of significant adverse events and maternal deaths….

For unknown reasons, however, the FDA also made the decision in 2016 to stop
collecting data on nonfatal adverse events related to Mifepristone, instead only
collecting data on maternal fatalities related to the drug. This change ignores the
women who may show up to their local emergency rooms with severe complications
potentially caused by the drug — women whose lives are typically saved not by their
abortionist, but by an on-call physician at the hospital. (Emphasis added)”

And:

One of the most significant reasons why an in-person visit has been required is for
proper medical oversight as well as a physical exam and ultrasound. These visits are
meant to accurately assess the gestational age of a woman’s pregnancy, as well as rule
out ectopic pregnancy, which is life threatening. The difference in size of an 8-weekold and 12-week-old preborn child is significant”

Mifepristone abortions are only approved for use up to 10 weeks gestation because the complication rates increase significantly beyond this stage.

IS THIS JUST PRO-LIFE PROPAGANDA?

The Cleveland Clinic, a respected healthcare institution and NOT pro-life, has a section:

“Who should NOT get a medical abortion?

Medical abortion is not a safe option for those who:

  • Are too far along in the pregnancy.
  • Have a pregnancy outside of the uterus (ectopic pregnancy).
  • Have a blood clotting disorder or significant anemia.
  • Have chronic adrenal failure.
  • Use long-term corticosteroids.
  • Have an intrauterine device (IUD).
  • Have an allergy to the medications used.
  • Do not have access to emergency care.
  • Can’t return for a follow-up visit.

It is important to discuss your medical history with your healthcare provider before a medical abortion procedure.” (Emphasis added)

So, how can abortion pills by mail be safe?

It is also disturbing that now CVS and Walgreens Plan to Offer Abortion Pills Where Abortion Is Legal”. The two chains said they would begin the certification process under a new FDA regulation that will allow retail pharmacies to dispense the prescription pills for the first time.

It is also disturbing that now the two chains said they would begin the certification process under a new FDA regulation that will allow retail pharmacies to dispense the prescription pills for the fist time.

Even worse, the American Pharmacists Association said in a statement that it had urged the FDA “to level the playing field by permitting any pharmacy that chooses to dispense this product to becomes certified.” (Emphasis added)

So, how can abortion pills by mail be safe?
It is also disturbing that now “ The two chains said they would begin the certification process under a new F.D.A. regulation that will allow retail pharmacies to dispense the prescription pills for the first time.
Also disturbing is that “The American Pharmacists Association said in a that it had urged the F.D.A. “to level the playing field by permitting any pharmacy that chooses to dispense this product to become certified.” (Emphasis added)

Also disturbing is that “The American Pharmacists Association said in a  that it had urged the F.D.A. “to level the playing field by permitting any pharmacy that chooses to dispense this product to become certified.” (Emphasis added)

CONCLUSION

Not surprisingly, unmentioned in these articles is informing the woman about the abortion reversal option that I wrote about in my 3/20/2018 blog titled “What You Need to Know About Medical Abortion and Abortion Reversal”

However, the pro-abortion ACOG (the American College of Obstetricians and Gynecologists) condemns abortion reversal, claiming that “Facts Are Important: Medication Abortion “Reversal” Is Not Supported by Science”, stating that “”So-called abortion “reversal” procedures are unproven and unethical“. They maintain this despite citing a “A 2012 case series reported on six women who took mifepristone and were then administered varying progesterone doses. Four continued their pregnancies. This is not scientific evidence that progesterone resulted in the continuation of those pregnancies.” And the article admits that “A 2020 study intending to evaluate medication abortion reversal in a controlled, IRB-approved setting was ended early due to safety concerns among the participants.” (Emphasis added).

As I wrote in my May, 2019 blog “New Study on Progesterone to Prevent Miscarriage Supports Use in Abortion Reversal“:

“(M)edical abortions can often be reversed by taking progesterone if the mother changes her mind after the first abortion pill to block progesterone is given but she hasn’t yet taken the second pill to expel the baby. There is now a website at www.abortionpillreversal.com for information on abortion reversal that includes a hotline phone number at 1-877-558-0333.

