Health Ministry committee to check Teva ALS trials
Former partner Proneuron accuses Teva of testing Copaxone on ALS patients despite the health risks.
Shay Niv and Gali Weinreb 10 Jul 08 14:52
The Ministry of Health and the Public Complaints Commissioner have appointed a special committee which will be legally mandated to study the conduct of Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) in the trials of its multiple sclerosis drug Copaxone on patients suffering from the muscular degenerative disease, Amyotrophic Lateral Sclerosis (ALS), often referred to as "Lou Gehrig's Disease". Sources inform ''Globes'' that the committee will hold its first session today.
According to a report submitted by biotechnology company Proneuron Biotechnologies Inc.,Teva is alleged to have tested Copaxone on ALS patients, despite knowing that previous trials on mice with ALD raised doubts as to 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 (Ichilov Hospital), where the trials were conducted in conjunction with similar trials in five other countries.

The investigation revealed that the Ministry of Health pharmacology division did not receive all the necessary information 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. 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. Proneuron presented evidence from Prof. Michal Schwartz, head of the Laboratory of Body/Mind Immunology at the Department of Neurobiology at the Weizmann Institute of Science, the scientist whose research formed the basis for the founding of Proneuron, who claimed that 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 borne out by the fact that the drug had been repeatedly tested in trials on multiple sclerosis patients and found to be safe.

In a response to a request from "Globes" a spokesperson for Teva said, "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."

Published by Globes [online], Israel business news - www.globes-online.com - on July 10, 2008

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