We have all heard about breakthroughs in medical science that come about through the use of medical trials and go on to save lives. On the surface, medical trials seem to be a fantastic initiative, but could it be that the very laws put in place to protect people are actually preventing the development of new treatments?
The idea of medical trials first came about in the late 1800’s when Carlos Finlay, a Cuban physician, opposed the theory that yellow fever was spread by dirty clothing and proposed that it was actually transmitted by mosquitos. His theory was immediately shot down, but in an effort to prove his point, he set up an experiment with real patients. He put half of the volunteers in a tent that was filled with mosquitoes and the other half in a tent that contained dirty clothing. Surprisingly, people did agree to take part in the experiment, even though a potential consequence was a slow and painful death from Yellow fever. Before taking part in the deathly experiment, the volunteers were made to sign an informed consent document to ensure that they were aware of the risks and were willing to participate in the experiment despite the potential hazards.
Thankfully, medical trials these days are far safer and even offer remuneration; even I must admit to having been tempted to take part in one to subside the lavish student lifestyle of St Andrews. Patients typically get paid around £1,000 for a couple of days in hospital, albeit with the risk of some minor side effects such as nausea and headaches. To me this just sounds like a standard Saturday morning with someone providing free food and paying you!
Carlos Finlay’s first trial was over 100 years ago, and since then technology has completely transformed our lives, yet we are still using the same basic principles today, even down to the informed consent forms. After a medical study is completed, all information is put away into storage; it cannot be networked and can only be used for that exact study.
It has been suggested that nowadays we are all ‘privacy crazy’ and don’t want any personal information available online. This seems harmless, but could it be stunting the progression of medical treatment? In the USA 1 in 4 men and 1 in 5 women die from cancer. Cancer patients rarely reported to have felt that they had been given personal privacy whilst in hospital. However, it is privacy laws which mean their records seem to be locked away and hidden from sight of anybody wishing to view them for research, even patients themselves have great difficulty getting hold of their own records. Only 3-4% of people with cancer actually sign up for a medical trial. Unfortunately this is the only data available for researchers to study in their attempt to find correlations or patterns in lifestyle between patients and their outcome. All other data is prohibited because of these privacy laws which have been created to ‘protect’ the patient.
A ‘commons’ is the name for a public good built through private goods. John Wilbanks is currently trying to create a ‘commons’ for medical data where people can legally volunteer their own medical records online (if they manage to get hold of them). These medical records could include genetics data and lifestyle choices with the hope that mathematicians can analyse this data and find new correlations in order to assist bio-scientists and medics in their search for novel treatments.
In 5 years Wilbanks’ aim is to have enough volunteered information to map small sample sizes against traditional research results to eliminate factors such as variations in peoples’ lifestyle and genetics. It is hoped that this will lead to a transformation within healthcare.
In evidence based medicine, it is suggested that positive findings are twice as likely to be reported as negative findings. This is mainly because, apart from being less interesting, nobody wants to publish a failed experiment. However, this is creating a biased sample of medical studies that have reported.
In 1980 a drug was developed to suppress abnormal heart rhythms in heart attack patients. A clinical trial was set up where 50 people were given the new drug and 50 given a placebo. Of the participants given the new drug 10 died and of the ones in the placebo group, only one died. The drug was deemed unsafe, all production was stopped and the findings unpublished.
A few years later someone else had same idea and developed a very similar drug, it managed to make it through testing and when prescribed to heart attack patients in America, over 100,000 people died, all because the medical trials from previous years were not published and available for the developers to read. Could these deaths have been prevented if the original trial had been published?
There is, however, a strong view that some trials are purposely buried to boost sales. For one antidepressant, 7 trials were carried out to test if that drug was a more effective treatment than the antidepressants that were already available. The upshot was one positive result with the other 6 tests providing a negative outcome. Only the one positive result was published. This was not an isolated occurrence and affects all fields of medicine. In total half of all trials are ‘missing’ from publications. Both doctors and patients are being misled by biased academic literature.
Research fraud might be defined as withholding half of the information revealed in a single study, yet it seems to be legal to release only half of the total number of studies carried out in an effort to produce the ‘desired’ research outcome. In 2008 the FDA amendment act was created which meant all clinical studies undertaken must be published within one year but only one in five companies have actually done so; furthermore, this law has not been enforced.
Overall an insane amount of extremely useful information is hidden away in an attempt to either protect patients or just boost profits. In the event that I fall ill, I will certainly not be opposed to specialists or researchers viewing my medical records in an attempt to better future treatment; furthermore, I would hope that my doctor would have access to all information to enable them to prescribe me with the best drugs possible. It is astounding that this is currently not always the case.
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