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HHS Told To Probe ‘Unethical’ Novartis Trials

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By Ed Silverman // March 16th, 2011

201103211158.jpg The federal government was asked by a watchdog group to investigate several allegedly “unethical long-term, placebo-controlled studies” for indacterol, a Novartis drug for treating moderate to severe chronic obstructuve pulmonary disease. Why? “The studies were marred by a failure to minimize risk to subjects and inadequate information provided to subjects,” according to Public Citizen.

In a letter sent to the Office for Human Research Protections at the US Department of Health and Human Services, the group alleges there six “unethical” studies in which placebo-control subjects received prolonged substandard care. Put another way, Public Citizen charges the patients were prevented from using widely acknowledged standard care and that informed consent was likely inadequate because placebo patients would not have known substandard care would be offered.

“The scientific question of whether indacaterol was better than placebo for treating moderate to severe COPD was not an important or clinically useful question, given the existing state of knowledge about COPD treatment at the time these studies were conducted. Rather, the important question is whether indacaterol is at least as good as currently available bronchodilator therapy,” the group writes.

Specifically, the watchdog group writes that more than 1700 subjects were assigned to placebo groups for three to 12 months and were allowed to use daily inhaled steroids and short-acting beta-agonists, but were not permitted to use any long-acting beta-agonists or short- or long-acting inhaled anticholinergics or to start inhaled corticosteroids.

The move comes just one week after an FDA panel voted 13 to 4 to back the med, but only at 75 mg, a lower dose than used in Europe. However, the same advisory committee voted 12 to 5 against endorsing the 150 mg dose. Two years ago, the FDA declined to approve the drug over safety issues and asked Novartis to look at lower doses.

However, Public Citizen does not want the FDA to look into this. Why? “It is clear 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. Therefore, since FDA is complicit in this unethical research, we urge OHRP to take the lead in investigating our allegations” (read the letter here).

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