Death By Medicine, Revisited (introduction)

By Gary Null and Helen Buyniski

 

By any measure, we are in the worst health crisis in American history. Out of a population of 335 million people, two thirds of us – adults and children both – are suffering from a wide range of health conditions, the majority of which are preventable. Our first effort at explaining how serious the conditions were and indeed to verify that they were real using only the mainstream medical community and the government’s official figures took several years with a group of highly qualified board certified physicians and academics with PhDs with deep experience in research scholarship.

Up until that point, no one had compiled all injuries and fatalities occurring as a result of medical treatment. The best that had been done was by Dr. Lucian Leape, a professor from Harvard who had written a groundbreaking report that had gone virtually unchallenged and unreported in the medical press. Later, the Journal of the American Medical Association (JAMA) would publish an article by Dr. Barbara Starfield showing that iatrogenesis was the third leading cause of death. Dr. Martin Makary reached the same conclusions over a decade later, publishing his findings in the British Medical Journal (BMJ). However, it was surprising and disheartening to find that with all the medical and scientific research expertise at these researchers’ disposal, they left out several important causes of death from their statistics. This showed gross flaws in their research methodology.

Our report was the most comprehensive to date published in the US. Once completed, we sent it for feedback and comment to more than 7,000 scientific publications, health reporters, and federal agencies. Not one single response was received. How is this even possible? We expected legitimate challenges and corrections; even admonitions would have been welcome. Instead, we got dead silence. Why?

Years have passed, and the state of American health has only worsened. The latest official reports show more heart attacks, more strokes, obesity, and diabetes including in children. There is more dementia, Alzheimer’s, and cancer than ever before. And yet we spent more on healthcare in 2017 than we’ve ever spent – $3.5 trillion, 17.9 percent of the nation’s GDP, and a number that is on track to further increase in 2018.1 So now we’re perplexed – if we tell people that we have the best healthcare system in the world, with the latest technology, the most pharmaceuticals and medical procedures, state of the art hospitals, and special treatment centers, we should have a population that is far more robust and healthy – but just the opposite is the case.

Then it occurred to us that we were also missing a very important piece of this puzzle. Why are we not preventing disease? How much is all this disease actually costing the patient, corporations, and society? The figures are both staggering and heartbreaking, as there is no discussion of this. We only become invested in a person after they are sick. We have only focused as a society on how to alleviate the symptoms of that person’s illness. When we compare our healthcare program and state of health and longevity with other developed nations, we are near dead last. How is this possible? Those individuals who’ve brought these dire statistics to our attention (Makary, Starfield, Leape, etc) have initiated no wider call for action. Nothing has happened. They too have been shouting into the void. This is a dialogue we desperately need. Our new article expands on the first to include a discussion on iatrogenesis, its causes, prevention, and most importantly how to resolve in part or whole all of these problems.

Costs

Dr. Leape – the first well-known physician to bring the iatrogenesis “problem” into the limelight, only to be largely ignored by the medical industry – notes that while some progress has been made, the situation is by no means resolved. Indeed, it has gotten much worse since 2009, thanks to skyrocketing premiums introduced by the Affordable Care Act and unaccompanied by an increase in quality of care. Depending on the study, medical error is estimated to cost anywhere from $20 billion2 to $980 billion3 a year –a significant sum by any measure. Our calculations place those costs somewhere in the middle, at upwards of $440 billion – but that is probably a low estimate, given how few of the medical errors that take place are ever reported.  

