dr dror schmuelly committee members

PROFESSIONAL STANDARDS COMMITTEE INQUIRY

CONSTITUTED PURSUANT TO PART 12 DIVISION 1

of THE MEDICAL PRACTICE ACT 1992 to HOLD AN INQUIRY INTO

A COMPLAINT IN RELATION TO

Date/s of Inquiry:

Committee members:

Legal Officer assisting

Committee:

Appearances for Health

Care Complaints

Commission:

Appearances for Dr Dror

Schmuelly

Date of decision:

Publication of decision:

Dr Dror Schmuelly

20,21 and 30 September 2010

Ms Helen Kiel, Chairperson (Legally qualified, not a

registered medical practitioner)

Dr Katherine IIbery (Registered medical practitioner)

Dr Helen Pedersen (Registered medical practitioner)

Mr Russell Smith (Lay person)

Ms Bridget Andersons

Ms Kate Richardson of Counsel

Ms Jo Montgomery, Hearings Officer

Mr Richard Weinstein of Counsel

Mr Tim Bowen from Dibbs Barker, Lawyers

23 November 2010

Refer to page 25 of this decision for details of non-

publication directions

SUMMARY

1. The complaint was in relation to Dr Schmuelly's inappropriate prescribing ofhuman growth hormone both for patients and himself, as well as prescribingRoaccutane for patients without authority, and completing Workcovercertificates for himself which he signed as both patient and doctor. Thecomplaint was found proven. Dr Schmuelly was cautioned and a conditionimposed on his registration requiring him to attend a course in prescribing ingeneral practice.

AMENDED COMPLAINT

2. A complaint dated 30 March 2010 against Dr Dror Schmuelly was referred by

the NSW Health Care Complaints Commissioner to be dealt with by aProfessional Standards Committee. This complaint was later substituted withan Amended Complaint, which was prosecuted before this Committee by theDirector of Proceedings acting as nominal complainant. The amendedcomplaint against Dr Dror Schmuelly is as follows:

Dr Schmuelly has been guilty of unsatisfactory professional conduct within themeaning of section 36 of the Act in that he has:

(i) demonstrated that the knowledge or judgment possessed, or careexercised, by him in the practice of medicine is significantly below thestandard reasonably expected or a practitioner of an equivalent level oftraining or experience

PARTICULARS OF COMPLAINT

3. The particulars of the complaint are as follows:

At all relevant times the practitioner provided care and/or treatment to PatientsA, B, C, 0, E, F, G, H, i, J, K, L, M, N, P, Q, R, S, T, U and V

1. On various dates between 1 August 2006 and 30 September 2007 as

set out in Schedule A to the Complaint the practitioner prescribed,dispensed and/or supplied a restricted substance, namely HumanGrowth Hormone, to Patients A, B, C, 0, E, F, G, H, I, J, K, L, M, N, P,Q, R, S, T

a) For a purpose or purposes that did not accord with the recognisedtherapeutic standard of what was appropriate in the circumstances;in breach of clause 33 of the Poisons and Therapeutic GoodsRegulation 2002;

b) In circumstances where the practitioner had not establishedPatients A to T suffered from growth hormone deficiency byreference to accepted tests.

2. On various dates between 1 August 2006 and 30 September 2007 the

practitioner prescribed, dispensed and/or supplied a restricted

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substance, namely Human Growth Hormone, to Patient U withoutconfirming whether Patient U suffered from growth hormone deficiencyby reference to accepted tests.

3. On various dates between 1 January 2006 and 20 September 2007 the

practitioner prescribed and supplied a restricted substance, namelyRoaccutane (isotretinoin), to Patient V and another patient or patientsunknown without a special authority to do so, contrary to therequirements of clause 36 of the Poisons and Therapeutic GoodsRegulation 2002;

4. On various dates between 25 January 2006 and 19 March 2008 the

practitioner inappropriately prescribed, dispensed, supplied and/oradministered Human Growth Hormone to himself;

a) For a purpose or purposes that did not accord with the recognisedtherapeutic standard of what was appropriate in the circumstances;in breach of clause 33 of the Poisons and Therapeutic GoodsRegulation 2002;

b) In circumstances where the practitioner had not established that hehimself suffered from growth hormone deficiency by reference toaccepted tests.

c) Contrary to the NSW Medical Board Policy "Medical PractitionersTreating Relatives and Self'

5. On various dates between 4 August 2006 and 19 March 2008practitioner inappropriately completed Workcover certificates certifyinghimself as either unfit or fit to work.

THE MEANING OF UNSATISFACTORY PROFESSIONAL CONDUCT

4. Section 36 of the Medical Practice Act 1992 states:

Meaning of "unsatisfactory professional conduct"

(1) For the purposes of this Act, unsatisfactory professional conduct of aregistered medical practitioner includes each of the following:

(a) Conduct significantly below reasonable standard

Any conduct that demonstrates that the knowledge, skill or judgmentpossessed, or care exercised, by the practitioner in the practice of medicine issignificantly below the standard reasonably expected of a practitioner of anequivalent level of training or experience.

5. The phrase "significantly below" is not defined in the Act. However in theSecond Reading speech when this legislation was introduced to Parliament itwas stated that:

"The first main purpose of the bil is to refocus the Health Care ComplaintsCommission (HCCC) on investigating serious complaints about health service

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providers. To achieve this, Commissioner Walker recommended thatunsatisfactory professional conduct be redefined so that only significantinstances involving lack of skil, judgment, or care wil result in an investigationor disciplinary action. ..... the reference to 'significant' in that context may referto a single act or omission that demonstrates a practitioner's lack of skil,judgment or care, or it may refer to a pattern of conduct. In any individualcase, that wil depend on the seriousness of the circumstances of the case."

STANDARD OF PROOF

6. For the Complaint to be proved, the Committee must be reasonably satisfied

on the balance of probabilities that Dr Schmuelly's conduct satisfies thestatutory definition of unsatisfactory professional conduct. As stated inBriginshaw v Briginshaw (1938) 60 CLR 336 "Reasonable satisfaction is not astate of mind that is attained or established independently of the nature andconsequence of the fact or facts to be established. The seriousness of anallegation made, the inherent unlikelihood of an occurrence of a givendescription, or the gravity of the consequences flowing from a particularfinding are considerations which must affect the answer to the questionwhether the issue has been determined to the reasonable satisfaction of thetribunal. In such matters 'reasonable satisfaction' should not be produced byinexact proofs, indefinite testimony, or indirect inferences".

EXHIBITS

7. The Committee has considered the following documents which were provided

by the parties prior to the hearing. The HCCC provided three volumes -volume one (tabbed 1 to 74); volume two (tabbed 75 to 93) and volume three(tabbed 94 to 125); and Dr Schmuelly provided one volume (tabbed 1 to 4)and further documents were tendered by Dr Schmuelly during the hearing.

PRELIMINARY ISSUES

8. At the outset of the proceedings the Committee was advised of someamendments to the complaint and a copy of the amended complaint wasprovided. An agreed statement of facts was tabled.

9. A non-publication order was made in relation to the name of Dr Schmuelly

pending the outcome of the proceedings, and in relation to the names of thepatients.

