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The American Heart Association--Protecting Industry Not Patients by Barbara Roberts, MD, and Martha Rosenberg

The American Heart Association--Protecting Industry Not Patients by Barbara Roberts, MD, and Martha Rosenberg

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) this month, 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?

By Barbara Roberts, MD 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.

Comments

It is clear that "Statins are the most effective CVD drug the medical/pharmaceutical complex has created. There are claims that the "Mediterranean Diet is roughly as good, if not better, than Statins - particularly with regard to effectiveness and lack of disabling side effects.

Medically, however, objective reviews of Statins continue to say that "Yes, it is the best drug treatment we have for CVD, but it is still evident that statins did (do) not prevent 60 to 80 percent of cardiac events.. So:

1) Even though it isn't very effective, that objective absolute risk (not the common 'relative risk") figures say that more than 20 people need to be treated before one CVD event is spared for severely afflicted secondary care cases and often more than 100 people need to be treated before one CVD event is spared for primary care (no pre-existing CVD, like the vast majority of current statinized patients -- it is the best care available by the medical community in spite of the fact that it isn't actually very good.

2) The very best you can do can still be unacceptably poor outcomes.

3) The common side effects can be not just inconveniences, but downright damaging (mine were, and my physician assured me that the horrible side effects in the case of my niece were "almost insignificant for recurrence for me".

The AHA/ACC solution to this problem of "the best not being excellent and in fact this 'best' actually sucks" is to:
DRUMROLL,
.....DRUMROLL LOUDER
..........Announce a simple Excel spreadsheet with few real equations as the mighty decision maker to aggressively promote and greatly expand the number of patients who will be forced to take the "Very Best Available" but "Not GOOD ENOUGH" medically approved drug class called statins.

More people being treated with "The best available" but "Not good enough" class of drugs is evidently the" best thinking that the medical community can create".

I doubt if that is the "best thinking that the medical community can create", and I encourage more to get in line to claim:

"THE VERY BEST THAT YOU CAN DO JUST ISN'T GOOD ENOUGH, START OVER WITH A NEW TEAM"

I watched a video of Dr. Hoffman talking about the problems with statin drugs. My husband was prescribed a statin medication by his doctor, but his cholesterol was "normal" just two years ago and remains at the same level today. I checked a few sources to find out how to wean him off of the statin medication. There were no such instructions anywhere. "My normal cholesterol is being maintained by taking a prescription medication." has got to be the stupidest thing anyone could say. If they obtained copies of their lab results each time the tests were done, they would kinow that statin drugs were doing little to nothing about thier "bad" cholesteraol and were probably only reducing the "good" cholesterol, which is exactly what happened with my husband. The doctors can prescribe all they wish. For me and my family, the research will be done to prevent the drug companies from destroying our quality of life.

Add me to the list of permanently damaged victims of statins promoted to doctors as safe and effective. Thanks to the poison of first Zocor and then Pravachol/pravastatin, described by BigPharma above as "… "Zocor and Pravachol -- have the fewest side effects," I am now unable to walk more than a few steps without the assistance of a cane or walker; my legs are in constant pain when standing or walking; and my ability to maintain my balance while standing has been substantially diminished. All for the profits of this industry and their unwitting, gullible, paid cheerleaders in the medical profession!

Thank you for this important article. The widespread use of a minimally effective drug is bad enough, but statins can and do cause significant harm to many people, and prescribing physicians seem to be blind to them. I am a physician and I took Lipitor for 2 years. During the first 6 months of therapy, I developed several serious medical issues that required more physician visits and more drugs. I became so ill that I thought I might have to retire from my own medical practice. It took me two years to figure out that the statin was causing my illness. After stopping the Lipitor on my own, I slowly regained my health over the next two years. When I tell my primary physician colleagues about my experience, I get a blank stare. I wonder if they are listening to their patients?

