When I attended “Why do we need evidence?” at the Edinburgh Fringe, I didn’t expect an event about the history of medical science to leave me despairing for its future. The long and in many cases tedious road to scientific discovery (which led to the discovery of antibiotics, genes, vitamins, and bacterial life forms) often brings me a sense of exasperated appreciation. We now live in an era of constant scientific advancement; new research, new drug trials, and new apparent wonder drugs capture our attention every single day. But this raises several questions: how did we get here? How far do we have to go? How much can we really trust the evidence?
As Iain Milne, Sibbald Librarian at the Royal College of Physicians of Edinburgh explained, James Lind
was a Scottish Physician who conducted the first ever recorded and controlled clinical trial in 1947. During his time serving in the Royal Navy, Lind recognised that scurvy (caused by a lack of vitamin C) was a huge problem amongst the sailors. Every physician had their own theory behind the elusive disease, promoting the use of various weird and wonderful ‘cures’ without any real evidence of their efficacy. Prior to beginning his trial, Lind reviewed the previous literature to decide which treatments had the best chance of success before distributing the treatments to different groups of scurvy stricken sailors. The group who received lemon and orange juice made a remarkable recovery, providing the first real evidence of a medical treatment being effective when compared to other treatments, and an untreated control group. Of course, Lind had no idea that these treatments worked due to the vitamin C found in the citrus fruits; the concept of vitamins hadn’t yet been conceived. Lind’s actions may now seem like the obvious way to test a new drug, but in his time this was revolutionary. Sadly, in Lind’s case the scientific community failed to understand the importance of this discovery.Consequently, scurvy raged on untreated for more than 40 years; at which point lemon juice was finally made available on Navy vessels.
Professor Silvio Garattini then took us through a brief history of the early Italian clinical trials aimed at tackling Malaria. These experiments, conducted in the late 19th and early 20th century, were impressive in terms their rigorous methodology and immediate impact. A sophisticated clinical trial conducted by Guiseppe Bastianelli, utilised age-matched patient groups to ensure that the control and treatment groups were as similar as possible, and gained assurances from not one but two nurses that patients were indeed taking their allocated treatment. Blood samples taken as part of the trial were centralised and analysed within the same laboratory in Rome, a practice which is rare even in present day trials. The trial followed up with patients after six months of treatment to gain a clear description of side effects occurring with the medication. Although there is no mention of randomisation or blinding (regarded as the cornerstones of modern randomised clinical trials to ensure that the unconscious biases associated with group allocation and assessing clinical outcomes are reduced) the attempts of Bastianelli and his colleagues were well before their time.
The final portion of the talk saw Sir Ian Chalmers, co-founder of the Cochrane collaboration, delve
into the inner workings of modern day clinical trials. Cochrane is a UK based organisation which conducts systematic reviews of clinical trials and other health care interventions to facilitate evidence-based medical decisions. Why do we need such an organisation? If you were to ask members of the public, he explained, it seems obvious that scientists would look to the literature before testing a new drug. Unfortunately, it is far from the case. Worse still, the results of many trials conducted both in pharmaceutical industries and within academia are never published, which means that even if researchers do want to review the research beforehand it may not even be available to them. To hammer home the need for independent research bodies like Cochrane, Sir Ian likened pharmaceutical companies to washing machine producers. We certainly don’t pick the best washing machine based on what the profit producing company claims; instead, we look to reviews, and independent recommendations. The issue of a lack of rigorous and evidence based research isn’t just counterproductive for scientific advancement; it puts patient health at risk. The oft-cited 2006 example, in which a trial went horribly wrong, turning volunteers into “elephant men” and fighting for their lives could have been prevented if a systematic review of the literature has been conducted beforehand.
As Sir Ian pointed out, it’s “life or death”. With all the optimism of past trial successes, this was a stark reminder of how far medical science has to go. In his closing remarks, Sir Ian emphasised the need for public engagement and action. Evidence matters, and it’s time that we start getting angry about it.
This article was written by Kaitlyn Hair and edited by Sam Stanfield.
Leave a Reply