The Swiss company, Novartis AG, announced that U.S. (federal) prosecutors are currently investigating its marketing practices, especially related to the drug known as Tekturna (Rasilez), a hypertension medicine, according to an article by Ryan Flinn in Bloomberg News, January 24.
On recommendations of an independent Data Monitoring Committee (DMC), Novartis abruptly discontinued an on-going double-blind, placebo-controlled, Phase II Altitude study, which included patients with type 2 diabetes and renal impairment. The Altitude study was to evaluate Tekturna (Rasilez) over the course of more than a year, but during the study some patients involved experienced more strokes and kidney complications than expected. (Bloomberg News, 1/24/13)
Novartis’ sales expectations for Tekturna (Rasilez) were drastically reduced by 31 percent. The DMC reported that patients receiving Tekturna (Rasilez) were unlikely to benefit from treatment. As a precautionary measure, the company announced in December 2011 that it would stop promoting Tekturna (Rasilez)-based products for use in combination with an ACE-inhibitor or angiotensin receptor blocker (ARB).
In addition to the existing concern about Tekturna (Rasilez), Novartis says it is the recipient of “a civil demand for information from the U.S. attorney’s office in Manhattan regarding its interactions with specialty pharmaceuticals” with regard to the cancer drug, Gleevec, and Gilenya, a medicine used by patients with multiple sclerosis. (Bloomberg, 1/24/13) If this were not enough, Novartis’ second largest division, its Alcon eye-care unit, headquartered in Fort Worth, Texas, is also being investigated by federal prosecutors in Dallas with regard to the exporting of Novartis’ products to Iran. (Bloomberg, 1/24/13)
Novartis has some explaining to do.