It continues to amaze me that these drugs (statins( are pushed onto people as a preventative measure, when studies clearly show that they do not prevent heart attacks and DO in fact cause serious damage to unsuspecting patients. (serious side effects). I my self am a victim of Statin Toxicity and have been left (eleven years after being prescribed) weak in the leg muscles and with memory issues. It was all put down to ageing - excuse me I was 46 at the time all this began to happen! Never have I been able to get a medical person to admit that their prescribe drugs were responsible for what has happened to my body. In all the time since, I have not been able to find a remedy to fix the problems either. There are many (unknown numbers) permanently damaged people... victims to the damage these drugs cause, being ignored by both the Pharmaceutical Entities responsible for concocting these terrible medications and pushing them upon an unsuspecting public, and the Medical establishment who follow blindly like sheep - and prescribe these drugs - and will not accept responsibility for their actions. My goodness Our Voices need to be heard, our injuries need to be accepted and a course of action needs to be started to ensure NO MORE are harmed in this way.

I was on many different statins, on and off, for almost ten years. I quit each one when I could no longer walk up or down my stairs without holding onto the railing due to leg pain. Twice, while driving, I could not remember where I was or what side of the road I should be on. I have not been able to sleep well since, and my memory is diminished. I developed an autoimmune disease. When my Mother was put on statins, she developed Polymyagria Rheumatica, and my sister immediately developed a blood clotting problem, which after extensive testing, her physician stated was from the statin and to stop it immediately. Many people should never be prescribed statins, especially women who have not had previous heart problems, for whom there is zero percent prevention or benefit from statin use, and can result in permanent, unrelenting damage.

I have been damaged by these statin drugs. I had a heart attack 5 months ago and cholesterol level was normal at the time . My cardiologist immediately put me on lipitor. Within two weeks I had severe muscle pains in my legs. It took another 6 weeks of pleading with the cardiologist to take me off the drug. He finally admitted that I was in the 1% who cannot tolerate the drug. WRONG! This is the figure the drug companies report to the medical profession. It more like 20% of the population who cannot tolerate them and athletes are less tolerant. I was an active tennis player and have played sport all my life. Now it feels like I have lead shoes on. My legs shake when I climb a ladder - absolutely no strength anymore. 20% of the population are harmed by this drug. Yet they say the absolute percentage saved is around 1% BUT 20% are harmed. Where does the benefit out weigh the risk here especially when diet and exercise are more effective than the drug? They say there is a new cholesterol lowering drug coming out. Please test it thoroughly and do not report lies for the sake of all of us. I for one will be very wary.

Statins certainly have made an impact to my life. At 51 years old I was fit, running, hiking up mountains and in good shape.

At my annual medical, I was told my cholesterol was reading high so I was put on a low dosage of Cestor.

Within weeks I was in agony, could not reach down to put my socks on, could not get into a car or pick up a glass and was in pain 24 hours a day. I was told I had "advanced rheumatism". After 3 months from being in great shape.

All of my medical readings went off chart (and they were all fine at the medical, ...except Cholesterol).

After three months I was off statin and it has taken 3 years to get close to normal. Any promotion of this poison is a disgrace.

Please please stop this commercial rubbish.

These new guidelines are a disaster. When statinophiles (you know who I mean) come out in droves against them, there is clearly something wrong. It used to be cholesterol that was the sole problem even though it wasn't. Now inflammation is considered important (as it should have been decades ago - McCully). But the new "guidelines" condemn millions more to being treated, all on the basis of RISK. This sort of "diagnosis by Risk" is valid for herds but as diagnosis for individual patients it is a disaster, particularly when considering the low individual probability of being affected and the subsequent trivial probability of benefit as rarely shown by NNTs.

These new guidelines are simply designed to promote BIG Pharma business and profits - no more, no less. My respect for medical "research??" in this field is now non-existent.

