Novartis Hopes To End Its Tasigna Stigma

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whoknows.jpgEarlier this week, the drugmaker claimed a much-hoped-for victory when the FDA finally approved its cancer med, which can be used as a treatment for chronic myeloid leukemia in patients who can no longer take Gleevec. The agency delayed approval last July after deciding to review study data.

That same week, a former global director of biostatistics filed a wrongful termination lawsuit, alleging he uncovered numerous violations of the drugmaker’s safety reporting system, which is used to process safety data from clinical trials, in particular the Tasigna cancer med trials. Both the former employee, David Olagunju, and his lawyer also say that three FDA employees met with them last June to review Novartis documents, prompting an audit, which the FDA has never acknowledged.

Does the approval mean the audit is over? A Novartis spokesman declined to comment, other than to say that “discussions with the FDA have been completed and the drug is approved.” In other words, read between the lines, although that’s still not a flat confirmation. An FDA spokeswoman hasn’t responded to an e-mail. Olagunju’s lawyer, Bill Courtney, tells us it doesn’t matter.

“We don’t know what, if anything, the FDA found,” he says. “Whether or not Tasigna was approved doesn’t have anything to do with our case. My client’s claim is that he was retaliated against for reporting what he believed were problems with safety data reporting.” No, but the inference has been that potentially important safety issues were at stake. Unless the FDA audit uncovered problems that are being addressed quietly, the approval may allow Novartis to finally mitigate the ruckus caused by the lawsuit.

Another lawsuit has cropped up, though. This time, shareholders are suing the drugmaker for allegedly withholding adverse info about Tasigna data earlier this year, and claim the failure to disclose caused the stock to trade at artificially inflated prices. You can read that one here.

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  1. Hey Ed, Thanks for this. How refreshing to see shareholders rise up to the challenge of trying to keep Big Pharma on the right path. If enough of us join together, we shall all benefit.

    Remember, today a shareholder, who knows tomorrow possibly a patient with one of these diseases, then you shall be trapped in the web of deceit.

    I wonder how many share holders sleep well at night knowing that their gains on shares are being made at the expense of sick and nearly dying people….

    It beginning to seem to me that the only true way of helping the world would be to sell off the shares of companies like this and invest the money directly into centers of research with key researchers who can’t be bought with dirty pharma’s money. These are the folks who really want to cure these diseases anyway..

  2. [...] - Tasigna moving forward. Galvus moving [...]

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