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You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Sharief v General Medical Council [2009] EWHC 847 (Admin) (27 April 2009) URL: http://www.bailii.org/ew/cases/EWHC/Admin/2009/847.html Cite as: [2009] LS Law Medical 389, [2009] EWHC 847 (Admin) |
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QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT
Upon An Appeal Under Section 40 of The Medical Act 1983 (as amended)
Strand, London, WC2A 2LL |
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B e f o r e :
Sitting as a Judge of the High Court
____________________
Dr Mohammad Sharief |
Appellant |
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- and - |
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The General Medical Council |
Respondent |
____________________
Ms Kate Gallafent (instructed by GMC Legal) for the Respondent
Hearing dates: 27th, 28th and 29th January 2009
____________________
Crown Copyright ©
Sir Thayne Forbes:
Introduction.
The Factual Background.
(1) In respect of Patient CAG: There was no sufficient evidence to justify the re-classification of CAG (i.e. from suffering from Secondary Progressive Multiple Sclerosis ("SPMS") to suffering from Relapsing Remitting Multiple Sclerosis ("RRMS")) in or around December 1999: paragraph 4(a) of the NoH.
(2) In respect of Patient EH: (i) There was no sufficient clinical evidence to justify the reclassification of EH (i.e. from SPMS to RRMS) in or around May or June 2000: paragraph 7(a) of the NoH;
(ii) Patient EH did not fulfil the criteria for inclusion in the Rebif/Avonex clinical trial in that he did not have RRMS: paragraph 7(b)(ii) of the NoH.
(iii) Dr Sharief knew of ought to have known that Patient EH did not fulfil the criteria for the trial, and his actions in admitting him onto the trial were inappropriate, unprofessional, were not in the best interests of the patient and were dishonest: paragraphs 7(b)(ii), 7(c) and 8 of the NoH.
(3) In respect of Patient A: (i) Patient A did not fulfil the criteria for inclusion in the Biogen study (in respect of the drug Natalizumab) in that a cranial scan did not demonstrate cranial lesions consistent with Multiple Sclerosis: paragraph 9(a) of the NoH.
(ii) Dr Sharief knew that Patient A did not fulfil the criteria for the Biogen study: paragraph 9(b) of the NoH.
(iii) Dr Sharief's actions in admitting Patient A onto the Biogen study when he knew that Patient A did not fulfil the criteria for inclusion were inappropriate, unprofessional, not in the best interests of the patient and were dishonest: paragraph 10 of the NoH.
(4) In respect of Patient E: (i) Patient E did not fulfil the criteria for inclusion in the Active Biotech trial in that she had not suffered relapses within the last 12 months: paragraph 12(a) of the NoH.
(ii) Dr Sharief knew or ought to have known that Patient E did not fulfil the criteria for inclusion in the Active Biotech trial: paragraph 12(b) of the NoH.
(iii) Dr Sharief fabricated a letter dated 22 January 2001 which purported to be to E's General Practitioner, Dr Kularatne, in which he falsely claimed to have spoken to E's GP: paragraph 12(c) and (d) of the NoH.
(iv) Dr Sharief's actions in this regard were inappropriate, unprofessional, not in the best interests of the patient and were dishonest: paragraph 13 of the NoH.
(5) In respect of Patient RYP: (i) Dr Sharief knew that Patient RYP did not fulfil the criteria for inclusion in the BMS-188667 clinical trial ("the BMS trial") in that Patient RYP had not been clinically stable in the two month period prior to signing informed consent: paragraph 14(b)(i) of the NoH.
(ii) Dr Sharief's actions in screening Patient RYP, as being suitable for inclusion in the BMS trial, when he knew that she did not fulfil the criteria for inclusion in the trial, were inappropriate, unprofessional, not in the best interests of the patient and were dishonest: paragraph 15 of the NoH.
(6) In respect of the Patient MM: (i) Dr Sharief knew that Patient MM did not fulfil the criteria for inclusion in the BMS trial and that she fulfilled the criteria for exclusion: paragraph 16 (c) and (d) of the NoH.
(ii) Dr Sharief sought to justify his actions to Professor Hughes (the Head of Department) by reference to an outdated trial protocol which Dr Sharief knew had been updated: paragraph 16(f)(i) of the NoH.
