Remembering Alan Wertheimer

By Emily Largent

A week ago, I received the sad news that Alan Wertheimer had passed away. Alan made many important contributions to the philosophical literature, including Coercion and Exploitation. And while Alan would tell you that he did not identify as a bioethicist, he made significant contributions to the bioethics literature as well. I am certain his work will continue to be influential in many areas.

On a personal note, Alan was a mentor and friend. I truly appreciated his intellectual generosity and his many kindnesses toward me.

I met Alan while I was a pre-doctoral fellow in the Department of Bioethics at the NIH. My initial impressions of him were shaped by the vivid and incisive hypotheticals he offered for our consideration; the pointed questions he asked in the Department’s Works in Progress sessions (which have a reputation for “combative collegiality”); the thoughtful and rapid comments he made on manuscripts; and a surprisingly competitive bowling outing that Alan took with the Department of Bioethics fellows. Continue reading

Pay Disparities in Nursing

By Emily Largent

I’ve mentioned on this blog before that I had a past life as a nurse.  Therefore, I wanted to call attention to an important new study that has just come out in JAMA: Salary Differences Between Male and Female Registered Nurses in the United States.  The study found that “[m]ale RNs outearned female RNs across settings, specialties, and positions.”  On average, male nurses make $5,150 more per year than female colleagues in similar positions.  This salary gap affects 2.5 million female RNs.

There is speculation that a male nurse may be perceived as more expert simply because he is a man. This explanation is deeply ironic.  Decades  of legal barriers kept men out of the field, and historically, some nursing schools refused to admit men due to sex stereotypes that categorized caring as a feminine trait.  The Supreme Court deemed this practice unconstitutional in Mississippi University for Women v. Hogan.  While that decision came down in 1982, research suggests that men continue to face pervasive barriers in nursing school (e.g., hearing anti-male remarks from faculty).

Ongoing identification of nursing as “women’s work” and the presence of gender bias in nursing can affect male nurses in different, seemingly contradictory ways.  On the one hand, the 2000 National Sample Survey of Registered Nurses found that men leave nursing at a higher rate in their first four years of practice.  Some have attributed that attrition to the harmful effects of gender bias.  On the other hand, it has been observed that–unlike women who enter male-dominated professions–male nurses who enter this female-dominated profession typically encounter structural advantages that tend to enhance their careers.

There is a need for more nurses.  According to the Bureau of Labor Statistics’s Employment Projections, the RN workforce is expected to grow to 3.24 million in 2022.  That is a 19% increase.  Nursing is a context that highlights how gender stereotyping hurts everyone–men who encounter discrimination, women who earn less than their male counterparts, and patients who benefit most when nursing recruits and retains excellent people.

I personally found nursing to be very rewarding.  I hope this study motivates employers to scrutinize their pay structures but also to appreciate and address the broader effects of gender bias on the profession.

M.C. v. Aaronson – Update

By Emily Largent

In 2013, M.C. (a minor child), by and through his adoptive parents, filed a complaint in federal district court against the physicians who recommended and performed M.C.’s sex assignment surgery and the South Carolina Department of Social Services (SCDSS) officials who authorized it.  This was the first lawsuit of its kind filed on behalf an intersex child who was given sex assignment surgery while too young to give informed consent.

By way of background, M.C. was born with ovotesticular difference/disorder of sexual development (DSD).  Ovotesticular DSD is a condition in which an infant is born with the internal reproductive organs of both sexes; the external genitalia are usually ambiguous but can range from normal female to normal male.  Shortly after birth, M.C.’s biological parents expressed their desire to relinquish their parental rights, and M.C. was placed in the custody of SCDSS.  A team of physicians subsequently evaluated M.C’s condition and recommended to SCDSS officials that M.C. undergo sex assignment surgery in order to make his body appear female.  SCDSS consented to the surgery, which was performed in April 2006.

M.C. was adopted in December 2006.  Initially, his adoptive parents raised M.C. as a female in accordance with his assigned gender.  M.C., however, refused to be identified as a girl.  His adoptive mother has described being “really sad that that decision [regarding surgery] had been made for him. . . . And it’s becoming more and more difficult just as his identity has become more clearly male.”  M.C. is now living as a boy with the support of his family, friends, school, and others.

