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0:00 - Intro with Joanna Junak
0:34 - Will Godfrey discusses a recent speech by Dr Brian King
5:03 - GFN Voices featuring David Sweanor and Clive Bates


Hello and welcome. I'm Joanna Junak, and this is GFN News on GFN TV. Today's program will Godrey of Filter will tell us about a recent speech by Brian King, the director of the FDA center for tobacco Products. And we will bring you the next part of our new series GFN Voices. Now let's turn to will. Hi, Will. Thank you for joining us. First of all, who is Brian King?

Will: Hi, Joanna. Dr. King was brought in as the director of the FDA's Center for Tobacco Products, or CTP, in early July, replacing Mitch Zeller. He now has a lead role in implementing the agency's heavily criticized PMTA process, which deems whether vaping products are appropriate for the protection of public health and may be authorized for sale. His appointment was unpopular among tobacco harm reductionists, as Filter reported at the time. They pointed to his former role in the CDC's damaging misinformation around the Socalled EVALI outbreak of 2019. Brian King's long history of obfuscation around the issue of tobacco harm reduction is hard to ignore, leading advocate Greg Conley told Alex Norse.

Joanna: What was the context of his recent speech?

Will: It was at the GTNF conference in Washington, D.C which I attended at the end of September. Delegates included many tobacco and nicotine industry reps, as well as academics, advocates and so on. And you could really tell that people were hanging on his words in the room for clues. The CTP. Of course, has rejected 99% of close to 6 million product applications received, authorizing just a handful of tobacco flavored products made by large companies. Smaller companies that were rejected have filed numerous lawsuits on the basis that the CTP's handling has been arbitrary and capricious. Juul, by far the most highprofile company to be rejected, recently launched a lawsuit of its own.

Joanna: What did King say?

Will: One incredible implication was that he's in an unenviable position, under intense pressure from both the pro and antivaping lobbies in a highly politicized process. King described his first three months as baptism by blowtorch. He did pay lip service to the risk continuum of nicotine products, a concept cited for years by FDA hierarchy but hardly reflected in its decisions. The risk continuum certainly exists, he said. It is not a mythical creature. Still, King and others have frequently given youth vaping vastly disproportionate weight in their assessments of relative risks. A number of King's comments sought to defend the CTP s chaotic record. It's easy to be an RTR regulator from the safety of a social media handle, he protested. And he described the timely processing of over 8000 recent applications for synthetic nicotine products, a responsibility newly handed to the FDA by Congress as a task that's herculean at best and impossible at worst. In the grand scheme of things, it's a relatively infant center, he said of the CTP. It's 13 years old. If it's still in its infancy, I don't understand when it's going to reach its adolescence, remarked attorney stacey Ehrlich. In a later session, King acknowledged room for improvement. He insisted I do listen and claimed that I actually wholly welcome the upcoming independent review of the CTP, led by the Reagan Udal Foundation, as a chance to improve processes. I'm confident that we're going to get very useful information, he said. But his words also included threats. I will say that when it comes to enforcement and compliance, nothing is off the table, he said. The FDA recently enlisted the Department of justice in sending lawsuit threats and product destruction demands to bake companies that hadn't submitted PMTAs. King said he's determined to enforce the law through any means that we have that is legally defensible. He arguably also demonstrated a great flare for timing his long talk, which covered CTP responsibilities and mechanisms, neatly occupied all the time that had been allocated to a Q and A session. Delegates exchanged some ironic glances when he concluded that he could take no questions because he had to leave immediately for a meeting with a legislator on the Hill.

Joanna: Thank you, Will. And now let's hear from our GFN voices with Clive Bates and David Sweeney.

Brent: What do you think of the conference so far? This year?

Clive: Conference is great. We're getting the usual updates science, policy, politics. It restores your faith that something can be done that possibly even the world will ultimately do the right thing and wipe out this smoking related disease epidemic. There's going to be still a longer pill struggle, and nothing's changed in that respect.

Brent: Now, David, do you share that optimism?

David: Yeah. As we discussed before, Brent, I think the facts you'll come out good, policy is contagious. We're seeing very effective things happen around the world. We're seeing tremendous opposition to that. But eventually I think that opposition has to crumble. As more of the science comes out, we see more of the results and how many people are moving to alternatives. We see what that means in terms of disease rights, it's a matter of, can we speed this up? And the irony of seeing groups like the World Health Organization trying to prevent it and trying to slow it down.

Brent: What's going to happen to the 8 million vapors in the US come shortly when the devices are pulled?

