Why Physicians Prescribe Junk Treatments

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.

[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.

[1] 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.

[2] 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.