Continue reading

UCLA, CREA, and FDA

By Emily Largent

Before law school, I worked as a nurse at Ronald Reagan UCLA Medical Center.  The work was interesting, as was the news.  I was there when the Los Angeles Times published an investigation revealing that Japanese gang figures received liver transplants at UCLA and when the Times reported on UCLA employees illegally viewing medical records of celebrities.

This week, UCLA made headlines once again when officials announced that nearly 180 patients may have been exposed to a potentially deadly superbug from contaminated duodenoscopes.  Seven UCLA patients–two of whom died–were infected with carbapenem-resistant Enterobacteriaceae (CRE) after a procedure known as endoscopic retrograde cholangiopancreatography (ERCP).  CRE are a family of germs that are difficult to treat because they have high levels of antibiotic resistance, and CRE can lead to death in up to 50% of patients who become infected.

This problem is not unique to UCLA.  The University of Pittsburgh Medical Center had a duodenoscope-related outbreak in 2012. Last month, Virginia Mason Medical Center in Seattle acknowledged that 32 patients were sickened by contaminated endoscopes from 2012 to 2014.  Eleven of those patients died.  From January 2013 to December 2014, the FDA received 75 Medical Device Reports (MDRs) related to possible microbial transmission from duodenoscopes.

The FDA issued a safety communication yesterday, February 19th, which warned doctors that the complex design of duodenoscopes may impede effective reprocessing.  Reprocessing is a multi-step process to clean and disinfect or sterilize reusable devices.  The FDA noted that multi-drug resistant infections have been associated with reprocessed duodenoscopes “even when manufacturer reprocessing instructions are followed correctly.” (UCLA stated that its scopes had been sterilized in line with the manufacturer’s standards.)  Nevertheless, the FDA urged medical providers to carefully follow manufacturers’ cleaning instructions and talk to patients about the benefits and risks of undergoing procedures involving duodenoscopes.

Some have argued that this did not go far enough.  What other options are available to the FDA?

Continue reading

Vaccines and the Presidential Campaign

By Emily Largent

The 2016 Presidential race is gathering steam, and this has led me to wonder what–if any–effect the recent measles outbreak might have on campaigns.  While a majority of the public holds the view that vaccinating kids is the right thing to do, a growing number of people are eschewing vaccinations.  Moreover, it has been said that skepticism about inoculations is “one of those issues that . . . grab people across the political spectrum.”

I was, therefore, interested to see that New Jersey Governor Chris Christie, who launched a political action committee last month ahead of a likely run for the GOP presidential nomination, said on Monday that parents “need to have some measure of choice” about vaccinating their children.  See also here. Continue reading

Caffeine and the Law

By Emily Largent

Generally speaking, law school goes more smoothly when the law student is caffeinated.  Consider that Justice Elena Kagan was known at Harvard Law School as the “coffee dean” for instituting free coffee for students (and, as an aside, expects to be known as the “frozen yogurt justice” for bringing frozen yogurt to the SCOTUS cafeteria).

Last year, the deaths of Logan Stiner and James Wade Sweatt drew attention to another place where caffeine intersects with the law: the regulation (or lack thereof) of powdered caffeine by the FDA.  Both men died after ingesting powdered caffeine.  One teaspoon of powdered pure caffeine is roughly equivalent to 25 cups of coffee.  Manufacturers encourage consumers to take between 1/16 and 1/64 teaspoon (see, e.g., here), though measuring such minute amounts with common kitchen tools may be impossible.  On it’s blog, FDA observes that the people most drawn to powdered pure caffeine are “children, teenagers, and young adults.”  It is not clear how common it is for individuals to overdose on caffeine powder, as the cause of death may be listed as “heart attack” in many cases.

Continue reading

FDA Updates System for Explaining Risks of Meds in Pregnancy

By Emily Largent

On Wednesday, the FDA published the “Pregnancy and Lactation Labeling Rule” (PLLR), which “requires changes to the content and format for information presented in prescription drug labeling . . . to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children.”  The FDA also issued draft guidance for industry to assist drug manufacturers in complying with the new labeling and format requirements.

