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NHS wasting tens of thousands a year on ‘wonder’ drug for stroke and heart attacks which does not work, experts claim

http://www.telegraph.co.uk/news/201...-heart-attacks/

Quote:

A new “hugely expensive” cholesterol drug does not improve overall survival chances for patients with heart disease and should be withdrawn from use, experts have said.

A coalition of doctors last night called on patients to be told that evolocumab, which was hailed as a “game changer” and “better than statins”, does nothing to prevent fatal heart attacks and strokes.

Fresh analysis of data shows the injectable medicine is costing the NHS more than £645,000 for every minor heart attack or stroke it delays, however a trial conducted by Amgen, which manufacturers the drug under the name Repatha, also showed a higher death rate among those taking it than in the placebo patient group.

Amgen says the 5 per cent higher death rate, which is not technically “statistically significant”, is explained by the relatively short duration of the trial - 2.2 years - and that a longer study would have shown a survival benefit.

But campaigners argue it is precisely because the death rate was higher among Repatha patients that the trial was wound up early.

Rival pharma company Pfizer abandoned its trial of a similar PCSK9 inhibitor drug last year, conceding it was “not likely to provide value to patients”.

Dr John Abramson, an expert in healthcare at Harvard Medical School, said: “In terms of the effect of these drugs on UK citizens, there is no evidence on this data that there is a death benefit in people at high risk of cardiovascular disease. “I think people should know that - it’s a hugely expensive drug.”

The injectable medicine, which is prescribed for people with a high cholesterol for whom statins are not working, costs £4,400 per patient per year.

Unlike statins, which slow the production of cholesterol, drugs like evolocumab block a protein which hampers the liver's ability to clear cholesterol from the blood.

The Amgen-sponsored trial of 27,000 people found it could lower cholesterol by almost 60 per cent compared with existing treatments.

Despite this, the NHS, which was told it should provide evolocumab by the National Institute for Health and Care Excellence (NICE) last year, would have to treat 74 people for two years with the drug to delay a single stroke or heart attack. These could be very minor events.

Sir Richard Thompson, former President of the Royal College of Physician and physician to the Queen, said: “You have to contrast the enormous expense and the difficulty of injecting this medicine with an amazingly small benefit to patients.

“Is it really worth it?” Amgen said Repatha decreases low-density lipoprotein, or “bad”, cholesterol to “unprecedented low levels” and that there was a “well established relationship between LDL-C reduction and cardiovascular events”.

There is, however, a controversy over the extent to which LDL cholesterol contributes to cardiovascular ill health. One of those campaigning against the orthodox view of a causal link is NHS Consultant Cardiologist Dr Aseem Malhotra.

“NICE needs to urgently revise its recommendations on the prescription of the drug to include information that the drug will not prevent a fatal heart attack or increase a patient’s lifespan by one day,” he said.

British researcher Dr Zoe Harcombe said it would have been a “disaster” for Amgen if the trial had continued and the higher death rate among the evolocumab cohort had reached statistical significance.

As well as an absent mortality benefit, researchers have said that the Amgen trial, which used participants in a range of countries, showed evocolumab did not benefit the European patients.

Professor Sherif Sultan, President of the International Society of Vascular Surgeons, said there was “no evidence of benefit to UK patients”, describing the NICE guidelines as “crazy”.

However, a spokesman for Amgen disagreed, saying: “We remain confident that Repatha is a clinically effective and cost-effective treatment in the very high risk patient group stipulated by NICE."

A spokesman for NICE, which claims to enjoy an unspecified commercial discount from evolocumab, said the organisation could not comment because of the general election campaign.

Huh? what would a NICE comment on a drug have to do with the general election? It would save the NHS money..isn't that a good thing for either party?