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Read This Before You Take That Statin

By Barbara Roberts and Martha Rosenberg | Dissident Voice | December 10, 2013

The American Heart Association (AHA) and the American College of Cardiology (ACC) recently released new cardiovascular disease prevention guidelines. They are an egregious example of much that is wrong with medicine today.

The guidelines propose a vast expansion of the use of statins in healthy people, recommending them for about 44 percent of men and 22 percent of healthy women between the ages of 40 and 75. According to calculations by John Abramson, lecturer at Harvard Medical School, 13,598,000 healthy people for whom statins were not recommended based on the 2001 guidelines now fall into the category of being advised to take moderate or high intensity statin therapy.

The American Heart Association (AHA) is a nonprofit organization with a mission to “build healthier lives free of cardiovascular disease and stroke.” Yet in its 2011-2012 financial statement, the AHA noted $521 million in donations from non-government and non-membership sources and many well-known large drug companies, including those who make and market statins, contribute amounts in the $1 million range.

Even as many in the medical community suspected the guidelines were a ploy to help the AHA’s drug partners sell statins, it was revealed that the guideline’s online calculator to determine cardiac disease risk over predicts risk by an astonishing 75 to 150 percent. But the guideline writers are standing firmly behind their faulty calculator.

Seven of the 15 authors disclosed ties to industry. Originally, the panel chair, Neil J. Stone, MD of Northwestern University, declared that he has had no ties to industry since 2008. Jeanne Lenzer, writing in the British Medical Journal (BMJ) recently, interviewed Dr. Stone who said: “When I was asked by NHLBI [National Heart, Lung and Blood Institute] to chair the [cholesterol] panel, I immediately severed ties with all industry connections prior to assuming my role as chair.” However, prior to 2008, he accepted funding and consultancy fees from multiple pharmaceutical companies, including Abbott, AstraZeneca, Pfizer, Merck, and Schering-Plough among others. Dr. Stone also told the BMJ that he will “definitely” not take any industry funding for two years. Are we to believe that by severing his ties in 2008 his mind became an instant tabula rasa, completely devoid of any conscious or unconscious bias towards the drug companies which had been paying him? To do so strains the bonds of credulity past the breaking point.

The financial ties between large pharmaceutical companies and the AHA are numerous and very remunerative for the AHA, including huge donations from Abbott, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb (BMS), Eli Lilly, Merck and Pfizer. BMS, along with Merck and Pfizer, are major funders of AHA’s Go Red For Women heart disease awareness campaign whose web site tells patients “If your doctor has placed you on statin therapy to reduce your cholesterol, you can rest easy–the benefits outweigh the risks” The site also proclaims that , “Zocor and Pravachol–have the fewest side effects,” and “statins may only slightly increase diabetes risks.” The Women’s Health Initiative, a federal study of over 160,000 healthy women to investigate the most common causes of death, disability and poor quality of life in postmenopausal women, showed that a healthy woman’s risk of developing diabetes was increased 48 percent compared to women who were not on a statin. And contrary to what statin apologists say about statins only increasing diabetes risk in people who are at high risk of developing it anyway, for example the obese, women on statins in the Women’s Health Initiative who were of normal weight increased their risk of diabetes 89 percent compared to same weight women not taking a statin.

In 2010, AHA received $21,000 from statin maker AstraZeneca to run an AHA course about “emerging strategies with statins” at the Discovery Institute of Medical Education and almost $100,000 for learning projects including “debating controversial topics in cardiovascular disease.” The AHA defended the deceptively marketed and controversial cholesterol drug Vytorin. Did that have anything to do with the $2 million a year the AHA was taking from marketer Merck/Schering-Plough Pharmaceuticals?

The AHA also rakes in millions from food companies which are also million dollar donors and which pay from $5,490 to $7,500 per product to gain the “heart-check mark” imprimatur from the AHA, renewable, at a price, every year. The foods so anointed have to be low in fat, saturated fat, and cholesterol yet Boar’s Head All Natural Ham (340 milligrams of sodium in a 2-ounce serving) somehow made the cut as did Boar’s Head EverRoast Oven Roasted Chicken Breast (440 milligrams of sodium in a 2-ounce serving). Such processed, high-sodium meats raise blood pressure, the risk of cardiovascular disease and the risk of diabetes. A review of almost 1,600 studies involving one million people in ten countries on four continents showed that a 1.8-ounce daily serving of processed meat raised the risk of diabetes by 19 percent and of heart disease by 42 percent.

