Wednesday, September 21, 2016

In praise of individual health mandates

Five years ago, my family was involved in a scary traffic accident en route to the Family Medicine Education Consortium's North East Region meeting. I was in the left-hand eastbound lane of the Massachusetts Turnpike when a westbound tractor trailer collided with a truck, causing the truck to cross over the grass median a few cars ahead of us. I hit the brakes and swerved to avoid the truck, but its momentum carried it forward into the left side of our car. Strapped into child safety seats in the back, both of my children were struck by shards of window glass. My five year-old son, who had been sitting behind me, eventually required twelve stitches to close a scalp laceration. Miraculously, none of the occupants of the other six damaged vehicles, including the truck driver, sustained any injuries.



Family physicians like me, and physicians in general, like to believe that the interventions we provide patients make a big difference in their eventual health outcomes. In a few cases, they do. But for most people, events largely outside of the scope of medical practice determine one's quality and length of life, and public health legislation is more likely to save lives than the advice of well-meaning health professionals. My colleagues can counsel parents about car seat safety until they're blue in the face, but state laws requiring that young children be belted into car safety seats are what made the difference for my son between a scalp laceration and a life-threatening injury.

The often-derided individual health insurance mandate that is a prominent feature the Affordable Care Act is often compared by supporters to car insurance. If governments can require drivers to be financially responsible for their cars, the argument goes, why can't they require people to be financially responsible for their health-related expenses? The hole in this argument, of course, is that people aren't required to own cars the way that they "own" their bodies. But even the millions of children too young to drive and adults who choose not to are required to use seat belts or safety seats whenever they are passengers.

That, to me, seems to be the more apt comparison. As insurance against unexpected accidents and injuries, laws requiring seat belts and child safety seats are, essentially, individual health mandates. And it's well past time that all Americans buckled up.

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This post first appeared on Common Sense Family Doctor on November 1, 2011.

Wednesday, September 14, 2016

Drowning in a sea of redundant or flawed systematic reviews

As a medical officer for the U.S. Preventive Services Task Force from 2006 through 2010, I authored or co-authored several systematic reviews of the effectiveness of screening tests. Lately I have been wanting to assemble a team of colleagues to perform a systematic review of a research question that, to my knowledge, has not been satisfactorily answered for at least a decade (when there was insufficient evidence to answer it), but have been putting it off because I don't have the time. Doing a high-quality systematic review can require countless hours of work, which as a physician / medical teacher / editor / blogger I have been unable to find in my schedule.

Clearly many others do find the time, though. In the current issue of The Milbank Quarterly, my one-time collaborator John Ioannidis, a prolific dean of evidence-based medicine who is best known for his 2005 paper "Why Most Published Research Findings Are False," takes on the problem of "The Mass Production of Redundant, Misleading, and Conflicted Systematic Reviews and Meta-analyses." Ioannidis discusses the implications of an astounding 2700% increase in the number of systematic reviews appearing in the indexed medical literature between 1991 and 2014, a period during which the number of PubMed-indexed items only increased by 150%. He argues that this massive increase is not explained by the need to "catch up" with older published literature; rather, only a small percentage of studies are being included in these reviews, and so many systematic reviews are cataloging the same bodies of evidence that "it is possible that nowadays there are more systematic reviews of randomized trials being published than new randomized trials."

For example, between 2008 and 2012, 11 meta-analyses appeared on statins for the prevention of atrial fibrillation after cardiac surgery. The second of these reported a sizeable and statistically significant benefit, and the next 9 had similar findings. Case closed? Apparently not, since 10 more meta-analyses of the same topic were published between 2013 and 2015! In some cases, excessive production of systematic reviews seems to have a marketing, rather than knowledge-advancing, purpose. Redundancy as stealth marketing is particularly pronounced for certain drugs, such as antidepressants, where financially conflicted authors produced 80% of the 185 meta-analyses published between 2007 and 2014.

Finally, Ioannidis points out that reviews may be original and methodologically well-done but still clinically useless because they are purposely not published; they pool studies of outdated genetic approaches (candidate gene studies with small sample sizes and fragmented reporting, a favorite of Chinese reviewers); or they don't find enough consistent evidence to draw conclusions. In all, he estimates that only 3% of currently produced meta-analyses are "decent and clinically useful," meaning, of course, that the other 97% are not.

