On Wednesday, April 3rd, the FDA announced it was looking into a possible link between seizures and vaping.
"Today, we’re notifying the public of another potential emerging safety issue of which the FDA has recently become aware. We have reports indicating that some people who use e-cigarettes, especially youth and young adults, are experiencing seizures following their use," wrote FDA Commissioner Scott Gottlieb in a joint statement with Principle Deputy Commissioner, Amy Abernethy, M.D., Ph.D.
While that sounds pretty alarming and the word “seizures” is scary in any context, the FDA was in fact basing this rather ominous warning on a mere 35 reported cases over the course of a decade.
Between 2010 and early 2019, during which time millions of Americans vaped, only 35 of them had a seizure that was reported to the FDA as being potentially linked to vaping. Even FDA Commissioner Scott Gottlieb couldn’t bring himself to call it an “epidemic.”
“While 35 cases may not seem like much compared to the total number of people using e-cigarettes, we are nonetheless concerned by these reported cases," Gottlieb continued. "We believe these 35 cases warrant scientific investigation into whether there is in fact a connection."
Gottlieb is well known for his anti-vaping stance and, when he issued the press release, was serving out his final week at the FDA after abruptly resigning in March.
Gottlieb was certainly right about one thing. Thirty-five cases over a ten year time span does not seem like much. Dr. Michael Eriksen, the former director of the Centers for Disease Control and Prevention’s Office on Smoking and Health, put the numbers into perspective. "It is 35 cases over 10 years. [That’s] three to five a year with millions of users. So [it’s a] one-in-a-million chance, while one out of two smokers die from smoking," he told Vox.
But this kind of clear headed rationality was a rarity in the ensuing news coverage. Within hours of the FDA's press release, headlines around the world began to bleat, "Vaping liked to Seizures!" Articles cropped up on Forbes, CNN, the Chicago Tribune, Fox News (which called the FDA's press release a "powerful statement") and dozens of other news websites. Time Magazine ran with the headline, "Vaping May Be Associated with Seizures, FDA Warns." CBS News asked, "Can Vaping Trigger Seizures?"
What was lacking in the coverage was the fact that almost no reporters took the time to actually investigate the FDA's statements, put them into context or do anything other than quote directly from the press release itself. One news outlet even incorrectly reported that a study had already been conducted showing a link between vaping and seizures.
Not only is this lazy reporting, it turns the press into a mouthpiece, a willing megaphone, a potential amplification system for government propaganda rather than what the press is supposed to be, a check and balance on governmental power, an accountability and early warning system for the benefit of the American people, the much lauded "Fourth Estate."
Because of this uncritical reporting, numerous questions were left unanswered. Why, for example, did the FDA take the time to write up a 1,187 word press release after finding a mere 35 possible cases? Was this normal behavior for the FDA? Why did the FDA issue the press release before conducting an investigation? Does the FDA usually issue a press release first and investigate later or was this an anomaly?
We decided to do what the mainstream media had refused to do. It took some digging but we found that the FDA's actions in this case were not consistent with their behavior in previous, similar situations.
Nexium, an over-the-counter acid reflux pill had 322 adverse events reports specifically involving seizures over the past nine years. No FDA press release. No investigation.
There are 34 adverse events involving seizures sitting in the FDA's Adverse Event Reporting System involving Nicotrol and Nicoderm CQ, two nicotine replacement therapy products. Again, no FDA press release. No investigation.
Since 2010, some 70,342 people have reported side effects from Chantix, the quit smoking prescription medication. Side effects ranged from pain to stress and anxiety to multiple sclerosis (!) to diabetes. 115 of them reported seizures. Yet, the FDA did not issue a press release regarding these adverse effects until after it had already concluded it's investigation. By the time the public learned of the link, the FDA had already wrapped up its investigation including adding new information to the Warnings and Precautions section of the drug label along with the patient Medication Guide.
Even more concerning, we uncovered instances in which the FDA has seemingly allowed companies to keep adverse events reports secret, concealing them from the public and doctors alike. For example, the FDA allowed Baxter International, the maker of the Colleague drug pump medical device, to hide 75,000 malfunctions of it's product, obscuring them in a single page summary. That summary specifically hid the large number of reported cases until the Star Tribute uncovered the truth.
