In furthering our scientific knowledge in human health, as with any other field of science, it’s vitally important that the reader has the ability to trust that the scientific findings are an accurate representation of what happened experimentally. That means being able to be sure that the results aren’t loaded with bias or someone else’s agenda.
Randomized controlled trials (RCTs) are generally accepted as the gold standard for unbiased determinations of health effects for given interventions, having formed the foundation of evidence in safety and efficacy testing of pharmaceutical drugs. Positive results from Phase 1, 2 and 3 clinical trials are the only gate that stands between a medicinal product and it’s release on a public that assumes its safety is thoroughly and accurately evaluated. It is of no surprise then that corporations have been found to be lining the pockets of investigators for years, and online sites like Retraction Watch, that describes itself as a site “tracking retractions as a window into the scientific process” reveals a very disturbing situation in which research papers are continuously having to be retracted on discovery of their falsification.
Retraction – digging out the dirt
In January of this year, the British Medical Journal (BMJ) published the results of a damning study that identified a systematic abuse of RCTs for evaluating the efficacy of drugs in 2013. From a random sample of 195 studies, a worryingly high 132 (68%) were found to include financial ties between the principal investigators and the pharmaceutical industry itself.
The most conspicuous result in these findings lies in the high rate of positive outcomes from said ‘tainted’ RCTs, with 76% of the investigators with financial links pushing favourably for the drugs they were in charge of testing – 20 of which even reported having a patent related to the study drug in question. If this exposure cannot be taken as highly suggestive of bias within the established evidence base, how much more damage must be done before its trusted dependency is called into question?
Unfortunately, it does not end there. In an ongoing internal investigation, major academic publisher Springer has uncovered – and retracted – a shocking 107 papers from a single cancer journal alone (Tumor Biology), all having been accepted with fake peer reviews. The faked reviews had been falsely submitted under the names of real researchers, generally with fake email addresses. Third-party editing services may have been used in some cases to produce the reviews.
Identifying the cause of the rot
In a 2013 interview with Dr Peter C Gøtzsche, Danish medical doctor, researcher and co-founder of one of evidence-based medicine’s biggest go-to’s, the Cochrane Collaboration, Dr Gøtzsche stated clearly to ANH-Intl the extreme danger in the handling of current drug testing. He highlighted the importance of having access to raw data from clinical trials to ensure transparency in proper science and medicinal work.
Dr Gøtzsche told us in 2013 that there is a ‘corruption of academic integrity and betrayal of the trust patients have in the research enterprise’; that ‘no self-respecting scientist should ever publish findings that they cannot confirm the original data for’.
The willingness for many doctors and scientists to attach their authorship to such papers which include raw data they have not had sight of and do know not the whereabouts of, is simply staggering. This kind of short-cutting of the established yet unwritten rules of the peer review process only occurs with corruption, where the authors gain some personal benefit (e.g. money or status).
Do uncorrupt RCTs pass muster?
If you were to take this deliberate distortion and corruption element out of RCTs, would all be fine and dandy? Could we reinstate RCTs as the key tool within the evidence-based medicine framework that drives so much modern day decision-making in western healthcare?
John Ioannidis, Professor in Disease Prevention in the School of Medicine and Professor of Health Research and Policy (Epidemiology) at Stanford University School of Medicine, famously demonstrated his concern about the accuracy of published research. In a 2005 study, Prof Ioannidis strongly argued the case that most published research findings (more than 60%) can be shown to be false, with greatly variable results depending on the investigators’ own perceptions. Something as simple as one single question studied by a few different, independent teams can be shown to produce wildly different results, based on the markers of their own choosing.
In fact, we raised this very issue with regards to Professor Edzard Ernst, the controversial alternative medicine critic in a 2007 piece entitled ‘Master Trickster of Evidence-Based Medicine’. Using the restrictive, objective lens that sits as the gate for current evidence trials, Ernst, a leading member of the UK and international Skeptic (Big S skeptic) Community, is somewhat of a posterchild for the unwitting confusions and biases that have plagued the establishment’s ability better understand how natural health therapies work. All this happens at the expense of the most important issue: the patient’s experience, which can be measured or evaluated both quantitatively and qualitatively, as well as objectively and subjectively.
RCTs and patient experience
Evidence-based medicine is not the villain – at least not in the original form it was proposed by David Sacket and Colleagues in the EBM Working Group in 1992 . The approach itself is still young, it’s been pulled around by a diverse range of interests, especially Big Pharma, and it’s now also distorted. Sackett complained just 4 years after the approach’s launch, in the British Medical Journal, it had been taken off-track, especially because clinical experience had been so often ignored.
It would perhaps be more respectful to the approach’s founders to refer to these flaws more as its ‘growing pains’. Trisha Greenhalgh, medical doctor and researcher from the Nuffield Department of Primary Care Health Sciences, University of Oxford, along with her colleagues, identified six different biases relating to EBM that devalue the patient in a key paper published in BMC Medicine in 2015.
Dr Greenhalgh et al argue that there has been a systemic ignorance in modern trials to patient experience, with any evidence emanating from the patient as being dismissed largely as anecdotal. Whereas many doctors would surely rely on direct feedback to form best practice, the entire concept of patient input can be found to be devalued, if not even suppressed, by the EBM’s ‘hierarchy of evidence’ that, as shown, can be malleable to bias and abuse.
ANH-Intl collaborative research project
It is more than timely that robust methodologies are found to report patient experience as part of a much more holistic system of evidence.
ANH-Intl is actively involved with collaborators in the UK, the Netherlands and the USA in a project that allows patients to self-report their experience. The approach aims to include the unique and often shifting needs of the patient, and most importantly, places the individual back in the driving seat of their own health.
Whereas current models of EBM are typically very detached, placing the locus of control in the medical professional, it is high time than more than lip-service is placed on the needs of the individual and the importance of preventing rather than just treating diseases or their symptoms.
Many primary care doctors now often forget to ask their patient’s the single most important question a doctor can ask of their patient: “How do you feel?”
We’re hopeful that it won’t be too long before healthcare professionals begin to appreciate that one of the most important parts of their job is building a trusted doctor-patient relationship. This relationship can reveal answers to many of the questions required to help them co-develop treatment programs that deliver the best possible health outcomes for their patients.