Pfizer’s internal documents regarding the antismoking drug Chantix should be unsealed before the U.S. Food and Drug Administration (FDA) holds a meeting next month to discuss whether or not the drug should carry a warning about suicide, said two expert witnesses in the multidistrict litigation.
According to National Law Journal, Dr. Joseph Glenmullen, an expert causation witness for party suing over the drug, and drug-safety researcher, Thomas Moore, both expressed that the documents should be available for public discussion.
Dr. Glenmullen and Moore, who was also a consulting expert in the Chantix litigation, said that Chantix and other smoking cessation drugs were linked to a higher risk of suicide, depression and violent behavior.
They want to ensure the public debate about the psychiatric side effects of Chantix
By unsealing the documents, they “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,” court documents show. The meeting is scheduled to take place on October 16th.
The scientists said that the sealed documents do not contain trade secrets, or any other form of information that should legitimately be kept secret; the documents are only hidden because Pfizer deemed them confidential.
Additionally, Moore says that he was subpoenaed by Pfizer for documents related to his research about the risks of Chantix. This was done to “harass and intimidate him because of the independent drug safety research he conducts.
The use and potential abuse of nonparty subpoenas in pharmaceutical litigation is also an important public policy issue separate from but part of the overall objective to provide the public with a fair and balanced record of the risks and benefits of Chantix.” says Moore.