The FDA hid another 300,000 adverse events, encompassing both injuries and malfunctions involving various medical devices, from the public by classifying them as corporate trade secrets. The Star Tribune's investigations again brought this to light. As former FDA official Madris Tomes noted, “Whenever you have thousands of reports and you list them as one ... that’s not transparency at all.”
In another instance, the FDA had 100 reports of serious complications, including "difficulty swallowing" and "dangerous swelling" as the result of Medtronic's Infuse spinal implant. The FDA still waited nine months to warn the public, and only did so after receiving additional reports of injuries from other sources even though this was an instance in which the correlation between the adverse events and the implant was quite clear.
Given these and numerous other similar instances, what was the real motive for putting out the press release based on only 35 cases before any investigation had been done? Was this Gottlieb taking a final shot at the vapers of the world on his way out the door, aiming to leave a cloud of fear and misinformation hanging in the air that he knew would be uncritically reported by the lap dog media and difficult to dispel? Did he hope to garner public support for the anti-vaping agenda he has pushed while at the FDA by implanting the connection between seizures and vaping in the minds of the public? Did Gottlieb realize, as all savvy politicians know, that making the connection in people's minds, even when no actual connection has yet been established, is, in effect, the same thing?
It's hard not to draw that conclusion, especially because there has been little background information offered in the 35 reported cases. Few contain details such as the brand of e-liquid being vaped, the nicotine level, the make or model of electronic cigarette or whether the vaper was also on medication, all important pieces of information needed to establish a definitive link.
Due to the extremely small number of cases and the dearth of details, the FDA hasn’t been able to establish any definitive pattern. Some cases occurred in first time vapers, others were seen in regular users, some happened immediately after taking a puff, others didn’t occur until days later. Because of all of these factors, the FDA has clearly stated that there is no established link between vaping and seizures, just a possible link that they are investigating.
One potential explanation for the seizure cases is that users are getting way too much nicotine. Seizures are a known potential side effect of nicotine poisoning and, with the proliferation of much higher nic levels with the rise of Juul Pods and nic salts, this is a possible explanation. The FDA stated that it is looking into this angle.
Another possible explanation is that the vapers who experienced seizures were using their electronic cigarettes to deliver other, ahem, substances or using them at the same time. In fact, at least a few of the 35 reported cases involved people who were also using marijuana or amphetamines (although no word on whether they were vaping them).
Amphetamines in particular, a term that encompasses both legal forms of the drug such as those used to treat attention deficit disorder and illegal forms of the drug generally referred to by the slang name “speed,” have been linked to seizures. The fact that most of the 35 reported cases of seizures occurred in young people who might be more likely to party irresponsibly potentially gives credence to this theory.
A third possibility is, of course, that the seizures had nothing to do with vaping and just happened to occur, in these 35 cases, in people who also vaped. Given that three million adults in the United States suffer from seizures, it's not surprising that at least some of them are going to have seizures after they vape. And, indeed, the FDA conceded that in at least a few of the thirty-five cases, the individual involved had "a prior history of seizure diagnosis." In other words, it was a condition the individual already suffered from that could have recurred without having any connection to the fact that the individual just happened to be vaping.
So does vaping cause seizures? It is abundantly obvious that we don't have any where near enough information yet to answer that question. In fact, we don't even have enough information to ask that question with any seriousness. For the FDA to call these 35 questionable cases an "emerging safety issue" that needs to be brought to the attention of the public is beyond ludicrous. Without a clear correlation to vaping, the so called association between vaping and seizures could be nothing more than a questionable cause logical fallacy, that is "when two events occurring together are taken to have established a cause-and-effect relationship." And that is why the FDA usually investigates first and issues press releases later.
Interestingly, shares in Altria Group, owner of a 35% stake in Juul which it purchased for 12.8 billion at the end of 2018, fell 3% on the FDA’s announcement.
“We want to be clear that we don’t yet know if there’s a direct relationship between the use of e-cigs and a risk of seizure. We can’t yet say for certain that e-cigarettes are causing these seizures,” Gottlieb concluded.
But the lack of a clear, direct relationship didn't stop Gottlieb from issuing an alarming press release to the public which he knew would proliferate across the web within hours, leaving many people with the distinct impression that a correlation had already been established or, at the very least, that there was legitimate cause for concern. After all, why would the FDA issue a warning to the public if there wasn't?
We can at least take comfort in the fact that Gottlieb, as of Friday when his resignation went into effect, is gone.
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