New deals for drugs: No heart attack or your money back
'Hugely expensive' cholesterol drug prescribed on NHS does not prevent fatal heart attacks or strokes, say experts
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survival chances for patients with heart disease and should be withdrawn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.
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”.
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.
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.
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.
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.
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.
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