Kill Bill, Volume 2

June 30, 2017 • By Dr. M Sara Rosenthal

Well, it’s time to bite our nails again over the Senate’s version of the “Kill Bill” called the Better Care Reconciliation Act of 2017. The name is deceiving because if passed, this bill will kill thousands of American citizens by denying them affordable access to healthcare, and dramatically altering Medicaid, which may leave many populations devastated. Drafted by only white, Republican males, this bill targets our vulnerable populations: the poor, the old – particularly those in nursing homes — the mentally ill, the disabled, pregnant women and their unborn children, and even NICU patients. (See: https://www.nytimes.com/2017/06/22/us/politics/senate-health-care-bill.html?hp and https://www.nytimes.com/2017/06/23/opinion/senate-obamacare-repeal.html?action=click&pgtype=Homepage&clickSource=story-heading&module=opinion-c-col-left-region&region=opinion-c-col-left-region&WT.nav=opinion-c-col-left-region).

The bill will allow states to opt out of covering vulnerable populations and essentially defunds Medicaid. It also eliminates caps on what insurance companies can charge people with complex health needs, and allows insurers to at least double what older people pay.

Here are the details of the bill: http://www.politifact.com/truth-o-meter/article/2017/jun/25/whats-senate-health-care-bill-here-are-five-key-pr/

Here is a nice summary by Atul Gawande: http://www.newyorker.com/news/news-desk/how-senates-health-care-bill-threatens-nations-health

Let’s be clear: this bill amounts to population control based on social Darwinism: the survival of the fittest. If you’re economically advantaged and can afford the ransom the insurance companies can now exact from this bill, you get to live. If you’re physically fit and free from chronic disease or disability, you get to live. The Republican Party argues this bill is “better” because you get to have “choices” the freedom to choose from a variety of unaffordable or inaccessible plans that will punish patients for their pre-existing conditions, and punish women for requiring prenatal and maternity care services. So if you like your healthcare, too bad – because you probably can’t keep it.

If you’re an endocrinologist burdened by too many diabetic patients, rest assured they’ll soon be gone from your practice if this bill becomes law. If you’re struggling with whether it’s more beneficent to observe “low risk” thyroid tumors (a still controversial practice), this healthcare law will remove your dilemma since many new thyroid cancer patients will not have access to treatment anyway.

When a healthcare reform bill drafted by the Republican party is so bad that only about 17% of voters approve of it, and even Republican senators are against it, it’s telling, but also perhaps a sign that reason will prevail with a bipartisan healthcare reform bill in the end. Indeed, if the “Better Care” bill passes, it will be America’s moral stain and shame. Even the American Medical Association states that this bill, as currently drafted, actually violates medical ethics. (See: https://www.forbes.com/sites/brucejapsen/2017/06/26/ama-says-mcconnells-trumpcare-bill-violates-do-no-harm-principle/#1674817b4040 )

Here is the AMA’s letter to Senators McConnell and Schumer, which states “Medicine has long operated under the precept of Primum non nocere, or “first, do no harm.” The draft legislation violates that standard on many levels.” For the full letter, see: https://searchlf.ama-assn.org/undefined/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2FBCRA-Letter.pdf

Not one single bioethics expert can endorse this “kill bill” – other than the endorsement of killing the bill itself. This bill is the health insurance equivalent of a travel ban – where insurance companies do “extreme vetting” of individuals with pre-existing conditions that will just cost too much to support.

Social Darwinism is not new; it was widely embraced throughout the early 20^th century and was the principal framework used to justify gassing the disabled, and other “undesirables” in Third Reich-era Germany. To recall a poignant line from the 2007 film, Sicko, a film that outlined the pre-ACA U.S healthcare system: “May I take a moment to ask a simple question? Who Are We?”