10. A number of objections to the HCCC documents were not contested.

11. In accordance with the savings and transitional provisions in clause 4 ofSchedule 5A to the Health Practitioner Regulation National Law (NSW), whichcame into force on 1 July 2010, this Inquiry is being dealt with in accordancewith the provisions of the repealed Medical Practice Act 1992. However anyfurther proceedings or appeal in relation to this Inquiry are to be dealt withunder the National Law (NSW) as if this Inquiry had been decided under theNational Law (NSW).

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ISSUES FOR DETERMINATION

12. The issues to be determined by this Committee are:

. Is the Committee comfortably satisfied the particulars of the complaintare proven?

. If yes, the Committee must then decide whether the complaint against Dr

Dror Schmuelly is proven.. If yes, the Committee must decide whether orders or directions made

pursuant to the Medical Practice Act 1992 are appropriate.

BACKGROUND

Reqistration

13. Dr Schmuelly was first registered in NSW on 7 January 1991 and currentlyholds general registration with the Medical Council of Australia. There are noconditions on his registration. The following Agreed Statement of Facts(Exhibit A) conveniently sets out the background to the complaint

1. Dr Schmuelly graduated from University of NSW with MBBS in 1991.

He undertook his internship at Sutherland Hospital and in thesubsequent year spent a few months working (at Sutherland Hospital)as an RM01. From about 1994-1998 Dr Schmuelly was a GP atcountry and city practices. From 1998 to 2009 Dr Schmuelly practicedmedicine as a GP at Pyrmont Harbourside Medical Centre. From 2003for approximately a 6 month period Dr Schmuelly practiced at CoffsHarbour Clinic. From 2004 to date Dr Schmuelly practices at 566Englehart Street in Albury.

2. On 20 March 2008 the Chief Pharmacist and Director of

Pharmaceutical Service Branch NSW Health, who had investigated DrSchmuelly for the prescribing of human growth hormone for himself andothers for non-approved purposes, complained to the NSW MedicalBoard. At this time the Health Care Complaints Commission wasnotified of the Complaint.

3. A s66 Inquiry was convened by the NSW Medical Board on 15 April

2008. The determination of the s66 Inquiry did not place restrictions onDr Schmuelly's practice on the basis of evidence and Dr Schmuelly'spresentation during the proceedings. Dr Schmuelly told the hearing hewould not continue to prescribe human growth hormone or isotretoin

(Roaccutane) without the involvement of an appropriate specialist. Hepreviously had ceased prescribing human growth hormone to hispatients following an interview with the NSW Pharmaceutical ServicesBranch in December 2007.

4. The Health Care Complaints Commission referred a complaint against

Dr Schmuelly to the NSW Medical Board on 30 March 2010 concerning

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the prescribing practices of human growth hormone and isotretinoin

(Roaccutane).

5. On various dates from 1 January 2006 - 30 September 2007 Dr

Schmuelly prescribed, dispensed and or supplied Human GrowthHormone to Patients A - U.

6. On 8 occasions between 25 January 2006 to on or around 19 March

2008 Dr Schmuelly prescribed human growth hormone to himselfwithout first diagnosing growth hormone deficiency by reference toaccepted tests and contrary to the NSW Medical Board Policy "MedicalPractitioners Treating Relatives and Self'.

7. In late 2007, Dr Schmuelly agreed to stop prescribing human growth

hormone without first diagnosing growth hormone deficiency byreference to accepted tests and in consultation with an endocrinologist.

8. On 3 occasions between 14 March 2006 and 4 July 2006 Dr Schmuelly

prescribed isotretinoin (Roaccutane) to Patient V and other unnamedpatients (as per response at Tab 109 HCCC documents) without therequired special authority to do so. Dr Schmuelly also admitted tosupplying his fiancée with isotretinoin on dates unknown.

9. Dr Schmuelly gave evidence at s66 Inquiry that he did not appreciate

that a special authority was required in order to be able to prescribe thedrug.

10. On the dates 4 August 2006, 5 April 2007, 27 April 2007, 9 May 2007,11 May 2007,18 May 2007 and 19 March 2008 Dr Schmuelly filled inWorkCover certificates for himself. There is no evidence, and DrSchmuelly denies, that these certificates have been submitted toWorkCover insurer as a basis of a claim.

EVIDENCE

The context of the complaint

14. Expert evidence was given in relation to the controversial issue of off-labelprescribing in general, and in particular, to the prescribing of HGH (humangrowth hormone) "off-label" for the treatment of "wellness" and "anti-aging". Itwas suggested that a "significant" or "respectable" minority of the medicalprofession supported the off-label prescribing of HGH for such purposes. Arelated issue was the importance of evidence-based medicine as ajustification for such prescribing.

15. The Committee is aware that at times a respectable minority of the medicalprofession may be on the forefront of new developments in medicine, and thatover time the respectable minority can become a well-accepted majority.

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However this usually occurs when new developments have been subjected toproper scrutiny and research, including strict protocols being set, patientsbeing informed as to the unorthodox nature of the treatment, and there is asignificant body of evidence-based medicine which supports thesedevelopments.

16. Drugs may be prescribed off-label when they are seen as part of a newdevelopment or trend in medicine but which have not yet been subjected tosuch scientific scrutiny.

17. Off-label prescribing generally refers to the prescription of drugs for a use for

which they are not authorised by a relevent regulatory authority according torelevant guidelines.

18. Dr John Carter gave evidence for the HCCC. Dr Carter is a clinical professorat the University of Sydney and a specialist endocrinologist. He is a memberof many professional organizations and committees and is the author and co-author of numerous articles.

19. According to Dr Carter, HGH has been used off-label as anti-aging therapyand also by athletes, both elite and non-elite, to improve muscle strength andrecovery from injuries.

20. Dr Carter in his report dated 26 October 2009 describes HGH as a poly-

peptide hormone which is formed by recombinant DNA technology. Most ofits biological activity is due to the induction of the production of IGF1 whichoccurs mainly in the liver and which stimulates linear growth in children byacting directly and indirectly (via IGF1) on the growth plates of long bones. Italso has specific metabolic actions, including the increased breakdown of fat,leading to mobilization of stored triglyceride, stimulation of protein synthesis,antagonism of insulin action and retention of phosphate, water and sodium.

21. The approved and accepted therapeutic uses of HGH, according to Dr Carter,are fo r

(a) growth failure in children, due to growth hormone deficiency(b) growth disturbances associated with gonadal dysgenesis(c) severe growth hormone deficiency in adults(d) pubertal growth retardation, associated with chronic renal failure.

22. Contra-indications for the use of HGH include the presence of a tumour and

allergies to any additive to the preparation. Dr Carter notes that HGH isexpensive and has potential serious side effects, and that the balance ofevidence from limited trials in patients with normal growth hormone, that isIGF1 levels within the conventional range for age levels, has not shown abenefit from HGH.

23. An IGF1 (insulin-like growth factor) level below the range for a patient's ageand gender may indicate proven growth hormone deficiency.

24. According to Dr Carter growth hormone deficiency cannot be diagnosed in the

absence of stimulation tests, although there is a high correlation betweenproven growth hormone deficiency and clearly low IGF1 levels in the serum.

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25. Dr Carter states in his report that there is no legitimate literature or recentresearch which would provide clinical justification for off-label use of HGH.

