We may all be in trouble if, as he suggests in a recent New York Times op-ed, Dr. Jerry Avorn is having a hard time keeping up with his reading. Avorn, a Harvard physician and epidemiologist, is best known for exposing some of the less appetizing sales and marketing practices of the pharmaceutical industry and for promoting publicly-supported—as opposed to corporate-sponsored—medical education about prescription drugs. As prolific an academician as there ever was, he counts himself among busy clinicians who get overwhelmed with the constant flood of research findings and updates, and often turn to clinical practice guidelines—typically developed by experts in their fields and/or leaders of professional associations—to keep up with their field’s state-of-the-art developments.
Technically, there’s nothing wrong with that, but there’s a catch that reporters, especially, must know. Let your fingers do your walking through the rolls of the US Department of Health & Human Services’ National Guidelines Clearinghouse, and you’ll find hundreds of generally up-to-date guidelines vetted by HHS’s Agency for Healthcare Quality & Research, in areas from allergy to urology and everything in between. Most are based on combinations of published research findings, data meta-analyses, and expert opinions. But, as Avorn mentions in his editorial, often that research is funded—and those guidelines potentially influenced—by the commercial interests of drug and medical device manufacturers hoping to expand their markets.
You will find no better description of this phenomenon than in a magnificent 2005 Seattle Times series called “Suddenly Sick” by Susan Kelleher and Duff Wilson. It should be required reading for all journalism students and, maybe even, for anyone who ever took a prescription drug. Kelleher and Wilson weave poignant (and most likely all-too-familiar) patient stories with in-depth reporting of the relationships forged among academic medicine, professional associations, and Big Pharma. The title refers to one of the most insidious practices that has, for years, been a regular element within pharmaceutical marketing and public relations plans: finding ways to lower the threshold of what’s considered a normal level of a particular health measure and getting them included in national clinical practice guidelines.
“Suddenly Sick” profiles several disease areas where this has happened. Two examples are hypertension (high blood pressure) and osteoporosis. The work of several international- and US-based clinical practice guidelines committees resulted in 2003 in a new diagnosis, called “pre-hypertension,” which considered people with blood pressures of 120/80 as in need of treatment. Before the “pre-hypertension” guideline, that number was well within normal limits. Another diagnosis described in the series was “osteopenia,” which expanded the osteoporosis—diagnostics and treatments—market substantially, by including most women over 50. The reporters make a direct link between Big Pharma’s influence and the emergence of these “pre-disease” diagnoses.
This all brings me back to the days when I, gracing the halls of PR agencies and their Big Pharma clients’ offices, participated as a consultant and writer in meetings designed to cultivate “key opinion leaders” and “thought leaders.” These were the physicians, researchers, and heads of disease/patient organizations and professional societies that pharmaceutical companies and their agencies targeted because they were already on, or were imminently to become members of—you guessed it—clinical practice guidelines development committees.
This task was often the top priority for the PR agency’s client contacts, who were either product managers or some who had a title like, “clinical liaison.” Some were given bonuses for cultivating those contacts and getting them onto such committees or advisory boards. No judgments—just the facts, dear reader.
The American Diabetes Association, for example, released updated clinical practice guidelines earlier this year. Take a look at the section that lists the names, affiliations, and grants for members of the professional practice committee. Under research grants (and there’s even a column for supplies), you’ll see some of the top diabetes drug and supply manufacturers: Novo-Nordisk, Eli Lilly, Aventis, Nestle, among many others.
Cynicism aside, clinical practice guidelines are good resources for healthcare journalists to get an idea of who the players are in a particular disease area. They’re good jumping-off points to find expert interviews, but should not be relied on solely as sources. Even those released by well-known organizations like the American Diabetes Association or the American Urological Association, which updated prostate cancer screening guidelines in May, must be scrutinized for potential commercial influence.
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