The Empire Strikes Back A Series of Critical Reviewsof Claims Made on Behalf of New Incontinence Products By John D. Perry, PhD |
The Empire Strikes Back #1
Ditropan XL and Alza Corporation
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Those of us who watch too much television have been overwhelmed recently by the number of commercials aimed at "overactive bladder", a condition which "isn't natural at any age", and for which we are advised to "see a doctor" (NOT a Continence Clinic!) for treatment.
The number of such ads has grown steadily in the past few months to become an everyday event, especially on CCN and MSNBC. What's behind this sudden downpour of ads, and why should WE be concerned?
There is a War of the Giants going on behind the scenes, and we are the target. In one corner are the makers and sellers of Detrol, the upstart brand of tolterodine tartrate. In the other, the makers of Ditropan XL (timed-release oxybutynin chloride).
For over 20 years Ditropan had a virtual monopoly on the medical management of Urge Incontinence. At trade shows, such as the ICS meetings in Boston and Halifax, they didn't even bother to promote their product. At one, they had a triple booth, devoted entirely to giving away Umbrellas (nice umbrellas, at that!). At another, they gave out the address of their hospitality suite -- which had one of the largest assortments of free booze and free fancy food that I've ever seen. No product info was necessary.
Of course everyone knew that "dry mouth" was a common side effect of Ditropan, and as many as 50% of patients simply stopped taking their medication (and resumed their symptoms) as a result.
Then, in December, 1998, following FDA approval of Ditropan XL, the maker started the "Taking Control" or "Take Control Again" campaign, featuring actress Stefanie Powers (who, unlike June Allison, doesn't actually *have* incontinence, but she *was* very sympathetic about people who are incontinent when she heard about them), with literature to every member of SUNA and WOCN, among others.
An internet campaign was begun in the name of the Bladder Health Council, using funds from ALZA corporation, the new owners of Ditropan XL. The web address is:
http://www.incontinence.org. Although that address is registered to the American Foundation for Urologic Disease in Baltimore, several of the internal pages have the title "Alza Website", so it isn't clear who wrote them -- or is it? Several of the subordinate internal pages link directly to the www.ditropanxl.com website.Both the bladder health council and the ditropanxl sites are a researcher's nightmare. There have been major revisions between December and May (and I'm glad I printed the pages to see this.) In spite of spending an obvious fortune on this project, there are major inconsistencies. (Moreover, some pages with broken links in December still have broken links today.)
For instance, on different pages, the incidence of "incontinence" is variously described as 5-7 Million, 10 million, and 17 million, in the USA. Sloppy work.
Our readers will be interested to note that there have been revisions in the "related links" list as well. Specifically, SUNA was NEVER listed as a resource, and APTA and WOCN have now been DROPPED. (Sorry!) Simon Fndn and IFFGD have now been added, and the use of "HIP" on the "after" page has been updated to "NAFC" now.
Perhaps the most disturbing changes concern the sloppy treatment of research effectiveness results. It is hard to know what to believe, and there are no references to published work. But here's the DitropanXL data: (n/s=not shown) and [ .. ]= calculated difference (before minus change)
| Study | Dec 98 | May 99 |
| 1 (N=) | 34 | (n/s) |
| baseline episodes | 15.9 per week | 15.8 |
| decrease | -15.8 | (n/s) |
| end of study | (n/s) [0.1] | 1.5 |
| % reduction | (n/s) [99%] | 90% |
| 2 (N=) | 53 | 53 |
| baseline episodes | 27.6 per week | 27.6 |
| decrease | -17.6 | (n/s) |
| end of study | (n/s) [10.0] | 4.8 |
| % reduction | (n/s) [64%] | 84% |
(Actually, by their current figures, it is 82%)
| 3 (N=) | 111 | 111 |
| baseline episodes | 18.9 per week | 18.9 |
| decrease | -14.5 | (n/s) |
| end of study | (n/s) [4.4] | 2.9 |
| % reduction | (n/s) [77%] | 83% |
(Actually, by their current figures, it is 85%)
(In May, the footnote for study 2, showing 17.6 decrease, is inadvertently repeated as a footnote to study 3, where it really doesn't fit the data!)
It is interesting to see that leakage data, like fine wines, appear to get "better" with the passage of time. By the time this data gets to a peer-reviewed journal, it ought to be really ripe. <g>
Two things are amazingly clear from the DitropanXL website; first, there is no significant difference in the EFFECTIVENESS of the two pills. [See their own data.]
The second point is rather strange; the most common side effect of DitropanXL is dry mouth -- found in 61% of patients. Now, if "XL" is supposed to be BETTER for dry mouth than plain, what is the "real" incidence of dry mouth for the "most-prescribed treatment for urge incontinence since 1975"? Worse than 61%? Apparently so.
That's enough for one day. PLEASE DON'T take my word for it; check out these websites for yourself.
See first hand the undermining of the AHCPR's guideline recommendation for "least invasive treatments first", and judge for yourself the respect shown for Continence Nurses and Women's Health PTs.
http://www.incontinence.org
See what the FDA said about Ditropan XL's advertising.
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Any opinions expressed in this series are those of the author alone. Any factual inaccuracies in the articles or citations should be brought to the attention of webmaster@incontinet.com and will be corrected at once. Copyright 1999 IncontiNet |