†††††† Fitness to PractiSe Panel†

20-24 March 2006

Third Floor, 350 Euston Road, London NW1 3JN

 

 

Name of Respondent Doctor: †† Dr Andrew John DOWSON

 

Registered Qualifications:†††††††††† MB BS 1984 Lond

 

Registration Number: ††††††††††††††††† 2953399

 

Type of Case: †††††††††††††††††††††††††††††††† New Case

Misconduct

 

Panel Members:†††††††††††††††††††††††††††† Mr Douglas Gentleman† Ė Chairman (Medical)

 

Rev John Philpott (Lay)

Mr Andrew Popat (Lay)

Professor Michael Whitehouse (Medical)

 

Legal Assessor: ††††††††††††††††††††††††††† Mr Gerald Godfrey CBE QC

 

Secretary to the Panel:†††††††††††††††† Mrs Nilla Varsani

 

Representation:

 

GMC: Mrs Sarah Plaschkes, Counsel, instructed by the Mills & Reeve Solicitors represented the General Medical Council.

 

Doctor: Dr Dowson was present and was represented by Mr Angus McCulloch, Counsel instructed by the Medical Protection Society.

 

Allegation:

 

That being registered under the Medical Act 1983,

 

1.†††††††† Between October 2001 and March 2004, you were Chief Investigator for research being undertaken by Allergan Research and Development (Europe), into the study of Botox (Botulinum Toxin Type A) for the prophylactic treatment of migraine headaches;

Admitted and Found Proved

 

2.†††††††† The research had received ethical approval from the Northern and Yorkshire Multi-Centre Research Ethics Committee (NYMCREC) on

14 August 2001;

Admitted and Found Proved

 

3.†††††††† The NYMCREC approved protocol for the research included,

 

a.†††††††† A requirement that all research subjects (the patients) had to personally visit the site office at regular intervals,

Admitted and Found Proved

 

b.†††††††† A requirement that the patientsí vital signs (heart rate, blood pressure and body temperature) were monitored and recorded at the visits to the site office,

Admitted and Found Proved

 

c.†††††††† A requirement that all potentially childbearing female patients undergo a pregnancy test, which had to be negative, prior to the administration of any study medication;

Admitted and Found Proved

 

4.†††††††† On 19 August 2003 an Allergan Site Monitor visited the site and discovered,

 

a.†††††††† On 10 12 occasions, visits were conducted via telephone, by yourself or the study nurse, rather than by the patientsí attendance at the office, as specified in the protocol,

Admitted and Found Proved

 

b.†††††††† On seven occasions, vital signs data was compiled and entered on the case report forms, using data recorded on previous visits therefore was not an accurate record of the patientsí vital signs on the relevant date,

Admitted and Found Proved

 

c.†††††††† There was no adequate record of the pregnancy tests that had been undertaken;

 

5.†††††††† Confirmation that pregnancy tests had been undertaken only became available when the study nurse returned from maternity leave;

Found Proved

 

6.†††††††† Patient 1700 had not undergone a pregnancy test on 21 August 2002 and 26 March 2003;

Admitted and Found Proved

 

7.†††††††† On 16 October 2003, you signed and dated an Allergan file note dated

30 September 2003, acknowledging non-compliance with the protocol as set out in sub-heads 4.a. and 4.b.;

Admitted and Found Proved

 

8.†††††††† As a result of your deviation from the protocol, the NYMCREC suspended its favourable ethical opinion by letter dated 15 March 2004;

Admitted and Found Proved

 

9.†††††††† Your conduct as described in Heads of Charge 4 a and b., and c., Head of Charge 5. and Head of Charge 6. were,

 

a.†††††††† Dishonest,

Found Not Proved

 

b.†††††††† Unacceptable,

Admitted and Found Proved in relation to allegations 4a and 4b

Found Not Proved in relation to allegations 5 and 6.

 

c.†††††††† Unprofessional, and

Admitted and Found Proved in relation to allegations 4a and 4b

Found Not Proved in relation to allegations 5 and 6.

 

d.†††††††† Not in the best interests of your patients;

Found Proved in relation to allegations 4a and 4b

Found Not Proved in relation to allegations 5 and 6.

 

And that by reason of the matters set out above your fitness to practise is impaired because of your misconduct.