Healthcare Access

Kill Bill, Volume 1

March 31, 2017 • By Dr. M Sara Rosenthal

The biggest bioethics story this month was, of course, the “death spiral” of the repeal and replacement of the Affordable Care Act (ACA), known as “Obamacare”.

The proposed replacement law, unveiled as the American Health Care Act (AHCA), was a “Kill Bill” in every way. Under the new law, it was estimated that 24 million Americans who currently have health insurance and access to healthcare, would have lost their coverage. As proposed, the AHCA would have removed the current requirement under the ACA of that mandated coverage for “essential health benefits” comprising 10 services: outpatient care, emergency room visits, hospitalization, maternity and newborn care, mental health and addiction treatment, prescription drugs, rehabilitative services, lab services, preventive care and pediatric services. Republicans argued that such coverage leads to higher insurance premiums. (See: http://www.vox.com/2017/3/23/15031322/the-fight-over-essential-health-benefits-explained).

Basically, the AHCA, which was being dubbed “Trumpcare” would have removed the requirement to cover what most would define as “healthcare”. Some columnists referred to the proposed bill as “cruel” (See: http://www.gq.com/story/trumpcare-exposed-gop-cruelty). Ultimately, once coverage of pre-existing conditions is removed, people die. (See: http://www.npr.org/sections/health-shots/2017/03/23/521220359/gop-health-bill-changes-could-kill-protections-for-people-with-preexisting-condi?utm_source=facebook.com&utm_medium=social&utm_campaign=npr&utm_term=nprnews&utm_content=20170323)

But there were many other problems with the bill that would have removed healthcare access, which included restructuring Medicaid, tax cuts, and eliminating the lubricant that allows the ACA to work in the first place: the individual mandate. (See: https://www.washingtonpost.com/blogs/post-partisan/wp/2017/03/24/your-guide-to-the-most-contentious-parts-of-the-gop-health-care-plan/?tid=a_inl&utm_term=.0d36a1dbe10f).

Ultimately, between thousands of protesters voicing opposition to the replacement bill and polling that demonstrated only 17% of Americans were in favor of the proposed replacement bill, the GOP killed the bill, preserving (for now) the ACA. Here are two postmortems from the New York Times:

But the ACA is not “saved”; it remains at risk of being underfunded or sabotaged (See: https://www.washingtonpost.com/opinions/the-real-way-republicans-can-deal-with-obamacare-actually-fix-it/2017/03/24/cef5eba6-10c8-11e7-9b0d-d27c98455440_story.html?hpid=hp_no-name_opinion-card-d%3Ahomepage%2Fstory&utm_term=.eb1a99cec9f0) and http://www.politico.com/magazine/story/2017/03/will-obamacare-really-explode-214949 )

As we ended the month, there were rumblings that there may be another attempt at crafting a Republican healthcare bill, which could be “Kill Bill Volume 2.” (And that may make some heads spin).

Reproductive Endocrinology

Not OK (la-ho-ma): A shocking new abortion bill

February 28, 2017 • By Dr. M Sara Rosenthal

One of the most enduring and favorite American musicals is Oklahoma!, first performed in 1943 (See: https://en.wikipedia.org/wiki/Oklahoma!). It was turned into a wonderful 1955 film starring, among others, Shirley Jones, Gordon MacRae, and Rod Steiger (See: https://en.wikipedia.org/wiki/Oklahoma!#1955_film_adaptation). In 1943, a timeframe when women were being empowered in the war effort and went to work, the plot was rather shocking, as the main character, Laurey, is the victim of a predatory male who wishes to sexually assault her. In the nick of time, she is rescued from the sexual assault. The Rogers and Hammerstein score is superb, and anyone who has seen one of many stage productions or the film, knows the many popular songs, including how to spell Oklahoma: O-K-L-A-H-O-M-A! Let’s not forget “Oh What A Beautiful Morning” and “Surrey with a Fringe On Top”. Even people who hate musicals love this one: There is no bad number in the production. So there’s no doubt that there is a warm, fuzzy feeling when Americans think of the state of Oklahoma.

It’s important to note that the musical, Oklahoma! was particularly popular because it resonated with female audiences who were often targets of sexual predatory behaviors. The play and film delivered moral rescue from a desperate situation, which culminated in “Poor Jud is Dead” (officially spelled “Poor Jud is Daid” – to maximize the accent). Although the villain, Jud, got what was coming to him, there was also audience empathy for him. He was lonely; he had an unrequited, burning attraction to Laurey, and didn’t know how to curtail it.

Unfortunately all our warm, fuzzy feelings about the State of Oklahoma were ruined this month, as news of an ethically egregious proposed House Bill 1441 — a proposed abortion law with a “fringe on top” — was reported to have advanced in the Oklahoma State Legislature. This Bill upends the woman-friendly plot of the musical, Oklahoma!

House Bill 1441 will require a pregnant woman in Oklahoma to seek written consent and permission of the father to approve any abortion; she would need to name the father, and if the father contested, he could opt for a paternity test.

See: https://www.washingtonpost.com/news/post-nation/wp/2017/02/14/oklahoma-bill-would-require-father-of-fetus-to-approve-abortion/?utm_term=.f53b11099995

and

http://thehill.com/homenews/state-watch/319635-oklahoma-house-advances-bill-to-require-mens-permission-for-abortions

The requirement to name the father is, of course, fraught with psychosocial risks and harms – including to the father, who may be married to someone else. What if it’s a highly secretive (yet consensual) affair?

In many states, including mine (Kentucky), we don’t legally recognize the rights of “baby daddies” who are not legally married to the patient. We don’t recognize them as legal surrogates, nor do we allow them to be surrogates for neonatal patients. At many hospitals, paternity tests are not routinely offered, either. Thus, access to a paternity test could be a problem for a father who feels wrongly named; and finding access could be an additional undue burden.

Bill 1441 does provide an exemption in cases of rape, incest, or when the mother’s health is at stake. This is still problematic as there can be different interpretations of what constitutes “rape”; it’s unclear whose perception of rape would be accepted should this Bill ever become law, as perpetrators could argue it was all perfectly consensual and the woman was just a “girl who can’t say No”. What about cases of domestic violence rape? In such cases, “people will say they’re in love”. But in reality, violence may increase or be triggered by an unintended pregnancy.

This proposed law is unconstitutional, which even its author, Representative Justin Humphrey, concedes. It is also unethical, misogynistic, and logistically impossible. The Bill’s author also stated that prevention of pregnancy is the “responsibility of the woman”. That may be difficult in States where contraception is not taught or accessible. Oklahoma, in fact, has a terrible record with respect to teaching about contraception and making it accessible (see: https://sexetc.org/states/oklahoma_).

It is self-evident that a woman has the right to make decisions about her body; she is not simply a “host” for the fetus, as the Bill’s sponsor states. She is an American citizen with civil rights; as a legal person, her rights “trump” an unborn, potential person with no legal status. A 1992 Pennsylvania law with similar overtones was struck down by the Supreme Court for these reasons. A pregnant patient and her fetus are a single biological entity pre-viability in which the practitioner’s ethical obligations are owed to the mother unless she presents her fetus as a patient. There is virtually no court that would hold that a capacitated pregnant woman does not have the constitutional right to make medical decisions for herself. From a bioethics perspective this proposed law completely violates the Principle of Autonomy and Respect for Persons.

As another song from Oklahoma! goes: “It’s a Scandal and an Outrage!”

