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FDA approval of inhaled insulin drug is premature

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The Food and Drug Administration (FDA) announced on June 27, 2014 that Afrezza, an inhalable form of insulin, has been approved for sale. The insulin powder is inhaled through the mouth into the lungs as a fast acting version of insulin. Afrezza is inhaled at the start of a meal or within 20 minutes of a meal.

Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research commented on Afrezza.

Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.

The test results of a 24 week study showed small improvements in the hbA1c levels of patients taking Afrezza versus an inhaled placebo. Afrezza provided a 0.4% improvement in hbA1C when used with long-acting insulin in Type I diabetics. When Afrezza was used with other oral anti-diabetic drugs in Type II diabetics, the reduction in hbA1c was better than the placebo. It would be interesting to find documentation of a drug with worse results than a placebo offered for sale.

The main advantage of Afrezza appears to be the elimination of injecting fast-acting insulin to get an equivalent reduction in hbA1c for Type I diabetics at mealtime. Using Afrezza in combination with oral anti-diabetic drugs was better than a placebo in reducing hbA1c.

When the benefits of being able to inhale insulin using Afrezza are measured against the documented risks from Afrezza, there should be serious contemplation as to whether the risks are worth the inconvenience of the injections. Afrezza has a box warning label that says it can cause bronchospasms in patients with asthma and COPD.

Type I diabetics must still inject long-acting insulin. Afrezza is not recommended for patients with a diabetic disorder called ketoacidosis. Patients that smoke are advised not to take Afrezza.

The FDA statement does not say that Afrezza causes lung cancer. However, a post-marketing study is being required by the FDA to determine the risk of pulmonary malignancy, cardiovascular risks, and the long-term impact of Afrezza on lung functions. One might ask why the FDA has let this product be marketed without knowing the risks of increased chronic lung diseases, lung cancer and heart failure.

The details of the FDA announcement warn that Afrezza’s common side effects are hypoglycemia (low blood sugar), cough and throat pain. How does the FDA classify acute bronchial spasm, potential increased risks of lung malignancy, other lung disorders and cardiovascular risks that require further testing?

Fiercebiotech, an industry watchdog group for the biotechnology industry, pointed out in Dec. 2013 that Pfizer spent years and millions of dollars trying to get an inhaled version of insulin approved. Pfizer could not prove that inhaled insulin provided benefit to diabetics over existing fast-acting insulin beyond avoiding an injection. Somehow the manufacturer of Afrezza got the FDA to approve Afrezza under the same limitations.

Approving Afrezza and then requiring “further studies” to see what the true impact of Afrezza is on long-term health is not fulfilling the mission of the FDA. Using 24 weeks of data is a short amount of time given that a lot of diabetics are going to use Afrezza to allow them to take fewer injections.

The approval of Afrezza before conducting the studies now required after approval is in conflict with the stated mission of the FDA.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

This is an example of a government agency that is supposed to be protecting consumers putting commercial interests ahead of the mission of the agency. The approval should be withdrawn until Afrezza has been documented as safe and effective, and not a "cure" that is worse than the existing means of controlling a disease.

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