Browsing Articles Written by

Dr. M Sara Rosenthal

Reproductive Endocrinology

Weiner Issues: Revelations from a Male Birth Control Study

October 31, 2016 • By

A groundbreaking study was published in JCEM last week stating that the elusive hormonal contraceptive for males has, at last, been achieved. You can read the full study here:

In an Endocrine Society press release, one paragraph launched several acerbic articles by journalists who cover women’s issues:

“Researchers stopped enrolling new participants in the study in 2011 due to the rate of adverse events, particularly depression and other mood disorders, reported by the participants. The men reported side effects including injection site pain, muscle pain, increased libido and acne. Twenty men dropped out of the study due to side effects.”

Cosmopolitan essentially called the study drop-outs “weenies”:

See also: and:

From a research ethics perspective, halting a trial early due to unacceptable side-effects is an ethically accepted, and expected practice, which is spelled out in The Belmont Report (See:

But there is also the issue of distributive justice, whereby the burdens and benefits of research ought to be evenly distributed. In other words, justice demands that women should not solely bear the burdens of risk surrounding hormonal contraception. It is “karmic” that women have little sympathy for the male “drop-outs” in the study. As one Op/Ed points out: “When some women resisted taking The Pill [when it was first introduced in 1960], citing health risks and side effects, Playboy dismissed the women as neurotic prudes who refused to ‘take responsibility’ for contraception.”


Unfortunately, since it is women who bear the consequences of no contraception, they have greater motivation for risk, leading to a “biology is destiny” ethics problem. The term “birth control” – a term that highlights autonomy over reproduction, was originally coined by Margaret Sanger, who died 50 years ago this year ( Sanger made the statement: “No woman can call herself free until she can choose consciously whether she will or will not be a mother.”

Thus, there are gender differences that motivate reproductive autonomy, as males are not biologically burdened with the consequences unless they choose to be. Male hormonal contraception could also be an appealing option for parents/guardians raising developmentally delayed males, or those who may be on the autism spectrum who are not competent to understand the consequences of their behaviors.

And finally, as my blog title suggests, this election has forced us to confront male predatory behavior, ranging from the Anthony Weiner case (which now threatens to upend the election) to Trump himself, whose leaked video confirmed his predatory behaviors. Convicted male predators in some countries are sentenced to chemical castration, which involves Lupron and estrogen, and which has been considered unethical by Amnesty International ( With a relatively safe method of at least protection from unwanted pregnancy, could male hormonal contraception become an ethically acceptable regimen for males with established sexually predatory behaviors, presuming they are medical candidates?


Thyroid Cancer

Thyroid Cancer Treatment Turns Into A Game Of Russian Roulette

August 31, 2016 • By

There is a perfect “thyroid storm” brewing within the thyroid cancer community that will certainly result in preventable deaths. The storm has to do with dangerous misconceptions of appropriate management for so-called “low risk” thyroid cancer.

The problem involves confusing two separate issues: biopsy of nodules under 1 cm and treating biopsy-confirmed thyroid cancers over 1 cm.

A recent piece in the New England Journal of Medicine, has been misconstrued by the national press to mean  that for most cases of thyroid cancer, treatment is not necessary. Here’s the original piece:

There is nothing new reported in this epidemiology paper. It confirms the problem of mass screening of thyroid nodules, and confirms that, yes, many biopsy-confirmed thyroid cancers will likely remain indolent.

Misconceptions arise in how this translates from epidemiology to the bedside.

Here’s where everyone agrees: don’t biopsy thyroid nodules under 1 cm. Leave them alone unless there is some other alarming feature, such as invasion beyond the thyroid capsule or obviously enlarged local lymph nodes.

Here’s where it turns into a game of Russian Roulette with the practitioner holding the gun to the patient’s head: tell the patient you will “place bets” that a small biopsy-confirmed thyroid cancer will remain indolent – something no one can currently predict. Odds are it will. But some of the patients will be the unlucky losers of the Roulette game. In fact, all aggressive thyroid cancers, and all eventual lethal thyroid cancers, started as small tumors.

