Novartis "life-threatening Door": how many potential victims – Novartis – Pharmaceutical industries
Pharmaceutical companies to produce "lethal" drugs? This is a people can not laugh listening to the black humor. However, such events are being staged in China. In Anhui, Zhejiang and other places, have been continuously be exposed for taking drugs, "telbivudine" serious adverse reactions and death. Production of the drug, is the world's leading bio-pharmaceutical giant – Novartis.
"Cake" behind the murder
"Telbivudine," as the nucleoside analogues, commercial name "element than the V", currently being used in the treatment of chronic hepatitis. Hepatitis B virus infection in China is the world's largest country, and about 30 million chronic hepatitis B, hepatitis B virus carriers in more than 120 million. April 2007, Novartis will "prime ratio V" into China.
However, the unexpected happened. "Hefei Evening News" reported that the end of 2008, 12 in a row taking telbivudine after 9 months due to serious adverse reactions, Anhui, Li Li 19-year-old youth died strength. The cause of death is given in the hospital: rhabdomyolysis syndrome caused by multiple organ failure. Subsequently, Li Li Li Li force will force the parents of other points of hospital visits and Beijing Novartis Pharma AG to court to claim 740,000 Novartis.
2009 9 months, commissioned by the court, Hefei Institute of Forensic Science and Technology Li Li force on the cause of death is given a final conclusion. Identification of the submissions indicated that Li Li force died of "taking the 'telbivudine' due to muscle damage, based on … … leading to rhabdomyolysis caused extensive multiple organ failure."
In fact, earlier, Ningbo, Jinhua, a total of five causes of drug-induced adverse reactions occurred, of which 2 died. Some patients and domestic forums, it was also reflected in the take "than the underlying factors" after palpitation, weakness, vomiting, shock and other symptoms. "Hefei Evening News" quoted Shanghai Ruijin Hospital, experts pointed out that taking the drug must regularly check the patient's body monitoring indicators, when abnormal, should be immediately suspended. In the "prime than the V" in the prospectus, whether side effects warnings, or advise regular check-ups should mark these words were not there.
With the fatal cases of contrast, Novartis in China's remarkable performance. According to data released by Novartis outside, less than 2 years of listing the "elements than V," has been ranked No. 3 market share. The article points out, in 2009, "than the underlying factors" in our domestic sales of about 28 million U.S. dollars. The Chinese market this huge "cake", to Novartis yield huge returns.
Were "watered down" the risk of
In fact, in 2008, the European Medicines Agency (EMEA), once released to take "telbivudine (factor than V)" warnings, and recommended that the instructions in the elements than the V to add a warning, warn doctors "Chronic hepatitis B patients with factor V exists than the risk of occurrence of peripheral neuropathy." EMEA also warned that have occurred using the elements than the underlying peripheral neuropathy cases. Subsequently, the risk warnings in the State Food and Drug Administration Web site, classified as part of "Drug Risk Alert."
As taking "factor than the V," would have serious adverse reactions, FDA approval of its listing at the time, requires warning labels on the highest-ranking black box label warning. At the same time, "than the underlying factors," there is another risk: Once you start taking immediate withdrawal will not, or will occur fulminant hepatic failure.
However, the process of promotion in China, Novartis Pharmaceuticals deliberately play down the relevant warning. Access to a lot of information I found, before the events in the death, no country with "plain than the V" category reported side effects related to the prompt. According to media reports, Anhui Province, an informed doctor, similar to the drug rebate rate of 20% of manufacturers do not want to mention side effects, doctors do not want mentioned.
In addition to marketing in the diluted drug effects suggest that Novartis case on lethal drugs together also downplayed.
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