Doctor, welcome back to the show. This is a first for me. In two years of this show, three years of my previous show, I've never had the government call my show out. Let me just start with this. Just explain to people because again, before I even wanted to ask you a reaction, I want to make sure people understand so that I'm framing this right. What you come on the show, we had a great conversation and then what happened?
Well, what happened is we received a warning letter from the FDA regarding the conversation we had on your show and I think they were concerned that I was having a conversation in under the context of promotion.
Okay. So, you're a world-renowned doctor. You've done a lot of really mind-boggling things. What was your reaction when you got a letter like this?
Well, obviously I was surprised, but I think Sean, let me just explain the context maybe of where the FDA came from or coming from. There's really a tension, a real tension between the first amendment of free speech and the FDA's policy of what they call promotional speech. So this tension has been going on for decades to the sense that actually there's been legal cases now in the courts between pharma and biotech companies and FDA to try and resolve this issue of what is free speech and what is promotional speech. So as it relates to our broadcast, the FDA considered a direct to consumer discussion because obviously your audience is that and this as you may know the administration has now taken on a high priority to crack down on what we call DTC marketing and I believe over 100 letters has now gone out to pharma with this FDA to multiple pharma companies to relate to this issue of what they consider direct to consumer promotional speech. So my reaction is we received this letter in that context as a high priority and then it elevated to a warning letter relating to two things. One a TV ad and two the Sean Spicer podcast. The TV ad as it turns out we never had the TV ad and here I am now with you.
Wait. So can I just be clear on something? So they cited a TV ad as problematic because in their opinion, I don't want to put words in your mouth, but I want to make sure I'm understanding this because in their opinion this supposed TV ad would have been a direct to consumer effort. Is that kind of what they would claim?
They would claim exactly what I'm going to clarify today with you.
Okay. But I'm sorry. So I just want to be clear. Was there ever an ad though?
No, what we had to do was because we wanted to make sure the FDA, we sent the FDA the potential transcript of that ad. An ad never aired. It's never aired at all.
But how would they, I don't, I guess what I'm missing here is how do they know there was an ad though? How, that's what I'm missing. How did they know there was a potential ad?
Well as part of our regulatory responsibilities we would send to the FDA ahead of time.
Oh you show them the, when you guys are doing in this world, I didn't, I never knew that. So you got to pre-clear it with them.
Yes. Anything that we think is promotional.
But your conversation is obviously live with your audience and I want to, I thought in my, and this is what we'll clarify today that I was talking very much about what the National Cancer Institute was saying, what we're talking about what's not approved and what we're doing in clinical development. But the concern and I get it. I get the FDA's concern that they needed for me to clearly distinguish the difference between what's approved and what's not approved.
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The issue really was that they considered my podcast with you promotional speech which then fell under very strict FDA rules. First of all, then somehow we should have put this in front of them first, but obviously it was a different vehicle as a podcast. So my response, so let me just give you my response was to immediately respond to the FDA and really clarify the context of the discussion that we had. So because the FDA considered our speech under promotional, I'm only allowed to speak about what is in the label, meaning the package insert about its indication. And then once I mention the name Anktiva, I also need to explicitly spell out the risk issues associated with that drug when given. So any other discussions off label would be considered not appropriate in a promotional setting. And if I speak about the clinical development and the pipeline and aspirations to cure cancer and the science, it has to be explicitly clear that it's not approved. So, look, as I said, I get it that the FDA's concern is about encouraging consumers to use a drug that's approved, but also informing the consumer about any safety issues. I understand that concern, but I think really to clarify to the FDA the issue surrounding our podcast really the conflation in their mind of my discussion with regard to the science of IL-15 and its potential activity under clinical development and its confusion when I use the word Anktiva. So once I mention the word Anktiva, the FDA's policy is that I need to explicitly identify the approved indication and importantly spell out the risk or safety profile. I did indeed mention Anktiva during our podcast was approved only for bladder cancer, but that's not enough. So Sean, if you don't mind,
Can I just say this? I'm the one asking the questions, right? Meaning when I asked you a question, I thought you answered it openly and honestly about what was available and what was not. And again, I'm not a doctor. I took first aid in like 8th grade, so I don't have any training in this. I admit that. But I get if you're promoting your product, if you're at a conference or if you're giving a speech or you're paying for television time, but when you're doing an interview and I'm asking the questions, I think you've always been open and honest and transparent because I ask, 'Okay, well, where could I get this or how could it do it?' And I don't know. I get it, but I'm also kind of like that it sounds like you've got to be a human lawyer walking around all the time.
It's basically that. I think you know so I live personally in a very strange world now right I am the owner of the LA Times so free speech and first amendment is really what I live for in the LA Times I'm a scientist and clinician I look after patients I'm an inventor I develop drugs that I think will make an impact but sadly I'm also the owner and founder of ImmunityBio with an approved product. So now I fall under first amendment but I also fall under the FDA policy that has real policy under what speech I can do under what are considered promotional. So you're right. Our conversation in my mind during that time was me under the context of speaking about IL-15 speaking about the patients that I have what I call single patient INDs in which I get authorization from the FDA because it's unapproved to give them treatment for where they have lung cancer, brain cancer, etc. But I think the concern was was this confusing to your audience? Was I in a funny way presenting or promoting Anktiva for its approved use of bladder cancer? So if you don't mind Sean I would like this purpose and thank you for giving me the audience an opportunity to clarify so that there's no question that I explicitly and the purpose of this podcast with me at least from you is to really clarify and if you don't mind I'd like to read directly from the label and the safety so that there's no confusion to your audience. So if I find the label directly if I may read.
Anktiva is an IL-15 receptor agonist FDA approved for use with BCG for the treatment of adult patients with BCG unresponsive non-muscle invasive bladder cancer NMIBC with carcinoma with or without papillary. That is the label. I didn't fully say with BCG and I didn't want to confuse anybody that Anktiva is going to be used as a single agent. I didn't want to confuse that in the bladder you have to put it intravesically meaning and I didn't want and that meantime when we do it in our clinical development subcutaneous I also needed to actually read the safety information when I say that in the promotional setting. So I apologize to you for taking the time but
I don't need the coming to my house. So go let's
Important for that your listeners also be aware of the risk of treatment to ensure we providing balanced information. So patients and providers considering treatment should be aware number one Anktiva labeling includes a warning for risk of metastatic bladder cancer with a delayed cystectomy. So let me put that in English for you. The natural cause of this disease in which we got this approved are patients with bladder cancer what they call BCG unresponsive. The only danger for these patients if they go from unresponsive to muscle invasive and lose their bladder by having what they call a cystectomy. The standard of care for these patients after they failed everything including BCG is to have their bladder removed. So the warning that the FDA is asked to say is that delaying cystectomy could lead to the development of muscle invasiveness or metastatic bladder cancer which could be lethal. So if patients do not have a complete response to treatment with Anktiva and even after induction Anktiva they should reconsider cystectomy. That's one thing I need to state if we would mention Anktiva. Next thing I need to state is Anktiva is for intravesical use only meaning it's for the bladder. The current development we're having is subcutaneous use but that's not in the label because it's for lung cancer, breast cancer etc. Obviously it's not in the bladder. It also says that may cause fetal harm because of the potential risk of the fetus female of reproductive potential. She should use effective contraception. And then the most common adverse reactions including laboratory test abnormalities including creatinine abnormalities, dysuria, hematuria, urinary frequency, micturition, urgency, urinary tract infection, increased potassium, muscular spasm, chills and pyrexia. And for more information about Anktiva, please talk to your doctor and visit anktiva.com where you can read the full prescribing information that is considered the safety information that I should make.
That's called an FDA hostage video. That's, I mean, look, I get it. And I appreciate but what was the remedy that they proposed? Is this what they wanted you to do to say, 'Okay, we got to go back out and tell Sean Spicer's audience. Here are all the risks and here's the only intended approved use.'
