FDA Is Urged To Suspend Trials Of Novartis Drug

FDA Is Urged To Suspend Trials Of Novartis Drug

July 20th, 2011 // 12:49 pm @

In letters to the FDA and the Office for Human Research Protections, Public Citizen charges that clinical trials being run by Novartis for its Ilaris medication – which is approved for treating several rare and serious genetic disorders – should be suspended. Why? The watchdog group says Novartis is taking a “shotgun approach” to its research and argues the drug is dangerous and the studies are unethical because patients are not being protected according to law.

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One study involves children, which the group argues may violate federal regulations designed to protect children in research. The drug, Public Citizen notes, can cause widespread inflammation in the body. Last month, an FDA panel did not recommend Ilaris be used to treat gout, and Public Citizen wants the agency to investigate ongoing trials involving patients with heart disease and diabetes.

“Since even a single dose…has many serious risks, including the known risk of life-threatening infections and possibly cancer due to suppression of the immune system, further clinical trials of this drug should proceed only if there is a reasonable basis justifying these great risks to subjects,” Michael Carome, deputy director of Public Citizen’s Health Research Group says in a statement. “For at least two of the ongoing studies, such a justification is lacking.”

We have asked Novartis for a comment and will update you accordingly.

In a study begun in April and sponsored by Novartis, 7,200 adults who have had heart attacks are being given injections or a placebo every three months. The subjects are to be followed for three years to see if Ilaris decreases the chances of further heart attacks, strokes and death from cardiovascular disease, according to Carome. But he maintains there is an apparent lack of preliminary data about potential benefits in preventing heart attacks and strokes and, therefore, there is “no reasonable justification for initiating such a large trial in heart attack patients.”

In a study funded by the National Institutes of Health, 66 patients ranging in age from six to 45 years old with newly diagnosed type-1 diabetes are being given monthly injections or a placebo for one year to see if their pancreases still produce insulin. The study began in October 2010. “The involvement of children raises additional serious ethical and regulatory concerns,” Carome says, because the risks “are not offset by any prospect of reasonably foreseeable benefits to the children.”

In the letter, Public Citizen asks the Office of Human Research Protections, which is part of the US Department of Health and Human Services, to investigate why the study was approved by an investigational review board, or IRB (read the letter here) and if Novartis has offered informed consent appropriately. The watchdog group notes that a search of ClinicalTrials.gov shows the drugmaker is also conducting trials in patients with type-2 diabetes, osteoarthritis and polymyalgia rheumatica, among others, with several studies involving repeated dosing over a prolonged time period.

Source: Pharmalot


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