Pfizer: Exubera ‘maintains long-term glycaemic control’ claim ruled misleading (AUTH/1944/1/07)

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Key facts

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Case number	AUTH/1944/1/07
Complainant	Drug and Therapeutics Bulletin / Director (complaint taken up by the Director following DTB article)
Company	Pfizer
Product	Exubera (inhaled insulin human)
Main issue	Promotional claim that Exubera “maintains long-term glycaemic control” (unqualified durability claim)
Materials involved	Sales aids (EXU608, EXU759), advertisements (EXU852A, EXU854F, EXU853F), slide set (EXU592a2/b2), mailings (EXU772, EXU773)
Applicable Code year	2006
Breach clauses	Five breaches of 7.2 and three breaches of 7.4
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	16 January 2007
Case completed	04 March 2007
Appeal	No appeal
Source	https://www.pmcpa.org.uk/cases/completed-cases/auth1944107-drug-and-therapeutics-bulletin-v-pfizer

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An article in Drug and Therapeutics Bulletin (Jan 2007) criticised Pfizer’s promotion of Exubera (inhaled human insulin), particularly the claim that it maintained “long-term glycaemic control”.
The PMCPA Director took the matter up as a complaint under the Code (Applicable Code year: 2006).
Pfizer’s promotional materials (sales aids, advertisements, a slide set, and mailings) used claims such as “Exubera – maintains long-term glycaemic control” and “Exubera – insulin to maintain long-term glycaemic control”, commonly referenced to Skyler (2004).
Pfizer argued there was supporting evidence (6-month, 2-year and 4-year data) and noted materials had been pre-vetted by the MHRA; it also argued it did not claim “routine” long-term use.
The Panel focused on what “long-term” would reasonably mean in diabetes and whether the cited evidence substantiated an unqualified “maintains long-term glycaemic control” claim.

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The Panel ruled the “maintains long-term glycaemic control” claim (and similar unqualified variants) was misleading and not capable of substantiation in the way presented.
Six-month studies were disregarded as not long enough to support a “long-term” claim in diabetes.
Skyler (2004) four-year follow-up had very small patient numbers and did not adequately demonstrate maintained control; HbA1c appeared to rise over time after an initial dip.
Two-year studies were more robust, but the claim gave no indication of the time period and there appeared to be possible differences between type 1 and type 2 diabetes responses; the unqualified claim was therefore misleading.
Breaches were found across multiple item types (sales aids, advertisements, slide set, and mailings).
No appeal was recorded.

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