Reproductive Endocrinology

Olympic Sized Concerns over Zika

May 31, 2016 • By

This month a huge story played out regarding the ethical tensions over the Summer Olympics, Zika, and its risks to women in their reproductive years.

Over 150 experts, including physicians, researchers, and bioethicists sent an open letter to the WHO to urge postponing or moving the Rio games. See:

The letter proposes there are serious conflicts of interest between the WHO and the IOC:

But then there was push-back from the CDC, which argued that there was no scientific basis for cancelling or postponing the games. See:

There was also the official response from the WHO and the IOC, stating that the Games will go on as planned:

But the Director of the CDC expressed shock and moral distress at a different kind postponement: funding for fighting Zika. The U.S. Congress has refused to consider funding at this time. See:

What is really playing out here are organizational ethics games, in which decision-making is affected by multiple conflicts of interest at every segment of this story.

If you’re interested in signing this letter, you can do so at this link:

And by all means, pass the torch by sending the link to this letter on.


Thyroid Cancer

Newsflash: Thyroid Cancer Patients who have Surgery have more Surgical Complications

April 8, 2016 • By

In the spirit of last week’s April Fool’s Day, I’d like to point out a paper recently published in THYROID from a Japanese group by Oda et al that’s been getting a lot of buzz:

This paper’s premise is to track the surgical side effects and complications (including scarring) of thyroid cancer patients with papillary microcarcinoma (PMC) who have surgery and then compare that to the treatment side effects in thyroid cancer patients with PMC offered “observation” instead. Guess what the results were? [Spoiler alert:] Yes, the PMC patients who have surgery have more surgical complications than patients who don’t.

It’s natural to ask whether there was any other point to this paper. For example, did the authors actually evaluate the long-term complications that can occur when a biopsy-proven thyroid cancer that is not surgically removed metastasizes? No. The patients were only followed for a median of 4 years in the context of a disease where recurrence may not be seen for decades. And they were only followed with ultrasound and thyroid function tests, which is not sufficient to conclude whether patients eventually developed distant metastases (radioactive iodine cannot be used as a therapy or diagnostic tool in patients who do not have surgery). Among the patients who did have surgery, many had merely a lobectomy, which also precludes any radioactive iodine follow-up. So in the end, the claims that the “oncological” outcomes were similar in the patients who had surgery and those who did not, cannot be known and cannot be stated. Since all aggressive, poorly differentiated thyroid cancers start out in each person as a “microcarcinoma” you can’t predict which PMCs will spread to distant sites.

See: and

So it’s reasonable to conclude that a number of those unfortunate patients who had not received surgery could develop lung or bone metastasis that are not recognized and don’t receive any treatment or follow-up.

This begs the question as to whether this paper makes any contribution to science. The answer is No.

Studies with questionable heuristic value like this one are certainly in good company. The British Medical Journal, for example, published a study on sword swallowing, which found there were more side effects when the swallower is distracted or swallowing multiple or odd-shaped swords (See: It also published a study stating that people with acute appendicitis may feel pain when traveling over speed bumps (See:

The main problem with the Oda et al paper is that it’s not a joke. Not only did it make it through the peer review process into a good journal, but this paper could become an “Emperor has No Clothes” vehicle for proponents of observation.

So the ethical issue here is one of publication ethics and epistemic integrity. It’s not that a “Duh Study” was published. It’s the fact that it’s being misrepresented as having heuristic value when it’s really Fool’s Gold.


Note: This blog was expanded from an initial Letter to the Editor I submitted to THYROID on 3/29/16 entitled “What Heuristic Value?” co-authored by Kenneth Ain, MD. Professor of Medicine and Director, University of Kentucky Thyroid Oncology Program, and Peter Angelos, MD, Ph.D., Professor of Surgery and Chief, Endocrine Surgery, and Associate Director, MacLean Center for Clinical Medical Ethics. The letter was not accepted for publication.

