The investigative Committee of Russia in Moscow took a decision to Institute criminal proceedings on signs of the crime under part 1 of article 238 of the RF criminal code (Rendering services not meeting safety requirements) after emergence in mass media of information that several patients of the Metropolitan research Institute of eye diseases named after Helmholtz had lost vision after the injection of the drug “Avastin”.
According to investigators, in September in the small operating room of the clinic of eye diseases, located on the street Suvorov in Moscow, 11 patients were rendered medical service that does not meet the security requirements of the health consumer. It is established that the victim held unregistered in accordance with the instructions on the application of intravitreal (eye) injection of the drug “Avastin”, which came partial loss of vision, explained in the Department.
In a criminal case has already been assigned the necessary forensic studies to determine extent of injury and the study of the chemical composition of the medicine. Now, investigators questioned employees and officials of the clinic and responsible for the acquisition and storage of drugs.
Last week, 30 September, in the UK drew attention to the fact that, “according to media reports, nine patients one of the Metropolitan ophthalmological clinics lost vision in providing medical services.” “From the information, it also follows that a possible cause of vision loss citizens was the introduction of substandard drugs,” – said the Agency.
In this regard, the capital Glaucus SK started pre-investigation, in which investigators interviewed hospital staff, including officers responsible for the acquisition and storage of drugs. Also will be established in all patients who may suffer harm.
The Director of the Department of public health & communications Ministry of health Oleg Salagai told reporters that “in connection with the emergence of information about the complications in applying the drug “Avastin” in the Institute of eye diseases. Helmholtz Minister of health Veronika Skvortsova was instructed the Federal service for supervision in the sphere of health to inspect on the given fact”.
“First you need to understand what happened and why, and whether it’s so, so early in the morning today, the health Ministry has already started to work, – said to journalists she Skvortsova. – Look, – it came very ambiguous, there are different data”.
The information that nine persons have completely lost vision after research Institute. Helmholtz they made a shot, “Avastin”, extended Life. According to him, now all victims are under the scrutiny of doctors, the hospital staff took their tests and began to investigate the cause of vision loss. According to one version, in cones with the drugs they were injected with, could be some infection, the report said.
The cost of one injections of “Avastin” – 10 thousand rubles, this drug is a cheaper analog of other medications, one dose of which costs patients 50 thousand rubles. Both drugs help with retinal detachment, but the difference between them is only in a manufacturer, according to the source of Life in the medical community. Get the shot, “Avastin” only in Moscow and St. Petersburg, according to the publication.
Fsbi “mnii GB named. Helmholtz” of Ministry of health of the Russian Federation is the country’s oldest ophthalmologic research centre and the head on the issue of ophthalmology in the health system, reported on its official website. “The latest medical developments, the experience of establishing and delivering eye care in difficult situations and can return vision even in the cases leading to blindness,” – noted in the materials on the website of the Institute. The Institute is the base of the center of medicine of accidents “Protection”.
Manufacturer of Avastin”, said that the drug is not registered for use in ophthalmology
The company Roche, the manufacturer of the drug “Avastin”, expressed deep concern in connection with the information appeared in mass media about cases of vision loss patients clinic of eye diseases of Helmholtz, said in a press release received in the editorial office NEWSru.com.
While the company stresses that “Avastin” is not registered for use in ophthalmology. In the instructions for medical use of the drug has a warning that the drug is not intended for intravitreal injection, said spokesperson Anna Terekhova.
In her words, “Rosh” repeatedly informed the Federal service for supervision in the sphere of health care and Federal development on the cases of severe lesions of the organs of vision, have developed in the use of “Avastin” for unregistered indications that were noted in patients in various countries around the world.
So in 2011, the company had distributed newsletters to physicians about the inadmissibility of the use of the drug for naturalistichnymi indications in ophthalmology. In addition, this information was published on the official website of Roszdravnadzor, the company said.
A spokesman for the company also noted that “Roche is working with health authorities and will do everything to facilitate a proper investigation of this situation. The company cannot give any further comment until the completion of the official inquiry concluded today.