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May 14, 2007

GSK and Schering-Plough Busted by FDA on Rival Products for Essentially Similar Bad Acts

NasoThe FDA has sent letters to S-P and GSK over their detail aids for Nasonex and Flonase respectively. Hilariously, the FDA accuses both companies of doing essentially the same thing: using misleading information about studies to create the impression that their brands are more effective than the evidence warrants.

Here's the text of GSK's detail piece:

• “Choose greater EFFICACY for your patients with SEASONAL ALLERGIC RHINITIS…” (original emphasis) above a chart titled, “SUPERIOR REDUCTION in Patient-Rated TOTAL NASAL SYMPTOM SCORES (TNSS) vs NASONEX1” (original emphasis) which in turn presents data that Flonase patients experienced a superior reduction of 25% (P=0.03) in TNSS versus Nasonex patients.

• “Patients given FLONASE experienced GREATER RELIEF of NASAL SYMPTOMS in a head-to-head clinical study of seasonal allergic rhinitis (SAR) sponsored by Schering Corporation, the maker of Nasonex®” (original emphasis).

The FDA didn't like that:

"These claims and presentations are misleading because they suggest that Flonase is superior to Nasonex for the treatment of seasonal allergic rhinitis symptoms, when this has not been demonstrated by substantial evidence or substantial clinical experience. The reference cited1 to support this claim does not provide substantial evidence for the following reasons. First, the study design raises multiplicity issues. It was designed as a placebo-controlled trial comparing Nasonex to placebo; the active comparison was not clearly planned. It is therefore difficult to determine exactly what significance level should be attached to that comparison. Second, the study was not replicated."

Here's what the FDA had to say about S-P's Nasonex:

• Page one of the Nasonex detail aid contains the headline claim, “Nasal allergy sufferers report Congestion at night can be a BIG problem” (original emphasis). ... "…the only nasal-inhaled steroid that's also FDA approved to help PREVENT congestion” (original emphasis).

What's the problem? As the FDA writes:

"Nasonex, however, is not specifically indicated for congestion."

Ouch.

Note how GSK's error -- claiming efficacy over another brand when there's a lack of head to head studies -- is essentially the same as AZ's error in the Arimidex/Bucket of Money fiasco.

Posted on May 14, 2007 |

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