Reproductive Endocrinology

Why Biology is Destiny in a Republican World

March 31, 2016 • By

On March 30, 2016, Donald Trump stated that he would want to “punish women” for seeking termination of their pregnancies (See: and

Within an hour, his campaign quickly tried to edit those comments and qualify that he wishes to, instead, “punish doctors” for helping women end unwanted pregnancies. Here is the statement:

Unfortunately, Donald Trump is merely articulating what has been the clear agenda of Republican legislators for years: punishing women by creating a climate in which Roe v. Wade (1973) becomes irrelevant, with the advent of TRAP laws: Targeted Regulation of Abortion Providers.

The result has been a return to the “coat hanger” – as access to safe and legal abortion has disappeared in dozens of states. See:

John Oliver recently did a comprehensive piece on TRAP laws, which you can view here:

On March 2, 2016, the Supreme Court began hearing arguments about TRAP laws in Texas in Whole Women’s Health v. Hellerstedt (See: It will soon decide whether Roe v. Wade has any real meaning anymore when it comes to abortion access. Several editorials about the Texas law appeared earlier this month. See, for example:


TRAP laws don’t just impact adult women; they impact any girl old enough to menstruate who can be raped. Do we really want to force preteen children who are raped and/or victims of incest  to become mothers because they can’t afford to travel to another state? These laws place unfair burdens on poor women and their children by punishing them for being poor and vulnerable by their biology. Contraception is typically inaccessible to many poor women, too, while many school districts even have bans on sex education (See:

But the most morally egregious TRAP law was recently passed in Indiana, in which it is now illegal to terminate any pregnancy due to a genetic abnormality. (See: This will now force girls and women without means to care for a potentially profoundly disabled child that requires lifelong, complex medical care. But at the same time, the very legislators who support TRAP laws, also support cutting government benefits for the poor.

Many young women probably don’t remember the iconic image of Geraldine Santoro, whose image was the cover story of a 1973 Ms. Magazine. The picture spoke to millions of women trapped by biology and circumstance. Desperate to end her unwanted pregnancy, Santoro and her boyfriend embarked on a DIY procedure, which ended with her bleeding to death alone in a motel room. (See: Santoro was not identified until the 1990s, when a film was made of her life (See: She died in 1964, and 52 years later, other women living under TRAP laws are at high risk of dying in exactly the same way.

It seems this month was a March to Access.

Reproductive Endocrinology

Mosquitos and Reproductive Ethics

February 29, 2016 • By

It’s a good thing February has an extra day this year. I needed it to ponder the unfolding story of the Zika virus, which earlier this month was declared by WHO to be an international public health emergency. (See: A good review of this crisis was just published in Newsweek today:

When we first heard about this mosquito-borne virus and microcephaly, it was a tragic pediatric ethics story. It echoes in some ways the birth defects eventually linked to the drug, thalidomide. But the thalidomide births (which did not cause brain damage) led to the question of reproductive rights, and whether women had the right to terminate pregnancies they knew were affected, as they felt a moral obligation to prevent a harmed life. One of the most public cases of a woman desiring to terminate a thalidomide-affected fetus was Sherri Finkbine, who traveled to Sweden to have her abortion. See the 1962 story from the BBC here: ( Finkbine was denied the right to an abortion by the Arizona courts before deciding to go to Sweden.

Now, over 50 years later in Brazil, women are facing the same dilemma from an insidious cause that is not a drug, but a bug. In a Catholic country where abortion is not accessible, women without means are having babies with microcephaly, resulting in severe impairment. A multidisciplinary group of Brazilian experts are now petitioning the supreme court to allow abortions for women who have contracted the virus. (See:  In Columbia, where women with the virus have access to abortion, fewer cases of microcephaly have been seen. (See: The Zika virus has also ignited feminist ethics questions with respect to unfair burdens on women solely because of their biological vulnerabilities (See:

Clearly, when poor countries are facing epidemic rates of catastrophic birth outcomes that could be prevented, other distributive justice questions are raised, which has forced even the Catholic Church to reconsider its positions. The Pope has declared that birth control is permissible until Zika is under control. (See:

Talk about a Leap of Faith on this February 29, 2016.


