We previously posted about the disastrous trial, implemented by Parexel International , of a new monoclonal antibody designated TGN 1412, manufactured by TeGenero AG,. All six healthy volunteers who got the antibody soon became critically ill.
Our first post noted that little was known about how the trial was designed, and about who had reviewed the ethical aspects of its protocol. A later post summarized questions posed in a BMJ editorial, including how were research subjects recruited and motivated, what were they told about possible risks, why were healthy volunteers rather than patients recruited, and why were all patients given the drug simultaneously? The BMJ editorial, a Lancet editorial, and our first post all called for more openness and transparency in drug research.
Now the UK Medicines and Healthcare Products Regulatory Agency has issued an interim report. (See news articles in the Times [UK], Nature, and the Boston Globe.) Basically, the MHRA "ruled out contamination, overdose, and procedural problems," as per the Globe. But it revealed nothing more about the trial protocol, nor how it was reviewed. For example, the Globe stated that "Parexel spokeswoman Jill Baker said that she couldn't comment on the design of the trial, but it had been approved by health authories and reviewed by an ethics committee in Britain." None of the other news accounts provided any other answers to the questions above.
The main conclusion of the report was that "the drug TGN 1412 caused an unprecedented and unexpected reaction that did not occur in tests on animals," per the Times. This seems to be stating the obvious. The questions remain whether this unprecedented and severe adverse drug reaction could somehow have been anticipated by perusal of animal testing data or understanding of the science behind development of the drug; or whether the adverse drug reaction could have been reduced by a differently designed or implemented trial?
The Telegraph reported that a lawyer for two of the trial participants is not happy. Ms Ann Alexander said "the MHRA's report gives no detailed information about the pre-clinical trials, about which there has been conflicting information since the trial was suspended."
So there is still little transparency to this trial. We still do not know the results of testing the antibody in animals, the design of the trial protocol, the justification for aspects of the trial design, or who reviewed the ethical aspects of the protocol.
This sad case still illustrates how commercially sponsored pharmaceutical research often remains hidden behind the veils of trade secrecy and business confidentiality. If pharmaceutical companies really want patients and physicians to trust them more, they should start making their human research more transparent.
The complexity of the white coat - I remembered staring at the computer screen with the radiologist hoping that by staring at the images, they would change in some way. It did not seem fair ...
3 hours ago