Regulators turn a blind-eye to conflicts of interest

By Dr Peter Wilmshurst

I am concerned that UK regulators are unwilling to deal with failure to disclose conflicts of Interest (COI), even when they undermine the integrity of research and have the potential to harm patients.

During 2014 and 2015, I was a member of the Alteplase Expert Working Group set up by the Medicines and Healthcare products Regulatory Agency (MHRA) to consider the licence of Alteplase for treatment of acute ischaemic stroke.1 The MHRA invitation in September 2014 said that disqualifying COI were financial association with the corporations that manufacture and market Alteplase or involvement in the clinical trials of Alteplase in stroke that would be discussed at the meetings. I had no COI.

Before each of the three meetings, members were sent an agenda.1 It was in black print other than a section highlighted in red print reminding us of the disqualifying COI and asking us to confirm again that we had none. At the start of each meeting, the chair, Professor Sir Ian Weller read out the disqualifying COI and asked members to disclose any. So there were seven opportunities for members to disclose disqualifying COI.

After the final meeting in June 2015, I discovered that four members had COI that should have disqualified them from membership. Two were professors, who each also made presentations to the Working Group, and two were NHS stroke consultants. I wrote to MHRA in August 2015 expressing my concerns that the COI policy had been breached. I had to write repeatedly before I got a reply ten months later in June 2016 from Dr June Raine (then Director of Vigilance and Risk Management of Medicines at MHRA and now its Chief Executive). She said that MHRA knew that one of the professors had disqualifying COI and had decided that he could be a member despite them. Other members of the Working Group were misled because we thought that the stated COI policy for membership applied to us all. The documents used by the Working Group and its minutes were placed on the MHRA website.1 The documents state the Working Group’s COI requirements and implied that they had been enforced. The professor in breach of the policy spoke at the press conference at which MHRA claimed that an entirely independent Working Group had reached the published conclusions. It seems to me that the MHRA knowingly allowed one member of the Working Group to have COI contrary to the stated policy and was complicit in misleading the public, the popular press and medical journals that had sent reporters to the press conference. MHRA could not complain that two stroke physicians had similar undisclosed COI.

However, Dr Raine said that MHRA was particularly concerned that the other professor had failed to disclose his multiple COI. Therefore I asked the General Medical Council (GMC) to consider whether his failure to disclose his COI amounted to misconduct.  The GMC refused to investigate my complaint.

It is my experience that the GMC does not understand the significance of COI or turns a blind eye to them, possibly because the doctors with the greatest COI are often very senior.

I was the principal cardiologist in the Migraine Intervention with STARFlex© Technology (MIST) Trial, sponsored by NMT Medical in the UK.2 Another member of the trial steering committee, Dr Simon Nightingale, and I refused to be authors of the paper published in Circulation because the steering committee were not allowed full access to the data (a fact confirmed by NMT in legal pleadings when they sued me unsuccessfully for libel)  and because, even without full access to the data, it was clear that the paper contained false statements about the methods and results. After the paper was published, I spent 18 months persuading Circulation to publish a correction, a new version of the paper and a data supplement.3 Nightingale and I had no input in these documents, which also contain false statements. Both versions fail to disclose COI of eight authors and a conflicted ghost author’s contribution to the paper.4

In 2008, I reported Dr Andrew Dowson, who was the trial’s chief investigator and the paper’s first and corresponding author to the GMC. Two years earlier, in 2006, the GMC had found Dowson guilty of serious misconduct for falsification of data on clinical record forms when he was chief investigator in an unrelated clinical trial.5 Dowson’s earlier misconduct was known to NMT before they appointed him to the MIST Trial.6,7 Nightingale and I were not informed. 6,7 Nor was the Multicentre Research Ethics Committee that approved the MIST Trial. 6,7

It took the GMC more than six years to bring charges against Dowson at a second Fitness to Practise Tribunal. In 2015, he was found guilty of multiple counts of misconduct including two counts of dishonesty in the MIST Trial and he was suspended from the Medical Register,6,7 but the GMC and the Medical Practitioners Tribunal Service (MPTS) failed to fully understand the importance of his failure to disclose COI in the flawed publication.

