Newspaper article

How the Pharmaceutical Industry Created, Defined and Marketed 'Overactive Bladder Disorder'

Newspaper article

How the Pharmaceutical Industry Created, Defined and Marketed 'Overactive Bladder Disorder'

Article excerpt

A new investigative report published jointly last weekend in the Milwaukee Journal Sentinel and MedPage Today tells the troubling tale of how, almost 20 years ago, the pharmaceutical industry successfully launched a disease-mongering effort to expand the market for new incontinence drugs.

As reporters Kristina Fiore, John Fauber and Matthew Wynn point out, two physicians with financial ties to the pharmaceutical industry gave incontinence a new name in the late 1990s: overactive bladder disorder. They also redefined the condition's symptoms to include a strong urge to urinate, not just uncontrolled leakage.

That meant 1 in 6 American adults suddenly qualified for treatment -- specifically, with a "promising" new drug called Detrol, which was approved by the Food and Drug Administration (FDA) in 1998.

"A massive new market for drug sales was born," the reporters write. "Last year, sales of drugs to treat overactive bladder reached nearly $3 billion, even though experts say the condition is best managed without drugs at all."

Today, medical treatments for overactive bladder number more than a dozen, and include, in addition to drugs, such things as Botox injections, implantable neuromodulation devices (Medtronic's InterStim) and prescription patches. Some of these products work marginally better than a placebo at controlling the urge to urinate, but have not been shown to be more effective than behavioral treatments, such as bladder training, pelvic muscle exercises, weight loss and fluid management.

Furthermore, the pharmacological treatments are not without risk.

"While overactive bladder is not a life-threatening condition, the drugs used to treat it have been included in more than 12,000 adverse event reports to the FDA since 2013," write Fiore, Fauber and Wynn. "That includes nearly 200 deaths and more than 700 hospitalizations."

Among the examples cited by the reporters are "a 77-year-old man [who] died from kidney failure after taking the overactive bladder drug VESIcare and several other drugs," and "a 51-year-old woman [who] was hospitalized with paranoid delusions and difficulty urinating after taking the generic overactive bladder drug oxybutynin and other drugs."

Creating a disease

The article quotes University of Minnesota bioethicist Dr. Carl Elliott, who calls overactive bladder disorder a prime example of "disease-mongering."

"The basic idea is selling a drug by selling a disease," he told the Milwaukee Journal Sentinel/MedPage Today reporters. "You expand the diagnostic category to create a larger market for the drug."

Indeed, Fiore, Fauber and Wynn uncovered a 2002 slide presentation made by a then vice-president of Pharmacia, the company that developed the bladder control drug Detrol.

One of the slides, titled "Positioning Detrol," carries this subtitle: "Creating a Disease."

That vice-president acknowledged to the reporters that the subtitle "was not a good choice of words," but he said the words should not be taken literally. …

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