Saturday, 10 September 2011

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 decade that has passed since that awful day, I completed my residency, got married to a wonderful woman, began my career as a family physician, and had two beautiful children who are, thankfully, still too young to begin to 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, tomorrow and evermore.

Thursday, 8 September 2011

Compromising the medical literature

To ensure that its clinical review articles reflect current medical literature, the American Family Physician journal (of which I am an editor) requires prospective authors to consult several evidence-based resources that synthesize the best available evidence from clinical trials and other high-quality studies. The goal of this process is to produce unbiased recommendations for primary care physicians. But what if the authors of clinical reviews are actually professional scientific writers paid by pharmaceutical companies, rather than the physicians whose names are listed as authors?

In fact, drug-company funded "ghostwriters" have been publishing articles in the medical literature for years. A study by the editors of JAMA found that from 2 to 11 percent of articles published in 2008 in six major journals (including the New England Journal of Medicine) were actually written by people who were not named as authors. While the study could not establish that these ghostwriters had been directly financed by industry, the practice of writing up a scientific study and then recruiting a lead author (usually an academic physician under pressure to "publish or perish") has been well-documented in the case of previous "blockbuster" drugs that were taken by millions of patients for common conditions but later turned out to have dangerous or fatal side effects, including Wyeth's Prempro and Merck's Vioxx.

Ghostwriting is not the only way that the pharmaceutical industry is able to influence the interpretation of evidence in its favor. A Letter to the Editor in the Sept. 1 issue of AFP points out that a 2005 Cochrane Review on medications for diabetic neuropathic pain (cited in a 2010 review article on this topic) unintentionally exaggerated the effectiveness of gabapentin in treating this condition due to the manufacturer's selective publication of favorable trials and suppression of unfavorable ones. In an accompanying editorial, Drs. Adriane Fugh-Berman and Jay Siwek review these and other "stealth marketing" tactics that can potentially compromise the medical literature, along with ways that readers can help correct these biases:

Distorted information, once ensconced in the medical literature, is propagated by industry and by well-intentioned authors who unwittingly cite these studies. The medical literature is a permanent record that scientists and physicians rely on for decisions that ultimately affect patient care. Although the scientific process is never linear, the self-correcting process by which evidence is continually refined can be corrupted by the infiltration of medical journals with research studies and review articles distorted by a hidden marketing agenda.

Although there is no foolproof way for readers to detect undue industry influence, readers should be alert for marketing messages that disparage older, generically available drugs or that position newer branded (or upcoming) drugs as more effective, more convenient, safer, or filling an unmet need. The last sentence of the abstract is typically where the marketing spin is inserted. Readers should alert medical journals to suspicious articles by writing letters to the editor.

**

The above post was originally published on the AFP Community Blog.

Thursday, 1 September 2011

The promise and pitfalls of medical apps

Doctors of my generation have experienced dramatic changes in the way we access the information we need to care for patients. As a medical student 15 years ago, my "peripheral brain" consisted of fat textbooks sitting on office bookshelves or smaller, spiral-bound references stuffed into the bulging pockets of my lab coat. As a doctor-in-training, I replaced those bulky references with programs loaded onto PDAs. Today, smartphone apps allow health professionals at all levels to access the most up-to-date medical resources such as drug references, disease-risk calculators, and clinical guidelines—anytime, anywhere.



Apps have several advantages over traditional medical texts. First, the information is always current, whereas many textbooks are already dated by the time they hit shelves. If I have a question, I can look up the answer on my smartphone without leaving my patient’s side. And unlike textbook chapters, many medical apps have interactive features that help doctors choose appropriate screening tests for patients, recognize when immunizations are due, or calculate a patient’s risk of developing heart problems. Lastly, apps can enable remote monitoring of high-risk patients and reduce the need for office visits. In a small study published in PLoS ONE, for example, researchers found that patients hospitalized for heart vessel blockages were able to complete "supervised" rehabilitation exercise sessions in their homes with a portable heart monitor and GPS receiver that transmitted real-time data to doctors via smartphone.



But smartphone apps also have downsides—despite their enormous potential to improve the quality and convenience of healthcare. While textbooks undergo rigorous review by experts, apps vary in quality and don't have to be vetted for accuracy or safety. That point was driven home to me recently when a colleague shared a nifty app she’d downloaded that acted as a mobile electrocardiogram (ECG) monitor: Just place your finger tip on the smartphone's camera, and your heart rate and electrical rhythm appear on screen. Visions of chucking our office's bulky and temperamental ECG machine briefly danced in my head—until I tried the app out and found the readings to be completely wrong.



Concerns about app quality prompted the U.S. Food and Drug Administration to propose in July that certain interactive medical apps be required to get agency approval before being distributed or sold, similar to how new drugs and devices are evaluated for effectiveness before being allowed on the market. Proponents of regulating medical apps argue that guidelines are needed to protect patients from apps that provide misleading or potentially harmful data. However, others worry that regulation may stifle the production of innovative apps—often developed by individual researchers on shoestring budgets—that could potentially be useful in patient care. Also, although the FDA doesn't intend to regulate apps that simply allow doctors to read digital versions of print publications, it isn't clear exactly how "interactive" an app needs to be to qualify for regulatory review.



How might the recent explosion of medical apps affect your future healthcare experiences? According to a recent article published in the Archives of Internal Medicine, more than 80 percent of doctors will own smartphones by 2012. So it's likely that your doctor already uses one or more popular medical apps to double-check drug doses or to read summaries of the latest medical research. If your doctor is tech savvy, he or she may also be storing your health information in one of several electronic medical record systems accessible via smartphone. Given the uneven performance of medical apps to date, it’s best to view them with caution, as you would any new medical device. My advice: Ask your doctor which apps she uses regularly and make sure you’re comfortable with their quality and their ability to protect your personal data. That way, you can feel reasonably assured that apps will be an asset, rather than a hindrance, to reaching your health goals.



**



The above post was first published on my Healthcare Headaches blog at USNews.com.