Thank you, Dr. Roberts! Only one of a few physicians in the world who "gets it" and is speaking out against the statin madness. I was prescribed a low-dose of simvastatin and was told to exercise and go on a low-fat diet. After less than two years, my health was ruined and it continues to go downhill while I cope with degenerative arthritis, pre-diabetes, neuropathy, and early-stage heart failure. NOW WHAT? Because of the pain and shortness of breath, I can hardly move let alone exercise, especially aerobic exercise, which would probably help me in my condition. The doctors I've seen are reluctant to declare simvastatin as the cause of my problems, and there seems to be no treatment for statin damage. Now I'm being told to either go back to exercising (heck no!) or wait for improvement which I've been doing for more than two years. Statins are potential poisons and it's time that the medical community owns up to this.

What is needed is for both the CDC and the FDA to be investigated to find out who allowed these drugs to be approved. "Follow the money" or "follow the favors" would be the most direct approach.

For those who have suffered from side affects that were not relived by stopping the drugs, there will probably be no compensation for the damage that has been done. Why? Because any kind of settlement of that kind would open the doors to liability issues going all the way back to the Salk and Sabin Polio vaccines. Since the governnmebt was the approving body on those, the liability would suprass the government's ability to pay. Research needs to be done to see if some of the damage can be reversed or at least relieved, but I would not look for any kind of "class action" with the CDC and FDA to be anywhere near adequate. Going after the drug companies would be the way to go; howver, any such action would be tied up in court forever. They have survived so many lawsuits already, that they know how to protect themselves and drag cases out until the victims are dead.

It is unfortunate that the citizens of this country are in this position, but that is what hapaens when "We the People" allow government to have a greater hand in our lives than is healthy. Yes, we need to fight back, but we need to enter the fray armed with evidence that cannot be refuted by the drug companies. So far, they have managed to defeat most of the actions brought against them.

What about the risk from taking a statin? I keep reading that "benefits outweigh the risks." How can one possibly assess personal risk when many of the various side effects/adverse events are not even recognized in the accompanying drug literature? The literature includes different warnings in different countries for the same statin. The criteria for prescribing them appears to vary, too. My devastating adverse reactions were not recognized by several well-intentioned doctors (including specialists) because they, themselves, were ill-informed; they relied on the drug's literature. As a (now former) volunteer for the AHA, I was disappointed to find that the resources and advocacy available there echoed that which I found in the drug literature from the pharmaceuticals, but not in real life.

I'm very familiar with the uselessness and biases of the American Heart Association. I actually phoned CDC before taking simvastatin. CDC said they got their information from the AHA. Now there's a horror! I had great cholesterol ratios, according to AHA, indicating low risk; but high LDL indicating high risk. What should I do in light of this contradiction? "What's your question? Take statin, take statin." I called twice and got the same response. So now from being extremely active and athletic and enjoying life to the fullest, I'm crippled, in constant pain, and can barely walk around the block. From hiking two hours most days, running up switchbacks, I'm pretty much stuck on the couch. I took simvastatin, 20 mg, for just 6 months. It has turned the happiest days of my life into a series of days to be endured as best I can. I despise the AHA, I truly do. On top of everything, because AHA is non--profit, the government (us) winds up subsidizing Big Pharma. Honestly, all this is starting to make the tobacco industry seem relatively benign.

When I was prescribed a statin after suffering a heart attack in 2004, I did what my doctor told me to do. I continued to do so for years, even after I began to have difficulties such as shortness of breath and difficulty sleeping. When I finally got to the point where I could no longer sleep - or if I did, I had terrible nightmares, I began to do research to discover if my drugs were the cause. I found that indeed statins have been shown to cause insomnia and nightmares in some patients. On stopping the drug, my cardiologist told me that I must have gotten my information from the National Enquirer, because statins surely were not the cause of my difficulties, even though I got progressively better after I stopped taking the drug. Then I discovered the website ProPublica, and found that my cardiologist had received a rather large grant for doing seminars from the very makers of my statin drug! Little wonder I have so little trust left for the medical profession. It's not about healing, or even ameliorating risk; it's all about profit.