Endocrine Research

The Endocrine Society Weighs in on Trump’s Travel Ban

January 31, 2017 • By Dr. M Sara Rosenthal

January, 2017 has been arguably one of the most chaotic months in the democratic history of the United States, with many Americans wondering if the country has devolved into an autocracy or dictatorship. Anyone trying to keep up with the news has probably become exhausted. There are many issues that have begun to dominate the science news, including a Scientists’ March on Washington. But that’s the not the subject for this month’s blog. Instead, it is the Executive Order issued January 27^th, which is the travel ban on 7 Muslim-majority countries (the word “ban” is the President’s words), which affected even permanent residents of the U.S. (something that is currently being potentially corrected or evaluated on a “case by case” basis), as well as people who have dual citizenship in one of the banned countries as well as another country, such as Canada. The ban has had immediate and dire ramifications for the scientific and medical communities. Several universities have issued statements, and in a rare instance, The Endocrine Society has now weighed in. Here is the official Press Release:

https://www.endocrine.org/news-room/current-press-releases/endocrine-society-responds-to-trumps-executive-order-on-immigration

In individual letters sent to members, it made these statements (bold added for emphasis):

“We are currently working with the broader research and medical communities on supporting legal efforts to overturn the order… [And] we have already heard concerns from colleagues in targeted countries about missing ENDO this spring. We also recognize that as a result of this order there are physicians and scientists training in the US who are now unsure of their status and patients from targeted countries blocked from participating in studies.”

There are clearly research and clinical ethical consequences to such orders from President Trump that were likely not considered, which may violate basic bioethics principles.

But the travel ban has had an unprecedented detrimental global impact on the U.S.’ relationships with other countries. Notwithstanding harsh criticism from various European countries, Britain, as well as Iran and Iraq, the President of the European Union made the statement today that the U.S. is now being considered a global threat to Europe on par with Russia. See: http://www.cnn.com/2017/01/31/politics/european-union-trump/

When the Acting Attorney General of the United States, Sally Yates, declared that she could not defend this travel ban in court because she was not convinced it was lawful, she was demonstrating moral courage. (See: https://www.nytimes.com/interactive/2017/01/30/us/document-Letter-From-Sally-Yates.html?_r=0). As is sometimes the case when speaking out against something that compromises professional and moral integrity, she was fired and called a “betrayer” by the White House. (See: https://www.nytimes.com/2017/01/30/us/politics/trump-immigration-ban-memo.html). Such an action recalled the “Saturday Night Massacre” of the Watergate era when former President Nixon fired then Attorney General, Elliot Richardson and his Deputy Attorney General for refusing to fire Archibald Cox, the Independent Prosecutor investigating the President.

All Endocrine Society Members should applaud the Endocrine Society’s moral courage in speaking out on this ethically and legally problematic ban. Future Society meetings may be best held in Canada, which has spoken out against the ban and can offer a safe travel situation for all Endocrine Society Members. (See: http://www.theglobeandmail.com/news/world/us-politics/trumps-travel-ban-on-citizens-from-muslim-majority-countries-causes-anger-chaos-in-us-andabroad/article33818462/).

The history of science and medicine is filled with refugee scientists’ accomplishments. What would have happened had we banned Albert Einstein from entering the U.S. in 1933, prior to the infamous and unfortunate banning of Jewish refugees who tried to flee later (See: https://www.theatlantic.com/politics/archive/2017/01/jewish-refugees-in-the-us/514742/)? Who knows what scientific discovery was on the ship we turned away, and how much science was lost to the ashes of the Holocaust? It is all the more ironic that this new Executive Order was signed on Holocaust Memorial Day. It’s worth noting that the influx of Jewish refugees who did get into the United States led to a 31% increase in patents. (See: http://news.stanford.edu/news/2014/august/german-jewish-inventors-081114.html)

Academics around the country have initiated petitions about this travel ban, such as this one: https://notoimmigrationban.com . We do not yet know the complete toll this ban has had on the academic medical community or patients. Stay tuned.

