None of these has important new answers. The Lancet editorial noted that the journal's request for the protocol of the trail was rebuffed by TeGenero, the manufacturer of the TGN 1412, and by the UK Medicines and Healthcare Regulatory Agency (MHRA) as "commercially sensitive."
The BMJ editorial listed the questions raised by this incident, which somewhat parallel the list of thing we did not know about the trial at the time of our first post on TGN 1412. The questions were:
- How were the volunteers recruited and motivated?
- How much accurate information, based on full risk analysis, do volunteers receive?
- How much money is too much, and when does money cloud the judgment needed to evaluate risks realistically?
- Why was the drug tested on healthy volunteers rather than patients?
- Why were all eight volunteers given the drug at the same time? [Actually, only six were given the drug, while two others got a placebo - Ed]
- What information did the ethical and regulatory bodies have before the trial?
- How much do regulatory and ethical bodies have to rely on information from investigators and sponsors, which may be subject to publication bias, rather than truly independent reviews?
- Finally, what does this trial tell us about the degree of transparency througout the process of developing new drugs?
This tragedy creates one more imperative for an open culture in medical research, a culture that many fear is increasingly losing its way.and the conclusion of the Lancet article,
the fact that [dreadful events] ... have occured should lead to maximum transparency to reaffirm trust in clinical trials and their regulation.mirror the conclusion of our first post about TGN 1412, "research subjects and future patients deserve complete transparency about the drug or device to be tested, and how the testing will be performed and supervised."
Maybe if enough people repeat this sentiment, it will actually have an effect on the increasingly opaque world of drug development and evaluation.