Dowson v The General Medical Council

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 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:-

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 appellant was required to sign a file note on the 16^th October 2003 (“the File Note”). It recorded the “protocol non-compliance and misconduct” of the appellant which he admitted. This involved 10 patients being followed up by telephone and not being seen in person as the data suggested, and in 5 of these cases vital signs data were recorded as having been taken although they had not been. Data from previous visits was used instead. The corrective action specified as agreed in the file note included “removal of all erroneous data” and correcting the records to show what had actually happened. No further study treatments were to be administered to patients at the appellant’s site and the two subjects who had not completed the treatment were to be withdrawn from the study. This involved the appellant’s effective removal from this trial as a Principal Site Investigator. The fact that the File Note contained an express admission of misconduct is a matter of some significance.

On 22^nd October 2003 the appellant wrote to his LREC to inform it of the contents of the file note and he sent a copy of it to the LREC on 28^th November. The LREC considered what action to take in January 2004 and reported the matter to the Northern and Yorkshire MREC which had authorised the Botox Trial. The Northern and Yorkshire MREC expressed concern that Allergan had not reported the problem to it, and Allergan accepted this criticism and apologised. Correspondence continued in February as that study was nearing its end.

Dr. Peter Wilmshurst is a cardiologist and the appellant is specialist in headaches and both specialities were relevant to the MIST Trial as will appear. The sponsor was NMT, an American company which manufactured the STARFlex device which is designed to close holes in the human heart. The hypothesis being tested was that closure of a congenital heart defect known as a patent foramen ovale (PFO) would resolve migraine in some patients. If that could be demonstrated the treatment would become common because the PFO is a common finding in the population, as is migraine. NMT eventually invested £1.7m in the MIST Trial which is a measure of the commercial potential if the treatment was shown to be effective.

While the MIST trial was in its early stages, the investigation into the appellant’s conduct in the Botox trial continued. In April 2004 the North and Yorkshire MREC decided that it would be a condition of its continued approval of the Botox Trial that the appellant should be replaced as Chief Investigator, and that happened. The appellant was therefore removed as Chief Investigator and his role as Principal Site Investigator at Guildford was severely curtailed as set out in the File Note. The case was also referred to the GMC but it appears that the appellant was not aware of this until the GMC wrote to him the following November.

At some point during these events, the appellant was appointed Chief Investigator of the MIST Trial. He did disclose his problems at the Botox Trial to NMT, but not to the MREC approving the MIST Trial which was the West Midlands MREC. The Panel by finding the MREC Non-Disclosure Charge proved held that this was a dishonest act which involved misconduct because it should have been obvious to the appellant that the MREC approving the MIST Trial and his role in it would wish to know that he had been removed from another clinical trial in the circumstances set out above as recently as the previous April (during the development of the MIST Trial). The Protocol for the MIST Trial was submitted for approval to the West Midlands MREC on 4^th September 2004, signed by the appellant in his capacity as Chief Investigator.

The formal agreement containing the terms of his appointment was not signed until 19^th September 2004 but his actual appointment clearly predated that. Otherwise the Protocol would have been misleading in describing him as the Chief Investigator. The Protocol is a long and complex document and no doubt a good deal of work had been done by Dr. Wilmshurst, the appellant and others on it. The appellant’s appointment was a change of plan from the way things had stood in February when he and Dr. Wilmshurst were described as co-Principal Investigators. The appellant’s Chief Investigator agreement provided for him to be paid £200 per hour his work as Chief Investigator and for a discretionary bonus which may be paid in addition. His defence to the Payments Charge which alleged non-disclosure of this agreement to the West Midlands MREC was that there was no duty to disclose this information, and that he had not been aware of it when submitting the protocol for approval on 4^th September 2004. The Panel found that he had known of the hourly rate because he had been paid about £4,000 in August 2004 at that rate. It found that he had not known of the bonus agreement at the relevant time, and that it was not a sufficiently certain entitlement to require disclosure in any event. This charge was therefore proved in respect of the £200 hourly rate.

The appellant was NMT’s second choice as Chief Investigator. Their first choice had decided not to become involved. NMT, as sponsor, was informed of the problems which had affected the appellant’s role in the Botox trial, but this did not trouble them. They still wanted the appellant to serve in that capacity on that trial. Dr. Wilmshurst and other doctors working on the MIST Trial were not informed. The GMC, in prosecuting the case, alleged that it was in the interest of both the appellant and NMT that he should continue to serve the Trial which would avoid disruption to it. Either expressly or tacitly, it was alleged, they had agreed not to tell anyone who might cause trouble. In this context that meant the West Midlands MREC and Drs. Wilmshurst and Nightingale with whom tensions were developing which later erupted into open conflict. Dr. Nightingale was a colleague of Dr. Wilmshurst and they both became members of the Steering Committee of the MIST Trial. The Steering Committee is described as follows in paragraph 11.2 of the Protocol

“The Steering Committee will consist of five specialists from the clinical sites and two representatives from NMT Medical. The Steering Committee will be weighted towards the migraine specialist field in lieu of the population being studied and the role of the committee to that end:

-

Three migraine physician specialists, one of which will be the Chief Investigator, Two cardiologists, one of which will be the Chief Investigator [this must mean Dr. Wilmshurst who was the lead cardiology specialist]

-

Two NMT representatives

This committee will oversee the day to day administrative management of the trial, answer specific questions related to study mechanics or entry criteria, monitor patient enrolment, clinical site progress and protocol compliance, recommend changes to the Date Safety and Unanticipated Adverse Events Monitoring Committee configuration, recommend publications and presentations using trial data or information, and assist Sponsor in executing the trial, making recommendations in study design where appropriate. The Steering Committee will meet prior to the initiation of the trial and on an ad hoc basis during the conduct of the trial, either in person or by teleconference.”

The MIST Trial was controversial because it involved sham surgery. This means that some patients were led to believe that they were fitted with a STARFlex device when they were not. Their subsequent complaints of migraine could then be compared with those of the cohort where the device had been fitted to see if it had produced any improvement. This obviously gave rise to serious questions of ethics which needed to be resolved by the MIST Trial, set out in its Protocol and approved by the West Midlands MREC.

This was a multi-site trial and patients were seen and treated in various hospitals up and down the country. The operator of each site was required to enter into a Clinical Trial Agreement (CTA) which identified which of its employees was to serve as Principal Site Investigator, responsible for the treatment of patients at that site. The appellant was the subject of one of these agreements in November 2004 when Kings College Hospital became a site in the MIST Trial. He was named as such in the CTA and was the subject of a warranty at Appendix 6 to the effect set out in the CTA Charge. This is in standard form and was a declaration that

That warranty in appendix 6 of the Kings College CTA was false in that the appellant was involved in an investigation by the GMC and secondly data produced by the appellant in the Botox Trial had been rejected because of concerns as to the accuracy of it. The appellant certainly knew about the rejection of his data and had known it for nearly a year. By the date of the Kings CTA he had been notified about the GMC investigation. Dr. Ernest Choy signed the CTA on behalf of Kings and there is no evidence that he knew of these events when he did so. The appellant’s evidence was that he had had a conversation with a Phil Barnes about it, but he did not say that he told Dr. Choy. The data concerned had been produced by the appellant at his Guildford private practice site and not at Kings.

The Guildford clinic became a site for the MIST Trial in February 2005. On 23^rd February 2005 the appellant signed a CTA with NMT on behalf of Practical Solutions in Medicine Limited. This included the warranties in Appendix 6. Because he is the director and shareholder of the company which operates the Guildford site he signed the CTA on behalf of the company therefore in effect giving a warranty about himself which was, to his knowledge, false in two respects. His defence on this count was that the CTA was an agreement with NMT which knew the true position at all times. This charge was found proved, and a finding of dishonesty was made. The Grounds of Appeal describe this decision as “bizarre”.

