From the category archives:

Ethics and policy

Smartphone key lock privacy mobile health Kenneth MandlPrivacy policies are a sore point for Internet users. At least once a year the pitchforks and torches come out when a company like Facebook or Twitter changes its policies around how it uses, sells or secures users’ data—things like browsing habits, phone numbers, relationships and email addresses.

You don’t hear as much hue and cry over the privacy of mobile health apps, where people store and track what are literally their most intimate details. But perhaps you should.

Because in fact, a recent survey of mobile health apps led by Boston Children’s Hospital’s Kenneth Mandl, MD, MPH, finds that only about 30 percent of mobile health apps have any kind of policy covering the privacy of users’ data. Full story »

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Ebola response ethics experimental treatment therapy ZMapp

Guinean Red Cross volunteers prepare to decontaminate a hospital in the capital, Conakry. (European Commission DG ECHO/Flickr)

The world paused for a moment when the news broke last week that two Ebola-infected American missionaries working in Liberia had received an experimental therapy called ZMapp. As I write this, both patients are back on U.S. soil, and seem to be responding well to the treatment.

But was it ethical?

That difficult question can be divided into two. First is the question of whether it was ethical to give the two patients a drug that, up to that point, had never been tested in people. The second—in some ways thornier—question is: Was it ethical to give the treatment to two Americans but not the nearly 1,850 West Africans infected in the outbreak (as of August 11)? Full story »

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Clinical excellence is the foundation of patient care. But at a recent TEDx Longwood event, Elaine C. Meyer, PhD, RN, co-founder and director of the Institute for Professionalism and Ethical Practice at Boston Children’s Hospital and an Associate Professor of Psychology at Harvard Medical School, offered insight on the other half of the health care equation: the human connection and the power of conversation.

Meyer’s moving presentation makes clear how communication—listening and sharing words of comfort—profoundly impacts patient experiences, as does its absence. Through heartfelt stories, including her own experience as a patient, her talk empowers physicians, nurses, social workers, psychologists and other medical staff to “be present” and communicate with patients and families compassionately.

“Dig deep, find your inspiration to have conversations,” Meyer says, because patients remember the words spoken to them and how those words made them feel.

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ADHD long term drug safety rare adverse events FDA approval Kenneth Mandl Florence BourgeoisYou’d think drugs meant to be taken by children for years would be studied in children for a long time to measure their long-term safety.

You’d think drugs for a condition affecting millions of children would be tested in many, many children to catch any rare side effects.

You’d think all this would happen before the Food and Drug Administration, an agency known for its strict criteria, approved them for marketing.

But if a new PLoS ONE paper by Boston Children’s Hospital’s Florence Bourgeois, MD, MPH, and Kenneth Mandl, MD, MPH, is any indication, you’d be wrong.

In it, the pair reports that the FDA approved 20 attention deficit hyperactivity disorder (ADHD) drugs over the last 60 years without what would be considered sufficient long-term safety and rare adverse event data.

Their findings, they say, point to larger issues in how the FDA’s approval process addresses the long-term safety of drugs intended for chronic use in children. Full story »

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boy with cerebral palsyThe start of what promises to be a lengthy, multi-part endeavor has begun unfolding on Capitol Hill. It’s an attempt to reform the Medicaid program so that children with medical complexity (those with a single, serious medical condition, or multiple chronic conditions) can receive higher quality care with fewer emergency department visits and fewer hospital admissions.

When you think of medically complex children, think of children living with conditions such as spina bifida or cerebral palsy, children dependent on ventilators or feeding tubes, or children with genetic disorders. They represent just 6 percent of the 43 million children on Medicaid—yet they account for about 40 percent of Medicaid’s spending on children. Their care is often fragmented and poorly coordinated.

The reform effort, led by more than 60 participating pediatric hospitals and supported by the Children’s Hospital Association (CHA), focuses on Medicaid because it’s the single largest insurance provider for children. The backdrop is a cost-conscious Congress that’s the most politically polarized ever, passing the fewest bills ever. Full story »

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Adult undergoes echocardiography guidelines for screening childhood cancer survivors for heart diseaseThe drugs and treatments developed over the last 50 years have transformed many childhood cancers from death sentences into largely curable diseases. However, those same drugs and treatments can have lasting or late effects on many different organ systems.

Such is the case with anthracyclines: Patients treated with these chemotherapy agents have a greatly elevated future risk of congestive heart failure (CHF).

