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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.