In 2001, an automated telephone survey paid for by a drug company asked adults a simple, uncomfortable question: How often do you go?
The results produced a striking number: Nearly 17% of adults in the United States — some 33 million people — were declared to have overactive bladder disorder.
And a massive new market for drug sales was born.
Last year, sales of drugs to manage overactive bladder, once simply known as incontinence, reached nearly $3 billion — even though experts in the field say the condition is best managed without drugs at all. […]
While overactive bladder is not a life-threatening condition, the drugs used to treat it have been included in more than 12,000 reports of problems to the U.S. Food and Drug Administration since 2013. That includes nearly 200 deaths and more than 700 hospitalizations. […]
The drugs themselves work moderately better than a placebo, studies show, but not more effectively than non-drug treatments that pose no risk. Such behavioral therapies include bladder training, pelvic muscle exercises, weight loss and fluid management. […]
There are now more than a dozen overactive bladder drugs and treatments on the market, ranging from Botox injections and prescription patches to Myrbetriq, which uses an advertising campaign featuring a cartoon bladder. […]
‘Creating a Disease’
For decades, bladder problems were identified as incontinence or “detrusor instability.” The detrusor is the bladder muscle, which can squeeze too often — or without warning — and lead to feelings of having to go.
The conditions were generally considered a consequence of people getting older.
What followed was an example of illness inflation — an effort driven by drug companies to create or expand the definition of conditions that are part of everyday life and to create guidelines that call for treatment with drugs that are expensive and often dangerous. […]
Starting around 2008, after conducting a “comprehensive evaluation of post-marketing reports,” the FDA began requiring drug companies that make such drugs to add a label warning about such side effects.
Yet the Journal Sentinel/MedPage Today review of FDA records found reports of problems related to the drugs are continuing — since 2013, they were cited in nearly 200 cases, with patients noting confusion, a “confusional state” or feeling abnormal.
The analysis included only cases reported by medical professionals and drug companies. Since drug companies are the only ones that are required to file reports they receive, the real total could be much higher.
Another side effect of many of the drugs linked to confusion is dry mouth. In clinical trials, it was reported in between 20% and 30% of patients, depending on the drug.
Dry mouth can lead to tooth decay, but it also makes people want to drink more — which can be a problem if a person has bladder issues.
Diana Zuckerman, president of the National Center for Health Research noted there is another factor arguing against the use of drugs to treat overactive bladder.
While incontinence episodes are reduced moderately, they are not eliminated. That means protective pads likely still are needed.
“All of these drugs have the potential for serious risk,” she said. “So what’s the actual benefit? To weigh that against risks that can be serious, it’s pretty unimpressive.”