The Hon Tanya Plibersek MP, Minister for Health
House of Representatives
Parliament House
Canberra ACT 2600
Dear Minister,
In response to the recent decision by the Health Minister to fund Botox treatment for axillary hyperhidrosis we have been prompted to submit this petition.
We would like to bring to your attention that palmar, facial, pedal and severe compensatory hyperhidrosis can have a negative social effect on a person’s life. Due to its high cost, Botox treatment is not accessible to many patients in Australia. We would like to petition for extended funding for Botox treatment for these conditions, rather than the current surgical treatments such as Endoscopic Thoracic Sympathectomy (ETS).
ETS has many common and undisclosed side-effects, including severe compensatory hyperhidrosis as found in reviews by FinOHTA [1] and 'ASERNIP-S' [2] . We wish to argue that the Medical Benefit Scheme (MBS) listing for ETS should be immediately suspended and urgently reviewed according to the strict guidelines set out by the Medical Services Advisory Committee (MSAC).
The level of endorsement (MBS listing) might impact on how the procedure is perceived by the public.
The recent MBS listing for Botox for axillary hyperhidrosis treatment sets out clear conditions and restrictions on its availability. There are no such conditions set out for the availability of the irreversible neurosurgical procedure, ETS.
We trust that decisions regarding funding are based on best available evidence regarding safety, effectiveness and cost effectiveness - and in this order. Available evidence however, cannot, and does not support the use of ETS as a safe procedure, and MSAC has never evaluated it.
In consideration of the provided supporting evidence, we hereby ask the Health Minister to:
Remove funding for Endoscopic Thoracic Sympathectomy and review the availability of this procedure, and the public’s exposure to it (including advertising, and infomercials), due to lack of reliable supporting evidence, and reports of adverse effects from the literature.
Extend funding for less harmful procedures (Botox and Ionthoporesis) for people with palmar, facial, pedal and severe compensatory hyperhidrosis. Patients with hyperhidrosis (and blushing) are evaluated by thoracic, vascular, general surgeons, with no training in treating or evaluating these conditions, nor in the field of Autonomic Nervous System (ANS). Patients should be evaluated and treated by specialists who are qualified to assess and treat these conditions (psychologists, dermatologists, neurologists).
Specify the alternative treatments patients have to trial before being able to undergo ETS - with sufficient funding, and time for these treatments to prove effectiveness.
Provide comprehensive and uniform information to all patients (including the internet) that describe the nature and consequences of this procedure, the foreseeability of complications, and recurrence, all based on high level evidence.
Clinical decision making can be tainted by bias, especially in the context of entrepreneurial medicine and elective procedures. Information provided to patients, especially in this setting can fall short of accepted standards of ‘informed consent’.
We look forward to your assistance in ensuring all Australians have a right to a fair medical system, where all surgical procedures have an objective trial, supporting evidence regarding safety, and alternative treatments are offered at a reasonable cost.
Sincerely yours,
[1] http://finohta.stakes.fi/NR/rdonlyres/A4F5CFC3-A6B4-43F5-8E2A-49689F3B7980/0/r026f.pdf
[2] http://www.surgeons.org/media/17412/RPT_2009-09-10_Evidence_essential_ETS.pdf
T(2)-T(3) ganglionectomy significantly decreases pulse rate and systolic blood pressure, reduces myocardial oxygen demand, increases left ventricular ejection fraction and prolongs Q-T interval. A certain loss of lung volume and decrease of pulmonary diffusion capacity for CO result from sympathectomy.
Histomorphological muscle changes and neuro-histochemical and biochemical effects have also been observed.
Clin Auton Res. 2003 Dec;13 Suppl 1:I40-4.
http://www.ncbi.nlm.nih.gov/pubmed/14673672
Several reports also demonstrate significantly lower heart rate increases during exercise in subjects who have undergone bilateral ISS [9–12] compared to pre-surgical levels. In spite of this high occurrence, recent reviews on the usual collateral effects of thoracic sympathectomy still do not include these possible cardiac consequences [6].