But according to Planned Parenthood :

 “…(only) a handful of states require doctors and nurses to tell their patients about (abortion reversal treatment) before they can provide abortion care. But these claims haven’t been proven in reliable medical studies — nor have they been tested for safety, effectiveness, or the likelihood of side effects — so experts like the American College of Obstetricians and Gynecologists reject these untested supposed treatments.” (Emphasis added)

Why don’t we all deserve to know all the facts and all the options like crisis pregnancy centers and abortion reversal when it comes to abortion instead of relying on a mostly biased media, Planned Parenthood and wealthy, pro-abortion healthcare provider organizations?

As a society, we can’t afford not to know!

“Repairing Our View of Dementia”

nancyvalko Alzheimer's, Compassion & Choices, culture, dementia, medical ethics

I have written often on the subject of dementia, most recently in my blog “Alzheimer’s Association Ends Agreement with Compassion and Choices” about the lethal discrimination against people with dementias like Alzheimer’s.

Having cared for a mother with Alzheimer’s as well as many patients and relatives of friends with dementia, I have found great satisfaction working with people with dementia. Helping them enjoy activities like music, tv, talking about past and present memories and laughing has been a real joy for me. Dementia does not automatically rule out a sense of humor or insight.

So I was delighted to find an article “Repairing Our View of Dementia“ in the Journal of the American Medical Association Neurology.

The author, Sujal Manohar, BS, BA, wrote:

“It is a rewarding experience each time I lead a virtual art gallery tour for adults with dementia. Though we are over 1000 miles apart physically and multiple decades apart in age, we connect over artwork through the Reflections Program at the Nasher Museum of Art at Duke University. However, I did not expect that one comment from a participant—sparked by an art piece—would lead me to reconsider societal expectations and our care of adults with dementia.” (Emphasis added)

“As I shared images of the Radical Repair Workshop, 1 participant was intrigued by the idea of broken objects. He asked the group what we do with things when they are broken. Reflecting on his own experience, he questioned what we could do with him now that he was broken. He paused for a moment, then wondered aloud whether he had any use. He was well aware of his cognitive changes, insidious yet undeniable; the participant knew he was not functioning the way he once did.” (Emphasis added)

Mr. Manohar responded:

“I explained that these artworks showed us that all objects are valuable, even if they do not serve their original purposes. They can come together to make something beautiful. I emphasized that objects can be used in various ways and everyone has challenges and differences—that does not mean they aren’t valuable.” (Emphasis added)

Mr. Manohar also encourages using not only the perspectives of caregivers and healthcare professionals but also the person experiencing dementia, his or her social history and finding ways to give the person purpose that accentuate their strengths rather than focusing on their challenges..

He also makes a good point that helping people with dementia find meaning in in their lives many also help their caregivers who often experience can experience depression and difficulty managing their own feelings while providing support.

Mr. Manohar’s insights and positive attitude can hopefully help our society reevaluate the worth and value of people with dementia and improving their lives as well as those who care for them..

Our society itself desperately needs this.

Alzheimer’s Association Ends Agreement with Compassion and Choices

nancyvalko advance directives, Alzheimer's, assisted suicide, dementia, end-of-life, law, Living wills, medical ethics, nursing, palliative care, terminal/palliative sedation, VSED

I was surprised to recently learn that the Alzheimer’s Association had entered into an agreement with Compassion and Choices to “provide information and resources about Alzheimer’s disease”.

Thankfully, the Alzheimer’s Association has now terminated that relationship as of January 29, 2023, stating that:

“In an effort to provide information and resources about Alzheimer’s disease, the Alzheimer’s Association entered into an agreement to provide education and awareness information to Compassion & Choices, but failed to do appropriate due diligence. Their values are inconsistent with those of the Association.

We deeply regret our mistake, have begun the termination of the relationship, and apologize to all of the families we support who were hurt or disappointed. Additionally, we are reviewing our process for all agreements including those that are focused on the sharing of educational information.