In March 2006 GMC proceedings in relation to the Botox Trial came to a conclusion. The Fitness to Practice Panel found that the appellant was guilty of serious misconduct, that his fitness to practise was impaired and that it would accept undertakings from him as to his future conduct on place of any other sanction. It expressly did not find that his conduct had been dishonest. The two charges in the present proceedings which relate to this alleged that he should at once have informed clinical colleagues within the MIST Trial of this and should also at once have informed the West Midlands MREC. His defence to these charges is that he complied with his undertakings which did not require him to make these disclosures and acted on legal advice about his obligations. He further said that the clinical colleagues all knew, except for Drs. Wilmshurst and Nightingale. These allegations were found proved but no finding of dishonesty was made.

In the end the MIST Trial produced negative results. No improvement in migraine was noted in the cohort which had been treated as against the placebo cohort. One possible explanation for this was that the STARFlex device does not work properly in achieving closure of the PFO. Another is that the STARFlex is not designed to have any effect on pulmonary (as opposed to atrial) leakage in the heart and pulmonary leaks continued to cause migraine. Another is that the hypothesis that the PFO and subsequent atrial leakage does not cause migraine and so the headaches will continue whether it is closed or not. It appeared that the MIST Trial was not designed so that it could reliably differentiate between these outcomes. For NMT this negative result was a disappointment and a financial setback. Although this failure was not terminal, the company did subsequently cease trading in 2011. What would perhaps have been even worse would have been proof that the STARFlex device not only did not prevent migraine but did not actually work in closing the PFO properly. It would then not have been useful for the purposes for which it had previously been applied. In the end, the reported result of the MIST Trial was that the STARFlex device was not generally undermined, but its use as a treatment for migraine was not validated. How this happened is the subject of the TCT charge.

The misconduct proved against the appellant was, therefore, as follows (re-organised into chronological order):-

The first 6 charges found proved allege either keeping quiet about the Botox problems at the Guildford site or, in one case (the CTA) positively misrepresenting them. The last charge alleges misrepresenting the results at a conference attended by cardiologists in the United States of America to preserve the utility of the STARFlex device which had been discredited by Dr. Wilmshurst although not by the results obtained by the MIST Trial protocol.

There are seven Grounds of Appeal which are set out at some length on behalf of the appellant. I will summarise them but, of course, have in mind the full document. In addition I will identify the Panel’s reasoning which is subject to attack on each ground and insert some references to relevant documents. As a general introduction 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. 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. I will deal with those two cases first, as do the Grounds. I will however deal with those two charges in chronological order.

Ground 2: The MREC Non-Disclosure Charge. It is said that this charge relates specifically to the appellant’s state of mind as at the 4^th September 2004 when the Protocol was submitted for approval by the West Midlands MREC. At that date he did not know he had been referred to the GMC because of his conduct of the Botox Trial. It is argued that NMT knew about the Botox Trial and so did the LREC, because it was, of course, the same LREC as had been involved with the Botox Trial. Strong reliance is placed on a statement of Dr. Janet Wisely whose statement was quoted by Professor Holm but who did not, herself, give evidence. The appellant relies his evidence that his employers at Kings Hospital had given the warranty when entering into their CTA in November 2004 although he had told Phil Barnes at Kings about the Botox Trial problem. He did not, however, say that he had told Dr. Choy who signed the CTA. The appellant points out that evidence of Dr. Jubb (chairman of the West Midlands MREC for part of the relevant time) was given in answer to a “rolled up” question in re-examination which invited him to consider the whole history including the finding of misconduct by the GMC in March 2006. He was asked if he would have expected to be told about all of that. He said he would, but at the time to which this charge relates, September 2004, the GMC proceedings had not been started, still less decided. He was not asked to say separately whether he would have expected to be told about the fact that another MREC had required the removal of the appellant from another trial in April 2004 when the MIST Trial protocol was submitted in September 2004. It was said that there was, therefore, no evidence to justify the finding made by the Panel:

“MRECs have a clear role in determining investigators’ suitability to manage a trial and ensure its scientific and ethical integrity. It was therefore a serious matter to fail to disclose information that would have been necessary to allow WMMREC to exercise those responsibilities.”

Ground 1: The CTA Charge. This complains that the finding that in signing the CTA on behalf of his company, and giving the warranty contained in Appendix 6, the appellant was guilty of misconduct and was acting dishonestly. It is said that this finding was against the weight of the evidence which is analysed in the Ground. In essence the appellant relies on the fact that NMT, as sponsor, was the party to whom the false warranty was given and it, as was common ground, knew the truth.

The Panel said that

“It was inherently dishonest to make materially false statements in a legal document even where the parties were aware of the false elements. Such documents are potentially disclosable and available for interrogation in the future: the panel considered that there was an element of dishonesty in creating a false record that had the potential to mislead…with regard to motive, the panel noted that the trial protocol required the standard CTA to be signed by any site wishing to participate in the MIST Trial. It follows that you could not have functioned as a Site Principal Investigator without signing the CTA and that would have undermined your credibility as Chief Investigator. The panel has seen evidence of NMT’s enthusiasm to retain you in the Chief Investigator role, so that you and the company had a strong incentive to sign these false statements. By doing so you were able to pursue your role as Site Principal and Chief Investigator.”

It is argued that this was a proforma contract and there was no evidence that anyone other than NMT would ever see it and it therefore did not have the potential to mislead. It is submitted that if the appellant and NMT had deliberately intended to create a document for accounting purposes it would have been amended to omit Appendix 6. Mr. Miller QC referred in oral argument to the fact that the CTA misstates the name of the appellant’s company as evidence that limited attention was given to its terms at the time when it was signed. However, I do not understand the appellant’s evidence to have been that he gave the Appendix 6 warranties because of carelessly failing to read the CTA properly. I have read his evidence on this issue and he was saying that he knew of the warranty and its meaning, but felt that NMT had waived it by asking him to carry on despite knowing about the Botox Trial problem and the GMC investigation. He referred to the fact that he had offered to stand down if that was required. Therefore his case appears to have been that he deliberately signed this CTA knowing that it contained a warranty which was untrue but that this was not misleading because the person to whom it was given knew the truth.

It is submitted that the Panel was wrong to find that the Protocol required the standard CTA to be signed by each site, and therefore wrong to regard it as a document which was designed to assist anyone but NMT. In fact, the Protocol says at paragraph 12.1

“Each physician participating in the trial will be required to sign an investigator agreement.”

And at 12.8.2 says

“Required Documentation

No Investigator may start the trial until they have met all criteria. This will include an acknowledgement that the following documents have been received:

- Signed Investigator’s Agreement, including names of all sub-investigators that may treat trial patients.

- Signed protocol”

Having set out the Grounds which relate to the two charges which allege dishonesty, it is convenient to record paragraph 32 of the decision of the Panel:-

“The paragraphs of the allegation which remain to be decided are separate and distinct. The panel has considered each allegation individually. However in the case of the dishonesty charges relating to non-disclosure, having first examined the separate issues, the panel did not then find it necessary to consider whether there was evidence of an overall pattern of dishonest non-disclosure.”

I think this means that the Panel did not use its findings of dishonesty identified above as cross-admissible evidence of dishonesty in respect of other charges. It would have been entirely proper to take into account the finding on the MREC disclosure charge when considering the CTA charge, and indeed both findings on some of the other charges where dishonesty was not proved. In approaching each allegation separately the Panel was scrupulously fair and adopted an approach which favoured the appellant.