(iii) Dr Sharief's actions in screening Patient MM as being suitable for inclusion in the BMS trial were therefore inappropriate, unprofessional, not in the best interests of his patient and dishonest: paragraph 17 of the NoH.
(iv) Dr Sharief's actions in seeking to justify his actions to Professor Hughes by reference to an out-dated protocol was misleading, unprofessional and dishonest: paragraph 18 of the NoH.
(7) In respect of the allegation of Forgery: (i) On or around 10th October 2001, Dr Sharief forged the signature of Dr Michael Douglas on a Federal Drugs Authority Representations and Warranties document: paragraph 19 of the NoH.
(ii) Dr Sharief's actions in this respect were misleading, unprofessional and dishonest: paragraph 20 of the NoH.
(8) In respect of the allegation that he had asked Sister Soudain to write a signature that purported to be his own: (i) On 18th April 2002, Dr Sharief asked Sister Soudain to append a signature purporting to be his own to an internal King's College research grant form: paragraph 21 of the NoH.
(ii) Dr Sharief's actions in this respect were misleading, inappropriate, unprofessional and dishonest: paragraph 22 of the NoH.
The Issues raised by this Appeal
Legal Framework
"Where the Panel find that the person's fitness to practise is impaired they may, if they think fit
(a) except in a health case, direct that the person's name be erased from the register;
(b) direct that his registration in the register shall be suspended during such period not exceeding twelve months as may be specified in the direction, or
(c) direct that his registration shall be conditional on his compliance, during such period not exceeding three years as may be specified in the direction, with such requirements so specified as the Panel think fit to impose for the protection of members of the public or in his interests."
"On an appeal under this section from a Fitness to Practise Panel, the court may
(a) dismiss the appeal;
(b) allow the appeal and quash the direction or variation appealed against;
(c) substitute for the direction or variation appealed against any other direction which could have been given or made by the Fitness to Practise Panel; or
(d) remit the case to the Registrar for him to refer it to a Fitness to Practise Panel to dispose of the case in accordance with the directions of the court."
"On an appeal from a determination by the GMC, acting formerly and in this case through the FPP, or now under the new statutory regime, whatever label is given to the section 40 test, it is plain from the authorities that the Court must have in mind and give such weight as appropriate in the circumstances to the following factors:
(i) The body from whom the appeal lies is a specialist tribunal whose understanding of what the medical profession expect of its members in matters of medical practise deserve respect;
(ii) The tribunal has the benefit, which the Court normally does not, of hearing and seeing the witnesses on both sides;
(iii) The question of primary and secondary facts and the overall value judgment to be made by a tribunal, especially the last, are akin to jury questions to which there may reasonably be different answers." (Original emphasis).
"[T]he obvious fact [is] that the appeals are conducted on the basis of the transcript of the hearing and that, unless exceptionally, witnesses are not recalled. In this respect, these appeals are similar to many other appeals in both civil and criminal cases from a judge, jury or other body who has seen and heard the witnesses. In all such cases the appeal court readily acknowledges that the first instance body enjoys an advantage which the appeal court does not have, precisely because that body is in a better position to judge the credibility and reliability of the evidence given by the witnesses. In some appeals that advantage may not be significant since the witness' credibility and reliability are not in issue. But in many cases the advantage is very significant and the appeal court recognises that it should accordingly be slow to interfere with the decisions on matters of fact taken by the first instance body. This reluctance to interfere is not due to any lack of jurisdiction to do so. Rather, in exercising its full jurisdiction, the appeal court acknowledges that, if the first instance body has observed the witnesses and weighed their evidence, its decision on such matters is more likely to be correct than any decision of a court which cannot deploy those factors when assessing the position. In considering appeals on matters of fact from the various professional conduct committees, the Board must inevitably follow the same general approach. Which means that, where acute issues arise as to the credibility of reliability of the evidence given before such a committee, the Board, duly exercising its appellate function, will tend to be unable properly to differ from the decisions as to fact reached by the committee except in the kinds of situation described by Lord Thankerton in the well known passage in Watt or Thomas ~v~ Watt (1947) AC 484, 487-488."