As a patient advocacy group and evidence-based organization, the Alzheimer’s Association stands behind people living with Alzheimer’s, their care partners and their health care providers as they navigate treatment and care choices throughout the continuum of the disease. Research supports a palliative care approach as the highest quality of end-of-life care for individuals with advanced dementia.” (All emphasis added)

ALZHEIMER’S DISEASE AND COMPASSION AND CHOICES’ RESPONSE

While countries like Belgium and the Netherlands have legalized assisted suicide for Alzheimer’s, no US state allows this-yet.

In the meantime, Compassion and Choices is the well-funded organization promoting medically assisted suicide laws and VSED (voluntary stopping of eating and drinking) for people in states without assisted suicide laws.

Now, Compassion and Choices has a whole section  on their website titled  “Dementia End-of-Life Care- Identifying your preferences before dementia takes hold” stating that:

“One in two older adults die with Alzheimer’s or another form of dementia” and that ”60% of Americans with dementia receive non beneficial burdensome medical interventions.”

Thus, Compassion and Choices insists that:

“Every mentally capable adult has the right to document their desire to decline medical treatments. In the early stages of dementia, patients may also choose to voluntarily stop eating and drinking. To learn more, go to the Compassion & Choices‘ Dementia Values & Priorities Tool and other resources.” (Emphasis added)

IS VSED REALLY AN EASY WAY TO DIE?

As I wrote in my 2018 blog “Good News/Bad News about Alzheimer’s”:

“Although media articles portray VSED as a gentle, peaceful death, a 2018 Palliative Practice Pointers article in the Journal of the American Geriatric Society  titled “Voluntary Stopping Eating and Drinking” states:

“VSED is an intense process fraught with new sources of somatic and emotional suffering for individuals and their caregivers…The most common symptoms encountered after starting VSED are extreme thirst, hunger, dysuria (painful urination due to concentrated urine NV), progressive disability, delirium, and somnolence.” (Emphasis added)

Most chillingly, the authors state:

 “Because an individual with delirium may forget his or her intention and ask for drinks of water, caregivers will struggle with the need to remind the incapacitated individual of his or her own wishes. This possibility should be anticipated and discussed with the individual in advance. While reminding the individual of his or her prior intentions may feel like coercion, acquiescing to requests for water will prolong the dying process for someone who has clearly articulated the desire to hasten death.” (Emphasis added)

The authors also state that if the patient’s suffering becomes severe, “proportionate palliative sedation and admission to inpatient hospice should be considered”. This is not the so-called peaceful death at home within two weeks that people envision with VSED.

Lastly, on the legal requirement of a cause on the death certificate, the authors state:

“the clinician may consider including dehydration secondary to the principle illness that caused the individual’s intractable suffering. Although VSED is a self–willed death (as stopping life support might also be), use of the word “suicide” on death certificates in this context is discouraged because in incorrectly suggests that the decision for VSED stemmed from mental illness rather than intolerable suffering.” (Emphasis added)

So, like physician assisted suicide, the real cause of death is basically falsified with the rationale that the deliberate stopping of eating and drinking to hasten death is just another legal withdrawal of treatment decision like a feeding tube.

And as I wrote in my 2020 blog “Caring for an Elderly Relative who Wants to Die”, a doctor trying to help his grandfather who did not have a terminal illness but rather was “dying of old age, frailty, and more than anything else, isolation and meaninglessness” found that just voluntarily stopping food and water (VSED) was too difficult and he had to use “morphine and lorazepam” during the “12 long days for his grandfather to finally die.”.

The lessons this doctor said he learned were that:

“despite many problems with physician-assisted dying (physician-assisted suicide), it may provide the most holistic relief possible for people who are not immediately dying, but rather are done living.”

And

“stopping eating and drinking is largely impossible without knowledgeable family members and dedicated hospice care.” (All emphasis added)

CONCLUSION

Years ago, my mother told me that she never wanted to be a burden on her family.

I never told my children that-especially when they were teenagers and already thought I was a burden to their lifestyles!

