Abraham Lincoln once said, ‘You can fool all people some of the time and some people all the time, but you can never fool all the people all of the time.’
Conflicts of interest are fatal to the pursuit of medical science because they have the potential to harm public health. Any such suspected interference by conflicted parties must be urgently addressed.
As a practising GP in Australia, I have seen the pursuit of science evolve both in healthy and diseased ways over recent decades. Surgery has made rapid progress with the invention of devices and robotics that have transformed gruesome surgeries into simple day procedures. However, the discipline of clinical medicine has taken a downturn due to the poor training of doctors, apathy in the profession, fear of litigation, and ‘defensive medicine’ along with corruption in the research industry and biased journalism. The list goes on. Since the 1960s, an incestuous relationship appears to have evolved between teaching and research institutions, governing bodies including boards and regulators, and pharmaceutical companies. Unfortunately, many clinicians remain ignorant of this.
Australia’s drug regulator, the Therapeutic Goods Administration (TGA), is a government authority responsible for evaluating, assessing, and monitoring medicines, devices and biological products. It is 96 per cent funded by pharmaceutical industry fees. The TGA stringently defends the independence of its regulatory decisions.
In an article in the BMJ in 2022, From FDA to MHRA: Are drug regulators for hire, author Maryanne Demasi writes that in the year 2020-21 the TGA approved more than nine of every ten drug company applications, adding:
Australia’s Therapeutic Goods Administration (TGA) firmly denies that its almost exclusive reliance on pharmaceutical industry funding is a conflict of interest (COI). In response to a query, the agency said, “All fees and charges are prescribed in our legislation. To provide transparency, the TGA fees and charges are published on the TGA website.”
Demasi further reports that the change in practices began in the United States in 1992 with the US Congress passing the Prescription Drug User Fees Act (PDUFA) which allows the industry to pay fees to have their drug assessment applications assessed promptly. These practices have since been adopted by regulators worldwide.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) receives 86 per cent of its funding from industry. The European Medicines Agency (EMA) took 89 per cent of its budget from industry, Japan’s Pharmaceuticals and Medical Devices Agency took 85 per cent, and the US Food and Drug Administration (FDA) took 65 per cent, the BMJ article reported.
The article also explored the percentages of drug approvals by the regulators. Australia’s TGA approves 94 per cent of new drug applications, the EMA 88 per cent, the MHRA 98.5 per cent, and the US FDA approve 69 per cent. It is reasonable to acknowledge a potential conflict of interest that has led to the question, can the Australian public trust drug regulators to be unbiased and free of obligations? These potential conflicts of interest could exist globally, raising further concerns for public health.
Big Pharma has been accused of shadowing medical literature since the 1970s, allegedly eroding the trustworthiness of journals. Over the years, there have been instances of falsified, massaged, and predetermined research making it to publication and then into doctors’ offices through the visits of drug representatives, which are scheduled weekly or fortnightly as friendly reminders. On the flip side, it is frequently stated that it takes about 17 years for research evidence to reach clinical practice. So, maybe doctors need scheduled scientist and researcher visits to discuss current science as opposed to the pharma rep visits that discuss new drugs on the market.
Stanford University Professor of Medicine, John Ioannidis, a frequently cited world-renowned expert in meta-research, wrote a paper in PLOS Medicine in August of 2005 titled Why Most Published Research Findings Are False in which he comments on the relationship between research quality and funding:
‘A research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser pre-selection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical models; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.’
Prominent voices in the field including Cochrane Collaboration co-founder Peter Gotzsche, former Chief Editor of the New England Journal of Medicine Marcia Angell, Lancet Editor-in-Chief Richard Horton, and BMJ Senior Editor Peter Doshi have all sounded the alarm over the quality of scientific literature. Unfortunately, poor-quality studies infiltrate media, healthcare systems, universities, and medical institutions, damaging the framework for policy-making, education, public health, and service provision.
Peter Gotzsche details the system failures caused by widespread industry corruption and impotent regulators in his 2013 book Deadly Medicines and Organised Crime. The crisis is further illustrated by former Editor of the New England Journal of Medicine Dr. Marcia Angell in her 2004 book, The Truth about the Drug Companies. Here, she outlines how health care is impacted by the malfeasance of the pharmaceutical industry which she claims is nothing short of an organised crime syndicate.
Since the start of 2020, the mantra ‘Trust the science!’ has made headlines across the world spread by so-called health experts. But what science are they referencing? The science known to most doctors is dynamic and evolving, changing like the seasons. Scientific ‘truths’ are rolled over as evidence proves contrary in time. This is the nature of science and is why science involves questioning and testing of a hypothesis. Doctors will trust a study if it is peer-reviewed, double-blinded, and placebo-controlled. However, such ‘gold standard’ studies are long-drawn, time-consuming and require a huge outlay of funds and resources which only the pharmaceutical industry can provide. The results of such studies are most often predictable owing to the conflicts of interest.
The time has come to ask: Do we continue to allow these questions to go unanswered? And how do we fix this dangerous and easily permeable culture? For now, let’s conclude that the answer to these questions is worth billions of dollars to the industry, and will likely not be given up without a fight.
This article is a republication of an article originally published here by the Spectator Australia.