Novartis Marketed Tasigna to Replace Gleevec

Economics may be the reason Tasigna was brought to market to replace Gleevec

Friday, November 3, 2017 - According to the National Cancer Institute, chronic myeloid leukemia (CML) is a cancer of the bone marrow that allows white blood cells to grow unchecked crowding and interfering with normal blood cell reproduction. The average age of CML diagnosis is 64 years old and there were over 1000 confirmed deaths from CML in 2017. Of those who die approximately 60% are male and 40% female. The effectiveness of anti-cancer chemotherapy drug Gleevec (imatinib), manufactured by Swiss drugmaker Novartis AG, is credited for doubling the 5-year survival rate for CML patients from 31% in 1990 to over 60% today.

In spite of Gleevec's effectiveness in prolonging the lives of CML patients, cancer chemotherapy is first and foremost a business and Novartis dominates the market. In 2015 Gleevec accounted for almost $5 billion in sales. To prepare for Gleevec going off patent in 2015, and in response to competitors selling less expensive generic drugs, Novartis launched its Gleevec replacement drug Tasigna on June 17, 2010, calling it a "second-generation drug". Less expensive, generic versions of Gleevec started hitting the market in 2016 and Forbes magazine estimates that insurance companies and the entire health care system could save $100,000 per patient over the five years should a chemotherapy patient switch to the generic form of the drug. Such a switch would have caused billions of dollars in losses for Novartis. To compete against generic drugs, Novartis launched and marketed Tasigna to cancer physicians around the world claiming it was more effective and more lucrative alternative for doctors that switched from Gleevec. Company marketing representative encouraged doctors and incentivized doctors to sell Tasigna with illegal contests, bonuses, and cash kickbacks. As a result of the charges brought by whistleblower David Kester and the US government, Novartis was forced to pay $390 million to settle federal and state False Claims Act charges. When doctors are given an incentive to recommend one cancer drug over another based on financial concerns their standards can become compromised and put a patient's health at risk.

Since switching from Gleevec to Tasigna, patients have reported a number of unexpected side effects, the worse of which is atherosclerosis, a thickening and hardening of the body's major arteries, a side effect that they were not made aware of beforehand. Tasigna atherosclerosis can lead to major health issues including strokes and heart attacks resulting in paralysis and even sudden death. As the arteries narrow and the flow of oxygen-rich blood becomes restricted, peripheral artery disease can develop and some patients experience irreversible necrosis (tissue death) of the toes and feet which requires amputation.

Cancer patients that develop atherosclerosis-related condition and the estates of those that have died as a result, are suing Novartis AG alleging that the company had a duty to warn them of the potentially deadly side effects, a warning that was given to Canadian health officials years earlier but never made its way to the American medical community. In 2013, Novartis and Health Canada warned Canadians of the link between atherosclerosis-related conditions and Tasigna anti-cancer treatments and included the language that between the years 2005 and 2013 277 cases of atherosclerosis were reported by Tasigna patients.

Cancer physicians in the United States have now been warned that taking Tasigna causes or worsens atherosclerosis. The warning strongly advises doctors to screen patients for the earliest signs of atherosclerosis and related diseases before, during, and after Tasigna treatments.

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