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Anatomy of a Deceptive Medical Study


“both doctors and pharmacists were succumbing to the alure of commercialism and thus became unreliable allies for the ‘intelligent’ consumer.”

-Nancy Tomes, Remaking the American Patient, written about the evolution of health and medical consumerism in the early 1900’s



In elders with high cholesterol or risk factors for heart disease, will statin cholesterol medicines help reduce strokes and heart attacks, extend life, and have no significant side effects? 28 randomized trials that included a small number of people over age 75 demonstrated no benefit and substantial risks (falls, fatigue, weakness) from statin use, especially high dose. I summarized some of these results in a review article with Alan Roth published by the largest peer reviewed journal in the country, concluding that statins should not be used in elders.

 

Now a new, larger study in the Annals of Internal Medicine suggests otherwise, demonstrating that in fact statins dramatically reduce strokes/heart attacks and extend life.  What are we to believe?  How did this study demonstrate an outcome that all other studies proved wrong?  The answer is illustrative about how patients and doctors can be manipulated by deceptive studies which in turn leads to widespread endorsement of new medical drugs or treatments by focusing on only that which helps sell the product being peddled.  In this and many cases, one or a few manipulative and poorly constructed studies are touted as being authoritative by the medical powers and the media thus erasing all doubt and all other evidence that speaks in a more nuanced, scientific, and caring language.  In health care, absolutism is the formula that best sells the illusion of good health.

 

Nancy Tomes book is one of many that explores the evolution of a commercialized medical landscape that emerged after the Flexner Report of 1917, when the AMA, industry, and academia all came together to craft a medical formula with which we still live today, one predicated on top-down dogmatic absolutism that generated huge profits and is touted as being scientific.  She writes about the 1920’s: “The worship of modern science meshed nicely with the ‘cult of the new’ so central to modern consumer culture, promoting the assumption that old was bad and new was good in medicine and elsewhere.”  Thus in health care, even today, the idea that new is better has become somewhat of a truism pushed by doctors despite the fact that they know little about the “novel” drugs and procedures they are promoting, many of which are far more dangerous than helpful.

 

Take Eliquis for example.  We have known that in elders with atrial fibrillation who have no bleeding or fall risk, blood thinners like Eliquis can reduce the chance of getting a noticeable stroke by about a half percent a year.  This has led to its widespread endorsement by doctors who toss blood thinners down the throats of elderly patients to the tune of many billions of dollars a year, no questions asked.  To doctors it is an absolute good, being both necessary and lifesaving, with side effect typically nonexistent.  Patients believe they will invariably get a stroke if they say no to this miracle drug.  But that’s because the studies promoting its use are deceptive.  They don’t include people who fall or bleed.  And now Eliquis has rushed ahead of all other drugs as being the leading cause of hospitalization in the elderly.  A new study that included elders with some aspect of frailty like fall risk explains why Eliquis is hurting elders so drastically; in fact, 15% of elders on this drug are hospitalized from major bleeds every year, 1% die a year from bleeding, and 1% of people get serious strokes from bleeding in their brains.  Yes, more people get strokes on the drug than off it, and more people die.  But all the carefully manicured studies that manipulated truth have frightened patients and empowered doctors to push drugs, the most intoxicating antidote to the uncertainty of getting sick or dying, even if these miraculous drugs actually increase the chance of getting sick or dying!

 

What about dementia?  Studies of those drugs carefully avoid judging success by noticeable improvement and end their trials at a year when placebo seems to be at least equal to drug.  Now a $50,000 a year drug that causes a massive amount of brain bleeds and elicits no noticeable improvement in dementia progression is being peddled as necessary and safe by neurologists, as we have discussed.  How about blood pressure? The one blood pressure study that demonstrated some benefit of tight blood pressure control in elders manipulated and exaggerated data but is used as the gold standard of how to regulate blood pressure in the elderly, even though every other study done on blood pressure lowering in the elderly disputed its findings and despite that tight control of blood pressure in elders saves no lives but causes falls, confusion, weakness, strokes, and kidney disease, and even though this study applies to a very tiny group of elders.  Same with diabetes, where endocrinologists insist on tight control of sugars in the elderly which we know to be detrimental, and to achieve this they use expensive new and unproven drugs including new forms of insulin.  Insulin now sits right behind Eliquis as the second most toxic drug that sends elders to the hospital.

 

And then there’s Paxlovid for COVID, where the first two studies clearly were designed to manipulate doctors and patients but, with more critically thoughtful reading (which generally doctors are not trained or inclined to do), showed no benefit and triggered potential harm.  The drug was prescribed to the tune of tens of billions of dollars because studies tricked doctors who then passed the misinformation to their patients who took a dangerous drug for fear that if they didn’t they may die.  Now a new Paxlovid study shows no benefit and potential risk, but due to myths weaved by the past studies and declarations by the media, doctors still prescribe it and patients still think they need it.

 

The list of how deceptive studies have led the medical community down perilous pathways goes on and on and has been documented by many books and articles, from Being Mortal to Ending Medical Reversals to The Danger Within Us.  It takes one doctored study designed by drug companies, written by complicit academic doctors, and published in an authoritative medical journal to alter the medical landscape and convince patients to be inappropriately drugged, even if every other study and every other bit of our experience tell us otherwise.

 

The cholesterol myth has been around for 70 years, and doctors are very quick to tout the benefit of measuring and treating cholesterol (typically with statins) at all ages and in all situations despite ample data that shows otherwise.  These doctors use drugs to fix numbers and then tout benefit if numbers improve, while at the same time discounting any negative side effects that they wash away as nonconsequential.  Thus, because 50% of all statin prescriptions are given to people over 75, and since no prospective and reliable studies show benefit in this age group, the myth makers and their adherents needed a study crafted to give them what they want, and this new study does the trick.

