MMA reaffirms its position on EECP

Maldivian Medical Association is greatly disappointed by the behavior and lack of any social responsibility shown by certain business enterprises involved in the health sector. From 28 March 2008 our web site has carried concerns regarding the clearly false and misleading statements contained in the leaflets distributed by the newly sanctioned clinic IMDC. Though the group chose to ignore these concerns, once the same concerns were raised in a public forum on 3rd April 2008 the representatives of the clinic chose to hastily attempt to demonize and discredit the medical community rather than recant the false claims. Though profits are expected to be high on priorities of any business enterprise the response seen is totally unbecoming of any group even remotely involved in matters dealing with health.

Representatives of IMDC have not only chosen to show utter disregard to the context and spirit of the statements made by MMA but also to the content. While we maintain that we are not an association conducting medical research our statements and findings reflect the current scientific knowledge base attaining consensus rather than conclusions of isolated studies. Hence we standby our observation that certain statements published and distributed by IMDC in their effort to promote EECP is both misleading and false. Here we present only some evidence for it but would like to invite all concerned to read our position statement number 02/08 dated 27 March 2008 before approaching us for more details.

IMDC Leaflet: Page 1, last sentence (in reference to EECP):
“The most advance and FDA approved treatment for heart patients”

1. American Heart Association/ American College of Cardiology: (ACC/AHA/SCAI) Practice guidelines, Circulation, 2006;113;e166-e286, February 21, 2006 states:
In patients with refractory angina who have no vessels suited for revascularization, a number of new therapies are being tested. Enhanced external counterpulsation (EECP) appears to decrease symptoms.

2. ACC/AHA guidelines for the management of patients with unstable angina and non–ST-segment elevation myocardial infarction
Other less extensively studied techniques for the relief of ischemia, such as spinal cord stimulation and prolonged external counterpulsation, are under evaluation.

3. Ontario Health Technology Advisory Committee, OHTAC, Literature Review of Enhanced External Counterpulsation
Completed February 2003
Updated March 2006
Very recently, investigation began into EECP as an adjunctive treatment for patients with HF. Anecdotal reports suggested that EECP may benefit patients with coronary disease and left ventricular dysfunction. The safety and effectiveness of EECP in patients with symptomatic heart failure and coronary disease and its role in patients with nonischemic heart failure secondary to LV dysfunction is unclear. Furthermore, the safety and effectiveness of EECP in the different stages of HF and whether it is only for patients who are refractive to pharmacotherapy is unknown.

4. 2005 ACC/AHA guideline update for the diagnosis and management of chronic heart failure
Until more data are available, routine use of this therapy cannot be recommended for the management of patients with symptomatic reduced LVEF.

Maldivian Medical Association observes: These statements by independent authorities in cardiology clearly shows the actual standing of EECP in the scientific community. It is indeed very different from the assertion that this was the most advanced therapy for cardiac patients. The role of EECP in cardiac care is currently just being evaluated and tested according to American College of Cardiology (ACC) and American Heart Association (AHA) and many other non profit professional organizations, and in such a situation it is definitely unethical and misleading to promote it to the public in this manner.

IMDC Leaflet: Page 4, Line 18 (in reference to EECP):
“EECP has numerous distinct advantages over surgery.”

1. Technology Evaluation Center (TEC), USA, External Counterpulsation for Treatment of Chronic Stable Angina Pectoris and Chronic Heart Failure, Assessment Program, Volume 20, No. 12, January 2006
The available evidence does not permit conclusions regarding the effect of ECP therapy on health outcomes or compared with alternatives. … It has not yet been demonstrated whether ECP therapy improves health outcomes in the investigational setting. Therefore, it cannot be demonstrated whether improvement is attainable outside the investigational settings.

2. Heart. 2003 August; 89(8): 830–833
At present, EECP use should be limited to patients with debilitating (functional class III and IV) refractory angina pectoris who are not candidates for revascularisation, are symptomatic despite being on maximal antianginal pharmacotherapy, and have no contraindications to EECP use.

Maldivian Medical Association observes: Here the Technical Evaluation Center, USA after much review of literature clearly states that the there is not enough evidence to compare EECP to other modalities whereas the IMD clinic has not only compared EECP to bypass surgery but are boasting of advantages over surgery thus unduly promoting it. As the authoritative academic journal “Heart” asserts, EECP should only be considered when bypass surgery (one form of revascularization) cannot be done. Thus to compare this second choice option to the primary therapy is misleading and has no evidence behind it.

IMDC Leaflet: Page 4, Line 24 (in reference to EECP):
“No side effects.”

1. Journal of the American College of Cardiology
Volume 33, Issue 7, June 1999, Pages 1833-1840, The multicenter study of enhanced external counterpulsation (MUST-EECP)
Exercise duration data were available for 57 subjects in the active-CP and 58 in the inactive-CP group. Fourteen subjects in active CP were not evaluable for exercise duration: four had protocol violations, seven (ie. 12.3%!) withdrew because of adverse experiences and three dropped out for personal reasons

2. Heart. 2003 August; 89(8): 830–833
The rate of adverse experiences was 4%. The placebo effect of the device can not be ruled out, as this report is from a cohort study.