The current system, which was developed in the 1970s, uses letters of the alphabet–A, B, C, D, and X–to denote risk, with X being the most dangerous.  The PLLR removes pregnancy letter categories from all prescription drug and biological product labeling.  The new system breaks the risk into three categories: Pregnancy, Lactation, and Females and Males of Reproductive Potential.  Companies will be required to provide a summary of risks, a discussion of the data supporting that summary, and relevant information to help clinicians make prescribing decisions.  The changes go into effect on June 30, 2015.  Labeling for over-the-counter medications will not change.

The PLLR should help many women, as there are more than 6 million pregnancies in the U.S. each year.  Research suggests that over 90% of women use at least one medicine during pregnancy, and about 70% use at least one prescription medicine.  I think the PLLR is a wonderful step to enhance patient education and decision-making.  It will not, however, address our limited current knowledge of the safety of medication use during pregnancy.  About 98% of medicines approved for use in the United States between 2000 and 2010 had limited data to assess the risk for birth defects, for example.  More research is urgently needed, and it’s unfortunate that the rule stops short of requiring companies to conduct studies if none exist.

The Civil Rights Movement and the Blood Supply

By Emily Largent

This year marks the 50th anniversary of the Civil Rights Act of 1964, and this semester, I have been fortunate enough to take a class on the Civil Rights Movement with Professor Randall Kennedy.  This has prompted me to examine the influence of race on healthcare delivery in the 1940s, ’50s, and ’60s.  Racism infected all aspects of the healthcare system, including medical schools and schools of nursing, residencies and post-graduate training, professional societies for doctors and nurses, ambulance services, outpatient clinics, staff privileges at hospitals, hospital admissions, and medical research.  Doubtlessly, the color line in medicine compounded physical ills with emotional and dignitary harms.

I find the stories related to the segregation of the American blood supply during World War II to be particularly interesting because they show that discrimination was a national (i.e., not just a Southern) problem, and there is a small connection to Harvard Law School.  Speak Now Against the Day: The Generation Before the Civil Rights Movement in the South by John Egerton has proven to be an excellent source of information on this topic.

Blacks made contributions to the war effort in many capacities.  William H. Hastie, a graduate of Harvard Law School, took leave from his position as Dean at Howard University School of Law (HUSL) to accept an appointment as civilian aide to Secretary of War Stimson.  Charles R. Drew, a physician who had conducted pioneering research on typing, preserving, and storing blood for later transfusion, helped both Britain and the United States establish blood programs to support military operations. In February 1941, Drew was made medical director of the American Red Cross blood bank program.

Late in 1941, the surgeons general of the United States Army and Navy informed the Red Cross that only blood from white donors would be accepted for military use.  Although it had been conclusively proven that there were no racial differences in blood, the military yielded to prevailing social bias and heavy political pressure.  In January 1942, the War Department revised its position, agreeing to accept blood from black donors, though also insisting on rigid adherence to segregation of the blood supply.  The Red Cross not only accepted that decision but declared that it had no interest in trying to settle racial-social controversies.  Later, Red Cross officials “suggested that those who persisted in criticizing the policy were unpatriotically attempting to cripple the blood donor service and thus harm the war effort itself.”  Continue reading

Update: Proposition 46

By Emily Largent

I previously wrote about California Proposition 46–which proposed to raise the cap on pain and suffering awards in malpractice cases from $250,000 to $1.1 million, require doctors to check a statewide database of drug prescriptions before prescribing some narcotics, and require doctors to undergo random drug and alcohol testing–here.

What happened?  On Tuesday, voters “soundly defeated a proposal to lift a decades-old cap on courtroom damages for medical negligence, after a multimillion-dollar political duel pitting trial lawyers against doctors and insurers.”  Proposition 46 was defeated by a 2-to-1 margin, with 67% of voters rejecting it. (There is some speculation that an error in translation for voter materials could have affected the way Vietnamese-speaking voters voted on Tuesday; however, there is no suggestion this would have changed the outcome.)

Proposition 46 was the most expensive race in California this election.  The No side spent close to $60 million in its efforts to see the Proposition defeated, almost seven times the spending on the Yes side.