"I do not find it necessary to review the many decisions of this House, for it seems to me that the principle embodied therein is a simple one, and may be stated thus: I. Where a question of fact has been tried by a judge without a jury, and there is no question of misdirection of himself by the judge, an appellate court which is disposed to come to a different conclusion on the printed evidence, should not do so unless it is satisfied that any advantage enjoyed by the trial judge by reason of having seen and heard the witnesses could not be sufficient to explain or justify the trial judge's conclusion; II. The appellate court may take the view that, without having seen or heard the witnesses, it is not in a position to come to any satisfactory conclusion on the printed evidence; III. The appellate court, either because the reasons given by the trial judge are not satisfactory, or because it unmistakably so appears from the evidence, may be satisfied that he has not taken proper advantage of his having seen and heard the witnesses, and the matter will then become at large for the appellate court. It is obvious that the value and importance of having seen and heard the witnesses will vary according to the class of case, and, it may be, the individual case in question."
The Parties' Submissions
"It is recognised that the Court has often demonstrated some reluctance to interfere with findings of fact made by a disciplinary body such as the GMC. This case is somewhat unusual in that the panel made serious findings of fact against a well-regarded specialist in a field within which the panel had no relevant expertise, against the weight of expert opinion, and upon an insubstantial evidential basis. "
"You must consider the case against and for Dr Sharief on each allegation separately. The evidence on the different allegations is different and therefore your findings need not be the same. If you have come to a decision of one allegation, whether in favour or against the doctor, you may of course take your conclusions into account in reaching your decision on another allegation. You must be careful, however, to avoid what might be called the "domino effect", that is assuming that if one proposition is established the others are as well."
Mr Hockton submitted that, on the facts of this case, the central part of that advice was wrong and/or insufficient because there was a clear risk that this part of this advice might result in the very "domino effect" against which the Legal Assessor then purported to warn the Panel.
"Having classified Patient CAG in June 1999 as having secondary progressive multiple sclerosis (SPMS) you reclassified her in December 1999 as having relapsing remitting multiple sclerosis (RRMS). The Panel heard from both experts about the need for good evidence before reclassifying a patient from SPMS to RRMS. There was a history of SPMS throughout Patient CAG's notes. The only evidence that you used to reclassify Patient CAG as suffering from RRMS was a clinically ambiguous letter from the patient's general practitioner (GP). Until you received this letter, it was clear not only to yourself but to numerous other doctors that Patient CAG had SPMS. You told the Panel that you spoke on the telephone to the patient's GP but you did not make a note of this significant and important conversation that led to your reclassifying the patient. Additionally you did not make any notes in the patient record about your decision, nor did you see the patient before you reclassified her."
On this basis the Panel found paragraph 4(a) of the NoH proved, namely that there was no sufficient clinical evidence to justify the reclassification of CAG in December 1999 as suffering from RRMS from the earlier classification that she was suffering from SPMS.
(i) The evidence clearly established various factors that were manifestly inconsistent with and thus pointed firmly away from any wrongdoing of the type alleged against Dr Sharief, namely Dr Sharief's established clinical excellence, the absence of any motivation for the alleged wrongdoing on his part and the inherent difficulties in classifying the state or sub-type of multiple sclerosis actually suffered by a patient: see paragraph 24(a) to (i) of Mr Hockton's written skeleton argument;
(ii) The significance of the evidence, including the competing expert evidence, relating to Dr Sharief's assessment of the patient on 10th January 2000, when he recorded a Kurtzke Expanded Disability Status Score ("EDSS") score of 5, having previously assessed it a month earlier on 6th December 1999 at 6.5: see paragraph 24(j) to (s) of Mr Hockton's written skeleton argument; and
(iii) The inconsistency between the Panel's finding that paragraph 4(a) of the NoH was proved but that paragraphs 4(b)(ii), 4(c) and 5(a) to (d) of the NoH were not proved (these latter paragraphs in the NoH were all concerned with an allegation that Dr Sharief had admitted patient CAG on to the clinical trial in question in or around May 2000 when he knew or ought to have known that she did not fulfil the criteria for inclusion): see paragraph 24(t) of Mr Hockton's skeleton argument.
"Just to let you know that I have received a letter from your GP Dr Cotton, and have in fact spoken to Dr Cotton about your MS. I am now satisfied that you have remitting rather than chronic progressive MS. Therefore, I am pleased to let you know that we will be able to invite you to participate in clinical trials at Guy's Hospital that are aimed for people with relapsing remitting MS."