26. However he also said in evidence that although it may not be illegal toprescribe drugs for uses not approved by the Therapeutic GoodsAdministration, such prescribing does happen. According to Dr Carter there isa significant "street value" for HGH.

27. Dr Walid Jammal also gave evidence for the HCCC. Dr Jammal is anexperienced general practitioner, graduating from the University of Sydney in1988. He is a Fellow of the Royal Australian College of General practitionersand currently works at the Hills Family General Practice.

28. According to Dr Jammal, the drug Valium is a good example of off-labelprescribing which occurs quite commonly. The use of Valium rectally tocontrol seizures is not "on label", however its use for this purpose is wellrecognised, and it is used widely, even in hospitals, for the management ofepilepsy.

29. In his report dated 9 May 2009 Dr Jammal notes that growth hormonedeficiency is in itself a very difficult diagnosis to make and often relies onspecialist advice and testing. He states that "There has been a trend to usegrowth hormone as an anti-aging remedy and for "wellness" without anyscientific data to back this treatment."

30. The most common side effects of treatment with HGH include oedema, fluidand water retention, arthralgia and myalgia. According to Dr Carter, othercommon side effects include paraesthesia, carpal tunnel syndrome andhyperglycaemia.

31. Dr Martin Hill is a Fellow of the Royal Australian College of GeneralPractitioners and is currently in general practice with a specialization inPreventive and Regenerative Medicine. He gave evidence on behalf of DrSchmuelly.

32. Dr Hill provided a report dated 8 September 2010 and in his report lists thesignificant generalized benefits of HGH, noting that many studies supportHGH supplementation for regeneration of muscle, bone, cartilage, nerves andsoft tissues. Dr Hill states that HGH administration may attenuate severalimportant decrements in body composition and in function associated withageing.

33. He also notes that the notion of partial HGH deficiency is well reported in themedical literature, and refers to significant age related decline, and that therationale for the prescription of HGH in partial HGH deficiency is supported bythe medical literature.

34. The rationale of 'partial HGH' deficiency as a basis for treatment is disputedby both Dr Carter and Dr Jammal.

35. In fact the Consensus Guidelines of a number of endocrine societies in

countries including Europe, Japan and Australia, cited by Dr Hill in a footnoteto his report, state that "partial GHD is not a well-defined clinical entiy inadults" ( see Footnote 247 ).

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36. Dr Hill states that the diagnosis of HGH deficiency should be made with

consideration of the presenting clinical symptoms and signs of HGHdeficiency in conjunction with baseline IGF1, IGFBP3, and urinary HGH tests.Dr Hill referred to these as bivariate tests. He also states that appropriate

imaging and serum gonadotrophins are important for evidence of pituitarydisease.

37. For Dr Hill the paradigm in preventive and regenerative medicine is "to treatthe age related decline to youth levels for purposes of prevention of diseasei.e it is a preventative approach."

38. Dr Hill gave evidence that he himself prescribed HGH to patients with a poor

quality of life and said that they improved remarkably with treatment.

39. Attached to Dr Hills report is an extensive bibliography which contains 256

articles on the use of human growth hormone in a variety of different contexts.Dr Hill however conceded in evidence that he had only read the abstracts ofthese articles and that most of the articles he listed concerned studies on theeffect of HGH on rats and other animals, on children with proven growthhormone deficiency, and on adults with proven growth hormone deficiency iebelow the IGF1 reference range for age.

40. As noted in the HCCC submissions, some of the articles listed by Dr Hillactually contradict his views and those of Dr Schmuelly, and in fact supportthe views of Dr Carter and Dr Jammal.

41. The voluminous literature on the prescribing of HGH which was before theCommittee also raised squarely the issue of evidence-based medicine, andthe importance of this trend in medical education and practice. This issue isfurther discussed below.

42. It is in the context of the debate about off label prescribing, the 'respectable

minority', and evidence-based medicine, that the complaint can now beconsidered.

The complaint

Particular 1 - Prescribinq of Human Growth Hormone

At all relevant times the practitioner provided care and/or treatment to PatientsA, B, C, 0, E, F, G, H, i, J, K, L, M, N, P, Q, R, S, T, U and V

1. On various dates between 1 August 2006 and 30 September 2007 as

set out in Schedule A to the Complaint the practitioner prescribed, dispensedand/or supplied a restricted substance, namely Human Growth Hormone, toPatients A, B, C, 0, E, F, G, H, i, J, K, L, M, N, P, Q, R, S, and/or T;

a) For a purpose or purposes that did not accord with the recognised

therapeutic standard of what was appropriate in the circumstances; in breachof clause 33 of the Poisons and Therapeutic Goods Regulation 2002;

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b) In circumstances where the practitioner had not established Patients A

to T suffered from growth hormone deficiency by reference to accepted tests.

43. Dr Schmuelly admits in his statement dated 1 September 2010 that in relationto patients A to T he prescribed human growth hormone ("HGH") in a manner"that was not in accordance with the approved indications".

44. Clearly this concession was not in the exact wording of the complaint. He

conceded in evidence, however, that he had prescribed HGH for a purposethat did not accord with the recognised therapeutic standard of what wasappropriate in the circumstances to Patients C, J, L, M, Rand T.

Evidence in relation to Patients C, J, L, M, Rand T

45. Dr Schmuelly also conceded that he did not perform the standard IGF1 testfor these patients. He said that his aim was to get a modest increase in theirHGH levels but not necessarily an optimal level band range. According to hisstatement he warned each of these patients about the potential side effectsand advised them to come back and see him if they suffered any side-effects.

46. In spite of Dr Schmuelly's concessions in relation to these patients, it isimportant to note each patient's particular circumstances.

47. Patient C was a 38 year old man who was a mercenary and a former SASsoldier, who suffered recurrent injuries including alleged 'ongoing musclebreakdown disorder' and many other symptoms. Dr Schmuelly in hisevidence agreed that he gave the patient 31 ampoules of HGH over a longperiod of time. He also conceded that the patient displayed possiblesymptoms of anabolic steroid abuse, and that he allowed the patient toincrease his own dose in order to treat his symptoms. No baseline blood testswere performed. Dr Schmuelly claimed that blood tests would not havechanged his diagnosis or treatment. He did not concede that the patientdisplayed classic drug-seeking behaviour, but acknowledged that he shouldhave worked harder with specialists in relation to this patient. According to DrCarter the HGH was not prescribed for an approved therapeutic purpose. DrJammal was concerned about the amount of HGH given to this patient andfound it a significant departure from the requisite standard, as did Dr HilL.

48. Patient J was a 39 year old man who had been a patient of Dr Schmuelly's

since 1999. He had generalized symptoms including sleep disturbances,fatigue, anxiety, hyperlipidaemia, tinnitus and borderline hypertension. InJune 2007 Dr Schmuelly ordered blood tests which revealed a normal IGFleveL. He was then prescribed HGH and warned about potential side-effects.Dr Hill, Dr Carter and Dr Jammal all expressed the view that the prescribing ofHGH for this patient was inappropriate.

