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Part 3: My Spirit is Broken: Will the New Statin Guidelines Do More Harm Than Good?

The statinization of society



Part 1: A $29-billion-dollar-a-year industry Part 2: The selling of a disease Part 3: The statinization of society In 2011, the Cochrane Collaboration published a meta-analysis, or a study of studies, on the effectiveness of statins for primary prevention of CVD. They concluded that 223 people with no previous history of CVD would have to be treated with statins for three years in order to avert one death. Even that figure was an exaggeration, since the meta-analysis included studies in which as many as 10 percent of participants did have a previous history of CVD. The authors concluded "Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk."
And yet, last November, the American Heart Association released new guidelines which could double the number of Americans deemed eligible for statin therapy. The most controversial part of the guidelines concerned individuals between 40 and 70 years of age, with no signs of CVD, and not afflicted with either diabetes or a rare genetic predisposition to pathologically high cholesterol levels. Moderate-dose statin therapy was recommended for all such individuals, regardless of blood cholesterol levels, provided the 10-year risk of developing CVD was judged to be in excess of 7.5 percent, as determined by their risk calculator, available at www.my.americanheart.org. Literally overnight, millions of previously healthy Americans were re-defined as having an illness requiring treatment with powerful drugs, presumably every day for the rest of their lives. The new AHA guidelines were based on a 2012 meta-analysis by the Cholesterol Treatment Trialists' Collaboration, led by Professor Sir Rory Collins, which concluded that statins for primary prevention reduced all-cause mortality by 9 percent for patients with less than a 10 percent risk of a heart attack. Doctor John Abramson is a Lecturer in the Department of Health Care Policy at Harvard Medical School and the author of Overdo$ed America. (He also describes himself as an expert in litigation, including a case that involves statins.) When he and his colleagues re-analyzed the data from the CTT Collaboration's 2012 paper, they found that statins for primary prevention of CHD in low-risk patients resulted in no significant reduction in either serious adverse events or all-cause mortality. Writing in October 22 issue of BMJ, they concluded "[T]he net benefit-harm equation has zero overall benefit (the small reduction in serious cardiovascular events is counter-balanced by a non-specified increase in other serious adverse events) and ignores the clear evidence of harm that has been demonstrated in clinical trials and observational studies." The next day an editorial in BMJ by Editor-in-Chief Fiona Goodlee noted that all of the studies included in the CTT meta-analysis were paid for by the drug companies. Studies funded by the drugmakers consistently report greater drug effects than those funded by other sources; this point is as well documented as anything in science, and was confirmed yet again by another meta-analysis published in 2012 by the Cochrane Collaboration.

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The day after the AHA revised guidelines were introduced, an op-ed piece in the New York Times written by Dr. Abramson and Dr. Rita Redberg, editor of JAMA Internal Medicine. The authors blasted the new guidelines, citing Dr. Abramson's re-analysis of the CTT data and noting "(B)ased on the same data the guidelines rely on, 140 people in this risk group [i.e., those with less than a 20 percent chance of developing CVD] would need to be treated with statins in order to prevent a single heart attack or stroke, without any overall reduction in death or serious illness. "At the same time, 18 percent or more of this group would experience side effects, including muscle pain or weakness, decreased cognitive function, increased risk of diabetes, (especially for the women), cataracts or sexual dysfunction." Prof. Collins, the head of the CTT Collaboration, in turn blasted the conclusions of Dr. Abramson and his colleagues --first in a private meeting with Dr. Goodlee, and then in an article in the Guardian in which he claimed that Dr. Abramson's article was a "serious disservice to British and International medicine." On 15 May 2014 BMJ published a correction to the article by Dr. Abramson and his colleagues, and Dr. Goodlee announced the formation of an independent panel to determine whether the article should be retracted in toto. And what was the point of contention that led Dr. Collins to demand a full retraction of the BMJ article? The article claimed that statin-related side effects occurred in 18-20% of patients, citing a 2013 paper by Doctor Huabing Zhang and his colleagues published in the Annals of Internal Medicine. The paper by Dr. Zhang and his colleagues actually said, "Statin-related events were documented for 17.4% of patients." In the end, BMJ resisted the calls for complete retraction of the paper, although on 15 May they did publish a correction which stated in part, "The primary finding of Abrmason and his colleagues --that the Cholesterol Treatment Trialists' data failed to show that statins reduced the overall risk of mortality among people with < 20% risk of cardiovascular disease over the next 10 years--was not challenged..." In a telephone interview, Dr. Abramson said "This problem has been framed in the wrong way, the way a magician frames something the wrong way in order to trick the audience. We need to re-frame the question: 'How do I prevent heart disease and stroke?' 80% of risk of heart disease and stroke comes from unhealthy lifestyles. What can I do to prevent it? Clearly what they can do is become physically fit. That and quitting smoking are far and away the most important things. "Losing weight isn't really the issue," he added. "The issue is being physically fit. Having spent years as a family physician, I know it I really hard for people to lose weight. People feel really guilty about not losing weight, but the principle issue is being physically fit." The medical literature bears out these assertions. A meta-analysis recently published last year in BMJ found exercise was just as good as statins in preventing mortality from coronary heart disease. Astonishingly, a University of Missouri study also published last year that compared exercise plus statins to exercise alone found that statins actually canceled out the benefits of exercise. That's bad news, at least for anyone who owns stock in drug companies. The good news is that a study at the University of Texas Southwest Medical Center found that exercise largely canceled out the harmful effects of elevated cholesterol levels. So why all the emphasis on statins instead of healthy living? Appendix 1 of the AHA guidelines gives us a hint. One or more of the panel members had taken money from each of the following companies: AstraZeneca (Crestor), Abbott Laboratories (Crestor), Merck (Mevacor, Vytorin), Novartis (Lescol), Pfizer (Lipitor, Caduet), and Teva Pharmaceuticals (Zocor). For the fiscal year 2011-2012, the AHA itself reports accepting contributions from Bristol-Meyers-Squibb (Pravachol), Schering-Plough (Vytorin), as well as AstraZeneca, Merck, Novartis, and Pfizer. Professor Sir Rory Collins has accepted research funding from AstraZeneca, Merck, and Pfizer. Teva Pharmaceuticals currently is under investigation by the Securities and Exchange Commission for alleged violations of US anti-bribery laws. Every single one of the other companies listed above has paid out hundreds of millions of dollars within the last few years to settle claims of illegal marketing of its products, including a whopping 2.3 billion dollars paid by Pfizer in what at the time was the largest health care fraud settlement in history. The US Department of Justice suit against Pfizer accuses the company of a variety of unlawful practices, including paying kickbacks to health care providers to induce them to prescribe its drugs. But even more alarming than that is the fact that, for the most part, the drug companies are the ones charged with assessing the safety and the effectiveness of their own products.