I was on Lipitor for more than 10 years. For most of those years, I experienced muscle ache in my legs. It was uncomfortable, but tolerable. Then, things got much worse. I had been a healthy guy and exercising regularly, and suddenly I began to have difficulty climbing stairs. After heavy exercise (yard work, painting) I became nearly incapacitated and couldn't engage in any physically difficult activity for months. And then I had ALS like twitching in my legs. After seeing a neuromuscular specialist at one of the most prominent university teaching hospitals I was diagnosed with myopathy, possibly due to long term statin use and benign fasciculation syndrome. Oh, and did I mention the memory problems. I had gone from capably leading a large teaching hospital to struggling with daily activities. I then went off statins and while my muscles haven't fully recovered, they are stronger than before. I can climb stairs more easily and do yard work without becoming incapacitated for days. I still have the twitching in my legs, my balance and leg strength haven't fully recovered and my memory is better, but less than before. It is time for leading researchers in cardiac care to stop drinking the cool aid and recognize the serious, disabling side effects from statins to reconsider the efficacy and potential harm done by statins. I hope that courageous person will step up and do what is right.

Statins cause permanent damage in a huge number of individuals. I'm one. At Johns Hopkins and Yale, I was told that statins had triggered an autoimmune disease, permanent, incredibly debilitating, painful. From weeks of 8-hour a day treks in the Himalayas, I now struggle to walk for 15-20 minutes. My leg muscles are rotting away. Many, if not most adverse effects (bad side effects) aren't reported. Pharmaceutical companies make it hell for MDs to substantiate an adverse effect. How do I know? One of my physicians told me. American Heart Association, funded hugely by pharmaceutical companies, is part of the problem. I called them before taking simvastatin, and I received a mindless, misinformed sales pitch. Take your statin drug. Miraculously, a year after my athletic life, and much of the rest of my life was destroyed, the "Experts" who have come up with new "Guidelines" have raised the acceptable LDL level to under 190. My doctor a year or so ago was trying to get me under 100. I will never recover from the horrid disease I now have--brought on almost instantly by 6 short months on 20mg of simvastatin. BEWARE, IT COULD BE YOU! Does anyone really believe that 25-35% of humanity needs a statin drug to be healthy? It's just a nasty business. Don't trust the warning labels on statins: lots of thing aren't reported.

I was aware that I was "allergic" to something when I was given Zocor in 2004. No one could explain why after 12 weeks I was so very exhausted, unable to sleep due to muscle and back pain. I blamed it all on my profession as a specialist in alcohol/drug addiction and marriage counseling. Gradually the symptoms eased with sporadic doses of pain meds and steroid shots. When my GP heard about it he stated that I could never take statins again because of the severe side effects. Four years later I had a stent placed in my heart and when I objected to the statin medication, I was told I would die if I didn;t take it. This time the reaction was immediate. Within 3 months I could not walk from the car into my office. Again the muscle pain and back pain caused lack of sleep. The doctor I saw said that I was losing muscle mass and immediately called the cardiologist. Again I was told that I had to take the medicine. Within 6 months I was unable to function. I lost my breath in brief walks, cried all the time and was not able to work. Four years later I am still noticing what little strength I have. I can not stand in line at the gas station, walk in the mall. Often there are spasms in the thigh area and calves. I had to close my office and move to another state for my siblings to help me. I was so very angry and this has not stopped. I can not explain what it is like to have doctors look at me and say that there is nothing wrong. My son said that he watched me age 10 years in 3 months. I don't know how statins can help anyone!! Now I am suddenly showing autoimmune disorders, continued weakness and fatigue and emotional ups and down. I am frightened that this "thing", like weakness will continue to spread very slowly to any muscle in my body and my heart will just not be able to keep beating. I tell anyone that will listen that these drugs are very dangerous and be very aware.!!!

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