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.
“We didn’t create a disease,” he said. “We created awareness of a condition so that people who suffered from the condition could recognize themselves and talk with their doctors.”
As anyone who watches television knows, the idea that urinary frequency or urgency is a medical condition that needs to be treated is widely promoted. (Think about the “gotta go right now” Detrol TV ad that shows a crossing guard stopping traffic so she can run to a nearby restroom, or the Myrbetriq ad in which a cartoon bladder drags a woman away from a bowling game to search for a restroom.)
What’s not made clear in those TV ads is the “big difference between having incontinence, or leakage, and just having frequency or urgency,” write Fiore, Fauber and Wynn.
“And there could be various reasons why people have to urinate a lot, from organ prolapse and prostate disorders to neurological dysfunction — conditions that may have nothing to do with the bladder,” the reporters add. “… When these conditions are missed, doctors say, and patients are deemed to have overactive bladder, it leads to the treatment of symptoms, but doesn’t actually cure anything.”
You won’t find that message in the TV ads.
“It seems like the disease has already been created,” Elliott told the reporters. “Pharmacia already did it when they re-branded incontinence as [overactive bladder] for Detrol, and it seems like [pharmaceutical companies] are just piggybacking on top of the work that’s already been done.”
In 2012, a panel of experts convened by the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction issued guidelines to physicians to help them diagnose and treat overactive bladder.
Although the guidelines state that nondrug behavioral training should be the first treatment offered to patients, they also emphasize that patients could be given drugs while undergoing behavioral therapy.
Furthermore, only about one page of the guidelines is devoted to behavioral therapies, while 20 pages discuss drugs and other treatments.
In 2014, another panel of experts, brought together by the American College of Physicians, issued guidelines for treating urinary incontinence in women. Their recommendations emphasized behavioral therapies, such as pelvic floor muscle exercises and bladder training, and advised against using drugs for stress incontinence. Drugs could be used, the experts said, but only when bladder training proved unsuccessful.
Eight of the 11 experts on the 2012 panel had financial ties to companies that market treatments for overactive bladder, report Fiore, Fauber and Wynn.
None of the six experts on the 2014 panel had such ties.