An Interview with Spike:
The FDA and electronic cigarette research
Part 1: Switching to Electronic Cigarettes | Part 2: National Vapers' Club | Part 3: Anti-Smoker and the Electronic Cigarette | Part 4: John Banzhaf | Part 5 The FDA and Electronic Cigarette Research | Part 6: Advice for Novices | Part 7: Mainstream Vaping
Background: The FDA maintains that the electronic cigarette is a drug delivery device, despite a ruling by Judge Leon to the contrary. The agency has been confiscating shipments of e-cigarettes, and has criticised the device in a press release. Here Spike Babaian tells us how she feels the agency is obstructing research into the electronic cigarette.
ECD: You've told me in emails before that you feel that the FDA is obstructing research in connection with e-cigarette. Can you tell me any more about that? How are they obstructing the research and what do you think is their motivation?
Spike: We have tried to do a number of studies.
We put forth two research proposals to IRBs - in America we have institutional review boards and may have to review for ethical purposes any study that’s done in the United States with human subjects. And our initial proposal was to do exhale vapor study and have subjects using the product and testing their exhale vapor and to determine if what they were exhaling was safe for bystanders and people around them.
We put forth proposals and initially the response was, “Yes we would be happy to review your proposal and determine whether or not it’s ethical.”
A couple of days later we got an email back saying we find that we are not qualified to review your proposal because we don’t have the medical knowledge required to determine whether or not its ethical.
So I said, “I’ll be happy to provide a medical expert on, you know, pulmonary specialties to provide that information for you and we’d be happy to pay someone as a medical expert who you choose to come and explain to you what the research study is.”
And they said, “No, we can’t do that you’ll have to go somewhere else.” So they said, “and we’ve also spoken with the FDA and they said you’re not allowed to do the study because your product is a drug delivery device.”
This was a time before the determination to come down from federal court that the product was a tobacco product and not a drug delivery device. So we had no argument and we let it go.
Two weeks after that point we got the notification that Judge Leon, Richard Leon, Federal Court Judge, had determined that the product should be considered tobacco product and regulated as a tobacco product, not a drug delivery device and we applied again to a different IRB who might have medical expertise.
They claimed to have medical expertise for all studies including drug study so we figured even if they determine it’s a drug, they’d still have to review it because they said they have expertise in all areas.
So we requested to them and they said, “Yes, we’d be happy to review your product if you can send us a check for $2200,” which was what they charge if you are not going through a university.
We’ve raised enough money to do that and we went to submit the application and the check. And they said, “Well, you know we’ve spoken with the FDA and they determined that the product is drug delivery device and we would need a special number, a certification number before we can accept your proposal and you’ll have to go through the FDA and get approval first.”
And I said, “Well, we are not applying to sell the product and we don’t believe that it’s a drug delivery device. We just want to study its effects." And they said, “Well, the FDA has told us you are not allowed to do that.” So they refused to review our study.
So we have a third study that we are currently working on that. We’ve now raised a third of the funding for and in this study we have decided not use human subjects. We’ve elected to use a smoking machine as you would when they do secondhand smoke studies because it is not ethically sound to make people smoke cigarettes. So they use this machine to inhale and exhale smoke from a cigarette. So we’ve had the company to determine whether or not it can be used with e-cigarettes and whether or not it can inhale and exhale vapor. And they told us that it should.
So, we’re going to have the machine function to inhale and exhale instead of having human subjects. So, there is no IRB approval required. And hopefully this will stop the FDA from trying to stop our studies.
We‘ve also written to the FDA numerous times explaining to them that we’re trying to do research and that they are interfering with our research by claiming that the product is a drug delivery device, and we are trying to study the product as an environmental situation, in environmental situation to determine whether it is safe to bystanders and we’re not trying to study it and its effect as a drug delivery device even though that’s what they think it is.
And their response in email, which we have and can publish for proof, has been, “You can’t study the product unless you apply as a drug delivery device,” in essence forcing us to say, “Yes, it’s a drug delivery device” before we can do any research on the product. And this is where we’ve been stopped a number of times. And again, by having the machine use the product rather than a human being, we avoided this situation and allows us to be able to use the study regardless.
ECD: Why do you think they might be obstructing this research?
Spike: The only thing that I can think of is that they stand to lose money if we do it without the FDA. If this research were to be done and done and funded through the FDA, they’ve already admitted they would cost millions and millions of dollars. We’re able to do the study, we proceeded with the proposal with a quote of 76,000 and I believe that we can complete this study for less than a hundred thousand dollars if we don’t have to go through the FDA and if there are no human subjects and we are not intending to apply as a drug delivery device, there’s no reason we should have to go through the FDA. But I believe that they stand to lose money that we would have to pay them if we were to go and do this study through the FDA