The new guidelines might make sense if statins were truly as effective as their proponents claim, and if they had no adverse effects. But they have an increasing list of side effects, which affect at least 18 percent of people who take them. These range from muscle pain, weakness and damage to cataracts, cognitive dysfunction, nerve damage, liver injury and kidney failure.

Even the most avid statin proponents agree that statins do not prevent 60 to 80 percent of cardiac events. This is called “residual risk.” If there were a vaccine, say Vaccine X, that did not prevent 60 to 80 percent of cases of Infection Y, very few would be inclined to take it.

As Jerome Hoffman, MD, Emeritus Professor of Medicine at UCLA wrote recently with regard to these guidelines: “How did we arrive at a place where conflicted parties get to make distorted semi-official pronouncements that have so much impact on public policy?” How indeed?

~

Barbara Roberts, MD, FACC is an Associate Clinical Professor of Medicine at the Alpert Medical School of Brown University. She is the author of The Truth about Statins and How to Keep from Breaking Your Heart: What Every Woman Needs to Know about Cardiovascular Disease. Martha Rosenberg is a health reporter and author of Born with a Junk Food Deficiency.

December 11, 2013 Posted by | Corruption, Deception, Science and Pseudo-Science | , , , , , , | Leave a comment

Do You Really Need That Statin?

This Expert Says No

By Martha Rosenberg | Dissident Voice | August 22nd, 2012

Statins are medications which lower cholesterol by inhibiting an enzyme involved in its production by the liver and other organs. First approved by the FDA in 1987, statins are arguably the most widely prescribed medicine in the industrialized world today–and the most profitable, representing $26 billion a year in profits to the drug industry. In fact, Lipitor was the world’s best selling drug until its patent expired recently. Yet, most trials that prove statins’ effectiveness in preventing cardiac events and death have been funded by companies and principle investigators who stand to benefit from their wide use. In February, the FDA warned that statins can increase users’ risk of type 2 diabetes and memory loss, confusion and other cognition problems.

Barbara H. Roberts, M.D., is Director of the Women’s Cardiac Center at the Miriam Hospital in Providence, Rhode Island and Associate Clinical Professor of Medicine at the Alpert Medical School of Brown University. She spent two years at the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) where she was involved in the first clinical trial that demonstrated a beneficial effect of lowering cholesterol on the incidence of heart disease. In addition to The Truth about Statins: Risks and Alternatives to Cholesterol-Lowering Drugs, she is also author of How to Keep from Breaking Your Heart: What Every Woman Needs to Know about Cardiovascular Disease.

Martha Rosenberg:  Statins have become so popular with adults middle-aged and older in industrialized countries, they are almost a pharmaceutical rite of passage. Yet you write in your new book there is little evidence they are effective in many groups and no evidence they are effective in one group, women without heart disease. Worse, you provide evidence, including stories from your own patients, that they are doing serious harm.

Barbara Roberts: Yes. Every week in my practice I see patients with serious side effects to statins and many did not need to be treated with statins in the first place. These side effects range from debilitating muscle and joint pain to transient global amnesia, neuropathy, cognitive dysfunction, fatigue and muscle weakness. Most of these symptoms subside or improve when they are taken off statins. There is even growing evidence of a statin link to Lou Gehrig’s disease.

MR:  One patient you write about caused a fire in her home by forgetting that the stove was on. Another was a professor who experienced such memory loss on a statin he could no longer teach; others ended up in wheelchairs. The only thing more shocking than the side effects you write about is the apparent blindness of the medical establishment to them. Until half a year ago, there were practically no warnings at all.

BR: There is no question that  many doctors have swallowed the Kool-Aid. Big Pharma has consistently exaggerated the benefits of statins and some physicians used scare tactics so that patients are afraid that if they go off the statins, they will have a heart attack immediately. Yet high cholesterol, which the statins address, is a relatively weak risk factor for developing atherosclerosis. For example, diabetes and smoking are far more potent when it comes to increasing risk.