There are many possible solutions to this problem, including stricter standards for publication of reviews; altering current incentives for biomedical researchers to "publish or perish"; and establishing single, authoritative, publicly accessible systematic reviews that can serve as living documents to be updated periodically by teams of researchers (think Wikipedia for systematic reviews). After reading Ioannidis's article, I have decided that if and when I do find time to work on a systematic review again, I will do everything in my power to make it one of the 3% that are worth doing.

Sunday, September 11, 2016

9/11

On the morning of September 11, 2001, I was a family medicine intern making rounds at a teaching hospital in Pennsylvania. As I started writing a progress note on one of my patients, my senior resident emerged from the next room with tears streaming down her face. I couldn't imagine what had gone wrong. Had we just lost someone? Could I have possibly missed the distinctive overhead page for the Code Blue team?

It was worse than that - much worse. "It's horrible," she managed to say. "Absolutely horrible. I feel so bad for their families." I stepped into the room and saw both televisions airing live footage of the wreckage of the twin towers of the World Trade Center, where not one, but two commercial airliners had just crashed.

The rest of the day was a blur. It was nearly impossible to concentrate on the day-to-day routine of patient care when all I could think about were the thousands of lives claimed in the space of a few minutes. Later in the day I learned that a third plane had hit the Pentagon, and a fourth had crashed into a field about 150 miles west of my home. "This means war," one of my attendings stated flatly.

I had recently graduated from medical school in New York City, and after going home from the hospital, I tried calling former classmates who had chosen residency programs there. But the phone lines were jammed all night. It wasn't until the next day that I heard from a friend about how an army of physicians and medical students had mobilized at NYU's Bellevue Hospital, waiting for a massive influx of injured patients who never came.



In the 15 years that have passed since that awful day, I completed my residency, got married to a wonderful woman, began my career as a family physician, and had four beautiful children who are, thankfully, still too young to fully comprehend what kinds of warped beliefs would possess people to deliberately fly airliners into buildings full of their fellow human beings. Eventually, I know I will have to explain to them the events of 9/11. And tell them, too, about the healing that time, faith, hope, and love can bring about after even the most grievous of wounds.

To all the victims of 9/11, living and dead, may peace be with you, today and evermore.

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A slightly different version of this post first appeared on Common Sense Family Doctor on September 10, 2011.

Tuesday, September 6, 2016

The politicization of an epidemic: Zika virus and microcephaly

Every day for the past several months, Politico Pulse Check host Dan Diamond has posted a "Zika Virus update" on his Twitter account stating the number of days since the White House requested emergency funding to combat the epidemic (currently 211), how much Congress has appropriated in response ($0), and the number of Zika cases in the U.S. and its territories (currently >16,000). That there has been no funding response even as the virus continues to spread within the continental U.S. is testimony not only to longstanding Congressional gridlock, but to the politically charged nature of a sexually transmitted disease that can cause deformed babies, and therefore raise the issue of abortion. The Senate will vote today on a Republican-controlled bill that is identical to one that failed in late June due to Democratic objections over legislative "riders" stripping funds from the Affordable Care Act and Planned Parenthood. This vote has as much chance of succeeding as the earlier one did: zero. Both parties know this; they're just going through the motions. As a result, no new federal funding will be made available for disease surveillance or prevention, including the development of a vaccine.

As readers know, I get outraged whenever politics trumps science, especially when patients will suffer the consequences. But this story doesn't stop with the U.S. Congress. A potentially devastating piece of misinformation is circulating online that despite months of public health warnings, infection with the Zika virus is not responsible for Brazil's epidemic of microcephalic and otherwise brain-damaged babies. Instead, the story claims, the real culprit is the insecticide pyriproxyfen, which is manufactured by a Japanese affiliate of the widely reviled American biotech and agriculture company Monsanto. Supporters of this claim cite out of context a preliminary report published in the New England Journal of Medicine in June showed an extremely low rate of microcephaly in Colombia; of 12,000 women who were reported to be infected with Zika, none had given birth to a microcephalic baby. This finding is contrasted to Brazil, where pyriproxyfen was used to treat drinking water to kill mosquito larvae.

