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If you have high blood pressure, you may be at risk for heart disease. And given that an estimated 65 million Americans have hypertension, it's not surprising that drugs to treat it are among the most prescribed medicines in the world. But why stop at prescribing drugs to people whose readings are 140/90 or higher, the standard definition of high blood pressure? In the Apr. 20 issue of The New England Journal of Medicine, a research team reported on "prehypertension," the condition of being in danger of developing hypertension.

Prehypertension was first identified in 2003, and some studies claim as many as 50 million U.S. adults have the condition, defined as blood pressure readings from 120/80 to 139/89. This risk of being at risk can be modified with diet and exercise, but the NEJM study reports that it can also be treated with Atacand, a drug from AstraZeneca Pharmaceuticals PLC (AZN).

To a growing chorus of physicians and health-care specialists, the very idea of treating the risk of a risk is wrong. They have labeled the phenomenon "disease-mongering," defined as the corporate-sponsored creation or exaggeration of maladies for the purpose of selling more drugs. Prehypertension "is a classic case of a risk factor being turned into the disease," says Dr. Steven Woloshin of the Veterans Affairs Outcomes Group in White River Junction, Vt. "If you make a cut-off for blood pressure that's close to the normal range, then just about everyone can be diagnosed." An AstraZeneca spokesman responds that the trial was considered important enough to be published in the prestigious NEJM. "I think that speaks for itself."

DEMAND FOR A QUICK FIX

According to critics, disease-mongering is on the rise. It starts when a drug is developed for some once-rare condition. Then heavily promoted disease-awareness campaigns kick into gear, leading to increasing numbers of diagnoses and prescriptions. The list of suspects includes restless legs syndrome, social anxiety disorder, premenstrual dystrophic disorder, irritable bowel syndrome, female sexual dysfunction, and more. "Of course, some people have these diseases very seriously," says Dr. Robert L. Klitzman, a psychiatrist and bioethicist at Columbia University. "The problem is that mild cases are being made to seem more serious than they are."

The other problem, say the anti-disease-mongerers, is that the vagaries of everyday life, such as sadness, shyness, forgetfulness, and the occasional upset stomach, are being turned into medical conditions. Before Pfizer Inc.'s (PFE) Viagra was introduced, erectile dysfunction was a medical problem only when associated with an underlying biological cause, such as diabetes or prostate cancer. Now, Pfizer's Web site claims that half of all men over 40 have problems getting or maintaining an erection. Social anxiety disorder, defined as severe shyness, was rarely seen until GlaxoSmithKline PLC's (GSK) Paxil was approved to treat it. A disease-awareness campaign by Glaxo in the late 1990s, with the tag line "imagine being allergic to people," was quickly followed by rising prevalence estimates.

Disease promotion is not just the purview of drug companies. "Doctors should set more boundaries," asserts Dr. David Henry, a pharmacology professor at the University of Newcastle in Australia and a leading critic of disease-mongering. Then there are patients seeking a quick fix for conditions that might better be treated through lifestyle changes. "Drug companies are playing off the desire we all have to get rid of things that bother us," says Klitzman. But ridding oneself of bothersome symptoms without changing the behaviors that contribute to them can mean taking a pill every day for years, a proposition that is both risky and costly.

YOUNGER AND YOUNGER

Also of concern are efforts to expand the definition of serious diseases to cover more and more people. Loosened criteria for bipolar disorder, a dire psychological disease once thought to affect only 0.1% of the population, have led some experts to claim prevalence rates of anywhere from 5% to 10%. Dr. David Healy of Cardiff University in Wales says the higher estimates are based on ill-defined surveys that followed the introduction in the mid-1990s of mood stabilizer drugs, promising relief even for people with mild emotional swings. In the U.S., children as young as age 2 are being diagnosed as bipolar even though, in the classic definition of the illness, symptoms don't usually show up until the teens. "These young kids are started on two or three medicines when there isn't even any evidence that any of them work in children," says Dr. Jon McClellan at the University of Washington in Seattle.

Disease-mongering isn't new. The term was coined by Lynn Payer in her 1994 book Disease-Mongers: How Doctors, Drug Companies, and Insurers are Making You Feel Sick. But the advent of direct-to-consumer advertising in the U.S. in 1999 fanned the trend, say drug industry critics. Their complaints reached a critical mass this spring. The April issue of the journal PLoS Medicine ran 11 articles on disease-mongering to coincide with the first conference devoted to the topic, held Apr. 11-13 in Newcastle.

Drugmakers say they're only trying to educate patients who are struggling with serious illnesses. "We realize that not every medicine is for every person," says a spokeswoman for Glaxo, which makes drugs for restless legs syndrome, social anxiety disorder, and other diagnoses that are under fire. "The labels contain important information about whether it's appropriate, and we're confident that doctors consulting with patients will assess their health-care issues and the risks and rewards and make an appropriate decision."

The skeptics aren't convinced that doctors will be so discriminating, in part because many get their information about disease treatment from the drug industry. Pharmaceutical companies routinely subsidize continuing medical education courses for doctors. They fund research for diseases that then gets published in medical journals, and they underwrite patient advocate groups, which in turn promote the underwriter's drugs on their Web sites. Witness the Child & Adolescent Bipolar Foundation: It lists four pharmaceutical companies as major donors, including Eli Lilly & Co. and Janssen LP, makers of leading mood stabilizers.

All these factors come into play with restless legs syndrome, a case history detailed in PLoS Medicine. Defined as the urge to constantly move one's legs, the condition can be truly disruptive for people with severe symptoms, but such severity is considered rare. That didn't stop GlaxoSmithKline from launching a disease awareness campaign in 2003. The company kicked off the blitz with a press release stating that a "new survey reveals a common yet underrecognized disorder -- restless legs syndrome -- is keeping Americans awake at night." News articles proliferated, most stating that the condition affects up to 10% of adults in the U.S., based on the study Glaxo promoted.

In 2005, Glaxo's Requip, a treatment for Parkinson's disease, was approved for restless legs. At the same time the Restless Legs Syndrome Foundation, which receives funding from Glaxo, issued a press release about "a new national survey that shows [the] syndrome is largely underrecognized and poorly understood." A Glaxo spokeswoman says that most Requip prescriptions are written for Parkinson's.

The VA's Dr. Woloshin grants that some people are helped by Requip, Paxil, and Viagra. But he worries that overtreatment drains money from research into more serious illnesses. "None of these companies is coming up with a cure for TB," he notes. That's a disease no one is trying to monger.

By Catherine Arnst


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