Did Pfizer Discontinue 3500 Patients on a Clinical Trial in Error?
(Thursday, October 12, 2023)
Earlier this year, Pfizer suddenly dropped 3500 patients participating in a clinical trial to evaluate its vaccine for Lyme disease citing violation of Good Clinical Practices (GCP) at its CRO vendor. This week, the CRO announced that it was audited by FDA inspectors who found no violations. So, did Pfizer make the wrong decision to discontinue patients from its trial? Do the patients who were dropped from the trial have any rights towards this trial?
FDA audits are the gold standard for verifying compliance with regulations. FDA audits are thorough, conducted by well-trained inspectors, and are completely unbiased. It seems that an audit of Care Access, the CRO involved, by the FDA, was triggered by Pfizer’s decision. According to a news release from Care Access, the FDA inspectors spent about a week at the CRO and reviewed records related to the conduct of the study, patient safety, and data integrity. There were no findings by the FDA.
It should be noted that FDA inspectors review the site’s compliance based on FDA’s lease-burdensome approach which requires verification of compliance with the minimum regulatory requirements. Sponsors can ascribe to standards above what the FDA requires and global companies, like Pfizer, generally do that. So, it is possible that Pfizer may argue that even though Care Access met FDA’s standards, they don’t meet Pfizer’s standards. That still will not answer some critical questions for Pfizer. How did Pfizer select Care Access, and why did it wait till thousands of patients were enrolled to make a decision of this magnitude? Care Access’ business was likely hurt by this very public major event. So, now that they have been cleared by the FDA, does Pfizer owe them compensation?
More transparency is needed. The company must now disclose the specific GCP violations that led to the extreme action of discontinuing thousands of patients from its trial. Or perhaps the vendor can disclose the allegations of non-compliance from Pfizer now that they have been cleared by the FDA. Care Access has much to gain by clearing its name from this accusation by Pfizer, so it should take the first step in that direction by disclosing more info on Pfizer’s decision. The patients who were dropped from the trial must be informed about the current status and may explore legal options if they feel hurt by the decision. It has been more than 6 months since the patients were dropped from the trial, so most likely they can’t just be re-started on the trial.
One lesson for all: compliance verification is a complex issue that must be dealt with pragmatically. Patient safety may be compromised due to rash decisions as was likely the issue in this case.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC