by John-Michael Dumais, Childrens Health Defense:
According to an investigation by The BMJ, when GlaxoSmithKline Biologicals halted its RSV vaccine trial over preterm birth risks, Pfizer continued its similar trial while omitting these risks from consent forms. Experts criticized Pfizer’s lack of transparency as an ethical violation compromising informed consent.
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When Pfizer conducted a large clinical trial to test a new respiratory syncytial virus (RSV) vaccine for pregnant women — aimed at protecting their babies — the pharmaceutical giant failed to inform trial participants that GlaxoSmithKline Biologicals (GSK) had halted its trial for a similar vaccine due to a concerning safety signal showing a potential risk of preterm birth.
Even though Pfizer knew about the GSK trial and safety signal, it continued enrolling thousands of unsuspecting pregnant women without disclosing the preterm birth risk in its consent forms, according to an investigation by The BMJ.
To many healthcare advocates and experts, Pfizer’s omission represents an egregious violation of informed consent and a disregard for the autonomy of pregnant women participating in clinical research.
“Any failure to provide new and potentially important safety information data to trial participants is ethically problematic,” Dr. Charles Weijer, bioethics professor at Western University in London, Ontario, Canada, told The BMJ.
Children’s Health Defense CEO Mary Holland told The Defender:
“I am horrified that it’s even a question whether Pfizer should have told pregnant women that a previous clinical trial was halted because the RSV vaccine caused preterm birth. Of course it should have told them.
“The standard must be, ‘What would a reasonable pregnant woman want to know about this product?’ And any reasonable pregnant woman would want to know if it causes preterm birth. This cavalier attitude towards the truth and human life is alarming.”
After the safety signals emerged in GSK’s study, the U.S. Food and Drug Administration (FDA) took no action to halt enrollment or to pause or restrict Pfizer’s ongoing maternal RSV vaccine trial.
Statistically significant’ shouldn’t form sole basis of Pfizer’s decision
Months after GSK’s revelation of the concerning safety signal, Pfizer also began detecting a numerical imbalance in preterm births in its own trial data but said the data were not statistically significant.
According to The BMJ, Pfizer was tracking preterm births as an “adverse event of special interest” in its trial. But the company did not disclose this on consent forms given to thousands of pregnant trial participants across 18 countries.
“Once the results of the GSK trial on premature births became public, RSV vaccine studies in pregnant women should have been updated to include this possible preterm risk,” said Klaus Überla, Ph.D., chair of Clinical and Molecular Virology at the University Hospital Erlangen, in The BMJ report.
However, regulators took little action to encourage disclosure. The FDA ultimately limited approval of Pfizer’s vaccine to late pregnancy — specifically, for administration between 32-36 weeks only — due to preterm concerns. But the agency did nothing to restrict trial enrollment or require risk disclosure after the GSK findings emerged.
Some defend Pfizer’s lack of disclosure to trial participants by arguing the preterm risk was inconclusive. Dr. Joop van Gerven, an ethics chair in the Netherlands, told The BMJ that informing women “would have caused too much uncertainty.”
However, others challenged this notion. “The renewal of informed consent is a must,” Rose Bernabe, Ph.D., told The BMJ.
Bernabe, a professor of medical research ethics at the University of South-Eastern Norway, referenced guidelines from the Council for International Organizations of Medical Sciences, which state: “Researchers must renew the informed consent … if new information becomes available that could affect the willingness of participants to continue.”
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