Eur J Cardiothorac Surg 2001;20:1095-1100
http://www.sciencedirect.com/science/article/pii/S1010794001010028
The results of endoscopic sympathectomy deteriorate progressively from the immediate outcome
British Journal of Surgery ISSN 0007-1323 1999, vol. 86, no1, pp. 45-47 (12 ref.)
Australian Review of ETS surgery, 2009
"A lack of high quality randomised trial evidence on ETS means that it is difficult to make a judgment on the safety and effectiveness of this technique. There is potentially a number of safety issues associated with this procedure. ASERNIP-s suggests that a full systematic review including all available comparative and case series information, together with clinical inpuut, should be undertaken to provide up-to-date and comprehensive assessment of the safety and effectiveness of ETS." (ASERNIP-s Report No. 71, August 2009)
Australian Review of ETS surgery, 2001
The four case series were not critically appraised because they are prone to bias and have significant methodological problems. These studies represent level IV evidence according to the NHMRC criteria and one should not draw firm conclusions from their findings.
To date, the benefits or side effects associated with endoscopic thoracic sympathectomy for treating facial blushing have not been properly evaluated and reported.
Further research using a well-designed controlled trial is warranted to assess the efficacy of endoscopic thoracic sympathectomy for treating facial blushing.
Centre for Clinical Effectiveness - Monash
Swedish Review, 1999, 2002
The findings by SBU Alert show that poor* evidence is available about ETS as regards side effects, risks, and short-term effects. There is no* scientific evidence demonstrating the long-term results of the method or its cost effectiveness in relation to other methods.
(Swedish Council on Technology Assessment in Health Care (SBU), the Medical Products Agency, the National Board of Health and Welfare, and the Federation of Swedish County Councils.
Published: 1999-08-30 Revised: 2002-09-30
Finnish Review, 2005
Conclusions: The evidence of the effectiveness of ETS is weak due to a lack of randomized trials. The intervention leads to severe immediate complications in some of the patients, and to persistent side-effects for many of the patients.
UniversityofOuluand FinnishOfficeforHealthTechnologyAssessment
FinnishOfficeforHealthTechnologyAssessment
UniversityofHelsinki and FinnishOfficeforHealthTechnologyAssessment
UniversityofCopenhagenand FinnishOfficeforHealthTechnologyAssessment
Cochrane Database Syst. Review, 2003
”The practice of surgical and chemical sympathectomy is based on poor quality evidence, uncontrolled studies and personal experience.“
Cochrane Database Syst Rev. 2003;(2):CD002918.
UK Review of ETS surgery, 2003
We did not identify any controlled trials or cohort studies. The evidence about effectiveness, based on three case series, was therefore very limited. The main weakness of these studies was their lack of a comparison group and their resulting inability to exclude a placebo response to surgery. In addition, the methods of assessing outcome were poorly described and not validated, and the range of outcomes assessed was limited. The studies provided very limited evidence that sympathectomy improves blushing. Side effects were common.
London: Bazian Ltd (Editors), Wessex Institute for Health Research and Development, University of Southampton 2003: 11
Wiley & Sons, Inc, news release, 2004
"Lifestyle" surgical procedure carries unrecognized risk of complications.”
Hoboken, NJ: John Wiley & Sons, Inc, British Journal of Surgery, Feb 5, 2004
"
Sympathectomy is a technique about which we have limited knowledge, applied to disorders about which we have little understanding." Harald Breivik Professor og avdelingsoverlege Anestesiavdelingen, Rikshospitalet
http://www.pfizer.no/templates/Page____886.aspx
M. Hashmonai, ISSS President
6th International Symposium on Sympathetic Surgery (ISSS) 4th -6th May 2005, Vienna Medical Academy, Austria
