Beginning Friday, patients seeking experimental treatments in new clinical trials will no longer be delayed from joining those studies as a result of the government shutdown.
The National Institutes of Health received permission Thursday to recall a handful of furloughed workers to reopen its clinical trials registration website and start processing new applications, which had stopped during the shutdown.
Many hospitals, including Dana-Farber Cancer Institute, require patients receiving experimental drugs to be formally enrolled in a clinical trial registered on the site. Leo Finn, a Dana-Farber patient, told the Globe Wednesday that a drug he desperately needs for his metastatic bile-duct cancer would be delayed because he would not be able to join a new trial.
Finn was contacted by his Dana-Farber physician Thursday and told that he could join the new trial and get cabozantinib — a drug approved for thyroid cancer but still experimental for other cancers — next month as planned.
“It couldn’t be any better; it’s exactly what we wanted,” said the 48-year-old father of three who was with his family at Disney World for a long-planned vacation.
“The inability to register new trials was a very unusual circumstance, and we went to great lengths to overcome issues generated by the recent government shutdown,” Dana-Farber president, Dr. Edward Benz Jr., said Thursday. “We greatly appreciate the help of the National Institutes of Health, which this afternoon provided the clearance needed to open the trial and begin providing new treatments for our patients.”
After being contacted by reporters about the case, US Representative William R. Keating, a Democrat representing Finn’s district, said in an interview that he reached out to Finn and then spoke to NIH director Francis Collins Thursday morning to see whether the problem could be fixed.
“We were able to determine that certain people who were essential had been classified as nonessential,” Keating said. “NIH staff clearly conveyed to me that they were grateful because they thought people who were furloughed should be back on these issues.”
Officials at the Department of Health and Human Services gave NIH the green light to allow certain staff to return to work and begin processing new applications on the registration website, www.clinicaltrials.gov, NIH spokesman John Burklow said.
But patients hoping to join trials at the NIH hospital will still have to wait until the shutdown ends. The Republican-led House of Representatives passed legislation Wednesday to restore funding for the NIH, but the measure died in the Senate as the White House insisted on restoring funding to all government agencies.
“It’s something I supported, but it was caught up in the fact that so many other people in so many other agencies of the government are also affected right now,” Keating said.
Finn said he already rescheduled his Dana-Farber appointment to undergo a bone scan and fill out paperwork for the trial, which had been canceled earlier in the week; he will go in after he returns next week.
The drug is his final effort to shrink tumors in his bones and liver that started growing again after standard chemotherapy drugs stopped working.Deborah Kotz can be reached at email@example.com. Follow her on Twitter @debkotz2.