However, there was no note or record of any such conversation between Dr Sharief and Dr Cotton. As it seems to me, it was therefore open to the Panel to conclude as it did, namely that the only evidence to justify Dr Sharief's reclassification of patient CAG in December 1999 was the clinically ambiguous letter from her GP dated 17th December 1999 and that this was insufficient. In my view, that was a finding that the Panel was entitled to make on the evidence
"Paragraph 7(a) [i.e. no clinical evidence to justify the reclassification of patient EH in or around May or June 2000] has been found proved. Having classified Patient EH in February 2000 as having SPMS you reclassified him three or four months later as having RRMS. You said in your evidence that your main basis for reclassifying Patient EH as suffering from RRMS rather than SPMS was that the patient had bounced back after receiving physiotherapy. The only record of the patient receiving physiotherapy was in 1997, three years before the reclassification. In the light of the background material, the Panel accepted Dr Hawkins' evidence that there was no evidence to justify the reclassification of this patient.
Paragraph 7(b)(ii) has been found proved. Patient EH did not fulfil the criteria for inclusion in the study in that he did not have RRMS.
Paragraph 7(c)(i) and 7(c)(ii) [i.e. Dr Sharief knew or ought to have known that patient EH did not fulfil the criteria for inclusion] have been found proved. You had patient EH's history in the material dating back to 1998 and were aware of that history. You knew the criteria in the trial protocol. You deliberately reclassified this patient when you knew that patient EH did not fulfil the criteria for inclusion on the trial.
Paragraph 8 has been found proved. The Panel has judged that your actions in admitting Patient EH onto the Rebif/Avonex trial were in appropriate, were unprofessional, were not in the best interests of your patient and were dishonest."
(1) It was Professor Bates' evidence that, on the basis of his full clinical history, EH was suffering from RRMS at the material time, thus supporting Dr Sharief's reclassification. It was Professor Bates' view that EH fulfilled the criteria for inclusion in the trial and that his inclusion was probably beneficial to EH.
(2) In his evidence during cross-examination, Dr Hawkins made a number of important concessions in that he accepted that the distinction between RRMS and SPMS is not always an easy one, there is no simple test, there is scope for disagreement between experienced doctors, the examining doctor is best placed to make the necessary judgment and, as a well-qualified neurologist, Dr Sharief had been well-placed to make the judgment in EH's case. When asked whether he accepted that Professor Bates' diagnosis of RRMS the material time was a reasonable one, Dr Hawkins replied: "Yes. Professor Bates is a reasonable man." Mr Hockton submitted that, in the light of this particular concession alone, the Panel's adverse findings were difficult to sustain, particularly in relation to dishonesty.
"Paragraph 9(a) (as amended) [i.e. that patient A did not fulfil the criteria for inclusion in the study in that a cranial scan did not demonstrate cranial lesions consistent with MS] has been found proved. You reported [on 5th April 2002] that there were a number of lesions (either 9 or 18) consistent with MS on the cranial MR scan which you saw ["the 2002 scan"]. Although the Panel accepted that the late Dr Bingham reported that there was [sic] one or two minute focal abnormalities on that MRI scan, it has accepted the evidence from Professor Yousry and Dr Butler that the scan did not demonstrate any cranial lesions consistent with MS.
The Panel has not considered the earlier MS scan used in the CORAL study, as you had not seen it and did not report on it.
Paragraphs 9(b)(i) and 9(b)(ii) have been found proved. You knew that Patient A did not fulfil the criteria for inclusion onto the Biogen study.
Paragraph 10 has been found proved. The Panel judged that your actions in admitting Patient A onto the Biogen Study when you knew that Patient A did not fulfil the criteria for inclusion were inappropriate, were unprofessional, were not in the best interests of the patient and were dishonest."
(1) Professor Yousry first analysed the 2002 scan in May 2002, at which time he "agreed [with Professor Miller] there was no definite lesion": see his email dated 8th May 2002. In his oral evidence before the Panel, Professor Yousry indicated that he thought that there was one possible lesion, but that it could be "partial volume" (or a "Virchow-Robin space"). However, even if there were to have been one lesion visible, Professor Yousry was perfectly clear that the relevant criteria under the Biogen protocol would still not have been satisfied, stating that the presence of one lesion would not be sufficient to make a diagnosis of MS and therefore would not fulfil the requirement that the lesion be "consistent with MS" (see Transcript Day 7/25 A-E).