3. Journal of the American College of Cardiology
Volume 33, Issue 7, June 1999, Pages 1833-1840, The multicenter study of enhanced external counterpulsation (MUST-EECP)
More patients in the active-CP group reported adverse events than in the inactive-CP group: 39 (55%) versus 17 (26%), p < 0.001. Ten of the 25 events reported by the 17 patients in the inactive-CP group were considered device-related, involving either the skin, lower legs or back.

4. Heart. 2003 August; 89(8): 830–833
Compared with patients without heart failure, significantly fewer patients with a history of heart failure completed the course of EECP and exacerbation of heart failure was more frequent in them.

5. Heart. 2003 August; 89(8): 830–833
At six months, (after EECP) patients with history of heart failure, although maintaining their reduction in angina, were significantly more likely to have experienced a major adverse cardiac event.

6. European Society of Cardiology, E-journal of Cardiology, Volume 3, 2004
EECP has not been associated with life-threatening complications; however, some bothering side effects may occur during treatment, including leg or back pain, skin abrasion or edema, headache, dizziness, epistaxis and respiratory discomfort.

Maldivian Medical Association observes: These evidence clearly shows that the claim to ‘no side effects’ is entirely false and baseless. It is also inconceivable that the clinic while preparing the promotional leaflet was not aware of this fact as we have quoted from major American, European authorities as well as from the only randomized major study (MUST EECP) done on EECP.

IMDC Leaflet: Page 4, Line 22 (in reference to EECP under “Advantages over surgery”):
“No additional medication.”
Maldivian Medical Association comments: Since after surgery it’s only the current medication that is continued (it is expected that all concerned are aware of this medical fact) this statement can only be in reference to the same medication. And as it alludes to a difference between surgery patients and patients undergoing EECP the only logical conclusion is a difference in medication between a post surgical patient and post EECP patient. Hence despite a sentence within the same document to the contrary (highlighted by the group in public) this is an untenable misleading claim still existing in the promotional leaflet.

It is hoped that this time rather than taking issue with professional bodies including the AHA and ACCP (which it is hoped even the clinic’s representatives recognize as leading professional authorities in Cardiology) the clinic named IMDC will exert efforts to promptly discontinue the use of misleading and false medical statements in their promotional material.

However the initial response by the clinic and its representatives of not correcting its misleading claims but rather targeting those who brought the subject to public notice is evidence to the fact that the claims were not an oversight but a deliberate attempt to dupe the public. This testified intention to continue aggressively in this path with no regard to other considerations is a greatly disturbing attitude which is intolerable in health sector whatever is the background of the involved party/parties. While this association does not consider it its job to question the integrity, whether professional or not, of such groups we do openly question the intentions of the said group.

The fact that many a cardiac patient not only gets referred for EECP wrongfully but indeed gets the procedure done while being prime candidates for bypass surgery is a sad truth we unfortunately have to see very frequently in Maldivian patients. And it gives us no pleasure to note that some of these patients have subsequently suffered repeat infarctions (heart attacks) which we can safely presume a prior CABG could have helped prevent. Thus when the same procedure, which in reality is a medical fall back option, is launched here with promotional claims which are not fully truthful we are justified in bringing to the public the fact that people do wrongfully get referred for EECP. The association cannot be held responsible for losses in profits incurred due to a sensitized and informed public.

While, as we noted in our press conference, some standard research and service institutions do offer EECP in accordance with current guidelines, as a last resort when nothing else is possible, these hospitals do not advertise it as the most advanced care for cardiac patients or claim it has nil side effects. Thus rather than comparing the Maldivian clinic to these reputed centers where the standard options are also readily available, it is strongly advised that IMDC take steps to ensure it does not become just another center where Maldivian cardiac patients are exploited. This association has no material benefit or loss linked to business of clinics and thus whatever statements we issue is done in the interest of the general public only. And we do not give any weight to arguments such as ‘this many people/clinics agree with us’ when giving an opinion which should be based on study of hard medical evidence.

We would also like to categorically state here that despite the wishes of some investors this association will not act as an advisor to business ventures in health sector, and thus will not approach any investors with advice regarding how to conduct themselves. But it is expected that certain standards will be adhered to by such enterprises and in case there is disregard to these and it comes to the notice of this association we will not hesitate to bring it to the notice of the responsible authorities and ultimately to the public.

We reiterate that despite all efforts to thwart us, the Maldivian Medical Association will continue to take up such issues and where the rights of patients are trampled upon, consideration will not be given to the profits of any investing party. Thus all are advised to stick to good practice and ethical standards while advertising/promoting as well as while practicing.