But what about when everything goes according to plan? That $440 billion is a mere drop in the bucket compared to the staggering $3.5 trillion Americans spent on healthcare in 2017, more than twice the amount the next two countries spend on healthcare combined and almost 18 percent of US GDP. According to a study published in JAMA earlier this year that compared the US with 10 other wealthy countries, we spend more than four times more on administrative costs, up to three times as much on pharmaceuticals, and yet achieve the lowest life expectancy of the bunch, with the average American living to 78.8 years while the mean of all 11 countries was 81.7 years. We also have the highest infant mortality rate at 5.8 deaths per 1,000 live births.4

According to the CDC, which does not track iatrogenic deaths, heart disease (CVD) is the leading cause of death in the US, accounting for 1 in every 4 deaths and killing almost 634,000 Americans in 2015.5 When one adds the deaths from stroke to the total, the number climbs to nearly 800,000, amounting to one in three American lives lost every year.6 Heart disease and stroke cost the nation $555 billion per year in healthcare services, medications, and lost productivity. The American Heart Association (AHA) believes these costs could double by 2035,7 a possibility that “could bankrupt our nation’s economy and healthcare system,” according to AHA president Dr. Steven Houser.

”The fact that CVD could singlehandedly bankrupt our nation’s healthcare system is disturbing,” Houser said. “But it’s a real possibility if we don’t act soon to do a better job of preventing what are largely preventable disorders.”8

In our medical system, however, doctors are not rewarded for preventing diseases. There is no medical billing code for a clean bill of health. Doctors who keep their patients out of the hospital are, if anything, punished by being deprived of the cash that flows to their peers in in-demand specialty fields like oncology and cardiology. Thus, expecting doctors to shift to a preventative care model without also fixing a system that only rewards treatment of the already-sick is expecting doctors to take food out of their own mouths.

Cancer is the second leading cause of death according to the CDC, killing 595,930 Americans in 2015.9 Direct medical costs in 2015 amounted to $80.2 billion.10 Because more people develop cancer every year, total care costs are expected to reach $173 billion by 2020.11 While not as financially devastating as heart disease, this is another condition we are exacerbating as a society by failing to address the causes or arrest the onset of the disease until the patient is already sick. All of this suffering and expenditure could be avoided if the profit motive was removed from healthcare, but too many people are benefiting on too many levels from the current model for meaningful change to be enacted.

An appeal to the CDC

Since the publication of the original Death By Medicine in 2009, other reports have periodically surfaced to remind the medical industry of the scope of the iatrogenesis problem. Like ours, these warnings have gone largely unheeded, sinking without a trace in the ever-widening money pool of medical spending.

In 2016, Dr. Martin Makary of Johns Hopkins University wrote to Dr. Thomas Frieden, Director of the Centers for Disease Control and Prevention, to request the agency include medical error on its list of causes of death published every year. Makary had published a study earlier that year in the BMJ revealing that a minimum of 251,454 deaths were attributable to medical error annually. He emphasized that this figure was a low estimate because it only included patients who died in hospitals and did not include outpatient deaths or deaths that occurred after discharge.

In his letter, Makary and his colleagues merely requested the CDC allow clinicians to list medical error as a cause of death on death certificates, given its prevalence. The current model limits recording options to diseases, morbid conditions, and injuries, as itemized by the International Classification of Disease billing codes, while causes not found on that list – those he calls “human and system factors in medical care” – are excluded. He recommends an additional field on death certificates that would indicate whether preventable complications of medical care were the primary cause of death, allowing a fuller picture of the circumstances without necessarily creating a legal liability.12

Bringing the high rate of medical error into the open, Makary hopes, will bring to bear the forces needed to begin to solve the problem. Government funding flows to cancer and heart disease research, while medical error is a forgotten backwater discussed only in hospital committees, the proverbial elephant in the room sucking up all the air while the medical profession hesitates to even speak its name. Being able to share best practices, and avoid worst practices, can only help both patients and doctors.

Sunlight is the best disinfectant – literally, in this case. He received no response from the CDC.

Progress?