Ground 3: The Payments Charge. This is a challenge to the sufficiency of the evidence which supported the Panel’s finding of non-dishonest misconduct by failing, on 4^th September 2004, to disclose the fact that the appellant was to be paid £200 per hour as Chief Investigator. It is asserted that the appellant did not know as at 4^th September what he would be paid as an hourly rate as Chief Investigator. The Panel found that he did, because he had charged for extensive work prior to 4^th September 2004 at that hourly rate. For some of that time he had clearly already been appointed as Chief Investigator because he signed the application form in that capacity. The formal agreement evidencing his appointment was not signed until after 4^th September 2004, but this did not mean that terms had not been agreed as to the hourly rate before that. This is a finding of primary fact which was plainly open to the Panel and I shall not consider it further.

The Ground points out that the evidence was that the level of financial detail in the application form was more than would have been expected at the time for an industry sponsored trial. This evidence came from Dr. Jubb. The appellant also relies on evidence from Professor Hall, who had said that the appellant had provided enough information to meet the requirements of the West Midlands MREC who could always ask for more information if they required it. In addition, it is argued that the standard form application form used by the appellant when seeking MREC approval for the MIST Trial did not include a question asking what the Chief Investigator was to be paid. There are three relevant questions in this form.

In fact, after the date of the application, the appellant signed his agreement with NMT which contained a bonus provision and at a later stage again he bought some shares in NMT. Although he was charged with failing to disclose these matters to the MREC, the Panel found these elements not proved. The proved allegation related only to the hourly rate. This finding was based on Good Medical Practice (GMP) paragraph 14, see below. The Panel said

“43…..In the present case it seemed to the panel self-evident that a doctor who had not disclosed “all financial interests and sums of money” to be paid for research could not be said to have met his or her express obligation to do so under paragraph 15 of GMP.

“44.

The panel considered that you had a responsibility to ensure that this section of the form was completed accurately and fully, not least because as noted by Professor Holm and others, MREC has to determine whether the financial arrangements are compatible with the proper conduct of the trial. It did not seem to the panel that it was reasonable to expect the West Midlands MREC to ask for additional detail as suggested by Professor Hall, particularly when it had not way of knowing what payments had been excluded.”

Ground 4: the MIST Trial personnel non-disclosure charge. This again attacks the evidential basis for the finding that the appellant should have disclosed the fact that he had been dismissed from the Botox Trial to professional colleagues also involved in the MIST Trial before the start of the Trial. This complaint is really a simple assertion that the appellant had no obligation to make this disclosure because NMT knew and the LREC also knew. Further it is said that the importance of this information can be judged by the reaction of Dr. Wilmshurst and Dr. Nightingale when they learnt of the GMC Fitness to Practise hearing some time after March 2006. Neither suggested, even at that stage, that they could not work with him and made no complaint about not being told about the Botox Trial any earlier.

Ground 5: the GMC Outcome MIST Trial disclosure charge. It is said that there was no proper basis for this finding. The argument is that there was no duty to inform the MIST Trial Steering Committee about the finding that he had been guilty of misconduct in his conduct of the Botox Trial and required to give undertakings. Those undertakings required the appellant to inform certain people in the context of future clinical trials of the events surrounding the Botox Trial. They make no mention of the need to inform anyone involved in current ongoing trials, such as the MIST Trial. The appellant further relies on the legal advice which he received about his obligations at that time and points to the fact that his solicitors and counsel who appeared in the GMC proceedings did not advise him that he ought to inform the Steering Committee of the MIST Trial. It is submitted that if the GMC had required him to do that an undertaking to that effect would have been required.

It was agreed by the appellant that he had not informed every member the Steering Committee and the issue was whether he was thereby in breach of his professional duty. The Panel relied on evidence from Professor Holm and held that findings of impairment and misconduct in relation to a recent clinical trial were matters which clearly needed to be disclosed to those working closely with the appellant on a new trial. This would have been necessary both to preserve their trust in the appellant’s integrity and also to ensure that they could take whatever action they deemed appropriate to protect the reputation and viability of the trial.

The Panel made a finding of fact that the appellant was told by his lawyers at the relevant time that he was not required to tell the steering group of the MIST Trial or the MREC (see below) of the findings against him. However, they found that this advice related to the terms of the undertakings and amounted to advice that the undertakings did not require such disclosure, which they did not. They drew a distinction between the legal obligations created by the undertakings and the professional obligation created by GMP and Helsinki. They said this

“The panel can understand why you might have allowed yourself to rely on this advice, and to treat it as covering your professional duties as well as your legal ones. however, it considers that the obligation to to inform the Steering Committee colleagues of the GMC findings was so clear cut that he should have recognised that duty. They held that the legal advice was best seen as a mitigating factor, rather than a defence to the charge. The fact of the advice was the reason why the Panel found that this allegation did not involve dishonesty.”

Ground 6: the GMC Outcome MREC disclosure charge. This charge is substantially the same as that covered by Ground 5 except that it alleged that the West Midlands MREC should have been informed. The arguments are also the same, except that the appellant relies on evidence given by Professor Holm who said that if he had been advised by his lawyers to tell certain people about the outcome of the GMC proceedings, he would have accepted that advice and acted on it. The Panel decided to “set aside” this piece of evidence because they did not agree with it. The Ground complains that they did so “with no expert or factual evidence to support their decision and with no apparent medical scientific experience of their own to fall back on.” The Ground also complains that there was no established mechanism in 2006 by which the MREC would have expected to be informed about the outcome of such GMC proceedings.

Ground 7: the TCT Charge. This Ground complains that the Panel’s findings on this charge were wrong and irresponsible. It is submitted that there was no basis for the finding that the appellant ought to have told the conference of the doubts about the claimed closure rate of 94% of PFOs in the trial. This conference took place in 2007 before the publication of the paper in 2008 which reported the findings of the trial in a way specifically approved by the MREC and a number of co-authors of the Paper. The reporting of the trial in the Paper was consistent with what the appellant had said to the conference and no co-author is said to have been culpable in that regard. The complaint also alleges that the Panel became involved in the resolution of a difference of medical opinion about the results which they were advised not to do and which they had no proper evidential basis to do. Mr. David Mason, the legal adviser of the Panel, had advised as recorded in paragraph 22(3) of the decision:

“..that the Panel does not have the material to decide whether the figure quoted was correct and does not need to do so. He advised that the issue of whether it was acceptable not to qualify the 94% figure should be considered with reference to whether it was correct not to disclose the two ad hoc reviews which were outside of the trial protocol.”

The trial cardiologists conducted echocardiograms on the patients after they had fitted the device to determine whether they had succeeded in their aim of closing the PFO. This involved an element of “marking their own work” and was the subject of some discussion. It was, however, the process approved by the West Midlands MREC in the Protocol. Dr. Wilmshurst was dubious about the results which, if correct, invalidated his hypothesis that a PFO might cause migraine. He therefore reviewed the echocardiograms and decided that the device had failed to close the PFO in a far greater number of cases than 6%. This was the subject of further review by Dr. Missault, a cardiologist and member of the Safety Board of the MIST Trial who disagreed with Dr. Wilmshurst. The disputes involved a good deal of technical disagreement. Not all the echocardiograms had been retained and in any event Dr. Missault contended that the cardiologist reviewing the echocardiogram on screen in real time would have a better opportunity to make an accurate finding than a doctor viewing only the retained image.

