MannKind Corp. (MNKD)

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MannKind Corporation: Why Lantus and Afrezza Do Not Cause Cancer
Published: Saturday, 23 August 2014 12:19 Written by Doctor Hung Tran, MD, MS
Disclosure: We are long on MNKD and we do not have any financial relationship with any company we cover.

360 Catalyst Keys

The ORIGIN trial – studied insulin glargine (Lantus) in patients with Type 2 diabetes and presented at the American Diabetes Association (ADA) in 2013 – proved that insulin does not cause malignancy. The same fallacious notion that Lantus causes cancer or neoplasm now directs toward Afrezza
Critics misapprehended the data (on insulin and cancer) due to the difficulty and often misunderstood relationship between statistical correlation and causality
Patients with Type 2 diabetes often have other coexisting diseases such as obesity, hypertension, and/or hypercholesterolemia, which collectively refer to as "confounders." Obesity is a confounder of interest because there is a plethora of literature proving that obesity increases risk of cancer
The United States Food and Drugs Administration (FDA) has mandatory post-approval surveillance (i.e. phase 4 trials) studies of all drugs and Afrezza is not an exception
Pulmonary hyperplasia is a requisite for lung cancer, but all clinical trials did not show any evidence of hyperplasia. MannKind's clinical trials data proved Afrezza is indeed safe. If hyperplasia occurs, it will occur in patients who participated in the Affinity trials already. Moreover, patients who were on Exubera and then switched to Afrezza, in an ongoing trial, do not exhibit signs and/or symptoms of hyperplasia such as decreasing total lung capacity (TLC), forced expiratory volume (FEV1), force vital capacity (FVC), and etcetera; otherwise, the trial should have been halted
Patients exposed to carcinogens like tobacco smoke are found to have elevated levels of insulin-like growth factors receptors (IGF-Rs) in the lungs, which means carcinogens cause an increased in IGF-R. Hence, IGF-Rs are simply biomarkers produced by cancerous lungs rather than causing lung cancer
The human physiology has evolved over centuries, and natural substances produce by our body (i.e. insulin) do not cause cancers or else, we are already extinct