The key omission here is that most of the women in the Columbian study were still pregnant at the time the study was published. In fact, the only thing that the study's authors felt confident enough to conclude about the data was that Zika infection during the third trimester of pregnancy did not seem to be associated with microcephalic newborns, a finding that made sense given what is known about critical stages of fetal neurologic development. It was subsequently confirmed by a study of Brazilian and French Polynesian live births that reported "a strong association between the risk of microcephaly and [Zika] infection risk in the first trimester and a negligible association in the second and third trimesters." This study estimated that Zika infection raises the risk of having a baby with microcephaly from 2 in 10,000 (0.02%) to between 1 and 13%.

So what is keeping the pyriproxyfen hypothesis alive, a full six months after officials from the World Health Organization first shot it down? You guessed it: politics. Pro-life groups who worry about physicians advising Zika-infected pregnant women to abort their babies are apparently seizing on this misinformation to further muddy the waters of counseling, even though one could argue based on real data that the vast majority of Zika-infected babies will be fine anyway. Environmental groups, on the other hand, can't resist another opportunity to attack Monsanto.

How could this misinformation harm patients? Less insecticide in the air and water means fewer opportunities to control the mosquitoes that transmit Zika virus. Women who are even a little bit confused about the real cause of these birth defects might neglect to take mosquito-avoidance precautions or disregard the CDC's travel advisories. (And absent Congressional action, the CDC is rapidly running out of funding to deliver appropriate public health messages.) I am pro-life, I oppose abortion and capital punishment, and I believe that protecting the environment is a moral imperative. But I also believe in science. A public health crisis of brain-damaged babies is bad enough. Making it worse by twisting the facts to serve one's politics is nothing less than despicable.

Tuesday, August 30, 2016

Overcoming HPV vaccine hesitancy

Human papillomavirus (HPV) vaccines, which prevent infection with HPV genotypes that cause cervical, anal, vaginal, and penile cancers, are hardly new. The quadrivalent and bivalent HPV vaccines were reviewed in American Family Physician in 2007 and 2010, respectively, and a 9-valent vaccine was approved by the U.S. Food and Drug Administration in 2014. Although long-term studies have yet to demonstrate that HPV vaccines reduce cancer rates, a recent systematic review found that introduction of the quadrivalent vaccine in 9 countries (including the U.S.) was associated with a 90% reduction in infections from the targeted genotypes and similar reductions in genital warts and high-grade cervical abnormalities. Women who receive HPV vaccine are at considerably lower risk for undergoing colposcopy and associated invasive diagnostic or therapeutic procedures.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) recommends that all boys and girls receive the 3-dose HPV vaccine series at age 11 to 12. However, CDC data from 2014 show that only 40% of girls and 21% of boys had completed the series by age 17. (These percentages increased slightly in 2015.) In contrast, 80% of 13 to 17 year-olds had received meningococcal vaccine, and 88% had received TdaP (tetanus, diphtheria, and acellular pertussis) vaccine, which provide protection against serious, but comparably rare, infections. Earlier this year, all 69 National Cancer Institute-designated Cancer Centers released a consensus statement expressing concern about persistently low HPV vaccination rates in the U.S. compared to other countries, which they labeled a "serious public health threat."

A 2015 AFP editorial by Drs. Herbert Muncie, Jr. and Alan Lebato examined parental and physician impediments to HPV vaccination. Parents often express concerns about vaccine safety and worry that their children may be more likely to start having sex after receiving the vaccine. Family physicians can reassure parents on both of these questions:

Parental safety concerns about the HPV vaccine increased from 4.5% in 2008 to 16% in 2010, although the reported adverse effects have been minor (e.g., injection site reactions, syncope, dizziness, nausea, headache). Studies have shown that adolescents who receive the HPV vaccine do not initiate sexual activity earlier, nor is their risk of acquiring an STI increased.