49. Patient L was a 28 year old man who presented with symptoms following an

injury and was also noted to have "flat cheek bones". Dr Schmuelly

prescribed HGH to assist him with recovery from the injury. Dr Carter notedthat there are no controlled trials to indicate that HGH assists with recoveryfrom injuries in adults with normal growth hormone levels, and found that theprescribing was not in accordance with evidence based-medicine and notprescribed for an approved purpose. Dr Hill noted that it was not appropriatefor a practitioner to be prescribing HGH supplementation in a young person

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less than 30 years of age unless there are conclusive symptoms and signs ofdeficiency and blood and urine investigations which indicate deficiency. Hesaid however that Dr Schmuelly's prescription was not significantly below thestandard of a practitioner of equivalent level of training or experience. DrJammal however stated that the prescribing was a significant departure fromthe standard and said he could not understand how the symptoms, in thepresence of a normal IGF level, could be interpreted as an indication forgrowth hormone ("GH") treatment.

50. Patient M was 47-year-old man who suffered from chronic back pain followinga car accident and had a history of musculoskeletal injuries as well asdecreased libido, anxiety and insomnia. Dr Carter noted that no blood testshad been taken to determine the patient's IGF1 level and that therefore theHGH was not prescribed for an approved therapeutic purpose. Dr Hill notedthat the prescription of HGH treatment was significantly below the standard tobe expected of a practitioner of an equivalent level of training and experience.

51. Patient R was a 47 year old man who had been a soldier in New Guinea and

suffered from a variety of symptoms including an exacerbation of injuries,decreased libido, anxiety and exhaustion. Dr Schmuelly stated in evidencethat he gave the patient HGH to recover from the use of steroids and that hebelieved that this was a lifesaving measure as the HGH was not going toharm him, was not going to be long-term, and the patient was returning toPNG in a few days to continue a dangerous job. Dr Carter noted however thatthe HGH was prescribed for relatively non-specific symptoms, and was not forapproved therapeutic purposes. Dr Jammal could not understand the rationalefor the prescribing to this patient, and therefore found it a significant departurefrom the requisite standard.

52. Patient T was a 28 year old male who complained of erectile dysfunction and

reduced libido, and who also suffered from hypogonadism. Dr Schmuellyconceded in evidence that the patient also had a history of using anabolicsteroids. He only saw the patient once. Dr Carter, Dr Jammal and Dr Hill wereall of the view that Dr Schmuelly's prescribing of HGH for this patient wassignificantly below the relevant standard

Findinqs in relation to the above patients

53. Dr Jammal was unable to comment on Patient M as he did not have thepatient's notes. Dr Hill in relation to Patient L was of the view that DrSchmuelly's conduct was not significantly below the standard. However DrCarter, Dr Jammal and Dr Hill were otherwise unanimous in their opinion thatin relation to his treatment of these patients, Dr Schmuelly's conduct wassignificantly below the standard reasonably expected or a practitioner of anequivalent level of training or experience.

54. The Committee has no difficulty in finding the particulars in relation to theabove patients proved.

Evidence in relation to the remaininq patients

55. The circumstances in relation to the other patients referred to in Particular 1 ofthe complaint can now be considered.

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56. Patient A was a 74 year old man who was a long-standing patient of DrSchmuelly's, and had been consulting him since 1998. Dr Schmuelly says inhis statement that "My rationale for prescribing 1 IU/d of HGH was an attemptto aid patient A's overall management with regards to a chronic airflowlimitation, back and shoulder injuries, osteopoenia, central adiposity, reducedmuscle mass/ strength and exercise capacity, impaired psychological well-being, sleep disorder, fibromyalgia, elevated lipoprotein.a, CRP and lethargy/fatigue." Dr Schmuelly noted that although the patient did not suffer any harmfrom the GH therapy, he did not derive any benefit from it. Dr Hill notes in hisreport that this patient was aged 74 "and therefore severely HGH deficient",and stated that Dr Schmuelly's conduct was not significantly below standard.In evidence, however, he conceded that HGH was more risky because of thepatient's advanced age and the increased risk of pre-existing cancer. DrCarter notes that there is no evidence of growth hormone deficiency with thispatient and was of the opinion that it was not prescribed for an approvedtherapeutic purpose.

57. The Committee finds this particular proved.

58. Patient B was a 69-year-old female patient, married to Patient A, who alsohad a complex medical history and on 17 May 2006 reported insomnia,palpitations, increased perspiration and blurred vision, with the symptomsworsening over the past six months. Dr Schmuelly says in his statement thathe provided the patient with repeat prescriptions for HGH between October2006 and May 2007. He at all times monitored her therapy, and believed shewas benefiting from it. Whilst Dr Hill concluded that Dr Schmuelly's

prescription of HGH was appropriate, Dr Carter again notes that there was noevidence with this patient of growth hormone deficiency and that theprescribing of HGH was not in accord with recognized evidence-based

medicine and it was not prescribed for an approved therapeutic purpose. DrJammal comments that he cannot see any concrete or definitive clinicalrationale for the prescribing of HGH in this patient.


60. Patient 0 was a 78 old woman also with a complex medical history. DrSchmuelly says that his intention in recommending and prescribing HGH forthis patient was to improve her symptoms. Dr Hill states that "the rationale fortreatment with HGH in this patient is sound", although he says that he wouldhave preferred to see more documentation of symptoms and signs ofdeficiency. Dr Carter notes that prior to starting this patient on HGH, her IGF1level was normaL. Dr Carter concludes that the prescribing of HGH was not inaccordance with recognized evidence-based medicine, and was notprescribed for approved therapeutic purposes. Dr Jammal again commentsthat he cannot see any concrete or definitive clinical rationale for theprescribing of GH in this patient.


62. Patient E was a 38-year-old male who had been diagnosed with growthhormone deficiency at age 40 and reported a ten year history of erectiledysfunction, depressed mood and reduced ability to cope with stress. DrSchmuelly considered that the patient was experiencing continued growth

hormone deficiency and prescribed HGH. Dr Carter was not critical of Dr

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Schmuelly's prescribing with this patient. Dr Jammal however noted that therewas no indication of current human growth hormone deficiency and thatprescribing growth hormone for performance anxiety was not a medicallyacceptable rationale. Dr Hill was not critical in his report of Dr Schmuelly'sprescribing of HGH for this patient but conceded in cross-examination that ifpre-existing growth hormone deficiency cannot be established, the patientneeds to be re-assessed.

63. The Committee does not find this particular proved.

64. Patient F was a 52-year-old woman who had consulted another doctor and

then Dr Schmuelly for signs and symptoms associated with a metabolicsyndrome known as Syndrome X. Dr Schmuelly states that based on hisreview of the literature he was aware that Syndrome X was known to respondsafely to treatment with low dose HGH therapy. Dr Schmuelly's noteshowever also refer to HGH treatment for "wellbeing" and "anti-aging". Dr Hillcomments that he would expect better documentation in the written clinicalnotes but that the prescribing of HGH for this patient was appropriate. DrJammal, however, points out that this patient had been on varying doses ofHGH for many years with no real indication of any valid reason, and says thiswas not appropriate. Dr Carter also notes that there were no laboratory testsavailable and no evidence that HGH was prescribed for approved therapeuticpurposes.


66. Patient G was a 38-year-old man who complained of decreased energy,decreased libido, erectile dysfunction, increased anxiety and sleepdisturbance. According to Dr Schmuelly after he prescribed HGH the patient'ssymptoms improved. Dr Hill was not critical of the prescribing. Dr Jammalnotes however that the symptoms were very non-specific and that as therewas no direct evidence of GH deficiency in the patient, there was no concreteor definitive clinical rationale for the prescribing of GH. Dr Carter notes thatthe patient's IGF1 was in the middle of the physiological range and that therewas no evidence of growth hormone deficiency. The prescription of HGH wastherefore not in accord with recognized evidence-based medicine and notprescribed for approved therapeutic purposes.


68. Patient H was a 41 year old patient who consulted Dr Schmuelly only once in

August 2007. He had been involved in three motorcycle accidents andsuffered multiple orthopaedic injury and other injuries. He was due to havesurgery to remove the intramedullary naiL. Dr Schmuelly did arrange bloodtests in this patient and noted a relatively low IGF leveL. He prescribed a shortcourse of HGH but did not see the patient again. Dr Hill was not critical of DrSchmuelly's prescribing. Dr Carter however commented that there was noevidence in the literature on adults without growth hormone deficiency thatHGH would assist in this particular situation to increase recovery post surgery.He therefore concluded that the prescription was not for an approvedtherapeutic purpose.


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70. Patient I was a 37-year-old taxi driver who had suffered a number of bony

injuries and also reported erectile dysfunction, failure to respond to Viagra,reduced exercise capacity, sleep disturbance and insufficient energy. Hismain problem was chronic back pain. Dr Schmuelly referred the patient forblood tests and noted that his IGF-1 level was below his age adjusted

minimum, which he said was consistent with growth hormone deficiency. DrCarter however points out that the pre-HGH treatment level was within thenormal range and there was no evidence of hormone deficiency. He says thatit appears that the HGH was prescribed to assist the patient with recoveryfrom trauma as well as his other symptoms, and concludes that thisprescribing was therefore not for an approved therapeutic purpose. Whilst DrHill states that the rationale to assist recovery from these injuries is supportedin the literature, Dr Jammal comments that he cannot see any concrete ordefinitive clinical rationale for the prescribing of GH in this patient.


72. Patient K was a 60-year-old woman who suffered from multiple signs andsymptoms including central adiposity and weight gain, sleep disturbances, dryskin and hair, and hot flushes and hair loss. Dr Schmuelly states that her

blood tests indicated that her IGF1 level was normal, but well below the upperlimits of normaL. He said his rationale for prescribing HGH was to assist thepatient with her symptoms. Dr Carter notes that the patient had nobiochemical evidence of growth hormone deficiency and said that althoughreference had been made to the fact that the patient's symptoms had beenshown to respond to HGH supplementation, this was true, but only in growthhormone deficient patients and not growth hormone replete patients. Hetherefore concluded that HGH was not prescribed for approved therapeuticpurposes, as the patient was not HGH deficient. Dr Hill noted that the patient'spost menopausal symptoms should have been addressed before HGH wasprescribed, but also noted that HGH may be considered as a valid hormonaltreatment. Dr Jammal noted the use of the term "anti-aging" in the clinicalrecord and could not see any definite indication for GH use in this patient.


74. Patient N was a 47-year-old woman with a range of symptoms includingdecreased energy, decreased libido and concern about osteoporosis. DrSchmuelly referred her for blood tests and her IGF one level was within thenormal range. According to Dr Schmuelly the tests suggested that she mightnot be peri-menopausal or oestrogen or testosterone deplete, but that hersymptoms could be caused by HGH deficiency. Dr Schmuelly prescribedHGH on the basis that it could assist her symptoms. Dr Hill however wascritical of Dr Schmuelly prescribing HGH for this patient as her baselinehormones were recorded as normal and her IGF1 was not consistent withHGH deficiency. He said that HGH supplementation would not be his firstchoice of treatment and that Dr Schmuelly's prescription of HGH wassignificantly below the standard expected of a practitioner of equivalent levelof training or experience. Both Dr Jammal and Dr Carter noted that the IGF1level was well within the normal range, Dr Carter concluding that the HGHwas not prescribed for a recognized therapeutic purpose, and Dr Jammalnoted that there was no clinical indication for its use.


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76. Patient P was a 45-year-old male who had multiple problems following a car

accident including pain in his lumbar spine, his right hip and right knee. DrSchmuelly stated that he prescribed HGH therapy to assist the patient'schronic pain as well as his hyperlipidaemia. Dr Carter, Dr Jammal and Dr Hillall noted that there were no indications for prescribing HGH with this patient.


78. Patient Q was a 45 year old man who had had a back injury, dyslipidaemia,central adiposity, impaired mood and anxiety, and other symptoms. Accordingto Dr Schmuelly his IGF1 Level was within the physiological range but belowthe maximum age range. He prescribed HGH to assist with the patient'schronic pain as well as his reduced libido and hyperlipidaemia. Both Dr Carterand Dr Jammal noted that there were no indications for the prescribing ofHGH, but Dr Hill however noted that the IGF1 level was consistent withdeficiency, and the prescribing was appropriate.


80. Patient S was an 82-year-old male who reported multiple symptoms including

knee pain, increased weight, poor sleep patterns, decreased stamina anderectile dysfunction. Dr Schmuelly said that he prescribed HGH to improve thepatient's various symptoms. Dr Hill concluded that the prescription of HGHwas significantly below the standard expected of a practitioner of equivalentlevel of training or experience because of the lack of care of the patient'sother urgent medical conditions. Dr Carter was of the opinion that theprescription was not for approved therapeutic purposes and Dr Jammal notedthat " the diagnosis and treatment of GH deficiency in the elderly is fraughtwith difficulty and danger, and specialist advice before embarking ontreatment would have been more appropriate". Dr Jammal was therefore ofthe opinion that the prescribing was a significant departure from theappropriate standard.


82. The Committee finds Particular 1 in relation to all patients proved, with theexception of Patient E.

Dr Schmuelly's evidence qenerally in relation to Particular 1

83. Dr Schmuelly stated at the beginning of his evidence that he regretted hisactions and that he had stopped prescribing HGH after being visited by thePharmaceutical Services Branch. He stated that he had gained insight into theissues raised and that that he saw himself as an old-fashioned conservativepractitioner. He said that this was probably why he did not undertake as manyblood tests as some doctors. He stated that he did not like to over-test andincrease costs to patients.

84. Although Dr Schmuelly took IGF1 levels from all but 5 patients (Patients B, C,F, P and S), it was clear from the evidence in relation to each patient that hedid no other tests to establish hormone deficiency.

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85. According to his s40 response to the complaint, the reference range used by

Dr Schmuelly for patients aged between 39 - 54 years old was 360ng/ml. Hetold Martin Power that he regarded the recommended age range as arbitraryand probably wrong.

86. In evidence, the Committee heard that Dr Schmuelly's views were based on a

different paradigm of what constitutes "normal levels". His paradigm disputesthe concept of accepting age-adusted levels of IGF1 as normal, ratherpreferring levels closer to the levels found in young people as targets to aspireto in therapy.

87. He aimed to get a modest increase in IGF levels but not to necessarily get toan optimal level band range. He tried to get symptomatic patients into a higherrange, but denied at one point in his evidence that he treated patients only foranti-aging, and insisted that he treated patients according to their individualsymptoms.

