Andrew John Dowson v The General Medical Council
| Jurisdiction | England & Wales |
| Judge | Mr. Justice Edis |
| Judgment Date | 23 November 2015 |
| Neutral Citation | [2015] EWHC 3379 (Admin) |
| Court | Queen's Bench Division (Administrative Court) |
| Docket Number | Case No: CO/1265/2015 |
| Date | 23 November 2015 |
[2015] EWHC 3379 (Admin)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Justice Edis
Case No: CO/1265/2015
Stephen Miller QC and Judith Rogerson (instructed by RadcliffesLeBrasseur) for the Appellant
Simon Jackson QC (instructed by GMC Legal, London) for the Respondent
Hearing dates: 5th, 6th and 7th October 2015
Dr. Andrew Dowson ("the appellant") appeals under s. 40 of the Medical Act 1983 ("the Act") from a decision of the Fitness to Practise Panel ("the Panel") of the Medical Practitioners Tribunal Service (part of the General Medical Council) dated 19 th February 2015 directing that the appellant's registration be suspended for four months. The respondent ("the GMC") investigated and prosecuted the case before the Panel and appears as respondent under section 40(9) of the Act. Section 40 of the Act is set out in an Appendix to this judgment.
At this stage in these proceedings I am considering the appeal against the findings made in the Panel's Stage 1 determination on the facts which was given in writing on 3 rd February 2015. What follows my conclusions will be considered after a further hearing once the parties have had an opportunity to consider them.
The charges which were found proved
The Panel determination runs to 42 pages and followed a hearing which took 9 weeks. In it, they dismissed some charges, found others proved and in two cases found that the appellant had acted dishonestly. I am going to identify in detail only the charges which were proved and against which this appeal is brought. I shall set the charges out in their final form which was reached after some amendment during the hearing. The Panel found the following 7 charges proved:-
i) Paragraph 2 (" the Payments Charge"): In your role as "Chief Investigator" to the MIST Trial you did not ensure that all the details of personal payments received by you for taking part in the study and your possible entitlement to a bonus payable by the sponsor NMT was disclosed in the Application Form for ethical approval submitted to the West Midlands Multi-Centre Research Ethics Committee on or about the 4 th September 2004. This charge related to an hourly rate of £200 and a discretionary unquantified bonus payable under the terms of an agreement between the appellant and NMT which the Panel found had been signed by the appellant on the 19 th September 2004. The Panel found that the appellant ought to have disclosed the hourly rate but not the bonus payment. This was because they found that on 4 th September 2004 he knew he would be paid £200 per hour but there was no evidence that he knew that the agreement, when signed, would provide for a bonus. The Panel concluded that this failure was not dishonest.
ii) Paragraph 3 (" the CTA Charge"): In your role as "Site Investigator" on or about the 23 rd February 2005 you signed a "Clinical Trial Agreement" on behalf of Practical Surgeons in Medicine Limited which provided your medical services to the sponsor of the clinical trial (NMT) for the purposes of the conduct of the clinical trial and you declared that
a) You were not involved in any regulatory or misconduct litigation or investigation by the General Medical Council or other regulatory authorities; and
b) No data produced by you in any previous clinical study had been rejected because of concerns as to the accuracy or because it was generated by fraud.
The Panel found both limbs proved and found that this was dishonest.
iii) Paragraph 8: (" the MREC non-disclosure charge") In September 2004, at the time of applying for ethical approval of the MIST Trial, you did not disclose to the West Midlands Multi-Centre Research Ethics Committee concerns that he had been expressed by the Northern and Yorkshire Research Ethics Committee as to your role as the Chief Investigator of the Botox Clinical Trial. The Panel found this proved and that that the non-disclosure was dishonest.
iv) Paragraph 9: (" the MIST Trial personnel non-disclosure charge"). Prior to the start of the MIST Trial you did not inform all fellow Site Principal Investigators and/or all Steering Committee members that (a) the Northern and Yorkshire Research Ethics Committee has recently found you unsuitable to act as Principal Investigator in a Botox clinical trial because of research misconduct; and (b) that this misconduct had been referred to the GMC. The Panel found this proved and concluded that the non-disclosure was not dishonest.
