Case summary: Dowson v The General Medical Council  EWHC 3379 (Admin)
High level summary
This was an appeal against the GMC's Medical Practitioners Tribunal Service's ('the Panel') order of a four month suspension, on the grounds that the conclusions of the Panel were not supported by the evidence. The challenge was not generally about the conclusions of fact but about whether those facts disclosed amounted to misconduct and, in two cases, dishonesty. Edis J dismissed the appeal, upholding the findings of the Panel on all but one of the charges that had been found proven.
Dr Dowson conducted research trials and this research, and the lecturing that flowed from it, made up approximately 50% of his income.
Research trials are conducted according to a protocol. The protocol has to be approved by the Local Research Ethics Committee (LREC) or, if part of a multi centre trial, the Multi-Centre Research Ethics Committee (MREC) with the LREC supervising at individual sites. A multi centre trial has a Chief Investigator who coordinates the trial across the multiple sites and Principal Site Coordinators who are responsible for the work done at individual sites.
In 2003 Dr Dowson was appointed the Chief Investigator for a 'Botox trial', looking at Botox as a treatment for migraines. Dr Dowson specialised in the treatment of headaches and ran clinics at Kings College Hospital and at a private clinic in Guilford. Dr Dowson was the principal site investigator for the Guilford site.
It was discovered that Dr Dowson had departed from the protocol at the private clinic in Guilford. He subsequently signed a file note dated 16 October 2003 admitting his "non-compliance and misconduct". This departure from the protocol involved 10 patients being followed by telephone, rather than in person and in five of these instances, vital signs data was recorded as having been taken when it could not have been.
On 22 October 2003, Dr Dowson wrote to his LREC to inform them of the contents of the file note. The LREC reported the matter to the Northern and Yorkshire MREC in January 2004. In April 2004, the Northern and Yorkshire MREC replaced Dr Dowson as the Chief Investigator for the Botox trial and referred the matter to the GMC. Dr Dowson was not aware of this referral until the GMC wrote to him in November 2004.
Dr Dowson continued to have limited involvement as principal site investigator for the Botox trial, but was appointed Chief Investigator to a further and unrelated trial at some point during this time. The other trial was a MIST trial, which was a trial to test if the closure of a small heart defect (patent foramen ovale – PFO) using a device called a Starflex (manufactured by NMT) would resolve migraines in some patients.
NMT sponsored the MIST trial with an investment of £1.7m. Dr Dowson declared his "non-compliance and misconduct" regarding the Botox trial to NMT, however he did not declare this to the West Midlands MREC who were approving the multi-centre MIST trial, nor to any others involved in the trial. The protocol for the MIST trial was submitted for approval on 4 September 2004 signed by the Chief Investigator, Dr Dowson.
As a multi-site trial, the operator of each site was required to enter into a Clinical Trial Agreement (CTA) which identified who was to serve as the principal site investigator. Kings College was a site for the MIST trial. Dr Dowson was the Principal Site Investigator and subject at a warranty in the CTA to declare that:
- the site investigator was not involved in any regulatory of misconduct proceedings and
- no data produced by the Site investigator in any previous study had been rejected due to concerns with accuracy or fraud. Dr Dowson's Guilford clinic became a site for the MIST trial in February 2005. Dr Dowson signed the CTA with NMT on behalf of Practical Solutions in Medicine Limited (Dr Dowson is the Director and shareholder). Dr Dowson therefore gave a warranty on behalf of the company and therefore on behalf of himself which he knew to be false as he had been notified of the GMC investigation and that the data produced by him in the Botox trial had been rejected due to concerns with accuracy.
In March 2006, GMC proceedings relating to the Botox trial concluded with a finding of impairment on the basis of misconduct, but with no findings of dishonesty. Undertakings were offered and accepted and placed on Dr Dowson's GMC registration.
The MIST trial proved negative results. One possible explanation was that the device did not close the cardiac defect satisfactorily. Dr Dowson reported the results of the MIST trial to a conference in 2007, but did not tell the conference about doubts of the rates of closures achieved with the device.
Dr Dowson's conduct was investigated by the GMC with regards to his role in not declaring relevant issues from the Botox trial to the relevant parties of the MIST trial and misrepresenting MIST results at a conference.