What do the most recent American Thyroid Association (ATA) clinical practice guidelines say? (See:

Well, the guidelines do not recommend observation-only for biopsy-confirmed thyroid cancer and state that there is “not enough evidence” observation is more beneficial than treatment. But the authors do state that IRB-approved randomized controlled-trials regarding observation for papillary carcinomas under 1 cm, also known as papillary microcarcinomas, would help to generate data on this question. Clearly, there is a big difference between enrolling such patients in a clinical trial to investigate the validity of this approach, and having clinicians routinely do this in their clinical practice outside of a research setting and without any research subject protections in place.

What do guidelines say about radioactive iodine (RAI)? Nuclear medicine experts worldwide recommend RAI as beneficial in follow-up and treatment (See: Of note, the ATA’s recent guidelines were not endorsed by the nuclear medicine community in either the United States or Europe. (See, for example:

As a result, the best consensus guidelines to follow regarding radioactive iodine therapy would be the 2009 ATA guidelines, which were endorsed by the entire nuclear medicine community.

What do bioethicists think? Bioethicists who appreciate the nuances of thyroid cancer treatment believe patients must be told about the full treatment options available, including potential benefits of radioactive iodine, as well as the risks associated with observation. Routine observation should not be done outside of the research setting. We say so here:

What will patients say should they become aware that they were not fully informed of their risks and treatment options? Some will say they were unwitting players in a game of Russian Roulette, which can have serious medico-legal consequences for practitioners who are playing this game.


The Power of Postmenopause

July 30, 2016 • By

On July 29, 2016, at age 68, Hillary Clinton accepted the democratic nomination for President of the United States. Yes, she is a woman of a certain age. The benefits of her being a woman in politics post-menopause became the subject of a Time article by Dr. Julie Holland last year that spiraled out of control:

The point of the article was to provide some medical facts about postmenopausal women in the face of harmful perceptions that women are somehow hormonally incapacitated past menopause. One of the points made was to emphasize that women are now living one-third of their lives post-menopause to an average age of 81, which means that even if elected President in November, Hillary easily has four more years with good preventative healthcare (notwithstanding my concerns about her thyroid medication earlier this year:

Whether endocrinologists agree with the facts in the Time article is another story, but in 2015, the first set of evidence-based guidelines authored by women were published by the Endocrine Society on the treatment of menopause. See: and

The theme of the practice guidelines is to offer individualized therapies to peri- and postmenopausal women, as it is clear that one size does not fit all, and there are a myriad of biological variations of menopausal symptoms and age-related risks.

Several of Hillary’s critics argued that Holland unfairly championed the nominee’s age when, previously, male nominee’s ages had been questioned. Ronald Regan famously said at age 73 at a 1984 debate: “I will not make age an issue of this campaign. I am not going to exploit, for political purposes, my opponent’s youth and inexperience.”

But there has never been a female nominee for the U.S. Presidency before, which makes the issue of Hillary’s postmenopausal achievement personal for many women. The feminist adage, “the personal is political” has perhaps never been so pronounced as it is in this election. Given that her opponent, Donald Trump (70) has made menstrual periods a reason to discount a critical female journalist (“She had blood coming out of her…wherever”), when his “gloves come off,” as he announced yesterday (see:, will Hillary’s hormonal status become a major political issue? Certainly her voice has (See:, which is also a biological feature associated with menopause:

Hillary wore a white pantsuit, which was an historical nod to the Suffragette movements in Britain and the U.S. (See: It’s critical to note that women’s reproductive status and rights were always at the center of being denied the vote, or in participating in the political process. (See:

But there is also evolutionary power that comes after menopause. Evolutionary biologists propose that menopause favors natural selection because women are biologically more secure once they are no longer vulnerable to the risks of pregnancy and childbirth:

This has been self-evident in the story of American politics. As living conditions and reproductive justice improved for American women – both occurred precisely because they participated in politics. And then so did their lifespans. In 1992, there was a population explosion of menopausal women who were Boomers (see: This is Hillary’s cohort (Hillary was 45 in 1992, and just becoming First Lady). Nancy Pelosi, the first female House Speaker, was born in 1940, and began her career when she was elected in 1993 (age 53).

