Tuesday, February 3, 2015

Overactive bladder: Is it a "disease"?

According to the Urology Care Foundation, the official foundation of the American Urological Association, 33 million Americans suffer from overactive bladder (OAB). That's 30% of all men and 40% of all women in the United States. The foundation estimates that the actual number is much larger because many people who have overactive bladder problems are embarrassed and do not seek care.

This represents a nearly twofold increase since 2001 when a paper written said 17 million people had the problem.

Its' not clear how either of the two sources cited above obtained their information.

Maybe you didn't know that there are two kinds of OAB. "Dry" is the one where the patient is able to get to the bathroom on time. "Wet" is the form that is accompanied by leakage of urine also known as the urge incontinence.

Here is something else you probably didn't know. The disease was virtually unknown before 1997.

What happened in that year?

A drug company, Pharmacia, had a drug called Detrol that they were originally going to market for the treatment of urinary incontinence. However the number of people with urinary incontinence was small. They decided to focus on people who had urinary frequency and urgency and declared that incontinence was not absolutely necessary to make the diagnosis of OAB.

As related in the book "Our Daily Meds," the drug company had to convince people who went to the restroom frequently and were previously treated with conservative measures such as restricting fluid intake and eliminating caffeine from the diet that OAB was not just an annoyance or inconvenience but a serious condition requiring professional medical care. They named it "Overactive Bladder."

A special supplement to the journal Urology in 1997 contained 30 articles about OAB, a number of which were written by doctors who were paid by Pharmacia.

Here is a graph by year for the 4803 papers listed in PubMed on the subject of OAB since the term first appeared in 1977.

Of the 69 papers written before 1997, only 7 used the term "overactive bladder."

There are now seven drugs for the treatment of OAB on the market. Consumer Reports says that none of the seven is clearly more effective than the others. The monthly cost of these drugs can be as low as $4.00 for a generic to $300 for a brand name medication.

In 2010, the website Decision Resources predicted that "the OAB drug market will increase from approximately $3 billion in 2009 to nearly $4 billion in 2019 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan."

Not a bad return for treating a disease that did not even exist until 18 years ago.


DCanes said...

I take issue with this post. (I have to say, overwhelmingly I love your posts in general).
I'm a urologist who occasionally treats patient with OAB, though it's not my subspecialty area. You're implying some kind of deceit here, and that's unfair.
It is standard practice to first try behavioral management (limit fluid intake, void on a schedule, limit caffeine and bladder irritants). Medications are not prescribed before first trying these obvious fixes. When this doesn't work, OAB medications often significantly improve these patients' quality of life. Understand, many of them are captive at home, or know the locations of every bathroom along their daily routes. They are grateful when the anticholinergic medications give them their lives back.
You may take issue at labeling this a "disease," but it's often what's needed to raise awareness and give patients courage to bring up embarassing issues to their PCPs. I have a problem with direct to consumer drug marketing, but this is a real symptom complex that in many cases does not resolve after limiting fluid intake.

Skeptical Scalpel said...

DCanes, thank you for commenting. I would be amazed and disappointed if everyone agreed with everything I wrote.

My problem is that this disease apparently went from obscurity to an epidemic with more than 10% of Americans being afflicted in a mere 18 years. Can you explain scientifically how that could have occurred? Before 1997, did 10% of the US population have it and just not tell anyone? Could the constant barrage of TV ads about OAB have any impact?

I think direct marketing of drugs to consumers is one of the worst things that ever happened.

DCanes said...

I don't see why this is so unusual. Whenever a symptom complex is first described, there is a surge of prevalent cases that come to the surface. Yes, they all had it and didn't know it was a "thing." Same goes for "metabolic syndrome" before it was described. I'm sure there are infinite examples. Millions of teenagers had "texting thumb" before texting thumb tendonitis was described.
At the heart of it all, I do agree that direct drug marketing to consumers is horrible, but the implication that OAB is a fake disease dreamed up to make profits is not correct.

Skeptical Scalpel said...

I see your point, but I'm not sure your examples are convincing. Metabolic syndrome comprises diseases that had been identified and treated for many years. There were already a number of drugs being used to treat the components. I don't believe anyone has come up with a drug to treat texting thumb, but I would not be surprised if a company did so.

