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Friday 19 December 2014

New 'Game-Changing' Heart Drug. Or new threat to our health

Pulse announced today (19th December 2014) that a new 'game-changing' heart drug was to be fast-tracked through the drug approval system. The drug is called LCZ696 and is being developed by Novartis. It is a combination of two 'antihypertensive' drugs, Valsartan (Diovan), an 'angiotension II receptor blocker, and a new drug, Sacubitril, a 'neprilysis inhibitor'.

So, as with most conventional medical drugs, the purpose and function of the new drug is to 'block' and 'inhibit' bodily functions

As a result, I predict danger, and massive harm to the patients who will be given this drug, probably as soon as September 2015. But, of course, I could be wrong! This could be a first for the Big Pharma industry - a safe drug - that actually works.

But this is not the usual process. Normally, drugs are introduced by pharmaceutical companies as 'game-changing', and doctors, the NHS parrot these hopes, and the media comply with such assessments, without question. Then, reality begins to dawn!
  • Soon, 'side-effects' are noted. Then 'adverse reactions'. These are downplayed, balanced by some game of 'risk-benefit' analysis.
  • Then, when the harm the drug is causing becomes more obvious, drug regulators place them under restriction, and place 'black-box' warnings on the packaging. But the drug is too profitable, and doctors who have prescribed it are reluctant to admit that they may have damaged their patients. So it is kept on sale, and the suffering continues.
  • Then, the harm caused by the drug begins to clearly outweigh any possible benefits, which it has been found anyway, have been severely over-hyped.
  • So the drug is withdrawn, as quietly as possible. Or on some occasions, drug regulators will actually ban it.
I have described this process elsewhere. Will this new 'wonder drug' fit into this regular, too predictable pattern? I intend to follow and report on the progress of this drug on this blog over the next few years - so we will see!

But the signs are not good. Both drugs restrict, interfare and meddle with the normal functioning of the body. Fast-tracked drugs have had, in the past, an even worse record then those that go through the normal process. And Valsartan, one of the drugs used in this new combination, already has a record of serious 'disease-inducing effects'.

Valsartan (Diovan).
Shortness of breath, pounding heartbeat (or weak pulse and slow heart rate), fluttering in the chest, weakness, confusion, rapid weight gain, fainting, muscle weakness, headache, dizziness, flu symptoms, nausea, stomach pains, diarrhoea, back pain, blurred vision, skin rash - et al.

And as Wikipedia has already pointed out, tests on this new drug have already identified that the problems are likely to be similar to all antihypertensive drugs.

               "Common adverse effects the main study were cough, hyperkalemia (high potassium levels in the blood, which can be caused by valsartan), renal dysfunction, and hypotension (low blood pressure, a common side effect of antihypertensives). 12% of the patients withdrew from the study during the run-in phase because of such events."

Yet the European Medicines Agency (EMA) are happy to fast-track new drugs if "the medicine is expected to be of major public health interest particularly from the point of view of therapeutic innovation".
In the Pulse article it outlines what Novartis are saying about the new drug, prior to launch.
               "Treatment with LCZ696 was shown to significantly reduce cardiovascular deaths and heart failure hospitalisations when compared with 'gold-standard' treatment....." with other drugs.
Pulse report that 'GP experts' have told them that the "drug could be a ‘game changer’ in the management of heart failure, because it appears to be so much more effective than established treatments".

So LCZ696 is really something for us all to look forward to! It is already being proclaimed as another triumph for the conventional medical establishment, who cannot get it to us quickly enough! And naturally, nowhere in the article is anything mentioned about side-effects, adverse reactions, or disease inducing reactions to the drug!

So, just watch this space over the next few years, and we will see whether the hype of the conventional medical establishment, backed by Big Pharma funding, is correct. Or whether my more mundane prediction is more accurate!