MannKind Corporation: Why Lantus And Afrezza Do Not Cause Cancer

Published at Retail Investor 360: Saturday, 23 August 2014 12:19 Written by Doctor Hung V. Tran, MD, MS.

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

The Story. 2015 will mark a new era of diabetes care as Sanofi SA ADR (NYSE: SNY) teamed up with MannKind Corporation (NASDAQ: MNKD) to launch the revolutionary ultra rapid-acting insulin called Afrezza. Revolutionary in its designs and kinetics Afrezza will treat $28 million patients with diabetes in the United States (US) initially and then potentially 382 million patients worldwide, as Sanofi will rapidly gain the Europe Medicines Agency (EMA) approval for Afrezza. We recently debunked a common misperception, which stated that the required lung testing (spirometry) would hamper Afrezza's sales. According to our clinical familiarity with spirometry, the test can be quickly and easily performed with minimal discomfort while compensating prescribers, thus leading to sales improvements. Likewise, the focus of this research is to clarify the misapprehension that insulin and Afrezza cause cancer.It is quite easy to believe that insulin causes cancer because statistics, in fact, show that there are more cancer cases for patients with Type 2 diabetes taking insulin compared to the general population. The aforementioned statistics are, however, tricky, and needs to be analyzed by seasoned trial investigators or researchers as the higher number of cancer cases simply represents "CORRELATION" rather than a "CAUSAL" relationship per se.

More Insights. It is imperative to note that correlation and causal are two distinctive relationships. According the Australian Bureau of Statistics, correlation is a "statistical measure (expressed as a number) that describes the size and direction of a relationship between two or more variables. The Pearson Correlation Coefficient (r) can express the degree of correlation between two variables mathematically.

1 2 3 4
View single page >> |

We are long MNKD and we do not have any financial relationship with any company we cover.

How did you like this article? Let us know so we can better customize your reading experience. Users' ratings are only visible to themselves.

Comments

Leave a comment to automatically be entered into our contest to win a free Echo Show.
Moon Kil Woong 4 years ago Contributor's comment
It is possible the method of action or delivery system of Afrezza or something else tends to incite or inflame patients creating the risk of cancer rather than insulin itself. What is necessary is more studies or another drug or delivery system that doesn't have the same profile. Given the current tests and alternatives I would find it hard to recommend these until there is more conclusive evidence that there is not a risk. I would assume drug approval agencies like the FDA will tend to agree and require more trials.
Retail Investor 360 4 years ago Author's comment
Moon Kil Woong Again, I do not know your level of understanding in medicine or biostatistic, but based on your responses I strongly believe that you might benefits from reading up on basic biostatistic principles of "causation, correlation, and confounder." (Moon: "I would assume drug approval agencies like the FDA will tend to agree and require more trials). --The FDA requires all drugs to undergoes phase 4 or surveillance study so that does not mean insulin is not safe.
Retail Investor 360 4 years ago Author's comment
Moon Kil Woong I am not sure why the spacing on the article appeared messed up but I already send the info for the editor to fix. I am not sure where your understanding and knowledge of biostatistic and trial data investigation is so I am going to ask you several question to facilitate this discussion. What type of study is it? What info can we infer and conclude from such a study? What are the previous studies done on this topic? How reliable are these studies? Have you read the ORIGIN trial or the paper I presented in and comprehend it? I can tell you off the bat that the study mentioned looking at insurance databases, in the eyes of the seasoned clinical trial investigator, is not the gold standard. Docs would not make recommendation base on such a study. Information looking at the insurance data will NOT be able to establish CAUSAL but CORRELATION at best. If you pay careful attention to what you wrote: ""On June 26, 2009, Diabetologia published the results of four large-scale registry studies from Sweden, Germany, Scotland and the rest of the UK. The German study, of around 127,000 insulin-treated patients from an insurance database, suggested a possible link between insulin glargine and increased risk of developing cancer." -The key is the word LINK... which indicate correlation and not causal! Just like what I wrote in the article that back then people used to believed that coffee causes cancer, as there was a link between coffee drinkers and cancer. Now we all know that the link or correlation is "smoking" from the Harvard Medical School studying, which proved that coffee drinkers also tend to smoke. Smoking is the confounders that underlies the correlation in that case. Pertaining to the ORIGIN trials, this is a gold standard, international, randomized clinical trial, and quite large (high power) to establish there is NO causal relationship between insulin and cancer. The ORIGIN trial has proper randomization to allow investigators to clearly establish meaningful conclusion regarding causal relationship. You can call Sanofi's CMO and he'll be happy to talk to you further regarding the myopic notion that insulin causes cancer. As an MD and a member of the medical community, our responsibility is to inform the truth rather than spreading bias fear that insulin causing cancer, as ignorant can be even more damaging the cancer per se. I see that you're on the corporate side and you might not have the proper understanding of biostatistic or medicine properly analyze the data. Per your response, "I doubt those getting cancer taking these drugs care that much if its a corollary or casual one but that it increased their risk with may have resulted in their getting cancer." - I haven't heard of a single patients stating that insulin causes cancer. If anything, they've been saying insulin saved their life. It is rather the corporate/profits driven folks who have been spreading such lies... even in the face of clinical data.
Retail Investor 360 4 years ago Author's comment
There's several questions you should ask? What type of study is it? I can tell you off the bat that study looking at insurance databases, in the eyes of the seasoned clinical trial investigator, is not the gold standard. Information looking at the insurance data will NOT be able to establish CAUSAL but CORRELATION. The ORIGIN trials is randomized, global, and quite large (higher power) and it established there is NO causal relationship. As an MD and a member of the medical community, our responsibility is to inform the truth rather than spreading bias fear that insulin causing cancer, as ignorant can be even more damaging the cancer per se.
Moon Kil Woong 4 years ago Contributor's comment
This is the cause for concern. On June 26, 2009, Diabetologia published the results of four large-scale registry studies from Sweden, Germany, Scotland and the rest of the UK. The German study, of around 127,000 insulin-treated patients from an insurance database, suggested a possible link between insulin glargine and increased risk of developing cancer. Type 2 diabetics who used insulin glargine had a 2.9-fold greater chance of cancer, while those who took the generic drug metformin had an 8 percent lower risk, according to a study presented on 9 December 2011 at the San Antonio Breast Cancer Symposium. Researchers examined medical records of 23,266 patients in southern Sweden. We will see about Afrezza, however there is strong evidence to support that there is a relationship with glargine. I doubt those getting cancer taking these drugs care that much if its a corollary or casual one but that it increased their risk with may have resulted in their getting cancer. It certainly is a risk that must be weighed when addressing Afrezza and not one that can be automatically discounted.
Retail Investor 360 4 years ago Author's comment
"We will see about Afrezza, however there is strong evidence to support that there is a relationship with glargine." -- Again, the relationship here, as proven by the Golds standard ORIGIN trials is CORRELATION rather than CAUSAL, and INSULIN DO NOT cause cancer. Docs are NOT hearing their patients saying that insulin causes cancer. Unfortunately, we tend to hear such bias opinions from WS financiers who are either ignorant of medicine/statistics and/or have conflict of interests.