Novartis is a Repeat Offender for Fraudulent Drug Marketing

It may be just a matter of time before Novartis puts profits ahead of patient safety in marketing yet another life-threatening drug

Wednesday, August 29, 2018 - Novartis is the worlds leader in prescription drugs and no stranger to aggressive marketing, however, former Novartis sales manager David Kester recently said enough is enough. Kester blew the whistle and charged his "company, under the US False Claims Act, with perpetrating an illegal marketing scheme to sell their drugs. According to www.policymed.com, Novartis was specifically accused of corrupting pharmacist judgment by tying financial incentives to dispensing costlier and less effective Novartis drugs instead of rival products." One of those drugs, Tasigna, was used to refill prescriptions of cancer patients that were previously taking the company's other anti-cancer drug Gleevec. Gleevec was scheduled to go off patent and rather than lose market share to cheaper generic competitors, specialty pharmacists merely refilled cancer patient prescriptions with Tasigna. Tasigna/Gleevec patients were kept in the dark as to the potency and toxicity of Tasigna and the resultant adverse side effects. Tasigna patients almost immediately began developing QT prolongation, atherosclerosis, and peripheral artery disease, all of which have the potential to cause paralyzing strokes and sudden death. Specialty pharmacies Bioscript and Acredo Health were also charged in this case for participating in the illegal Novartis marketing scheme. As a result of Kester's actions, Novartis was forced to pay $390 million of the $1 billion fine the Department of Justice (DOJ) levied against them and to give the details of their marketing scheme. DOJ attorneys branded Novartis as "repeat offenders" as the company had a False Claims Act suit filed against them five years earlier in 2010, for $422.5 million. Novartis pleaded guilty to 'misdemeanor criminal allegations involving off-label promotion and kickbacks to doctors."

Prior to the large settlement, the FDA had sent a warning letter to Novartis regarding the marketing activities of their sales representatives on Facebook. The FDA alleged that Novartis Tasigna advertising violated the FDA's policy prohibiting the use of social media to market prescription drugs. The FDA stated in the letter that 'The ads did not adequately inform readers of the risks of taking Tasigna, including the black box warnings included on the warning labels, the ads incorrectly implied that Tasigna could treat all forms of CML, rather than a subset of people with the disease and that the ads used terms like 'next-generation" in describing Tasigna, suggesting that it was more effective than similar drugs, but the FDA said such claims are unsubstantiated."

The upshot of Mr, Kester's work is that Tasigna is now required to carry a "Boxed Warning" the most serious FDA designation reserved for drugs and medical devices that have the potential to cause serious injury or death in and of themselves. Tasigna's risks include developing atherosclerosis, the narrowing of the arteries leading to the extremities, brain, and heart, as well as necrosis of the extremities requiring amputation, paralysis from strokes, and sudden death from heart attacks. Atherosclerosis causes plaque to rapidly build up in the arteries leading to the extremities brain and heart. Kester earned $12 million of the $390 million that was returned to taxpayers through Medicaid and Medicare and was named "Whistleblower" of the Year. Tasigna Atherosclerosis lawsuits against the Swiss drugmaker Novartis are the best means for individual consumers to hold the pharmaceutical giant accountable.

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