Uncategorized

Putting a Price on Healthcare

December 31, 2016 • By Dr. M Sara Rosenthal

As we begin to reflect on the chaos of 2016, there is only one major bioethics story for healthcare providers: the fate of American healthcare access. Again. As December began, the picture for 2017 was beginning to fill in – particularly with the Cabinet pick of Dr. Tom Price as HHS secretary. Here are some alarming facts in a compelling piece published in the New England Journal of Medicine: (See: http://www.nejm.org/doi/full/10.1056/NEJMp1615714)

The authors, who both formerly served as Assistant Secretaries at the Department of HHS, make these points:

“…Price’s record demonstrates less concern for the sick, the poor, and the health of the public and much greater concern for the economic well-being of their physician caregivers.”
Price supports changing the Medicare and Medicaid systems so substantially that it would “shift financial risk from the federal government to vulnerable populations.”
“Price has also been a vociferous opponent of the Affordable Care Act (ACA) and a leader of the repeal-and-replace movement.” Essentially, Price endorses a dismantling of the American healthcare system with a “regressive” plan that “offers much greater subsidies relative to income for purchasers with high incomes and much more meager subsidies for those with low incomes.”

In essence, Price opposes any cost-sharing subsidies, which could “doom millions”. See: https://www.washingtonpost.com/national/health-science/trump-could-quickly-doom-aca-cost-sharing-subsidies-for-millions-of-americans/2016/12/21/05349066-c2fc-11e6-9a51-cd56ea1c2bb7_story.html?hpid=hp_hp-top-table-main_costsharing-10pm%3Ahomepage%2Fstory

Price is a polarizing figure for American doctors. Although the American Medical Association endorsed Dr. Price as a pick, many of its members were dismayed. Over 5,000 doctors have signed a petition opposing him, while many AMA members have spoken out, or not renewed their memberships. (See:

http://www.nytimes.com/2016/12/26/us/tom-price-hhs-donald-trump-cabinet.html?hp&action=click&pgtype=Homepage&clickSource=story-heading&module=first-column-region&region=top-news&WT.nav=top-news

Price also is a member of the Association of American Physicians and Surgeons (AAPS), which has been coined a “crank medical society” by Scienceblogs.com. The AAPS is noted for its anti-vaccine stance. (See: http://nymag.com/scienceofus/2016/12/tom-price-belongs-to-a-really-scary-medical-organization.html)

Advocates of women’s health are concerned that even the most basic contraception for women would become a challenge because “the extremity of Mr. Price’s views on women’s health.” For example, he was a co-sponsor of legislation that defines life at conception, arguing that “common forms of birth control constitute a murder weapon.” (See: http://www.nytimes.com/2016/12/28/opinion/how-donald-trumps-health-secretary-tom-price-endangers-women.html?action=click&pgtype=Homepage&clickSource=story-heading&module=opinion-c-col-right-region&region=opinion-c-col-right-region&WT.nav=opinion-c-col-right-region&_r=0

It gets worse. Price has alarming conflicts of interest according to a Wall Street Journal Report. He has all kinds of ties to the pharmaceutical industry, having traded over $300,000 in big pharma stock while in Congress. See: http://www.wsj.com/articles/donald-trumps-pick-for-health-secretary-traded-medical-stocks-while-in-house-1482451061

and

https://www.statnews.com/2016/12/02/tom-price-hhs-stock-portfolio/

Of course, the HHS Secretary cannot, alone, repeal the ACA. That is an act of Congress, which has made clear that it’s the first thing on its agenda in 2017. That is sending “red flags” (no – not the Russia hacking thing) across the healthcare spectrum. For example, as the New York Times reported:

“In a letter to Mr. Trump and congressional leaders this month, the two biggest hospital trade groups warned of ‘an unprecedented public health crisis’ and said hospitals stood to lose $165 billion through 2026 if more than 20 million people lose the insurance they gained under the law. They predicted widespread layoffs, cuts in outpatient care and services for the mentally ill, and even hospital closings.” See:

http://www.nytimes.com/2016/12/28/health/hospitals-medicaid-obamacare-trump.html?hp&action=click&pgtype=Homepage&clickSource=story-heading&module=first-column-region&region=top-news&WT.nav=top-news