Drs. Ben and Sarah Davies said...

SS. This is a bit of a crass post. OAB effects millions of Americans and is a massive problem. While I don't think you mean to be mean-spirited your post certainly sounds so. Lets be clear why OAB didn't exist 20 years ago - because physicians were not asking about it and patients were scared to tell their docs about it. In fact - hiding urinary incontinence sxs - is still a common roadblock in trying to help patients. Of course direct marketing is heinous - of course the proliferation of me-too drugs is silly, but none of those facts are OAB patient's fault. The rise of OAB drug coincides with the realization that OAB is a real (and profitable) problem - why you feel the need to make fun of the disease and not pharma I do not understand. Stick with General Surgery.

Skeptical Scalpel said...

My aren't we a little touchy. I'll say it's profitable--$3 billion 6 years ago and still rising is impressive.

Dr. Kai Probst said...

I'm with my fellow urologists David Canes and Ben Davies here. You are basically assaulting a whole group of patients by saying their problem is fake and made up by the pharmaceutical industry.
Yes, many times new drugs are the reason why a disease gets new attention or starts to be described properly, but thinking that OAB didn't exist before 1997 is just plain nonsense. Like Ben Davies said very precisely: this is one of those issues that patient have a very hard time dealing with, and are very reluctant to see a doctor about. Go and check on the statistics for erectile dysfunction before Viagra came out and see how it developed since then - and I hope you don't want to say that ED didn't exist before that as well.
Pushing a subject with money has its ups and downs: yes, the company makes a lot of cash but on the other hand a lot of patients finally have the attention they need and can get a remedy.
I think you dug too deep into a subject you don't know enough about, no offense intended. Your blog is still very enjoyable otherwise, so keep up your work!

Big George said...

As someone who owns a blog dedicated to stamping out doctor stupidity, I have to say that it seems obvious no statistics would exist for a disease prior to it being identified.

Skeptical Scalpel said...

Kai, thank you for the (mostly) kind words. I don't think I said every patient didn't have the problem. I just think it may be over-hyped.

Big George, I have to take issue with your comment. It's one thing to say what you said about something like AIDS which was truly a disease that came out of nowhere. I just found it hard to believe that >10% of the population kept quiet about OAB until the drug company gave it a name and started promoting their drug. Maybe that's what happened, but I doubt it.

Scott said...

I've gotta say that I totally agree with my fellow urologists. While I really enjoy most of your writing, I found this article completely insulting. I'm not sure why you find it so hard to believe that people were afraid to talk about symptoms like this with their doctor before this condition was widely discussed. As with many things in urology, patients can be less than forth coming and those are the patients who get to us in the first place! When a patient sees something on TV (as gross as direct marketing often is), they may feel that it's more appropriate to talk with their doctor about. To refer to OAB as a fabricated diagnosis is both ignorant and insulting to everyone suffering (and they are suffering though maybe just not as quietly as they once did) from this condition.

Anonymous said...

I'm a urology resident from the University of Toronto - you are speaking to our faculty next week.

While no citations of 'overactive' bladder exist before 1997, there are quite numerous reports of 'bladder instability', 'idiopathic bladder irritability', 'unstable bladder'.

These various terms refer to similar concepts, for example, 'Unstable bladder is due to decreased bladder capacity and reduced ability to inhibit voiding'. American Family Physician. 28(4):243-7, 1983 Oct.

A simple search on MEDLINE restricted to the years 1902-1983 (for illustrative purposes) with the keywords: unstable, irritability, and bladder reveals a vast scientific literature on this topic. Happy to send you the references if you are interested.

Your point about the commercialization of medical diseases is well taken. But I believe the bulk of your argument came from finding a lack of citations on the topic. I agree that the changes in terminology are confusing.

Will you agree that 'A rose by any other name smells just as sweet'?

Henry Woo said...

Interesting piece but I must disagree with you on this one SS.
OAB has always been around but under different labels or as an entity swept under the carpet.

Previously we have used terminology such as irritable bladder, frequency urgency syndrome, unstable bladder, detrusor instability etc etc as ways of describing this constellation of symptoms. In men, it was erroneously lumped in with BPH.

