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Anticancer drug expired: opening of the trial of two former laboratory leaders

2021-06-29T00:37:33.214Z


The trial of two former laboratory managers involved in the marketing of an anticancer drug whose expiry date had been ...


The trial of two former laboratory managers involved in the marketing of an anticancer drug whose expiry date had been falsified opened on Monday June 28 before the Paris Criminal Court.

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The two men, Alain Bouaziz, 67, and Valéry Monin, 57, managers of the Genopharm group, are being prosecuted for "

non-compliance with good manufacturing practices

", "

marketing without marketing authorization

" and "

deception on the quantity in active principle of a good

”. The prosecution accuses them of having sold the anticancer drug Thiotepa (manufactured by the German laboratory Riemser) without ensuring its compliance, thus posing "

a serious risk to public health

".

The scandal of Thiotepa, used in the fight against ovarian, bladder and breast cancer, but also against certain childhood cancers, erupted in March 2011 when the German manufacturer of the product had warned the health authorities that expired bottles were circulating on the market.

Subsequent analyzes by the French Medicines Agency had also noted that they no

longer

contained "

the required dose of active principle

".

Thiotepa was delivered in bulk, that is to say in unlabeled vials, by Riemser to the Alkopharma laboratory in Switzerland.

Alkopharma (a subsidiary of the French group Genopharm) was responsible for the packaging and labeling of the product which was then delivered to Genopharm which marketed it to hospitals.

10,000 non-compliant vials

But, from March 2010, Riemser produced another drug with the same active ingredients, Tepadina distributed by the Adienne laboratory.

"

Genopharm, which no longer held stocks that had not expired of Thiotépa, decided to sell the expired unsold lots to maintain its de facto monopoly and prevent Riemser from distributing Tépadina instead of Thiotépa

", maintains Me Eric Weil who represents Riemser, a civil parties at the trial.

The objective pursued by Genopharm was to prevent Riemser, the only competitor with regulatory authorizations for the marketing and new stocks of the same active ingredient, from stealing its market share,

” added the lawyer.

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Almost 100,000 non-compliant bottles of Thiotépa with falsified expiration dates were distributed until September 2011, mainly in France.

Patients who received doses of these expired batches had "

a loss of luck compared to other patients,

" said experts who came to testify in court.

But, to the question of whether these failures have claimed victims, no expert has been able to link a negative evolution of cancer to this expired drug.

This anticancer drug was always administered together with other products, which does not make it possible to establish a possible causal link, the experts noted.

The trial is scheduled until Wednesday.

Source: lefigaro

All news articles on 2021-06-29

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