[Peetwo]

The Empire Strikes Back MKII - 2016 Avmed & the one percenters?

Still trying to decipher what it all means but my gut feeling is this is not a good thing with reference to Avmed issues & the year ahead in 2016  :

REASONS FOR DECISION


Senior Member McCabe


22 December 2015

1.Warwick Daw is a commercial airline pilot. He also holds a private pilot’s licence. On 5 December 2012, he had a stroke. He was grounded for a time but he has since made a good recovery. On 12 August 2013, he applied for Class 1 and Class 2 medical certificates so that he could return to work as a co-pilot on commercial flights. He cannot fly without those medical certificates. The  Civil Aviation Safety Authority  (CASA) decided it would issue the certificates but with a limitation: he was only permitted to operate a simulator. Mr Daw has asked the Tribunal to reconsider that decision. He says the certificates should be issued without the limits CASA has imposed.
2. We agree with CASA’s decision. We explain our reasons below.

What happened?

3. Mr Daw developed difficulty speaking and using his right arm on 5 December 2012. He was in Fiji where he was working as a commercial airline pilot. He was admitted to a local hospital and then transferred to Brisbane’s Wesley Hospital on 7 December 2012. At the Wesley, he was placed under the care of a Neurologist, Dr Noel Saines.

4. Dr Saines ordered tests that showed a left frontal subcortical intracerebral haematoma of 2cm diameter with no evidence of any other abnormality in the brain. In other words, he had a stroke.

5. On 4 February 2013, Dr Saines wrote to Dr Ian Knox at the Wesley Emergency Centre. Dr Saines said Mr Daw “has made an excellent recovery and has only slight slowing of fine finger movements with the right hand”. After further assessment Dr Saines said on 15 April 2013 that “Mr Daw is perfectly well with no neurological signs and a blood pressure of 120/75”.

6. Mr Daw wanted to return to work. While he had previously been the pilot-in-command on commercial passenger flights, he said in evidence that he was only seeking to fly as a second officer, or co-pilot. He pointed out that in the unlikely event of another incident, he would not be alone in the cockpit.

7. CASA was not convinced. It was only prepared to issue Class 1 and 2 certificates that expressly limited Mr Daw to using a simulator. (Mr Daw does not technically require a medical certificate to operate a simulator. The certification was granted in any event because it enabled him to work in a training role.)

The legislation governing the issue of medical certificates

8. Section 20AB of the Civil Aviation Act 1988 (the Act) prohibits a person from performing a “duty that is essential to the operation of an Australian aircraft during flight time” unless he or she holds the relevant civil aviation authorisation (which includes a certificate issued under the regulations: s 3(1) of the Act) or is excused from holding that authorisation. Regulation 5.04(1) of the Civil Aviation Regulations 1988 (CAR) says the holder of a flight crew licence is required to hold a current medical certificate – which is a civil aviation authorisation. CAR 5.04(3) says a Class 1 medical certificate is required for persons operating as commercial pilots, while a Class 2 medical certificate is required for private pilots. (Mr Daw needs both because he holds both types of flight crew licence.)

9. The rules governing the issue of medical certificates are found in Part 67 of the Civil Aviation Safety Regulations 1988 (CASR). An applicant must lodge an application for a medical certificate under CASR 67.175 which includes all of the supporting documentation. If the applicant meets all of the requirements set out in CASR 67.180(2), a medical certificate must be issued: CASR 67.180(1). The certificate may be issued with any conditions that CASA considers are necessary “in the interests of the safety of air navigation”: CASR 11.056. But the requirements in CASR 67.180(2) include the following sub-regulation (at CASR 67.180(2)(e)):

(e) either:
(i) the applicant meets the relevant medical standard; or
(ii) if the applicant does not meet that medical standard--the extent to which he or she does not meet the standard is not likely to endanger the safety of air navigation...

10. This provision lies at the heart of the case. We understand everyone involved accepts the applicant does not meet the relevant medical standards which are set out in CASR 67.150 for Class 1 certificates and CASR 67.155 for Class 2 certificates because there is a risk of (a) another cerebrovascular accident and (b) epilepsy secondary to damage of the brain. In those circumstances the debate in this case is over the second limb of CASR 67.180(2)(e).

11. We will return to consider the application of the law after we discuss the medical evidence.

What the medical experts say

12. We heard (or received reports) from a number of medical experts who were called to assist us in deciding the issue. CASA relied on Dr Peter Clem, one of its senior medical officers, to explain CASA’s approach to assessing medical risk when it makes decisions about the certification of pilots in cases of this kind. Dr Clem gave oral evidence and provided a detailed statement (exhibit 2). He explained that in the 1970’s and 1980’s aviation medicine was influenced by safety risk analyses developed by the engineering profession. He described the “1% rule” which says that any mechanical failure risk greater than 1% unacceptably compromises safety. Practitioners of aviation medicine regularly adopted this approach when assessing pilots’ health but added more sophistication by considering what remediation or treatment could be instituted to counter a greater than 1% annual risk of an event that can cause incapacitation due to a medical condition. The possibility of remediation meant there was some flexibility in the process but it was ultimately necessary to quantify the risk in every case. Dr Clem said the most recent relevant medical literature must inform assessments of risk.

