Official guidance on new “breakthrough” cholesterol-lowering drugs to be offered to hundreds of thousands of NHS people should be reconsidered, according to a group of doctors concerned about how the decision was made. is.
They believe that the use of Incrisilane is recommended without the availability of clinical trial data for independent scrutiny. The National Institute for Health and Care Excellence (Nice) states that the drug can be a “game changer” to prevent heart attacks and strokes and recommends it to certain patients after consulting with a doctor or charity. bottom.
Incrisilane is injected twice a year into people with hypercholesterolemia who have previously had cardiovascular events, either alone or with statins and other cholesterol-lowering drugs, and another event occurs. You can reduce the chance of it happening.
According to the guidance of the UK Health Standards Agency, the manufacturer Novartis has proposed to administer inclisilane “by a nurse” in a primary care environment. In contrast, currently available cholesterol-lowering treatments such as alirocumab and evolocumab are usually prescribed in hospitals.
Maindelt Boysen, Deputy Chief Executive Officer of Nice, said last month:
“Therefore, we are pleased to recommend this as a cost-effective option for the NHS, backed by a groundbreaking deal between the NHS England and the NHS Improvement and Novartis. Mixed dyslipidemia caused will receive this drug over the next three years. ”
However, researchers, including Dublin-based general practitioner and professor of primary care medicine Susan Smith, argued that Nice recommendations were made for clinical trial data that were not available for independent scrutiny. ing. They state that the clinical importance of lowering LDL cholesterol (so-called “bad” cholesterol) in relation to cardiovascular risk remains “uncertain.”
In the BMJ editorial, they write: date. The drug may or may not prove to be a “game changer”. Clinicians and their patients need to be aware of the limits of evidence. “
Last month, a group of healthcare professionals, including former President of the Royal College of Physicians, Sir Richard Thompson, wrote an open letter to Nice and Chairman of Health Minister Sajid Javid, expressing concern about the recommendations. .. They said the lack of transparency by Nice in the decision-making process, lack of long-term data on efficacy and safety, and drug approval would result in the loss of expert confidence in Nice.
Dr. Aseem Malhotra, a cardiologist and co-signer, said: Overall evidence reveals that lowering LDL cholesterol is not clearly associated with prevention of heart attack, stroke or mortality and is certainly not good in association with very low levels of LDL cholesterol with increased mortality. I have.
“This unscientific obsession with lowering LDL cholesterol as the main focus of heart disease prevention and management should be stopped. Massive experiments over the last few decades have failed. Due to the great cholesterol scam. It’s time to stop falling. “
Nice said he followed the usual transparent process in creating guidance. This included “widespread involvement” with groups such as the Royal College of Physicals and Cholesterol Charity Heart UK.
A spokeswoman said: “The guidance acknowledges that there is no data to directly compare inclisilane with other lipids. [cholesterol] Although clinical trials are ongoing, there is still no long-term evidence of the effect of incrisilane on cardiovascular outcomes, reducing treatment.
“Despite these uncertainties, and due to the agreed discount on their price, Incresilan has previously experienced cardiovascular events and remains high in cholesterol levels after receiving lipid-lowering therapy. Is considered cost-effective in. “