88. However Dr Schmuelly conceded in cross-examination that he treated PatientB, who was in her late sixties, for" basically well being, anti- aging, a varietyof medical symptoms" but claimed that he was using the term "anti-aging" ina loose way.

89. He also said that he prescribed HGH for "well being" as patients' symptomsrelated to their well-being. He told Martin Power that he used HGH for well-being and anti-aging in relation to Patient U and Patient Q, or recovery frominjury.

90. According to Dr Schmuelly evidence-based medicine meant treatment based

upon knowledge he had at the time.

91. Dr Schmuelly was unable to nominate in his evidence any patient where hediscussed treatment with an endocrinologist prior to commencing treatmentwith HGH.

92. When asked his view now of treating patients with steroid abuse with HGH DrSchmuelly said he would probably do it differently, but he would still not leavethem "out to dry" because of any controversy about HGH.

Particular 2 - Prescribinq HGH without reference to accepted tests

2. On various dates between 1 August 2006 and 30 September 2007 the

practiioner prescribed, dispensed and/or supplied a restricted substance,namely Human Growth Hormone, to Patient U without confirming whetherPatient U suffered from growth hormone deficiency by reference toaccepted tests.

93. Dr Schmuelly in his statement notes that he treated Patient U, a 40 year oldman, for multiple signs and symptoms consistent with adult growth hormonedeficiency. Patient U was, according to the patient notes, on a "health kick".Dr Schmuelly denied giving HGH for "health kick" purposes, but said inevidence that the patient was 140 kg and wanted to be rescued from himself.

94. According to Dr Schmuelly although "the insulin induced hypoglycaemic test

is the gold standard test to investigate adult growth hormone deficiency, the

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diagnosis of growth hormone deficiency does not necessarily rest exclusivelyon a laboratory test result. The patient's history, results of clinical examinationand blood tests all contribute to the diagnosis." Dr Schmuelly consideredthere was sufficient basis to make the diagnosis of adult growth hormonedeficiency. Neither Dr Hill, Dr Jammal nor Dr Carter were critical of theprescribing of HGH for this patient, Dr Carter noting that this was the only oneof the patients the subject of the complaint who had a documented low IGF1level prior to commencing HGH therapy.

95. The Committee does not find this particular proved.

Particular 3 - Prescribinq and Supplyinq a Restricted Substance

3. On various dates between 1 January 2006 and 20 September 2007 the

practitioner prescribed and supplied a restricted substance, namelyRoaccutane (isotretinoin), to Patient V and another patient or patientsunknown without a special authority to do so, contrary to the requirementsof clause 36 of the Poisons and Therapeutic Goods Regulation 2002

96. Dr Schmuelly admits this particular and states that he was unaware at thetime that a special authority was required in order to be able to prescribe thedrug. He states that he thought that he could prescribe it privately and onlydermatologists could prescribe it under the Pharmaceutical Benefits Scheme.He prescribed at a very low dose, and Patient V (who was a 16 year old girl),responded well to treatment.

97. Dr Schmuelly also admitted prescribing the drug to his fiancée.

98. He said that in prescribing the drug, he took the precautions that adermatologist would have followed and prescribed it at a third of the dosemany of them would have used, thus minimizing potential side-effects. Heagreed in evidence that he was unwise to prescribe it for his fiancée, andnoted that she had an emotional dependence upon him.

99. He acknowledged that Roaccutane had a serious side effect for women ofchildbearing age and agreed that in retrospect it was a significant shortcomingon his part to prescribe it, although he insisted that he managed it

appropriately. He claimed that had he known he could not prescribe it hewould not have done so.


Particular 4 - Self-prescribinq HGH

4. On various dates between 25 January 2006 and 19 March 2008 the

practitioner inappropriately prescribed, dispensed, supplied and/oradministered Human Growth Hormone to himself,'

a) For a purpose or purposes that did not accord with the recognised

therapeutic standard of what was appropriate in the circumstances;in breach of clause 33 of the Poisons and Therapeutic GoodsRegulation 2002;

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b) In circumstances where the practitioner had not established that hehimself suffered from growth hormone deficiency by reference toaccepted tests.

c) Contrary to the NSW Medical Board Policy "Medical Practitioners

Treating Relatives and Self"

101. Dr Schmuelly in his statement admits to self-prescribing HGH after consultingwith his treating orthopaedic surgeon about the matter, and states that he self-prescribed HGH to assist in his recovery from injuries which he sustainedbetween 2001 and 2005, and when other forms of therapy had failed. Inevidence Dr Schmuelly also said that HGH worked well for him in treatingsleeplessness and pain.

102. It is significant to note that Dr Schmuelly acknowledged to Martin Power(Report p.9 para 4) that his self treatment with somatropin was not with thesupport of all his own treating specialists. He did not provide any evidencefrom his orthopaedic surgeon.

103. He said he was unaware of the New South Wales Medical Board policy inrelation to medical practitioners prescribing for themselves or immediatefamily members. He said he had stopped self-prescribing when he becameaware of the guidelines and now has a general practitioner.

104. When asked whether he is still prescribing it to himself he said he went off itfor a while, but each time he did so he started to deteriorate, and that shortdoses did not work for him, possibly because his injuries had become morechronic. He has now been on HGH for several months and the present coursehas almost finished. He said that a specialist physician now prescribes HGHfor him.

105. In spite of Dr Schmuelly's detailed rationale for prescribing HGH to himself, DrCarter concluded that as Dr Schmuelly's IGF1 level was not low, that theprescribing was not in accordance with evidence based medicine and not foran approved therapeutic purpose. Dr Jammal was of the view that it was asignificant departure from the requisite standard.


Particular 5 - Workcover Certificates

5. On various dates between 4 August 2006 and 19 March 2008 the

practiioner inappropriately completed Workcover certificates certifyinghimself as either unfit or fit to work.

107. Dr Schmuelly claimed both in his statement and in his evidence that he filledout Workcover certificates purely for his own records and that he had nointention of submitting any claims. He signed them both as patient and doctor.

108. He said that he did not see these certificates as medical certificates, and thathe was unsure at the time as to whether or not a GP should sign a medicalcertificate for himself. He claimed that he was not interested in compensationalthough he took a lot of sick leave and never got paid for time off. DrSchmuelly was unclear in his evidence as to his knowledge of the relevant

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Medical Board policy in relation to doctors signing medical certificates forthemselves.

109. Dr Schmuelly was unable to explain why he went to the trouble of completingthe certificates without ever submitting them.

110. There was no evidence from Dr Hill, Dr Carter or Dr Jammal in relation to thisparticular.


REASONS FOR DECISION

112. The Committee has carefully considered the evidence, and been muchassisted by the submissions of the parties.

113. Whilst the Committee places less weight upon the evidence of Dr Hill as hewas unfamiliar with much of the literature that he cited in support of his claimsabout HGH, it is important to note that even Dr Hill in his report was also ofthe opinion that Dr Schmuelly's prescribing in relation to patients J, M, N, R, Sand T was a significant departure from the expected standard.

