AUTH/2464/12/11: Healthcare journalist v Novartis – Galvus press release (no breach) | PMCPA Case

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Key facts

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Case number	AUTH/2464/12/11
Complainant	Healthcare journalist (pharmaceutical trade magazine)
Company	Novartis
Material	Press release (Galvus/vildagliptin)
Issue	Alleged implication of “few/limited treatment options” for type 2 diabetes with moderate/severe renal impairment; alleged use of out-of-date reference (Cavanaugh 2007)
Audience / distribution	Sent mainly to UK-based publishers including UK-specific publications (eg, BMJ) and online BBC Health News
Applicable Code year	2011
Clauses considered	2, 7.2, 22.2
Decision	No breach
Complaint received	7 December 2011
Case completed	3 February 2012
Appeal	No appeal

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

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A healthcare journalist complained about a Novartis Pharma AG (Basel, Switzerland) press release on EU approval of Galvus (vildagliptin) for type 2 diabetes patients with moderate or severe renal impairment.
The press release headline and text referred to “limited” and “few” treatment options and said the approval “expands treatment options”, including a quote describing a “much-needed new treatment”.
The complainant alleged the release was crafted to suggest there were few options when two other medicines already had licences for this population (Onglyza and Trajenta).
The complainant also alleged Novartis used an out-of-date reference (Cavanaugh 2007) to support the “few treatment options” assertion.
Novartis UK stated it had no part in creation/review/distribution; the release was created and distributed by global colleagues via a medical media agency.
The circulation list showed the release was sent mainly to UK-based publishers (including UK-specific publications such as BMJ and BBC Health News), bringing its UK use within scope of the ABPI Code.

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No breach of the Code was ruled.
The Panel found the press release did not imply Galvus had “plugged a gap in the market”; it conveyed there were already “a few” options and Galvus added to them.
On balance, the Panel accepted that treatment options were still limited despite the 2007 reference and subsequent approvals.

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