Schon seit Jahren beschäftigt sich die Agentur medandmore mit den speziellen Bedürfnissen der Selbsthilfegruppen und hat hier immer wieder neue Akzente gesetzt. Jährlich treffen sich Mitglieder der Selbsthilfegruppen und Vertreter der Industrie, um Berührungsängste und Barrieren abzubauen - medandmore verbindet!

Dear Doctor:

You undoubtedly are aware of the sleep aid drug Rozerem marketed by Takeda. The company's sales representatives surely have paid you many visits extolling the so-called virtues of Rozerem. You may also have seen the big "Zero" logo at meetings and in print ads (if not, see "Rozerem Sleeper Cell at Pri-Med Conference").

But you may not have seen recent Rozerem DTC reminder TV ads that Takeda has run in violation of its pledge to abide by PhRMA's Guiding Principles for DTC Advertising, which specifically bans reminder ads on TV (see "Rozerem Reverts to Reminder TV Ads"). As you may know, reminder ads mention the drug name but do not mention the indication or side effects.

In addition to that questionable behavior, Takeda also received a Notice of Violation letter from the FDA that said some of these ads were aimed at children and were not reminder ads at all and should include side effect information (see "Back to School for Takeda, Rozerem, and Abe Lincoln!").

The worst offense, however, is Takeda's claim that no one in the company was involved in the "approval, release or broadcast of the advertisement in question" (see "Takeda Borrows Cephalon's Excuse for FDA Warning Letter").

I am sure that like most people, you find that excuse hard to believe and, if true, it must give you pause. That is, either Takeda is not trustworthy -- it lied -- or it is incompetent.

I am asking you, therefore, to refrain from writing prescriptions for Rozerem in protest. There are several other alternative drugs available for the treatment of your patients with insomnia.

The next time you see a Takeda sales representative, tell him or her that you are boycotting the product until you are assured that Takeda takes the necessary steps to (1) determine who in their company and/or ad agnecy was responsible for the violative DTC ads, and (2) terminates the employment of the responsible employee or cancels the contract of the responsible ad agency.

Only you have the power to make Takeda comply with FDA regulations, PhRMA DTC Guidelines, and minimal industry ethical standards. FDA and PhRMA appear to be ineffectual in this regard.

Sincerely,

John Mack

Our preliminary review of the situation indicates that no one internal to Takeda was involved in the approval, release or broadcast of the advertisement in question.

Internationaler Frauentag: Gemeinsam gegen Harnverlust.

CASE STUDY : “POSITIONING DETROL® (TOLTERODINE) (creating a disease)"
The following is derived from an internet posted PowerPoint presentation downloaded from http://www.pmrg.org/presentations.html called ‘Positioning Detrol: creating a disease’
Following the merger of Pharmacia and Upjohn, Detrol® (tolterodine) was “identified as the first, new, global mass marketing opportunity”.
Later the presentation heading “Converting a niche product into a Mass Marketing Opportunity” is followed by:
• “Increase the diagnosis and treatment of urge incontinence”
• “Expand the appropriate patient population (beyond urge incontinence) to those with “overactive bladder syndrome” (OAB) (without incontinence)
The next part of the strategy or “critical success factors :”
• “Establish OAB as a serious medical condition with profound negative impact on people’s quality of life… among physicians, consumers, payers and regulatory authorities”
• “Establish Detrol® (tolterodine) as the therapy of choice for OAB”
And finally:
• “Educate PCPs (primary care physicians) (including OBGs) how to screen for, diagnose and treat OAB”
• “Drive potential patients to physician offices by using DTC [direct to consumer] and PR with symptom recognition"