Do Statins Really Work? Who Benefits? Who Has the Power to Cover Up the Side Effects?

Corporate-influenced medicine favors the one-size-fits-all paradigm of care, a paradigm that disregards individual human differences, circumstances, and needs.

Why? I believe the answer is simple; because the one-size-fits-all is the cheapest most profitable paradigm to get the largest number of customers.

“A key drive for unreliable research: the greater the financial interest in a given field the greater the likelihood the research findings are to be false.” –Professor John Ioannidis

For decades, the medical establishment in the U.S., Canada, and the UK has promoted statin drugs for an ever increasing population. Concomitantly, public health officials have advocated a low fat high carbohydrate diet, and the replacement of saturated fat with polyunsaturated fats.

By following this regimen, the medical “authorities” claimed, will prevent heart disease. Nobel Prize winners Dr. Michael Brown and Dr. Joseph Goldstein who discovered the central role that blood cholesterol played in the development of heart disease, prompted the pharmaceutical industry to develop statins. Although the scientists’ prediction that heart disease will have disappeared by the beginning of the 21st century, was decidedly wrong, the manufacturers of statins have profited beyond expectations – even though the drugs have not reduced heart disease.

Like so many flawed, but widely recommended medical regimens, this one is not about improving public health. Independent physicians who are not industry lackeys agree that cardiovascular disease are likely to be preventable through modifying the diet by lower sugar and carbohydrates, increased exercise, and eliminating tobacco use.

But healthy lifestyle regimens don’t generate billions of dollars!

A letter addressed to the UK Parliament urges Parliament to initiate a full public investigation into the marketing and promotion of cholesterol lowering statin drugs — The Great Cholesterol And Statin Con. The lead author is cardiologist Aseem Malhotra, MD; the letter was co-signed by a distinguished group of doctors, including the Past President of the Royal College of Physicians, the editor of the BMJ, and the Director of the Centre of Evidence Based Medicine in Brazil.

As Professor Rita Redberg, a cardiologist and a professor of medicine at UCLA-San Francisco, who is the Editor in chief of the Journal of the American Medical Association (JAMA) has been outspoken against the wide use of statins. She recently pointed out that:

“cholesterol is just a lab number, who cares about lowering cholesterol unless it actually translates into a benefit for patients?”

Empirical evidence: Despite the widespread use of statins, the U.S. death rate from coronary disease keeps increasing. What’s more, Americans have had more procedures to open blocked coronary arteries.

So, where are the benefits from all those statins?

Dr. Malhotra challenges not only the unsupportable widespread prescribing of statins – industry’s blockbuster profitable cholesterol lowering drugs; he has challenged the UK National Health Service for its doubly harmful food and statin recommendations; and he has also challenged the World Health Organization for its industry-supportive guidance.

Dr. Malhotra is making waves that should have been made long ago, but for the stranglehold and corrupting influence that drug manufacturers exert on clinical practice guidelines.

The reason is that the influential professional medical associations that issue practice guidelines are almost ALL beholden to drug manufacturers; they are, quite simply, “On the Take”.

Physicians have been hoodwinked into believing that a Low-cholesterol diet, supplemented by cholesterol-lowering statin drugs will prevent cardiovascular disease for which there is no evidence.

Manufacturers of statins implanted fear of cholesterol, thereby assuring high prescribing rates for statins which were enthusiastically accepted by U.S. doctors who were swayed by false claims about the drugs’ effectiveness in preventing heart attacks.

In 2000, Americans comprised more than half of the people worldwide taking cholesterol-lowering statins – 13 million out of a total of 25 million. But that was just the start of the big con.

In 2001, the statin guideline was revised by the American College of Cardiology (ACC) and the American Heart Association (AHA), and published in the Journal of the American Medical Association; a most influential medical practice guideline.

According to Dr. John Abramson, author of Overdosed America, 59% of the expert panel who wrote the guideline had significant financial ties to manufacturers.

The promotional ACC/AHA Guidelines increased the number of Americans who were routinely prescribed statins from 13 to 36 million. The additional 23 million people for whom statins were recommended had no signs of coronary disease, but rather were deemed to be “at risk”.

