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Drug Firm Disowns Liability

by Medindia Content Team on April 9, 2006 at 12:46 PM
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Drug Firm Disowns Liability

The German biotech firm TeGenero, the drugs company behind the clinical trial listed its potential side effects on its 12-page document prepared by Parexel. This consent form listed a side effect which can seriously harm the immune system. The clinical trial left six volunteers fighting for their lives. The consent form the men were asked to sign, which has been obtained by The Observer, warned that a possible effect of the drug was cytokine release. This includes a massive immune reaction to a chemical as it triggers an uncontrollable response from antibodies.

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It is otherwise called as a cytokine release or cytokine storm. This can be life-threatening but the form does not spell that out. It is also doubtful whether the doctor heading the trial at Northwick Park Hospital in north London verbally highlighted the specific nature of the cytokine risk to the participants. The form says that that the drug could cause a hives-like allergic reaction. The volunteers were struck down with symptoms within minutes of being injected with the drug. A string of possible side effects are listed on the form, revealed for the first time in this newspaper. The consent form says that the participants may not experience any side effects as the doses used in early human studies are always very small.

But sometimes unintended effects may be encountered during any trial with a monoclonal antibody drug, though they did not occur even at the highest tested doses in animals. The various side effects listed are immunosuppression, autoimmunity, cytokine release, and anaphylaxis. Even the Medicines and Healthcare Products Regulatory Agency (MHRA) which authorised the trial was notified beforehand that there was this risk of cytokine release. The study obtained approval from German and UK authorities.

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