13. Dr Clem also explained aviation medicine practitioners’ look at absolute risk, that is, the likelihood of something happening in the next 12 months rather than relative risk which is an individual’s risk compared to the general population. Dr Clem explained that even though the absolute risk percentage might seem a small number, it is still significant where aviation safety is at stake. He said any risk above 2% is unacceptable.

14. Dr Clem identified Mr Daw’s risk in his report dated 4 June 2015 by using the relevant medical standards and drawing on papers that he listed and attached. He concluded Mr Daw remained at an epilepsy risk of about 2% and that the risk of a cortical bleed was still at 2-3%. (It appears to be accepted that the risk of further events will decline over time.)

15. At the hearing, Dr Clem reported that even in the most recent literature reviews “without exception we (CASA) cannot find a post-stroke cohort that falls beneath the acceptable threshold of aviation safety”.

16. Dr Clem described Mr Daw as having two overlapping and separate risks of seizure and further stroke recurrence. The risk of Mr Daw succumbing to either of these conditions even with medical treatment exceeded aviation safety standards.

17. We were also provided with reports from Dr Saines, the applicant’s treating neurologist. He did not quantify the risk of another seizure or haemorrhage but CASA pointed out in submissions that Dr Saines conceded the risk was greater than that of the general population.

18. Other experts examined Mr Daw, including Dr Richard Adams. Dr Adams, a neurologist, wrote a report dated 14 July 2014 at the request of CASA (exhibit one at pp 71ff). After recounting the history and his observations upon examination, Dr Adams opined “The reason for this cortical haemorrhage is unclear”: (exhibit one at p 72). In those circumstances, he reported:

I think it is extremely unlikely that there will be a further cerebral haemorrhage. All I can say is that logic would suggest that the probability of such a haemorrhage in the future is minimally higher than the rest of the population.
There are no disabilities. There is no loss of function because of this haemorrhage.
I don’t think there needs to be any concern about possible development of dementia.
The possibility of an epileptic seizure in the future related to this haemorrhage is small but not nil. There is a limited amount of objective material that I can base my comments on. Mr Daw has now gone more than 18 months since the haemorrhage. Most patients who have epileptic seizures following a stroke do have seizures early on after the stroke. Nevertheless, a seizure some years after the stroke can occur. Seizures are more likely to occur with cerebral haemorrhage compared with infarct. Seizures are more likely to occur if pathology is in the cerebral cortex rather than purely being deep in the brain. The overall prevalence of epilepsy after a stroke is around 3%, which has to be compared to a prevalence of ½ to 1% in the general population. With Mr Daw we are now over 18 months since the stroke. I think the rest of life likelihood of a seizure secondary to this stroke is very small, probably 1 to 2%.
Any possible seizure would probably be focal in nature. By that I mean it would probably produce jerking of the right side of the body, with preservation of consciousness. Progression to loss of consciousness with such a seizure is an unlikely possibility.

19. Dr Michael Drane, another of CASA’s senior medical officers, alerted Dr Adams to an article in the journal Stroke.[1] In his letter to Dr Adams of 25 August 2014, Dr Drane said:

In your assessment, you made some comments about the likelihood of a recurrence. I note your comments about the uncertainty surrounding the underlying reason for this, and there was no clear cause identified.
In trying to determine the ongoing risk, the paper by Zia et al (2009) which I have attached seems to be relevant. It is based on a prospective population study, following the clinical course for 3 years. Earlier papers report an initial high mortality rate, mainly in the first few months, reducing over time. Zia et al extend their surveillance for an additional year, and two main conclusions seem to emerge.
Firstly, that while the mortality does seem to drop over the first two years, it accelerates after that. Secondly, when reading off the survival curve for the time covering the period when Mr Daw seeks aviation medical certification, the annualised mortality risk approximates to 6%. This is well outside the acceptable parameters for commercial flying.
There may be factors which I have not considered, or an error in my interpretation. Please could you enlarge on your comments in the light of these data, in order that I can finalise this reconsideration for Mr Daw.

20. Dr Adams responded in a letter dated 6 September 2014. He said:

In summary, I don’t have any grounds for strong disagreement to do with anything in the article or what you’ve included in your letter to me. However, Mr Dawes’ (sic) haemorrhage was very unusual and very difficult to fit into any neat category and hence made a really strong prognostic statement.

