Storm around an anti-psychotic drug

[22 December 2006 - 09h02]

Did the American pharmaceutical firm Eli Lilly minimise certain side-effects of its star anti-psychotic drug, Zyprexa? An article in the New York Times based on internal laboratory documents is what sparked off this crisis.

Zyprexa – olanzapine – is an “atypical” anti-psychotic drug. It is mainly prescribed to control the agitation and behavioural problems of schizophrenic patients and those suffering from bipolar disorders.

According to this article which was also printed by the Figaro in France, 30% of patients in the United States taking Zyprexa have experienced rapid weight gain of around 10 kg in one year. Some patients have even put on 45 kg! And that’s not all. This drug is also linked to an increase in blood sugar levels.

Well-known side effects

Weight gain and hyperglycaemia are in fact well-known side-effects of this drug. They are even featured in the product characteristics of the European Agency for the Evaluation of Medicinal Products (EMEA). According to this document, the weight gain is regarded as “very frequent”, in other words more than 10% of cases. That is why these side-effects “were not the subject of any communication by the health authorities in France”, says Nathalie Deleau at the pharmacovigilance unit of the AFSSaPS.

“Some studies have shown that the weight gain was a little higher in patients taking Zyprexa”, she continues, also pointing to certain special features of the American population: “very sedentary and well-known for having weight problems”. In other words, the terrain is particularly fertile for rapid, significant weight gain.

Side-effects that were known, therefore, but which Lilly apparently attempted to minimise, according to the American newspaper. In an internal letter in 1999, the Medical Director mentioned the fact that “the weight gain associated with olanzapine and the possible emergence of hyperglycaemia constitute major threats to the long-term success of this important molecule”.

A vigorous reply from the laboratory

Did the laboratory attempt to preserve a drug prescribed to 20 million patients all over the world which last year generated turnover of 4.2 billion dollars? In a press release, Lilly “vigorously disputed the New York Times article which was based on a selection of documents illegally given to it by plaintiffs’ lawyers”.

For this story has been going on in the United States for over six years. According to Agnès Renard, communications manager of Lilly France, “in 2005, after an amicable settlement, Lilly had to pay damages to 8,000 plaintiffs who were apparently injured. Given the American context where lawyers have a financial interest in these matters, people think that it may well work a second time”.

With regard to the problems of weight gain and hyperglycaemia, she underlined that “they were well known. We emphasise the fact to our patients that they must follow a healthy diet. Zyprexa constitutes 23 years of research which guarantee the safety of this product. I want to reassure patients. Above all, they must speak to their doctor before they do anything”.

Source : Interview with Agnès Renard, 19 December 2006, AFSSaPS, New York Times

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