So NICE and the National Obesity Forum have approved rimonabant Acomplia for use by NHS patients. UK. 24 June 2008. See article.
Why has the USA not approved it? because “On June 13, 2007, FDA’s Advisory Committee concluded that the French manufacturer Sanofi-Aventis failed to demonstrate the safety of rimonaban tand voted against recommending the anti-obesity treatment for approval” “The risk benefit ratio on the usage of Rimonabant is not yet established, so better alternates can be chosen.” See reference.
why has EU and the UK National Obesity Forum NOF given the nod to rimonabant but not the proven metformin? One need only look at the sponsors listed on the NOF website to guess- drug companies who all market anti-obesity wannabe drugs: Sanofi-Aventis, Abbott, Roche, Canderel.
It is the same with hypertension and lipidemia drugs: the most effective – metformin, nicotinic acid, and lowdose reserpine plus amiloretic- are not profitable, so despite their total safety and great efficacy in appropriate dose, big manufacturers will not pay for trials and marketing to promote them, so regulators and eg lipidemia / hypertension societies ignore if not delist them, as has happened to reserpine in UK, Europe and South Africa.
Why are Merck- Bristol-Myers Squibb not sponsors of NOF since they market the original Glucophage metformin?
Perhaps it is because this 85year old plant extract (developed in Scotland) is too successful, but out of patent: it is the only drug that has ever been tested in a double-blind randomized controlled trial RCT for 20 years, which in new overweight type 2 diabetics reduced all common major degenerative diseases and all-cause premature deaths by almost 40% (which no other patented drug does) without a single serious aderse effect- in fact it greatly reduces deaths from common lactic acidosis which is common in seriously ill older patients Similarly in three large RCTs in overweight non-diabetics (in USA, China and India), it halved the incidence of new diabetes. It’s primary purpose is to reduce appetite and insulin resistance and thus improving energy uptake into brain and muscle -and thus improve mood and exercise capacity, and reduce hypertension, lipidemia, cancer, vascular disease, arthritis and fat stores including in the liver.
Thus at any age it is the best drug for treating overweight and obesity, polycystic ovary syndrome PCOS, pregnancy overweight and pregnancy diabetes, type 2 diabetes, lipidemia, vascular disease and thrombosis risk. No other drug reduces obesity safely and sustainably by 20kg over 2 years as we have seen, and by 8% over 4 years as Glueck et al have reported, and halves all-cause mortality over 5 years in type 2 diabetes as it does in Canada.
Since some patients metabolize metformin very slowly and therefore do not tolerate average daily doses (500- >3500mg/day), metformin should simply be started at no more than about 125mg/day eg a quarter fragment of a small metformin tablet, and increased gradually to tolerance over weeks- which dose averages about 2500mg/day. Most trials eg the DPP in USA lost 25% of trialists at the outset because they ignored this obvious rule, starting foolishly at eg 500 and even 1000mg/day. As with any other chronic drug, the patient must be warned of signs of intolerance (which they should report promptly) -nausea, bloating, diarrhoea- on which they must promptly halve if not stop the drug till these symptoms settle then rebuild the dose to a well-tolerated level.
Thus nobody in their right mind would recommend or take any drug except metformin for increasing overweight or obesity let alone diabetes (even for the resistant overweight type 1 diabetic). Why use a drug like rimonabant with serious risk of hypertension, anxiety and depression when it is never required?
This is not to say that metformin is essential, since there are a thousand natura insulin-resistance and appetite- reducing natural nutritional microsupplements, out of which one can simply safely and cheaply combine a few dozen in one’s diet twice a day- fish oil, and most others in a powder blend. Naturally these are not patentable, hence they are against the interests of the big drug companies.
Perhaps the biggest fraud of all is to ignore prescription of metformin as an adjuvant to diet and lifestyle until the patient has sustained enormous damage in developing obesity and type 2 diabetes- with long experience that vascular, renal, lipidemia, eye and nervous system disease from this metabolic progression may occur well before obesity or diabetes become obvious. Why otherwise do we continue to see fat elderly patients worsening on glitazones, statins, sulphonylureas, and even highdose insulin? when all they need is optimal titration with metformin and the legion natural alternatives vailable.