As mentioned by others, OAB symptoms were not taken adequately seriously enough in the past but another important factor is that treatment for such symptoms was just plain terrible. These symptoms therefore fell into that group of conditions where nobody wanted to be an expert on because there was little that could be done about it. It was the type of condition that doctors did not want to ask about, in part due to frustration of there not being a great deal one could do about it. It was the type of condition where your heart sank as you read the referral letter before seeing the patient because you knew that there was little that you could do for that patient.

The term OAB was not coined by the pharmaceutical industry although it did arise from clinicians who were working with them in an advisory or research capacity. Rather, common usage of the term arose following the WHO First International Consulation on Incontinence held in 1998. This conference was not sponsored by the pharmaceutical industry. This consensus meeting as well as the efforts of other bodies such as the International Continence Society enabled us to better define lower urinary tract symptoms and more importantly enabled clinicians to talk the same language with standardised nomenclature.

So why has it become so big? First, better understanding of the condition and secondly, it coincided with the development of drugs that actually work. Once you have a condition where there is effective treatment, it is going to bring people out of the woodwork.

In short, I think your piece demonstrates how easy it is to make 1 + 1 = 3.

D Chen said...

I would point out that the critique on pharmas role in this ignores the high cost already incurred by the (mostly) women who have long experienced this problem but did not have a voice or ability to recognize it as a medical issue. Managing incontinence is already a big business and social cost (>$15B in many estimates for pads, etc) A recent study (yes, funded by pharma) estimates annual cost per person at $900 simply for managing urinary leakage (laundry, protection, incontinence pads). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1557394/
Maybe this is mostly cost shifting from Kimberly-Clark to meds, but there is well documented PRO quality of life improvement in addressing the root cause instead of only leaving patients to simply deal with the end result of the problem.

Vamsi Aribindi said...

Dr. Scalpel,
I think you are commenting on a very real problem- the re-labeling of normal variation as pathology by pharmaceutical companies eager to sell drugs. I think the purest representation of the problem is "age related hypogonadism", where endocrinology has turned normal decrease in testosterone levels as males age into a pathological process needing treatment with extremely expensive testosterone patches.

The question is, is Overactive Bladder a pure representation of this phenomenon? I'm not so sure that it is. I certainly agree that 10% of the population seems a bit high, but then again it is certainly true that the medical profession didn't recognize many diseases of every day life for many years.

Vamsi Aribindi

Skeptical Scalpel said...

I invite all of you to read this section of the book "Our Daily Meds" and tell me which parts of it are wrong. Here's the link: https://books.google.com/books?id=tyyvqAinhE8C&pg=PT17&lpg=PT17&dq=neil+wolf+ad+age+magazine&source=bl&ots=O47UgmQVBG&sig=rQMovbneaqYvuWH0fB7f49UFl1w&hl=en&sa=X&ei=Lw7SVNC8HMqNsQTEmIGgAQ&ved=0CC0Q6AEwAg#v=onepage&q=neil%20wolf%20ad%20age%20magazine&f=false

Scroll up to the beginning of the first chapter entitled "Creating a Disease."

artiger said...

Well Scalpel, I'll say that you aren't afraid to step out there in it.

Maybe as a decoy you could post something about ABIM's "we got it wrong with MOC" statement?

Skeptical Scalpel said...

Everyone is writing about MOC. I'll leave it to others. I see none of the closed minded urologists have commented on the link I posted in my comment of 7:27 this morning.

Henry Woo said...

Thanks for the reading suggestion. I will put it on the long list of books that I have to read. To be clear, I am not trying to defend the bad behaviour of pharma and I have in fact been quite critical of their behaviour here: - http://surgicalopinion.blogspot.com.au/2013/06/how-to-make-yourself-unpopular-with.html
Whilst the pharmaceutical industry has done much to deserve criticism, I really think that you have got it all wrong on the issue of OAB.
(Disclosure: I do NOT act in an advisory capacity nor am I in receipt of any remuneration from any pharmaceutical company but I do act in an honorary capacity as a site inverstigator in international multicenter clinical trials unrelated to OAB therapies)

Skeptical Scalpel said...

