PHARMA

Misinformation in medicine is so prevalent that it is undermining the foundations of evidence-based medicine, Dr. Aseem Malhotra claims. In this presentation from Dec. 15, 2019, Malhotra explains why “the best available clinical evidence unfortunately has been corrupted by commercial influence” and which steps need to be taken to fix a broken health-care system.

In his review of the corruption of continuing medical education (CME) by the pharmaceutical industry, Dr. Jason Fung presents a “behind-the-scenes tour of what really happens with medical education and Big Pharma from my perspective as a community physician.”

Dr. Maryanne Demasi recently interviewed Dr. Paul Rosch about his efforts to combat the lipid hypothesis, his understanding of the real causes of heart disease, and his views on what it means to be a pioneer who is willing to reject prevailing scientific dogma. Here, Demasi shares highlights from that interview, as well as her personal reflections on Dr. Rosch’s vast contributions to science and health.

Placebos are used in clinical trials to demonstrate that an experimental drug is superior to the control or “inactive” pill, but sometimes placebos can contain “excipients” such as chemicals, dyes, allergens, or other confounding agents, which might unintentionally bring about symptoms in trial participants. Maryanne Demasi, Ph.D., discusses the issues that arise when placebos are not inert and how these issues may be addressed by the medical journals publishing trial results.

In 1987, the American Heart Association claimed cholesterol-lowering statin drugs would “almost eliminate the necessity for bypass surgery and percutaneous coronary intervention (PCI), and eradicate CA (coronary atherosclerosis) by the end of the 20th century.” Unfortunately, as Vladimir Subbotin, an MD and Ph.D. with expertise in disease pathology, explains, “the prognosis stopped short of satisfying the predictions.” In this presentation, delivered at a CrossFit Health event on Dec. 15, 2019, Subbotin shares his explanation for why statins have failed to meet the AHA’s expectations. That failure, he claims, is due to a fundamentally flawed understanding of the pathogenesis of the disease. He presents an alternative hypothesis.

Evidence-based medicine (EBM) grew from the recognition that medical recommendations should become more scientific, Dr. Malcolm Kendrick explains. Unfortunately, several factors confound the endeavor. Kendrick notes life expectancies have begun to decline in the U.S. and U.K. and suggests this may be due, in part, to the unreliable evidence doctors use to treat their patients. Citing prominent voices from the scientific scholarship, he discusses several reasons why our most trusted studies — randomized controlled trials and meta-analyses — are unreliable. “Can EBM be salvaged?” Kendrick asks. “Only if the public and politicians, and of course doctors, wake up to the fact that ‘something has gone fundamentally wrong with one of our greatest human creations,’” he concludes.

“Evidence on medical interventions only has value when all the data can be seen,” Dr. Malcolm Kendrick claims. Unfortunately, despite some scientists’ attempts to draw attention to the selective reporting of clinical data, negative results often remain unpublished. Kendrick argues, “Evidence-based medicine, and therefore the entire medical research database, has been corrupted to the point that it is not just unhelpful but potentially extremely damaging to health.”

Evidence-based medicine (EBM) has been described as “the conscientious, explicit and judicious use of current best evidence in helping individual patients make decisions about their care in the light of their personal values and beliefs.” Unfortunately, according to Dr. Malcolm Kendrick, the unquestioned dominance of EBM in medical practice has, in many cases, created more problems than it has solved. In this three-part series, Kendrick discusses various reasons for the ineffectiveness of EBM. Here, he discusses how the widespread influence of the pharmaceutical industry over research priorities produces research that is more profitable than helpful, leading to problems such as the antibiotic resistance crisis.

In October 2013, cardiologist and professor of evidence-based medicine Dr. Aseem Malhotra published an editorial in the BMJ entitled “Saturated Fat Is Not the Major Issue.” There, he contradicted popular wisdom about saturated fat consumption contributing to heart disease and claimed the medical establishment’s focus on lowering cholesterol to improve heart health had led to the overprescription of statin drugs with negative side effects. Though the scientific evidence was on his side, many in the scientific and medical communities were not. Here he describes the history and inner workings of the ongoing conflict and the lessons to be gleaned from it.

The benefit of preventive drugs such as statins is often quantified as the “number needed to treat,” or NNT, which reflects the number of subjects who would need to be given a drug for one negative clinical event to be prevented. For example, if the NNT for a statin preventing cardiovascular death is 40, it suggests that for every 40 patients given a statin, one cardiovascular death will be prevented. This number, however, distorts the likely reality of the benefit distribution by suggesting a single subject receives the entire benefit while other subjects receive no benefit. This 2014 review aimed to quantify the clinical impact of statins differently, assessing the mean extension of life due to statin treatment. The analysis found the median benefit associated with statin use was 3.2 days in primary prevention and 4.1 days in secondary prevention. In other words, statins extended life expectancy by less than a week. Separate research suggests if the benefits of statins were explained this way, the majority of subjects would not choose to take them.