Scios hid deaths from Natrecor
When Merck decided to hide the number of deaths from a Vioxx trial, it was not the company that disclosed it. The New England Journal of Medicine, which published a paper written by Merck scientists, discovered the omission and made it public. It is expected that this misconduct on the part of Merck will come to haunt it it in ongoing Vioxx litigation.
In the case of Scios, the manufacturer of controversial drug Natrecor, at the least the company has come clean that it did not disclose two deaths during the PROACTION trial. These cases were not included in a report on the PROACTION study that was published in the 2005 October issue of the Journal of Emergency Medicine. In that publication, according to the company, the difference in all-cause mortality (patient deaths due to all causes, including those unrelated to medical treatment) at 30 days post treatment between the NATRECOR and placebo arms was not statistically significant. There are reports, however, that Natrecor damages kidneys.
There have been repeated calls for recall of Natrecor but the company says that it is confident these two additional cases have no impact on the overall benefit/risk profile of NATRECOR when prescribed according to the approved label.
The authors of the PROACTION report published in the Journal of Emergency Medicine will submit a study update to the Journal once the data collected through the final expanded analysis are complete. Also, the PROACTION data included in the currently approved NATRECOR product labeling do not include the two additional patient deaths. The company anticipates working with the FDA, as well as with relevant regulatory authorities in other countries, in coming weeks to determine the most appropriate way to ensure that these two cases are accurately reported as part of the full data set for this study.
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posted by eCreativa Media | 1:09 PM
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