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.

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

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.

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

Actual causes of death in the U.S.: not what you think

Any standard public health or medical school prevention text includes (or ought to include) some version of the figure below, which illustrates that the leading causes of death in the U.S. at the turn of the century (heart disease, cancer, stroke) were actually surrogates for what have come to be known as the actual causes of death: unhealthy behaviors such as tobacco use, poor diet, and physical inactivity.

The most effective preventive services that primary care clinicians provide, then, are not screening tests but counseling interventions that aim to change one or more of these behaviors for the better. Community-level initiatives such as tobacco-free restaurants and campuses, pedestrian-friendly cities, and increasing access to nutritious food sources play a critical role in changing health-related behaviors, too.

Unfortunately, the impact of behavioral or "lifestyle" approaches to prevention is likely to be limited by two factors: 1) even intensive interventions produce very modest benefits; and 2) behaviors don't exist in a vacuum, but are largely shaped by economic and social circumstances. Family medicine professor and former U.S. Preventive Services Task Force member Steven Woolf has published a number of studies showing that the risk of death is strongly associated with levels of college education and income; his research team at Virginia Commonwealth University worked with the Robert Wood Johnson Foundation to develop an interactive County Health Calculator that illustrates how many premature deaths could be avoided by eliminating educational and income disparities.

Researchers from Columbia University went a step further by publishing "Estimated Deaths Attributable to Social Factors in the United States" in this month's issue of the American Journal of Public Health. Using estimates derived from the literature on social determinants of health and year 2000 mortality data, they found that the "actual" causes of death looked like this:

1) Low education: 245,000

2) Racial segregation: 176,000

3) Low social support: 162,000

4) Individual-level poverty: 133,000

5) Income inequality: 119,000

6) Area-level poverty: 39,000

Clearly, we know a great deal more about successful strategies for fighting clinical and behavioral causes of death than we do about social causes, some of which often appear intractable. But I could not agree more with the authors' conclusion that "these findings argue for a broader public health conceptualization of the causes of mortality and an expansive policy approach that considers how social factors can be addressed to improve the health of populations." The point being: poverty, discrimination, and low education aren't just social or political issues best left to non-clinicians - they're health issues, too.

Mammograms and death panels: why the Preventive Services Task Force keeps pulling its punches

Health reform was supposed to have been good news for the U.S. Preventive Services Task Force. Until 2009, this independent panel of federally-appointed experts in primary care and preventive health was not particularly well known, and its evaluations of the effectiveness of clinical preventive services had no binding authority on public or private insurance plans. Within the small circle of physicians and policymakers who were aware of the their work, however, the USPSTF won accolades and respect for "calling it as they saw it," sticking strictly to the evidence and writing screening recommendations that frequently conflicted with more expansive guidelines promulgated by other professional organizations.

For example, the USPSTF differed from the Centers for Disease Control and Prevention in finding insufficient evidence to screen for hepatitis C, and only recommending HIV screening in high-risk patients (rather than universal screening between the ages of 13 and 64). Unlike the American Diabetes Association, which endorses testing for diabetes in all patients age 45 or older, the USPSTF found that the evidence supported screening only patients with high blood pressure. The Task Force clashed with the American Academy of Opthalmology in finding insufficient evidence to support routinely screening adults for glaucoma. And it checked the pharmaceutical company-supported enthusiasm for COPD screening by concluding that there was no benefit to routine spirometry in adults without respiratory symptoms.

A more politically-minded group (as federally-supported guideline committees tend to be) would probably have been unable to make such a series of controversial statements without stirring up a public backlash. But here, the USPSTF's low profile served to protect it from the advocacy groups that dominate conversations about federal coverage for health care services. But in 2009, that all changed, as the Task Force was prominently featured in health reform legislation proposed in the U.S. House and the Senate. Ultimately, the Affordable Care Act mandated that USPSTF-endorsed ("A" and "B") preventive services receive first-dollar coverage from Medicare and private health insurance plans.

