AUTH/2472/1/12 - Shire v Flynn Pharma
Case Number: AUTH/2472/1/12
Case Ref: Shire v Flynn Pharma
Description: Medikinet leavepiece
Breach: Breaches Clauses 7.2 and 7.3
Appeal: No appeal
Review: Published in the May 2012 Review
Complaint Received: 11 January 2012
Complaint Completed: 22 February 2012
Shire Pharmaceuticals complained about a Medikinet XL (methylphenidate prolonged release) leavepiece issued by Flynn Pharma. Medikinet was indicated as part of a comprehensive treatment programme for attention-deficit/hyperactivity disorder (ADHD) in children aged 6 years and over when remedial measures alone proved insufficient.
Shire noted that the second page of the leavepiece (headed ‘Extended Release Methylphenidate (MPH) Preparations Exhibit Different Pharmacokinetic Profiles’) featured plasma concentration-time curves from two comparative pharmacokinetic studies conducted in adults (Equasym XL vs Medikinet XL (Schütz et al 2009) and Equasym XL vs Concerta XL (González et al 2002)). There was no contextual information about the relevance of these comparative studies to the treatment of ADHD in children or any comment on the clinical significance of the data. Shire alleged that the graphs, with Equasym XL as the common comparator, invited readers to extrapolate a favourable but misleading comparison between the pharmacokinetic profiles of Medikinet XL and Concerta XL, when in fact there were no data to support this.
The front page of the leavepiece set the clinical question ‘How do you achieve a good start to the day for children and adolescents with severe ADHD who are hyperactive and/or inattentive at the start of the school day?’ and proposed Medikinet and Medikinet XL as the answer with only comparative pharmacokinetic data from adult studies to support it. Shire alleged that this presentation of adult pharmacokinetic data breached the Code as it was misleading and did not enable readers to form a rational opinion of the therapeutic value of Medikinet XL.
Shire alleged a further breach as the inclusion of comparative adult pharmacokinetic data implied that Medikinet XL had a superior clinical profile compared with Equasym XL and Concerta XL although no clinical studies had shown this to be so.
The detailed response from Flynn is given below.
The Panel noted that the front page of the leavepiece posed the question ‘How do you achieve a good start to the day for children and adolescents with severe ADHD who are hyperactive and/or inattentive at the start of the school day?’ Page 2 was headed ‘Extended Release Methylphenidate (MPH) Preparations Exhibit Different Pharmacokinetic Profiles’ and featured two graphs which showed the mean methylphenidate plasma concentration-time profiles in healthy adult volunteers for three different medicines. The first graph (Medikinet XL 20mg vs Equasym XL 20mg (adapted from Schütz et al))clearly showed that at 2 hours post-dose, Medikinet XL 20mg achieved higher methylphenidate plasma concentrations than Equasym XL 20mg. The second graph (Equasym XL 20mg vs Concerta XL 18mg (adapted from González et al)) also showed that 2 hours post-dose, Equasym XL 20mg achieved higher methylphenidate plasma concentrations than Concerta XL 18mg.
In the Panel’s view, the graphs encouraged readers to compare the plasma concentration-time profiles of Medikinet XL, Equasym XL and Concerta XL and concluded that, in the first few hours post-dose, Medikinet XL achieved a higher methylphenidate plasma concentration than the other medicines. In that regard the Panel considered that some readers might assume that this resulted in a clinical advantage for children who were hyperactive and/or inattentive at the start of a school day thus answering the question posed on the front page of the leavepiece.
The Panel noted that although the leavepiece did not refer to any clinical data, it did not state that the depicted pharmacokinetic differences in healthy adult volunteers had not been shown to have consequential differences in clinical outcome when used to treat ADHD in children. The Panel noted Shire’s submission that there were no clinical studies to show that Medikinet XL had a superior clinical profile to either Equasym XL or Concerta XL.
The Panel considered that the presentation of the pharmacokinetic data was such that the comparisons of Medikinet XL with Equasym XL and Concerta XL were misleading as alleged. A breach of the Code was ruled.