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Clare Dyer reports that both Dr Dowson and Dr Mullen have been referred by the General Medical Council (GMC) to hearings of Fitness to Practise Panels of the Medical Practitioners Tribunal Service (MPTS) to answer allegations of misconduct in the Migraine Intervention with STARFlex Technology (MIST) Trial.[1,2] Dr Dowson and Dr Mullen were first and second authors of the paper reporting the results of the trial in Circulation and were two of the three “responsible authors” of the paper.[3] They were both members of the trial steering committee and writing committee.
Dr Nightingale and I were also members of the steering committee, but we refused the offer of authorship because we knew that the paper contained statements that were false. The paper subsequently had a major correction,[4,5,6] but I believe that the correction remains incomplete and that important financial conflicts of interest remain undeclared.
I complained to the GMC about the conduct of Dr Dowson and Dr Mullen, as well as some others involved in the MIST trial. What surprises me is that the GMC has referred Dr Dowson and Dr Mullen to the MPTS to explain entirely different allegations. Dr Mullen has been referred to answer allegations about an abstract submitted to a small meeting. Dr Dowson has been referred to answer many allegations, but particularly about the paper published in Circulation. Dr Dowson (the first author) of the Circulation paper must answer allegations that he failed to ensure that Circulation had accurate information about the results of the trial and that he failed to reveal that a vice president of the sponsoring company, NMT Medical, helped to write the paper. Why have the other two “responsible authors” (Dr Mullen and Dr Peatfield) not been asked to answer the same allegations? Dr Peatfield has been given only advice about future conduct.
As one directly involved in these events, I find it difficult to understand the GMC’s differing treatments of the three "responsible authors".
References
1. Dyer C. GMC refers investigator in libel case to fitness to practise panel. BMJ 2012;345:e6291
2. Dyer C. GMC accuses cardiologist of submitting trial data to a congress knowing they were wrong. BMJ 2012;345:e6580
3. Dowson A, Mullen MJ, Peatfield R, Muir K, Khan AA, Wells C, Lipscombe SL, Rees T, De Giovanni JV, Morrison WL, Hildick-Smith D, Elrington G, Hillis WS, Malik IS, Rickards A. (2008) Migraine intervention with STARFlex Technology (MIST) Trial: a prospective, multicenter, double-blind, sham- controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation, 117, 1397-1404.
4. Correction. (2009) Circulation, 120, e71-72. Available at http://circ.ahajournals.org/content/120/9/e71.full
5. Migraine Intervention with STARFlex Technology (MIST) Trial Data Supplement. (2009) Circulation. Available at http://circ.ahajournals.org/cgi/content/full/CIRCULATIONAHA.107.727271/DC1
6. Dowson A, Mullen MJ, Peatfield R, Muir K, Khan AA, Wells C, Lipscombe SL, Rees T, De Giovanni JV, Morrison WL, Hildick-Smith D, Elrington G, Hillis WS, Malik IS, Rickards A. (2009) Migraine intervention with STARFlex Technology (MIST) Trial: a prospective, multicenter, double-blind, sham- controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Latest version. Circulation. Available from http://circ.ahajournals.org/cgi/content/full/117/11/1397
Competing interests:
My competing interests are stated in my response.
Re: GMC accuses cardiologist of submitting trial data to a congress knowing they were wrong
Clare Dyer reports that both Dr Dowson and Dr Mullen have been referred by the General Medical Council (GMC) to hearings of Fitness to Practise Panels of the Medical Practitioners Tribunal Service (MPTS) to answer allegations of misconduct in the Migraine Intervention with STARFlex Technology (MIST) Trial.[1,2] Dr Dowson and Dr Mullen were first and second authors of the paper reporting the results of the trial in Circulation and were two of the three “responsible authors” of the paper.[3] They were both members of the trial steering committee and writing committee.
Dr Nightingale and I were also members of the steering committee, but we refused the offer of authorship because we knew that the paper contained statements that were false. The paper subsequently had a major correction,[4,5,6] but I believe that the correction remains incomplete and that important financial conflicts of interest remain undeclared.
I complained to the GMC about the conduct of Dr Dowson and Dr Mullen, as well as some others involved in the MIST trial. What surprises me is that the GMC has referred Dr Dowson and Dr Mullen to the MPTS to explain entirely different allegations. Dr Mullen has been referred to answer allegations about an abstract submitted to a small meeting. Dr Dowson has been referred to answer many allegations, but particularly about the paper published in Circulation. Dr Dowson (the first author) of the Circulation paper must answer allegations that he failed to ensure that Circulation had accurate information about the results of the trial and that he failed to reveal that a vice president of the sponsoring company, NMT Medical, helped to write the paper. Why have the other two “responsible authors” (Dr Mullen and Dr Peatfield) not been asked to answer the same allegations? Dr Peatfield has been given only advice about future conduct.
As one directly involved in these events, I find it difficult to understand the GMC’s differing treatments of the three "responsible authors".
References
1. Dyer C. GMC refers investigator in libel case to fitness to practise panel. BMJ 2012;345:e6291
2. Dyer C. GMC accuses cardiologist of submitting trial data to a congress knowing they were wrong. BMJ 2012;345:e6580
3. Dowson A, Mullen MJ, Peatfield R, Muir K, Khan AA, Wells C, Lipscombe SL, Rees T, De Giovanni JV, Morrison WL, Hildick-Smith D, Elrington G, Hillis WS, Malik IS, Rickards A. (2008) Migraine intervention with STARFlex Technology (MIST) Trial: a prospective, multicenter, double-blind, sham- controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Circulation, 117, 1397-1404.
4. Correction. (2009) Circulation, 120, e71-72. Available at http://circ.ahajournals.org/content/120/9/e71.full
5. Migraine Intervention with STARFlex Technology (MIST) Trial Data Supplement. (2009) Circulation. Available at http://circ.ahajournals.org/cgi/content/full/CIRCULATIONAHA.107.727271/DC1
6. Dowson A, Mullen MJ, Peatfield R, Muir K, Khan AA, Wells C, Lipscombe SL, Rees T, De Giovanni JV, Morrison WL, Hildick-Smith D, Elrington G, Hillis WS, Malik IS, Rickards A. (2009) Migraine intervention with STARFlex Technology (MIST) Trial: a prospective, multicenter, double-blind, sham- controlled trial to evaluate the effectiveness of patent foramen ovale closure with STARFlex septal repair implant to resolve refractory migraine headache. Latest version. Circulation. Available from http://circ.ahajournals.org/cgi/content/full/117/11/1397
Competing interests: My competing interests are stated in my response.