v) Paragraph 10: (" the GMC Outcome MIST Trial disclosure charge"). That following a GMC Fitness to Practise Hearing which concluded on 24 th March 2006 concerning the Botox clinical trial in which you were the Chief Investigator and a Site Principal Investigator you did not immediately inform all the MIST Trial Steering Committee (i) that a GMC Fitness to Practise Panel had determined that your fitness to practise was impaired by reason of misconduct that arose out of your role as a site principal investigator in the Botox clinical trial; and (ii) that as a consequence of the GMC's Fitness to Practise Panel's Determination undertakings were offered by you and accepted by the Panel which were then recorded on your GMC Registration. The Panel concluded that this charge was proved but that the non-disclosure was not dishonest.
vi) Paragraph 11: ("the GMC Outcome MREC disclosure charge") Following the GMC hearing referred to in paragraph 10 above you did not immediately inform the West Midlands Multi-Centre Research Ethics Committee that undertakings were placed on your GMC Registration. The Panel concluded that this was proved and that the non-disclosure was not dishonest.
vii) Paragraph 12: (" the TCT Charge"). In October 2007 you attended a TCT conference in your role as Principal Investigator where you (a) stated that the closure rate of atrial shunts was 94% and (b) did not qualify your statement regarding the closure rate of atrial residual shunts. The Panel concluded that this was proved and that the non-disclosure was not dishonest.
Facts necessary to understand the charges
Clinical trials on behalf of pharmaceutical or other commercial suppliers of medical treatments are conducted by doctors who are subject to the jurisdiction of the GMC in so doing. They involve very significant ethical questions. Commonly these may concern the way in which patients may be treated for experimental purposes and the way in which their consent to treatment is obtained. I am not concerned with any such aspects of either of the two clinical trials which are the subject of this case. Ethical issues also arise because of the conflict of interest which may exist between the interests of the sponsor (commonly the company which wishes to test a proposed new product) and the patients present and future. The sponsor will wish to show that its product works and a good deal of money may turn on the result. The interests of patients who may be treated in the future by that product and of the community at large lie in the trial being conducted rigorously and its results reported accurately so that ineffective or dangerous treatments are not prescribed for them by their doctors. The sponsor is paying for the trial and chooses and then pays the doctors who work for it. That, it hardly needs to be said, is a situation which requires a very high level of integrity from the doctors and proper regulation and review. By referring to the risk of results being skewed by a conflict of interest I am not making any comment about the frequency with which it might actually happen or any observation at all about the ethics of those who sponsor clinical trials. The risk exists and must be managed. One would expect that it is successfully managed so that very high standards prevail. I have no reason to believe that this is not the case.
Clinical trials may be run from a single site if that site has enough patients to provide a suitable cohort for the exercise. Otherwise they involve multiple sites. All research sites are subject to a degree of supervision from a Local Research Ethics Committee (LREC). The regions of the country are also covered by Multi-Centre Research Ethics Committees (MREC). If a multi-centre trial was regulated by all the LRECS responsible for all its individual sites a degree of chaos might result. The role of the MREC is to approve and authorise the trial centrally and the LREC will then continue to be responsible for supervising the sites which are participating, but the effective supervision of the trial rests with the MREC. The trial will have a Chief Investigator. This is a doctor with a wide range of responsibilities for co-ordinating the clinical trial across the sites, managing the collation and analysis of the data, and publishing the results. Each site will have a Principal Site Investigator (also a doctor) responsible for the work done there for the trial. The trial is always defined in a document called the Protocol. The MREC gives approval for the Protocol and the trial must thereafter be conducted in accordance with it.
In 2003 the appellant was the Chief Investigator on a clinical trial sponsored by Allergan to test the usefulness of Botox as a treatment for migraine (the Botox Trial). The appellant is a specialist in headaches and runs a clinic at Kings Hospital London and a private clinic in Guildford in that field. At the material time over half his income came not from treating patients but from research and lecturing. In the course of the Botox Trial he was also the Principal Site Investigator for his private clinic in Guildford where some of the work was done. In that latter role he departed from the Protocol for that Trial. When this was discovered by the sponsor the...
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