A matter of shame! and of concern.

A picture taken on January 16, 2016, in Rennes, western France, shows the logo of the Biotrial laboratory

“France drug trial: Brain-dead man dies in hospital”

What is a drug trial? It is a defined sequence of activities that test a potential drug for safety of the patient and efficacy for the condition that it is being prescribed for. A potential drug undergoes many safety tests in the lab as well as in small and large animals before it is tested in humans. This consists of 3 stages –

  • Phase I tests for safety. A small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any side effects
  • Phase II sees the drug given to people who have a medical condition to see if it does indeed help them
  • Phase III trials are only for medicines or devices that have already passed the first two stages, and involve them being compared to existing treatments or a placebo. The trials often last a year or more, involving several thousand patients.

Each country has laws and regulations for the testing and marketing of drugs. Over time these have become stricter. The Indian drug research scenario is rather arid and few original new drugs come out of our system. But we do have laws by which even those tested and approved abroad have to have a final Phase III trial on Indian patients before it gets marketing approval. In the last few years, there has been considerable attention drawn to certain unethical practices in the conduct of these trials which has resulted in Supreme Court intervention and a major slowing of International trials in India.

In the early post-war days of euphoric discovery, there was the Thalidomide tragedy in Germany in the late 1950s. (https://en.wikipedia.org/wiki/Thalidomide) Around 10,000 babies were born around the world without arms/legs etc. after the mothers took  the drug for pregnancy related nausea. Following that disaster, and the many stories of unethical use of prisoners and mental home inmates for drug testing, many regulatory mechanisms were put in place. And over the years, with increasing awareness, there has been increasing demand for transparency in the conduct of clinical trials. In the recent past, the regulations have been considerably tightened and companies have to take all precautions that trials are conducted in an appropriate and ethical manner.

In spite of that things go wrong. About a decade ago, a promising new entity, TGN1412 was given to 6 healthy volunteers (Phase I)  but “after very first infusion of a dose 500 times smaller than that found safe in animal studies, all six human volunteers faced life-threatening conditions involving multi-organ failure for which they were moved to intensive care unit.” (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964774/)  And much changed after this experience, and my understanding was that new drugs could not be given to many subjects at the same time in a Phase I study.

Obviously this is not the case as the headline above shows. (http://www.bbc.com/news/world-europe-35337671). The drug was a pain killer and developed by a well established Portuguese company and the trials done by a reputed French firm Biotrials. It leaves many questions for us – while it is indeed a matter of shame that healthy recruits, who are recruited into such studies by appealing on their sentiments regarding service to mankind etc., should suffer such adverse events, there is no alternative testing option to a Phase I in human! So, do we stop drug development? There is a constant demand for new drugs for established diseases, and we keep seeing new diseases as well – Ebola and now Zika!!

Is the ‘sacrifice of a few for the good of many’ an acceptable principle in the 21st century? The drug lobby is large and powerful and in the absence of any viable alternatives, testing will go on. And in this country, where financial reward is an easy inducement, recruitment is never difficult. I can only hope that there is a more intense public dialogue  with an overall recognition that there is a need to re-assess matters, and that no individual is made to make this kind of extreme sacrifice for ‘society’s benefit’.

 

 

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