Dr Dowson appeared before the Panel where the following allegations were found proved:
- Failure to disclose an hourly rate payment when submitting the protocol to the West Midlands MREC
- Dishonesty failing to inform the West Midlands MERC when submitting the protocol, of the action taken in relation to the Botox trial
- Failing to disclose the Botox trial events to all fellow Site Principal Investigators/Steering Committee members of the MIST trial
- Dishonestly giving a warranty on behalf of his company when signing a CTA
- Failing to disclose the outcome of the GMC Botox proceedings to all Principals Site investigators/ Steering Committee members of the MIST trial
- Failing to disclose the outcome of the GMC Botox proceedings to the West Midlands MERC
- Failing to report to the TCT conference in 2007 that a review had been conducted by Dr Wilmhurst, who had concluded that the device had not achieved anywhere near the 94% closure rate reported.
Dr Dowson appealed on seven Grounds set out at length and summarised in the Judgment. Mr Justice Edis stated that:
"The Grounds are challenges to the conclusions of the Panel which assert that the conclusions were not supported by the evidence. The words 'bizarre' and 'irresponsible' appear in the Grounds as well as other pejorative adjectives."
Mr Justice Edis went on to state; "The substance of the complaint is not generally about conclusions of fact but about the determination of whether those facts disclosed misconduct and in two cases dishonesty" (para 21).
With the exception of the TCT charge, Mr Justice Edis found that the conclusions of the Panel were not wrong and should be upheld adopting the approach set out by Sir Stephen Silber in Gosalakkal v GMC  EWHC 2445 (Admin) which Mr Justice Edis felt to be particularly apt to the case given "the challenge is to the approach of the panel to the evidence, and the expert evidence in particular" (para 43).
The High Court also dismissed Dr Dowson's appeal on the Panel's findings of dishonesty. Mr Justice Edis went on to consider that the Panel "was scrupulously fair and adopted an approach which favoured the appellant" as a finding of honesty on one charge was not used as "cross admissible evidence of dishonesty in respect of other charges" (para 28).
Mr Justice Edis considered the proper approach to the dishonesty issue and considered that the Panel correctly applied the test in Ghosh (R v Ghosh  EWCA Crim 2) modified by the decision in Hussain (Hussain v GMC  EWCA Civ 2246). Edis J noted Longman LJ's approach in Hussain purportedly adapting the first limb in Ghosh to the relevant standard of "reasonable honest doctors", not people. Edis J, however, did not find it necessary to resolve the possible elevation of the standard of the first limb for members of the medical profession as he stated that:
"it is reasonable to assume that the medical profession is at least as scrupulous about integrity in its professional work than the population at large might be" going on to say "in this case it seems to me that the relevant standard is the same whether it is derived from the standards of reasonable and honest doctors and reasonable and honest people. What is necessary is to attribute to which ever notional group is the theoretical arbiter enough knowledge of the context and purpose of the activity involved to allow an informed judgment to be developed" (para 49).
Findings of misconduct in relation to conduct in ethically approved clinical trials Mr Justice Edis noted that there was a great deal of evidence in this case about ethical standards in research projects. Mr Justice Edis recognised that doctors involved in clinical research trials are involved in "very significant ethical questions" with issues of consent and the competing interests of a patient's wellbeing and the commercial interests of the sponsor. In addition to expert evidence from both parties, the GMC relied on published ethical standards including the World Medical Association Declaration of Helsinki (2000) and Ethical Principles for Medical Research involving Human Subjects (Helsinki).
Mr Justice Edis noted that it was not for the an individual chair [of a MERC]…to set standards of conduct for doctors involved in research, stating that whilst individual witnesses give valuable context to the various events, the assessment of the extent of the doctor's duty is not for the witnesses but for the Panel, stating;
" ...if the evidence is that particular conduct is widely accepted as appropriate by the profession that will be powerful evidence that it is not misconduct. In the end, though, the decision is for the Panel and not any witness"(para 61).
Mr Justice Edis stated that the ethical judgments the Panel was required to make is not an application of published codified standards as there is not a code to cover every factual situation. The Panel has to assess the appropriate ethical standards affecting a doctor depending on the particular circumstances of the case, and in this case the Panel was entitled to come to the findings that it did.