Privatized medical research

"We have privatized medical research," Dr. Abramson warns. "Now rather than asking the question how can people decrease their risk of heart attack or stroke, the research is performed to see how the drug can increase their profits. That's not against the law. That's their job. That's their fiduciary duty." Meanwhile the statinization of society proceeds apace. Just last March, Sir Doctor Magdi Yacoub, Professor of Cardiothoracic Surgery at Imperial College of London, gave an interview for BBC Radio 4 in which he opined that everybody over 40 should take statins. As for Sulette Brown, she had to retire from the job and the life she loved so much. Although she stopped the statins, the deterioration she believes they caused has not reversed itself. No longer able to care for herself, she moved in with her sister and brother-in-law in Michigan, where she still lives today. "I was in Oklahoma for 35 years," she adds. "None of my friends or my support system or peers are around me anymore. "The thing I regret most is the depression that never leaves. We've tried all kinds of things and it does not go away. My spirit is broken." List of Sources 1. Taylor, F. et al. 2011. Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2011 Jan 19;(1):CD004816. doi: 10.1002/14651858.CD004816.pub4. 2. Taylor, F. et al. 2013. Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2013 Jan 31;1:CD004816. doi: 10.1002/14651858.CD004816.pub5. 3. Cholesterol Treatment Trialists' Collaborators 2012. The effect of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 380:581-590. 4. Abramson, J. et al. 2013. Should people at low risk for cardiovascular disease take a statin? BMJ 347:f6123. 5. Goodlee, F. 2013. Stains for all over 50? No. BMJ 347:f6412. 6. Lundh, A. et al. 2012. Industry sponsorship and research outcome (Review). Cochrane Database of Systematic Reviews 2012 Dec 12;12:MR000033. doi: 10.1002/14651858.MR000033.pub2. 7. Abramson, J. and R.F. Redberg 2013. Don't give more patients statins. New York Times November 13 2012. 8. Bosely, S. 2014. Doctors' fears over statins may cost live, says top medical researcher. Guardian March 21 2014. 9. Goodlee, F. 2014. Adverse effects of statins. BMJ 348:g3306. 10. Abramson, J. et al. 2014. Correction: Should people at low risk for cardiovascular disease take a statin? BMJ 2014;348:g3329. 11. Naci, H. and J.P. Ioannidis 2013. Comparative effectiveness of exercise and drug interventions on mortality outcomes: metaepidemiological study. BMJ 347:f5577. 12. Mikus, C.R. et al. 2013. Simvastatin impairs exercise training adaptations. Journal of the American College of Cardiology 63:709-714. 13. Farrell, S.W. et al. 2012. Cardiorespiratory fitness, LDL cholesterol, and CHD mortality in men. Medicine & Science in Sports and Exercise 44:2132-2137.


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Patrick D Hahn -- Bio and Archives

Patrick D Hahn is the author of Prescription for Sorrow: Antidepressants, Suicide, and Violence (Samizdat Health Writer’s Cooperative) and Madness and Genetic Determinism: Is Mental Illness in Our Genes? (Palgrave MacMillan). Dr. Hahn is an Affiliate Professor of Biology at Loyola University Maryland.



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