British Medical Authorities Discipline
Enzyme Potentiated Desensitization Developer

Stephen Barrett, M.D.


In 2006, the British General Medical Council (GMC) reprimanded Dr. Leonard M. McEwen for soliciting patients to support McEwen Laboratories, a company owned by himself and three family members. The GMC Fitness to Practice Panel concluded that McEwen had "breached the confidence of patients" and that his fundraising activities were "inappropriate and unprofessional"because they "exploited the vulnerability of patients." The GMC order (shown below) required him to have his practice monitored for one year to demonstrate that he respected patient confidentiality and did not exhibit any conflict of interest between professional and business activities. McEwen Laboratories produced the products used in Enzyme Potentiated Desensitization (EPD), a dubious treatment for food allergies and intolerances. His solicitation, which asked for minimum donations of £5000, said that production of EPD would cease if adequate funds could not be raised. The U.S. Food and Drug Administration has prohibited the importation of EPD products since 2002.


Dates of Fitness to Practise Panel Hearing: 29 August - 1 September 2006

Name of respondent doctor: McEWEN, Leonard Maitland
Registered qualifications: BM BCh 1958 Oxfd
Registration Numbers: 0485807

Panel: Dr C Bharucha (Chair), Mrs A Thorne, Dr T Okitipki, Mr S Lord
Legal Assessor: Mr P Gribble
Secretary to the Panel: Mr G Wilkinson

Type of Case: Misconduct

Representation:

GMC: Mr Ramasamy, Counsel, instructed by the GMC in-house legal team.
Doctor: Dr McEwen was present and was represented by, Mr Whitting Counsel, instructed by the Medical Defence Union.

Charge

“That being registered under the Medical Act 1983,

‘1. In 2004, at various times, you were working as a private practitioner offering medical advice and treatment for allergies and food intolerances; Admitted and found proved

‘2. During the course of your work you saw patients and provided them with Enzyme Potentiated Desensitisation (“EPD”) treatment; Admitted and found proved

‘3. After the commencement of their EPD treatment, a letter was sent to a group of EPD your patients on behalf of McEwen Laboratories Ltd; Admitted and found proved

‘4. The letter indicated that,

a. EPD treatment was manufactured by a small family company, McEwen Laboratories Ltd, Admitted and found proved

b. To secure the future of EPD treatment, McEwen Laboratories Ltd needed to take steps towards full licensing and marketing of the product, Admitted and found proved

c. McEwen Laboratories Ltd intended to raise capital through a new company, Epidyme Ltd, Admitted and found proved

d. Epidyme Ltd needed to raise approximately £300,000 in order to commence operations, Admitted and found proved

e. The minimum investment level was £5000, and Admitted and found proved

f. Without this capital the production of EPD would not be able to continue; Admitted and found proved

‘5. You were the scientific Director of, and a shareholder of, McEwen Laboratories Ltd; Admitted and found proved

‘6. You permitted provided McEwen Laboratories Ltd to use with the names and contact details of the patients at head of charge 3.; Found proved as amended

‘7. You permitted provided McEwen Laboratories Ltd to use with the details of the nature of treatment administered to the patients at head of charge 3.; Found proved as amended

‘8. You encouraged patients to invest in Epidyme Ltd by implying that, without such investment, their treatment would no longer be available; Found proved

‘9. Your actions were designed to further your own financial and commercial dealings; Found not proved

'10. Your actions as set out above were,

a. In breach of confidence, Found proved

b. Inappropriate, Found proved

• Unprofessional;' Found proved

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

Having considered submissions on impairment the Panel determined as follows:

Determination

“Dr McEwen:

The Panel has given careful consideration to all the evidence adduced in this case. It has taken account of the submissions made by Mr Ramasamy on behalf of the General Medical Council (GMC) and those made by Mr Whitting on your behalf.

The Panel has considered, under the General Medical Council (Fitness to Practise) Rules Order of Council 2004, 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 heard that you have worked for a number of years as a private practitioner offering medical advice and treatment for allergies and food intolerances. During the course of your work you saw patients and provided them with Enzyme Potentiated Desensitisation (“EPD”) treatment, which was manufactured by a small family company, McEwen Laboratories Ltd. The Panel has heard that you were the Scientific Director of, and a shareholder of, McEwen Laboratories Ltd, owning 34% of the company. You were one of four Directors of the company, the others being your wife and two of your sons.

