Former top manager of MannKind, an American biotechnological company, sues his employers for falsifying results of clinical trials of their anti-diabetes drug in Russia. Diabetes is a group of metabolic problems, due to which human body doesn't produce enough insulin to control blood sugar (Type I), or organism's cells do not adequately react to insulin produced (Type II).

Biotechnologists of MannKind company have been performing clinical trials of their new diabetes treatment in the Russian Federation and at the same time have negotiated with Moscow government about further cooperation. John Arditi, former senior director for regulatory affairs of MannKind company, accuses the company in misreporting results, obtained during testing the newest anti-diabetes treatment in our country.

Mr. Arditi's lawsuit is related to "Afrezza", insulin for inhalations. Insulin is a substance, which helps those, suffering from diabetes, control sugar content in their blood. "Afrezza"'s reported benefit is that patients with diabetes do not receive insulin with injections, but simply inhale it; insulin dissolves in patient's lungs and enters his blood stream. The inhaler is as small as palm of a hand. The drug, useful for patients with both types of diabetes is currently reviewed by FDA (Food and Drug Administration, USA).

 

 

The lawsuit, claiming clinical trials "scientifically negligent", is based upon several facts, one of which is same blood pressure in all Russian patients, who have participated in the trials, during several months of the trials. Mr. Arditi, who lost his job soon after he told FDA about suspicious trials, suggests the trials could have been based upon fictitious patients. However, MannKind biotechnological company denies everything and claims that independent experts didn't find anything wrong in the trial procedure and results.

Experts believe that John Arditi's lawsuit may be a serious problem for approval of insulin inhaler by FDA. The lawsuit has already caused a significant drop of MannKind’s shares. Former head of the Moscow government has met the head of MannKind's CEO Alfred Mann last year – the discussion between the two businessmen was dedicated to possible cooperation with the capital's health and biotechnological establishments in the field of treating diabetes, a serious and dangerous disease.

However, some experts think that insulin inhalations aren't a perfect solution for patients with diabetes. Delicate cells of alveolus aren't suitable for delivering insulin into blood stream, they say, because lungs were designed for dealing with gases. Insulin injections nowadays are almost painless, because insulin is injected with tiny and very sharp needles. Sometimes insulin is sold inside a syringe, which is very convenient, since you don't have to do anything with ampoules. Sometimes patients take insulin for tens of years, and consequences of a long-term inhaling of insulin are not studied enough, medical experts say.

Source: Gazeta.ru

Kizilova Anna