SILVER SPRING, Md. -- There is general agreement that opioids may be useful for treating children in pain, but just as with adults, children are at risk for developing tolerance.
That was just one of the points made during a full day of testimony about the FDA's current procedures for clinical trials of opioids in children.
Charles Berde, MD, of Boston Children's Hospital said opioids have essential uses in the pediatric population, for cancer (mainly mucositis and tumor-related pain) and life-limiting illnesses, as well as other acute conditions such as postoperative pain and children who have critical illnesses and require mechanical ventilators.
Berde testified during the first day of a planned 2-day joint meeting of the the Anesthetic and Analgesic Drug Products Advisory Committee, the Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee.
But he also argued that children can develop a "profound opioid tolerance" and use of the drug may lead to withdrawal syndromes in infants and children.
Berde and others noted that although the FDA's current policy requires evidence of efficacy most evidence comes from trials in adults. Berde said that children and adults have some epidemiologic differences in their responses to pain.
"There is an age-dependence for the likelihood of chronic pain," he said. "The time course of pain seems different by age -- there are aspects where recovery seems faster in children."
Steven Weisman, MD, of Children's Hospital of Wisconsin, noted that pediatric trials present unique difficulties.
Among the challenges, Weisman said, are limited ability of children younger than 8 to self report the nuances of pain. Moreover, he said children have variable baseline functional levels -- pain to one child is not necessarily pain to the other.
In addition to the challenges in obtaining the data, there were also challenges in getting the data funded.
Gary Walco, PhD, of Seattle Children's Hospital, testified that there were 35 institutions who were willing to partner with his hospital to do studies, but funding was the limiting factor. He added that "pain is not a disease," and thus, difficult to fund as opposed to something like pediatric oncology, for example.
"We did look at partnering with industry and if you want to risk your career, you'll do opioid studies and take money from drug companies in the current political environment," said Walco.
In fact, the current political climate already deterred one planned study on oxycodone use in 6-month to 24-month olds. Weisman said the investigators decided to put the study on hold "for fear of media."
"We're not subservient to pharma. We're trying to figure out a way to do these studies, but we cannot find other funding sources," he said.
Another consideration is the current media focus on the so-called opioid epidemic.
Chris Feudtner, MD, of Children's Hospital of Philadelphia, argued that the opioid epidemic needs to be examined from both an individual and a population point of view, but that population concerns should not be the deciding factor in the labeling of a medication (namely including the risk of potential opioid abuse).
"The FDA should not be asking for longer labels. The label shouldn't be about whether that medication is going to disappear from your medicine cabinet at some point," said Feudtner. "We can address this problem through prescribing practices, but it should not be a labeling issue."
He warned the committee not to "overstep" regulatory requirements and take on other tasks, such as public health considerations, just because "other players have stepped away," and reiterated that the issue is about drug regulation, not trying to control a public health problem.
The committee plans another full day of testimony Friday and then is expected to vote on recommendations.