 

We know based on several studies (including one of Baltimore doctors) that only ten percent of doctors who prescribe medicines understand the risks and benefits of what they are prescribing and typically amplify benefits and negate risks.  This is especially true of specialists who prescribe the lion share of medicines based on fallacious evidence typically not appropriate for elders and always favor newer and less well studied medicines.  As the quote to start off this blog demonstrates, this is not a new problem in American health care and it isn’t going away.

 

This is compounded by the fact that the medical institutions that pay doctors to conduct drug-company studies, and the journals that print these studies, are largely financed by the very drug companies whose drugs are being evaluated.  The Annals of Internal Medicine, along with other prestigious journals such as JAMA and New England Journal of Medicine receive the bulk of their journals’ funding from drug company ads.  If an environmental magazine received all its funding from Exxon-Mobile and BP; likely most people would not accept any studies in that journal that decried alternative energy.  Then why are we so accepting of medical studies in journals financed by drug companies?  An article tackles that questions, but as of now nothing is being done to curb this, and people blindly accept studies published in these journals despite their specious origins.

 

And so now to the cholesterol study, published in Annals, not financed by drug companies, but clearly intended to promote the use of drugs in a vulnerable population that has been proven to be resistant to such drugs and even harmed by them.  This study was not a prospective randomized trial (which is the only type of study truly valid), was done only in Chinese people from Hong Kong, and comes to conclusions not supported by the data.  In fact, this article tells us nothing that is of value (but it will be used by doctors, especially cardiologists, to justify drugging people who should be kept on as few medicines as possible) while it tells us everything about how companies and journals use manicured studies to promote an agenda antithetical to science and care.

 

The study employs a concept called data mining whereby the authors look at a cohort of patients through their electronic medical record data, ascertain who of these should be taking statins based on prevailing criteria (which has never been validated for elders), and then evaluate after five years whether people on cholesterol medicines did better than those off it.  What they found was that indeed people on these medicines did better in all outcomes, and that the improvement was significant.  That’s the press release and what 90% of doctors will use as sufficient evidence of efficacy without actually reading the article or its methods.  Here are some flagrant flaws of the article and why its findings can’t be generalized or even accepted:

 

·       The study was done in Hong Kong on a targeted Chinese population; there is no reason to believe these findings would be the same in our country or in other ethnic groups.

·       While the study examines outcomes such as heart attacks and strokes, it never defines criteria for those.  Both can be picked up based on lab testing or CT screening in the absence of symptoms, and those types of events tend to be clinically nonsignificant.  So, we don’t know how many clinically important events statins prevented.

·       The study did not control for diet and exercise.  We know from prior studies that people who tend to be healthy (eat well, exercise, don’t smoke) are more trusting of doctors and more likely to take medicines.  Thus, the improvement in outcome could well be from lifestyle differences between the two groups, not the statins themselves.

·       The study excluded anyone who had been on a statin and stopped it.  In other words, people who were intolerant of statins were not part of the data analysis, thus removing a large group of people from the study who likely would have adverse outcomes from the drug.

·       In considering side effects, the study only looked at those that are measurable, myopathy (muscle damage with high muscle blood levels) or liver dysfunction (again, based on abnormal lab tests).  The authors, after excluding anyone with a prior statin reaction and narrowing the definition of side effects, then declared that the drugs were safe.  But we know based on prior studies, and based on ample clinical experience, that statins destroy the muscles of elders without altering blood tests, and this destruction increases the risk of pain, weakness, and falls, as well as causing fatigue and metal fogginess, all outcomes that the study designers believed not to be important enough to track.

 

Even with its problematic design that provided an advantage to those who took statins likely not related to the effect of the statins, the overall improvement in outcome was tiny.  Only about 1% of people avoided a bad event in 5 years, and we don’t know the extent of the bad events, or even if they lived substantially longer.  Most significantly, we don’t know how these toxic medicines impacted them otherwise, since the researchers simply did not care about such trivial matters as falls, pain, weakness, or quality of life.

 

The proliferation of junk studies like this published in major medical journals has led to a flawed medical dogma that always seems to find benefit and negate risk.  The public thinks that this is science and must be regarded as being valid.  It is not.  Doctors want to prescribe medicines and patients want to take medicines.  The use of medicines allays fear of death, illness, and uncertainly.  When misleading studies like this are released—just like what has been done with Eliquis, Paxlovid, dementia drugs, and so many others—it leads to physician behavior and patient acceptance that in the end causes far more harm than good.  The case of Eliquis should be a dire warning of what happens when we blindly medicalize aging and promise to eradicate illness with drugs and tests, because now Eliquis is filling our hospitals and morgues with people who were told that the drug is necessary and beneficial.

 

Major media outlets, also heavily financed by the drug industry, typically publish the results of these types of studies and conduct interviews with prestigious academic doctors who help drug companies design and carry out flawed research.  There is no nuance in their reporting; even if 30 prior studies came to a conflicting conclusion, when one study, even one as manipulative as this one, shows drug benefit, then that study is all that doctors, the media, and company advertisers promote.  The loser is always the patient, who trusts their doctor and who is fed a meal of pills that make them sick but deludes them to think they are being saved by a doctor who is caring and who is well versed on the data and how to apply that data to each specific individual.  That trust is clearly misplaced.  It is a very sad and tragic situation indeed when health care is transformed into a dogmatic religion that deceives people into making themselves ill.  But that’s the fuel for our 4-Trillion-dollar health care industry, whose costs continue to accentuate as life expectancy and health plummet, all benefiting the doctors and industries who light the flames of myth.

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