Fitness to Practise is impaired

 

Determination on impaired fitness to practise:

 

Dr Dowson:

 

The Panel has given detailed consideration to the submissions made by Ms Plaschkes on behalf of the General Medical Council and those made by Mr McCulloch on your behalf. It has noted and accepted the advice of the Legal Assessor.

 

The Panel has considered on the basis of the allegations found proved, whether your fitness to practise is impaired pursuant to Section 35C (2) (a) of The Medical Act 1983, as amended, by reason of your misconduct.

 

The Panel has been informed that between October 2001 and March 2004, you were Chief Investigator for a research study into the prophylactic treatment of migraine headaches, which had received ethical approval from the Northern and Yorkshire Multi-Centre Research Ethics Committee (NYMCREC). The NYMCREC approved protocol for the research included a requirement that all research subjects (the patients) had to personally visit the site office at regular intervals, that the patientsí vital signs (heart rate, blood pressure and body temperature) were monitored and recorded at those visits and that all potentially childbearing female patients undergo a pregnancy test, which had to be negative, prior to the administration of any study medication.

 

The Panel has heard and you have admitted that on 19 August 2003 a Site Monitor visited the site and discovered that on 12 occasions, visits were conducted via telephone, by yourself or the study nurse, rather than by the patientsí attendance at the office, as specified in the protocol and that on seven occasions, vital signs data were compiled and entered on the case report forms, using data recorded on previous visits. This therefore was not an accurate record of the patientsí vital signs on the relevant date.† Moreover you then signed the case report forms as accurate, when they were not.

 

On 16 October 2003, you signed and dated a file note dated 30 September 2003, acknowledging non-compliance with the protocol as set out above. As a result of your deviation from the protocol, the NYMCREC suspended its favourable ethical opinion by letter dated 15 March 2004.

 

You have admitted that your actions were unacceptable and unprofessional. The Panel has also found proved that your conduct was not in the best interests of your patients.

 

The Panel has considered the General Medical Councilís guidance Good Medical Practice (2001), which states that doctors must keep clear, accurate, legible and contemporaneous patient records which report the relevant clinical finding, the decisions made, the information given to patients and any drugs or other treatment prescribed. It also states that you must be honest and trustworthy when completing or signing forms. This means that you must take reasonable steps to verify any statement before you sign a document and you must not write or sign documents which are false or misleading because they omit relevant information. Furthermore in relation to research Good Medical Practice also states that if you participate in research you must put the care and safety of patients first and that you must conduct all research with honesty and integrity.

 

Doctors occupy a position of privilege and trust in society and are expected to act with integrity and to uphold proper standards of conduct. It is the duty of the Panel to maintain public confidence in the profession and to uphold public confidence in the ability of the profession to regulate itself.

 

In the light of the allegations that have been found proved the Panelís professional judgement is that your fitness to practise is impaired pursuant to Section 35C (2)(a) by reason of your misconduct.

 

The Panel will now invite further submissions, under Rule 17(2)(l), from Ms Plaschkes and Mr McCullochas to the appropriate sanction, if any, to be imposed on your registration. Submissions on sanction should include reference to the Indicative Sanctions Guidance, using the criteria as set out in the guidance to draw attention to the issues, which appear relevant to this case.

 

Determination on sanction:

 

Dr Dowson

 

The Panel has already determined and announced that your fitness to practise is impaired by reason of your misconduct, in particular your unprofessional and unacceptable actions in recording vital signs data on the case report forms of several patients in the study in which you were engaged, and then signing their case report forms as accurate, when they were not. The Panelís task now has now been to decide what action, if any, to take in relation to your registration.

 

The Panel has considered the submissions made by Ms Plaschkes, Counsel on behalf of the General Medical Council, the submissions that Mr McCulloch has made on your behalf, as well as the oral evidence given by Mrs T in relation to your character. It has noted and accepted the advice of the Legal Assessor.

 

The Panel has borne in mind that any sanction imposed must be proportionate and that its purpose is not to be punitive, but to protect members of the public and the public interest. The public interest includes, not only the protection of patients, but also the maintenance of public confidence by upholding proper standards of conduct and thereby the reputation of the profession. The Panel has taken into account the Indicative Sanctions Guidance published by the General Medical Council.††

 

Ms Plaschkes has confirmed that there have been no previous proceedings against you by the General Medical Council. However it is her submission on behalf of the GMC that a period of suspension would be appropriate in your case as the facts found proved against you represent a serious departure from the standards set out in Good Medical Practice. Ms Plaschkes has also brought to the Panelís attention the guidance issued by the General Medical Council on Good Practice In Research in February 2002.