The West Midlands MREC considered this question after it had withdrawn ethics approval from the MIST Trial and said this

“The Committee debated the accuracy of the different interpretations of the echocardiograms and felt the original cardiographer would have a clearer image on screen when reading the echo live. The committee recognised that this was appropriate for the study, although recognised that subsequent studies may use a different protocol. ”

Ethics approval was reinstated so that the result could be published as they ultimately were in the Paper. This was why the paper reported the results of the finding of the study per Protocol without reference to the two subsequent reviews which were outside the Protocol and for which no approval had been given the MREC or consent by the patients. Dr. John Thompson in his evidence to the Panel had criticised the Protocol, and both subsequent reviews. He was critical of all three in different ways and said that in this unsatisfactory situation the only proper way of reporting the results was to do so according to the Protocol.

In fact, what the appellant said to the conference was that the “closure rate was 94% as reported per protocol by implanting cardiologist” (this was written on a slide) and said orally

“Now some have suggested that the results of the study may be due to incomplete PFO closure or residual leaking. Similar to what has been reported in other studies reporting looking at residual leaks with the STARFlex device, a 94% closure rate was observed and reported in the MIST study, per protocol by the interventional cardiologist checked for the presence of a moderate or large PFO at follow-up. Trivial shunts or secondary shunts, such as pulmonary shunts, were not evaluated as part of the study. These may have been important.”

The Panel discussed this evidence and its consequences at length. It summarised its finding at paragraph 265

“The panel determined that the words you used were technically accurate but failed to reflect the level of uncertainty that should properly have been attached to the reported closure rate. The panel considered that your reporting of the data was unbalanced and misleading, but in the absence of any reliable measure, could not be characterised as dishonest.”

Sir Stephen Silber sitting as a Judge of the High Court set out the position in Gosalakkal v. GMC [2015] EWHC 2445 (Admin) and neither side suggested his formulation was in error. I shall adopt it, with gratitude. It is precisely apt in the present case, where, as I have said, the challenge is to the approach of the Panel to the evidence, and the expert evidence in particular. It is said that the evidence did not justify the findings of misconduct. Sir Stephen said this

12 Appeals under s. 40 of the Act are by way of re-hearing (CPR PD52D, paragraph 19). The Court will allow the appeal where the Panel's decision was: (a) wrong; or (b) unjust because of a serious procedural or other irregularity in the proceedings before the Panel (CPR 52.11).”

13 This Court can allow an appeal where the decision of the panel is wrong (CPR 52.11 (3) (a)). In the light of some of the submissions of the appellant, it is appropriate to set out some of the guidance given by the Court of Appeal as to how this court should deal with appeals from fact-finding bodies and, in particular, when this court can interfere with decisions of the Panel.

14 Those established principles are that:

“(i)

The court must have in mind and must give such weight as appropriate in the circumstances to the following factors –

(a)

The body from whom the appeal lies is a specialist tribunal whose understanding of what the medical profession expects of its members in matters of medical practice deserves respect;

(b)

The Tribunal had the benefit, which the Court normally does not, of hearing and seeing the witnesses on both sides; and

(c)

The questions of primary and secondary facts and the over-all value judgment made by the Tribunal, especially the last, are akin to jury questions to which there may reasonably be different answers”. Meadows v. GMC [2007] QB 462 [197], per Auld LJ);

(ii)

“The Appeal Court conducting a review of the trial Judge's decision would not conclude the decision was wrong simply because it is not the decision the Appeal Judge would have made had he or she been called on to make it in the court below. Something more is required than personal unease and something less than perversity has to be established… I would pose the test for deciding whether a finding of fact was against the evidence to be whether that finding by the trial judge exceeded the generous ambit within which reasonable disagreement about the conclusions to be drawn from the evidence is possible”. (Assicurazioni Generali SpA v. Arab Insurance Group [2003] 1 WLR 577 [197], per Ward LJ);

(iii)

“The difficulty or ease with which that test could be satisfied will depend on the nature of the finding under attack. If the challenge is the finding of a primary fact, particularly founded upon an assessment of the credibility of witnesses, then it will be a hard task to overthrow” (ibid);

(iv)

“First, as a matter of general law, it is very well established that findings of primary fact, particularly if founded upon as assessment of the credibility of witnesses are virtually unassailable” (Southall v. GMC [2010] EWCA Civ 407 [47], per Leveson LJ with whom Waller and Dyson LJJ agreed); and

(v)

“Since a principal purpose of the Panel's jurisdiction in relation to sanctions is the preservation and maintenance of public confidence in the medical profession rather than the administration of the retributive justice, particular force is given to the need to accord special respect to the judgment of the profession decision-making body in the shape of the Panel”. (Fatnani and Raschid v. GMC [2007] EWCA Civ 46 [19], per Laws LJ).

The appellant accepts that the Panel was correctly advised by the legal assessor that the test to apply when considering whether he was dishonest was that set down in R v Ghosh [1982] QB 1053, as perhaps modified by the decision in Hussain v The General Medical Council [2014] EWCA Civ 2246.

Kirschner v The General Dental Council [2015] EWHC 1377 (post-dating the Panel’s decision) confirms that the Ghosh test still applies to disciplinary proceedings. At paragraph 22 Mr Justice Mostyn said:

“The tribunal should first determine whether on the balance of probabilities, a defendant acted dishonestly by the standards of ordinary and honest members of that profession; and, if it finds that he or she did so, must go on to determine whether it is more likely than not that the defendant realised that what he or she was doing was by those standards, dishonest.”

In Hussain v GMC [2014] EWCA (Civ) 2246the main judgment of the Court of Appeal was given by Bean LJ, who said

“41 In short, I conclude that given the Panel's findings of fact on allegations 4 and 7, which they were entitled to reach, their finding of dishonesty in respect of those charges was inevitable. On this basis it is unnecessary to recite the well-known authorities about the degree of deference due to the opinion of a professional disciplinary body as to what conduct is to be considered dishonest by the standards of the profession.”

I interpolate that the authorities not cited by Bean LJ also require deference to the judgment of the Panel about what constitutes serious misconduct.

Longmore LJ concurred with this judgment, but then added, at paragraph 51, the following:

“I would only add that I am a little troubled about the Ghosh direction given by the legal assessor in this case. It would have been standard in a criminal case. But this was a professional disciplinary hearing and it seems to me that in future it would be right and proper for the first part of the direction to be adapted to read that the panel should decide "whether according to the standard of reasonable and honest doctors [not people] what was done was dishonest". There may be a not unimportant difference between the two as shown by the decision of the judge in this very case.”

It does not seem to me that it is necessary to resolve the precise terms of the Ghosh test in this context. In the criminal courts it is actually quite unusual to come across a case where the two limb Ghosh direction is relevant. The first limb is premised on the proposition that dishonesty is an ordinary English word which everyone understands. It is only when the defendant in question has a mindset or belief system which means that s/he does not share that common understanding that it is necessary to consider whether, subjectively, the defendant knew that by ordinary standards (if not by his own) what s/he was doing was dishonest. In the present case the appellant did not say that his standards of honesty were any different from anyone else’s, or that he had some unusual motive for failing to tell the West Midlands MREC about the problems on the Botox Trial or signing a CTA with a false warranty in it. There was also no evidence that reasonable and honest doctors have any different view of what is required in the two particular situations where dishonesty was found than that held by reasonable and honest people. 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. If that is right then the test propounded by Longmore LJ would impose a higher standard than the test which applies to non-medical endeavours. It would be unwise for me to attempt to follow that line further in a case where the evidence and the facts render any such enquiry unnecessary. 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 or 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.