Prop. 46: Lawyers v. Doctors

By Emily Largent

California Proposition 46, the Medical Malpractice Lawsuits Cap and Drug Testing Doctors Initiative, is on the November 4, 2014 ballot.  If approved by voters, the initiative would: increase the state’s cap on non-economic damages that can be assessed in medical negligence lawsuits; require hospitals to test certain physicians for drugs and alcohol; and require healthcare providers to check a statewide prescription drug database before prescribing or dispensing certain drugs to a patient for the first time.

The  debate over Proposition 46 has been framed as a battle between doctors and lawyers.  See also here or here.  It’s not hard to see why.  Attorneys have contributed the vast majority of the “yes” campaign‘s $9 million fund.  By contrast, nearly three-fourths of the “no” campaign‘s $57 million has come from six insurance companies; other big backers include the state medical and dental associations.  (It is the most expensive campaign in California this year.)  While the two sides have made a variety of arguments for and against Proposition 46’s various provisions, I want to focus on the putative costs and cost-savings:

First, Proposition 46 would increase California’s current $250,000 limit on non-economic awards (which dates to the Medical Injury Compensation Reform Act of 1975) to $1.1 million, and provide for annual adjustment for inflation going forward. The non-partisan Legislative Analyst’s Office estimates that increased state and local government health care costs from raising the cap likely range from the tens of millions of dollars to several hundred million dollars annually.  On the other hand, a RAND study of EDs in three states with strict malpractice limits found the caps had little effect on the cost of care.  Continue reading

Happy National Health Observances!

By Emily Largent

Perhaps you already knew that October is National Breast Cancer Awareness Month. Did you also know that it is:

  • Domestic Violence Awareness Month,
  • Eye Injury Prevention Month,
  • Health Literacy Month,
  • Home Eye Safety Month,
  • National Bullying Prevention Month,
  • National Down Syndrome Awareness Month,
  • National Medical Librarians Month,
  • National Physical Therapy Month, and
  • Sudden Infant Death Syndrome (SIDS) Awareness Month?

On top of that, we have (just to name a few): Mental Illness Awareness Week (Oct. 6-10); National Depression Screening Day (Oct. 9); Bone and Joint Health National Awareness Week (Oct. 12-20); World Pediatric Bone and Joint Day (Oct. 19); and World Psoriasis Day (Oct. 29).  Background on what it takes to make it onto the H.H.S. Office of Disease Prevention and Health Promotion’s national health observances (NHOs) calendar can be found here.

These campaigns can have different goals: raising general awareness of a health need; changing behavior–for example, convincing individuals to change risky behaviors or to take steps toward disease prevention; soliciting donations for research;  increasing early detection; enabling patient support groups; or influencing legislators and policy.  It appears that NHOs can make a difference.  They are not, however, free of controversy.

For example, a primary goal of National Breast Cancer Awareness Month (NBCAM) is to encourage regular breast examination so that cancer can be diagnosed at an early stage.  It has been found that the NBCAM campaign was initially effective in increasing diagnoses, but the effect has diminished over time as the movement has matured, and it seems that the benefits of mammography screening programs have been overestimated.  Unsurprisingly, it has been suggested that it is time for NBCAM to shift focus.  Additionally, many have been critical of the commercialization of NBCAM (see, e.g., the NFL’s “A Crucial Catch” campaign).

What do you think of NBCAM?  Of NHOs more broadly?  Personally, I was surprised at how few of the October NHOs I was aware of, even though medical charity is a topic of  personal and academic interest for me.

A Lack of Pep for PrEP

By Emily Largent

The Kaiser Family Foundation (KFF) recently conducted a survey of gay and bisexual men in the U.S. focusing on attitudes, knowledge, and experiences with HIV/AIDS.  The survey results, released Thursday, can be found here.  I was most interested in the finding that only a quarter of those surveyed know about PrEP (pre-exposure prophylaxis).

PrEP (brand name Truvada) is a combination of two medicines (tenofovir and emtricitabine) that has, if taken consistently, been shown to reduce the risk of HIV infection in people who are high risk by up to 92%.  The FDA approved an indication for the use of Truvada “in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk” in 2012.  The U.S. Public Health Service released the first comprehensive clinical practice guidelines in May of this year. Continue reading

Of Morals and Smartphones

By Emily Largent

Although many lament that the ubiquity of smartphones has contributed to a recent decline in etiquette, a study published this week in Science suggests that smartphones’ ubiquity may make them a valuable–if surprising–tool for studying modern morality.

