How Many? Novartis Says 10,000 Side Effect Cases Were Never Filed
By Ed Silverman WSJ
Two months ago, NovartisNOVN.VX +1.95% acknowledged its staff in Japan hid safety reports concerning patients in a clinical study of leukemia medicines. The evidence had been shredded or online files were deleted. At the time, the drug maker did not specify the actual number of cases, although some Japanese media reported the initial findings involved about 30 instances.
Now, though, Novartis says that at least 10,000 cases were uncovered and may never have been reported – and that the cover-up was actually in connection with 10 different medicines. These include the two leukemia treatments – Gleevec and Tasigna – as well as the Xolair asthma drug; the Exelon patch for Alzheimer’s and Parkinson’s diseases, and the Neoral medicine used to mitigate organ rejection.
A Novartis spokesman says the investigation is continuing and the drug maker has not yet determined if any of these safety reports were associated with confirmed adverse events or serious adverse events. As noted previously, some salespeople helped doctors rate the severity of side effects, and the drug development division failed to inform the product safety team about the cases, which date as far back as 2002.
The findings were reported to the Japanese Ministry of Health, Labor and Welfare last Friday, as well as to other health authorities, including the FDA, the spokesman tells us. He adds that Novartis considers “any delaying in filing” safety reports to be a “clear breach” of the company code of conduct and that Novartis employees are being required to undergo additional training in reporting adverse events.
The extent of the problem underscores the difficulties the drug maker may have in rehabilitating its image and, by extension, its business in Japan, where Novartis has endured a sobering series of scandal over its clinical research practices.
The first involved several Japanese universities, which said some clinical study results for the widely used Diovan blood pressure drug had been altered to highlight the benefits. The drug maker insisted it was not involved in the questionable research, which led to the retraction of several medical papers, but did concede that an employee had participated in the trials and that it was a conflict of interest.
By Ed Silverman WSJ
Two months ago, NovartisNOVN.VX +1.95% acknowledged its staff in Japan hid safety reports concerning patients in a clinical study of leukemia medicines. The evidence had been shredded or online files were deleted. At the time, the drug maker did not specify the actual number of cases, although some Japanese media reported the initial findings involved about 30 instances.
Now, though, Novartis says that at least 10,000 cases were uncovered and may never have been reported – and that the cover-up was actually in connection with 10 different medicines. These include the two leukemia treatments – Gleevec and Tasigna – as well as the Xolair asthma drug; the Exelon patch for Alzheimer’s and Parkinson’s diseases, and the Neoral medicine used to mitigate organ rejection.
A Novartis spokesman says the investigation is continuing and the drug maker has not yet determined if any of these safety reports were associated with confirmed adverse events or serious adverse events. As noted previously, some salespeople helped doctors rate the severity of side effects, and the drug development division failed to inform the product safety team about the cases, which date as far back as 2002.
The findings were reported to the Japanese Ministry of Health, Labor and Welfare last Friday, as well as to other health authorities, including the FDA, the spokesman tells us. He adds that Novartis considers “any delaying in filing” safety reports to be a “clear breach” of the company code of conduct and that Novartis employees are being required to undergo additional training in reporting adverse events.
The extent of the problem underscores the difficulties the drug maker may have in rehabilitating its image and, by extension, its business in Japan, where Novartis has endured a sobering series of scandal over its clinical research practices.
The first involved several Japanese universities, which said some clinical study results for the widely used Diovan blood pressure drug had been altered to highlight the benefits. The drug maker insisted it was not involved in the questionable research, which led to the retraction of several medical papers, but did concede that an employee had participated in the trials and that it was a conflict of interest.