There was a great deal of evidence in this case about ethical standards in research projects. I think the Panel understood that as being relevant to the context within which the judgment is to be made, rather than to establishing some special rule as to what dishonesty means when it is alleged against a doctor. In my judgment they were right do so. Had they adhered firmly to that approach, it might have led them to take a rather more robust view on how much of that evidence was actually helpful. The Fitness to Practise hearing lasted 48 days. Dr Peter Wilmshurst gave evidence over three days, and Dr Nightingale gave evidence over 2 days. As a matter of fact they were the only two members of the Steering Committee who were not told about the outcome of the GMC Botox proceedings in March 2006. Dr Hawker and Dr Jubb each gave evidence over half a day. They were doctors who had been successive chairmen of the West Midlands MREC. Professor Holm gave evidence over 3 days. The appellant gave evidence over 3½ days. Professor Hall gave evidence over 2 days. Dr Thomson gave evidence over a day. Professor Hall and Dr. Thompson were called as experts on behalf of the appellant. The Panel therefore heard 3 days of expert evidence in a case which concerned the more simple ethical aspects of a complex clinical trial. It is an important part of this appeal to rely on some of the detail of that evidence and to contend that the Panel ought not to have followed the views of Professor Holm as faithfully as they did. It is also said that the finding of the Panel on the TCT charge involved it deciding a complex issue of cardiology practice in order to decide whether Dr. Wilmshurst’s view of the failure rate of the STARflex device on the Trial was of such weight that it was misconduct for the appellant to fail to refer to it. This issue also occupied a good deal of time.

The role of the Fitness to Panel in the decision process as to what constitutes misconduct and dishonesty in cases of this kind is not simply that of deciding between rival expert witnesses on the issue. In criminal cases dishonesty is for the court and evidence about what the standards of reasonable and honest people are is not admitted. Honesty is an ordinary English word, and not a technical construct. I have to assess the way in which the Panel used the expert evidence which was called before it. The approach of the parties to that evidence at the Panel hearing and before me differed, and my task is to determine whether the approach of the Panel was appropriate.

The GMC relied on three principal sources of published ethical standards and on the evidence of Professor Holm, a medical ethicist acting as expert witness, and on witnesses from the West Midland MREC, Dr. Jubb and Dr. Hawker. I shall deal with the witness evidence below and first set out the published material.

Good Medical Practice (GMP)

There is more specific guidance about the research context in a document called “Research: The Role and Responsibility of Doctors” published by the GMC in 2002 and now withdrawn. This starts

“This guidance sets out the standards expected of all doctors working in research in the NHS, universities and the private sector or other circumstances. It develops the general principles and standards on research set out in our other guidance documents and should be used in conjunction with them. ”

“You must always follow the principles in this guidance and take note of other governance and good practice guidelines issued by the Departments of Health and other authoritative bodies. You must observe and keep up to date with the laws and statutory codes of practice which affect your work.”

It continues as follows:-

“Good Practice in Research

Conflicts of Interest

13.

You must always act in the participants’ best interests when carrying out research. You must ensure that your judgment about the research is not influenced, or seen by others to be influenced, by financial personal political or other external interests at any stage of the process. You should always declare any conflicts that may arise to an appropriate person, authority or organisation, as well as to the participants.

Funding and Payments

14.

You must be open and honest in all financial and commercial matters relating to your research and its funding. In particular, you must

- declare to research ethics committees, prior to the research being approved, all financial interests and sums of money which you know, or estimate, will be paid for the research undertaken; accept only those payments which have been approved by the research ethics committee;

- not allow your conduct in the research to be influenced by payment or gifts.”

The obligation is, therefore, only to accept payments which have been approved by the MREC. The appellant received payment for his work as Chief Investigator of the MIST Trial at the rate of £200 which was not a rate ever approved by the West Midlands MREC.

The World Medical Association Declaration Of Helsinki (2000), Ethical Principles For Medical Research Involving Human Subjects (Helsinki).

The appellant accepted in evidence that Helsinki applied to his work, as it clearly did by virtue of this declaration even if for no other reason. I note in passing in relation to this application form that it involves a mandatory requirement for a Summary CV of the appellant and one was provided dated 8^th June 2003. This, of course, pre-dated the appellant’s dismissal from the Botox Trial but it does not appear that the West Midlands MREC asked for an up to date document. No doubt this is a procedure which has been improved since 2004. The definition of the role of the ethics committee in Helsinki has a direct bearing on the researcher’s obligations in regard to it. The appellant was required, of course to answer its questions honestly, but his obligation went beyond that to include a positive obligation to volunteer material as paragraph B4 makes clear.

THE EXPERT EVIDENCE. The Panel is criticised in this appeal for attaching too much weight to the evidence of Professor Holm who was called on behalf of the GMC. He is a professor of medical ethics and his evidence was attacked as being essentially theoretical because he has limited experience of clinical trials. The submission was made to the Panel and is repeated on this appeal that greater weight should have been given to the views of Professor Judith Hall OBE who is a distinguished anaesthetist and Dr. John Thompson who is a distinguished congenital cardiologist. The Panel expressed their findings about these witnesses, whom they heard at length, as follows:-

“27.

The panel was impressed by the careful and cogent analysis of ethical and professional issues provided by Professor Holm. Whilst it was persuaded by his judgments on most issues, it considered that his expectations of the level of nuanced scrutiny of guidelines to be expected of a practising clinical researcher were sometimes unrealistic (eg in relation to exceeding the requirements for disclosure imposed by a journal’s own publication policy).

“28.

The panel found Professor Hall’s evidence on the pragmatics of applying for approval for clinical trials and on the running of such trials to be both credible and helpful. However, it felt that her evidence on ethical and professional standards lacked consistency and clarity. In this area, it seemed to the panel that Professor Hall sought to provide evidence that, whilst remaining honest, was shaped o as to be as helpful as possible to your case, rather than reflecting a more neutral position.

“29.

Dr. Thompson’s evidence on the cardiological aspects of the case was particularly clear and helpful, including his account of the weaknesses of the three attempts to measure atrial closure rate. However, the panel found his evidence on the reporting of equivocal findings and on the statistical plausibility of Dr. Missault’s findings to be less cogent and persuasive. It noted that these matters fell outside his specific areas of clinical expertise and it accorded them less weight.

“30.

With respect to the oral evidence, the panel was satisfied that all of the witnesses made an effort to assist the panel and that they were honest and conscientious in their approach. In general the panel found the factual evidence provided by all witnesses to be credible within the limits imposed by memory. However, there were aspects of the arguments and opinions advanced by some witnesses that the panel found less convincing and to which it attributed less weight.”

Professor Hall described the terms of Helsinki as “aspirational” and there was some issue about how it applied to the profession generally. In view of the terms of the application form signed by the Chief Investigator of this clinical trial this was not a live issue for the Panel in this case. The appellant accepted this in evidence. This approach of Professor Hall to Helsinki was one reason why the Panel felt that her evidence, while honest and helpful, tended to take the positon which was most helpful to the appellant. They therefore approached her evidence with care when it conflicted with other evidence or with their own assessment of the ethical position. This was a rational conclusion and one which I do not intend to upset.