Instead, I told them that the “circle of life” includes caring for each other at all ages and stages. Such caring also eliminates future guilt and leaves a sense of pride that we did the best we could for each other during our lives.

When my mother developed Alzheimer’s in the late 1980s (and later terminal thyroid cancer), a friend asked if I was going to feed her. At the time, my mother was fully mobile and able to get ice cream out of the freezer and eat it. I was shocked and offended.

“Do you want me to tackle her?!” I asked my friend.

“Oh, no!”, he answered, “I was talking about a feeding tube later on.”

I told him that my mother would die of her disease, not from deliberate starvation and dehydration.

Near the end of her life, we did spoon feed my mother and she enjoyed it very much before dying peacefully in her sleep.

For decades now, I have enjoyed caring for many people with Alzheimer’s or other dementias both personally and professionally but I remain alarmed by the all too common attitude that people with Alzheimer’s “need to die” either by VSED or physician-assisted suicide.

I am pleased with the Alzheimer’s Association’s decision to end its agreement with Compassion and Choices.

Canada and the Euthanasia Endgame

nancyvalko assisted suicide, disability, education, end-of-life, euthanasia, law, Living wills, medical ethics, pro-life

Several nations like Belgium and the Netherlands have had legalized assisted suicide and/or euthanasia, even for minors and for people just “tired of life” But now the worst is Canada which legally approved MAiD (medical aid in dying) it in 2016, according to Alex Schadenberg of the Euthanasia Prevention Coalition

Alex Schadenberg quotes Kevin Yuill, a professor who spoke at the Euthanasia Symposium in Brussel in November who said:

“Canada has the dubious honour of being the global capital of euthanasia. Through its medical assistance in dying (MAID) programme, Canada killed more people with lethal injections last year than any other country on Earth – many of them poor, homeless or hopeless. And soon, from March 2023, lethal injections will be offered to anyone who judges their mental-health difficulties to be intolerable.”

Even worse, some people with disabilities are saying that they are being pressured to take a lethal overdose.

In a November 2022 UK article titled “Canadian man alleges hospital is pressuring him to end his life by assisted suicide”, a man with a disease affecting his brain and muscles is suing his Canadian hospital after secretly recording the hospital staff, stating:

“They asked if I want an assisted death. I don’t. I was told that I would be charged $1,800 per day [for hospital care]. I have $2 million worth of bills. Nurses here told me that I should end my life. That shocked me”.

Mr. Foley has applied for “direct funding” from the Canadian government to “employ agency workers of his own choosing and manage his schedule”.

  

The article also cited “a pro-assisted suicide and euthanasia group of doctors in Canada have recently said that doctors have a “professional obligation” to initiate discussion of assisted suicide and euthanasia with patients who might fit the legal criteria. They claim there is nothing in Canadian law which forbids this.”

CANADIAN STATISTICS

The UK article also notes that:

“In 2021, 10,064 people ended their lives by assisted suicide and euthanasia, an increase of over 32% from the previous year, accounting for 3.3% of all deaths in Canada.

According to the latest report on Medical Assistance in Dying from Health Canada, 17.3% of people also cited “isolation or loneliness” as a reason for wanting to die. In 35.7% of cases, patients believed that they were a “burden on family, friends or caregivers”. (Emphasis added)

Canada was set to approve MAiD for people with mental illness but recently, the Canadian government announced its plan to temporarily delay MAiD eligibility  for people whose sole medical condition is mental illness.

CONCLUSION

In 1993, just 3 years after Nancy Cruzan, a woman in a so-called “vegetative state” died a long 12 days after her feeding tube was removed in my home state of Missouri, a letter in the Journal of the American Medical Association by Dr. Ezekiel Emanuel, a prominent ethicist and one of the future architects of Obamacare, acknowledged that the actual proof purported to show that the Cruzan case met Missouri law requiring “clear and convincing evidence” that Ms. Cruzan would not want to live in a so-called “vegetative” state rested only on “fairly vague and insubstantial comments to other people”.