Why Flint Should Make You Sick

January 31, 2016 • By

The most dominant ethics story this month is the unfolding public health and pediatric ethics disaster caused by unethical and incompetent actors in Flint, Michigan.

The saga and health consequences of the decision to switch Flint’s water source to the Flint River is nicely outlined in the Time cover story published January 21, 2016: (See . If you can’t get past the “pay wall” to “The Poisoning of an American City”, here are other good reviews of the crisis:

The consequences of lead poisoning to endocrine development can be explored here, although more research is clearly needed within the pediatric endocrine context:

Flint is an organizational ethics story that became a health disparities story. In this case, shortsighted decisions were motivated by budgets and greed. There was no consideration of potential environmental or health consequences of switching water sources, which is the hallmark of competent decision-making. Such considerations are especially critical when children’s health is at stake, as special protections in public health decision-making need to be in place for our most vulnerable populations.

What makes this a health disparities story is that once the water was switched, the complaints from a poor community were disregarded, as those who became ill from the water were disenfranchised.

This isn’t the first time poor American children have been lead poisoned this century. Researchers were called out in 2001 for exposing poor children to lead in an infamous paint study: (See:

Baltimore has had a particularly shady history of lead exposure in poor communities:

For more on lead poisoning and race, see:—and-everywhere-else

Although the Flint water crisis has been compared by others to Hurricane Katrina, this crisis is more comparable to the terrible decisions made in the early 1980s surrounding the public blood supply. In the early days of AIDS, the blood industry decided it was too expensive to screen potential blood donors, which led to the unnecessary spread of HIV/AIDS into the public blood supply, but particularly into the pediatric population. We are still recovering from those decisions. The Executive Summary of the Institute of Medicine Report, HIV and the Blood Supply can be seen here:

Flint echoes many painful health disparities and global health episodes in which members of a disenfranchised community were not heard.

What may be the most instructive about the Flint saga are the moral heroes of the story. (See: ). Of note is Dr. Mona Hanna-Attisha, who demonstrated moral courage and spoke up on behalf of her vulnerable patients and their families.

Ultimately, this infamous public health disaster we will now always refer to as “Flint” is about sickening business decisions and a failure of accountability.



Editing Ourselves: 2015 and CRISPR

December 31, 2015 • By

The biggest bioethics story of the year was the breakthrough in human genome editing using CRISPR-CAS9. As one bioethicist put it, long-term employment is here to stay for all bioethicists in light of these new, truly slippery slope technologies (See:

While it’s nice to know that bioethicists will have job security, I’m not sure the bioethics community is comfortable about the reason.

Fears of human genome editing were simmering by Spring 2015, after multiple studies published by various research groups around the world surrounding gene editing using the technology CRISPR-CAS9 (See: In response, there was a call for a moratorium on gene editing of human germ lines because there were concerns that the science was ahead of the ethical implications (See: and

But it was too late; a Chinese team of researchers published in April 2015 that they had performed such an experiment on human embryos. (See: ).

And then the debates raged regarding the ethical implications:

The year closed with an historic summit on human gene editing held December 1-3, 2015. This summit was comparable  to the 1975 Asilomar conference, in which the scientific community felt that self-regulation about recombinant DNA technology was necessary (See:

The International Summit on Human Gene Editing held December 2015 led to moral consensus on three key issues:

  1. Refrain from research and applications that use modified human embryos to establish a pregnancy.
  2. Caution in development of clinical applications until we know more about safety and efficacy, and the risks of inaccurate editing.
  3. Moratorium on ‘germline’ editing — the deletion of a gene prenatally in an effort to erase an inherited disease from an embryo and prevent it from being passed on to future generations.