For this reason, the Children’s Oncology Group (COG)—which brings together pediatric cancer experts from around the globe—currently recommends screening childhood cancer survivors with echocardiography every year or two, depending on their level of anthracycline exposure, for signs of asymptomatic left ventricular dysfunction (ALVD). If left untreated, this clinically silent condition can progress to congestive heart failure.

But are we screening the right survivors at the right times using the right methods? Answering that question for cancer and CHF would require prospectively studying thousands of survivors (itself a challenge, given childhood cancer’s relative rarity) for decades, which is neither financially nor logistically feasible. Full story »

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direct-to-consumer genetic testingLast November, the U.S. Food and Drug Administration issued a “cease and desist” order to 23andMe, a major purveyor of direct-to-consumer (DTC) genetic testing. In its letter to the company—issued after three prior warnings—the FDA reiterated its view that 23andMe’s Personal Genome Service (PGS) constitutes a medical device requiring further premarket evaluation:

FDA is concerned about the public health consequences of inaccurate results from the PGS device…we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses.

The FDA’s order, based on potential rather than actual medical harm, has generated a great deal of controversy. In a recent critique published in Nature, Robert Green, MD, MPH, of the Partners HealthCare Center for Personalized Genetic Medicine, and Nita Farahany, PhD, JD, of the Duke Institute for Genome Sciences and Policy, argued against regulating DTC genomic interpretation services as medical devices:

… doing so could put FDA regulations in greater tension with the First Amendment of the US Constitution, which protects the rights of individuals to receive information, and of ‘commercial speech’ ….the agency should avoid restricting consumer genomic testing unless faced with empirical evidence of harm. Full story »

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medical costsCan putting a price tag on childhood obesity propel treatment and prevention efforts into comprehensive action? Perhaps, says David Ludwig, MD, PhD, of Boston Children’s Hospital.

Although the U.S. Task Force on Childhood Obesity set a goal of dropping obesity prevalence among youth to 5 percent by 2030, efforts have failed to make a significant dent. Recent data indicate only slight dips in obesity prevalence among 6- to 19-year-olds in some states. And other data show that the prevalence of extreme obesity in children continues to rise.

With nearly 20 percent of U.S. children tipping the scales as obese, policymakers need not only to act but also to justify the investment in childhood obesity treatment and prevention programs.

Duke University researchers offered a helping hand in a review article in the April 7 online Pediatrics, estimating the incremental lifetime direct medical cost of childhood obesity. Their economic model showed a $19,000 incremental lifetime medical cost of an obese child relative to a normal-weight youth.

Ludwig, who directs the New Balance Foundation Obesity Prevention Center Boston Children’s Hospital, provides insights into the next steps. Full story »

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heavy child running ShutterstockSchools have manned the front lines in the battle against childhood obesity. Through the Healthy, Hunger-Free Kids Act of 2010, First Lady Michelle Obama has promoted low-cal lunches, fresh produce and more. Now, she hopes to ban junk food and soda marketing in schools.

Are these efforts enough to turn the tide? Offering healthy foods and promoting physical activity at school may not be enough to negate the impact of other unhealthy influences in students’ homes and neighborhoods, according to Tracy Richmond, MD, MPH, of Boston Children’s Hospital’s Division of Adolescent Medicine.

Richmond recently published a study in PLOS One that looked at how a school’s physical activity or nutrition resources might influence fifth grade students’ body mass index (BMI).

The study focused on 4,387 students in Birmingham, Ala., Los Angeles and Houston. “We wanted to find out if certain schools look ‘heavier’ because of their composition—meaning that kids at higher risk of obesity, like African American girls or Hispanic boys, cluster within certain schools—or whether something structural in the school influences BMI, like the facilities or programs offered,” explains Richmond. Full story »

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chopping block CHIP

Some believe that ACA's insurance exchanges leave gaps in pediatric protection.

Funding for the federal Children’s Health Insurance Program (CHIP) will run out in 2015. Will this leave many kids without health insurance?

About 8 million children currently receive health insurance through CHIP, created in 1997 to bring coverage to children whose families earn too much to qualify for Medicaid but not enough to buy private insurance. States administer the program and receive federal matching funds to cover costs. In 2009, Congress reauthorized funding for CHIP through 2015.

What will happen to CHIP beyond 2015 is uncertain, not just because of the funding deadline but also because of changes brought on by the 2010 Affordable Care Act (ACA). Many believe that the ACA’s Medicaid enrollment incentives and expanded tax credits will add so many lower-income kids to the insurance rolls that CHIP will become unnecessary and simply go away. Others, however, say that the plans sold through the ACA’s insurance exchanges could produce gaps in coverage for children, making it crucial to keep CHIP funded. Full story »

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