Wow what an anticlimax.. Months after the tragic death in January of a clinical trial volunteer, the medical experts (CSST) in France have declared BIA 10-2474, the experimental drug administered was the problem. It has to to be read to be believed.
I bet you could have picked anyone off the street and presented with the evidence they would have come to the same conclusion and yet it has taken months for these EXPERTS to the same and they have virtually absolved everyone. Again LeFigaro in their assessment, pulls no punches. The CRO Biotrial comes out roughed up by the CSST compared to the company Bial whose drug it was and it seems the regulator (ANSM) is of course is blameless. This is a travesty, if this happened anywhere else I could imagine the regulator’s job would be on the line. The Google translate of the LeFigaro article which roughly translates as “blame the molecule and not the people that should have ensured this molecule went nowhere near a human”.
The preclinical toxicity data is ignored, the irreversible nature of the drug is ignored – the real tragedy is that the manufacturer did not do more preclinical work to consider how the compound was causing the animal toxicity. A little digging usually results in some answers. I can bet LeFigaro will chase this further. I eagerly await reading the full report when it is translated.
** Google translate of the LeFigaro article from today – its not perfect but you get the idea **
clinical trial Rennes cleared the agency accused Biotrial
Keywords: Clinical trial in Rennes, ANSM AGENCY OF DRUGS, Biotrial, Bial, CSST
By Anne Jouan – the 04.19.2016
The twelve experts commissioned by the drug agency come to make their conclusions. According to them, the agency has not sinned by validating the clinical trial in Rennes, but Biotrial, the investigator was not careful.
January 25, Dominique Martin, head of the French drug agency (ANSM) appointed a Scientific Committee Specialized Temporary (CSST) to study the causes of the deadly clinical trial in Rennes. On 17 January, for the first time in Europe, a man was killed during a clinical trial and five others were hospitalized with neurological disorders. After this accident, ANSM as the Portuguese Bial laboratory entrenched themselves behind the industrial and medical confidentiality not to disclose to a stunned international community, testing documents.
The CSST therefore delivers its final conclusions after several weeks of work, corresponding, in his words, by “a significant amount of work (estimated at more than 600 hours in total).” Nothing new compared to the intermediate report end of March. What about the responsibility of the French Agency which has validated this test? The SSTC still not say. “It was not within the powers of the CSST (unlike the two inspections in progress, that of the General Inspectorate of saociales business and the judicial inquiry, Ed) to rule on the validity of the authorization of the test by ANSM after consulting the Brest Patient Protection Committee “. We are reassured. How experts – including more than half work for the arrangement could they speak ill while subsidies they receive depend on this agency?
One of the volunteers had already had a stroke before the test
Regarding pre-clinical studies now conducted on animals. The CSST confirmed that Le Figaro wrote, that “rats and mice, brain damage, especially at the seahorses” in three animals treated with very high doses. But for the CSST curiously, “these attacks (…) seem quite frequently observed in rodents in studies of this type and were not a priori capable of generating a signal that such attacks do not seem to have been observed with other inhibitors of FAAH “. And to conclude this chapter, that nothing in the data that the CSST has studied “constituted a kind of signal to indicate a passage against-humans”. The ANSM therefore not wrong to validate the protocol.
If the agency is unharmed, it does not hold true for Biotrial. The critical CSST and age healthy volunteers, “the dispersion of volunteers recruited ages (18 to 55) is high, some being relatively old compared to what is generally observed in Phase 1 studies” . Experts instructed by the Agency also criticized the inclusion of volunteers not so healthy. They note as well: “We note, in addition, the inclusion of several volunteers that can be considered as a potential risk factor vis-à-vis certain adverse drug reactions.” According to our information, one of the volunteers had done well before the start of the trial strokes, without the date of the accident can be given with certainty. But this stroke made it more vulnerable especially for a voluntary molecule targeting the central nervous system. “One can only wonder, especially in the case of a molecule acting through the central nervous system, the balance provided for selection, inclusion and tracking of volunteers did not include a neuropsychological evaluation with maintenance clinical and cognitive tests, “notes besides the CSST.
transmission request of the internal investigation to justice
The lawyer for the family of the deceased volunteer, Jean-Christophe Coubris reacted to this report. “Consider that preclinical trials show no toxicity of the product is in total contradiction with the information disclosed by the Figaro and Mediapart,” alluding to a confidential internal survey carried out on 18 January. “This rating refers to the concern of a scientific assessor to the existence of toxic effects on the central nervous system of dogs, mice, rats and monkeys have been subjected to pre extra clinical trials referred. A priori, the Medicines Agency has ignored this warning. ” And the lawyer added: “We ask that the internal and confidential note be forwarded to the relevant authorities as soon as possible so that we can make informed in the interest of the manifestation of the truth.”
But the CSST experts do not leave count. They thus conclude: “The occurrence of circumstances, the stereotypical character and the evolving profile of neurological involvement strongly suggests the responsibility of the product tested.” Palice sleep quietly.