114. It is clear that Dr Schmuelly prescribed HGH to patients with a wide variety ofmedical conditions and symptoms. The youngest patients were 28 years old(Patients Land T) and the oldest was 82 (Patient S). Dr Schmuelly prescribedHGH for chronic pain, sleep disturbance, obesity, reduced ability to cope withstress, low libido, erectile dysfunction, and recovery from musculoskeletalinjury and surgery. He also prescribed it for symptoms such as depressionand lack of energy, as well as for 'anti-aging' (Patients B, P, U and N) and'well being' (Patients B, K and Q).

115. Dr Schmuelly rationalised his prescribing of HGH for his patients by using anIGF1 reference range recommended in an article by the drug companyScigen, which as noted in the HCCC submissions, produces HGH for profit.As noted above, he thought that the recommended IGF1 range is "anarbitrary, artificial range" and "probably wrong".

116. The fact that he chose not to use the recommended IGF levels is at odds withhis claim in evidence that he is an old-fashioned conservative practitioner. Hisrationale for prescribing HGH was clearly unorthodox.

117. Dr Schmuelly, in support of the use of HGH, relied upon the work of a leadinganti-aging doctor from Belgium, Dr Thierry Hertoghe, and an anti-agingadvocate from the United States, Dr Gordon.

118. Dr Hertoghe is a Professor of Endocrinology and the author of a publicationon hormone therapies (which appears to be the last reference in Dr Hill'sbibliography). It is entitled The Hormone Handbook - the Keys to SafeHormone Therapies: How to do it and how to solve therapy problems.

119. Dr Gordon is Associate Clinical Professor at the University of SouthernCalifornia and the University of California in Los Angeles.

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120. A DVD showing both Dr Hertoghe and Dr Gordon speaking at conferenceswas provided to the Committee. There was little or no information providedabout the conferences, even in relation to precisely when and where theyoccurred or in what context.

121. Dr Schmuelly submits that the Committee should accept on the basis of theabove information that both Professor Hertoghe and Dr Gordon are reputableinternational practitioners.

122. On the basis of such limited information, the Committee does not accept thissubmission. In fact, the DVD of Dr Hertoghe and Dr Gordon did little to assistDr Schmuelly's case. It was almost evangelical in its promotion of the benefitsof HGH, and the excerpts shown to the Committee appeared to lackobjectivity.

123. Furthermore, this DVD did not demonstrate a balanced analysis of the risksand benefits of HGH, outline protocols for safe prescribing, or refer to thehighly unorthodox nature of the views promulgated and that HGH prescribingis currently off-label and that patients should be warned.

124. As noted in the HCCC submissions, Dr Hertoghe in his book on the subjectalso expresses caution in relation to the use of optimal age ranges, and notesthat his values are based upon his own subjective experiences and those ofhis colleagues and hence do not represent evidence-based opinions.

125. Dr Schmuelly, like Dr Hertoghe, relied heavily upon anecdotal evidence fromhis patients in regards to its benefits, as well as his own experience with HGH.He was unable to point to any evidence-based research which would justifyhis prescribing of HGH to the above patients.

126. He seemed unaware of the relevance or significance of evidence-basedmedicine, and as noted above, seemed to equate anecdotal evidence withevidence-based medicine.

127. The Committee is mindful of the fact that the practice of medicine would nothave evolved without some trial and error, and that the discipline of evidence-based medicine is quite a recent phenomenon in medical education and

practice.

128. Evidence-based medicine (EBM) is the "conscientious, explicit and judicioususe of current best evidence in making decisions about the care of individualpatients. The practice of evidence based medicine means integratingindividual clinical expertise with the best available external clinical evidencefrom systematic research." 1 It aims to increase the use of high quality clinicalresearch in clinical decision making.

129. The Committee notes that Dr Schmuelly may have had minimal training in thisrespect.

130. However this does not justify in the Committee's mind Dr Schmuelly relyingpurely on anecdotal evidence to justify his prescribing practices.

1 1

(Sackett, D.L. et al (1996). Evidence based medicine: what it is and what it isn't. BMJ; 312:71-72.).

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Respectable minority view

131. The Committee is asked to accept in relation to Particular 1 that because atthe relevant time there was a respectable minority view in relation to theprescribing of HGH, the Committee ought not therefore find that DrSchmuelly's conduct amounted to unsatisfactory professional conduct. Insupport of this argument Dr Schmuelly refers to a number of well-knownauthorities.

132. The Committee rejects this submission. Clearly whether or not there is arespectable minority in relation to the prescribing of HGH is not of itselfdeterminative of whether or not conduct may amount to unsatisfactoryprofessional conduct. Each case must be determined on its own facts.

133. Each case must also be seen in the context of a shifting paradigm in scienceand medicine, and the need for some rigour if practising outside establishedpractice. Such rigour would include establishing or following protocols and aclear rationale for treatment, providing written information to patients, and

obtaining their written consent when prescribing off-labeL.

The evidence in relation to a "respectable minority"

134. The evidence of the "respectable minority" consisted of that of Dr Hill inAustralia, and DVD evidence of presentations at conferences by Dr ThierryHertoghe from Belgium and Dr Mark Gordon from the United States, referredto above.

135. The Committee was not persuaded by Dr Hill's evidence, and accepts theHCCC submission that Dr Hills beliefs in relation to the prescribing of HGHdid not stand up to scrutiny. He was clearly unfamiliar with the literature thathe cited, which as the HCCC noted, could not be used to support a view thatthe prescription of HGH for wellness, aging, or recovery from injury isrecognized as therapeutically appropriate.

136. As noted in the HCCC submissions, Dr Hill, even when given the opportunityduring the proceedings, was unable to nominate any randomised double-blindstudies supporting the use of HGH in adults without conventionally definedHGH deficiency, and which he could show were relevant to the patients thesubject of the complaint.

137. The voluminous literature on the prescribing of HGH referred to by Dr Hill andDr Schmuelly generally proved to be largely irrelevant in relation to thepatients the subject of the complaint, as most of the patients did not haveestablished human growth hormone deficiency as defined by orthodoxmedicine and the Guidelines.

138. And, in fact, some of the articles referred to by Dr Hill were supportive of theviews expressed by Dr Carter and Dr Jammal, rather than those of DrSchmuellyand Dr Hill.

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Relevant case law in relation to a respectable minority

139. The Committee also accepts the submissions of the HCCC in relation to therelevant "respectable minority" case law. The cases such as Qidwai v Brown(1984) 1 NSWLR 100 and Cranley v The Medical Board of Western Australia(Unreported, Supreme Court of Western Australia (Ipp J) 21 December 1990)refer to professional misconduct rather than unsatisfactory professionalconduct, and there appear to be no cases where the 'respectable minorityview' analysis has been applied to unsatisfactory professional conduct.

140. And as the HCCC also notes, the courts have rejected in a number ofprofessional misconduct cases the submission that the conduct of thepractitioner was accordance with a body of respectable minority opinion.

141. In view of the only available evidence before the Committee of a "respectableminority" who support the off-label prescribing of HGH and the fact that thereare no relevant authorities directly on point, the Committee cannot assumethat there is a 'respectable minority' in relation to the unorthodox prescribingof HGH in Australia.

