We all know that before any new medication becomes available for doctors to prescribe, it must go through extensive testing to ensure essentially two things: First, it must actually works in modifying a disease process or minimizing symptoms of a disease beyond just the placebo effect. Second, it must achieve this goal safely, or at least to the point where the intended effects clearly outweigh the unwanted or ‘side’ effects.
Generally speaking, trials typically start out as laboratory experiments to first understand the molecule’s chemical properties. Once a theoretical hypothesis as to how it might work in the body, animal studies begin. Physiological measurements are taken to assess how the potential drug might work and also to monitor its effect on the rest of the body. If there is clear potential for benefit with little risk for serious harm, then comes a human trial.
Before a drug makes it to market (if it qualifies), nearly $1billion might be spent. In the vast majority of cases, private pharmaceutical companies cover the costs, hoping for a substantial return. With vast amounts of money at stake, one has to wonder if the conclusions drawn from these privately funded studies are accurate, or, did they conclude that the drug works a little better than it actually does, or that it’s a little safer than it actually is.
Dr. John Ioannidis is the director of the Stanford Prevention Research Center and his job is to meticulously analyze and assess whether the conclusions drawn from a study are actually consistent with the data that was collected. At the World Congress of Research Integrity in 2013, he stated:
“Empirical studies suggest that most of the claimed statistically significant effects in traditional medical research are false positives or substantially exaggerated”. He recommended that clinicians “not jump on the results of a single study, even if it came out in a prestigious journal and was widely covered”.
The unfortunate fact is that clinicians often use single studies to justify a treatment choice.
When a groundbreaking study is published and a drug goes to market, the next step for researchers is to replicate the study to see if the same results are found. Dr. Ioannidis says that follow-up studies “almost always found an effect that is smaller –usually much smaller – than the original highly cited study”.
Thus, the current arena for medical research is a privately funded, closed-door process, where conclusions are often exaggerated to encourage more drugs to be approved to sale to the public.
For clinician and patients alike, the lesson in this is to appreciate that new and highly touted research should be viewed as something interesting but not yet something to act upon, until it has be validated by several other studies. Proceed cautiously.
Dr. Sal Meli
Squamish Integrated Health