Women’s careers in politics are usually not possible until their childrearing years are over, given the demands parenting places on women’s time.

Whatever the opinions are about Hillary and trust, it’s impossible to deconstruct the public attitudes about Hillary without being entangled in gender bias, which becomes particularly brutal past menopause. As difficult as it is for our appearances to become objectified as young women, aging on a very public stage is not pleasant for women when their wrinkles, “cankles”, cellulite, and adiposity become part of someone’s debate prep. Carly Fiorina (61) is another case in point, when Trump remarked that she had an ugly face during the primary season (see: That remark dominated the news just when Fiorina was being praised for her oratory skills, which stood out against her 17 male opponents. Once her face was up for debate, her popularity plummeted, even as the remark was criticized.

Today, we have about a greater than 50% chance of electing the first female President, an achievement that would be virtually impossible for any pre-menopausal woman, given our social arrangements. In fact, all glass-ceiling breakers who came before Hillary were also women of a “certain age”. Golda Meir was 71 when she became the first woman Israeli Prime Minister in 1969. Margaret Thatcher was 54 when she became Britain’s first female Prime Minister; she was the longest serving Prime Minister of the 20th century (1979-1990).

The question for Hillary and the country is really this: are there enough American women voters past menopause who will support her, given that young women leaned toward an even older Bernie. (His shouting was not an issue for his supporters.)

Elections are no longer determined by white men; they are dying out:

So the power of postmenopause in 2016 isn’t just about the nominee. It’s about one of the largest voting blocs: female baby boomers who are not going to “Boo” but vote. Amid hot flashes and all, they will “feel the burn” for a political revolution that could put the women in charge, now that Theresa May (59) has become the second female British Prime Minister.



Reproductive Endocrinology

Undue Burden Aborted

June 30, 2016 • By

June 27, 2016 will stand as one of the most important SCOTUS decisions surrounding reproductive justice and women’s health since Roe v. Wade. I’ve previously blogged about Targeted Restrictions on Abortion Providers, or TRAP laws (See: These laws essentially sentence vulnerable or impoverished women to parenting by removing access to pregnancy termination services. Typically, these laws are particularly punishing to women in poverty who were raped or abused, who are unable to travel far.

As of now, the Supreme Court has ruled that these TRAP laws are unconstitutional and pose an undue burden on women seeking safe and legal abortion, which remains their constitutional right.

A fuller exploration of these laws from the perspective of women’s healthcare providers can be seen in the documentary film, Trapped, which debuted earlier this month on PBS. Here is the link to the film. You can freely stream it until mid-July:

The U.S. Supreme Court ruled that in the Texas case of Whole Women’s Health v. Hellersted , the TRAP laws being challenged had nothing to do with making abortion safer, or making women’s healthcare safer, and everything to do with making abortion access more difficult, and hence, posed an undue burden on a constitutionally protected right for all women. (See:

For more analysis on this major decision, see the following:

It is virtually impossible to find any bioethicist who does not support a woman’s autonomy in the decision of pregnancy termination pre-viability. TRAP laws help to force postponement of termination procedures past viability. These laws also could force women’s health clinics offering termination services to women to close by imposing onerous requirements that generally have nothing to do with patient safety.

This SCOTUS decision validated constitutional protections for women’s reproductive rights and health. And the absence of a ninth Supreme Court Justice didn’t make a difference in this 5-3 decision.

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!