142. Whilst it accepts that there are clearly proponents of the use of HGH overseas(such as Dr Hertoghe and Dr Gordon), there was no evidence before theCommittee of the therapeutic guidelines for the prescription of HGH in othercountries. Its status therefore in relation to off-label prescribing in other

countries was unclear.

Continuinq medical education

143. It was also submitted by Dr Schmuelly that the prescription of HGH in

circumstances that are unorthodox is promoted at conferences that attractcontinuing medical education points, and which are endorsed by the RoyalAustralian College of General Practitioners.

144. These conferences are run by the Australasian Association of Anti-AgingMedicine (A5M), and the American Association of Anti-Aging Medicine (A4M).

145. Dr Schmuelly provided the Committee with a media release that describes the2009 A5M Conference and related workshops as accredited by RACGP forthe first time (Exhibit K). The A5M website prominently displays RACGPaccreditation.

146. Dr Schmuelly provided what he said was a non-exhaustive list of 9 seminarshe attended between 2002 and 2008. The list is significantly lacking in detail,and it is impossible to assess the educational content or quality of these

seminars.

147. However Dr Schmuelly did not provide any specific documentation ofattending any conference that advocated prescribing HGH off-label in themanner in which he prescribed, nor any protocol for so-doing.

148. On the basis of this evidence, the Committee was unable to identify whichseminars Dr Schmuelly attended in relation to HGH which specificallyattracted CME points.

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149. The Committee is therefore not persuaded by the submission that theprescription of HGH in circumstances that are unorthodox is promoted atconferences that attract CME points.

150. It was not at all clear to the Committee that the seminars about HGH whichattract CME points actually promote the off-label prescribing.

Whether the conduct amounts to unsatisfactory professional conduct

151. Unsatisfactory professional conduct is any conduct that demonstrates that the

knowledge, skill or judgment possessed, or care exercised, by the practitionerin the practice of medicine is significantly below the standard reasonablyexpected of a practitioner of an equivalent level of training or experience.

152. As noted above, in the Second Reading speech ..... the reference to'significant' in that context may refer to a single act or omission thatdemonstrates a practitoner's lack of skil, judgment or care, or it may refer toa pattern of conduct. In any individual case, that wil depend on theseriousness of the circumstances of the case."

153. The Committee accepts the evidence of Dr Carter and Dr Jammal that DrSchmuelly's conduct in relation to the particulars found proved above, issignificantly below the standard reasonably expected of a practitioner of anequivalent level of training or experience.

154. Dr Schmuelly's pattern of conduct in the prescribing of HGH to both patientsand himself, and of Roaccutane to patients including his fiancée, indicates alack of both judgment and care.

155. The Committee finds Dr Schmuelly's explanation of the completion ofWorkcover certificates for himself unsatisfactory and unconvincing.

FINDINGS

156. Having found Particulars 1 (with the exception of Patient E), 3, 4 and 5proven, the Committee finds that Dr Schmuelly's conduct amounts to

unsatisfactory professional conduct.

ORDERS

157. The Committee acknowledges that Dr Schmuelly has not prescribed HGHsince 2007 and has expressed remorse over his conduct.

158. The Committee also notes that Dr Schmuelly has acknowledged and agreeswith many of the views expressed by Dr Carter and accepts the need formore research into HGH.

159. However in the Committee's view Dr Schmuelly still lacks insight in a numberof respects:

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· He gave little or no evidence of his appreciation of the real risk topatients associated with the prescribing of HGH off-label or ofaccepting that there was no justification for prescribing it.

· He expected the Committee to accept evidence from him at face valueabout the various courses he attended without being able to properlysubstantiate either his attendance or their relevance. He provided noneof the usual documentary support such as certificates of attendance,receipts for fees paid or other objective evidence.

· He also expected the Committee to accept at face value that manydoctors in Australia prescribe HGH off-labeL. Apart from the evidence ofDr Hill, he provided no other objective evidence in this respect, exceptfor a list of doctors who are part of the anti-aging movement in Australia(Exhibit N). This document did not provide evidence of their prescribingpractices.

· He provided a DVD to the Committee which he did not appreciate was

of little assistance to his case. He was unable to provide the most basicinformation about its source.

160. In sum, Dr Schmuelly's lack of insight about of the importance of evidence-based medicine was reflected generally in his presentation of evidence beforethe Committee. In the Committee's view, Dr Schmuelly's lack of insight canbe addressed by a condition that he undertake a course in evidence-basedmedicine rather than by placing him under supervision, the conditionproposed by the HCCC.

161. The Committee having found the complaint proven therefore:

1. in accordance with section 61 (1 )(a) of the Act, cautions Dr Schmuelly.2. in accordance with section 61 (1 )(c) and (d) of the Act, directs that the

following conditions be imposed on Dr Schmuelly's registration:

i. To complete within 12 months of the date of these Conditions and at

his own expense the distance education course "Issues in GeneralPractice Prescribing" conducted by the Department of GeneralPractice, Monash University.

a) Within 14 days of the date of these Conditions, he must provide

evidence to the Council of enrolment in the Issues in General

Practice Prescribing course.

b) Within two weeks of completing the Issues in General Practice

Prescribing course, he is to provide documentary evidence to theCouncil that he has satisfactorily completed the course.

ii. These conditions may be varied, amended or removed at the

discretion of the Medical Council of New South Wales.

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PUBLICATION OF DECISION

162. Pursuant to section 180(1) of the Act the Committee provides a copy of thiswritten statement of decision to Dr Dror Schmuelly, the Health CareComplaints Commission and the Medical CounciL.

163. Pursuant to section 180(3) of the Act the Committee provides a copy of thiswritten statement of decision to Dr Schmuelly's solicitor Mr Tim Bowen and DrJohn Carter, Dr Walid Jammal and Dr Martin HilL. Pursuant to section 180(3),the Committee also provides de-identified copies of the decision to theRACGP and the Royal Australasian College of Physicians for educationalpurposes.

NON-PUBLICATION DIRECTION

164. Pursuant to Schedule 2, clause 6 of the Act, the Chairperson may

a) direct that the name of any witness is not to be disclosed in the

proceedings, or

b) direct that all or any of the following matters are not to be published:

· the name and address of any witness,· the name and address of a complainant,· the name and address of a registered medical practitioner,· any specified evidence,· the subject-matter of a complaint

165. This direction does not operate to exclude any provision of the Act and doesnot preclude the Medical Council from undertaking its statutory functions.

166. 'Publication' may include communicating either in writing or verbally to anyperson.

167. A non-publication order was made in relation to the name of Dr Schmuellypending the outcome of the proceedings, and in relation to the names of thepatients referred to in the complaint.

168. The non-publication order in relation to the name of Dr Schmuelly made at theoutset of the proceedings will therefore lapse. The non-publication ordermade in relation to the names of the patients will continue.

APPEAL

169. An appeal against this decision is available under section 158 of the HealthPractitioner Regulation National law (NSW), or section 158A if the appeal iswith respect to a point of law. Such an appeal is to be made within 28 days ofthe handing down of the decision (or such longer period as the Executive

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Officer of the Medical Council of NSW may allow in any particular case).

I

¡: - ¿?'- cL // .- ~"I(~ ~Ms Helen KielChairperson

:; 3 H-v c/ c.6~ c) l rvDate

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dr dror schmuelly committee members

Documents