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.  The 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 pharma’s clinical trials.  Thus because of the confluence of all these 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.