Ominously, he also noted that:

“..increasingly it will be our collective determination as to what lives are worth living that will decide how incompetent patients are treated. We need to begin to articulate and justify these collective determinations.” (Emphasis added.)

“(O)ur collective determination as to what lives are worth living” is the very real and frightening potential endgame of legalized euthanasia and it should be stopped now!

How Accurate Is Prenatal Testing?

nancyvalko abortion, disability, hospice, law, medical, medical ethics, palliative care, terminal/palliative sedation

I have written about the alleged accuracy of prenatal blood testing before as both a nurse and a mother in my blog “A Dark Side of Prenatal Testing” and “Two Wonderful Stories: A Prenatal Misdiagnosis; Man Saves Grandchild from Abortion”.

Now, ProPublica, a self-described nonprofit investigative newsroom, just published an article titled “They Trusted Their Prenatal Test. They Didn’t Know the Industry Is an Unregulated “Wild West.”

The authors tell the story of a mother who had an in vitro diagnostic test (IDT) that came back negative, meaning her baby did not have the serious conditions that were tested for.

However, when the mom delivered her daughter, the baby had serious problems and only lived 28 hours.

The autopsy showed that the baby had an extra 13th chromosome, a condition that was part of the testing. The chances that the baby would have not have this or two other serious conditions was “greater than 99%.”

The test was a simple blood draw designed to check for an array of genetic anomalies but the mother, a science researcher, read academic articles showing a higher risk of inaccurate results than she realized.

The mom found other women reporting problems with the tests also so she tried contacting the company that made the test, hoping she would help other families.

She was unsuccessful.

She found out that if she had taken other common commercial tests like some for Covid-19 or pregnancy, the company would have had to inform the US Food and Drug Administration about “reports of so-called adverse events.”

The mom found out that the test she took fell into a regulatory void:

“No federal agency checks to make sure these prenatal screenings work the way they claim before they’re sold to health care providers. The FDA doesn’t ensure that marketing claims are backed up by evidence before screenings reach patients. And companies aren’t required to publicly report instances of when the tests get it wrong — sometimes catastrophically.

The broader lab testing industry and its lobbyists have successfully fought for years to keep it this way, cowing regulators into staying on the sidelines.”

The stakes are high for families with the article stating:

 “Upwards of half of all pregnant people (sic) now receive one of these prenatal screenings.”

And that the companies stress that “ultimately, it’s the responsibility of health care providers, who order the tests, to inform patients about the limits of screenings.”

CONCLUSION

When I had my last child in 1985, I was offered but refused amniocentesis. In my case, it was offered because I had previously had Karen, my daughter with Down Syndrome.

Some people asked if I was brave or stupid. I told them that I was just well-informed after researching both amniocentesis and CVS.

I knew that both procedures carry a risk of miscarriage and that I would never abort a child because of a disability. I also knew that such procedures can only test for some of the thousands of known “birth defects” and I personally met families who were erroneously told that their child had a defect but were born healthy.

After that, I was remarkably worry-free during my last pregnancy and delivered a healthy girl.

But maternity care has changed a lot since 1985, especially since the American College of Obstetricians and Gynecologists (ACOG) now states that Abortion is Healthcare Abortion is Healthcare | ACOG

But despite the possible inaccuracies of prenatal test, there is help if a baby is diagnosed with an unexpected condition like Down Syndrome or Trisomy 13.

Thankfully, there are even programs like Perinatal Hospice & Palliative Care: Continuing Your Pregnancy that can help in the event of a prenatal diagnosis that indicates a baby may die before or after birth.

Where there is love, there is always hope!

Are Near-Death Experiences Real?

nancyvalko brain death, CPR, end-of-life, family, medical ethics, organ donation

In a November 4, 2022 Medscape article titled “‘Lucid Dying’: EEG Backs Near-Death Experience During CPR”, researchers found brain wave recordings taken during in hospital cardiac arrest resuscitation (cardiopulmonary resuscitation) lends support to near-death experiences reported by some people who survived cardiac arrest.

