Case study 3 - assignment PDF

Preview

Summary

assignment...

Description

Cholesterol Confusion, Statistical Deception and the Statin Controversy – Case Study #3

Abigail Dispo(645) Anmad Sohail(257) Braydon Wraxall(302) Emily Lascu(683) Mazen Campong (196) Navreen Jhawar(187)

Ontario Tech University, Faculty of Health Sciences HLSC3821 Public Health II Wally Bartfay Friday, March 26 , 2021 th

1. The cholesterol hypothesis, also known as the diet-heart hypothesis, originated from American physiologist Ancel Keys, who believed that dietary saturated fat raises cholesterol to cause coronary heart disease. (1) His hypothesis primarily revolved around three concepts: (1) increased cholesterol is associated with increased cardiovascular disease, (2) Dietary saturated fat increases cholesterol,(3) since dietary fat increases cholesterol, dietary fat increases cardiovascular disease risk. (2) To prove his theory,

Keys formulated a graph showing an exponential growth between the amount of coronary heart disease deaths and the amount of saturated fat (in calories) associated with it. However, the graph misinterpreted only six countries’ results without considering the data from 22 other countries to elicit the exponential increase. (1) There is no relationship to distinguish the relevance between coronary heart disease and saturated fat as we would have found countries with much higher heart disease levels eating saturated fat. (1) Therefore, the association of cholesterol with coronary heart disease does not necessarily prove causation. These data results indicate no sufficient evidence to support this hypothesis, especially with the role of statins. Statins are primarily known for lowering cholesterol levels in individuals with atherosclerotic heart disease. (3) Given the perceived relationship of low cholesterol levels leads to low incidence and risk of coronary heart disease, statins were produced to deliver these results. However, throughout all statin trials, serious concerns have been raised regarding clinical study results, premature trial terminations, under-reporting of adverse side effects, decrease patient follow-ups, and monetary influence by pharmaceutical companies.(3) These inefficiencies show how statins do not primarily aid in benefitting the public’s benefitbeing but for pharmaceutical companies’ benefit. 2. Throughout pharmaceutical rein within the healthcare industry, there has been a rising motive to increase production and reap profits. This pushes leniancy within company standards and results in a product that can cause more harm than good. Recent findings have shined light on Statins regarding its effectiveness, and claims have shown support towards falsified trial results. Many studies have been conducted to test whether Statins could prevent heart disease. One study was conducted to test the hypothesis that claimed

Statins had an effect to prevent heart disease. This study had a 5 year timeline with 2000, healthy middle aged men as participants. The results concluded that there was an ARR (absolute risk redcution) of 1% with a NNT (number needed to treat) of ≥100.(4) The statistics were presented to the public and other healthcare professionals with a RRR (relative risk reduction) statistic. The RRR value is misleading to the public as it is a statistical tool which is used to amplify the true effects that Statins have on the user.(4) The RRR value that was shared with the public stated that the statin treatment reduced heart disease by 50%, while the ARR (actual reduction rate) was 1%.(4) Clear bias and manipulation of events has led to a wide misrepresentation of the efficacy of Statins. A second trial supports the fraudulent claims, as an investigation was conducted to test the effectiveness of Rosuvastatin. This study took 17,802 healthy individuals with elevated levels of C-reactive protein but no signs of prior CHD or elevated cholesterol levels.(4). This analysis was concluded after a median follow-up of 1.9 years, with outcomes regarding harmful cardiovascular causes. (4) After many patients experienced lifethreatening cardiovascular issues, it was reported that between fatal and nonfatal CHD, only 0.41% of the population benefited from the medication.(4) The miniscule effects were published with an inflated positive point of view as Forbes magazine quoted “It’s spectacular ... We finally have strong data’ that a statin prevents a first heart attack.”(4) Forbes magazine is one example of how manipulated information from drug companies has reached mass publicity, and caused confusion within the healthcare industry. Other trials have also been conducted to expose the falsified claims regarding the reduction of mortality rates caused by fatal CHD. A trial was conducted to test whether the use of Atorvastatin reduced fatal CHD. The publicized effects of Atorvastatin recorded a

