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Why Patients are Given Inferior Treatments
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An essential summation of what pharma has done to the evidence base and its consequences

Over and over again I hear people blame people for causing harm.  Step back; don’t blame the trees, but the environment that creates the forest.  As Prof. Ben Goldacre  wrote in Bad Pharma: “A perverse system produces perverse results.”  The harm lies in the system.  Below is a short explanation that shows how the tobacco ethics of corporations has been used by pharma to pervert a patient first system into a marketing first system over the last 40 years.  Through a physician’s eyes the methods the main ways in which pharma shapes the practice of medicine. 


 Why Patients are Routinely Given Inferior Treatments http://healthfully.org/rep/id11.html  --  4/13/16

When pondering why doctors who means well can get it so wrong, simply look to pharma.  Since 2004 when I started healthfully.org I have been examining health issues and discovered the corruption worked by pharma.  A major shift began in the Reagan era:  medical colleges became ever increasingly dependent upon pharma for funding and as a consequence are pharma-friendly KLOs (Key Opinion Leaders) have replaced the previous generation of independent KOLs.  KOLs run clinical trials, author most journal articles, sit on committees that write clinical guidelines, write medical textbooks, most are university professors, and they give the required continuing education classes of doctors, which are pharma funded.  For services the KOLs receive 6-figure yearly income. Thus there is a seamless content connection between clinical trials, textbooks, school classes, clinical guidelines, and continuing education classes.  Starting in medical school the future doctors are taught that for every condition there is safe and effective pills—the mantra of pharma.  Every noted expert in a field of medicine is a pharma-friendly KOL.  Pharma through KOLs has framed the medical subjects to promote their profits.  Pharma has replaced the scientific foundation of medicine with tobacco science—the spin too often is dazzling heights.  It is all about profits and pharma is very good at marketing.  

With broad strokes I shall describe the method used to create our broken medical system.  Forty years ago pharma gave university professors funds to run clinical trials and permitted them to write unhindered the journal articles.  That has changed, for the last 3 decades pharma has been running directly or indirectly all the large clinical trials;[1] and they own the results.  Pharma designs all its clinical trials for market objectives; it is tobacco science.  (The few trials funded by the FDA support pharma’s goals.)  The phase-3 clinical trials, which pharma submits to the FDA, are fundamentally tobacco trials carefully designed to make the drug seem better than it is.  The only study that compared the raw data that had been submitted to the FDA found that all 74 journal articles derived from these trials were biased; the average positive bias 32%.[2]  If the drug performs better than nothing at all (a placebo) for the condition treated a very pharma “friendly” FDA will grant a patent of exclusivity (which typically with extensions lasts 16 years). Side effects are seldom used by the FDA to deny a patent.  Frequently the FDA uses a surrogate outcome, for example the lowering of cholesterol level or blood pressure rather than heart attacks.  For statins and antihypertensive drugs, the surrogate endpoint in the short-term phase 3 does not inform doctors on the incidence of death, heart attack, and all the side effects, or how real-world patients will fare[3].  Pharma uses a very select group of volunteers in their clinical trial, ones that will respond better than the real-world population.  Pharma now outsources most clinical trials to corporations which run them in under-developed countries.  This presents more wiggle room for cooking the raw data to favor the drug.  And it gets worse.   After approval by the FDA, pharma runs low-quality, phase-4 trials not submitted to the FDA which to an even greater extent hide side effects and exaggerate benefits, or serve other marketing objectives such as on new uses for the drug, show off-patent drugs are inferior, etc.  The results of clinical trials are written up by and for pharma in a way that adds even more bias.[4]  They are published in medical journals after a rubber-stamped peer review.  Reviewers never see the raw data.  The journal articles by design misinform doctors as to how their patients will do.  Drugs are taken based upon bias-journal articles that claim for the real-world population they will significantly lengthen and/or improve the quality of life. The method of reporting patient side effects has been given to pharma, thus it is broken.  Physician on a voluntary basis can send a report of a patient side effect to the drug manufacturer.  That manufacturer “evaluates” the thousands of physician’s reports and sends their summation to the FDA, often years later.  Over-and-over again harm surfaces years later; for example, Vioxx and Celebrex caused over 55,000 U.S. deaths from heart attacks and strokes before it became public 5 years after Merck & the FDA had strong evidence of the association of Vioxx with heart attacks.  The doctors are aware that the broken information system harms patients, yet they rely upon it; why? 

Nine compelling factors explain why doctors play ball with big pharma:  1) clinical guidelines are written by KOLs to promote drugs; 2) hospital administrators use those guidelines to set up treatment goals which their physicians must meet as a condition of employment.  3) difficulty of researching the journals for the best treatments because of the mountains of tobacco science arising from a fractured system of peer review and clinical trials;  4) those same KOLs write the chapters in medical textbooks;  5) KOLs give continuing education classes (CEC); 6) through the combination of 1, 3, 4, & 5, pharma frames the discussion of medical topics for their financial gains; 7) ad post hoc fallacy:  what was done works; 8) human factors including patient expectations, peer approval, supervisor approval, and substantial financial rewards given by pharma who tracks the prescriptions given by physicians; and 9) the negative consequences for practicing medicine that is contrary to the clinical guidelines.  The confluence of these factors and human tendency of doctors to bond with their profession (we are a social animal, like soldiers in an army) entail that 95% of physicians won’t go into independent practice like Dr. Stephen Sinatra.  Wearing the boots of the physician opens the doors of perception, thus what follows is as seen through the eyes of a main-street cardiologist.     

Knowing the journals are full of tobacco science doesn’t change the fact that I must work within the existing structure in which treatments are dispensed.  First, at the heart of medical practice are the clinical guidelines. I know that select pro-pharma KOLs create guidelines for the American Heart Association, the National Institute for Health (NIH) and others based mainly upon the dodgy marketing phase-4 trials.  I know that if sued for malpractice for deviating from standard practice that in courts it is unlikely that I could convince a jury and judge that guidelines are rubbish!  Second, these guidelines are used by my hospital administrator to set up treatment standards.  They are incorporated into the patients’ computer records. For example, if a patient’s blood pressure is high, the computer screen will list recommended drugs.  What I prescribe is recorded in that record.  Moreover the hospital administrator as supervisor sets up goals which the doctors must meet to continue employment at that hospital.  I must meet those standards to remain affiliated with my hospital.[5]  This condition of employment entails that my finding what is in the best patients’ treatments will reduce my ability to sell the patient on the mandated treatment, and eventual ending in termination of my position.  I have observed among most of my colleagues a reluctance to question the junk guidelines and their junk science. Third, I do not go to a university medical library to access online the journals and attempt to find, for example, what is in the best way to control hypertension for additional reasons.  Pharma funds, direct, and also own the data of their clinical trials.  Because clinical trials are dressed as science, I would have to read each journal article and look for gaps in analysis.  Most times all I find is that the body of the article does not support two parts of the journal article. its conclusion and abstract.[6]  I know that the journal articles receive a sham-peer review:  the reviewers read only what pharma includes in manuscript; the raw data and other details necessary for a critical review are not sent as axillary materials.  The published evidence is marketing spin dressed as science.  The task at arriving at spin free answer on how best to treat hypertension would consume over 800 hours, and my conclusion would be tentative given that most trials are not designed to provide answers, just promote sales of a drug. Knowing this I am highly skeptical of what I read in the journal articles—a source I seldom turn to.  Fourth, given the broken evidence base, I turn to the leading experts, pharma’s KOLs.  These doctors & professors obtain their status mainly by partaking in clinical trials which pharma sets up, controls, and owns the data.  They researchers sign a contract that gives pharma control over the data and publications.  The journal articles that the KOLs publish with their names as authors are with few exceptions ghost-written by companies hired by pharma.  Pharma pays these KOLs an honorarium for their services.  These same KOLs lecture me in a pharma-funded and ran CEC—continuing education classes required by law.  There I am told the best treatment for hypertension is combination of 3 Pfizer drugs if the class is funded by Pfizer.  I hear a plausible modus operandi (method of operation) on how these drugs work.  