Food and Drug Administration investigators found in May that Columbia was not adequately assuring the safety of radioactive drugs being used in research, leading to a series of changes at the Medical Center’s Radioactive Drug Research Committee.
Those findings were detailed in a warning letter sent by the FDA to Columbia in September, which detailed concerns about the RDRC—including that the committee failed to assure the quality of radioactive drugs and that the committee failed to assure that investigators were immediately reporting adverse effects associated with the drugs.
CUMC spokesperson Doug Levy said that the RDRC’s membership has since been restructured. The committee’s former chair, radiology professor David Brenner, has been replaced by another radiology professor, Chaitanya Divgi.
“Over the past year, CUMC has put into place new personnel, policies, and procedures designed to ensure full compliance with FDA requirements,” Levy said in an email, adding that Columbia officially notified the FDA of changes to its protocols in early October as the warning letter requested.
The FDA’s warning letter also said that the RDRC “failed to protect the safety and welfare of human subjects,” and addressed procedural issues, such as the RDRC's failure to attain the required quorum at meetings.
After reviewing the letter, Phillip Devlin, a radiation oncology professor at Harvard, said that he didn’t think Columbia’s violations would have posed serious health risks. Devlin noted that while the University might not have properly assured the quality of its radioactive drugs, it’s unlikely those drugs were actually harmful.
“I would guarantee you that the pharmacist and nurses absolutely have guaranteed its purity,” Devlin said. “It’s just that nobody had written it down.”
“When I saw this letter, I saw something I have seen in many, many hospitals,” he added. “Really, my sense says that a lot didn’t go wrong.”
FDA spokesperson Patricia El-Hinnawy told Spectator that Columbia has worked cooperatively with the FDA.
“They are interested in resolving this,” El-Hinnawy said. “We expect that they will continue to correct the things identified in the letter.”
The FDA first discovered radioactive drug-related violations at Columbia in April 2010, at which point all clinical radioactive drug research was put on hold as the FDA conducted an investigation. Levy said that Columbia has been working with the FDA since then to address the violations, noting that the RDRC’s scope of responsibilities is limited.
“We have been working with the Food and Drug Administration to address concerns that were raised about CUMC’s Radioactive Drug Research Committee, a committee that reviews certain research protocols that involve the compounds used in PET imaging,” Levy said in an email.
Levy added that the FDA’s September warning letter merely reiterated findings the government organization presented to Columbia in May. The changes CUMC has instituted should make the RDRC “fully compliant,” he said.
El-Hinnawy said that the warning letter is part of an ongoing process. Generally, the first step in this process is an inspection by trained FDA investigators, who then prepare a report of everything they find to be out of compliance. This is followed by dialogue between the FDA and the organization in violation—in this case, the warning letter and discussions between the FDA and Columbia.
El-Hinnawy noted that in addition to potentially causing medical risks, Columbia’s violations could have skewed the results of research studies.
“The other problem would be the problem with the data and outcome to the study, if you don’t have a standard uniform product of what you were studying,” she said.
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