21. CASA pointed out in its final submissions that Dr Adams only assessed the risk of seizure, not haemorrhage. CASA says the risk of seizure at 1-2% is unacceptably high.

22. Dr Warren Harrex prepared an opinion based on a file review on 14 August 2014. He noted the history of the intracerebral haemorrhage and the hypertension for which Mr Daw takes the medication Caduet. Dr Harrex considered Dr Adams’s report of 14 July 2014 but did not see Dr Adams’s later response to Dr Drane’s letter and the literature review. Dr Harrex wrote:

The evidence in the literature suggests risk of recurrence is very low and both ICH and seizure risk less that (sic) 2% per annum. This supports the advice provided by Dr Adams. Probably the most important clinical finding for aeromedical disposition (in the absence of further episodes) is the BP control.
Young age, minimal risk factors, good control of BP, no residual disability, no new symptoms for > 18 months, risk < 2% per annum. If does develop recurrence, likely to be focal with no loss of consciousness (Dr Adams).
I recommend Class 1 WSP. Would like review to include regular BP recordings, rather than just at renewal medical.

23. CASA pointed out in its final submissions that Dr Harrex was a general practitioner. CASA said we ought to prefer the evidence of a neurologist.

24. CASA requested a file review by Dr John Cameron, a consultant neurologist. Dr Cameron was provided with a number of papers related to assessing risk after cerebrovascular accidents especially further occurrence and seizures.[2] His report is dated 10 June 2015. He opined (at p 5):

Overall it would appear from these large studies that people who have suffered a spontaneous intracerebral haemorrhage have a shortened life prognosis and also a risk of developing recurrent haemorrhage and other cerebral vascular events.
It is always difficult to apply one person to these studies such as in Mr Daw’s presentation. He is a younger man who had a small intracerebral haemorrhage in an unusual site for an intracerebral haemorrhage.
He may not strictly be typical of the cohorts in the above-quoted groups. Nevertheless he is in middle age, he has suffered a spontaneous intracerebral haemorrhage and it appears that he has a past history of hypertension and hypercholesterolemia. In view of his history, risk factors and age I believe one could quite reasonably assume that he has an increased risk of mortality and increased risk of recurrence of intracerebral haemorrhage compared to the general population;
and at page 8:
His risk of seizure activity is certainly above that of the general population for at least the next 3 years. This in itself is a preclusion involving a Class 1 or Class 2 licence.

25. In his oral evidence, Dr Cameron said if Mr Daw had a seizure during vulnerable times of a flight (for example, during take-off or landing) there was a risk of catastrophe. He disagreed with Dr Adams’s suggestion in his report dated 14 July 2014 that the presence of a co-pilot would circumvent this problem. Dr Cameron said a co-pilot might not pick up a seizure if it manifested itself in only disturbed consciousness or inappropriate motor activity rather than the more obvious tonic-clonic movements of a generalized seizure. Dr Cameron also drew attention to Mr Daw’s hypertension. Dr Cameron identified that as a risk factor for another cerebrovascular accident.

26. Mr Daw produced a letter from his nephrologist, Dr Simon Fleming, dated 11 August 2015 stating Mr Daw was on antihypertensive medication to protect his remaining kidney after he donated the other one. Mr Daw suggested the medication was prophylactic in the sense he took it as a precaution against damage to his remaining kidney should he develop blood pressure. He denied being prescribed the medication because he already had hypertension. We note Dr Harrex referred to hypertension medication in his report of 14 August 2014 when he emphasised the importance of controlling Mr Daw’s blood pressure. Dr Cameron pointed to medical evidence indicating the antihypertensive medication was not just prophylactic. He noted Dr Adams took a blood pressure reading of 140/90. He also noted there was a routine histological examination of Mr Daw’s donated kidney that showed arteriosclerotic changes consistent with already existing hypertension.

27. Dr Cameron reiterated there were a number of factors in Mr Daw’s case that significantly elevate the risk of another cerebrovascular accident. These include:

1. • hypertension (a particular risk when the applicant only has one kidney);
     
   • hypercholesterolemia;
     
   • Mr Daw’s age (he is 53); and
     
   • the fact Mr Daw has already had one episode of an intracerebral bleed.
     

28. Mr Daw represented himself at the hearing. He asked Dr Cameron during cross-examination to consider the possibility that the intracerebral haemorrhage was from a singular small arteriovenous malformation. If that were the case, Mr Daw argued he was being unnecessarily restricted as the single arteriovenous malformation was now gone.

29. Dr Cameron agreed with Mr Daw that the cause of Mr Daw’s intracerebral haemorrhage was uncertain and there was a possibility that it was caused by such a singular arteriovenous malformation which was obliterated by the cerebrovascular accident. But even if this was the actual cause of the 2013 incident, other risk factors remained such as Mr Daw’s age, hypertension, hypercholesterolemia and evidence of pathology in his vascular system. Dr Cameron suggested there is still an elevated risk of cerebrovascular accidents.