Henry, thanks for the link. Nice post. You think I got it all wrong? You believe that 10% of the people in the US (and I presume Australia too) have OAB and the drug companies didn't create a demand for their drugs? Please read the link I posted in my comment above and then let me know if it changed your mind in any way.

Drs. Ben and Sarah Davies said...

"none of the closed minded urologists have commented on the link" this from a surgeon without a name. you have literally no idea what you are talking about. just stop it already. its embarrassing and offensive

Henry Woo said...

Yes. I think that the figures are absolutely real but of course skewed towards the older population (and there are many more of them than back in 1997). Just because people you mix with do not have the problem does not mean that it is not out there - many avoid going out for the very reasons of having OAB symptoms. Frequency Urgency and Nocturia are not really that FUN to have.

Both industry and non-industry data comes up with similar figures. The data mirrors my clinical experience working as a urologist seeing people suffering from OAB on a daily basis. It mirrors the experience of other urologists, including those who have commented here.

I did click your link which took me to some book reviews and opportunities to buy the book. Maybe its a geo-block or something but there was no option to read an electronic version. The 4 Australian suppliers offered to me either said it was not available or 'out of stock'. My only option is to purchase from a US supplier/Amazon or Ebay and that will take time - even when I receive it, I have all these Ben Goldacre, Atul Gawande, etc etc books to read. So that's my excuse for not being able to respond to a chapter on the subject in that book.

Anonymous said...

Dr. Woo and others - here is the link to the Google Books page that Skeptical Scalpel is referencing: http://goo.gl/rSMIMR

There may in fact be a geo-block on the page which is why you aren't able to read it. To summarize, it's a description of marketing strategies used by the drug company Pharmacia in hawking Detrol, involving physicians on its payroll, paying to publish the proceedings from its own symposia in Urology, and generally behaving in its own interest, that is to say unscrupulously.

I disagree with both parties on this page. OAB is clearly a clinical entity that we see often. However, I think the real scandal - and what is being missed in the exchange here - is the gaming and cynical manipulation of urologists and other physicians in order to ensure that Pharmacia controlled the OAB market. In other words, it's not that drug companies "manufactured" OAB, it's that drug companies used doctors as pawns in a bid to corner the demand for OAB treatments. Either way, it's disgraceful.

Skeptical Scalpel said...

Dr. Woo and Anon, thanks for your comments. A friend just send me a link to an article about a recent paper describing an association between anticholinergic use and dementia. Some of the OAB drugs are in this category. Here's the link. http://www.medscape.com/viewarticle/838788?src=wnl_edit_tp10

Skeptical Scalpel said...

Readers might be interested in the two links that follow. The first is a description of the marketing strategy for Detrol and overactive bladder as told by the Pharma Marketing Blog. The second is the slide deck used by the marketing exec at Pharmacia which discusses how it all was done..



Anonymous said...

I've avoided commenting as I follow this from a distance, and even though I'm just a naive medical student, that slide set is pretty damning.

Skeptical Scalpel said...

Anon, you are welcome to comment at any time. I agree with your assessment of the slides.

William Reichert said...

This post reminds me of a similar phenomenon going on with the
diagnosis of "sleep apnea". Initially sleep apnea was diagnosed when a person was shown to have many episodes of total apnea during a night of sleep for several seconds at a time..Then ,later, the diagnosis was broadened to include folks did not show apnea but showed "hypopnea" or episodes when the breathing was not absent but somewhat shallower than other times. Then finally the diagnosis was further broadened to include folks do did not have apnea, and did not have hypopnea but had episodes when the breathing was normal but took a little more "effort" to breathe. A lot of money is being made running the tests to diagnose this disease. I will not take a position on the "outcomes".

Skeptical Scalpel said...

Good point. By the way, it is amazing how threatened some urologists were by this post. One of them stopped following me on Twitter and blocked me from seeing his tweets..

Skeptical Scalpel said...

For all the naysayers:

Two days ago, the Milwaukee Journal-Sentinel published an investigative report that backs up everything I said in the above post.

If you are interested, here's a link to the story: http://www.jsonline.com/story/news/investigations/2016/10/16/overactive-bladder-drug-companies-helped-create-3-billion-market/92030360/

Post a Comment

Note: Only a member of this blog may post a comment.