Granted, the joint FDA advisory panel voted 10 to 9 to remove the label, but it’s not really the vote that counts. It’s the sentiments behind the vote that count. We will know more about those when the meeting transcripts are published, but judging by the scant reporting of the actual meeting, it seems that all or nearly all panelists were quite concerned about the way data was collected in this trial, and that the 10 that voted in favor only did so on the logic that removing the label will increase the use of Chantix and enable more people to quit smoking, thereby saving lives on net. The vote was actually 10-4-5 for remove, reword, retain respectively, but we are counting it as 10-9 for simplicity.
In order to understand why the chances of removal of this label are so small, first let’s consider the nature of the FDA itself. The FDA is a regulatory body subject to public pressures. The worst thing that can happen to it is to look stupid. The most obvious way it can look stupid is to approve a drug that hurts or kills people, or is even suspected of hurting or killing people by the public even though a drug may have absolutely nothing to do with whatever bad thing happened. That’s the starkest way to put it.
In cases where people have terminal illnesses anyway, then of course the chances of getting a drug approved are greater because the pressure is usually coming from the other side in those cases. If the FDA rejects a cancer drug for instance, and then it conducts further studies and it is found to be effective, then the FDA gets some flak for delaying its approval. Any deaths they likely won’t be directly blamed for, because the underlying disease is terminal anyway.
It’s different with a drug like Chantix, because it is not a necessary drug even for what it is trying to help achieve, which is to help people quit smoking. It is not treating anything terminal directly. While it may be true that removing the boxed warning will save people on net by helping more quit smoking, these sorts of results are not headliners. They are what some economists would call the “unseen”. What is “seen” by contrast is if someone commits suicide or hits his or her spouse while on Chantix, and Pfizer and the FDA get blamed when the newspapers are looking for sensationalist stories.
Take the recent example of Tesla Motors Inc. (NASDAQ:TSLA) autopilot system. Car accidents happen all the time. People are killed. Car accidents will also eventually happen on autopilot, and autopilot will get bad press, even if autopilot actually reduces the incidence of car accidents per mile travelled, something that needs extensive statistical analysis. The latter requires thinking at least 2-steps deep, but seeing a headline like “Driver on Tesla Autopilot Killed” is immediately seen, and only 1-step deep. Few delve into statistical analysis to broaden their knowledge in these cases.
One of the most egregious blunders from which medical regulatory bodies in general have not recovered and likely never will, was the thalidomide fiasco of the 1950’s and 60’s. A drug designed for morning sickness in pregnant women but later found to cause severe birth defects as a terratogenic poison. People affected by this in utero are still alive today without limbs as a permanent testament to what the FDA, at all costs, does NOT want to get blamed for. Granted, the FDA never approved thalidomide and the phenomenon was mostly international, but that doesn’t change the point.
So let’s think of some hypotheticals here. Let’s say the boxed warning label is removed and there’s a story of a murder-suicide somewhere in the US, heaven forbid. Let’s say it’s found that this person was on Chantix at the time, and had no prior history of violent behavior. The FDA will have to weather a storm of controversy it can easily avoid, or at least greatly lessen, if the warning label remains on the Chantix box as is. Once the label is there, removing it means the FDA is absolutely sure that there is no connection between psychiatric side effects and Chantix. There will be pressure to put the label back on. There might be congressional hearings on Capitol Hill. The public does not have the patience to wade through statistical studies of course, least of all politicians, and putting the label back on after taking it off will make the agency look stupid, wishy-washy, and incompetent.
