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Johnson & Johnson Still Hiding the Ball – Will It Ever Learn?

In the recent Risperdal litigation, there is strong evidence that Johnson & Johnson (J&J) manipulated data in various studies to hide the true risk of gynecomastia (breast growth) in children.  Despite ongoing litigation and a recent settlement of a whistleblower lawsuit with the federal government for $2.2 billion for off-label marketing of their drug Risperdal, J&J continues its devious behaviors, putting potential drug sales over consumer safety.  Will it ever learn?

In documents released ahead of an FDA advisory panel meeting on January 16, agency staff yesterday expressed suspicion that the data submitted by J&J demonstrate that Xarelto (rivaroxaban) is effective for treating acute coronary syndrome in patients with a previous history of heart attack.  The FDA staff specifically questioned the method by which J&J analyzed the clinical trial data citing a lack of evidence that the therapy provides a significant clinical benefit or meets an unmet need. “It is unclear how to choose the metric for determining when the benefit of [Xarelto] is greatest,” they remarked, adding “not only does the effect of [Xarelto] not appear to be greater earlier, but an effect in the first 90 days or so is not apparent at all.”  Agency staff further remarked that J&J’s therapy is also linked to increased bleeding risks.

Based on the FDA’s comments, there is a low expectation that Xarelto will be approved for treating acute coronary syndrome.  However, sales of this drug is expected to increase in 2015 to $1.2 billion, from $703 million in 2013.  Currently, Xarelto is FDA-approved for preventing deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery, for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF), and for treatment and reduction of the risk of DVT and pulmonary embolism.

Doctors should be aware that this drug is linked to an increased bleeding risk and not clinically shown to help patients with acute coronary syndrome.

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