Bye, Felicia: Gottlieb Leaves FDA After Bizarre Seizure Warning

Based on 35 self-reported incidents over nine years that may connect vaping to seizures, the FDA issued a press release and a statement from the commissioner claiming that the reports “warrant scientific investigation.” 

Of course, there are a few problems.

“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigarettes and a risk of seizure,” said the commissioner in a joint statement with Deputy Commissioner Amy Abernathy. “We can’t yet say for certain that e-cigarettes are causing these seizures.”

In fact, the FDA admits that some of those who made reports already have a history of seizures, some coincided with other drug use (including amphetamines), and some of the seizures occurred up to a day after vaping.

But despite knowing that the seizures may have no connection to vaping or nicotine, the most powerful public health official in the country decided to create an uproar over self-reported “adverse events” that haven’t necessarily even been validated by medical professionals.

That led to headlines like these:

• E-cigarette users are reporting seizures to the FDA
• US investigates seizure risk with electronic cigarettes
• FDA Warns of Incidents of Seizures Associated With Vaping
• Nicotine-induced seizures could be a side effect of vaping
• Vaping may cause seizures, especially among teens, FDA says
• FDA Probing Link Between Seizures and Vaping
• Health officials investigate seizure risk with electronic cigarettes

The headlines are the reason for the FDA action. The agency is “regulating” by inciting public fear and demands for bans and restrictions. Gottlieb knows that more than 10 million Americans have used e-cigarettes over the decade they’ve been available, and he knows that reports to poison control centers and the FDA’s “safety reporting portal” are notoriously unreliable, often baseless and even nonsensical. But he couldn’t help himself from throwing another bucket of gasoline on the bonfire of public fear and misunderstanding over vaping that the FDA has been stoking since 2009.

The commissioner is leaving the FDA Friday, and the departure can’t happen soon enough for vapers and other supporters of vaping’s harm reduction potential for people who smoke. The leader who arrived promising to clear a path for vaping as an aid to help Americans who smoke improve their lives now leaves office as the chief cheerleader for the national moral panic that he calls a vaping epidemic. Gottlieb reportedly will return to the American Enterprise Institute as his temporary replacement Ned Sharpless takes over at the FDA.

Yes, nicotine poisoning can cause seizures, but as far as we know it’s probably impossible to get nicotine poisoning by vaping or smoking. It would require rapid ingestion or injection of a life-threatening dose of nicotine to cause the most severe symptoms of nicotine overdose — including seizures. Before reaching that threshold, a vaper would feel many lesser side effects and slow down or stop using nicotine.

Seizures are temporary electrical disturbances in the brain, and are typically a sign of an underlying neurological problem like epilepsy. According to the CDC, about 3.5 million Americans have active epilepsy.

It’s very possible that the people who reported seizures after vaping would have had a seizure anyway, because of epilepsy or some other neurological disorder. Or they could have been precipitated by other drug use. There is simply no evidence that vaping or nicotine caused any of the events.

But if nicotine was the cause, where are the thousands of reports from smokers? Around 35 million Americans smoke cigarettes currently, and many more have smoked over the 130 or so years that cigarettes have been sold. Has the FDA ever thought it important to investigate cigarette-related seizures? Surely if nicotine is the culprit here, there must be many, many more examples of seizures brought on by cigarettes.

Michelle Minton of the Competitive Enterprise Institute reported that the FDA Adverse Event Reporting System shows 34 complaints of seizures associated with just two brands of nicotine replacement therapy products, and more than 500 connected to the quit-smoking drug Chantix. Minton says that the FDA didn’t comment publicly on the Chantix allegations until after it had completed its investigation. And there’s never been an investigation of seizures caused by NRT products.

In fact, issuing a public statement on any kind of health risk based on such flimsy evidence is highly unusual for a public health agency like the FDA. American Vaping Association president Gregory Conley thinks the agency is preparing to defend its controversial Deeming Rule when the final deadline for premarket tobacco applications drives almost all independent vaping companies out of business.

“The fearmongering from the FDA is only going to get worse from here. We are now less than two-and-a-half years away from the FDA requiring every vaping product on the market to retroactively undergo what the agency calls ‘premarket’ review,” said Conley in a statement.

“In a post-Gottlieb world, FDA will have to defend themselves against members of Congress asking how they can justify eliminating tens of thousands of American jobs,” he added. “The only way they can do that is with a misinformation campaign.”