As the number of Xarelto lawsuits approaches 2,000 and the drug’s connection to fatal bleeding becomes more widely known, manufacturer Janssen Pharmaceutica is pulling out all the stops on its marketing campaign – including a recent television ad featuring a quartet of prominent celebrities.
The four celebrities – NBA player Chris Bosh, NASCAR driver Brian Vickers, golfing legend Arnold Palmer and Saturday Night Live alumnus Kevin Nealon – move in widely separated social and professional circles, and would be unlikely to meet for a casual luncheon under most circumstances. However, Janssen would have us believe they’re all old friends who decided to meet up for a friendly game of golf, then retire to the clubhouse to talk about how “treatment with XARELTO® was the right move” for them.
Vickers assures viewers about how Xarelto was “proven to treat and help reduce the risk of DVT (deep vein thrombosis) and PE (pulmonary embolism) blood clots,” while Nealon points out that “Xarelto was also proven to reduce the risk of stroke in people with ‘A-Fib’ (atrial fibrillation, or irregular heartbeat) not caused by a heart valve problem.”
Of course, there’s no mention of FDA concerns over aspects of the clinical tests (specifically, whether or not test subjects had been at the optimal level of blood clotting for a sufficient period of time), nor the fact that post-market studies were funded by the manufacturer and its marketing partners at Bayer.
During the after-game luncheon, in which viewers see the four celebrities chowing down on healthful salads, a voice-over acknowledges that “for people with ‘A-Fib’ currently well-managed on warfarin, there was limited information on how Xarelto and warfarin compare in reducing the risk of stroke.” Nonetheless, Vickers shares his experience: “You know, I tried warfarin…but the blood testing and dietary restrictions…” Nealon commiserates: “Don’t get me started on that.”
This has been the big selling point of Xarelto. Warfarin patients are at risk for some 500 interactions with other prescription drugs as well as various foods high in Vitamin K, such as spinach. Those drug interactions are of particular concern among elderly patients, many of whom take several different medications. Xarelto (also known as rivaroxaban) has fewer than 50 interactions and requires far less in the way of expensive, time-consuming patient testing. The ad acknowledges that patients on Xarelto “may bruise more easily, and it may take longer for bleeding to stop.”
That is a gross understatement. In fact, the bleeding may not stop at all until the drug has been removed from the system, as there is no approved reversal agent. Patients taking rival medications Pradaxa (dabigitran) faced similar problems; however, that drug could sometimes be removed by putting the patient on emergency dialysis. Due to Xarelto’s particular mechanism of action, this is not an option for Xarelto patients. The ad goes on to state: “Xarelto may increase the risk of bleeding if you take certain medicines…Xarelto can cause serious, and in rare cases, fatal bleeding.” The voice-over advises patients to seek emergency help in the case of emergency bleeding – but again, there is no mention how such bleeding should be handled.
Meanwhile, our celebrity endorsers are seen as they continue to enjoy their post-luncheon round of golf, to the accompaniment of sprightly guitar music. As Vickers tells Nealon in a confidential tone as they watch Palmer sink a putt, “You know, Xarelto is the Number One prescribed blood thinner in its class,” to which Nealon responds, “That’s a big win.”
It wasn’t such a big win to those who allege that they been injured or killed by Xarelto, says Levin Papantonio attorney Ned McWilliams who is helping to head the national litigation against those involved in the manufacture and promotions of Xarelto. Executives at Janssen and its parent company Johnson & Johnson, which has been target in several liability lawsuits in recent years, know they’re facing some serious trouble, especially with recent studies published in major medical journals. Although a small San Francisco biotech firm has come up with a promising reversal agent, that drug – Annexa-R – is still undergoing clinical trials, with no indication as to when or if it will get FDA approval. In the meantime, Janssen and Bayer are determined to wring as much revenue out of Xarelto as possible, taking advantage of America’s obsession with celebrities in order to manipulate consumers and boost sales.
Hopefully, all four of Xarelto’s celebrity cheerleaders will continue to live healthy, productive lives. However, if any of them wind up suffering uncontrolled bleeding like almost 2,000 other patients, it could put a serious damper on the drug maker’s current marketing ploy.