(2) Equally, Dr Butler did not find any lesions indicative of MS on the 2002 scan (see Transcript, Day 5/20D).
"Paragraph 12(a) [i.e. that patient E did not fulfil the criteria for inclusion in the Active Biotech trial in that she had not suffered relapses within the last 12 months] has been found proved.
Paragraphs 12(b)(i) and 12(b)(ii) [i.e. that Dr Sharief knew or ought to have known that patient E did not fulfil the criteria for the trial in question] has been found proved.
Paragraph 12(c) [i.e. that Dr Sharief had fabricated the letter dated 22 January 2001] has been found proved.
Paragraph 12(d) [i.e. that Dr Sharief's claim to have spoken to E's GP was false] has been found proved.
The Panel has noted that:
1. there is no evidence of Patient E's relapse in her GP records,
2. there is no evidence of Patient E's relapse in hospital records,
3. there is no evidence of Patient E's relapse in her diaries, and
4. Patient E has no recollection of a relapse, although the Panel accepts that her memory has been affected by the disease.
When asked by Sister Soudain about Patient E's lack of documented relapses you produced a letter that you said you had written to her GP following a telephone conversation you had with the GP about the relapse. This letter was dated 22 January 2001 although it has been accepted that this was an error and should be 22 January 2002. The letter was addressed to Dr Kuleratne, who was not at that time Patient E's GP. Since April 2001 her GP had been Dr Craighill. Dr Craighill confirmed that there is nothing in Patient E's records to show:
1. that Patient E had either seen or spoken to Dr Craighill,
2. that Dr Craighill had telephoned you about Patient E, or
3. the letter you had sent to Patient E's GP.
The Panel did not believe your account of the telephone call you say you received before you claimed to have written the letter in January 2002.
Paragraph 13 has been found proved. The Panel has found that you fabricated the letter, dated 22 January 2001, which purported to be to E's GP, Dr Kuleratne, in which you falsely claimed to have spoken to E's GP. The letter contained false information about a relapse. Patient E did not, therefore, fulfil the criteria for inclusion in the Active Biotech study in that she had not suffered documented relapses within the last 12 months. You knew that she did not fulfil the criteria for inclusion on the trial. Your actions in this regard were inappropriate, were unprofessional, were not in the best interests of your patient and were dishonest."
(1) the Panel erred in deciding to admit patient E's statement into evidence under rule 34 of the General Medical Council (Fitness to Practise) Rules Order of Council 2004 ("the 2004 Rules");
(2) in any event, the Panel wrongly attached weight to patient E's recollection of her recall history and the absence of any entry in her diary, in the absence of oral evidence from her;
(3) the Panel wrongly attached weight to the fact that the disputed letter was sent to a former GP; and
(4) the Panel failed to have sufficient regard to the "Source Documents" form (which indicated that the patient did satisfy the inclusion criteria) or to the fact that the monitors raised no issue in relation to this case or to the fact that no direct evidence was adduced in support of the alleged fabrication of the disputed letter, which appears to be entirely genuine.
"Evidence
34.
(1) Subject to paragraph (2), the Committee or a Panel may admit any evidence they consider fair and relevant to the case before them, whether or not such evidence would be admissible in a court of law.
(2) Where evidence would not be admissible in criminal proceedings in England, the Committee shall not admit such evidence unless, on the advice of the Legal Assessor, they are satisfied that their duty of making due inquiry into the case before them makes the admission desirable.
"
"Mr Kitching, you have made an application on behalf of the General Medical Council to read the witness statement of Patient E. You told the Panel that, until recently, Patient E was going to attend the hearing, but has recently decided that she could not cope with attending. Although she is suffering from multiple sclerosis, it is not contended that she is unfit to be a witness because of her bodily or mental condition.
You have drawn the Panel's attention to the relevant provisions of the General Medical Council (Fitness to Practise) Rules Order of Council 2004, namely Rules 34(1) and 34(2), and to the provisions of the Criminal Justice Act 2003, dealing with the admission of hearsay evidence in criminal proceedings, section 114(1)(d), which allows a court to admit evidence if it is satisfied that it is in the interests of justice for it to be admissible.
