For-profit stem cell clinics that had run-ins with the FDA could have a harder time misleading patients into thinking their studies have the government’s seal of approval.
The National Institutes of Health wants to clamp down on for-profit stem cell clinics that market their products as being based on research included in studies at ClinicalTrials.gov, implying the federal government has endorsed the treatments. The NIH’s National Library of Medicine oversees the repository of more than 300,000 studies posted by companies or investigators but doesn’t monitor individual study records.
The potential changes come after the Food and Drug Administration sought to shut down some for-profit stem cell clinics over practices that could put patients at risk, including one incident where several patients went blind after receiving experimental therapies.
While the NIH is still considering changes to its website, it has taken steps to make its disclaimers more prominent “to help ensure that users are aware that the listing of a study on the site does not reflect endorsement of the trial by the Federal government.”
However, more needs to be done, ethicists and researchers said.
“The problem with the disclaimer,” is that “for so many people, ClinicalTrials.gov is this trusted, essential, valuable resource that they go to,” University of Minnesota bioethicist Leigh Turner, who has written about pay-to-participate stem cell studies on ClinicalTrials.gov, said.
Flag Warning Letters
The National Library of Medicine could link to FDA warning letters or issue retractions the same way published studies can be revoked from the medical literature, Turner suggested.
For example, the FDA in October 2018 issued a warning letter to StemGenex Biologic Laboratories LLC over findings the company put patients at risk. StemGenex had previously described its research as “at the forefront of collecting data to support the safety and efficacy of stem cell therapy through five clinical studies registered with the National Institutes of Health.” That language no longer appears on the company’s about us page.
More rigorous standards for posting studies to the database should be considered, Karen J. Maschke, a research scholar with the Garrison, N.Y., bioethics research institute The Hastings Center, said. “The answer might be no, there’s not much more they can do. But I think it’s worth having the conversation.”
Submit Study Protocols
One solution might be a requirement to submit the study protocol—the document that describes the the study objective, design, plan to implement that design, statistical considerations, and other aspects for organizing the clinical trial.
“Everybody who’s anybody in this world of science and clinical trials knows what a good protocol looks like,” Maschke said.
However, Maschke, who co-authored a book and articles on medical technologies and regenerative medicine, acknowledged that would add costs and time.
“I grapple with it because it’s a difficult problem for the NIH or anybody who’s got a website who’s holding information. The content holders always have to make a decision about what content’s going to be on their site,” Maschke said. “We know this from Facebook and all these other places.”
The database should also be automated to include an FDA investigational new drug application number, or proof an institutional review board has approved the study, which means the study has undergone an ethics review. If they don’t have those things, the NIH should ask why not before posting those entries, Turner said.
Clinical trials typically build on animal studies or other pre-clinical research to study a specific intervention with narrow criteria for who can participate. Studies like a Cell Surgical Network trial, claiming to treat conditions ranging from autoimmune diseases to osteoarthritis to erectile dysfunction, are usually a red flag. Charging to enroll in a study is another red flag as drug companies or other sponsors usually cover those costs, which the International Society for Stem Cell Research pointed out in its consumer guide. The FDA sought to shut down Cell Surgical Network and U.S. Stem Cell last year out of concern they were exposing patients to harm.
The FDA in a recent letter to Senate Finance Committee Chairman Chuck Grassley (R-Iowa) said anyone submitting a study record on ClinicalTrials.gov must provide information, accept terms and conditions, and indicate whether the study has been evaluated by an institutional review board.
“Collectively, the steps described above aim to ensure that entries listed on ClinicalTrials.gov are, in fact, research studies,” the FDA said.