Wednesday, May 9, 2007

Trials and tribulations

One of the biggest biotech disasters of the last year was the clinical trial in England where six patients got sick -- and two almost died -- after being injected with an experimental antibody in a London hospital.

The testing-gone-wrong sent shockwaves through the industry, because antibodies have been some of the most successful biotechnology drugs of the past decade. The mess in London showed that the wrong antibody can be extremely dangerous, and triggered calls for tighter controls on clinical trials.

British authorities and an independent academic panel in the UK investigated the incident and essentially cleared the German biotech firm that made the drug and the Waltham company that ran the trial. The investigators decided that the problem that caused patients' bodies to swell up was unpredictable.

But a panel of industry experts convened by BIO this afternoon attacked the British conclusions: The UK investigators simply didn't understand clinical trials, they said. The problem was avoidable -- early data on the drug should have triggered a "red flag," said one speaker, and the trial should never have happened at all.

It may not be a coincidence that the all-industry panel decided that tighter regulation isn't needed. But clearly the argument over the dangers of testing antibodies in humans is far from over.
(By Stephen Heuser, Globe staff)

Posted by Boston Globe Business Team at 06:07 PM

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