Leape, who was honored by the National Patient Safety Foundation in 2007 with the founding of the Lucian Leape Institute to study healthcare safety, is losing patience with the industry he’s worked in all his professional life. “It’s incomprehensible to me that hospitals can continue to not follow practices that are known to make a real difference,” he told Health Leaders. He believes a depoliticized regulatory agency (he uses the Federal Aviation Agency as a model) is the solution to the medical industry’s problems, a group with powers to inspect and discipline but no conflicts of interest to prevent them from doing their job. And he suggests regulators not underestimate the value of “shaming” – public reporting – in encouraging compliance with safety standards.13

Like Makary, Leape believes it is time to leave the Institute of Medicine’s figure of 98,000 iatrogenic deaths behind and adopt a more realistic number. NASA toxicologist John T. James’ 2013 estimate of 440,000 deaths caused by medical error per year14 is supported by these and other experts. However, they admit that even the Global Trigger Tool James used does not catch all medical errors, particularly those that represent actions that should have been taken but weren’t. The true number of medically-induced deaths is probably much higher.15 Indeed, our calculations found it was more than double James’ statistic.

Yet the medical industry forges ahead with business as usual, in which they take credit for all healing but eschew responsibility for all complications, up to and including death. They cannot have it both ways, yet that has not stopped them from trying. An individual who receives the flu vaccine and does not get the flu is not praised for living a healthy lifestyle, adhering to a healthy plant-based diet, exercising every day, and getting enough sleep – but if he does get the flu, it must have been something he did. Writ large, this is the story of the entire medical system.

Defending the Indefensible

Dr. Haider Warraich, a cardiologist at Duke University, published an editorial in the New York Times that epitomizes this head-in-the-sand approach to medical harms. He reflexively defends ineffective treatments the medical establishment is starting to cast aside while dismissing patients who seek to better understand their condition by doing their research as gullible and superstitious peasants who need a medical specialist like himself to lead them out of the wilderness.

The graphic that accompanies Warraich’s op-ed says it all – an angry-looking overweight woman depicted in red tones, her face lit up even redder in the glow of her iPhone, towering over a white-coated doctor one third her size. Patients who research the treatments prescribed for them, even though they are clearly unhealthy and in need of (faith) healing, are questioning the received wisdom of the doctor as interpreter of divine will. They are effectively cheating on him with their iPhones, and that’s unforgivable. Even though the major scientific journals publish their studies online, “the internet” is reduced to a swamp of false information sure to lead the patient off the shining path illuminated by the medical professional.

Warraich focuses on statins in his paean to medical orthodoxy. He describes a patient who has a minor heart attack after neglecting to take her medication because of “scary things she had read about statins on the internet.” Claiming any of the drugs’ adverse effects can be ascribed to the “nocebo effect,” Warraich defends the drugs and even proposes criminalizing the spread of information on their harms.

In 2015, Diamond and Ravnskov destroyed the case for statins with a seminal article in the Expert Review of Clinical Pharmacology that deconstructs how Americans were tricked into embracing statins as a “miracle drug” for preventing heart attacks. While they acknowledge the effectiveness of the drugs in lowering cholesterol levels, they call into question the accepted wisdom that high cholesterol is a causative factor in cardiovascular disease. The researchers cite dozens of studies published in peer-reviewed medical literature, and outline a diabolically clever campaign of statistical deception using a statistical tool called “relative risk reduction.” During the 2008 JUPITER trial of rosuvastatin (marketed as Crestor by AstraZeneca, which sponsored the study), a miniscule difference in the rate of heart attacks between the control and drug groups was recast statistically as an impressive drug effect, even though more people actually died of heart attacks in the drug group than in the control group:

“[R]egarding fatal and nonfatal CHD, less than one-half of 1% of the treated population (0.41%) benefited from rosuvastatin treatment, and 244 people needed to be treated to prevent a single fatal or nonfatal heart attack. Despite this meager effect, in the media the benefit was stated as ‘more than 50% avoided a fatal heart attack’, because 0.41 is 54% of 0.76.”16

Worse, the drug group displayed an increase in diabetes. Although the number of incidences were small, they were not treated to the same statistical magic as the dip in heart attacks. A patient’s cancer risk increases with statin treatment, and a link with central nervous system disease has also emerged. More than one statin trial ended with an increase in suicidal or violent deaths among subjects treated with the drug.17 18 19 20 The researchers note that low blood cholesterol levels are prevalent among “criminals, in people with diagnoses of violent or aggressive-conduct disorders, in homicidal offenders with histories of violence and suicide attempts related to alcohol, and in people with poorly internalized social norms and low self-control,” as well as other psychiatric disorders.21

