A Pediatric Cardiologist from Georgia has pleaded guilty to illegally targeting teens for a cholesterol drug that was only approved by the FDA for a rare disorder. According to court documents, Dr. Eduardo Montaña colluded with pharmaceutical company Aegerion to sell their drug Juxtapid to teenagers with heart problems, even though the drug was not approved for their conditions. Dr. Montaña violated HIPAA laws of patient privacy by supplying the pharmaceutical company private medical records of 280 teenagers without patient knowledge or consent. Drug company Aegerion was found guilty of criminal wrongdoing in a Massachusetts court. Juxtapid, which received FDA approval in 2012, costs over $330,000 per patient per year, so the drug company had strong financial motives to expand its sales. Dr. Montaña was a willing accomplice in their criminal activities, and reportedly hoped to get a kickback for himself. He requested a $236,000 grant from Aegerion. In the conviction against Aegerion in this case with Dr. Eduardo Montaña, District Judge William G. Young lamented how the U.S. Government allows criminal pharmaceutical companies to get off so easily, and continue doing business. Existing laws that protect pharmaceutical companies apparently prevented Judge Young from automatically issuing the harshest penalty, as the federal government generally strikes a plea bargain deal with the pharmaceutical company to keep them in business. Judge Young wrote: "What is left unexplained is why the government does not simply let Aegerion collapse in disgrace. Surely Aegerion is not too big to fail."
Cardiologist: Millions of People Taking Statin Drugs Will Continue to Have Far Greater Chance of Harm than Benefit
Two recent articles published in the UK mainstream hard copy and online newspaper Express revealed there’s something wrong with cholesterol-lowering statin drug prescription policies, quoting several doctors who claim statins cause more harm than benefit. Dr. Rita Redberg, a cardiologist professor at the San Francisco Medical Center, states: “Unfortunately, until all data is available and discussed with patients, millions of people taking these [statin] drugs will continue to have far greater chance of harm than benefit.” Dr. Rita Redberg's name might be familiar to our readers, because she appeared in an Australian two-part TV news documentary that has often been featured in several Health Impact News articles. Both parts were connected thematically and produced by Dr. Maryanne Demasi, Ph.D. And it was Dr. Demasi’s British Medical Journal (BMJ) article and study review that the Express article was reporting rather favorably with quotes from other doctors supporting her findings. The article’s focus was on the controversy it had ignited regarding the widespread use of cholesterol-lowering statin drugs.
The least publicized actual side effect of cholesterol-lowering statin drugs that complements the dangerous intended effect of reducing cholesterol is they also block CoQ10 production, which is already waning among those aged 40 and older. That’s the age when people begin getting prescribed statins per the newest statin drug guidelines. The irony is that CoQ10 is vital for good heart health! CoQ10 is on high demand from cells in muscle tissue, and the muscle that works the most without rest is the heart. Instead of supplementing CoQ10 when one reaches the 40 year plus mark, he or she will likely be prescribed statin drugs for life as a preventative against cardiovascular disease and heart attack. As statin drugs decrease one’s already lowered CoQ10 production from aging, the heart can get slowly weaker, leading to congestive heart failure. This is when the heart keeps beating, but it is so weak it isn’t strong enough to maintain blood flow throughout to meet the body's needs. Instead of the pain that accompanies a sudden heart attack, gradually one begins to have less and less energy. Excessive tiredness comes in that may be incorrectly attributed to aging or being out of shape. Exercise only further exposes one’s breathing problems. Distended belly and leg swelling also occur. This can go on for years with increasing disability until there is a total heart failure. The newest guidelines for statins almost require physicians to put patients on statins as a preventative practice for life. As the CoQ10 deficiency worsens from statins, the poor patient goes into a debilitating spiral without any recognition to its true cause.
Aggressive lowering of low-density lipoprotein cholesterol (LDL-C) has been the cornerstone of preventative cardiology for decades. Statins are widely used as the go-to solution for the prevention of heart disease owing to their ability to slash LDL-C levels, a ‘surrogate marker’ of cardiovascular disease (CVD). Indeed, statins are one of the most widely prescribed class of drugs in the world. But this phenomenon begs two questions: is the enthusiasm for aggressive lowering of LDL-C justified; and is pharmacotherapy superior to lifestyle intervention? In summary, for many patients at high risk of CVD, one of the safest and most effective ways to reduce the risk of heart attack and stroke is to consume a high fat and low glycaemic load Mediterranean diet and engage in regular exercise. At the very least, exercise interventions are often similar to drug interventions in terms of their mortality benefits in the secondary prevention of coronary heart disease, and do not come with side effects.
