Leukemia drug crisis averted, but shortages will persist

Shortages of drugs — many of them injectable cancer drugs — have spiked in the last few years.

Federal officials say they have addressed the latest crisis, a shortage of preservative-free methotrexate, a drug used to treat childhood leukemia. But doctors and parents alike say without a long-term fix to the system, they are not resting much easier.

Since he was diagnosed over the summer with leukemia, 4-year-old Dominic Schalk has been treated with methotrexate.

A few weeks ago, his mother, Angelina Schalk, who lives with her husband and son in the Art Museum neighborhood, started seeing messages from other parents on a national leukemia email list, saying their kids’ treatments had been postponed because the hospital didn’t have the drug.

Living in fear

“We were sick to our stomach,” Schalk said. “You get sick enough that your kid has cancer … but how do you tell somebody that their kid died from something that is curable?”

The cure rate for Dominic’s kind of leukemia is 90 percent, but methotrexate is an integral part of his therapy.

“You live in fear anyway that you’ll make a mistake or that something will happen and the cancer will come back, so you have to do what they say when they say to do it,” Schalk said. “So the thought that you don’t get to do it then because someone isn’t producing it is disgusting.”

Some hospitals ran out of the version of the drug used for childhood cancer earlier this month after one of the four companies that produces it shut down production.

The Food and Drug Administration requested emergency supplies from a foreign producer, and fast-tracked an application for another U.S. company to start making the drug.

Regulators in ‘reactive’ mode

The FDA reacted quickly once the shortage reached crisis level, said Dr. Peter Adamson at the Children’s Hospital of Philadelphia.

“Right now we’re in a very reactive mode. A crisis is developing or has occurred, it starts the process. That’s not the way it ought to be,” Adamson said. “We need to get to the root causes of why there are shortages.”

The FDA is charged with making sure drugs are being produced safely but it can’t force companies to make them. FDA officials says their hands are somewhat tied in preventing drug shortages.

Dr. Armand Keating, president of the American Society of Hematology, said that should change.

“What we think is really important is to provide the FDA with greater authority to combat these drug shortages effectively,” Keating said. “I don’t think we’re there yet.”

Last year, President Barack Obama signed an executive order asking drug companies to disclose voluntarily when they were having problems that might interrupt production. The American Society of Hematology is pushing for legislation to make that reporting mandatory.

The group also wants the government to track drug supplies and pay more for certain medicines.

Other shortages expected

“Many of the drugs that have been in short supply are older agents that are generic, and so I think one other possibility is to look at options for economic incentives for manufacturers of generic agents,” Keating said.

Any of these fixes would take time. Adamson at CHOP said there are seven or eight childhood cancer drugs on the FDA shortage list — and no one thinks the medical community has seen the last of the shortages.

“It’s not a matter of if there’s another drug crisis, it’s simply a matter of when,” Adamson said.

Meanwhile, Angelina Schalk continues to monitor the shortage list, keeping an eye on other drugs Dominic needs to continue his battle against cancer.