It’s clear to any bioethicist that the new GOP-led Congress is about to step into the mire of what scholars call a “wicked problem”. Anyone who looks closely at the muckiness of the U.S. healthcare system will see that there are two options: a market-based system, which basically looks like the ACA, or some form of a single-payer universal healthcare system, which is what every other democracy has. So for the GOP, it’s a wicked problem of BernieCare of ObamaCare, because voters will not like any of the voucher-based plans they have been discussing for years, which do not resolve distributive justice problems.

The GOP Congress, in recognition of this “wicked problem” has come up with a “neither fish nor fowl” solution, called Repeal and Delay. But that has problems, too, according to the Urban Institute, which estimates that “repeal and delay” would “increase the number of uninsured by 4.3 million people near immediately”. (See: https://www.brookings.edu/research/why-repealing-the-aca-before-replacing-it-wont-work-and-what-might/)

As for the Trump voters, they don’t want to see the ACA repealed, either, which makes their vote for Trump perplexing. In two of the poorest states (one of them, mine), the uninsured rate has fallen from 25 percent in 2013 to 10 percent today. One reporter decided to investigate the paradox of the Trump voter and ACA-lover, and took a deep dive into my own state of Kentucky (See: http://www.vox.com/science-and-health/2016/12/13/13848794/kentucky-obamacare-trump.) Voters who understood that their Kentucky healthcare of “Kynnect” was “Obamacare” simply didn’t take Trump seriously about taking it away. They thought he was kidding, proving the adage of “taking him seriously but not literally”. Other voters who love their healthcare in Kentucky, didn’t understand that what they love, is in fact, Obamacare, proving there is a wide gap in understanding the law. (See: https://www.washingtonpost.com/opinions/trump-voters-didnt-take-him-literally-on-obamacare-oops/2016/12/20/46ef3cae-c6f3-11e6-bf4b-2c064d32a4bf_story.html?hpid=hp_no-name_opinion-card-c%3Ahomepage%2Fstory&utm_term=.0decc010c34c )

Patients who voted for change are going to get it in 2017. It just may not be the change they want. And many bioethicists fear some may have unwittingly voted for their own executioner if their healthcare goes away.

Uncategorized

Apocalypse Now: Bioethics Issues in the Trump Era

November 30, 2016 • By Dr. M Sara Rosenthal

On November 9, 2016, as the stock market fell 800 points and the Canadian immigration website crashed, we elected what other countries call a “dangerous” and “unthinkable” President. Here is Germany’s take: http://www.spiegel.de/international/world/spiegel-editorial-trump-is-a-dangerous-president-a-1120925.html. Canada had this to say: https://www.thestar.com/news/world/uselection/2016/11/09/donald-trump-wins-america-elects-an-unthinkable-president.html.

In the U.S., more than half the population of this country (particularly those who work in the areas of bioethics, health law, healthcare, or human rights ) compared waking up on November 9^th to waking up in a nightmare. Here’s a sample of the editorials from that morning:

http://www.nytimes.com/2016/11/09/opinion/were-near-the-breaking-point.html?action=click&pgtype=Homepage&clickSource=story-heading&module=span-abc-region&region=span-abc-region&WT.nav=span-abc-region

https://www.washingtonpost.com/opinions/a-prayer-for-america/2016/11/08/05fee4d2-a5e8-11e6-8fc0-7be8f848c492_story.html

In terms of national and global impact, the reality of a Trump Presidency is only comparable to 9/11. What some are calling “mourning in America”; “11/9”; “Trumpocalypse” or an “electoral catastrophe”, the United States under a President Trump will be, for many, like watching a car crash in slow motion. Aside from the risk of global and climate disasters at the hands of a President who does not believe in climate change, can still be “baited with a tweet”, and has declined (as of this writing) his daily intelligence briefings, bioethics in the United States is about to go through a hostile takeover. There are four main categories that will be affected once the transfer of power is complete.

