AUTH/2913/12/16: Anonymous v Janssen — MSL discussion about CANVAS updates at PCDS conference (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2913/12/16
Complainant	Anonymous, non-contactable
Company	Janssen
Product / therapy area	Canagliflozin (Invokana) / Type 2 diabetes (SGLT2 inhibitor)
Setting	12th National Conference of the Primary Care Diabetes Society (PCDS), Birmingham, 24/25 November 2016
Allegation	MSL offered CANVAS study information and asked HCP to sign a form for delivery of results; HCP allegedly left uncomfortable
Company position	MSL corrected inaccurate CANVAS timeline in HCP presentation; HCP requested updates; form used to capture unsolicited request; HCP later confirmed no issue
Clauses considered	2, 3.1, 3.2, 9.1
Panel decision	No breach of the Code
Notable Panel comment	Concern that request forms could enable ongoing one-way updates “ad infinitum”; advised review to ensure compliance (Clause 1.2 exemption queried)
Complaint received	5 December 2016
Case completed	10 January 2017
Appeal	No appeal
Applicable Code year	2016

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

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An anonymous, non-contactable complainant alleged a Janssen medical science liaison (MSL) approached a health professional at a UK primary care conference and asked how they wanted to receive information about the CANVAS study (canagliflozin/Invokana).
The complainant said the MSL asked the health professional to sign a medical information form so information could be delivered when results were announced, leaving the health professional uncomfortable.
Janssen said the interaction followed the health professional’s presentation, which contained incorrect CANVAS timeline information; the MSL approached privately to point out the error.
Janssen said the health professional then asked to be kept updated on emerging CANVAS clinical data, so the MSL asked them to complete an “Emerging Clinical Data Request Form”.
Janssen provided an email from the health professional stating they had no issue with the approach.

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No breach of the Code was ruled.
No breach of Clauses 3.1 and 3.2: the Panel did not consider the MSL’s reference to CANVAS (in context) was such as to promote Invokana.
No breach of 9.1: no evidence the MSL failed to maintain high standards.
No breach of Clause 2: no bringing the industry into disrepute.
Panel nevertheless expressed concern about the company’s apparent ability to send “updates… ad infinitum” off the back of one request and advised Janssen to review its arrangements for clinical updates to ensure Code compliance.

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