Cognitive problems are closely linked with statin treatment, to the extent that discontinuing the drugs often alleviates the symptoms. Padala et.al tested their hypothesis in a 2012 study by discontinuing statins in a group of patients with Alzheimer’s disease. Twelve weeks later, the study’s participants were performing markedly better on cognitive tests. When placed back on the statins, their cognition deteriorated to its previous level.22

Statins deplete the body of CoQ10 and selenium, two essential nutrients required for proper heart and nerve function. CoQ10 deficiency manifests in the muscle and joint pain experienced by many statin patients and contributes to aging, as the nutrient is a powerful antioxidant that normally protects DNA from free radical damage. As statins lower the body’s CoQ10 levels, heart and nerve function decline. The consequence is the neurodegenerative side effects so many researchers have observed. Selenium deficiency is associated with an increased risk of cancer, another side effect of statins the medical-industrial complex has unsuccessfully tried to sweep under the rug. These are not mere chance events unrelated to the actions of the drugs, nor are they some “nocebo effect” conjured through the black magic of internet research.

The packaging and selling of statins to healthy people as “anti-atherosclerotic insurance” is one of the most egregious frauds perpetrated on the American public in recent decades. A 2012 advisory by the Cholesterol Treatment Trialists’ Collaborators suggested expanding the pool of patients recommended for statin therapy, since even the least at-risk population could be shown (using the aforementioned statistical trickery) to benefit. While a 2013 revision shifted the primary treatment criteria from LDL-C levels to a “risk assessment” that takes into account other health factors for individual patients, this refactoring had the effect of increasing the numbers of Americans taking statins, not decreasing it. By 2016, fully half of men ages 60 and older were taking statins – up from 36 percent 10 years ago. The percentage of women taking the drug has increased more slowly, from 33 to 38 percent.23

A further revision of treatment guidelines, issued by the American Heart Association earlier this year, actually emphasized a “heart-healthy lifestyle” before mentioning statin drugs. This was a monumental shift given the exclusively pharmaceutical focus of most of American medicine.24 Yet Dr. Warraich does not utter a word in favor of lifestyle measures such as a plant-based low-calorie diet and regular exercise. To posit that such natural interventions might have a beneficial effect on his cardiac patients is heresy to the pharmaceutically-faithful. It is not enough that the next nine points of treatment in the new AHA guidelines deal with when and how to prescribe statins.  Dr. Warraich and his colleagues cannot monetize a healthy lifestyle and it is anathema to their pharmaceutical-based view of medicine.

That the AHA guidelines for managing cardiovascular disease with cholesterol-lowering therapies even mention lifestyle changes at all is an encouraging development. Their common-sense recommendations represent an island of sanity in an ocean of big-pharma faith-healing.

“Patients should consume a dietary pattern that emphasizes intake of vegetables, fruits, whole grains, legumes, healthy protein sources (low-fat dairy products, low-fat poultry (without the skin), fish/seafood, and nuts), and  nontropical vegetable oils; and limits intake of sweets, sugar-sweetened beverages, and red meats. This dietary pattern should be adjusted to appropriate calorie requirements, personal and cultural food preferences, and nutritional therapy for other medical conditions including diabetes. Caloric intake should be adjusted to avoid weight gain, or in overweight/obese patients, to promote weight loss. In general, adults should be advised to engage in aerobic physical activity 3-4 sessions per week, lasting on average 40 minutes per session and involving moderate-to vigorous-intensity physical activity.”25

It seems so obvious, and yet it took decades of expensive, flawed medical research, policy and practice to reach this point. How many patients died needlessly because cardiologists like Dr. Warraich wanted to get more people on statins? How many cancer and dementia patients currently in the throes of their illness might have held onto a quality of life a little longer if they hadn’t had these drugs pushed upon them?