In other cases, physicians have been the primary obstacles to vaccination: they are sometimes reluctant to bring up the topic of sex, they believe the vaccine is unnecessary because Pap smears will detect early cervical cancer, or they present the vaccine as "optional" or don't offer it at all. Drs. Muncie and Lebato suggested several effective strategies for improving HPV vaccination rates:

Instead of discussing the vaccine as a means of STI prevention, physicians can present it as a way to prevent cervical cancer in women and oropharyngeal cancer in men. They can mention that immunologic response is greater in younger adolescents, so earlier immunization is prudent. Physicians should encourage HPV vaccine administration at the same time that other adolescent vaccines are given. They should review immunization status at every visit, and administer the HPV vaccine at any time—including during sick visits.


An editorial in AFP's July 15th issue by Drs. Jamie Loehr and Margot Savoy provided additional tips for physicians on addressing and overcoming vaccine hesitancy in general. More immunization resources, including the latest childhood and adult immunization schedules from the ACIP, are available in AFP's Immunizations Topic Collection.

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This post first appeared on the AFP Community Blog.

Thursday, August 25, 2016

A family medicine perspective on cholesterol screening in children

The publication of the U.S. Preventive Services Task Force's updated guidance on screening for lipid disorders in children and adolescents has re-ignited an ongoing debate about the effectiveness (or lack thereof) of pediatric guidelines recommending universal screening for high cholesterol. As it did when it last reviewed this topic in 2007, the USPSTF concluded that there remains insufficient evidence to assess the balance of benefits and harms of this preventive service. Published reactions to this statement were mixed. Labeling lipid screening in children "low-value care," Dr. Thomas Newman and colleagues argued that any potential benefits of screening would likely be outweighed by harms and costs:

Recent analyses suggest possible benefit of statin treatment among selected adults whose 10-year risk of cardiovascular disease (CVD) events is less than the 7.5% value recommended by the American College of Cardiology and American Heart Association, ... although this remains controversial. No models suggest treatment at CVD risk levels anywhere near those seen in children. Because the absolute risk of CVD events in childhood is close to zero, screening and treatment in childhood will likely to lead to costs and harms without quantifiable benefit.

On the other hand, Dr. Stephen Daniels countered that requiring improvements in clinical outcomes such as cardiovascular events to recommend cholesterol screening was inconsistent with the USPSTF's previous recommendation to screen for obesity in children, which focused primarily on evidence for weight reduction:

In its analysis, the USPSTF noted that obesity is a common and serious health problem with long-term adverse consequences for which behavioral change therapy is available and successful. Why should we screen for obesity but have insufficient information to reach a conclusion for screening for heterozygous FH [familial hypercholesterolemia] when there seem to be important parallels in these clinical entities?

Both Dr. Newman and Dr. Daniels raise good points, and although Dr. Newman is himself a pediatrician, their opposing views represent the different perspectives of internists (adult physicians) and pediatricians. Much preventive decision-making in adults, from breast cancer to cardiovascular risk reduction, is driven by 5 to 10-year time frames. To the internist, if a child with high cholesterol at age 13 has a virtually zero risk of having a heart attack by age 23, why bother to screen? To the pediatrician, screening is justified because many childhood conditions have lifelong consequences, and it doesn't make sense to turn a blind eye when an intervention is available. Not every overweight child is destined to become an obese adult, but many will. Kids who don't know they have high cholesterol levels are probably less likely to behave in ways that lower those levels (even though good nutrition and physical activity should be emphasized at all well-child visits), and may end up with two-plus additional decades of atherosclerotic damage by the time they are diagnosed as thirty-something adults.

As a family physician who cares for patients across the entire lifespan, from newborns to nonagenarians (and centenarians, when I eventually see one in the office or hospital), I am sympathetic to both perspectives. I don't screen the vast majority of my child and adolescent patients for high cholesterol, and I do not prescribe cholesterol-lowering medications to children. My threshold for testing a child's cholesterol levels is based on my assessment that an abnormal result would alter my approach or the behavior of my patient and/or his or her parents. For example: the overweight child whose parents aren't particularly motivated by body mass index but who might be moved by a blood test. Or the normal-weight adolescent whose diet consists mostly of fast food and doesn't do any physical activity more vigorous than texting. I am all for debating the evidence, while recognizing that medicine remains an art.