Authors

Emily Largent is an Assistant Professor of Medical Ethics and Health Policy at the Perelman School of Medicine. She also teaches at the University of Pennsylvania LawSchool. Her research examines ethical and regulatory issues arising in human subjects research and when integration of clinical research is integrated with clinical care; she has a particular focus on Alzheimer’s disease research. Emily received her PhD in Health Policy (Ethics) from Harvard and her JD from Harvard Law School. Prior to that, she received her BS in Nursing from the University of Pennsylvania School of Nursing and completed a fellowship in the Department of Bioethics at the National Institutes of Health.

FDA Updates System for Explaining Risks of Meds in Pregnancy

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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  The FDA also issued draft guidance for industry to assist drug manufacturers in complying with the new labeling and format requirements.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

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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.”  Read More

Update: Proposition 46

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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

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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.  Read More

Happy National Health Observances!

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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

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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. Read More

Of Morals and Smartphones

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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.  Read More

Is it ethical to hire sherpas when climbing Mount Everest?

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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

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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.