Tuesday, July 25, 2017

Homeless man sues Novartis for deceptive clinical trial

Now here's a story you don't see very often. (Ever, in fact.)

A former clinical trials subject is suing Swiss pharma giant Novartis, alleging the company was not honest with participants about what they were being tested for. 

The case dates back to 2007, when Novartis hired a company in Poland to test a vaccine for bird flu following the Europe-wide outbreak of the H5N1 virus. The trials were carried out on homeless and poor people in the Polish city of Grudziadz, where they were paid around two francs for participation. 

But one former subject, named as Grzegorz S, says participants were told the vaccine was for the conventional flu virus, and he has launched a civil suit against the Basel-based company.

According to consumer magazine Beobachter, the man had no idea that the vaccination was administered as part of a clinical trial. "I never agreed to be used as a guinea pig. If I had known what the vaccinations were, I would not have participated," he told the magazine. 

The puzzle in this story comes later.  This paragraph suggests that subjects died in the trial, but the relationship between the deaths and the trial is unclear.

After the tests, the director of one Grudziadz homeless centre, Mieczyslaw Waclawski, told a Polish newspaper that 21 people from the centre had died. While the deaths were not conclusively linked to participation in the trial, the figure was a significant rise from the average of around eight.

A criminal case into the trials was concluded in Poland earlier in 2017, with three doctors and six nurses charged, though Novartis was not put under investigation in connection with that case.

What is meant by an "average" of eight deaths?  Could 21 homeless people have actually died in this trial?

This calls for more investigation. Watch this space.

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