I learn that hypertension accelerates the formation of plaque in arteries and the blood clots which cause heart attacks and strokes.  Of the over 120 drugs in 7 categories--based on their method of action--the best are those by Pfizer.  At the end of the class I am given 4 journal reprints all of which are on Pfizer’s drugs. I follow the KOL’s recommendations because it is considered sound medicine.  Moreover, my colleagues believe in managing hypertension saves lives.  Over and over again I hear the KOLs mantra:  “safe and effective”.  What they tell me--though spun--provides material for discussion with patients and colleagues.  Fifth, given the marketing distortion favoring sponsor, for my main source I turn to medical textbooks, Wikipedia, and The Merck Manual for information on drugs, treatments, and information on the causes and processes involved on various conditions.  I rely on these sources though I know that they promote the uses of the newer drugs and distort for that purpose the biology behind related to the condition. It is better than CEC.  There is a seamless fit between guidelines, textbooks that tie into a scenario.  In this way pharma frames the discussion of drugs, treatments, and causes.  Sixth, we think in temporal-causal order:  I take Tylenol and 80% of the time within two hours my headache is gone; therefore I believe Tylenol works.  I give hypertensive medications and 80% of my patients don’t have a heart attack within 5 years.  This is the ad post hoc ergo propter hoc fallacy (post hoc fallacy) which means “after this because of this”.  Selective memory enhances this fallacy.  Thus I have faith in some of the treatment guidelines, and the others I am uncertain as to their merit.  Seventh, there are pleasing human factors.  I like to help my patients.  Most are thankful that I am trying to manage their hypertension, because they believe, like me, that by lowering blood pressure their risk for an adverse event is significantly reduced.  Their family is thankful, and my colleagues praise my efforts.  The clinic’s administrator is pleased that I follow the hospital’s guidelines.  Being part of the medical establishment is being part of a revered organization; I am proud of the title “doctor”.  I receive over $20,000 in perks from Pfizer for promoting their patented drugs based upon my prescribing record obtained from IMS Health.  These human factors are another reason to follow the guidelines for hypertension, though I am moderately skeptical about some of them.  Ninth, I know a critic of the broken system, but I don’t believe his claim that hypertension drugs do more harm than good.  He ignores the positive clinical published trials, and he has cherry picked the negative evidence.  Pharma and the media fortunately have marginalized the critics, thus limit the harm they cause.  These critics, because they don’t follow the guidelines, don’t work at a large clinic or hospital.  In private practice, most have a small patient base and thus limited income. Doctors such as Stephen Sinatra don’t receive referrals from me or my colleagues.  Most patients want the latest, best drugs, not what Dr. Sinatra recommends:  fish oil, CoQ10, l-carnitine, d-ribose, etc.  I believe that Dr. Sinatra has a religious faith in naturalistic, alternative medicine--a faith contradicted by clinical trials.  Thus because of the confluence of all the reasons stated above, I won’t break rank with my colleagues.  I sincerely attempt to do the best for my patients in our imperfect, corporate-governed world.   

          We now have seen how pharma shapes the practice of medicine and harms everyone.  There is a fundamental conflict between maximizing profit and patients.  A perverse system produces perverse results.  Pharma is very good at marketing.  What causes corporations to aggressively market ethanol, sugar-water, and tobacco products; this too applies to pharma.  I call this “tobacco ethics”.   Books could be filled with examples of how corporation vigorously defend their right to harm.  Through direct to consumer advertising (allowed also in New Zealand and South Korea) they establish  emotional bonding to promote sales, even though we all know what they are up to.  Over and over again you watch advertisements of drugs showing smiling actors giving a testimonials on a drug.  The corporate media has painted a pro-pharma rosy picture that is quite different from reality.  Daily you watch KOLs explain how the latest wonder drug works.  It is all carefully scripted to make it seem that you are getting fair and balanced analysis.  But these advertisements create cognitive dissonance, which has turned over half the population and most seniors into pill poppers. 