But “fake medical news,” to doctors steeped in the orthodoxy of the pharmaceutical based medical model, is more of a menace than the incompetence of their own profession. Similar to “fake news” in general, the menace has been blown wildly out of proportion as the latest trend in fear. Certainly confirmation bias is always a danger. If a patient is seeking out supporting evidence that their toenail fungus is terminal, they will find it somewhere online. However the volume of information available to patients on the internet is a valuable resource that should not be trivialized or demonized. Indeed, patients who do their own research before blindly accepting a doctor’s recommendations should be commended for taking care of their health. Even CNN – hardly considered a maverick when it comes to medical coverage – suggested patients discuss the risks of statins with their doctors before filling their prescriptions after a study published in the Annals of Internal Medicine this year suggested that the risks outweighed the benefits when the drugs are prescribed to prevent CVD.26

Dr. Warraich moralizes that “Silicon Valley needs to own this problem” and “be held responsible for promoting or hosting fake information.”27 Is this a call to suppress all criticism of medical modalities he favors?  Will he own up to his own field’s problems, which are far more numerous and deadly than a few misleading articles (and certainly more detrimental than the looming spectre of the Informed Patient)? While he admits the scientific community has a responsibility to patients to maintain trust, and chides a group of National Institutes of Health researchers who published a study on the benefits of moderate drinking funded by Big Alcohol, he saves most of his venom for the media. After all, the media didn’t have to cover that terrible study, did they? One might argue the traditional responsibility of the Fourth Estate is to warn the people when powerful interests are threatening them, but would Dr. Warraich rather journalists stick to publishing pharmaceutical company press releases?

And why should we subscribe to Warraich’s views? Does he think we are too dim-witted to make up our own minds about a particular treatment? His ideal patient takes the drugs they are given, regardless of their effects, even when they are contraindicated by published science. Even as official guidelines have shifted away from prescribing statins to treat moderately high cholesterol, and as the medical community is faced with incontrovertible evidence of the drugs’ negative effects, Warraich stands by this protocol. Why is he so concerned about who is taking statins, anyway?

Dr. Warraich, it turns out, is one of the authors of a 2017 study called “National Trends in Statin Use and Expenditures in the US Adult Population From 2002 to 2013.” Published in JAMA Cardiology, the study decries statin drugs’ “suboptimal uptake in higher-risk groups.” Researchers received funding from some of the largest pharmaceutical firms: Sanofi, Novartis, Amgen, and Regeneron.28 Elsewhere in his op-ed, Warraich scolds Tennessee physician Mark Green, recently elected to Congress. The Congressional candidate was the subject of an epidemic of media pearl-clutching when he responded to a town hall question with assurances that he would “get the real data on vaccines” from the CDC. Green stated, “there is some concern that the rise in autism is a result of the preservatives that are in our vaccines.” He never declared that vaccines cause autism, as he is being accused of doing, but merely echoed concerns his constituents had shared with him that the data might have been “fraudulently managed.” Green was forced to eat his words after being torn to pieces by Left- and Right-leaning media outlets alike. Concerns about the HPV vaccine, which has been linked to hundreds of deaths, as well as side effects including paralysis and sterility, are lamented as benighted superstition, even though there is no evidence the vaccine actually protects against the later-life cervical and other cancers it is advertised to ward off.30 By 2014, the CDC had already paid out almost $6 million to severely injured victims of Merck’s Gardasil HPV vaccine.31

Perhaps conceding that the old guard of the medical-industrial complex cannot win the battle for hearts and minds with science – because the science is not on their side – Dr. Warraich ends with a call to arms for other would-be propagandists: “physicians and researchers need to weave our science with stories.”  

A note on statistics

Wherever possible, we have updated the statistics used in the original book to reflect more recent studies. However, in many cases newer figures were not available. The vast majority of medical research is still funded by pharmaceutical companies uninterested in bankrolling an examination of how they are failing patients. In those cases where researchers did follow up on one of the studies we used, the updates were often light on statistics and heavy on rhetoric, suggesting their authors did not want to look too deeply into the matter lest they find nothing has changed.