MR: One group you say should not be given statins at all because there is no benefit and significant risk is women who have no heart disease.

BR: In three major studies of women without diagnosed heart disease, but who were at high risk (in one of these studies, each participant had to have high blood pressure and three other risk factors), 40 women out of 4,904 on statins had either a heart attack or cardiac death, compared to 44 women out of 4,836 on placebo. That is not a statistically significant difference. Since the likelihood of experiencing a statin side effect is about 20 to 25 percent, the risk of putting a healthy woman on a statin far outweighs the benefit. Still, statins are routinely given to this group because the guidelines are shaped by Big Pharma. The guidelines are not supported by the evidence and in the case of healthy women I don’t follow them.

MR: You give a story in your book about your 92-year-old patient who had a total cholesterol of 266,  triglycerides of 169, HDL cholesterol of 66, and LDL cholesterol of 165. Her primary care doctor wanted her to take a statin, but you did not feel she needed to because she had no evidence of heart disease, had never smoked, did not have high blood pressure and was not diabetic.

BR: Yes, and today she is 103 and a half and doing fine, never having taken a statin.

MR: In The Truth About Statins you explain pretty clearly how studies have made statins look more effective and safer than they are. How has this been done?

BR:  First of all, the studies are of short duration and some of them even have a “run in” phase during which people are given the drug to see if they tolerate it. If not, they are not enrolled in the study.  Secondly, study subjects are cherry-picked to exclude the very elderly, people with liver or kidney disease or those with any chronic illness that might “muddy” the results–

MR: In other words, the very people who will be taking them?

BR: Yes, and, of course, patients will also be staying on the drugs for life unlike trial subjects. Then, the data from the studies are usually given in terms of relative rather than absolute risk. The absolute risk of a cardiac event is only reduced by a few percentage points by statins and in some patients, like the women without heart disease we just talked about, the reduction is not even statistically significant. In some studies surrogate endpoints like inflammation or artery thickness are used but a favorable change in surrogate markers does not always translate into clinical benefit. In addition, many studies use composite end points which include not only “hard” end points like heart attack or death (which are pretty hard to misdiagnose) but also “softer” end points like the “need” for revascularization or the occurrence of acute coronary syndromes. For example, studies may be performed in many countries with very different rates of revascularization procedures, making use of this as an end point very problematic.

MR: This brings to mind the JUPITER trial which enrolled people without heart disease, with normal levels (less than 130) of LDL or bad cholesterol, but evidence of increased inflammation as measured by the hsCRP test and treated them with placebo or rosuvastatin. JUPITER stood for “Justification for the Use of Statins in Prevention” and both the study and its principle investigator were funded by AstraZeneca, who makes the statin Crestor. The principal investigator also holds the patent for the hsCRP blood test. Why was JUPITER regarded as medical science and not marketing?

BR: Actually the JUPITER study was criticized to some extent. But you have to remember that medical journals depend upon Big Pharma for their ads and reprint orders just as medical centers and medical professionals rely on Big Pharma for funding. It is a Round Robin situation that probably won’t change until the patients, doctors and the public demand change. As for CRP, it can also rise if a patient has a cold, bronchitis or is taking post menopausal hormones.

MR: You are very outspoken about the problem of industry shaping  and influencing medical practice yet you also admit that you accepted Big Pharma money yourself.

BR:  In 2004, Pfizer asked me to become a speaker, specifically on Lipitor. I told the drug rep who invited me to be a speaker that I would be interested in giving talks on gender-specific aspects of cardiac disease, but not in just talking about their statin and I gave lectures in restaurants and hospitals. Despite the fact that Pfizer was sponsoring my talks, I never failed to point out that there was no evidence that Lipitor–or any statin–prevented cardiac events in women who did not have established cardiovascular disease. They tolerated this until one day a regional manager came to one of my talks and then I was disinvited. I was on the speaker’s bureau for another company, Abbott, but when they began to insist that I use their slides rather than my own, I gave up being on any Big Pharma speaker’s bureaus. I write in my book that even though my interactions with drug and device companies complied with ethical guidelines it does not mean I was not influenced.