Here is the position paper:

See also this summary of the position paper in Nature:

Other summaries of the Summit are here:

A good perspective on the Summit authored by one of the organizers is here:

Although the Summit concluded with a moratorium on germ line editing, reproductive endocrinologists already use PGD to eliminate genetic diseases, which some argue should be the superior method to deal with genetic disease in which there are some normal embryos (See: I blogged about PGD in July 2015 (see:

Jumping ahead, what are the basic ethical implications of human gene editing? Well, that’s the problem – we just don’t know. Based on the questions raised by PGD, it’s not just about access issues, “super race” or designer babies, but we could be eliminating “defects” from the genome that are, in fact, attributes, or introducing “attributes” that wind up changing the human condition in unfathomable ways.

Some food for thought with your champagne tonight!


Death, Taxes, Turkey, and ISIS: This Year’s Diabetes Awareness Month

November 30, 2015 • By

This has not been a good month for anyone in the world. But there has been some especially bad news about diabetes this month, too.

On Veteran’s Day, the International Diabetes Federation called upon the G20 world leaders — who were about to meet in Turkey Nov 15-16 — to discuss a sugar tax to help reduce, and pay for the global disease burden of both obesity and diabetes.

Diabetes has now emerged as the biggest “killer disease” globally, surpassing HIV, tuberculosis and malaria combined. (See: and

The IDF compared the crisis in diabetes to the global financial crisis of 2008, and pointed out that the global economy is at stake if we cannot get the epidemic under control. Currently 415 million adults globally have diabetes (the largest number of cases are in China), and we spend $673 billion in diabetes care. By 2040, one in every 10 adults in the world are expected to be diabetic, with cases projected to reach 642 million with healthcare spending on diabetes to reach $802 billion.

Then the Paris attacks of 11/13 happened, and no one in Turkey talked about diabetes. And fewer Americans talked about turkey. Instead, the global response to the Paris ISIS attacks dominated all discussions. Once again, the U.S. is faced with debating sending ground troops to fight a war – perhaps even a world war. This time, we’re going to need a lot of troops, and resource allocation is a problem. Our strained, all-volunteer military is exhausted after multiple tours in Iraq and Afghanistan.

Here’s where all this connects.

In the U.S., we don’t have enough fit people to even recruit into the volunteer military because of obesity issues. See:

In fact, my first blog was about this problem. See:

The number of ground troops needed from the U.S. to fight ISIS is estimated to be around 50,000 (see:

If we need that many, we’re going to have to bring back the draft. (In fact, Russia just did that last month).  It may be that bringing back a draft, along with a sugar tax, would also solve the “diabesity” problem. Our young adults would be forced to get fit. Our older adults would consume less sugary foods, and would even help pay for the war.

Is it ethical to have a draft? At times, it is ethically justified to have a military draft; WWII met that criteria. And maybe, in the face of this heinous threat, now would be a good time to bring it back. Making our young adults fit could not only combat the obesity threat at the same time, but may prolong more lives, even when weighing the risks of putting them in harm’s way.

Not quite the usual Turkey talk in November, but that’s how Diabetes Awareness Month went down in 2015.

Breast Cancer

Boo: Scary New Guidelines for Breast Cancer

October 30, 2015 • By

This year, it’s fitting that Breast Cancer Awareness Month is in October, because just in time for Halloween, diagnosis and treatment of early breast cancer just got scary.

New breast screening guidelines are recommending fewer screenings beginning at age 45 instead of 40, as well as eliminating clinical breast exams (See: and ).

