One healthy volunteer is brain-dead and five others have been hospitalized. Of those five, two suffer from neurologic damage that might be irreversible, and two others are critically ill. The drug administered, known only by its code name BIA 10-2474, is an investigational drug targeting anxiety and motor disorders related to Parkinson’s disease, and chronic pain in people with cancer and other conditions. All six participants were administered the drug at the same time.
In July, when the study began, Bial reported that 108 participants went through the trial and were administered the drug “without any moderate or serious reaction.”
The question on everyone’s minds: what happened?
Answers are slow to come. Mel Lewis, owner of Cognito Communication Consulting and former communications manager at Merck Serono, said, “It’s an interesting case of communication in the clinical trials space. The industry is not well-served by the perceived lack of transparency.”
Transparency is one aspect some expect to change in direct response to the Bial trial. Bioethicist Arthur Caplan, founding director of the Division of Medical Ethics at NYU Langone Medical Center, said, “This will increase pressure for more disclosure of data from phase I trials. There should have been immediate disclosure when a subject died. If there are any other subjects in analogous trials, they need protection.”
Furthermore, the lack of information makes it more difficult to assess how else the industry may change in response, to avoid similar incidents in the future. John Naim, director of the Clinical Trials Research Unit at West Virginia University, summed up the feelings of many in the industry when he said, “I don’t have enough details about the incident to comment, other than it was a tragedy.”
As for whether the incident may prompt new or tighter regulations, that remains to be seen. For now, some in the industry feel what happened in the Bial trial will not have such far-reaching effects. Caplan said, “If it does not happen voluntarily, it will not happen. Disasters overseas do not trigger regulatory reform here. They should. They don’t.”
Caplan also feels the Bial trial is not very likely to result in more scrutiny of CROs, and explains, “The deaths are rare, the FDA is already overwhelmed, and Congress is not a friend of more regulation of pharma.”
Some wonder if the Bial incident will have a negative impact on the Right to Try legislation, which grants terminally ill patients access to investigational drugs if they believe it will help them and if they have a prescription from their doctor.
As the leader of the only independent group tracking Right to Try and compassionate-use issues, Caplan does not expect the Right to Try legislation to be significantly affected by the Bial incident. “It may cause a little push back, but nothing meaningful,” he said. “Support for this deeply flawed, pointless legislation is so strong that even though Right to Try does nothing to get anyone access to anything, it has not stopped states from enacting these feel-good laws.”
With so many details of the study yet unknown, the industry can only wait for the eventual impact of the Bial trial incident. It seems likely that there should be consequences, but ultimately the impact may not be far reaching.
Lisa Chontos is a freelance medical writer with 15 years of experience writing for hospitals, biotech firms, pharmaceutical companies and publications like CenterWatch. You can contact her at email@example.com.
This article was reprinted from Volume 20, Issue 03, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »