An expert witness in the multidistrict litigation over Chantix (varenicline), a smoking cessation drug, has moved to unseal court records in advance of a Food and Drug Administration (FDA) meeting to consider whether the drug should carry a warning about suicide risk.
Dr. Joseph Glenmullen, an expert causation witness for the plaintiffs, and Thomas Moore, a drug-safety researcher, called for the unsealing of thousands of Pfizer Inc. internal documents, National Law Journal reports. Both wrote about how smoking cessation treatments like Chantix are associated with a higher incidence of depression, suicide and violence toward other people. The two experts “want to ensure the public debate about the psychiatric side effects of Chantix includes a balanced scientific record, which was examined in depth in the Chantix litigation,” according to court documents. The FDA meeting is scheduled for Oct. 16.
Chantix helps smokers quit by blocking nicotine’s action in the brain, according to WebMD. Chantix is used in conjunction with a stop-smoking program. The FDA panel will examine whether behavior changes, psychiatric symptoms, and thoughts of suicide some Chantix users experience should require the drug to carry a black box warning, National Law Journal reports.
Glenmullen and Moore have requested that the court unseal documents used in support of the claim for punitive damages, National Law Journal reports. The scientists argue that the documents do not contain trade secrets or other information that should be kept out of the public record. But Pfizer had stamped the documents confidential. An attorney for the two scientists said that documents obtained in litigation are sometimes the only way to level the “playing field” between the pharmaceutical industry and the public interest.
In seeking the document release, Moore said Pfizer had subpoenaed documents related to his research, personal communications, and publications about the risks of using Chantix to “harass and intimidate” him because of the drug safety research he conducts, according to National Law Journal. He said using subpoena power against someone not a party to the case is an abuse of subpoena power.