Meanwhile, there is a growing trend to recommend “doing nothing” for a diagnosis of DCIS when there is no way to predict which early breast cancers will remain indolent, and which will become invasive. (See and )

These are dramatic shifts that fly in the face of the breast health mantra: “prevention and early detection” as explained to women here:

Right now, the experts in the breast cancer community sharply disagree about screening guidelines and early breast cancer treatment (See:

The Principle of Beneficence in clinical ethics obligates healthcare providers to maximize benefits, while minimizing harms. Early detection and prevention fit these criteria, as there is still a greater balance of benefits than harms in stopping invasive breast cancer before it starts. Meanwhile, leaving biopsy-confirmed breast tumors inside of women, when early treatment is available, could violate the Principle of Non-Maleficence, which, at minimum, obligates healthcare providers not to deny patients a standard treatment when one exists. Those who defend “doing nothing” make the “over treatment” argument, and are concerned about false positives and iatrogenic harms. However, millions of women in countries where early detection and prevention are accessible are alive because of early detection, diagnosis and treatment (See:

Much Ado About Nothing

Merely watching, or observing the natural history of an untreated disease resembles another study that the public eventually found unethical: The Tuskegee Syphilis Study, in which observation (what is generally meant by “active surveillance” or “watch and wait”) of a known disease was presented as a standard of care to poor African-American patients who were not informed that treatment (when it became available) was an option. (See:

The study led to the formation of codified research ethics guidelines in The Belmont Report, which specifically outlined special protections for vulnerable populations in the Principle of Respect for Persons. (See: )

Yep, I went there.

Proponents of observational (“active surveillance”) protocols really hate it when bioethicists yell “Tuskegee” in a crowded clinic. But unfortunately, I need to go there because that’s where this is going when you factor in the widening gap in healthcare disparities, poor access to genetic screening for BRCA1 and 2 mutations (costs range from $500-4000), and the dozens of barriers to informed consent that include low literacy, low numeracy, and non-English speaking patients. Few know about “Tuskegee India” – a U.S. funded cervical cancer study in the late 1990s that repeated Tuskegee’s design flaws. Here, over 250 vulnerable women in unscreened control groups — without proper consent — died from cervical cancer in a study designed to look at whether screening made a difference — when we already knew that it did. See:

If you’re going to change breast cancer screening guidelines, it must be balanced with improved access. Since so many vulnerable populations do not have access to women’s healthcare, it’s ethically problematic to change guidelines to avoid over-diagnosis and over-treatment when so much under-treatment exists. At least 15 million U.S. women have no healthcare access at all (not including undocumented women), while breast cancer continues to affect African American women disproportionately due to both initial access and follow up. See:

The ACS Guidelines even admit: In the United States, barriers to access continue to exist among low-income or uninsured women, those without a usual source of care, or those residing in rural counties.

Telling women to skip their screenings (which include some 5-10% of women in the general population who do not know they are BRCA1 or 2 carriers) is ethically problematic. Telling women with biopsy-confirmed breast tumors that observation is a “reasonable treatment alternative”, when there is not enough evidence to conclude that, is also ethically problematic unless women are told what the risk of doing nothing entails. In our unequal healthcare system, where coverage is not uniform, informed consent my be insufficient, and many are lost to follow-up, these new guidelines are…well… just scary.


Reproductive Endocrinology

Planned Attack on Women’s Reproductive Healthcare

September 30, 2015 • By

Yesterday, Cecile Richards, president of the Planned Parenthood Federation, testified before Congress regarding the now-infamous doctored videos manufactured by anti-choice activists. (See:  and

You can watch the entire testimony here:

Despite the facts, Republican members of the House Oversight and Government Reform Committee continued their line of questioning as if the videos were factual. Their questioning also revealed such alarming ignorance of women’s healthcare, and the organizational structure and funding of Planned Parenthood, that one wonders whether they truly demonstrated an adequate level of decision-making capacity — a basic standard we demand from patients for informed decisions, which requires Understanding, Appreciation and Rationality. Most of the questions asked of Ms. Richards did not meet this standard, including one member asking her if she believed in “selling baby parts”— phrasing that demonstrates stunning levels of medical illiteracy and ignorance of the laws surrounding fetal tissue research (see:

The Chairman of the committee belligerently presented an inaccurate slide from a pro-life organization, claiming it came from Planned Parenthood (see: When Ms. Richards politely noted the source of the slide was from “Americans United for Life,” an anti-choice lobby, and assured the Chairman it was not accurate, he yielded the floor.