Clive: Most of the existing 8 million vapors will find some kind of workaround. They'll mix their own liquids. They'll buy devices on the black market. They'll use what they've already got. They will be fine. The people we should be worried about are the remaining 30 million smokers for whom vaping will become much more difficult thing to switch to. So it's not just the existing stock of vapors, it's the potential vapors in the future that the FDA is going to be blocking from switching from high risk to low risk. The way they're carrying on in the states now, essentially millions more will get sick and die as a result of basically completely incompetent regulation by the food and Drug Administration.

Brent: Gentlemen, we started reporting on this about a year or so ago. It felt like there was a movement within tobacco control research, with public health research that started really going in favor of balance, more balanced research, I'm thinking Dr. Ken Warner, Abigail Friedman, Peter Hayek. We even just had Dr. Rick Costerman on from the University of Washington and Jonathan Fold. So am I imagining it or are we actually seeing an effective pushback within public health research?

David: Well, I think there has been effective pushback for some time. I think we're seeing more of those people organizing, speaking out. What's amazing is that others are choosing to ignore them. You can get some of the leading people in the field coming together to say, you got it wrong. What you're doing is killing people, and yet you have those who are being well funded on the absence only side doing exactly what absence only people do. So I think it's no different than saying we have really good information on what we should do in terms of teaching people sex education, but we have absence only people totally opposing it. We've got very good information what we can do to reduce the harms from illicit drugs. But we've got an awful lot of people pushing an abstinence only agenda. And I think the more progress you see in terms of the science, the human rights, the basic effect of public health interventions, the more angry the absence only people get, the more vicious, the more vocal, because they're still fighting their battle. And that's not about science, it's not about reason, it's not about humanism. They're on a different agenda.

Clive: Yeah. I mean, there's really good science to support tobacco horn reduction. The scientific case for it is strengthening all the time. But the scientists involved tend not to have 150 decibel loud hailers to make the argument that's coming from the activist scientists who'll do some kind of study, they'll find some kind of effects and then it's in the press. It's all about press releases, about statements about amplified by the activist complex of sort of these well funded groups that then creates a big sort of propaganda front. And that goes all the way up in the United States to the CDC. We saw them making a pseudoscientific case for these outbreaks of lung injury being connected to vaping. And they're not, they're just not in the science. It's absolutely clear that they're not. But that hasn't stopped them shouting really loudly that this is a problem and deterring people from switching from smoking to vaping. So it's a quality versus loudness problem.

Brent: If you had a couple of minutes to sit down with Sonya Johnson at Health Canada, what would you advise Health Canada to do?

Clive: I would say regulate vaping products in the consumer interest, stop trying to stop people using these products. Make them safer, make it so that people understand what's in them. Make it clear what the relative risks compared to smoking are. And then let consumer choice and a relatively free, lightly regulated market do the heavy lifting on wiping out smoking in Canada. Almost everything else has the opposite effect. You'll end up, if you try and get too extreme or too prohibitionist with vaping regulation, you'll end up with protecting the cigarette rate, more smoking, more disease and death and you'll have basically failed in your machine.

Brent: And then also too is not part of the problem. The shouting at researchers and shouting them down and ostracizing them from events and so forth.

Clive: Yeah, I mean for good scientists doing careful diligent work on harm reduction, the atmosphere has become increasingly intimidating. They're constantly being it's constant hints that they're only doing this because they support big tobacco. They're supported by Big tobacco that they don't understand, they don't understand youth or they don't care anything. And these are really decent people, never had a conflict in their lives doing very good work and yet they don't feel they can speak out just because the media and the public arena is so hostile and the science that they're doing is so unwelcome. Quite this huge complex of interest that is threatened by it. You've got to remember, if there wasn't a lot of harm we wouldn't have all these university departments studying tobacco, we wouldn't have all these activist organizations, these health agencies. There'd be nothing for them to do. So they're very conflicted. They need the harm because that's what makes them relevant and so that's what they find. The Tobacco Control Industrial complex. It is a complex. It has all the features of a complex. Tightly bound organizations, a great deal of money, huge conflicts of interest. As I say, a lot of them, their careers, their grants, their conferences, everything about their lives are contingent on them finding things like vaping to be harmful. Otherwise there's no reason for them to exist.

Joanna: That's all for today. Tune in next time here on Gfntv or on our new podcast for more tobacco harm reduction updates. And on Tuesday, Dr. Colin Mendelsohn, Tobacco Treatment Clinician, founding chairman of the Australian Tobacco Harm Reduction Association, will join us to discuss his summarizing. A twelve month review of Australia's Vaping regulations. Thanks for watching or listening. See you Next time.