Throughout the past there have been a variety of incidences in which clinical trials have gone wrong; from molecular issues to logistics and of course, study designs, there are a variety of reasons that clinical trials fail and they all lead to the same disastrous conclusions; while the balance between proper procedure and participant care sometimes walks a thin line, clinical trials do go wrong, and we’ve put together a list of five clinical trials that have ended badly for both the patients involved and the pharmaceutical companies.
The trial for TGN1412 definitely comes to mind when speaking of the word ‘catastrophic’; conducted in 2006, TGN1412 was meant for the treatment of B cell chronic lymphocytic leukemia (aka B-CLL) and rheumatoid arthritis, and this monoclonal antibody was a strong agonist for the CD28 receptor of the T-cells.
During the trials, which were conducted in London, England by Parexel, a company that carries out clinical trials on behalf of pharmaceutical companies, administration of the drug proved to be a catastrophe and the six men who received it were nearly killed after their white blood cells basically vanished from their bodies; while all survived, they were plagued by a variety of healthcare issues afterward, from the development of lymphoma to the need for amputation of several key body parts.
Needless to say proper clinical trials and also training in areas such as pharmacovigilance help to prevent such problems and limit their impact.
In an utterly disastrous clinical trial that took place in 2009, Synta Pharmaceuticals was forced to halt the testing of a skin cancer medication that was administered to test subjects in conjunction with paclitaxel chemotherapy; the drug was designed to amplify oxidative stress within the body, resulting in the self-destruction of cancer cells and while this process was not supposed to occur in healthy cells, it did.
While the exact statistics are not known, the results clearly showed an alarming increase in deaths among those patients who were taking the Synta drug and trials were halted.
In a recent example, it was found that Tamiflu, which the British government spent half a billion pounds stockpiling in order to combat a major flu epidemic, was proven in trials not to be as effective in preventing flu side effects as was reported and that Roche, the company that manufactured the drug withheld crucial information about its performance.
While Tamiflu was supposed to be a sort of miracle cure for the devastating side-effects of the flu, it has now been found that in withholding performance statistics on the drug, the company has not actually broken any laws, which to many is not surprising; it is alleged that for many pharmaceutical companies, withholding information on medication performance during trials is quite routine.
Another way in which drug trials have been known to go wrong is in cases where the trial showed the drug to do serious damage but the information is kept secret and the drug is approved for use despite having the capacity to damage patients’ health.
This is what happened with GlaxoSmithKline’s drug Avandia (rosiglitazone) which was formulated to treat diabetes, as well as with Merck’s Vioxx, an anti-inflammatory, both of which were found to cause significantly elevated risk of cardiac issues, yet the findings were suppressed and the drugs were both approved for prescription use; when discovered, both instances resulted in enormous scandal that rocked the foundation of the pharmaceutical industry.
While clinical trials are generally thought to be a vital part of the testing and release of any new medication, the results in the case of a trial going wrong can be absolutely devastating, as is proven in the case of these five horrible examples of trials that went very wrong.