Federal service on surveillance in healthcare (Roszdravnadzor) has withdrawn from the Russian market a series of drug “Avastin”. A corresponding letter signed by the head of service Mikhail Murashko, was published on the organization’s website.
At the end of September this year due to the use of “Avastin” in the clinic. Helmholtz has lost vision 11 patients. According to the results of the preliminary investigation into the incident, the Central investigation Department of the Investigative Committee of Russia (GSU SKR) across Moscow brought criminal case according to p. 1. article 238 of the criminal code of Russian Federation (“Manufacture, storage, transportation or sale of the goods and production, performance of works or rendering services not meeting safety requirements”). As noted by the representatives of the capital of GSU SKR, patients provided does not meet the security requirements of the health consumer.
“Avastin” drug produced by Swiss pharmaceutical company Roche. In Russia, packaged in the company of GK “R-Pharm” CJSC “ORTAT”. The drug is used in cancer patients.
Roche in a statement published on the website of the company, said that “Avastin” is not registered for use in ophthalmology. In his instructions there is a warning that the drug is not intended for injection into the cavity of the eye, warns the manufacturer. As noted in Roche, the company did not deliver the drug in the Helmholtz Institute.through its official partner of “R-Pharm”.
Roche draws attention to the presence of “Avastin” analogue drug “Alegra”, which produces a Russian company BIOCAD. The company suggests the need to find out what the drug was administered in the clinic. Helmholtz.
BIOCAD registered “Alegra” in November 2015, the drug is not supplied in the clinic. Helmholtz stated the General Director of the company Dmitry Morozov. “Alegro” as “Avastin”, cannot be applied in ophthalmology, he said.
As told a source in the Federal Antimonopoly service, the drug “Avastin”, despite the statements of representatives of Roche and can be used for the treatment of ophthalmic diseases. This follows from the case competition authority of Italy ICA, which in February 2014, accused Roche and Novartis of colluding (presentation of the representative of the Italian Minister Giovanni Pitruzella is available).
According to the materials of the case, the company has entered into an agreement in 2011 to keep sales of the Novartis drug “Lucentis” for the treatment of the retina. The fact that the treatment of ophthalmic diseases “Lucentis” significantly more expensive “Avastin,” according to ICA. When Roche became aware of the fact that “Avastin and Lucentis”, can be used to treat diseases of the retina, the companies agreed not to amend the statement of a Swiss drug. For collusion, the two companies were fined 180 million euros.
Ophthalmologist, who requested anonymity, said that we are not talking about the use of the drug for other purposes, that trying to point the pharmaceutical companies. In his opinion, the cause of the incident in the clinic. Helmholtz is the human factor. In Russia there is no culture division doctors drugs smaller than in packages, doses, whereas the use of “Avastin” is to be the expert emphasizes.
For example, in Germany, he said, for this purpose, special syringes, which are then stored under sterile conditions at a certain temperature. Most likely, involves the expert in the clinic. Helmholtz had either violated the conditions of storage of the drug, or incorrectly entered.
To attract a doctor for the drug not in the instructions is almost impossible, says the project Manager of the pharmaceutical areas of VEGAS LEX Maria Borzova. “In theory it is possible to apply article 14.4 of administrative offences code of the Russian Federation and 238 of the criminal code, which relies on the Investigative Committee. But in practice, to prove the guilt of the doctor on the case so the prosecution will be very difficult,” said Borzov.