Healthcare access. Repeal of the Affordable Care Act as well as repeal or reform of Medicare and Medicaid are on the agenda. This seems especially likely with the pick of Tom Price for Health and Human Services Secretary. See: http://www.nytimes.com/2016/11/30/opinion/tom-price-a-radical-choice-for-health-secretary.html?action=click&pgtype=Homepage&clickSource=story-heading&module=opinion-c-col-right-region&region=opinion-c-col-right-region&WT.nav=opinion-c-col-right-region&_r=0

and

http://www.nytimes.com/2016/11/28/us/politics/tom-price-secretary-health-and-human-services.html?hp&action=click&pgtype=Homepage&clickSource=story-heading&module=a-lede-package-region&region=top-news&WT.nav=top-news&_r=0

Reproductive justice. Attempts to defund Planned Parenthood, not cover contraception, and repeal of Roe v. Wade are all on the 2017 menu. Although Trump’s first SCOTUS appointment does not necessarily guarantee revisiting Roe v. Wade, challenges to the law are sure to come. If abortion law returns to the jurisdiction of individual states, there could be access in blue states, but most of the country is currently under Republican rule. So we could be looking at more stories like this: http://www.nytimes.com/2016/11/29/us/tennessee-woman-accused-of-coat-hanger-abortion-faces-new-charges.html?module=WatchingPorta

Human rights violations. Since the election, white supremacy hate crimes – especially targeting Muslims, Hispanics, African Americans and Jews – have skyrocketed. How will we navigate the intersection of healthcare and human rights? For example, will Muslim healthcare providers feel safe in a post-Trump America? Will Muslim patients? What about the prospect of “sanctuary hospitals”? With a reported “white nationalist” appointed as Chief White House strategist (see: http://www.nytimes.com/2016/11/15/us/politics/donald-trump-presidency.html) and an Attorney General pick with a documented history of racism (see: http://www.cnn.com/2016/11/17/politics/jeff-sessions-racism-allegations/) things are getting morally uncomfortable. Here is the ACLU’s position on some of these issues: https://www.aclu.org/letter/aclu-letter-president-elect-trump-published-new-york-times

Conflicts of Interest. The President-Elect has a dizzying and multi-layered thicket of conflicts of interest that violate the Emoluments Clause, even if his children run his business instead. How can any healthcare provider be expected to adhere to conflicts of interest policies when POTUS 45 could openly use the Presidency to enrich himself? See:

http://www.nytimes.com/2016/11/26/us/politics/donald-trump-international-business.html?_r=0

http://www.nytimes.com/2016/11/25/opinion/donald-trumps-caldron-of-conflicts.html?action=click&pgtype=Homepage&clickSource=story-heading&module=opinion-c-col-left-region&region=opinion-c-col-left-region&WT.nav=opinion-c-col-left-region&_r=0

http://www.huffingtonpost.com/entry/donald-trump-conflict-of-interest_us_58349547e4b09b6055ff367d?section=us_politics

More veterans. With the pick of Michael Flynn for the NSA, we may see a fresh ground war and a draft. (But — perhaps a decline of obesity in those we draft.) See: http://www.nytimes.com/2016/11/19/opinion/michael-flynn-an-alarming-pick-for-national-security-adviser.html?action=click&pgtype=Homepage&clickSource=story-heading&module=opinion-c-col-left-region&region=opinion-c-col-left-region&WT.nav=opinion-c-col-left-region.

Presidential Capacity. With a President who struggles with impulse control, shows clear signs of narcissistic personality disorder, and questionable competencies to run the country, there may indeed be a need for invoking the 25^th Amendment, section 4. Let’s see what happens in December before I go into this.

One thing is clear: we’ll certainly have a White Christmas in a Trump Administration.