The best fix for cognitive dissonance is studies, and it starts with knowing that the system is broken.  The best video on bad pharma is by is the President’s Lecture at the University of Montana.  Harvard Professor Marcia Angell’s M.D., gives us a carefully structured lecture with an excellent delivery.  It is based on her book, The Truth about Drug companies.  As she wrote:  We certainly are in a health care crisis, ... If we had set out to design the worst system that we could imagine, we couldn't have imagined one as bad as we have.”  Her book woke me up and responded with the Recommended Sections to the website.  I have pasted a collection of journal articles which confirm the quotes that the system is broken.  I have published warnings on bad meds, better choices and better diet. I lean heavily upon a critical chorus of scientists and doctors and have accumulated the most complete evidence based exposure of those myths.  I have sorted out why the Western diet causes fatty liver, insulin resistance, obesity, and cardiovascular disease and their comorbidities, from their health consequence.  While looking at the bad, you will find what I take daily for health.  I hope you notice the gorilla in the room.  I have prepared a list of books and links to videos.so you too will understand. 

 



[1] Less than 1 per year major government trials are ran, and without exception is done with consultation with pharma and ran by their KOLs.  The last to trouble industry was the ALLHAT trial completed in 2002, which found a very cheap diuretic better than patented drugs.   Guidelines were adjusted to recommend for hypertension starting treatment with a diuretic.  Results for all these drugs in the prevention of heart attacks was not statistically significant. There was no placebo group compare to side effects or to show that there was a reduction in heart attacks and deaths, which there isn’t, and is why pharma uses blood pressures instead.       

[2] The New England Journal of Medicine in 2008 published a study of 74 journal articles on 12 antidepressant agents involving 12,564 patients. “According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive.”   This entails that our government through its FDA supports corporate profits more than public health:  the FDA is part of the problem and not the fix.  The journal articles on all of the trials have all been spun to make the drugs worth their side effects.  See recommended gateway for the index of article exposing bad pharma, and healthful alternatives.     

[3] Pharma selects patients that will respond better than the norm to the drug.  Then usually they run a wash out period in a phase iii trial:  the volunteers are given the drugs for a month or more, then those whose results are unfavorable are culled from the group.  Then the trial is started with the remaining volunteers.   This wash out period is not referenced in the journal articles.  

[4] An industry has developed of companies which ghost-write the articles, then submit the article to the putative lead person on the trial, research, or review of treatment choices for a signature by the KOL.  By this methods a trial is submitted on an average to over 6 different journals to published the spun favorable outcomes. 

[5] Pharma through an assortment of ways pumps billions of dollars into the coffers of corporate hospitals for them to set up guidelines incorporated into the hospital-patient record system, and pharma buys from data-mining companies the performance of the hospitals and their doctors.  For a fee, pharmacies sell their prescription records.  Maine and New Hampshire barred this practice, but had their laws declared unconstitutional by the Supreme Court in June 2011. 

[6] Over 90% of the time doctors read just the abstract and/or conclusion section of the article.  The detailed, long body of the article  is spun to favor pharma in those two summary sections; it is a standard practice often done by a pharma ghost writer.

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Health is essential for quality of life.  Given the proclivity for injurious behavior (the prime examples being obesity, tobacco, soldiering, and recreational drugs) I can only conclude that the rational function of the brain is primarily social, including the generation of reasons for what is inexcusable; and the rest of what we do is quite similar to the actions of our cats and dogs.  I wish that all people would develop a love of philosophy (the term in Greek means love of wisdom).  With such love there would be a commitment to hold beliefs in proportion to the evidence in support there of, and there would be a drive for to live a truly moral life. 

 

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Disclaimer:  The information, facts, and opinions provided here is not a substitute for professional advice.  It only indicates what JK believes, does, or would do.  Always consult your primary care physician for medical advice, diagnosis, and treatment. 

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