30. Dr Cameron acknowledged that assessing Mr Daw’s individual situation in comparison to the populations cited in the journal articles was not easy. He conceded that many of the studies used by CASA were based on much older patients. However, he said that all the studies cited showed that if a person has one intracerebral bleed there is an increased risk of further bleeds.

31. Dr Cameron also noted that in studies of seizures occurring after an intracerebral haemorrhage the maximum first time was in the first 3 years and then the risk falls. But the location of Mr Daw’s intracerebral haemorrhage in the subcortical/cortical area put him at increased risk. The reason for this is that the presence of haemosiderin (which is a breakdown product of blood) particularly in the cortical or subcritical area of the brain made seizures more likely.

32. Dr Cameron also considered a proposition raised by Mr Daw that pilots are trained to cope with a medical emergency of a co-pilot in the cockpit. Dr Cameron agreed there was such training but also emphasised a debilitated commercial pilot in the cockpit could have catastrophic consequences, particularly if an incident occurred at the most vulnerable times in a flight such as take-off or landing.

33. Dr Cameron is a well-credentialed and experienced neurologist with an interest in aviation medicine. He has also held a commercial pilot’s licence and has experience of the demands of flying. He is well-placed to make a risk assessment. We prefer his opinion on that basis. He considered the risk of seizure and the risk of haemorrhage. In his considered view, Mr Daw’s medical risk exceeded the safety risk profile for aviation medicine in Australia. His view is consistent with that expressed by Dr Clem who assessed the risk of seizure at 2% and the risk of haemorrhage at 2-3%.

The likelihood of endangering air safety

34. Once it is accepted the applicant does not meet the medical standards for a Class 1 or Class 2 medical certificate – and we are satisfied he does not – it becomes necessary to focus on “the extent to which he or she does not meet the standard” and ask if that is “likely to endanger the safety of air navigation”. The key word in that tortured provision is “likely”. What does it mean in this context?

35. It should be said at once there is a very low risk that Mr Daw would experience another cerebrovascular accident while at the controls of a passenger aircraft. But the evidence of Dr Cameron and Dr Clem establish that he is more likely to experience such an event given his history.

36. Dr Clem explained how the “1%” rule came to be adopted by CASA. CASA pointed out it was accepted as a useful guide in Hazelton and  Civil Aviation Safety Authority  [2010] AATA 693. CASA urged that we should take it into account in this case.

37. We agree that the so-called “1% rule” is useful when making assessments of what is “likely to endanger the safety of air navigation” – although it can only ever be a guide. Dr Clem acknowledged that numerical criteria were useful but added (exhibit 2 at [30]):

...the ultimate decision is made on the basis of a judgment as to whether there is a real and substantial (and not trivial) risk to the safety of air navigation.

38.We accept that approach to CASR 67.180(2)(e)(ii) is consistent with the legislative scheme that includes provisions like s 9A(1) of the Act. That provision instructs CASA to “regard the safety of air navigation as the most important consideration”.

39. We are satisfied, in particular on the basis of the evidence provided by Dr Cameron, that issuing a Class 1 or Class 2 medical certificate to the applicant in light of his failure to meet the medical standards is likely to endanger the safety of air navigation given the non-trivial risk of him experiencing a further cerebrovascular accident. We are not satisfied it is possible to devise conditions that would acceptably ameliorate the risk: none were suggested, apart from the applicant’s concession that he would work only as a co-pilot rather than as pilot-in-command.

Conclusion

40. The decision under review is affirmed.

On second thoughts I definitely get the creepy feeling that the Empire is stealthily but surely striking back..
MTF..P2

Ps A note to Doc Drano & his motley crew of Hoodoo Voodoo cyberdocs who have so obviously lost touch with their physical patients, courtesy Dr Rob Liddell from his submission to the ASRR review.. : Dr Robert Liddell PDF: 108 KB

..The dangerous result of CASA’s draconian regulatory measures is that now many pilots tell CASA as little as possible about any medical problems in order to protect themselves from expensive and repetitive investigations or possible loss of certification . Most pilots are responsible people and they have no desire to be in charge of an aircraft if their risk of incapacity is unacceptable. When their DAME and their specialist believe they meet the risk target for certification without endless further testing demanded by CASA and the advice of their own specialist is ignored by the regulator then the pilot’s lose confidence in the regulator.


In medical certification CASA appears to have lost sight of the fact that all pilots self-certify themselves fit to fly every day they take control of an aircraft. The only day in the year when a doctor has any control over their fitness to fly is the day that they have their medical examination.


Dr Robert Liddell

  

Merry Xmas & lets hope for ASRR reform progress free from CASA persecution & discrimination...

MTF...P2