Mr Hockton, on behalf of Dr Sharief, opposes the application and contends that it would not be in the interests of justice to admit the statement. He submits that it would not be fair to Dr Sharief, as Patient E could not be cross-examined; that Patient E has problems with recollection; and that she has refused to disclose her contemporaneous diaries. Mr Hockton submits that the factors of probative value and reliability are not satisfied in this case and that Rule 34(2) is not satisfied either.
The Panel has taken into account all of the matters it has heard and the submissions of you and Mr Hockton.
On the advice of the Legal Assessor, the Panel first considered whether the statement would be relevant to the proceedings. It determined it would be. The Panel next considered whether it would be fair to admit the statement. In doing so, it balanced the interests of the GMC and of Dr Sharief and determined that it would be fair to admit the statement. The Panel recognises, however, that it will have to judge the weight to be attached to Patient E's evidence in the light of all the evidence and submissions.
The Panel is satisfied, in accordance with Rule 34(2) of its Procedure Rules that its duty of making due inquiry into this case makes the admission of the evidence desirable and the Panel accedes to your application. The Panel, therefore, did not find it necessary to decide whether the evidence would be admissible or not under the provisions of section 114 of the Criminal Justice Act 2003."
(1) Dr Sharief's letter of 22 January 2002 (i.e. the "fabricated" letter, which had apparently been mistakenly dated 2001) was addressed to Dr Kularatne and on its face purported to be a response to a telephone call from patient E's GP the previous week.
(2) Dr Kularatne ceased to be patient E's GP at the latest on 2 April 2001 when he sent her medical records to the relevant Primary Care Trust.
(3) There is no record in patient E's GP notes of:
(i) any relapse by patient E around January 2002;
(ii) Dr Craighill (by then her GP) having seen or spoken to patient E around January 2002; or
(iii) any conversation between Dr Craighill and Dr Sharief around January 2002.
(4) There is no record of any relapse by patient E around January 2002 reported in her diaries.
(5) Patient E has no recollection of any relapse around January 2002.
(6) Patient E was screened for inclusion on the Active Biotech trial on 2 September 2002.
(7) As at 4 September 2002, when Sister Soudain raised the issue with Dr Sharief, no letter of 22 January 2002 (or 22 January 2001) was contained in the medical notes held by the MRSC.
(8) On 12 October 2002 Carolyn Reid, Secretary at the MRSC, sent copy letters about patient E to Dr Craighill, which she explained ought to have been sent to him because patient E had come under his care in January 2001. The copy letters did not include any letter dated either 22 January 2002 or 22 January 2001.
(1) it could not have been Dr Kularatne who spoke to him in January 2002 in connection with patient E (see Transcript, Day 9/85B-C); and
(2) it was a fair assumption that if patient E had seen Dr Craighill with regard to a relapse, there would have been a note to that effect in her medical records (see Transcript, Day 9/85A).
(1) As for Mr Hockton's point summarised in paragraph 64(2) above, the Panel expressly recognised the limited weight to be placed on the absence of any recollection by patient E of a relapse (see the terms of the ruling quoted in paragraph 67 above). In any event, as Ms Gallafent observed, even if patient E's evidence (i.e. as set out in her statement) were to be wholly discounted, Dr Sharief would still face the insuperable difficulty that there was no record in either patient E's GP records or her hospital records of any such relapse.
(2) So far as concerns the point summarised in paragraph 64(3) above, as it seems to me, the Panel did not wrongly attach weight to the fact that the letter of 22 January 2002 was addressed to a former GP. I agree with Ms Gallafent that it is clear from the Panel's expressed reasons (see paragraph 63 above) that the fact that the letter of 22 January 2002 was addressed to Dr Kularatne was not, of itself, a matter upon which the Panel placed any or any significant reliance in reaching its conclusion that Dr Sharief had made false claims about patient E having had a relapse within the relevant timescale. Rather, the fact that the letter in question was addressed to Dr Kularatne was simply part of the factual background. As Ms Gallafent observed, it is clear from the Panel's reasons that the critical facts were that, irrespective of the identity of the apparent recipient of the letter of 22 January 2002, no GP (or hospital) had recorded any relapse and/or relevant attendance by patient E around January 2002 or any telephone conversation with Dr Sharief about any such a relapse around that date.