Asked how he would grade the government response to 1999’s seminal Institute of Medicine report, To Err Is Human, one of the first to shine a light on the then-obscure problem of medical error, Dr. Leape was pessimistic. “I would give them an F, at best a D minus, as they have done very little. Although there was some increase in funding for research early on after the 1999 IOM report, since then the federal government has not done much to provide incentives, financial or other, to improve safety,” he said.32

In a 15-year follow-up of the IOM study published in British Medical Journal Quality & Safety, Mitchell et.al. found that while incident reporting programs had proliferated, patient safety had not improved at the same rate. Incident reporting systems fail to record most patient harms, and medical authorities estimate that only 10-14 percent of adverse incidents are reported.33

Our figures, then, while alarming, are extremely conservative. We are not optimistic that this current report will be any more honestly received and reviewed than the first, and we fully expect that this report and its authors will be challenged by those whose job is to defend all existing protocols and medical procedures, irrespective of how deadly they are. Still, we are obligated as principled researchers to call attention to this problem – nearly 1 million people dying every year at the hands of an industry that claims to cure people is a sick joke, a modern-day form of human sacrifice. We cannot dismiss these casualties as the cost of doing business, any more than we can dismiss so-called “collateral damage” in war as the cost of safety at home.

 

NOTES

1 National Health Expenditure Data. “NHE Fact Sheet.” Centers for Medicare & Medicaid Services. https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/nhe-fact-sheet.html Retrieved 21 Dec 2018.

2 Rodziewicz, TL et.al. “Medical Error Prevention.” StatPearls 27 Oct 2018. https://www.ncbi.nlm.nih.gov/pubmed/29763131

3 Andel, C. et.al. “The economics of health care quality and medical errors.” Journal of Health Care Finance. 2012 Fall;39(1):39-50. https://www.ncbi.nlm.nih.gov/pubmed/23155743

4 Papanicolas, Irene et.al. “Health Care Spending in the United States and Other High-Income Countries.” JAMA. 2018;319(10):1024-1039. https://jamanetwork.com/journals/jama/article-abstract/2674671

5 National Vital Statistics Reports. “Deaths: Final Data for 2015.” Centers for Disease Control and Prevention. 27 Nov 2017. https://www.cdc.gov/nchs/data/nvsr/nvsr66/nvsr66_06.pdf

6 Benjamin, EJ et.al. “Heart Disease and Stroke Statistics: 2017 Update.” American College of Cardiology. 9 Feb 2017. https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2017/02/09/14/58/heart-disease-and-stroke-statistics-2017

7 American Heart Association. “Cardiovascular Disease: A Costly Burden for America – Projections Through 2035.” American Heart Association. 14 Feb 2017. http://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_491543.pdf

8 Fischer, Kristen. “Why Heart Disease is on the Rise in America.” Healthline. 3 Mar 2017. https://www.healthline.com/health-news/why-is-heart-disease-on-the-rise

9 National Vital Statistics Reports, op.cit.

10 American Cancer Society. “Economic Impact of Cancer.” American Cancer Society. https://www.cancer.org/cancer/cancer-basics/economic-impact-of-cancer.html Retrieved 21 Dec 2018.

11 Mariotto, A.B. et.al. “Projections of the Cost of Cancer Care in the United States: 2010-2020.” Journal of the National Cancer Institute. 2011 Jan 19; 103(2):117-128. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107566/

12 Makary, Martin. “RE: Methodology used for collecting national health statistics.” 1 May 2016. https://www.documentcloud.org/documents/2822345-Hopkins-CDC-letter.html

13 Clark, C. “Q&A: Lucian Leape Wants Tougher Patient Safety Regs.” HealthLeaders. 28 Mar 2013. https://www.healthleadersmedia.com/clinical-care/qa-lucian-leape-wants-tougher-patient-safety-regs

14 James, John T. “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care.” Journal of Patient Safety. September 2013; 9(3):122-128. https://journals.lww.com/journalpatientsafety/Fulltext/2013/09000/A_New,_Evidence_based_Estimate_of_Patient_Harms.2.aspx