 

The Panel has considered all the factors that Mr McCulloch has advanced in mitigation on your behalf. In particular it has noted that the misconduct occurred over a relatively short period of time, the lack of actual harm to any patient, and the constrained circumstances in which you were working at the time.

 

The Panel has borne in mind your expressions of deep regret and apology, and your acceptance that you made a serious mistake. It accepts that you have insight into your actions and that it is very unlikely that you would repeat them. It notes the stepsthat you have taken to ensure that there will be no repetition of this misconduct. You have attended a course on Good Clinical Practice in pharmaceutical research, adopted an annual appraisal system, taken steps to control your workload and increase your staff, and introduced external audit of your work.

 

The Panel has read the many testimonials submitted on your behalf. They speak very highly of your conduct and integrity as a doctor, and they show that you have made a valuable contribution to the field of headache and migraine and are likely to make a further major contribution in the future. They also show that throughout your career you have been prepared to go to considerable lengths to ensure that the best interests of patients are protected. The testimonials paint a picture of a hardworking, caring and professional doctor for whom the actions that have brought you in front of the General Medical Council have been out of character.

 

In its deliberations on sanctions, the Panel first considered the submission made by Mr McCulloch that it would be appropriate in this case, despite having found your fitness to practise to be impaired, to conclude this case with a reprimand or admonishment.

 

It would however be wholly exceptional to conclude such a case in that way. Having regard to all the evidence and the submissions made, the Panel is of the view that such exceptional circumstances do not apply in your case. The Panel considers that to conclude the case in this way would be insufficient to maintain public confidence in the profession or to uphold the proper standards of conduct of registered medical practitioners who are engaged in research.

 

The Panel therefore went on to consider whether to accept the undertakings you have offered in relation to your future conduct. The Panel is mindful of its duty to protect the public interest, which includes the maintenance of public confidence in the profession and the upholding of proper standards of conduct and behaviour. It is also mindful of the need for proportionality in balancing this duty with your interests as a registered medical practitioner.

 

The Panel has considered the submissions made by Ms Plaschkes and Mr McCulloch regarding these undertakings. It has also considered the GMC Procedure and Guidance Note on Undertakings, and has carefully assessed whether the undertakings satisfy all the requirements of that document: sufficiency, transparency, whether they are specific, measurable, attainable and realistic, and whether you have sufficient insight to abide by them.

 

The Panel has decided that it is able to accept the undertakings referred to above which you have given on oath and signed. These are:

 

  1. To continue to undergo regular appraisals by a General Medical Council approved appraiser and to abide by the advice given in those appraisals. The next such appraisal shall be performed by 23rd September 2006. Thereafter the appraisals shall be performed once a year. Each such appraisal shall be forwarded by you to the General Medical Council as soon as practicable after its completion.

 

  1. To undergo a further course on Good Clinical Practice (as set out in the ICH[1] Good Clinical Practice Guidelines) and to arrange the attendance of the practice nursing staff on such a course within the next year, by 23rd March 2007. The certificates of attendance shall be forwarded by you to the General Medical Council as soon as practicable on completion.

 

  1. To notify all employers, all research contractors and all prospective employers or research contractors whether of a paid or unpaid position for which Registration with the General Medical Council is required of the determination.† In the case of prospective employers or research contractors, this notification must be at the time of application.

 

  1. To inform in writing the General Medical Council before undertaking any position of employment or under a research contract for which Registration is required.

 

You have agreed that the above undertakings will apply for the following periods, by reference to the numbered undertakings above:

 

1.      5 years

2.      1 year

3.      3 years

4.      3 years

 

You offered an additional undertaking, to abide by the principles of Good Medical Practice and Good Practice in Research. However all doctors should abide by the principles of Good Medical Practice.

 

The Panel has therefore determined to make no further direction in relation to your registration.†

 

The written undertakings, which you have given today, will be notified to the Registrar of the GMC so that the necessary steps for monitoring your compliance with the undertakings may be put in place.†

 

That concludes the hearing of your case.

 

Confirmed

 

 

 

 

 

 

††††††††††† 24 March 2006†††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††††† Chairman



[1]International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)