In the Medscape article and according to lead investigator Sam Parnia, MD, PhD:

“These recalled experiences and brain wave changes may be the first signs of the so-called ‘near-death’ experience, and we have captured them for the first time in a large study,” lead investigator Sam Parnia, MD, PhD, with NYU Langone Health, says in a news release.

Identifying measurable electrical signs of lucid and heightened brain activity during CPR, coupled with stories of recalled near-death experiences, suggests that the human sense of self and consciousness, much like other biological body functions, may not stop completely around the time of death, Parnia adds.” (Emphasis added)”

According to the article, the researchers used “audiovisual testing of awareness with continuous real-time EEG and cerebral oxygenation monitoring” during the resuscitation.

While only 53 of the 567 patients survived (9.3%), 28 survivors completed interviews with 11 reporting “unique, lucid experiences during resuscitation.”

According to Dr. Parnia:

“Our understanding of death has gone through a seismic shift in the last few years,” and

“The biological discoveries around death and the postmortem period are completely different to the social conventions that we have about death. That is, we perceive of death as being the end, but actually what we’re finding is that brain cells don’t die immediately. They die very slowly over many hours of time,” Parnia noted. (Emphasis added)

Dr. Parnia presented the findings November 6 at a resuscitation science symposium at the American Heart Association (AHA) Scientific Sessions 2022 in Chicago.

The Medscape article also noted that not everyone agrees:

“Ajmal Zemmar, MD, PhD, with University of Louisville, Louisville, Kentucky, noted that several studies, including this one, “challenge the traditional way that we think of death — that when the heart stops beating that’s when we die.”

The observation that during cardiac arrest and CPR, the brain waves are still normal for up to an hour is “fairly remarkable,” Zemmar told theheart.org | Medscape Cardiology.

“However, whether there is conscious perception or not is very hard to answer,” Zemmar cautioned. 

“This type of research tries to bridge the objective EEG recordings with the subjective description you get from the patient, but it’s hard to know when conscious perception stops,” he said.”

WHAT DOES THIS ALL MEAN?

Over the decades, there have been many studies of near-death experiences and an October 31,2022 Medscape article by a nurse practitioner who describes how both negative and positive near-death experiences can impact an individual.

There is even a 2020 Frontiers in Neurology article “The Neurology of Death and the Dying Brain: A Pictorial Essay” that explores some of the potential effects of issues like near-death experiences on the clinical determinations of death and organ donation.

But whether or not you believe in near-death experiences, there is one crucial lesson here: We must always treat any ill person-awake or presumed unconscious-with the respect due any person when we talk to and care for them.

I have often told the story of “Mike”, a young man catastrophically injured in a car crash whose doctor said the if he survived, he would be a “vegetable”. We nurses talked to Mike and eventually he started to respond to us but not the doctor.

Mike was shipped off to a nursing home but almost two year later, he returned to thank us and told us he was getting married. When we laughed and told him how he started to respond to us but not the doctor, Mike became very serious and said he would not respond to the doctor because he heard the doctor call him a “vegetable”!

CONCLUSION

But my favorite story is about working on a medical floor caring for an elderly gentleman who was dying and showed no awareness of his 4 adult sons sitting at his bedside.

I encouraged his sons to talk to him, but they said they didn’t know what to say and didn’t think he could hear anyway.

I took the man’s hand and noticed that it was strong and callused like a man who worked with his hands.

I asked the sons was their dad did and they all started relating stories about his love of farming and then told funny stories about how their dad reacted to their antics growing up.

Pretty soon, all the sons were laughing and telling their dad how much they appreciated him as I quietly left at the end of my shift.

When I returned the next day for my next shift, I was not surprised to learn that the dad had peacefully died during the night with his sons at his side. But I was surprised to find that one of the sons stayed until I came back and wanted to talk to me.

“Lady, you were right! He did hear us!” he told me.

It turned out that the sons had continued talking to their dad after I left and when they said they were ready to leave, their dad opened his eyes, looked at them, smiled and then closed his eyes and peacefully died.

What a wonderful memory for his sons-and me!