Tuesday, August 10, 2010

Tales from the PMCPA contd..... The Case of the Borderline Personality Disorder

An anonymous complainant alleged that the content of an AstraZeneca meeting was misleading and promoted Seroquel (quetiapine) outwith its marketing authorization.  Seroquel was licensed for the treatment of schizophrenia and bipolar disorder.

The subject of the meeting was ‘Cognitive treatment of borderline personality disorder (BPD)’.  The first part concerned the use of cognitive therapy but according to the complainant soon moved onto which medicine should be used, of which Seroquel was recommended as the medicine of choice.  It was not implied or stated that Seroquel was unlicensed for this diagnosis. The complainant considered that this was a contrived attempt to draw attendance on one subject then manipulate the talk to the use of an unlicensed medicine therefore deliberately misleading the audience.

The detailed response from AstraZeneca is given below.

The Panel noted that the parties' account of the meeting in question differed.  The complainant alleged that the meeting, held almost 6 months' previously, was about cognitive treatment of borderline personality disorder and included a recommendation that Seroquel was the medicine of choice.  The complainant had stated that the meeting was held in the last week of October or the first week of November.  AstraZeneca submitted that the only meeting it had sponsored at the named venue in October/November 2009 was held on 5 November.  The meeting was about schizophrenia, in line with the Seroquel summary of product characteristics (SPC), and that borderline personality disorder was only referred to by the speaker in order to answer an unsolicited question from the audience.

The Panel was very concerned to note that AstraZeneca had not been able to provide copies of the invitation, agenda or slides used at the meeting.  This was wholly unacceptable.  In that regard the company had no record of the proceedings and thus had been unable to provide a robust response to the complaint.  The meeting had been sponsored by AstraZeneca; the local representative had briefed the speaker.  The company was thus responsible for the format and content of the meeting.  In that regard the Panel disagreed with AstraZeneca’s submission that the presentation was educational and thus did not require certification.  This submission appeared to contradict AstraZeneca’s speaker guidance document which stated that meetings organised by the sales force were classified as promotional.  AstraZeneca was responsible for what the speaker said on its behalf and in the Panel’s view his slides should have been certified. The meeting confirmation note given to the out-patient manager stated that the meeting would comprise a presentation on an AstraZeneca product in the management of schizophrenia.  The form further stated that the meeting would last 50 minutes and a simple buffet would be provided.

The agenda for the meeting as recorded on the territory management system stated that the meeting title was 'Schizophrenia case study'.  The meeting approval document on the territory management system referred to Seroquel, a schizophrenia case study, acute schizophrenia and schizophrenia in the community.

The Panel noted that AstraZeneca had provided accounts of the meeting from three of the attendees. When asked what the meeting was about one person stated that it was about schizophrenia and that they thought borderline personality disorder might have been mentioned.  A second person stated that the meeting topic was the management of borderline personality disorder with psychotherapy; they could not remember anything being presented on schizophrenia and they further stated that quetiapine was not mentioned.  A third person also stated that the meeting was about the management of borderline personality disorder; they did not think that schizophrenia was discussed.  The third person thought that, in discussion with the audience, anti-psychotics were mentioned a little but were not the main focus.  Neither the Panel nor AstraZeneca knew the complainant's identity.

The Panel noted that the complainant had the burden of proving their complaint on the balance of probabilities.  The complainant had provided no material to support their allegation.  Two of the three witness statements, provided by AstraZeneca, however, appeared to give some support to the complainant's allegation in that both attendees thought the meeting was about borderline personality disorder.  However, when one was asked if quetiapine was mentioned they said 'No, it was just an educational talk'.  The other attendee thought anti-psychotics were mentioned a little but were not the main focus.  When asked more generally about any discussion about pharmacotherapy, the attendee stated 'From memory the "usual thing" that although nothing is licensed in personality disorder some medications exert some useful impact’.  The Panel considered that there was no evidence to show that AstraZeneca had promoted Seroquel outwith its marketing authorization as alleged.  Taking all of the circumstances into account, the Panel did not consider that on the balance of probabilities Seroquel had been promoted for borderline personality disorder.  No breach of the Code was ruled.  The Panel further considered that although there appeared to be some confusion about the topic of the meeting, there was no evidence to show that delegates had been misled about Seroquel.  No breach of the Code was ruled.  The Panel did not consider that it had any evidence to show that the meeting was disguised promotion.  No breach of the Code was ruled.  Similarly the Panel considered that it had no evidence to show that the representative had not maintained a high standard of ethical conduct.  No breach of the Code was ruled.

The Panel noted that AstraZeneca's record of the meeting was extremely limited.  This was wholly unacceptable.  The company did not know what invitations had been sent on its behalf, nor had it certified the presentation delivered.  In the Panel's view this was extremely poor practice.  The Panel was concerned that material that would have helped AstraZeneca respond to this complaint had either not been generated or copies had not been kept.  This had left the company vulnerable and unable to robustly respond to the allegations made.  Nonetheless the complaint at issue was about the content of the meeting, not the arrangements for it and in that regard there was no evidence to show that high standards had not been maintained.  The Panel ruled no breach of the Code.



Stephany said...

Summer 2007 inpatient psychiatric hospital in Seattle, WA. USA held a "lunch and learn". The poster board outside of the room said "How to treat Borderline Disorder with Seroquel". This presentation was given by a Pharma rep and the attendees were hospital doctors, staff and nurses, during the business day. The hospital patients are mostly Medicaid patients.

I was appalled at the off-label presentation use of Seroquel and more appalled that the hospital permitted the talk at all.

Kudos to the person who filed this report.

Anonymous said...

Cover up, denial of wrong doing, misleading presentations for off label use....Not AstraZeneca.... This just couldn't be... I just read something from their PR guy saying they were in complete compliance with all sales target projections.