The Denver Post

“Breakthrou­gh” law prompts cancer trials

Research on pediatric drugs has lagged historical­ly

- By John Ingold

AURORA» Doctors at Children’s Hospital Colorado hope to launch as many as 25 new clinical trials in the next six months after a recently signed federal law opened the floodgates to test experiment­al cancer drugs for children.

“The pediatric oncology community is really excited,” said Dr. Lia Gore, the director of Children’s Center for Cancer and Blood Disorders.

While there are hundreds of cancer drugs in developmen­t to treat adults, research on pediatric cancer drugs has lagged historical­ly. Gore said essentiall­y only four new drugs have been approved to treat childhood cancer since 1979.

But the RACE for Children Act, signed this month by President Donald Trump, aims to change that by allowing clinical trials in children when there is evidence that a drug being developed for adults could help them, too.

Gore gave the example of an adult drug designated specifical­ly for lung cancer. Previously, the drug couldn’t be tested for children because children so rarely get lung cancer — even though the drug also holds promise for treating a completely different childhood cancer. The new law will allow clinical trials for children based on the “molecular target” of the drug, not the name of the cancer.

The bill was sponsored by Colorado U.S. Sen. Michael Bennet, who attended a celebratio­n of the bill’s signing Tuesday at Children’s, along with new Food and Drug Administra­tion Commission­er Scott Gottlieb. Sen. Cory Gardner was among the bill’s co-sponsors.

Bennet called the bill “a breakthrou­gh for kids fighting cancer,” while Gottlieb expressed equal optimism.

“We have a lot of opportunit­y ahead of us,” he said.

The celebratio­n highlighte­d a daylong tour by the two men that also included a meeting at the University of Colorado Hospital and a presentati­on for a state legislativ­e committee. Those stops focused on curbing the nation’s opioid epidemic, which Trump recently declared a national emergency.

At the hospital, the men listened as doctors explained new emergency department procedures for reducing opioid prescripti­ons. For instance, the hospital has modified its digital medical records system so doctors can more easily check the state’s Prescripti­on Drug Monitoring Program when writing a prescripti­on. Doctors also have been encouraged to prescribe smaller amounts of opioids at one time.

The result has been a dramatic drop in opioid prescripti­ons. Three years ago, about 20 percent of emergency room pa-

tients left the hospital with an opioid prescripti­on. Today, it’s about 12 percent.

“Our answer,” said Dr. Jason Hoppe, an emergency medicine specialist at the hospital, “has been exposing fewer people.”

Later, Bennet said he is hopeful that federal, state and local government­s can work together to address the opioid crisis. He said he would be watching for recommenda­tions being prepared by the legislatur­e’s interim committee on opioid addiction. He also said he is optimistic federal lawmakers will put together a bipartisan bill soon to reform health care in the country, nodding to hearings scheduled next month by the Senate health committee, on which Bennet sits.

“I believe it will happen,” Bennet said of the possibilit­y of a bipartisan bill gaining traction in Congress. “But I don’t know it will happen.”

 ?? Photos by RJ Sangosti, The Denver Post ?? Colorado U.S. Sen. Michael Bennet and Food and Drug Administra­tion Commission­er Scott Gottlieb reflect on their tour of the University of Colorado Hospital’s emergency department in Aurora on Tuesday.
Photos by RJ Sangosti, The Denver Post Colorado U.S. Sen. Michael Bennet and Food and Drug Administra­tion Commission­er Scott Gottlieb reflect on their tour of the University of Colorado Hospital’s emergency department in Aurora on Tuesday.
 ??  ?? Gottlieb, left, talks with Dr. Richard Zane during the tour.
Gottlieb, left, talks with Dr. Richard Zane during the tour.

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