AUTH/2241/6/09: Consultants in Child and Adolescent Psychiatry v Lilly (Strattera Support Service) – No breach | PMCPA Case

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Key facts

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Case number	AUTH/2241/6/09
Complainant	Two consultants in child and adolescent psychiatry
Company	Lilly
Product	Strattera (atomoxetine)
Issue	Alleged inappropriate direct patient contact by pharma employees and potential biased advice via a support service; letter asked clinicians to recruit patients
Referral routes	Clinician referral (Service Authorisation + patient/carer consent) and patient-initiated via pharmacies (still requiring clinician authorisation)
Panel finding	No breach; no Lilly employee patient contact; service delivered by independent nurses; data aggregated/anonymised; service offered post-prescribing
Clauses considered	2, 9.1, 18.1 and 22.2
Outcome	No breach
Complaint received	18 June 2009
Case completed	3 August 2009
Applicable Code year	2008
Appeal	No appeal
Additional sanctions	Not stated

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

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Two consultants in child and adolescent psychiatry complained about Lilly’s Strattera (atomoxetine) Support Service and a letter asking clinicians to recruit patients.
They alleged the service involved pharmaceutical company employees having direct contact with patients/carers early in treatment, which they considered inappropriate and potentially biased.
Lilly said the service was a non-promotional, third-party programme providing telephone support to carers/patients after the prescriber had decided to start Strattera.
Patient/carer contact was delivered by registered nurses employed by the service provider (not Lilly employees); adverse reactions were reported to Lilly via SOPs.
Two referral routes existed: clinician referral (after signing a Service Authorisation document) and patient-initiated via pharmacies (still requiring clinician authorisation before enrolment).
Patients/carers had to provide consent before enrolment; data seen by Lilly was aggregated and anonymised.
The Panel noted the letter and patient/carer information sheet did not make it “abundantly clear” that neither Lilly nor its representatives would have direct patient contact, and did not mention follow-up calls at 6, 9 and 12 months (though these were described in Lilly’s response).

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No breach of the Code was ruled.
The Panel found Lilly employees had no direct contact with patients; contact was with a nurse employed by the service provider.
The Panel did not consider the service/letter inappropriate or biased, and noted patients were only told about the service once the prescribing decision had been made.
The Panel observed it would be helpful for companies to make the position on patient contact “abundantly clear” when introducing service offerings to health professionals, especially where third-party providers are involved.

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