In mid October, the FDA convened a special meeting of drug safety and psycho-pharmacology experts to look at whether or not the smoking cessation drug Chantix needed to continue to carry a black box warning. There have been numerous warnings on the drug starting in 2008, a year after it had come to market. The current warning includes a link to serious neuropsychiatric symptoms including depression, violence/aggression, psychosis, and suicidal thoughts. There have also been reports related to insomnia, dizziness, loss of consciousness, seizures and other serious side effects.
Pfizer, the drug maker, apparently had new data showing that the reported serious adverse events were not caused by the drug but due to individual’s mental conditions and angst of quitting smoking. Therefore, they believed the black box warning was unnecessary and asked the FDA to remove it from the drug label. Pfizer’s own Christopher Wohlberg, MD stated, “it was time to unring the alarm bell” on Chantix.
Pfizer (with two rows of paid experts to explain) presented that their clinical trials evidence and 4 observational studies proved no such serious adverse effects existed. They got 2.5 hours to make their case. It was followed by various presentations by the FDA about their concerns regarding Pfizer’s latest studies. It was fun observing the expressions and body language of Pfizer’s experts during FDA presentation.
Next up was the open public comments portion of the hearing where a few of us presented including Institute of Safe Medication Practices, People’s Pharmacy, and National Center for Health Research. I (KW) was proud to represent the voices of families who live every day with the real world consequences of a failed drug safety system. In addition to these comments, a Citizen Petition was sent to the FDA asking them to keep the black box warning and even consider strengthening it. It had 5 strong supporting organizations to endorse it, including Institute of Safe Medication Practices, Consumer Reports, National Physicians Alliance, National Center for Health Research, and Public Citizen. Its very enlightening and believe it was helpful for this hearing.
Ultimately, the panel voted 17-1 to keep the current black box warning.
Over the years, I have presented at numerous FDA hearings starting with the antidepressants hearings in 2004/2006 after the death of my husband. I wanted to share a couple of my observations contrasting the Chantix hearing to the antidepressants hearings.
1) The FDA actually presented a qualitative review of the type of adverse events from their Medwatch system. They challenged how comments like “feeling like a zombie”, “couldn’t get out of bed”, and “wasn’t myself” which aren’t a diagnosis would be coded. Compare this to antidepressant hearings where we were told our stories/experiences were “anecdotal” because it didn’t happen in a double blinded controlled placebo study. It was nice to see the FDA not ignoring the real world narrative. There were way too many reports, despite Pfizer’s attempt to blame the victim and their underline mental health and issues of cessation withdrawal.
2) There were no Chantix victims to describe first hand what it was like for them or their loved one. That’s because the 2700 victims were silenced in their legal settlement agreements with Pfizer. Pfizer learned from the antidepressant hearings where it was victim after victim telling their powerful story in the open public forum. Its hard to ignore these real life experiences. So Pfizer shut them up.
Here’s a video that I put together to represent actual Chantix victims experiences. I opened my presentation with the video.
3) In addition, there were no attorneys testifying during open public forum. During the antidepressant hearings there were several attorneys that spoke on behalf of their clients and about unsealed documents. All Chantix documents and discovery including expert depositions are forever sealed and public health knowledge is lost. Its a shame and we need the FDA to get their hands on these legal records. In the antidepressant litigation, attorneys were able to get confidential documents unsealed where many of the psychiatric (including suicide) risks associated with these drugs were well known and documented before they were released to the public. Power in documents!
What was the same, however, between the two hearings is how those with contrasting scientific/clinical evidence like Thomas Moore (Chantix) and David Healy (antidepressants) were not allowed to formally present their findings. Rather they have to try and do within the allotted public hearing time. 6 minutes and 3 minutes surely isn’t enough time when compared to Pfizer’s 2 1/2 hour presentation.
Even though we had a victory with the 17-1 vote, we will still need to keep an eye on the large post market safety study that will be completed in fall of 2015. Until then, the black box warning remains on Chantix.