I have referred in my statement of the law above to the deference the courts accord to the expertise of the Panel. Mr. Miller in his written submissions made some observations about the experience and background of the members of this particular Panel, to undermine the respect which the court should accord to it. The submission was also designed to suggest that the Panel should not have differed from the expert evidence of Professor Hall and Dr. Thompson. This was said to be so because the Panel itself had little experience of the research environment and the expert evidence relied on by the GMC came from Professor Holm, an academic ethicist. I did not find the reference to the constitution of the Panel helpful. It was not suggested that it was appointed by any irrational or unfair process and it is not for the court to enquire into the suitability of any particular Panel unless there is some such challenge. The court will treat the findings of the Panel with respect, which is not the same as following them slavishly. The Panel was required to use its own judgment to decide whether the charges were proved and I am required to use mine to decide whether it was wrong. As Lord Millett said of the Privy Council when it exercised the appellate jurisdiction from the GMC in Ghosh v General Medical Council [2001] 1 WLR 1915 , 1923, at paragraph 34:

“The Board will afford an appropriate measure of respect to the judgment of the committee whether the practitioner's failings amount to serious professional misconduct and on the measures necessary to maintain professional standards and provide adequate protection to the public. But the Board will not defer to the committee's judgment more than is warranted by the circumstances.”

The Panel was required to make a series of ethical judgments. It had to decide what the appellant ought to have done in particular circumstances, and whether his failure to act in that way amounted to misconduct. These judgments could not be made by simply applying GMP or Helsinki because there is no code which covers every factual situation to be found there. Some of the submissions on behalf of the appellant invited the Panel (and now invite me) to deal with this simply as a matter of expert evidence and evidence from the chairmen of the West Midlands MREC who gave evidence. Unless a witness said that conduct was unacceptable, the Panel was bound to treat it as acceptable. I do not accept that as an appropriate approach to this type of decision. Of course, 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.

Stanley Burnton J, as he then was, said this in David v. GMC [2004] EWHC 2977 (Admin) at paragraph 59:-

“Where there are genuine but conflicting views as to the appropriate ethical response to a defined situation, held by responsible bodies of medical men and there is no relevant guidance of the GMC or applicable legal rule, it may be difficult to see the conduct consistent with one view could be serious professional misconduct.”

In the area with which I am concerned there is, in my judgment, is a clear rule from the GMC which requires “honesty and integrity”, GMP paragraph 52. Further, Research: the Role and Responsibility of Doctors (2002) paragraph 14 requires doctors to be “open and honest in all financial and commercial matters relating” to their research, and Helsinki requires the “researcher to provide monitoring information to the (MREC) especially any serious adverse events. The researcher should also submit to the (MREC) for review information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects.”

These are repeated and clear statements of the already obvious need for integrity and candour in this area. The Panel was entitled to find that they did require disclosure of the matters covered by the first 6 charges which it found proved and that it should not follow the evidence of Professor Hall, who took a contrary view. The way in which scientific research findings should be reported is a somewhat different matter, and the full disclosure of the issue to the MREC complies with Helsinki. This is why the Panel should, in my judgment, have taken a different view of the evidence in relation to the TCT charge.

This approach applies also to the West Midlands MREC chairmen and to the extract from a witness statement of Dr. Janet Wisely on which the appellant places substantial reliance. Dr. Wisely is the Chief Executive of the Health Research Authority has responsibility for the regulation of medical research in this country. Part of the system it operates includes the ethics committees. She therefore has a significant insight into the conduct expected of researchers and valuable evidence to give. In the end, neither party called her to give that evidence. She had made a witness statement and an extract was quoted and relied upon by Professor Holm. It was therefore put into evidence as written evidence. Each side relied on a different part of it. The appellant relied on her views about whether the existence of a GMC investigation should have been communicated to the West Midlands MREC. She was not cross-examined and asked to explain what she had said. Her view was that there was no obligation on a researcher to tell the MREC that s/he was under investigation by the GMC. She did not wish to change that view when she was consulted about this case, long after the event. She said

“I was cautious about changing this and requiring a declaration to the REC about an investigation as I felt that it would be very difficult to judge if the investigation should prevent suitability as a Chief Investigator and that RECs would, understandably, be cautious and many Chief Investigators may inappropriately be prevented from active research.”

Dr. Wisely’s view was that it was up to the Sponsor to ensure the responsibility of the Chief Investigator. The Chief Investigator should inform the sponsor who would be expected to investigate and take whatever action was required, presumably without any oversight by the MREC which had approved the research Protocol. She said this about an email she sent when consulted in 2010

“In the absence of any sanction against the investigator, I did not think the West Midlands REC could decline the investigator as suitable. I stated that once the sanctions by the GMC have been made, I think the responsibility is clearer”

Had she given evidence, she would no doubt have been asked about the Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. This does not directly apply to the MIST trial which did not involve a medicinal product but a device for closing PFOs. However, there seems no rational explanation for any lower standard of care being applied to a trial which involves implanting a device in the hearts of the patients than for testing medicines. The GMC argued that it was a relevant source of guidance for this reason. Dr. Wisely’s response to this was not known, so the Panel had to form its own judgment. Article 6 of this Directive provides for the role of an ethics committee. It requires the Ethics Committee to give its opinion, before a clinical trial commences on any issue requested and it is required to consider 11 matters in particular by paragraph 3. The fourth of these is “(d) the suitability of the investigator and supporting staff.”

No doubt Dr. Wisely would have been asked to consider the particular facts of this case had she given this evidence at the hearing. As a general rule I can readily understand why it would be very difficult for an MREC to assess the significance of an unsubstantiated pending complaint and why it might be appropriate to rely on the GMC to exercise its interim powers to protect the public if it considered it necessary to do so. That explains why she considers it unnecessary for the MREC to be told about pending complaints. However, the present complaint was not just any investigation. Its particular characteristics were

It appears to me that the Panel, for these reasons, was entitled to come to the view that Dr. Wisely’s statement contained a statement of a general rule which could not simply apply to this case. The MREC would have had no difficulty at all in deciding whether the misconduct in the Botox Trial affected its evaluation of the appellant’s suitability as Chief Investigator of the MIST Trial. The charge on which the Panel found dishonesty in this respect did not allege that the appellant had failed to tell the MREC about the GMC investigation. It alleged that he had failed to tell it about his dismissal by the North and Yorkshire MREC from the Botox Trial. In the absence of convincing evidence from Dr. Wisley exonerating the appellant of this charge the Panel was entitled to regard her statement as of limited weight.

Similarly, submissions based on the way in which the chairmen of the MIST Trial MREC expressed themselves in evidence (the chair changed hands during the relevant events) must be assessed on the basis that it was not for an individual chair of an MREC to set standards of conduct for doctors involved in research. The conduct of doctors is a matter for the doctors, and to be judged by the GMC. Therefore, whether a chairman would have hoped to be given a piece of information, or whether he would have expected to be given it is an irrelevant nuance in the way in which he expressed himself. If it was the duty of the doctor to provide the information it should have been provided whatever the view of the particular chair of the particular MREC. Their evidence gave valuable context to the various events, but the assessment of the extent of the doctor’s duty was not for them but for the Panel.

With these observations about the proper approach to evidence in a case about ethics, rather than clinical malpractice or criminal misconduct, I now turn to my conclusions about the Panel’s findings on the charges.

With the exception of the TCT Charge, I find that the conclusions of the Panel were not wrong and should be upheld.