As we have reported frequently here at Health Impact News, sales of drugs to lower cholesterol are the top selling drugs of all time. It is a $100 billion a year industry. The cholesterol-lowering drug Lipitor is the best-selling drug of all time, grossing over $140 billion, with no serious close competitors in the history of pharmaceutical drugs. One out of every four Americans over the age of 50 is taking a statin drug to lower their cholesterol. However, these block buster drugs have run through their patent life, and now generics dominate the market. So Big Pharma is looking at new ways to patent new drugs to lower your cholesterol. The latest? A vaccine is being developed to lower your cholesterol. In recent years, class action lawsuits have been stacking up against statin drug manufacturers due to the terrible side effects, including diabetes. Is this another reason for turning to vaccines to "cure" cholesterol? In this country, lawsuits against vaccines are prohibited while civil suits against prescription or over-the-counter drugs are allowed.
The pharmaceutical empire strikes back. After the recent few years of increasing “statin deniers” getting an occasional mainstream media appearance, vested interest parties are coming up with studies to “prove” statins (cholesterol-lowering drugs) are safe. The problem is most folks on the fence, as most are, will be distracted by these studies no matter how biased and without merit they may be. Doctors who know the truth about statins are forced to pick any such statin safety study apart in response in order to straighten out doctors who prescribe statins based on pharmaceutical reps’ presentations and industry biased studies. One such doctor who is outspokenly critical of statin drugs, Scottish General Practitioner (GP) Malcom Kendrick, M.D., recently focused on a Lancet paper that intended to prove side effects from statin drugs were not only greatly exaggerated, but all in the patients' heads. According to the paper, patients were suffering from the “nocebo effect,” due to all the rising information regarding statin side effect symptoms publicly reported. In addition to his analysis of the study and comparisons to other studies, Dr. Kendrick offers his personal and professional experiences of taking patients off statins and watching them recover from torn or ravaged muscles and early onset dementia, among other side effects. Dr. Kendrick’s father, whose side effects had him wheel chair bound until his doctor-son convinced him to quit taking statins is an example he offered. No nocebo effects had them in such terrible shape that was relieved when they got off statins.
A 2017 meta-analysis of 29 studies has concluded that consuming dietary dairy fat has no negative effects on all cause mortality or mortality from cardiovascular disease (CVD) and coronary heart disease (CHD). This includes dairy fats of all types. One of the researchers, Ian Givens of England’s Reading University, commented on the record: “There’s been a lot of publicity over the last 5 to 10 years about how saturated fats increase the risk of cardiovascular disease and a belief has grown up that they must increase the risk, but they don’t.” Actually, dairy and other animal sourced saturated fats have been wrongly condemned as a contributor to obesity and higher cardiovascular risk since Ancel Keys' notorious seven countries study over 50 years ago, which spawned the “lipid theory” of heart disease and obesity.
Since 2015 there have been a few pharmaceutical companies working on a new cholesterol-lowering drug type as a replacement for the older class of statin drugs, such as Lipitor. Lipitor was the best-selling drug of all time, but its patent expired a few years ago. The new mantra is getting LDL cholesterol levels lower than statin drugs. The drug class of these new cholesterol-lowering drugs is a PCSK9 inhibitor. Of course, this is madness for two reasons: (1) Cholesterol and fats, in general, are not the cause of heart disease; (2) cholesterol is vital for hormone production and nervous system and brain function. The fact is that cholesterol is vitally essential for good health, and lowering cholesterol artificially can and does lead to more immediate health problems, and a lower life expectancy. So why the focus for a new cholesterol-lowering drug? Once again, we follow the money.
War on Saturated Fats Has Harmed People in Poor Countries Who Shunned Traditional Fats Like Coconut Oil
One of the most pervasive dangerous food myths has been the lipid hypothesis or theory of heart disease. It proclaims that eating foods containing saturated fats are the root cause of obesity and heart disease. It has prevailed for over a half-century and is only now beginning to deteriorate. The most obvious harm done by the false propaganda against saturated fats in traditional foods are with regions that relied heavily on saturated fats for centuries, especially edible tropical oils such as coconut oil prior to the lipid hypothesis or theory's dogma that permeated and replaced their traditional diets. A recent paper, “Coconut oil and palm oil's role in nutrition, health and national development: A review,” was published in the September 2016 Ghana Medical Journal (GMJ).
Cholesterol does not cause heart disease in the elderly and trying to reduce it with drugs like statins is a waste of time, an international group of experts has claimed. A review of research involving nearly 70,000 people found there was no link between what has traditionally been considered “bad” cholesterol and the premature deaths of over 60-year-olds from cardiovascular disease. Published in the BMJ Open journal, the new study found that 92 percent of people with a high cholesterol level lived longer. The authors have called for a re-evaluation of the guidelines for the prevention of cardiovascular disease and atherosclerosis, a hardening and narrowing of the arteries, because “the benefits from statin treatment have been exaggerated”.