Thiotepa, the generic stale of an anti-cancer proposed by Alkopharma despite the controls
Published the 14.01.2018 at 22h42
More than 100 000 bottles of this Drug, an anticancer expired, were administered to the sick swiss, and French, of which half of them children, between 2007 and 2011, reported The Sunday Morning and the SonntagsZeitung.
A laboratory Luxembourg of generic drugs, based in Martigny, Switzerland, Alkopharma, has falsified the expiry dates of this cancer out of date. They had a shelf life of 18 months and did so more in an effective dose of the active principle. Certain drugs have been sold until seven years later.
The case dates to 2011, but the agency in charge of monitoring the drug market in Switzerland, Swissmedic, has filed an appeal against the sentence too light Alkopharma to falsification of expiration dates, especially because the judge has not upheld the endangerment of the health of the patients.
Failure of the supervisory authorities
These are not the regulatory authorities in france and switzerland, which are at the origin of the discovery of the scandal health. It is the German laboratory Riemser, himself a manufacturer of the Drug, which has revealed the problem in 2011, after the completion of the assays, and found that the bottles expired Alkopharma did not contain the higher the dose of active principle required.
According to the results of the investigation in switzerland, the laboratory Alkopharma, falsified the expiry date of the Drug the generic labels. In fact, one of the characteristics of this cancer is that its shelf life is 18 months. However, some of the bottles would have been sold up to seven years later. The swiss Authority for market surveillance of medicines, Swissmedic, has appealed the decision of the swiss courts because it claims that there has been a danger to the health of the patients.
A loss of chance for patients
Thiotepa is used in the treatment of cancers of the ovary, bladder and breast, but also of cancers of the child. The Tiotépa outdated Alkopharma has been used in most of the major swiss hospitals, but especially in France, where would have been consumed the majority of the bottles expired (more than 98 000 100 000).
It is obviously a loss of opportunity for many people French. But it is very difficult to attribute the failure of the treatment of the sick in an insufficient activity of the Drug expired. The decline in the effectiveness of Thiotepa out of date is estimated to be between 10% and 20% and, in the measure where this drug is administered in conjunction with other drugs, as part of a multidrug therapy, it will be very difficult, if not impossible, to determine what are the patients whose health and lives were endangered.
A judicial procedure as a minimum
In Switzerland, the justice going to reopen this case following the use of Swissmedic, while focusing its efforts on the laboratory Alkopharma. Four former officials of Alkopharma had been sentenced in June 2016 to simple fines. In France, it is more complicated. The German manufacturer Riemser, to the origin of the discovery of this fraud, thanks to the assays in 2011, is opposed to the distributor of the Tiotépa in France, the laboratory Genopharm
A investigation for “aggravated tort of deceit, falsification of drug substance and forgery and use of forgery” has been opened by the parquet floor of Paris, but it is not known when and if the justice will refer the case to a court or if she will give a non-place.
Two people are still under investigation, including the boss of Genopharm which requires a non-place. He himself counter-attacked by filing the end of November a complaint against the laboratory Riemser for ” deception, false witness and false accusation “.
A fraud on a generic
The only ones that are not on the harness are, paradoxically, the health agencies that have yet authorized the laboratory Alkopharma to market generic and have not been able to discover the deception, exposing thousands of patients to run to the front of a treatment failure.
According to the national security Agency of medicines and health products (MSNA), after the revelations in April 2011, the Drug continued to be available until October 2011, when another generic was made available, that is to say 5 months after.
A letter to all physicians and pharmacists of the hospital has been sent by the MAN to inform them of the replacement Thiotepa : “The under-dosing, noted during the various analyses, does not lead to a decline of significant efficacy or toxicity “. Close the ban !