The consumer watchdog group Public Citizen is calling for the Office for Human Research Protections (OHRP) to launch an investigations into clinical trials conducted by Novartis for the drug indacaterol, which is being developed to treat chronic obstructive pulmonary disease (COPD), after accusing the drug maker of ethics violations for allegedly allowing people to suffer a potentially life-threatening respiratory illness for several months without proper care.
In a letter sent on Wednesday to OHRP director Jerry Menikoff, Public Citizen urged that the FDA not be handed the investigation, saying that the agency has a conflict of interest because the trials were conducted with the full knowledge of the FDA. Both the FDA and OHRP are part of the U.S. Department of Health and Human Services.
The consumer organization says that during clinical trials, Novartis denied COPD sufferers treatment while giving them a placebo for three to six months. The group also says that they do not believe that the test subjects were able to give informed consent to be participants in the indacaterol trials because they were not adequately educated about the risks and discomfort that could be suffered by the placebo group.
The series of six studies were conducted from 2008 through 2010 to test the efficacy of indacaterol, which is designed to increase bronchodilation. About 1,700 subjects suffering from moderate to severe COPD were given placebo pills instead of the actual drug, the group claims, leaving them open to suffer COPD side effects, which in some cases can be lethal.
“In this case, it is clear that FDA has a conflict of interest and should not be asked to investigate our allegations because Novartis conducted these placebo-controlled trials with the full knowledge and endorsement of the FDA.” Public Citizen wrote. “Therefore, since FDA is complicit in this unethical research, we urge OHRP to take the lead in investigating our allegations.”
The subjects were allowed to use rescue inhalers, daily inhaled corticosteroids, or short-acting beta-adrenoceptor agonists. However, Public Citizen points out that, according to the Global Initiative for Chronic Obstructive Lung Disease guidelines that proper treatment of COPD requires regular treatment with one or more long-acting bronchodilators.
Indacaterol is currently approved in Europe under the brand name Onbrez, but has not yet been approved in the U.S. It is a once-a-day medication for the treatment of COPD, and is delivered through the use of a dry powder inhaler.