Most moral judgment experiments are lab-based and driven by hypotheticals. By contrast, this was a field experiment that focused on the moral judgments people make in their daily lives. The authors recruited 1,252 adults from the U.S. and Canada. Participants were contacted via text message five times each day over a three-day period. Each time, they were asked “whether they committed, were the target of, witnessed, or learned about a moral or immoral act within the past hour.” For each moral or immoral event, participants described via text what the event was about; provided situational context; and provided information about nine moral emotions (e.g., guilt and disgust). Political ideology and religiosity were assessed during an intake survey.

Participants reported a moral or immoral event on 28.9% of responses (n = 3,828). Moral and immoral events had similar overall frequencies.  The authors found political ideology was reliably associated with the types of moral problems people identified.  Liberals mentioned events related to Fairness/Unfairness, Liberty/Oppression, and Honesty/Dishonesty more frequently than did conservatives.  By contrast, conservatives were more likely to mention events related to Loyalty/Disloyalty, Authority/Subversion, and Sanctity/Degradation.  Continue reading

Is it ethical to hire sherpas when climbing Mount Everest?

By Emily Largent

In “Is it ethical to hire sherpas when climbing Mount Everest?,” a short piece out today in the British Medical Journal, I suggest that the question of whether it is ethical to pay sherpas to assume risks for the benefit of relatively affluent Western climbers is a variant of cases–common in medical ethics–where compensation and assumption of risk coincide.  Consider offers of payment to research subjects, organ sales, and paid surrogacy.  As a result, medical ethics can offer helpful frameworks for evaluating the acceptability of payment and, perhaps, suggest protections for sherpas as we look forward to the next climbing season on Everest.

I owe particular thanks to Nir Eyal, Harvard Medical School Center for Bioethics and Harvard School of Public Health Department of Global Health and Population; Richard Salisbury, University of Michigan (retired); and Paul Firth, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital.

Take a look and let me know what you think.

“Gluten-Free” Labeling – Feeding a Fad

By Emily Largent

As of August 5, 2014, all foods labeled “gluten-free” must meet the requirements of the gluten-free labeling final rule.  The rule implements a portion of the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, which directed the Secretary of Health and Human Services to issue a regulation to define the term “gluten-free.”  The U.S. Food and Drug Administration (FDA) set a gluten limit of less than 20 parts per million for foods that carry the “gluten-free” label, which is the lowest level that can be reliably detected using scientifically validated analytical methods.

According to the FDA, the “final rule provides a uniform standard definition to help consumers with celiac disease manage a gluten-free diet.” Celiac disease is an immune reaction to eating gluten–a protein occurring in wheat, rye, and barley–that causes damage to the lining of the small intestine. This damage limits patients’ ability to absorb nutrients and can lead to a host of serious health problems. While there’s no cure for celiac disease, following a strict gluten-free diet can alleviate its symptoms. The new labeling requirements will surely give patients with celiac disease a powerful tool for managing their health, and has been lauded by patient advocacy organizations such as the American Celiac Disease Alliance.

Yet, folks with celiac disease won’t be the only ones keeping an eye on the new labels. While only three million Americans have celiac disease, avoiding gluten has become a food fad. Eleven-percent of households report that they buy gluten-free products, and almost a third of Americans report that they are trying to avoid gluten. Food producers feeding the growing appetite for gluten-free have put the gluten-free label on foods that never included gluten, like vegetables and yogurt. As a result, U.S. sales of foods labeled gluten-free (which may or may not have had gluten to begin with) have doubled to $23 billion in the past year from $11.5 billion four years ago.

Unfortunately, current research doesn’t support the numerous health claims that have been made about gluten-free diets. Moreover, buying gluten-free isn’t necessarily a healthier option—many gluten-free foods contain fewer vitamins, less fiber, and more sugar.  It will be interesting to watch what happens to the sale of “gluten-free” foods as the gluten-free labeling final rule takes effect.

Introducing the 2014-2015 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2014-2015 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.

Continue reading