Mon, Sep-02-19, 11:34
We need a Parliamentary inquiry to push for the raw data on statins and their effects
Transparency and raw data is needed to show us who really benefits from taking statins, and what side effects they can have
Dr Asseem Malhotra
It’s been almost 35 years since scientists Michael S. Brown and Joseph L. Goldstein won the Nobel Prize for discovering how blood cholesterol played a central role in the development of heart disease. It was their work that led to the pharmaceutical industry developing statins.
Statins are drugs that lower cholesterol, and they both reduced heart attacks, and extended lifespan, within a few years of prescription. In 1996, Goldstein and Brown confidently predicted the end of heart disease as a major public health problem before the beginning of the 21st century.
However, their prophecy was never fulfilled. On the contrary, the decades-long campaign to lower cholesterol through diet and drugs has completely and utterly failed to curb the global pandemic of heart disease. Indeed, heart disease still remains the biggest killer in the Western world and the UK has recently seen a rise in death rates from the condition for the first time in 50 years.
It is still little known or understood amongst the wider medical community that insulin resistance, linked to excess body fat, is the most important risk factor for heart attacks. It is also a clear sign of impending type two diabetes. A disease which costs the NHS £10 billion annually.
The good news is insulin resistance can be effectively combatted through a combination of dietary changes, moderate activity and psychological stress reduction.
My patient’s experience
A few weeks ago, an alarmed and confused patient in his late forties, who I shall call Mr Smith, came to see me for a consultation. Four years earlier, he suffered a heart attack where severe blockages were found in his right coronary artery. These were opened up and kept open with metal stents.
He was prescribed atorvastatin, which is standard practice for heart attack patients regardless of cholesterol levels. After starting on atorvastatin, he began experiencing severe muscle pain on exercise. His symptoms disappeared within a week of stopping the drug.
As an alternative to his statin, he decided to adopt an ultra-low fat vegan diet which he believed may halt or even reverse heart disease through lowering cholesterol. Within months he dropped his total cholesterol from 5.2mmol/L to 3.2, now placing his levels in the bottom five per cent of the population.
Despite sticking religiously to the diet, he began to develop chest pain when he did exercise, and a repeat heart scan showed a 70 per cent blockage in another artery. One that had been completely clear four years before. “How is this possible?” he asked me, clearly upset. “How could I develop more heart disease in such a short space of time with such low cholesterol?” His case was not unusual, nor inexplicable.
It was clear that Mr Smith had not addressed 20 years of very high-stress levels that preceded his heart attack, and still continued. He described the level of stress as eight on a scale of zero to 10. I suggested mindfulness meditation and a low refined carbohydrate Mediterranean diet. He ended up looking forward to ditching the supplements he needed to take for his nutrient-deficient vegan diet and eating fish and eggs again.
There is still controversy about the true rate of side effects from statins because independent researchers have been unable to access the raw data from statin trials. This is a crucial part of solving the statin and cholesterol puzzle, as it is with all drugs.
In 2014, a Cochrane review concluded the UK had wasted almost half a billion pounds in stockpiling a flu treatment, Tamiflu. Academics from the Cochrane Collaboration analysed tens of thousands of pages of patient data from drug company Roche. Having eventually been allowed access to this raw data, they found the drug to be no more effective than paracetamol. However, they highlighted worrying side effects in some people taking it to prevent flu, such as kidney problems.
Rather than accept the need for greater scrutiny, highly influential cardiologists are attacking those who question the benefits of statins. Those who believed that side effects are much more prevalent are denounced as peddlers of “fake news” or “fake science”. They are compared to “anti-vaxxers”. One Cardiologist, Ann Marie Navar, even wrote in a recent editorial in JAMA Cardiology that inappropriate fears about statin side effects are coming from social media wellness bloggers and that “the number of lives lost to inadequate prevention owing to inappropriate concerns about statins could number in the millions”, but this is not evidence-based. The side effect literature and remarkably high discontinuation rate come from very credible sources.
The largest statin survey in the United States, last updated in 2014, found 75 per cent of those prescribed the medication stop it within a year of prescription with 62 per cent of those stating side effects as the reason. Even as far back as 2002, when there was no social media or public awareness of statin side effects, a paper in JAMA of more than 40,000 patients found 60 per cent of heart attack patients aged over 65 will stop the drug within two years.
In 2015, the American College of Cardiology published an article online entitled “statin intolerance, not a myth” estimating a true side effect rate of up to 15 per cent.
In addition to explaining that more than 300 drugs are known to interact with statins, the authors stated physicians should be aware of the most common risk factors associated with statin intolerance. These included being on higher doses, being aged over 70, being female, having Vitamin D deficiency, kidney and liver disease, alcohol abuse, Asian ethnicity, low body mass index, genetic predisposition and excessive physical activity.
So how effective are statins in preventing and treating heart disease? When one removes the industry funded PR and hype, the results appear pretty underwhelming.
In 2015, new research published in BMJ Open found that despite tens of millions more people being prescribed statins across many European countries, there was no evidence that this had any effect on cardiovascular mortality over a 12-year period.
If you strip down the statin trials to their moving parts, the data actually reveals that, even in those who have established heart disease, the benefits are very small. Even in this high-risk group, the average increase in life expectancy from taking the drug religiously for five years is a meagre four days, according to an analysis of randomised trials.
When you combine this with data suggesting more than 50 per cent simply stop taking the medication within two years, it’s easy to explain why there has been no discernible population benefit.
Some highly credible researchers even question whether there is any genuine benefit of statin drugs in those who already have heart disease. Eminent French Cardiologist Professor Michel De-Lorgeril, points out that since more stringent regulations on reporting of clinical trials were introduced in 2006 only one statin has been tested in clinical trials. It demonstrated no benefit at all in four trials, and these included a significant number of patients with established heart disease.
Professor Luis Correia, Cardiologist, and the director of the Centre for Evidence-Based Medicine at the Medical School of Bahia in Brazil told me: “It would be of great benefit to do an independent of industry re-trial of statins in heart attack patients to see what the benefits truly are – if any.”
Sir Richard Thompson, former President of the Royal College of Physicians, said: “In my view, these conflicts of interest and the true incidence of side effects from statins need to be fully and publicly investigated.”
John Abramson, an expert in pharmaceutical litigation and a lecturer at Harvard Medical Scool, told me: “Doctors and patients are having to engage in shared decision making on whether a statin should be prescribed on biased and selected data which itself is non-transparent. It’s not just bad science, it’s ethically dubious too.”
We continue to have an epidemic of misinformed doctors and misinformed and unwittingly deceived patients. In large part, this has been driven by a multi-billion-dollar food and drug industry that profits from the fear of cholesterol.
It’s now time for a full public parliamentary inquiry to push for the raw data on statins to find out who really benefits, and to determine who has been manipulating and hiding data on debilitating side effects. Until then it’s better we focus healthcare resources on tackling the real root cause of heart disease through prioritising lifestyle changes.
Dr Aseem Malhotra is an NHS Consultant Cardiologist and Professor of Evidence Based Medicine