The EPD Study Office of McEwen Laboratories maintained a database of patients in order to assist in the evaluation of the efficacy of EPD treatment. The information held on this database was drawn from treatment evaluation forms completed by patients who had received EPD treatment. This included forms from patients who had received EPD treatment from you. You were responsible for obtaining this information and the use of the information supplied for clinical purposes.

In 2004 a group of patients who had commenced EPD treatment received a letter. You were the first signatory of this letter in your capacity as a doctor. The letter indicated that in order to secure the future of EPD treatment, McEwen Laboratories Ltd needed to take steps towards the full licensing and marketing of the product, intended to raise capital through a new company, Epidyme Ltd, and that Epidyme Ltd needed to raise approximately £300,000 in order to commence operations. The letter stated that the minimum level of investment was £5,000 and that the capital raised was intended “to begin the process of exploiting on a commercial scale the intellectual property of McEwen Laboratories Ltd.”

A decision was taken in June 2004 by the Directors of McEwen Laboratories Ltd, at a Board meeting, to use information held on the database as the source material for the letter soliciting funding. You were present at the meeting in your capacity as Chairman/Managing Director and Scientific Director of McEwen Laboratories Ltd. You acquiesced to the use of the information held on the database and therefore permitted McEwen Laboratories Ltd to use the names and contact details of the patients, all of whom had received EPD treatment.

The EPD patients were informed in the letter that “we are writing to you because we believe that you have received one or more shots of EPD” and that “we hope you have benefited from EPD and would like the treatment to remain available.” The letter concluded with the sentence that “we know that without this capital the production of EPD will not be able to continue”. You thereby encouraged patients to invest in Epidyme Ltd, in which McEwen Laboratories Ltd would be the majority shareholder, by implying that, without such investment, their treatment would no longer be available.

The Panel has found that by your actions you have breached the confidence of patients and that your actions were inappropriate and unprofessional.

The GMC's guidance ‘Good Medical Practice' (2001) states that patients must be able to trust doctors with their lives and well-being. To justify that trust, doctors as a profession have a duty to maintain a good standard of practice. Doctors must respect and protect confidential information and must avoid abusing their position as a doctor.

‘Good Medical Practice' also states that you must not exploit patients' vulnerability and must not encourage your patients to give money which will directly or indirectly benefit you. You wrote to a group of patients, who you knew to be vulnerable, on the basis of information which you had received in order to assess the efficacy of their treatment. By doing so you encouraged them to invest in Epidyme Ltd and thereby abused your position as a doctor. This breach of the guidance is relevant notwithstanding the Panel's acceptance that your actions were designed to ensure that a supply of EPD for patients was available by establishing a new viable company .

The GMC's guidance ‘Confidentiality: Protecting and Providing Information' (2004) states that patients have a right to expect that information about them will be held in confidence by their doctors. Confidentiality is central to trust between doctors and patients. Without assurances about confidentiality, patients may be reluctant to give doctors the information they need in order to provide good care . It goes on to state that you must inform patients about disclosure and seek patients' express consent to disclosure of information, where identifiable data is needed for any purpose other than the provision of care or for clinical audit.

The Panel noted your evidence and that of your son, Ian McEwen, that while you took advice on the legal and financial proprieties of your course of action in writing to patients, you gave no consideration to the ethical appropriateness with respect to your duties as a medical practitioner. In giving evidence that you did not consider your actions to be improper and that you would act in the same way in the future, you demonstrated a dismissive attitude to the guidance set out by the GMC. The Panel considers that you have thereby failed to demonstrate an understanding of your professional obligations as a medical practitioner.

In your actions you fell seriously short of the standards of conduct expected of a medical practitioner. In the light of the allegations that have been found proved and your breaches of ‘Good Medical Practice', the Panel has determined that, by reason of your misconduct, your fitness to practise is impaired.

The Panel will now invite further submissions and evidence, under Rule 17(2)(l), from Mr Ramasamy and Mr Whitting as 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.”

Fitness to practise found to be impaired

Having considered submissions on sanction the Panel determined as follows:

“Dr McEwen:

Having determined that your fitness to practise is impaired, the Panel considered what action, if any, it should take with regard to your registration. The Panel has considered the submissions made by Mr Ramasamy on behalf of the GMC and those made by Mr Whitting on your behalf.