MR: In journalism, when a reporter takes money from someone she is writing about, she is regarded as no longer a reporter but a publicist. Yet doctors who consult to Pharma are not judged as harshly and most contend they are not influenced by industry money….

BR: They are wrong.  An article in the American Journal of Bioethics in 2003 found that gifts bestow a sense of indebtedness and influence behavior whether or not the recipient is directly conscious of it. More recently, research presented at a symposium at Houston’s Baylor College of Medicine called the Scientific Basis of Influence and Reciprocity mapped actual changes in the brain when gifts are received.

MR: I was surprised to find recipes in your book and even more surprised by some of your dietary recommendations such as avoiding a low-fat diet and eating a lot of olive oil. A lot of experts have recommended a low-fat diet.

BR: The first thing I prescribe to my patients who have low levels of the “good” or HDL cholesterol is two to three tablespoons of olive oil a day and in every case the HDL increases. Olive oil is rich in polyphenols which have anti-inflammatory and antioxidant effects. Several studies have shown that the Mediterranean diet reduces total mortality and especially death from cardiovascular disease yet it gets little media attention. The Mediterranean diet is a plant-based  diet that includes colorful vegetables, fruits, whole grains, beans, cheese, nuts, olive oil, seafood, red wine with meals, and very little meat.

MR: You indict professional medical associations like the American Heart Association (AHA) for profiteering at the public’s expense by calling harmful foods healthful in exchange for corporate money.

BR: For years, the AHA preached the gospel of the low-fat diet, calling it the “corner- stone” of its dietary recommendations though there was, and is, no evidence of its benefit. The AHA rakes in millions from food corporations for the use of its “heart-check mark.” Some of the so called heart healthy foods it has endorsed include Boar’s Head All Natural Ham which contains 340 milligrams of sodium in a 2-ounce serving and Boar’s Head EverRoast Oven Roasted Chicken Breast which contains 440 milligrams of sodium in a 2-ounce serving. High sodium intake raises blood pressure which increases the risk of cardiovascular disease. In addition, studies have shown that eating processed meat increases the risk of diabetes and atherosclerosis.

MR: You are not afraid to express strong opinions. You say that the AHA has “sold its soul,” that medical centers conducting drug trials for Big Pharma have become “hired hands” and that one university medical center is Big Pharma’s “lapdog.” Are you afraid of retaliation from Big Pharma, medical centers or the colleagues you work with?

BR: I haven’t received any communiqués from Big Pharma. A few colleagues have expressed dismay, but I am thick-skinned and hard-headed and don’t care what they say. My main concern is the health and safety of my patients.

~

Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: martharosenberg@sbcglobal.net.

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$tatin Nation trailer1

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Film Synopsis:

We are told that cholesterol is a major cause of heart disease. At least 40 million people are currently taking cholesterol-lowering medications, known as statins, and millions more people are avoiding foods that contain saturated fat and cholesterol.

The basic idea is that dietary saturated fat raises cholesterol levels, and these two substances somehow clog-up our arteries, causing a heart attack. This idea is often referred to as the diet-heart hypothesis.

However, a numbers of doctors and researchers have been challenging this hypothesis for decades, and the latest heart disease statistics reveal some alarming facts. Such as:

● People with high cholesterol tend to live longer

● People with heart disease tend to have low levels of cholesterol

● Cholesterol-lowering of a population does not reduce the rate of heart disease

In addition, despite their widespread use, and description as “wonder drugs” statin medications do not extend life for the majority of people who take them.

Cholesterol-lowering has become a huge global industry, generating at least $29 billion each year. Have the facts about heart disease, cholesterol and cholesterol medications been distorted by pharmaceutical companies  and food manufacturers keen to increase their profits?

If the focus on cholesterol has been a mistake, then the greatest cost is associated with the lost opportunity to tackle heart disease.

Producer/Director:   Justin Smith

Editor and Motion Graphics:   Justin Keating

Director of Photography:   Stephen Ellis

3D Animation:  Tim Greenfield

Sound Design:  Graham Donnelly

August 22, 2012 Posted by | Corruption, Deception, Timeless or most popular, Video | , , , , | 1 Comment