The Tribunal found that parts of the published paper in Circulation were written by a vice president of NMT and that his role was not disclosed, but the Tribunal decided that Dowson’s failure to disclose that COI did not constitute misconduct because Dowson told the Tribunal that the vice president wanted his role kept secret.7

Dowson admitted to the Tribunal that he bought NMT shares one week after the steering committee’s members were told that preliminary data were encouraging, which was six weeks before the data were made public. He sold the shares at a profit before the final negative results were revealed. The Tribunal decided that Dowson’s undisclosed share dealing did not constitute misconduct, because his shares were worth less than $50,000 (about £32,000 at that time) and the Tribunal decided that an amount less than $50,000 was too small to influence a doctor.7 I wonder how many members of the public are gullible enough to believe that doctors cannot be influenced by sums less than $50,000 / £32,000.

The Tribunal also heard that Dowson was paid £2,000 per week during the trial for his role as Principal Investigator. His payments starting in July 2004 and continuing for almost four years until March 2008, when the paper was published.7 In addition Dr Dowson was paid for each patient consultation.7 (To avoid COI, Nighingale and I refused NMT’s offers of payment.) Dr Dowson’s contract with NMT also included the possibility of a bonus depending on certain performance outcomes,7 which many people would consider a COI. He was also paid for his role in a follow-up NMT Trial (MIST 3).7 I calculate that in total, NMT may have paid Dr Dowson more than £400,000, which was very much greater than the value of his share ownership and much greater than the Tribunal’s arbitrary $50,000 limit. But, because the GMC put no charges over Dr Dowson’s failure to disclose in the paper his substantial payments from NMT, the Tribunal could not make a finding with respect to that non-disclosure of COI.

When rejecting Dowson’s appeal against the Tribunal’s decision, Mr Justice Edis wrote “Some readers of this judgment may be surprised to learn that the Panel (MPTS Tribunal) found that the appellant was not guilty of misconduct when, in the circumstances set out above, he subsequently bought shares in NMT and signed an agreement which potentially gave him a bonus after the application for approval had been granted. He did not tell the West Midlands MREC about these things.”6

Mr Justice Edis also wrote “He (Dowson) now created a false document ……. which was part of the records of the MIST Trial.”6 A strand of Dowson’s defence to the charge of dishonesty in the MIST Trial was that the sponsor, NMT, colluded in the dishonesty. In the worst examples, that is the danger from COI.

Despite MPTS findings of dishonesty upheld in the High Court of England and Wales, the paper in Circulation has not been retracted.

Unless regulators, such as the MHRA, strictly enforce disqualifying COI and unless the GMC punishes doctors who dishonestly conceal their COI, we will not achieve transparent disclosure.

References

  1. https://www.gov.uk/government/publications/alteplase-for-treatment-of-acute-ischaemic-stroke-independent-review accessed 13 April 2022.
  2. Dowson A, Mullen MJ, Peatfield R, et al. 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 2008;117:1397-1404.
  3. Dowson A, Mullen M, Peatfield R, et al. “Correction”, Circulation 2009;120: e71-e72, available from http://circ.ahajournals.org/cgi/content/full/circulationaha;120/9/e71
  4. Wood S. Former co-PI of MIST trial alleges data mismanagement, misinformation. Heartwire October 26, 2007.
  5. General Medical Council: Fitness to Practise Panel – Misconduct. Andrew John Dowson. Transcript March 24, 2006.
  6. Mr Justice Edis. Judgement in Andrew John Dowson versus the General Medical Council. 23 November 2015. Neutral Citation Number: [2015] EWHC 3379 (Admin). https://www.bailii.org/ew/cases/EWHC/Admin/2015/3379.html  accessed 13 April 2022.
  7. Medical Practitioners Tribunal Service. “Transcripts: case of Dr Andrew Dowson”. (2014-15)

2 responses to “Regulators turn a blind-eye to conflicts of interest”

  1. What an absolute disgrace, the whole system stinks of corruption and greed. Once the regulatory bodies are taken over by dishonest people, or those who want to keep their heads down, corruption becomes endemic. “All that is necessary for the triumph of evil is that good men/women do nothing.”

    Liked by 1 person

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