Any provider of women’s healthcare should be alarmed that funding for critical reproductive healthcare services are being debated by Congressional representatives who don’t seem to meet the same standards of decision-making capacity we would demand of patients or their surrogates. They do not understand or appreciate the facts of how Planned Parenthood is funded; what fetal tissue research is; or even, at minimum, that the videos in question are not authentic.  Further, they do not demonstrate rationality — an ability to reason with the information provided to them by Planned Parenthood.

The only thing that was clear about this “hearing” was that the Republicans were unable to listen.



Lessons About Death and Dying on 9/11

September 11, 2015 • By

On this 14th Anniversary of 9/11, healthcare providers of all disciplines should remember the lessons about death and dying on 9/11, elucidated in my 2013 paper: “The End-of-Life Experiences of 9/11 Civilians: Death and Dying in the World Trade Center.” (See:

The powerful lesson from those trapped and dying in the World Trade Center 14 years ago this morning was truth-telling. These tragic civilians still had decisions to make, and needed the truth so they could make decisions about where to die and how to die. In the North Tower, civilians who called emergency operators by dialing 9-1-1 were told: “Stay where you are”, which was a high-rise fire script that was completely inappropriate for what was unfolding on impact floors. Trapped civilians — who realized they were at the end of life —  made other decisions: they exercised their right to palliative approaches to an imminent death by breaking windows (when they were told not to) and jumping. Some made the choice to call loved ones and guarantee that their coordinates and circumstances were known. These were short calls, as time was short, with a consistent message: they told a loved one that they were trapped in a fire; they couldn’t get out; and they loved them.  Voicemails later became critical forensic evidence in deaths that were classified as homicides.

In the South Tower, hit second, but first to collapse, civilians had a close-up view to the horrors unfolding in the North Tower, and perceived their lives were threatened in the 16 minutes prior to their own tower being hit. Despite hearing an intercom message that their building “was secure” and to “return to your offices”, many made autonomous choices to self-evacuate and leave the building, saving themselves from being trapped on impact floors. Some made a different choice in those 16 minutes: they made “reassurance calls” to family members with a consistent message that they were in the “other building” (Tower 2), and they were safe.  Some of those calls delayed evacuation, but illustrate that connection and communication was a priority. Those in the South Tower who were trapped also made calls to 9-1-1 operators demanding to know whether firefighters would get to them in time as their environment deteriorated, but they were denied proper end-of-life dialogues. Instead of being asked by a skilled responder: “Is there someone I can call for you?” when callers explained they could no longer breathe, they were asked to spell their names, and even transferred or put on hold. This interfered with critical closure calls many would have made to family members instead of dying on hold with a 9-1-1 operator. Some callers simply called family and died on the phone with their loved ones. Several of these calls are available in the public record: (
and )

The lessons learned about death and dying on this terrible morning on September 11, 2001, are not new: they reinforce what end of life experts have known for over 40 years (See: Kubler-Ross, E., 1969 On Death and Dying. New York: Macmillan). People at the end of life want the truth so they can make choices about how to die and where to die.

In recent years, endocrinologists have found themselves in the position of needing to have end-of-life discussions. Especially those who deal with end-stage renal patients who are not transplant candidates, or patients with devastating diagnoses such as anaplastic thyroid cancer (See If you can’t tell the truth, reach out to a colleague who is expert in end-of-life dialogues so you can allow patients to make critical decisions. Trapped civilians who were in the towers teach us that even in the most imminent and dire circumstances, we can still make a myriad of end-of life decisions so long as we are told the truth.