The cost was estimated at $20 to $30 billion annually. The ACC/AHA recommendations deceived clinicians; they were not, as was claimed, based on evidence of benefits.

In 2012, the Lancet published a meta-analysis of 27 randomized trials, concluding that the benefit for people with a low risk of disease “greatly exceeds any known hazards.” As is the case with many bombastic claims about the use of pharmaceutical products – be they statins or vaccines – the benefits were greatly exaggerated, while the risks wee minimized. Statins have been shown to cause muscle problems in 53 out every 1,000 patients treated and more likely to develop diabetes – the risk is greater for women. An accompanying Lancet editorial promoted Statins for All by the Age of 50 Years (2012).

In 2013, the ACC/AHA recommended statins for more than 26 million Americans – based on an extrapolation from a risk calculator. That was pretty good news for statins manufacturers. Pfizer, Merck, and Britain’s AstraZeneca. Statins became the top selling drugs.

Several doctors tried to pull the lid off the scam.

Dr. Malcolm Kendricks who wrote the book The Great Cholesterol Con: The Truth About What Really Causes Heart Disease and How to Avoid It (2008), is one of those doctors.

Dr. Rita Redberg is another one, who put it plainly:

“People have a very exaggerated idea of the benefits. It is about billions of dollars that cannot be ignored”.

The April 2008 issue of the Journal of the History of Medicine and Allied Sciences, published a series of articles such as “How the Ideology of Low Fat Conquered America by Ann F. La Berg who wrote:

“Ironically, in the same decades that the low-fat approach assumed ideological status, Americans in the aggregate were getting fatter, leading to what many called an obesity epidemic. Nevertheless, the low-fat ideology had such a hold on Americans that skeptics were dismissed.”

Dr. Malhotra lifts the issue beyond statins per se, and points to the fundamentally flawed cause and effect model for cardiovascular disease.

That model focuses on the wrong culprit; fat in the diet is NOT the cause of cardiovascular disease. That is the reason that statins, which lower cholesterol, do not lower the incidence of cardiovascular disease.

Dr. Malhotra looks at the wider meaningful health considerations, as do physicians practicing integrated, holistic medicine which looks at the patient’s entire life situation.

“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[4]. It is also a clear sign of impending type two diabetes. A disease which has become the single largest cost to the NHS, accounting for approximately 10% of the budget.

The good news is that Insulin resistance can be effectively combatted through a combination of dietary changes, moderate activity and psychological stress reduction [5]”

Do Statins Really Work? Who Benefits? Who Has The Power To Cover Up The Side Effects? By Aseem Malhotra, MD (cardiologist), European Scientist, Sept. 3, 2019

[Excerpts]
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. Unfortunately, the atorvastatin caused severe muscle pains on exercise. Fortunately, 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, even reverse heart disease through lowering cholesterol. Within months he dropped his total cholesterol by 40% 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 seventy 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?’
I explained to him his case was not unusual, nor inexplicable.

It’s been almost 35 years since scientists Brown and Goldstein won the Nobel prize for discovering how blood cholesterol played a central role in development of heart disease. It was their work that led to pharmaceutical industry developing statins.

These are drugs that lower cholesterol, and they both reduced heart attacks, and extended lifespan, within a few years of prescription. Just how significant the impact was and how reliable this data is we’ll come to later. In 1996, Goldstein and Brown confidently predicted that we may now see the end of heart disease before the beginning of the 21st century[2].

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[3].

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[4]. It is also a clear sign of impending type two diabetes. A disease which has become the single largest cost to the NHS, accounting for approximately 10% of the budget.

The good news is that Insulin resistance can be effectively combatted through a combination of dietary changes, moderate activity and psychological stress reduction [5].

Unfortunately, we remain trapped in a flawed model for heart disease, which promotes low fat high carbohydrate diets and the replacement of saturated fat with polyunsaturated fats. This, despite that fact that. when tested in multiple randomised controlled trials (RCTs) (considered the gold standard form of evidence) no real benefit has ever been seen from reducing saturated fat or even replacing it with polyunsaturated fat despite significant reductions in blood cholesterol. In fact, the dietary guidelines may have caused harm, as pointed out by two cardiologists in a stinging peer reviewed paper recently published in the BMJ’s Evidence Based Medicine Journal [6].