There is a procedural complaint about late formulation of charges and amended particulars which might, if substantiated, constitute a serious procedural or other irregularity in the proceedings before a Panel and require this appellate court to interfere with its findings. Mr. Miller QC submitted that the allegations of dishonesty were not properly put in cross-examination. Mr. Jackson QC responded by drawing my attention to the transcript for Day 24 page 43 at D where he concluded his cross-examination of the appellant and said that he had put the allegations of dishonesty and offered to go through them from the new document. Mr. Miller said “No thank you.” I do not need to deal at any length with the procedural history of the formulation of the charges or the way in which the cross-examination of the appellant proceeded. This is because I asked Mr. Miller whether he wished to draw any prejudice to my attention. It would have been open to Mr. Miller to apply to recall any witness during the hearing before the Panel who might have been able to elucidate any issues which arose after the evidence of that witness. It would equally have been open to him to seek to recall the appellant if he had some answer to the allegations which he had not given because they had not been put to him. Equally, he could inform me of any such answer and make good his case that the appellant was prejudiced by his failure to give it at the hearing. Mr. Miller did not make any submission of this kind and I conclude that although the procedure may not have been as smooth as everyone would have liked, in the end the hearing was not unjust. The issue, therefore, is whether any of the findings of the Panel were wrong.

I have indicated the reason in principle why I conclude that most of the submissions made on behalf of the appellant should fail. It is that their underlying theme is that the Panel ought to have approached the evidence differently. Where the Panel has made a finding of primary fact I decline to disturb it for the reasons given in the brief review of authority above. So far as the evaluative aspect of the Pane’s decision is concerned, the appellant’s submissions are based on the sometimes unspoken premise that unless a witness asserts that a doctor’s behaviour amounts to misconduct or dishonest behaviour it is not open to the Panel to find that it does. As I have explained, I do not think that it is the function of witnesses to decide these questions. That is the function of the Panel I shall briefly go through the charges once more in the order in which they appear at paragraph 22ff above and indicate why the findings were, for the most part, not wrong and why the finding in respect of the TCT charge was wrong.

The MREC Non-Disclosure Charge. As I have pointed out above, this alleged that the appellant should have told the West Midlands MREC that he had been dismissed from the Botox Trial for misconduct by the North and Yorkshire MREC. I have stripped away the evidence of Dr. Wisely and the other opinion evidence about this for the reasons I have explained above. The appellant’s real defence was summarised in paragraph 93 of the decision of the Panel, namely that the LREC knew and the appellant “legitimately and reasonably believed that there would have been communication between the LREC and the MREC.” In other words, he was accepting that the MREC ought to have been told but that he assumed they knew. Professor Hall said that this was a developing area and that people were not certain of the roles of respective committees at the time. The appellant was not saying that he did not know who the West Midlands MREC was or what its job was. He could hardly do so given his extensive experience as a researcher. Whatever the general state of uncertainty may have been, the appellant knew the structure. The Panel accordingly said

“95.

The panel accepts that there may have been some ambiguity about responsibilities and reporting lines within the regulatory environment at that time. However, at the launch of a major and controversial new trial, the panel considers that it should have been self-evident that the body responsible for ethical approval would have expected to be told of your history of research misconduct.”

“245.

The panel has no doubt that you recognised the relevance and potential impact of the concerns expressed by the NYMREC. You must have known that, had these been communicated to WMMREC at the time of your application for approval of the MIST Trial, there was a risk that your appointment as Chief Investigator would have been questioned. The panel considers it unlikely that you simply assumed the information would reach WMMREC by another route, It has concluded that, in all probability, you recognised that you should have disclosed it yourself, but chose not to do so, in order to maximise the chances of gaining approval for the MIST Trial and your role as its Chief Investigator.”

Those paragraphs contain findings of fact about the state of mind of the appellant. The Panel had heard him give evidence and had to consider where the probabilities lay. There was no serious dispute that the West Midlands MREC needed to know about the Botox Trial and the appellant did not tell it. It was plainly open to the Panel to conclude that this was done for a rational motive, and to reject that suggested, namely that the LREC knew and the appellant assumed the information would be passed on. No rational and honest practitioner would delegate the performance of an important professional obligation to the chance that someone else might perform it on his behalf. The motivation found by the Panel was far more likely, or at least it was open to the Panel to find that it was.

The CTA Charge. The warranty contained in Appendix 6 of the CTA was false. In September 2004 when submitting the application for approval, the appellant had, by now, been found to have dishonestly suppressed his dismissal from the Botox Trial. He now created a false document which had the same effect and which was part of the records of the MIST Trial. These two allegations are plainly cross-admissible and the Panel erred, if at all, only in deciding not to treat them as such.

The real defence of the appellant to this charge was that the document was required by NMT who knew the truth. He was asserting that they both together therefore decided to enter into an agreement which they both knew contained a false statement of fact. He did not explain why either of them wanted to do this. It is asserted on his behalf that Appendix 6 could simply have been omitted. So it could have been, but anyone inspecting the records of the MIST Trial in order to audit its processes or monitor it would wonder why this CTA was not in standard form.

The Panel said that

“It was inherently dishonest to make materially false statements in a legal document even where the parties were aware of the false elements. Such documents are potentially disclosable and available for interrogation in the future: the panel considered that there was an element of dishonesty in creating a false record that had the potential to mislead…with regard to motive, the panel noted that the trial protocol required the standard CTA to be signed by any site wishing to participate in the MIST Trial. It follows that you could not have functioned as a Site Principal Investigator without signing the CTA and that would have undermined your credibility as Chief Investigator. The panel has seen evidence of NMT’s enthusiasm to retain you in the Chief Investigator role, so that you and the company had a strong incentive to sign these false statements. By doing so you were able to pursue your role as Site Principal and Chief Investigator.”

I have summarised the appellant’s arguments about this above. However, in my judgment it was plainly open to the Panel to conclude that the appellant wanted to sign the same form of document as the other sites in a procedure which was slightly at variance with that stipulated in the Protocol so that the role of his site would not be questioned on any audit which might take place. The documents were required for the purpose of creating an appearance of reliable and competent research and the Appendix 6 warranties were part of that function. The Panel was entitled to come to the view that it did.

The Payments Charge. The proved allegation related only to the hourly rate. This finding was based on GMP paragraph 14,which is set out above. The Panel said

“43…..In the present case it seemed to the panel self-evident that a doctor who had not disclosed “all financial interests and sums of money” to be paid for research could not be said to have met his or her express obligation to do so under paragraph 15 of GMP.

“44.

The panel considered that you had a responsibility to ensure that this section of the form was completed accurately and fully, not least because as noted by Professor Holm and others, MREC has to determine whether the financial arrangements are compatible with the proper conduct of the trial. It did not seem to the panel that it was reasonable to expect the West Midlands MREC to ask for additional detail as suggested by Professor Hall, particularly when it had not way of knowing what payments had been excluded.”

This charge is less clear than the first two, which no doubt explains why no finding of dishonesty was made. Some readers of this judgment may be surprised to learn that the Panel 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. This does show, however, that the Panel was scrupulously focussing on the precise terms of this charge and on the evidence relating to it. The application form does not expressly require the information which was not provided but offers opportunities to provide it. The relevant paragraph of “Research: the Role and Responsibilities of Doctors” prevents acceptance of payments which are not approved by the MREC. This creates an obligation to ensure that the MREC is aware of the payment so that it can be approved. The appellant certainly did accept payments calculated at £200 per hour for his work as Chief Investigator on the MIST Trial and the West Midlands MREC had not approved this. In my judgment this finding was open to the Panel. The fact that they almost certainly would have approved remuneration at the level had they been told about it is a reason why this finding was not accompanied by a finding of dishonesty.

