Novartis is under the gun over the deadly side effects caused by Tekturna (Aliskiren), its blood pressure pill, the so called “wonder drug.”
Recently Tekturna’s clinical trials were canceled by Novartis due to a high number of strokes and kidney problems among diabetic test subjects. Tekturna HCT, Valturna, TekAmlo and Amturnide are all variations of Teckturna (Aliskiren).
During the ALTITUDE clinical trials, Novartis was testing Tekturna and hoping that a positive result could lead to an expansion of its use in the treatment of diabetic hypertension. The results were disastrous. Novartis discovered that Tekturna may actually increase the risk of non-fatal strokes, kidney problems and other health risks.
Health Canada Investigates
As a result of the Tekturna clinical trial findings, a safety review of the potential Tekturna problems was launched in Canada, by their federal regulators, Health Canada. The Novartis anti-hypertensive drug is sold under the brand name Resilez.
What did Novartis do Wrong?
According to experts, Novartis engaged in extraordinary reckless behavior. Novartis was allegedly instructing its sales representatives to engage in “off-label marketing” of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in the diabetic patient population while claiming it had “protective effects” on these patients.
In fact, it was not specifically indicated for use in diabetic patients and actually caused serious adverse health effects.
Novartis’ Aggressive Off Label Marketing
Novartis engaged in an aggressive off-label marketing campaign to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide specifically for use in the diabetic patient population, a use for which each of the drugs is not indicated and most importantly not FDA approved.
Novartis Sales Reps Under Fire
Because Tekturna is the only drug on the market that is a Direct Renin Inhibitor, this allowed for Novartis to heavily promote the drug (or one of its combinations) for use in the diabetic patient. Sales representatives voiced concerns about selling these drugs for uses for which they were not indicated. Company managers refused to budge.
In fact, sales representatives were trained to illegally used an unbranded sales aid (approved for a disease state, not a drug) that showed the effect of Renin in a rat kidney in order to sell Tekturna and Valturna to the diabetic patient population. This sales aid was used by Novartis to convince medical prescribers that these drugs had positive health effects for the diabetic patient population.
Novartis trained its sales representatives to make claims that Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide would significantly lower blood pressure, protect the heart, protect the kidneys and protect end organs. Flash cards anyone?
Medical Claims Not Supported
Such claims were unsupported by medical science and in fact, contrary to medical data that suggests that the drugs Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide cause an increase in cardiovascular risk, including stroke, renal complications, hyperkalemia and hypotension, especially in the diabetic patient population.
What Novartis Knew or Should Have Known?
During the time that Novartis was actively engaging its sales representatives to use such tactics, it is believed by some that Novartis possessed and still possesses information that Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide causes serious health risks, some of which has been released via the ALTITUDE clinical trial.
According to some experts, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide have minimal blood pressure lowering effects and are of little benefit to patients. To the contrary, these drugs can cause more harm than good. Moreover, Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide carry serious cardiovascular and renal side-effects when used in combination with an ACE or ARB, a use which is most common.
Novartis Paid Kickbacks?
On December 20, 2011, Novartis temporarily suspended the promotion of Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide for use in combination with an ACE inhibitor or ARB.
But prior to its December 20th action, Novartis paid kickbacks in the form of speaker fees and “Lunch and Learns” in order to promote Tekturna, TekturnaHCT, Valturna, TekAmlo and Amturnide to the diabetic patient population.
For another great article on the topic, look at Attorney Larry Jones, of Jones Ward’s blog.