The authors also point out two trials actually revealed an INCREASE in death rates from the group that lowered cholesterol versus the one’s that didn’t. Cardiologist and Editor in chief of JAMA internal medicine, Professor Rita Redberg pertinently points out “ cholesterol is just a lab number, who cares about lowering cholesterol unless it actually translates into a benefit for patients? [7]”

Yet the fear of cholesterol is very much imprinted on the minds of doctors and members of the public. A message that has been enthusiastically driven by a multi-billion-dollar low-fat cholesterol lowering industry. Next year it’s predicted that total revenues from sales of cholesterol lowering statin drugs could reach US $1 trillion.”

All of this raises and important question. Is high cholesterol really a risk factor for heart disease at all?

High cholesterol first appeared to emerge as a risk factor for heart disease during the Framingham heart study, which studied five thousand people in the town of Framingham, near Boston, over several decades, starting in 1948.

However, what most medical students, academics, doctors and the public don’t know is that it was only those people with genetically very high levels of total cholesterol over 10mmol/l ( >380mg/dL) that were more likely to die of heart disease.

At the other end of the spectrum, those with low cholesterol less than 3.8mmol/l (<150mg/dL) did have a lower risk of heart disease – although they didn’t live any longer with those with higher levels. For the remaining 90% of the population, the total cholesterol had no predictive value.[9]

The association between heart disease and cholesterol levels was so weak that William Castelli, one of the co-directors of Framingham, stated in medical journal Atherosclerosis in 1996 that unless LDL cholesterol (commonly known as “bad” cholesterol) was greater than 7.8mmol/L (300mg/dl) “ it had no value in isolation in predicting those individuals at risk of developing coronary heart disease”[10]

Yet despite this, current guidelines used by doctors around the world put a red flag warning next an LDL level of more than three 3mmol/L. And for those suffering heart attacks the “target” is to keep total cholesterol even lower, and LDL below 2mmol/L. Such targets are not based upon on any robust evidence but do serve to ensure that we are medicating tens of millions more people on cholesterol drugs.

For the majority who’s LDL-cholesterol falls above 7.8mmol/L this value applies to those born with a condition known as Familial Hyperlipidaemia which affects approximately 1 in 250 people. But it’s interesting to note that even in this group 50% of men and 70% of women will NOT develop premature heart disease without treatment….

… Professor of medicine and statistics at Stanford University John Ioannidis who has studied the area in great detail has found that seventy per cent of healthcare professionals fail tests on their understanding of evidence-based medicine[11]. Therefore, their advice to patients will be fatally flawed.

It was also Ioannidis, who wrote a paper entitled “why most research findings are false”[12].

A key drive for unreliable research he said was “the greater the financial interest in a given field the greater the likelihood the research findings are to be false.” The ‘evidence’ is then incorrectly passed on to patients. No wonder my patient was angry.

It is not just financial interests that bias research findings but also intellectual hubris in medicine too. It was the father of the evidence based medicine movement the late Professor David Sackett who said

“Fifty percent of what you learn in medical school will turn out to be either outdated or dead wrong within five years of your graduation, the trouble is no one can tell you which half so you have to learn to learn on your own.”

In the past 30 years, there have now been 44 randomised controlled trials that reveal no cardiovascular mortality benefit from diet or various drug trials from lowering cholesterol. Most conspicuous was the recent ACCELERATE trial with over 12,000 patients at high risk of heart disease that revealed no reductions in heart attack, stroke or death despite a 37% reduction in LDL-cholesterol [13].

But how many doctors actually keep up with the latest evidence? Many will defend the cholesterol lowering dogma with their more inquisitive patients by saying they’re just following guidelines, unaware that the guidelines themselves are based upon biased research often written by scientists with strong personal or institutional financial ties to the industry[14].

To muddy the waters further In 2016 a systematic review, revealed no association with LDL cholesterol and heart disease in those aged over sixty and an inverse association with all-cause mortality, in other words the higher your cholesterol in this age group, the longer you would live [15].

Read the rest of this powerful essay by Dr. Malhotra at European Scientist.

Read the full article at AHRP.org.