We Need to Know – Death of a Healthy Volunteer

The news is just breaking that a clinical trial conducted in France, and involving healthy volunteers has resulted in several of them being seriously injured. One of them died over the weekend, after being pronounced brain dead shortly after being dosed. Naturally, we have to wait for the investigations to be conducted and the dust to settle to find out what, if anything, could have been done better.

We were here not too long ago for TeGenero’s debacle with TGN1412 (2006). Healthy volunteers were seriously injured during their participation in a first in man study. After an extensive series of investigations we identified the following, amongst other issues:

• The healthy volunteers were not truly informed consented
• The study was poorly designed
• The CRO did not demonstrate an appropriate level of competence
• The animal toxicology and efficacy studies that predicted issues in humans were not interpreted appropriately prior to research subject enrollment

The death of any research subject is tragic, but the death of a healthy volunteer is something that should not happen.  I have admiration for someone that would put his or her health on the line to further medical science.   No healthy volunteer expects to put their life on the line. We have to ensure that we are asking the right questions to find out what went wrong.

When something like this happens the tendency is to take cover and try to deflect blame as much as possible. It has been truly disappointing to see the French Health Authority representatives giving out as little information as possible. These tragedies are relatively few, but when they occur we need an open process so that everyone can learn the lessons that need to be learnt.

I understand that there is a need to gather all the information from the documentation systems, but when someone has been declared brain dead in a clinical trial, other participants in the clinical trial have a right to know so that they can determine if it is in their best interests to remain in the clinical trial. Other researchers conducting research on similar molecules need to review their data to determine if their patients are likewise at risk. To keep this information under wraps is inappropriate.

I recall when Jesse Gelsinger died during his participation in a gene therapy trial, the US FDA and Recombinant Advisory Committee very professionally conducted an open and transparent Advisory meeting, soon after his death. The result of the open and rapid review was that numerous failings that had taken place were uncovered. I daresay the same failings are still ongoing in similar institutions today, but at least others could learn from the mistakes of the team that conducted this study.

I extend my condolences to the research subject’s family, friends and colleagues. For his sake, we must find out what went wrong, and how the risk of this happening again can be significantly reduced.

Lorna Speid, Ph.D.

Lorna is the author of Clinical Trials: What Patients and Healthy Volunteers Need to Know. This book was published by Oxford University Press in 2010.  Anyone considering entering a clinical trial is recommended to ask for a copy from their local libraries, or to purchase a copy online or in major bookstores.