Petition to the Health Minister - Australia: February 2012

Tuesday, February 21, 2012

Petition to the Health Minister - Australia, February 2012

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

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

"Sympathectomy is a technique about which we have limited knowledge, applied to disorders about which we have little understanding." Associate Professor Robert Boas, Faculty of Pain Medicine of the Australasian College of Anaesthetists and the Royal College of Anaesthetists http://www.pfizer.no/templates/Page____886.aspx

"This is a field in which the unknown is still substantial and some of the known - controversial." M. Hashmonai, ISSS President at the 6th International Symposium on Sympathetic Surgery (ISSS) 4th -6th May 2005, Vienna Medical Academy, Austria

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sympathectomy affects the heart, sweating, and circulation

heart rate was significantly reduced at rest (14%), at sub-maximal exercise (12.3%), and at peak exercise (5.7%), together with a significant increase in oxygen pulse (11.8, 12.7, and 7.8%, respectively). The rate pressure product (RPP) was also significantly reduced following the surgical procedure at all three study stages, while all other physiological variables measured remained unchanged. It is suggested that thoracic-sympathetic denervation affects the heart, sweating, and circulation of the respective denervated region

Eur J Appl Physiol. 2008 Sep;104(1):79-86. Epub 2008 Jun 10.

Acquired cardiovascular disease following Sympathectomy

We found statistically significant differences (P < .05) in both time and frequency domains. Parameters that evaluate global cardiac autonomic activity (total power, SD of normal R-R intervals, SD of average normal R-R intervals) and vagal activity (rhythm corresponding to percentage of normal R-R intervals with cycle greater than 50 ms relative to previous interval, square root of mean squared differences of successive normal R-R intervals, high-frequency power, high-frequency power in normalized units) were statistically significantly increased after sympathectomy. Low-frequency power in normalized units, reflecting sympathetic activity, was statistically significantly decreased after sympathectomy. Low-/high-frequency power ratio also showed a significant decrease, indicating relative decrease in sympathetic activity and increase in vagal activity.

The Journal of Thoracic and Cardiovascular Surgery
Volume 137, Issue 3, March 2009, Pages 664-669

Surgical and chemical sympathectomy can alter cellular proliferation

Surgical denervation and chemical sympathectomy can alter cellular proliferation, B- and T-cell responsiveness and lymphocyte migration in lymphoid organs [17].

In vitro studies have shown that neuropeptides can have numerous effects, either inhibiting or stimulating the proliferation, differentiation and functions of immune cells [19]* Development of systemic lupus erythematosus in mice is associated with alteration of neuropeptide concentrations in inﬂamed kidneys and immunoregulatory organs

Neuroscience Letters 248 (1998) 97– 100

Sympathectomy results in significant interference of regulatory processes of the body

"ESB (whether as ETS as ETSC or ELS) generally represents a substantial interference in regulatory processes of the body. Therefore decision for this operation requires that previously conservative treatments were made. An ESB is therefore at the end of a treatment history, and never at the beginning."

Dr. Christoph H. Schick, ETS surgeon, President of the International Society of Sympathetic Surgery (ISSS)

text has been translated by google from German

http://www.dhhz.de/index.php?page=8&subPage=&section=32

DYNAMIC CEREBRAL AUTOREGULATION IS ALTERED BY GANGLION BLOCKADE

After ganglion blockade, systolic and pulse pressure decreased significantly by 13% and 26%, respectively. CBF velocity decreased by 6% (P <0.05). In the very low frequency range (0.02 to 0.07 Hz), mean blood pressure variability decreased significantly (by 82%), while CBF velocity variability persisted. Thus, transfer function gain increased by 81%. In addition, the phase lead of CBF velocity to arterial pressure diminished. These changes in transfer function gain and phase persisted despite restoration of arterial pressure by infusion of phenylephrine and normalization of mean blood pressure variability by oscillatory lower body negative pressure.

Conclusions-: These data suggest that dynamic cerebral autoregulation is altered by ganglion blockade. We speculate that autonomic neural control of the cerebral circulation is tonically active and likely plays a significant role in the regulation of beat-to-beat CBF in humans.

Circulation. 106(14):1814-1820, October 1, 2002.

Muliptle organ failure as a consequence of elective sympathectomy

In the post-sympathectomy patient, the abnormalsympathetic skin response may lead to peripheral vascular failureor the reduced cardiac chronotropic response may impair thebody’s capacity to compensate for shock. These may havecontributed to the rapid development of shock and severe multipleorgan dysfunction syndrome in this patient.
He had multiple organ dysfunction syndrome develop, with severerenal and hepatic failure, grade II hepatic encephalopathy,and disseminated intravascular coagulation. He responded remarkablywell to aggressive supportive measures including forced alkalinediuresis, and he was eventually discharged home after 1 month. The patient was previously a healthy, physically fit, nonsmoker.He worked as a body building trainer and led an active, sportylifestyle. The only significant medical history was that hehad received thoracic sympathectomy for axillary hyperhidrosis4 years ago at another hospital.

http://ats.ctsnetjournals.org/cgi/content/full/84/3/1025

SYMPATHECTOMY MAY CONSTITUTE MALPRACTICE

Referring an anxious patient with palmar hyperhidrosis to surgery may constitute malpractice

"A surgical treatment for anxiety-triggered palmar hyperhidrosis is not unlike treating tearfulness in major depression by severing the nerves to the lacrimal glands."

"Referring an anxious patient with palmar hyperhidrosis to surgery without first completing a proper trial of psychotropic medication may constitute malpracticeespecially if the patient experiences some of the more severe surgical complications which can occur during sympathectomy" (Bracha et al. 2006 .

Br J Dermatol. 2006 Dec;155(6):1299-300.

Neuroma following nerve injury/surgery

When a nerve is cut, the piece of nerve that is beyond the cut point eventually dies, however, its Schwann cells, the cells that encircle the nerve fibers remain for a much longer time. These Schwann cells secrete a chemical messenger known as nerve growth factor that tells the cut end of nerve where to grow back. So the cut end of nerve will send out multiple sprouts in the direction of the nerve growth factor, however, these sprouts do not go out in an orderly manner, instead they grow out in all directions and eventually cluster and form a knot of nerve fibers. This eventually leads to the formation of a TRUE neuroma or a END BULB or STUMP neuroma.

www.tarsaltunnelcenter.com/assets/recurrent.shtml

our ignorance of the mechanisms of primary hyperhidrosis and of the effect of sympathetic ablation

Segmental myoclonus was associated with thoracic sympathectomy

Spinal myoclonus was associated with laminectomy, remote effect of cancer, spinal cord injury, post-operative pseudomeningocele, laparotomy, thoracic sympathectomy, poliomyelitis, herpes myelitis, lumbosacral radiculopathy, spinal extradural block, and myelopathy due to demyelination, electrical injury, acquired immunodeficiency syndrome, and cervical spondylosis.

http://www.ncbi.nlm.nih.gov/pubmed/3753263

Spinal myoclonus is typically associated with a localized area of damaged tissue (focal lesion). The injured area may include direct damage of the spinal cord or may cause abnormal changes in the function of the spinal cord.

http://www.wemove.org/myo/myo_pc.html

Spinal myoclonus following a peripheral nerve injury: a case report

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2526081/

autonomy is fundamentally inadequate in healthcare settings

Informed consent is one of the foundations of bioethical discourse. Bureaucrats have forced doctors and researchers to fill out endless forms in the belief that informed consent will enhance patients’ autonomy.

However, questions are being asked about whether this business of informed consent is really working. In an early online article in the Journal of Medical Ethics, Neil Levy, the Australian editor of another journal, Neuroethics, argues that bioethicists need to rethink informed consent.

Why? Because the lesson of all of modern psychology and of post-modern philosophy is that our rationality is terribly flawed. We are blind to the future consequences of our actions; we are not objective in assessing claims that touch us personally; we overestimate the effects of setbacks on our well-being; we are unreliable in estimating how bad or how good events made us feel. In short, human reasoning is subject to many fallibilities.

Somewhat surprisingly, Arthur Caplan, of the University of Pennsylvania, probably the best-known bioethicist in the US, agrees with Levy. In a companion article, he says:

“autonomy is fundamentally inadequate in healthcare settings and requires supplementation by experience-based paternalism on the part of doctors and healthcare providers…

“A large number of studies have shown that huge percentages of people who give their informed consent to treatment or to their involvement in research do not really understand what they have chosen. Autonomy lives with hope and hope, in the form of the therapeutic misconception, often trumps autonomy.”

Questioning informed consent shakes a pillar of modern bioethics and the call for more benevolent paternalism is sure to face stiff opposition.

http://www.bioedge.org/index.php/bioethics/bioethics_article/9979#comments

disparity between what is known in practice and what appears in the literature

The March 2004 edition was quite outstanding, with an excellent editorial reminding the reader that only good results are published. The review on thoracoscopic sympathectomy highlighted the disparity between what is known in practice and what appears in the literature.

‘Know Your Results’, the topic of the ASGBI Annual Scientific Meeting, is of outstanding importance; what is more, the surgeon has to go on knowing his/her results to ensure standards of practice do not slip.

The Journal appreciates comments and criticism and the correspondence column remains a crucial part of the BJS in its interaction between editors and reader. It is also part of the scientific process.

A more robust and incisive criticism of articles known to be flawed would prevent the retractions that have recently been published in the Lancet.

Christopher Russell, Chairman, BJS Society

Association of Surgeons of Great Britain and Ireland, ANNUAL REPORT 2004

The courts have become the sole policing body for the medical profession

Major lawsuits, with the major judgments that go with them, may not completely keep negligent physicians from practicing, but they are the one way that currently exists to deter these individuals from practicing their inept brand of medicine. "

Over the years, we have given a lot of thought to why the medical profession adheres to this code of silence. What is it about this profession that causes it to protect its own at the expense of the public?"

Harvey F. Wachsman: Lethal Medicine

Publisher: Henry Holt & Co

ignorance of the mechanisms for primary hyperhidrosis and of the effect of sympathetic ablation

"These observations further emphasize our ignorance of the mechanisms responsible for primary hyperhidrosis and of the effect of sympathetic ablation on the function of the remaining sympathetic system."

"Only investigators who deviate from accepted standards innovate and thus advance science. Obviously, such deviations may also result in disasters;"

Statement made by the former President of the International Society of Sympathetic Surgery, and ETS surgeon, Moshe Hashmonai (Invited Commentary) Endoscopic Lumbar Sympathectomy Following Thoracic Sympathectomy in Patients with Palmoplantar Hyperhidrosis World J Surg (2011) 35:54–55 DOI 10.1007/s00268-010-0809-5

Petition to the Health Minister - Australia

Tuesday, February 21, 2012