FDA Should Reject Dangerous Lung Medicine, Public Citizen Tells Advisory Committee

April 17, 2013

FDA Should Reject Dangerous Lung Medicine, Public Citizen Tells Advisory Committee

Fluticasone/Vilanterol Combination Therapy, Studied in a Series of Unethical Clinical Trials, Is Risky, Provides Little Added Benefit to Patients

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should not approve the proposed combination therapy fluticasone/vilanterol (proposed trade name: Breo Ellipta) for the treatment of chronic obstructive pulmonary disease (COPD) because it is not substantially more effective than the single ingredient vilanterol but leads to an increase in several serious side effects, Public Citizen said today in testimony to the FDA’s Pulmonary and Allergy Diseases Advisory Committee.

COPD is a group of progressive, irreversible lung diseases including emphysema and chronic bronchitis, caused in most cases by smoking. Fluticasone/vilanterol is the latest in a long line of combination therapies developed to treat the disease that consist of an inhaled corticosteroid (ICS) and a medicine known as a long-acting beta agonist (LABA), which opens up constricted airways.

Four clinical trials were designed to test the combination of fluticasone/vilanterol therapy against vilanterol alone for up to one year. The combination of fluticasone/vilanterol did not provide any substantial benefit over vilanterol in improving COPD symptoms, but did lead to an increased number of serious side effects compared with subjects getting only vilanterol, including bone fractures and infections such as pneumonia.

Public Citizen also testified that two of the four pivotal trials were unethical because investigators withheld effective, standard treatments, including other ICS/LABA therapies, for almost six months, from hundreds of subjects with severe COPD, instead giving some placebo pills and others substandard care with inhaled steroids alone. Such trials are permitted, and unfortunately not uncommon, under the FDA’s current regulatory system governing drug approvals.

“This new combination therapy, never arguably a breakthrough drug to begin with, was conclusively shown to be more risky, and not substantially more effective, than vilanterol alone in the pivotal trials,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group. “And that two of the trials that denied effective treatments to hundreds of severely ill patients were even allowed to go forward – without objection from either the FDA or local institutional review boards – is a sad testament to the lack of adequate protections that exist for trial subjects today.”

Read today’s testimony.

A minor edit was made, changing “no more” to “not substantially more” in the first paragraph on April 22, 2013.