15 Allen, Marshall. “How Many Die From Medical Mistakes in US Hospitals?” NPR. 20 Sep 2013. https://www.npr.org/sections/health-shots/2013/09/20/224507654/how-many-die-from-medical-mistakes-in-u-s-hospitals

16 Diamond, D.M. et.al. “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. 2015 Mar;8(2):201-10. https://www.ncbi.nlm.nih.gov/pubmed/25672965

17 Muldoon, M.F. et.al. “Lowering cholesterol concentrations and mortality: a quantitative review of primary prevention trials.” BMJ. 1990 Aug 11;301(6747):309-14. https://www.ncbi.nlm.nih.gov/pubmed/2144195

18 Kaplan, J.R. et.al. “Assessing the observed relationship between low cholesterol and violence-related mortality. Implications for suicide risk.“ Annals of the New York Academy of Sciences. 1997 Dec 29;836:57-80. https://www.ncbi.nlm.nih.gov/pubmed/9616794

19 Davison, K.M. et.al. “Lipophilic statin use and suicidal ideation in a sample of adults with mood disorders.” Crisis. 2014 Jan 1;35(4):278-82. https://www.ncbi.nlm.nih.gov/pubmed/25113893

20 Boston, P.F. et.al. “Cholesterol and mental disorder.” British Journal of Psychiatry. 1996 Dec;169(6):682-9. https://www.ncbi.nlm.nih.gov/pubmed/8968624  

21 Diamond, op.cit.

22 Padala, K.P. et.al. “The effect of HMG-CoA reductase inhibitors on cognition in patients with Alzheimer’s dementia: a prospective withdrawal and rechallenge pilot study.” American Journal of Geriatric Pharmacotherapy. 2012 Oct;10(5):296-302. https://www.ncbi.nlm.nih.gov/pubmed/22921881

23 Carroll, Margaret D. “QuickStats: Percentage of Adults Aged ≥20 Years Told Their Cholesterol Was High Who Were Taking Lipid-Lowering Medications,* by Sex and Age Group — National Health and Nutrition Examination Survey, 2005–2006 to 2015–2016.” Morbidity and Mortality Weekly Report. Centers for Disease Control and Prevention. 13 Jul 2018. https://www.cdc.gov/mmwr/volumes/67/wr/mm6727a6.htm

24 Grundy, S.M. et.al. “Guideline on the Management of Blood Cholesterol.” American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. 2018. https://www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000000625

25 ibid.

26 Howard, Jacqueline. “Are statins overprescribed? Why the risks and benefits are so complex.” CNN. 3 Dec 2018. https://www.cnn.com/2018/12/03/health/statin-side-effects-benefits-study/index.html

27 Warraich, Haider. “Dr. Google Is a Liar.” New York Times. 16 Dec 2018. https://www.nytimes.com/2018/12/16/opinion/statin-side-effects-cancer.html

28 Salami, J.A. et.al. “National Trends in Statin Use and Expenditures in the US Adult Population From 2002 to 2013.” JAMA Cardiology. 2017;2(1):56-65. https://jamanetwork.com/journals/jamacardiology/fullarticle/2583425

30 Tomljenovic, Lucija et.al. “Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?” Annals of Medicine. 2011; Early Online 1-12. https://www.scribd.com/doc/127818325/Annals-of-Medicine-HPV-Vaccine

31 Lind, Peter. “US court pays $6 million to Gardasil victims.” Washington Times. 31 Dec 2014. https://www.washingtontimes.com/news/2014/dec/31/us-court-pays-6-million-gardasil-victims/

32 Buerhaus, Peter I. “Is Hospital Patient Care Becoming Safer? A Conversation With Lucian Leape.” Health Affairs. Nov/Dec 2007:26(6). https://www.healthaffairs.org/doi/full/10.1377/hlthaff.26.6.w687

33 Mitchell, I. et.al. “Patient safety reporting: a qualitative study of thoughts and perceptions of experts 15 years after ‘To Err is Human.’” BMJ Quality & Safety. Jul 2015:25(2). https://www.researchgate.net/publication/