More than 100,000 expired bottles of Thiotépa, an anticancer drug, have been sold in Switzerland and especially in France (98,000) with a false expiration date. The responsible laboratory Alkopharma manufactures generics and is based in Luxembourg and went through a Genopharm distributor for France. The failure of controls allowed this scandal to last at least 7 years.
More than 100,000 vials of Thiotepa, an expired anticancer drug, used in ovarian, bladder and breast cancers but also in children, were administered to Swiss and French patients between 2007 and 2011, half of which of children, reported Morning Sunday and the SonntagsZeitung. An old story but which is coming back to the fore because of the lightness of the sentences handed down in Switzerland and the trial which is still not relevant in France.
Alkopharma, a Luxembourg generic drug laboratory based in Switzerland, has falsified the expiration dates of expired vials of this anticancer drug. These had a shelf life of 18 months and therefore no longer contained an effective dose of active principle: 86% against an accepted minimum dose of 95%, or even less because some vials were resold up to 7 years after their date. expiration!
The case dates back to 2011, but according to Le Matin the body in charge of monitoring the drug market in Switzerland, Swissmedic, filed an appeal this year against Alkopharma’s overly light conviction for falsifying expiry dates, in particular because the judge did not accept the endangerment of the health of the patients.
Failure of supervisory authorities
It was not the Swiss and French regulatory authorities who were behind the discovery of this health scandal. It was the German laboratory Riemser, itself manufacturer of Thiotepa, which revealed the problem in 2011.
Following an agreement with Alkopharma, it had authorized the latter to manufacture and market Thiotepa in France. Alkopharma seems to have overestimated sales and had to take back stocks not sold by its reseller in France, Genopharm laboratories. It appears that Alkopharma then repackaged the vials that had passed the expiration date (normally 18 months) to put them back into circulation.
It was the Riemser laboratory which observed the fraud after performing the assays: the expired bottles of Alkopharma no longer contained the required dose of active principle. The Swiss Medicines Market Surveillance Authority, Swissmedic, appealed against the decision of the Swiss courts because it maintains that there has been a risk to the health of patients.
A loss of luck for the sick
Thiotepa is used in the treatment of ovarian, bladder and breast cancer, but also childhood cancer. Alkopharma’s expired Tiotepa has been used in most large Swiss hospitals, but especially in France where the majority of expired vials (more than 98,000 out of 100,000) are said to have been consumed.
This is a loss of luck for many French patients. But it is very difficult to attribute the failure of the treatment of patients to insufficient activity of the expired Thiotepa. The decrease in efficacy of expired Thiotepa is estimated at around 15% and, since this drug is administered together with other drugs, as part of a multidrug therapy, it will be very difficult, if not impossible to determine. who are the patients whose health and life have been endangered. Some even claim that 15 to 20% more Thiotepa would not have changed anything for the patients and this is the position of the ANSM.
A minimum judicial procedure
In Switzerland, justice will reopen this case, following the appeal of Swissmedic, while concentrating its efforts on the Alkopharma laboratory. Four former Alkopharma managers were sentenced in June 2016 to simple fines of a few thousand Swiss francs while the fraud involves more than 200,000 francs in Switzerland, but more than 3 million euros in France!
In France, it’s more complicated. The German manufacturer Riemser, at the origin of the discovery of this fraud, opposes the distributor of Tiotépa in France, the laboratory Genopharm.
An investigation for “aggravated deception, falsification of medicinal substance and forgery and use of forgery” has been opened by the Paris prosecutor’s office, but it is not known when the justice will send the case to a court or if it will pronounce a non- place. Two people are still indicted, including the boss of Genopharm who claims a dismissal. He himself counter-attacked, by filing a complaint against the Riemser laboratory at the end of November for “deception, false testimony and slanderous denunciation”.
Generic fraud
The only ones who are not in the hot seat are, paradoxically the health agencies which have yet authorized the Alkopharma laboratory to market a generic of Tiotepa and which have not been able to discover the deception, exposing thousands of patients to run to the market. faced with a failure of their cancer treatment.
According to National Agency for Medicines and Health Products Safety (ANSM), after the April 2011 revelations, Thiotepa remained available until October 2011, i.e. 5 additional months with the expired drug, when another generic was made available. A letter to all doctors and hospital pharmacists was sent by the ANSM to inform them of the replacement of Thiotepa: “The under-dosage, observed during the various analyzes, does not lead to a significant drop in efficacy, nor to a toxicity ”.
Tuesday morning, La Tribune de Genève revealed that the boss of Alkopharma had already had problems of non-compliance of his drugs in France, “before he came to settle in Switzerland”. And that since his departure from Switzerland, he has settled in the United Kingdom, “where he has resumed the production of drugs and has started to put non-compliant products on the French market”.
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