The MIST Trial personnel non-disclosure charge. This finding was really based on the evidence of Professor Holm who performed the proper function of an expert witness by explaining the practical importance of sharing information between colleagues. This supported a finding that in the context of a research trial of this kind the general principle found in GMP of openness required the appellant to disclose the decision of the North and Yorkshire MREC to remove him from the Botox Trial and to refer the case to the GMC. That duty was owed to all those who had a legitimate reason to be informed. The Panel said that this was necessary to preserve trust and to allow them to make an informed choice about their involvement in the trial. So far as the GMC referral was concerned, the Steering Committee could have planned for the possible impact of the GMC findings on the reputation and integrity of the trial. The Panel decided that the disclosure to individual colleagues was required before they signed their CTAs and became contractually committed to the MIST Trial and held that the disclosure was required before January 2005 for that reason. In my judgment this finding was open to the Panel.

The GMC Outcome MIST Trial disclosure charge. The Panel held that there was aduty to inform the MIST Trial Steering Committee about the finding that he had been guilty of misconduct in his conduct of the Botox Trial and required to give undertakings. It was agreed by the appellant that he had not informed every member the Steering Committee and the issue was whether he was thereby in breach of his professional duty. The Panel’s finding was very much the same as the previous one and is sound for the same reason. In this instance the Panel held that the legal advice received by the appellant about who he should tell about the GMC outcome was an answer to the allegation of dishonesty, although not to the allegation of misconduct by breaching a clear professional duty. The legal advice was right in relation to the legal duty created by the undertakings but, in the view of the Panel, wrong in relation to the general professional duty of transparency (if it extended to that duty). It would be wrong to allow the appellant to shelter behind that legal advice except to the extent that it removes the stigma of dishonesty.

The GMC Outcome MREC disclosure charge. The Panel foundthe West Midlands MREC should have been informed. Professor Holm who said that if he had been advised by his lawyers to tell certain people about the outcome of the GMC proceedings, he would have accepted that advice and acted on it. The Panel decided to “set aside” this piece of evidence because they did not agree with it. They were entitled to do this “with no expert or factual evidence to support their decision and with no apparent medical scientific experience of their own to fall back on” for the reasons I have given above when dealing with the proper approach to evidence in this area. It is not clear to me why the West Midlands MREC were not entitled to know about the finding of the GMC, and the evidence I have quoted above from Dr. Wisely would suggest that it was. Her view was that once the sanction was known, the MREC could reliably assess its implications for the suitability of the Chief Investigator. It will be recalled that the “rolled up” question asked of Dr, Jubb in re-examination elicited his view about the whole sequence of events, including the GMC finding. The complaint that there was no established mechanism in 2006 by which the MREC would have expected to be informed about the outcome of such GMC proceedings is relevant to dishonesty which was not found proved.

The TCT Charge. In my judgment the Panel was wrong in its finding on this allegation. I have foreshadowed my reasoning at paragraph 64 above in my treatment of the evidence on this issue. This evidence occupied a considerable amount of time and was technical. In the end, it established that the report by the appellant to the conference in 2007 was in line with the way in which the MIST Trial was reported in the Paper in 2008. That Paper was specifically approved by the West Midlands MREC. It was also the work of a number of co-authors. The Panel criticised the information which had been placed before the West Midlands MREC and said that it would have taken a different view had the issue been explained to them differently. I am not satisfied that the scope of the enquiry (wide though it became) was such as to enable the Panel to come to that conclusion reliably. A lot of people were involved in the series of events which included the withdrawal of ethical approval at that stage in 2007 and its reinstatement after investigation. The approach of the Panel to “group culpability” is expressed in this summary of Mr. Mason’s advice

“The Legal Assessor advised the panel that it should consider your alleged actions and inactions in the various contexts in which they arise. It would be no answer to an allegation of culpable behaviour to say that others were also involved. However, the basis of the way in which the GMC puts its case is that you should not be held responsible for collective actions and decisions.”

The way in which the reporting of the results of the MIST Trial was dealt with was very much a collective action. It involved the West Midlands MREC in two quorate meetings. The letter which the Panel felt had misled the West Midlands MREC was from Nigel Trim, Managing Director of Matrix Contract Research, dated 7^th September 2007. That letter had followed a meeting between the investigators and Professor Sir John Lilleyman and Dr. Janet Wisely. Professor Lilleyman is a former President of the Royal College of Pathologists and I have described Dr. Wisely above. The West Midlands MREC received a letter of advice from Professor Lilleyman and they also had a copy of the draft of the Paper. The West Midlands MREC said that it was important to publish the negative findings, namely that the STARFlex device did not stop migraines. The paper referred to pulmonary shunts as a possible confounding feature. The device closes atrial shunts but not pulmonary shunts. The Paper did not seek to show why the results were negative. It did not report the results of the two extra-Protocol reviews of closure rates by Dr. Wilmshurst and Dr. Missault.

It appears to me that a determination that a single individual in this chain of events was guilty of misconduct when he did no more than accurately foreshadow the Paper in his remarks to the TCT conference is flawed. I do not think that anyone (not even their authors) claimed that the two ad hoc reviews had sufficient scientific validity to be worth publishing in their own right. The Panel’s determination on dishonesty on this charge is of interest:-

“The panel determined that the words you used were technically accurate but failed to reflect the level of uncertainty that should properly have been attached to the reported closure rate. The panel considered that your reporting of the data was unbalanced and misleading, but in the absence of any reliable measure, could not be characterised as dishonest.”

I do not understand that last sentence. If the appellant had colluded in the suppression of publishable data which suggested that the STARFlex device did not work as well as was believed, and had done this by reporting the data in an unbalanced and misleading way, this was dishonest by any measure. If he had not, then it is not clear to me what the finding of misconduct was based on.

In its determination on misconduct at paragraph 175, the Panel said that the appellant should have “made it clear that, on the basis of the reviews, there was some uncertainty about the closure rate achieved in the trial and it might have been lower than the per protocol figure.” What he said was “….some have suggested that the results of the study may be due to incomplete PFO closure…”. The finding, therefore, is that it was misconduct to fail to say that one cardiologist had reviewed a sample of echocardiogram images and concluded the closure rate was lower than 94% and another had done a similar exercise and concluded that it was not. Neither of these ad hoc studies was intended to produce valid research data. It was therefore a difficult problem to resolve. Some doctors would no doubt have done what the Panel found ought to have been done, but the question was whether it was serious misconduct to take another view, and to do what the appellant did. The fact that the whole issue had been placed before and decided by the MREC before the TCT Conference was highly relevant to the proper application of Helsinki. That question should be approached with the words of Stanley Burnton J as he then was in David v. GMC quoted above in mind.

There was a difference of opinion been the cardiologists, Dr. Wilmshurst and Dr. Missault, about whether the suggestion that closure rates were lower than 94% was right or not. The appellant, as a headache specialist, was not in a position to resolve this, and the whole issue was dealt with by the West Midlands MREC in the way I have described. I do not think that it was properly open to the Panel to conclude that in following the approved approach the appellant was guilty of misconduct.

The Panel concluded that had misled the West Midlands MREC and his letter contained “distortions errors and omissions”. It then concluded that the appellant must have known of the omissions because he was due to appear before the West Midlands MREC in relation to the letter if required. This suggests that the appellant was complicit in misleading the MREC. This is why it finds

“In these circumstances even if WMMREC’s letter was taken as an endorsement of your action in reporting only the per protocol findings, the panel considers that your professional obligations to report findings honestly and fairly should have taken precedence over the WMMREC opinion.”

So the appellant has been held liable for a non-dishonest breach of a duty to be honest.

I find that the Panel became involved in a detailed analysis of quite a complex issue and lost its focus on the nature of the case against this appellant on this charge which was that he had dishonestly suppressed two ad hoc reviews. This case failed as soon as the West Midlands MREC approved the publication of the per protocol results only. This finding is therefore quashed.