Reproductive Endocrinology

Weiner Issues: Revelations from a Male Birth Control Study

October 31, 2016 • By Dr. M Sara Rosenthal

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: http://press.endocrine.org/doi/pdf/10.1210/jc.2016-2141

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”:

http://www.cosmopolitan.com/health-fitness/a8038748/male-birth-control-study-stopped/

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: http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/).

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.”

(See: http://www.post-gazette.com/opinion/Op-Ed/2013/04/15/Men-women-contraception-Where-is-The-Pill-for-men/stories/201304150142)

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 (http://www.biography.com/people/margaret-sanger-9471186#synopsis). 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 (https://www.amnesty.org/en/latest/news/2016/10/indonesia-halt-chemical-castration/). 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 Dr. M Sara Rosenthal

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: http://www.nejm.org/doi/pdf/10.1056/NEJMp1604412

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: http://online.liebertpub.com/doi/abs/10.1089/thy.2015.0020).

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: http://erc.endocrinology-journals.org/content/21/6/R473.full). 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: http://www.ncbi.nlm.nih.gov/pubmed/26883666).

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: http://www.futuremedicine.com/doi/abs/10.2217/ije-2015-0010?journalCode=ije

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.

Menopause

The Power of Postmenopause

July 30, 2016 • By Dr. M Sara Rosenthal

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: http://time.com/3763552/hillary-clinton-age-president/?xid=emailshare

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: http://endocrineethicsblog.org/why-hillary-clintons-thyroid-needs-healthcare-reform/).

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: http://press.endocrine.org/doi/pdf/10.1210/jc.2015-2236 and http://endocrineethicsblog.org/ethics-of-authorship-whats-so-new-about-the-upcoming-clinical-practice-guidelines-for-menopause-they-were-written-by-women/

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: http://www.cnn.com/videos/politics/2016/07/30/trump-gloves-come-off-carroll-dnt-ac.cnn), will Hillary’s hormonal status become a major political issue? Certainly her voice has (See: http://www.huffingtonpost.com/entry/complaining-hillary-clintons-voice_us_579add5de4b0693164c0b55c?section), which is also a biological feature associated with menopause: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3991439/

Hillary wore a white pantsuit, which was an historical nod to the Suffragette movements in Britain and the U.S. (See: http://qz.com/745349/hillary-clintons-all-white-pantsuit-at-the-dnc-recalls-centuries-of-american-feminist-history/). 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: https://www.americanprogress.org/issues/women/news/2013/08/26/72988/womens-equality-day-celebrating-the-19th-amendments-impact-on-reproductive-health-and-rights/).

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: http://phenomena.nationalgeographic.com/2013/04/18/why-menopause/

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: http://www.nytimes.com/1992/10/21/opinion/mighty-menopause.html). 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: http://www.huffingtonpost.com/entry/donald-trump-carly-fiorina_us_55f17d22e4b03784e2781531). 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 20^th 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: http://www.nytimes.com/2015/11/03/health/death-rates-rising-for-middle-aged-white-americans-study-finds.html?_r=0

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 Dr. M Sara Rosenthal

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: http://endocrineethicsblog.org/why-biology-is-destiny-in-a-republican-world/). 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: http://www.pbs.org/independentlens/videos/trapped-full-film/

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: http://www.scotusblog.com/2016/06/opinion-analysis-abortion-rights-reemerge-strongly/)

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

http://www.npr.org/sections/thetwo-way/2016/06/27/483686616/supreme-court-strikes-down-abortion-restrictions-in-texas

http://www.nytimes.com/2016/06/28/us/supreme-court-texas-abortion.html

http://www.npr.org/sections/health-shots/2016/06/27/483698407/fallout-from-supreme-court-ruling-against-texas-laws-abortion-restrictions

http://www.reuters.com/article/us-usa-court-abortion-idUSKCN0ZC0JL

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.

1 2 3 4 5 6