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Doctor questions new drug's use
By Cai Wenjun |
May 22, 2012, Tuesday
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Print Edition
Print Edition
A local doctor is questioning whether the German pharmaceutical giant Bayer AG illegally sells and promotes a blood-clotting prevention medicine for a use not approved by China's State Food and Drug Administration.
Dr Zhang Qiang, director of Shanghai East Hospital's vascular surgery department, said Bayer's rivaroxaban was only approved by the SFDA for prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery. But Zhang said it was sold and promoted for VTE treatment recently.
"I started to realize the problem in the past two weeks, after many patients consulted me about rivaroxaban prescribed by doctors in their hometown for VTE treatment," Zhang told Shanghai Daily yesterday. "After I checked the medicine and professional websites and articles abroad, I found it is not approved by China for VTE treatment."
Some patients said online that they are told it was a clinical trial but they should pay for the medicine, which must be free to any trial participants under Chinese and international practice, Zhang said.
The medicine was just approved in Europe for VTE treatment at the end of last year.
"But Chinese have different physical conditions than Europeans," he said.
"Clinical testing is a must for any new use in China."
Most Chinese patients are using warfarin for VTE treatment. The price is only 0.29 yuan per (4 US cents) pill and each patient should take one to three pills per day depending on their individual conditions. But patients need to undergo blood tests every week for doctors to control side effects.
Both rivaroxaban and warfarin have bleeding as a side effect.
Both medications prevent the formation of blood clots. Rivaroxaban's main advantage is that it does not require such close monitoring or dose adjustments.
"However, the possibility of bleeding of warfarin is 1.2 percent and rivaroxaban is 0.8 percent in European tests. But the price of rivaroxaban is 99 yuan per pill," Zhang said. "Following doctors' direction and receiving blood tests every week, bleeding can be greatly avoided for patients using warfarin," he said.
"Rivaroxaban is a good medicine and I will prescribe it to my suitable patients after it is approved by SFDA," Zhang said. "But every step should be in line with the laws and regulations."
According to China Business News, Bayer said its clinical trial for the new indication had been completed in December and it had applied for SFDA to approve the new indication.
The company was waiting for the SFDA's evaluation, but it didn't rule out the possibility that in some regions of the country, the clinical trial is still going on, the Bayer official told China Business News.
Dr Zhang Qiang, director of Shanghai East Hospital's vascular surgery department, said Bayer's rivaroxaban was only approved by the SFDA for prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery. But Zhang said it was sold and promoted for VTE treatment recently.
"I started to realize the problem in the past two weeks, after many patients consulted me about rivaroxaban prescribed by doctors in their hometown for VTE treatment," Zhang told Shanghai Daily yesterday. "After I checked the medicine and professional websites and articles abroad, I found it is not approved by China for VTE treatment."
Some patients said online that they are told it was a clinical trial but they should pay for the medicine, which must be free to any trial participants under Chinese and international practice, Zhang said.
The medicine was just approved in Europe for VTE treatment at the end of last year.
"But Chinese have different physical conditions than Europeans," he said.
"Clinical testing is a must for any new use in China."
Most Chinese patients are using warfarin for VTE treatment. The price is only 0.29 yuan per (4 US cents) pill and each patient should take one to three pills per day depending on their individual conditions. But patients need to undergo blood tests every week for doctors to control side effects.
Both rivaroxaban and warfarin have bleeding as a side effect.
Both medications prevent the formation of blood clots. Rivaroxaban's main advantage is that it does not require such close monitoring or dose adjustments.
"However, the possibility of bleeding of warfarin is 1.2 percent and rivaroxaban is 0.8 percent in European tests. But the price of rivaroxaban is 99 yuan per pill," Zhang said. "Following doctors' direction and receiving blood tests every week, bleeding can be greatly avoided for patients using warfarin," he said.
"Rivaroxaban is a good medicine and I will prescribe it to my suitable patients after it is approved by SFDA," Zhang said. "But every step should be in line with the laws and regulations."
According to China Business News, Bayer said its clinical trial for the new indication had been completed in December and it had applied for SFDA to approve the new indication.
The company was waiting for the SFDA's evaluation, but it didn't rule out the possibility that in some regions of the country, the clinical trial is still going on, the Bayer official told China Business News.
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