In considering the issue of sanctions, the Panel took account of the GMC's Indicative Sanctions Guidance. A ny sanction imposed must be proportionate and 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 in the profession and, declaring and upholding proper standards of conduct and behaviour.

In its deliberations the Panel took account of the bundle of supportive testimonials provided on your behalf and in which you were described as a caring doctor and that patients had benefited greatly from the treatment which they had received from you.

The Panel first considered whether to conclude your case and take no further action. It considered that it would be insufficient to take this wholly exceptional course of action in the light of your breaches of good medical practice and your failure to recognise these at this hearing. This course of action would not be in accordance with the Panel's duty to protect the public interest.

The Panel next considered whether it would be sufficient to impose conditions on your registration. Any conditions must be appropriate, proportionate, workable and measurable.

In considering whether the imposition of conditions is appropriate in this case, the Panel has borne in mind that it has received no evidence of clinical incompetence on your part. The Panel is satisfied that there are identifiable areas of your practice, which can be addressed, namely ethics, professional obligations when business interests are involved and the issue of patient confidentiality.

The Panel has accepted the view that, while you have acted inappropriately and unprofessionally, you did so in order to ensure the availability of a supply of EPD for patients. The matters which have brought you before this Panel relate to your lack of appreciation of the conflict between your professional and business involvement. The breach of confidence related to your failure to appreciate your duty to protect information which you had received in order to assess the efficacy of patients' treatment. You used it for a wholly different purpose which related to your business interests.

The Panel has been told that you have not previously been the subject of complaint to the GMC in relation to your fitness to practise and that there have been no complaints from patients. It took account of the bundle of supportive testimonials which were submitted.

The Panel is satisfied that it is sufficient and proportionate, weighing the interests of the public with your interests, to impose conditions on your registration. The Panel has therefore determined that your registration shall be subject to conditions for a period of 12 months.

In deciding on a period of 12 months the Panel considered that you required this period in order to demonstrate improvement in the identified areas. The conditions are as follows:

1. You must identify a named medical practitioner who will act as a mentor to you. The mentor must be approved by the GMC before mentoring commences.

2. You must have meetings with the mentor at regular and frequent intervals.

3. You shall discuss with the mentor your approach to the principles of medical practice and in particular the areas of:

4. You must notify the GMC promptly of any post you accept for which registration with the GMC is required and provide the GMC with the contact details of your employer and PCT on whose Medical Performers List you may be included.

5. You must allow the GMC to exchange information with your employer, or any organisation for which you provide medical services.

6. You must inform the GMC of any formal disciplinary proceedings taken against you, from the date of this determination.

7. You must inform the GMC if you apply for employment outside the UK.

8. You must inform the following parties that your registration is subject to the conditions, listed at 1 to 7 above:

Unless you exercise your right of appeal, this decision will take effect 28 days from when written notice of this determination is deemed to have been served upon you. A note explaining your right of appeal will be provided to you.

A Panel will review your case at a hearing to be held before the end of the period of conditional registration. It will then consider whether it should take any further action in relation to your registration. You will be informed of the date of that meeting, which you will be expected to attend. At that review, the Panel will expect you to demonstrate that you have recognised and remedied the areas where you fell short of the standards expected of a medical practitioner. The Panel would expect to receive information as to the frequency and regularity of the meetings with your mentor.

Shortly before that date you will be asked to provide the GMC with names of professional colleagues and other persons of standing to whom the GMC may apply for information as to their knowledge of your conduct since this hearing of your case.

The Panel will now invite submissions on whether it should consider the immediate imposition of conditions.”

Conditions for 12 months

Having considered further submissions, the Panel determined as follows with respect to immediate sanction:

“Dr McEwen:

Having reached a determination that your registration should be made subject to conditions, the Panel has now considered whether conditions should be imposed immediately. The Panel notes Mr Ramasamy's submission on behalf of the GMC that immediate conditions should be imposed and that of Mr Whitting who opposes this.

The Panel considers that it is necessary for the protection of members of the public and in the public interest that your registration should be made subject to conditions forthwith. In reaching this decision, the Panel had regard to the reasons for its finding of impairment of fitness to practise and, in particular, your lack of insight in stating to this Panel that you would act in the same way again.

The conditions will take effect immediately and will be in effect until such time as the Panel's substantive decision takes effect.

That concludes this hearing.”

Immediate conditions imposed

Confirmed

1 September 2006
Chairman

This page was posted on July 25, 2007.

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