HHS Accused of Lax Trial Oversight

HHS Accused of Lax Trial Oversight

January 10th, 2013 // 2:05 pm @ jmpickett

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In a strongly worded missive, a consumer watchdog group is accusing the US Department of Health & Human Services of “dangerously lax oversight” of a clinical trial that is being sponsored by the National Institutes of Health, because children are being exposed to risks and these are not properly disclosed to their parents or guardians.

The trial involves canakinumab, a powerful immunosuppressant that is being studied in children as young as six years of age with Type I diabetes. Since early 2011, however, Public Citizen has contended the trial, which is being run by several universities, is unethical because HHS is allegedly overlooking risks and failing to conduct proper oversight.

In arguing its case, Public Citizen contends that a single dose of canakinumab may cause life-threatening infections and the possible risk of malignancy. Known as Ilaris, the drug is sold by Novartis (NVS) and currently approved to treat a group of rare genetic disorders called CAPS in adults and children 4 years of age and older. An FDA advisory committee two years ago rejected the drug for treating gout, citing safety concerns.

The watchdog group has actually twice written HHS previously to urge the agency to halt the trial (see here and here), but sent its latest letter after the HHS Office of Human Research Protection in November wrote two participating universities that the “allegation of noncompliance is unproven.” The OHRP was apparently referring to the earlier Public Citizen protests (here is the OHRP letter).

In its letter, Public Citizen maintains the NIH fails to protect children by violating a law that requires the agency to justify risks based on anticipated benefit to subjects; ensuring the anticipated benefit is at least as favorable to the subjects as alternatives, and adequately soliciting parental or guardian consent. Instead, the watchdog writes that the OHRP is relying on “flimsy and insufficient” rationale and evidence.

“More disturbing, OHRP’s explanation for its determinations reflects a stunning disregard for, and an apparent lack of understanding of, the very regulations that agency is charged with enforcing. Unless these determinations are reversed, OHRP has effectively eviscerated the special HHS regulatory protections intended for children — a population of vulnerable subjects who are unable to consent to participation in research on their own behalf,” the watchdog writes (here is the letter).

In an e-mail, Michael Carome, the deputy director at the Public Citizen Health Research Group, writes us that “we are concerned that OHRP’s determinations in this case have wider implications, because they will weaken the special protections for children involved in human experimentation more broadly.”

Unless HHS can further explain its decision, Public Citizen wants the agency to retract its decision that the trial complies HHS regulations, suspend the study and require compliance with the special provisions of HHS regulations designed to protect children as a condition for allowing the research to continue.

We asked the HHS and its OHRP for comment and will update you accordingly.

[UPDATE: An HHS spokeswoman got back to us to say that “OHRP cannot comment on cases that are currently under review.”]