whopping 36% RRR of fatal CHD with an ARR of only 1.1%.(4). Bias needs to be eliminated by enforcing common units of measurement among all company result findings. Furthermore, therenneeds to be more awareness adressed regarding the RRR statistic by the FDA to clear any misunderstandings within the healthcare industry. 3. Diamond and Ravnskov (4) state that three serious adverse effects of prolonged statin use include cancer, myopathy, and the central nervous system (CNS). Most stain trials occur within 2 - 5 years, which is too short to determine whether cancers will develop within these patients. However, there is strong evidence that low cholesterol and statin use contributes to an increased risk of cancer. This association is especially true amongst women with over ten years of statin use, who have an increased risk of developing breast cancer. There is evidence that discusses the association between low cholesterol and disorders of the central nervous system. A study done by Muldoon et al. discovered that low cholesterol resulted in diagnoses of violent or aggressive behaviour, which determined that altered cholesterol levels result in psychiatric disorders. Low cholesterol levels are a biomarker of severe depression and suicidal behaviour, as well as decreased cognitive function and Alzheimer’s disease. Myopathy is the most common adverse effect experienced amongst statin users, especially in women and older adults. Dubroff and Lorgeril (3) state that data from the largest statin survey by the National Lipid Association determined that approximately 30% of patients experience muscle pain, and 57% of the patients in the survey state they stopped using the drug because of the side effects. Diamond and Ravnskov (4) states that although the use of statin promises substantial benefits to users, in actuality, the drug is unable to reduce mortality rates and the adverse side effects are significant.

4. There are several alternative theories as to why atherosclerosis may develop that are independent of cholesterol metabolism and where future prevention strategies can be optimized. One area that has been linked to atherosclerosis is the genes of some individuals that may make them more susceptible to developing complications. Research has found 46 loci that have been linked to atherosclerosis and may be the cause of coronary heart disorder without any link to cholesterol. With this knowledge, future research into these genes may provide alternative ways to deal with atherosclerosis and CHD. Another area that shows how atherosclerosis may develop independently of cholesterol is at the cellular level. T lymphocytes and macrophages likely play a role in atherosclerosis since it is an inflammatory disease. Using this knowledge, future prevention strategies can be carried out with a specific focus on anti-inflammatory medication and methods like diets that naturally fight against inflammation. Other studies have shown a relationship between developing atherosclerosis and increased blood glucose levels with no connection to cholesterol. It was found that people who drink sweetened beverages were more likely to develop atherosclerosis and this is important because further research and implementation of healthier diets could be the key to helping individuals suffering from atherosclerosis instead of relying on statins. Another theory as to why people develop atherosclerosis independent of cholesterol levels could be due to red meat, specifically the L-carnitine found in red meat that is metabolized into trimethylamine oxide which influences atherosclerosis. By focusing on researching and establishing healthier plant-based diets in the future, rather than statins, atherosclerosis can be eliminated without individuals even developing the condition.(3)

5. The Mediterranean diet has been shown to prolong life and lower the risk of diabetes, cancer, and coronary heart diseases. Instead, we should consider the contradictions in the cholesterol hypothesis and the demonstrated advantages of a balanced lifestyle that includes a Mediterranean diet to avoid CHD. Various research has proven that the Mediterranean diet decreases cardiovascular events and mortality while not reducing cholesterol levels. “The Lyon Diet Heart Study utilized the Mediterranean diet and reported a 70% mortality reduction. Subsequent studies of the Mediterranean diet have confirmed these findings and also shown a reduced risk of cancer, diabetes, and Alzheimer’s disease.”(3) Although we can't modify our genes, epigenetic studies have shown that the Mediterranean diet can alter the expression of atherogenic genes positively. Inflammation markers and coronary heart disease can also be decreased by adopting a Mediterranean diet. Coronary heart disease is a complex disease, and the assumption that it can be avoided or cured by merely lowering cholesterol tends to be unfounded. The Mediterranean diet is rich in plant-based foods that have been minimally processed helping with the reduced risk of establishing coronary heart disease. Research supports the use of the Mediterranean diet as a healthy eating pattern for the prevention of cardiovascular diseases, increasing lifespan, and healthy aging.

References: 1.

Statin Nation: The great cholesterol cover-up. [Internet]. Statin Nation. [cited 2021Mar30]. Available from: https://www.youtube.com/watch?v=aN_Cpd_NpMY&ab_channel=EliSharon

2.

Ramsden CE, Zamora D, Majchrzak-Hong S, Faurot KR, Broste SK, Frantz RP, Davis JM, Ringel A, Suchindran CM, Hibbeln JR. Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73). BMJ [Internet]. 2016 Apr 12 [cited 2021Mar30] ;353:i1246. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4836695/

3.

DuBroff R, de Lorgeril M. Cholesterol confusion and statin controversy. World J Cardiol [Internet]. 2015 Jul 26 [cited 2021Mar30];7(7):404-9. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4513492/

4. Diamond, & Ravnskov (2015, February 12). How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease. Expert Review of Clinical Pharmacology, 8 (2). doi:10.1586/17512433.2015.1012494...