Recommended Exposing Pharma

Why Physicians Give Junk Treatments

Why Patients are Routinely Given Inferior Treatments http://healthfully.org/rep/id11.html  --  9/3/16

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.  Typically 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 continuing medical education (CME) classes required of doctors, that are pharma funded.  For services the KOLs receive 6-figure income. There is a seamless content connection between journal articles, textbooks, school classes, clinical guidelines, and continuing education classes.  Starting in medical school the future doctors are taught that for every condition there are 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 sales.  Pharma has replaced the scientific foundation of medicine with tobacco science—the spin often to 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, staring in the Reagan years:  pharma runs 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 (obtained by the Freedom of Information Act) 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 trials do not inform doctors accurate on the incidence of death, heart attack, and 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—more wiggle room.  The marketing department works with the corporations hired to make their drug seem better than it is in other ways besides manipulating the raw data.  One method is to run a wash-out period, whereby they start a test trial, then eliminate a large number of volunteers based upon their response (washed out), then with the smaller group start collecting raw data for the clinical trial.  And it gets worse.   After approval by the FDA, pharma runs low-quality, phase-4 trials not submitted to the FDA.  They blatantly serve marketing objectives, such a finding new uses, exaggerating benefits, superiority to off-patent drugs, etc.  The results of these clinical trials are written up for pharma in a way that adds even more bias.[4]  Pharma owns the raw data and won’t share it with the medical journals, thus the peer reviewers see only the biased write-up; this makes the process of review a sham.  And it gets even worse:  The method of reporting patient side effects has been given to pharma by the FDA, thus it is broken.  Physician on a voluntary basis can send a report of a patient side effect to the FDA which forwards it to the drug manufacturer who “evaluates” the reports and sends their summation to the FDA 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.  Evidence for this side effect was exposed in 2000, but it took 5 years for Vioxx to be removed.  Reluctantly the FDA pressured Merck to remove Vioxx.  Of those drugs not worth their side effects, very few are banned.  Though banned in all industrial countries, the me-too version of Vioxx, Celebrex is still on the market and heavily advertised.  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.  Doctors are aware of the broken information system, yet they rely upon pharma and the FDA; why? 

Eight compelling factors explain why doctors play ball with big pharma:  1) clinical guidelines are written by KOLs which provide legal protection from malpractice suits; 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 in CME classes provide advice consistent with guidelines, treatment protocols  and textbooks, which is considered sound medicine by collogues and patients; 5) through the combination of 1, 3, & 4 pharma frames the discussion of medical topics for their financial gains; 6) ad post hoc fallacy:  what I’ve done is why the patient is doing better; was done works; 7) human factors including patient expectations, peer approval, supervisor approval, and substantial financial rewards;  8) 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.  They are 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 my hospital.  I must meet those standards to remain affiliated with my hospital.[5]  This condition of employment entails that my research uncovering 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, directs, 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—this takes hours for an article.  Most times all I find is that the body of the article does not support abstract and conclusion which have positive bias.[6]  I know that the journal articles receive a sham-peer review.  No solid conclusion is possible since industry funded studies support industry. Why bother spending hundreds of hours trying to find an uncertain answer when I must follow the guidelines and administrators protocols?  Fourth, I turn to the pharma’s KOLs to provide safe, simple, guidance.  I use their textbooks, their Wikipedia articles, their Merck Manual, the reprints of journal articles given me in my continuing medical education class funded by Pfizer.  There I am told the best treatment for hypertension is combination of 3 Pfizer drugs.  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.  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, through the combination of 1, 2, 3, & 4, I follow the convenient, safe (for me) advice of KOLs.  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.  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”.  And I receive over $30,000 in perks from Pfizer for promoting their patented drugs.  (Pfizer and others companies purchase from IMS Health a list of my patient filled prescription.)  These human factors are another reason to follow the guidelines for hypertension, though I am moderately skeptical about some of them.  Eight, 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 in a hospital or a large clinic.  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 pharma’s clinical trials.  Thus because of the confluence of all these reasons stated above, I won’t break rank with my colleagues.  As an older physician, as the corporate inroads grew starting in the Thatcher-Reagan years, I have watched the golden era of medicine come and go.  There is a fundamental conflict between maximizing profits and serving patients. Knowing this doesn’t change the world I work in.  I sincerely attempt to do the best for my patients in our imperfect, corporate-governed world.   

An excellent article on the mandated continuing medical education being funded by pharma and turned into product marketing by Dr. Jason Fung and another in the BMJ. 

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