Thiotepa: 100,000 stale doses of this anti-cancer drug used in France and the scandal continues

More than 100,000 outdated bottles of Thiotepa, an anticancer drug, have been sold in Switzerland and especially in France (98,000) with a false expiry date. The responsible laboratory Alkopharma manufactures generics and is based in Luxembourg and it passed through a distributor Genopharm, for France. The failure of controls has allowed this scandal to last at least seven years.

More than 100,000 bottles of Thiotepa, an expired anti-cancer 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 them children, reported Sunday Morning and SonntagsZeitung. An old story but which returns to the front of the scene because of the lightness of the sentences pronounced in Switzerland and the trial which is still not relevant in France.
Alkopharma, a Luxembourg-based generic drug company based in Switzerland, has falsified the expiration dates of expired vials of this anti-cancer drug. These had a shelf life of 18 months and therefore no longer contained an effective dose of active ingredient: 86% against a minimum accepted dose of 95%, or even less because some vials were resold up to 7 years after their date of expiry!
The case dates from 2011, but according to Le Matin, the body in charge of overseeing the Swiss medicines market, Swissmedic filed an appeal this year against Alkopharma's too light condemnation for falsifying expiry dates, in particular because the judge did not hold the endangering of the health of the patients.

Failure of supervisory authorities

It is not the Swiss and French regulatory authorities that are behind the discovery of this health scandal. The German laboratory Riemser, itself a manufacturer of Thiotepa, revealed the problem in 2011.
Following an agreement with Alkopharma, he had authorized the latter to manufacture and market the Thiotepa in France. Alkopharma seems to have overestimated sales and had to take back the stocks left by its reseller in France, Genopharm laboratories. It appears that Alkopharma then reconditioned the vials beyond the expiry date (normally 18 months) to put them back into circulation.
It is the Riemser laboratory that found the fraud after performing assays: the expired bottles of Alkopharma no longer contained the dose of active ingredient required. The Swiss Medicines Market Surveillance Authority, Swissmedic, has appealed the decision of the Swiss courts as it claims that the health of the patients has been endangered.

A loss of luck for the sick

Thiotepa is used in the treatment of cancers of the ovary, bladder and breast, but also cancers of the child. The expired Tiotépa from Alkopharma has been used in most major Swiss hospitals, but especially in France, where most of the expired bottles (more than 98,000 out of 100,000) would 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 the patients to an insufficient activity of the expired Thiotepa. The decreased effectiveness 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 sick whose health and life has been endangered? Some even say that 15 to 20% of Thiotepa more would have changed nothing for the sick and this is the position of the ANSM.

Minimal legal proceedings

In Switzerland, justice will reopen this case, following the appeal of Swissmedic, while concentrating its efforts on the laboratory Alkopharma. Four former officials of Alkopharma were sentenced in June 2016 to simple fines of a few thousand Swiss francs while fraud carries 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 is opposed to the distributor of Tiotépa in France, the laboratory Genopharm.
An investigation for "aggravated deception, falsification of drug substance and false and use of forgery" has been opened by the Paris prosecutor's office, but it is not known when justice will refer the case to court or if it will pronounce a non-compliance. place. Two people are still indicted, including the boss of Genopharm who claims a dismissal. He himself counter-attacked, filing in late November a complaint against the laboratory Riemser for "deception, false testimony and slanderous denunciation."

A fraud on a generic

The only ones who are not in the hot seat are, paradoxically the health agencies that have allowed the laboratory Alkopharma to market a generic Tiotépa and have not been able to discover the deception, exposing thousands of patients to run to in front of a failure of their anticancer treatment.
According to the National Agency for Safety of Medicines and Health Products (ANSM), after the revelations of April 2011, the Thiotepa remained available until October 2011, an additional 5 months with the expired drug, date on which a other generic has been made available. A letter to all hospital doctors and pharmacists has been sent by ANSM to inform them of the replacement of Thiotepa: "The underdosing, found during the various analyzes, does not lead to a significant decrease in efficacy, nor to a toxicity ".
Tuesday morning, The Tribune de Genève reveals that the boss of Alkopharma had already had problems of non-compliance of his drugs in France, "before he comes to settle in Switzerland." And since his departure from Switzerland, he has moved to 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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