Scrutiny of the USPSTF quickly intensified, especially after it issued a politically-radioactive new statement that stepped back from recommending routine mammography for women in their 40s. It was tagged as a "death panel" that, in the words of one spectacularly misinformed newspaper columnist, had "gone rogue" and ought to be immediately dissolved. (Not coincidentally, there is a Roger Maris-sized asterisk in the ACA's list of USPSTF "A" and "B" services that basically directs insurers to disregard the USPSTF's 2009 breast cancer recommendations and instead rely on the 2002 version.) With the Task Force literally fighting for its very survival, it was perhaps inevitable that politics would begin trumping science - which goes a long way toward explaining why members were willing to meekly go along with the absurd cover story that their November 2010 meeting was cancelled due to "scheduling conflicts."

In the 17 months since the passage of health reform, the USPSTF has been only a shadow of its independent self. After publishing an average of one new statement per month for most of my tenure on their staff (2006-2010), a public comment process imposed by the Agency for Healthcare Research and Quality turned into a bottleneck for releasing timely, evidence-based recommendations. None of the 4 new statements that have successfully traversed the public comment process has been particularly noteworthy. Osteoporosis: a modest expansion of screening to more high-risk women under the age of 65. Testicular cancer: a reaffirmation of the near-universal consensus that screening is not necessary. Prevention of newborn gonorrhea eye infections: affirming the standard of care. And earlier this week, the USPSTF retreated from its previous recommendation against screening for bladder cancer was not warranted, instead finding insufficient evidence to make a statement one way or the other.

Of course, a Task Force that makes few waves is exactly what the current Administration wants. Never mind that clinicians and patients must continue to wait for long-overdue updates on screening for prostate cancer, screening for oral cancer, breast cancer chemoprevention, and vitamin D and calcium supplements. (All of these topics had already been voted by the Task Force and were within months of publication in March 2010 but have been subsequently delayed, postponed, or suppressed from entering the public comment queue.) How long can this state of affairs reasonably continue? As the 2012 elections draw nearer, how likely is it that the USPSTF will be permitted to advance any science with even remotely political implications? And - though it pains me to ask - is a Task Force that is forced to pull its punches due to politics really that much better than no Task Force at all?

Is climate change a clinical health issue?

At first glance, the topic of the cover article of American Family Physician's August 1st issue, "Slowing Global Warming: Benefits for Patients and the Planet," might seem out of place in a journal that aims to provide practical clinical guidance for family physicians. Past summer-themed articles have included reviews of heat-related illness, medical advice for commercial air travelers, and even health issues for surfers. By recognizing climate change as a clinical health issue, AFP joins other widely read medical journals such as The Lancet and BMJ in recognizing the essential role that physicians can play in mitigating the negative impacts of environmental stress on patients' health.

After summarizing the serious potential health effects of climate change, Dr. Cindy Parker recommends that primary care clinicians counsel patients regarding two lifestyle changes that are likely to improve personal health as well as slow global warming: reducing meat consumption and increasing "active transportation" (substituting bicycling or walking for short car trips). In addition, physician practices and larger medical organizations can positively affect climate change by "going green":

Medical offices and hospitals can help by recycling; using recycled items and Energy Star certified appliances and computers; minimizing waste and waste transport by replacing single-use items with sterilizable or washable items; purchasing wind-generated electricity; and reducing energy use by turning off appliances, computers, and lights when not in use. In 2008, the U.S. health care sector spent $8.8 billion on energy to meet patient needs, not including the transportation of employees or patients to and from health care facilities, resulting in 8 percent of all U.S. greenhouse gas emissions.

In an accompanying editorial, Dr. Robert Gould reviews several national and international initiatives that encourage hospitals and health systems to reduce greenhouse gas emissions, including the Healthier Hospitals Initiative and Health Care Without Harm.

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

The best recent posts you may have missed

Every other month or so, I post a list of my top 5 favorite posts since the preceding "best of" list on this blog, for those of you who have only recently started reading Common Sense Family Doctor or don't read it regularly. Here are my favorites from June and July:

1) No easy victories in cancer screening and prevention (6/7/11)

2) The difference between health care costs and investments (7/27/11)

3) How politically unpopular research helps us make better medical decisions (7/13/11)

4) Advanced access and other ways to see a doctor - stat (6/29/11)

5) Malpractice reform: unfinished business (7/6/11)

If you have a personal favorite that isn't on this list, please let me know. As always, thank you for reading!