(3) As for the main point summarised in paragraph 64(4) above, I agree with Ms Gallafent that the "Source Documents" form, which recorded under the heading "Final Inclusion Criteria" at box 1(a) that patient E had suffered one "documented" clinical exacerbation in the previous year and appeared to have been completed on 2nd September 2002 (two days before Sister Soudain raised the issue of the absence of such documentation), does not call the Panel's findings into question. As Ms Gallafent pointed out, Dr Sharief himself accepted that box 1(a) might not have been ticked on 2nd September 2002, but ticked on the screening visit on 30 September 2002 (see Transcript, Day 9/82H). This is also consistent with the evidence of Dr Davies, who pointed out that a number of other "Final Exclusion Criteria" could not have been completed on 2 September, because it would have been necessary to await the results of the scan and laboratory tests conducted on 2 September, which results would not have been received until at least 48 hours or thereabouts later (see Transcript, Day 4/22G-23C)
"Paragraph 14(b)(i) has been found proved. You knew that Patient RYP did not fulfil the criteria for inclusion on the trial as you had seen her six days before you screened her and you knew that she was not clinically stable throughout the two month period prior to signing informed consent and that she had a relapse in October which was clearly within that two month period.
Paragraph 15 has been found proved. Your actions in screening Patient RYP as suitable for inclusion when you knew that she did not fulfil the criteria for inclusion on the trial were inappropriate, were unprofessional, were not in the best interests of your patient and were dishonest."
"Paragraphs 16(c)(i) (as amended) and 16(d)(i) have been found proved. The Panel found that you knew that Patient MM was not clinically stable for the two months prior to informed consent and that she had had exacerbations during that period. On 8th November 2002 you knew that Patient MM had had intravenous steroids in early October, yet you screened MM as suitable on 11 November 2002. You knew that MM did not fulfil the inclusion criteria for the trial and you knew that MM fulfilled the criteria for exclusion from the trial.
Paragraph 16(f)(i) has been found proved. You knew the protocol had been updated as you signed the amendment to the protocol.
Paragraph 17 has been found proved. You knew that MM did not fulfil the inclusion criteria for the trial, you also knew that she did fulfil the criteria for exclusion and that the protocol had been updated. Your actions in screening MM as being suitable for inclusion on the BMS-188667 trial were therefore inappropriate, unprofessional, not in the best interests of your patient and were dishonest.
Paragraph 18 has been found proved. You deliberately sought to justify your actions to Professor Hughes, the Head of your Department, by reference to an outdated trial protocol. That was misleading, unprofessional and dishonest."
"Paragraph 19 (as amended) has been found proved. The Panel has accepted Sister Soudain's evidence that you nominated Dr Douglas as Sub-Investigator. Sister Soudain did not know Dr Douglas and would not have had the authority to nominate him as Sub-Investigator. Also, you admitted during cross-examination that it was you who nominated him for this role. The Panel accepted her evidence that she spoke to you after recognising your handwriting on the document, and you admitted to her that you had signed Dr Douglas' name on the document because Dr Douglas was out of the country.
Paragraph 20 has been found proved. Your actions on or around 10 October 2001, in forging the signature of Dr Douglas on the representations and warranties document were misleading, unprofessional and dishonest."
"Q. All right. Do you know who Dr Douglas is?
A. I have never met him. I believe he was a registrar at St Thomas'.
Q. Do you know where he was working in October? If you do not, then October 2001?
A. All I know is that Dr Sharief had said that he was out of the country.
Q. Do you know who nominated him as sub investigator?
A. Dr Sharief.
Q. I think you spoke to Dr Sharief about the signature that we can see on this page?
A. I had spoken to him about an FDA 1572 financial disclosure form, which also had a similar signature on it, which I believed was not Dr Douglas's.
Q. What did he say when you spoke to him?
A. Well, I said to him, "Look, this is clearly your handwriting, Mohammad. That is a forgery and I am not prepared to submit this to the FDA." He said to me, "What could I do? He is out of the country. It is just a bit of paper. It does not matter."
Q. Just to get it clear, you were speaking to him about two signatures on two different documents at that time?
A. I was speaking to him only about one signature on the FDA 1572."
Conclusion