Teva Is Being Investigated Over Copaxone Trial
Make a commentBy Ed Silverman // July 11th, 2008 // 9:13 am
The Israeli Ministry of Health and the Public Complaints Commissioner have appointed a special committee to study how Teva Pharmaceutical conducted a trial of its Copaxone multiple sclerosis drug, according to Globes.
According to a report submitted by Proneuron Biotechnologies, Teva allegedly tested Copaxone on ALS patients, despite knowing that previous trials on mice with ALD raised doubts about its safety. As early as six months ago, the Ministry of Health comptroller began investigating the conduct of the Health Ministry, which approved the trials, and the Tel Aviv Sourasky Medical Center, where the trials were conducted in conjunction with similar trials in five other countries, the paper writes.
The investigation revealed that the Ministry of Health pharmacology division didn’t receive all the necessary info before approving the trials, especially the fact that the earlier trials on mice had failed and that patients were not given a proper consent form, Globes continues. The conclusions reached by the ministry’s controller indicated that a further investigation was necessary.
The committee will conduct a further review of the claims first raised by Proneuron, which had a business collaboration with Teva. The collaboration was subsequently terminated, and Proneuron sued Teva over allegations that the generic drugmaker sabotaged a trial for a drug that would have competed with Copaxone. (Back story).
Proneuron presented evidence from Michal Schwartz, a professor and head of the Laboratory of Body/Mind Immunology at the Department of Neurobiology at the Weizmann Institute of Science, whose research formed the basis for the founding of Proneuron and claimed the mice died in the trial.
In response, Teva confirmed that the mice had died from Copaxone, but insisted that this had no connection to its effect on humans, a claim which it said was supported by the fact that the drug had been repeatedly tested in trials on MS patients and found to be safe.
A Teva spokesperson told Globes: “Teva welcomes the setting up of the investigative committee, which will make it clear that the trial was conducted in accordance with the most stringent criteria for clinical trials.”
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ALS, Copaxone, Proneuron Biotechnologies, Teva Pharmaceuticals