Genzyme pays another $32.5M for cheating on one of its product’s supposed applications

Genzyme’s $22.28M (€20M) penalty wasn’t enough for the US Department of Justice to resolve its criminal marketing of Seprafilm. Sanofi’s biotech subsidiary will therefore have to pay another $32.5M (€29,2M) to avoid further legal implications.

Criminal charges caught Cambridge-based Genzyme by promoting its tape-like Seprafilm for wrong allegations between 2005 and 2010, up until one year before French Sanofi acquired the big biotech.

Seprafilm is a clear film that is put between internal tissues after a surgery, so that these do not start sticking together when the wounds heal. It was approved by the FDA for use in certain types of operations, namely open abdominal or pelvic laparotomy. However, these surgeries were being more and more ousted by a more favorable laparoscopic procedure.

Of course, Genzyme wasn’t happy about the decreasing sales and it startet counteracting the losses by instructing surgeons to turn Seprafilm into a liquid “slurry” so that it could be adapted to the more common laparoscopic surgery.

That worked out for 5 years, but then the criminal charges got on to the track and fined the company for intentionally putting surgeons up to misuse its medical device.

Genzyme admitted this already and payed $22.28M (€20M) in December 2013. But that’s not enough for the Department of Justice, so Genzyme will soon fork out another $32.5M (€29,2M).

That a big pharma or biotech company puts more value on profit than on the patients safety is certainly no particular case. Just think about the big scandal in France, triggered by Bayer‘s Diane 35, a drug against acne, which was used as a contraceptive pill. Or French Servier, it faced a criminal trial for giving the diabetes treatment mediator to healthy women who just wanted to slim. This profit maximization claimed between 500 to 2,000 lives due to heart damages.

And the cheating can already begin in the phase of clinical trials. One month ago, Bavarian Nordic came under suspicion to have misinterpreted results of a phase II study. Can we still trust the medical claims of drug manufacturers?

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