Well, we proposed the remedies. The first remedy proposes we took off the video off our website, your podcast. And then, as you know, I wrote to you to say, would you, you know, there's three options. One, you can take it off your pod, delete it, remove it or whatever. Or if you prefer, I would come on the show to clarify and make sure that there was no misconception or misleading of your audience.
I like to think I have a great show. I know I do. I know a lot of important people watch the show because I hear from them including some very, very, very senior people in the United States government. But here's my question for you. How does something like this happen? I would love more people at the FDA to watch the show. I cover a lot of major topics. I cover a lot of wellness issues and frankly I wish more people in the government at HHS at large watched the show because they could learn a little something about what's going on out there. The Secretary Kennedy and others are pushing. Do you think that somebody was out to, like somebody clearly watched the show and ratted on you?
Is that a question Sean? I guess I mean, like I said, I'm just wondering, this doesn't sound like there's a bunch of dudes at the FDA or dudettes that are sitting around watching the Sean Spicer show every night. I wish they do. I hope more people do. But I guess my question is like this seems a little weird like somebody wanted to come after you. Well, in the warning letter, the FDA referred to what they call their Bad Ad program and that they received some of this issue information from through the Bad Ad program. Who that may be or what was received from them obviously I have no idea but they did acknowledge they have this program and somebody sent them whoever watched your show. Well, I have a couple ideas.
So let me ask you this. In terms of the drug itself. And by the way, can I just ask you again if this is not about your drug, just as a medical professional, for example, in the GLP-1 space, for the longest time before I think it was like Wegovy became an issue, there was a lot of doctors prescribing Ozempic, which is a type two diabetes drug. Here's me telling you this, but people would say, 'Oh, the doctors can prescribe these GLP-1s off label or for, you know to be honest any off label' like again not with respect to your drug. Just so that we're keeping this above board, but can't medical professionals generally take an FDA approved drug and use it for other intended consequences if they believe it's in the best interest of the patient?
The answer to that is yes. I think let's talk about the medical practice of medicine which is independent of me as a founder or anything about Anktiva. So the medical practice is yes doctors could prescribe anything off label. The question however is when it goes in this off label issue the burden then goes on the patient meaning the reimbursement of that drug by the insurance company in off label is then in the hands of the insurance company.
Okay. So while the doctor may approve it off label then the patient may have to come out of pocket or the doctor may have to come out of pocket or the hospital may not receive reimbursement. So on the use of off label it's a viable option provided you could afford to pay for the drug which then says access meaning who could afford to pay for the drug? If you're wealthy you can and if you're poor you can't right and if in the Medicaid world I doubt that they would approve a reimbursement for an off label use so it's all about reimbursement.
So look you and I have known each other 10 years and I would like to think that you bring your best stuff to the Sean Spicer show but I see you a lot of people really interested in talking to you hearing some of the things that you're doing in medicine You're a very popular guy, a well sought-after guy. What made this, I just don't get it. I see your clips. Sometimes you send them to me, sometimes I get a Google alert that you've done something. I follow you. Why? I don't get it. I'm still baffled like what was unique about this interview in your mind or your team's mind that is different from and again I'm glad in the sense that you and I can have these discussions that are more probing or if you will and that aren't as stained maybe but I see you get a lot of media attention. You're a very smart popular guy who's doing some amazing revolutionary things. And I was like why this show? What was it so unique that did your lawyer say to you, well this phrase was different than you've ever said before?
Well, I don't know truly obviously I truly don't know the fact as I said there's a Bad Ad program somebody may have reported your show since you have a popular show.
Yeah, I appreciate I mean again it's a badge of honor to some degree but I just you're a very popular guy. I'd like to think I'm the only guy who has you on, but I'm not. And you say some very, I mean, you've become very very sought-after because of the amazing things that you're doing in the field of medicine. Leave it at that.
Well, I think you know it just ironically happened to be the time when the Saudis approved us for lung cancer. And I got to be very careful about that because that is approved only in Saudi Arabia for subcutaneous use for patients with lung cancer who fail checkpoint inhibitors. Now there are companies that make checkpoint inhibitors and these failed checkpoint inhibitors again I have to be very explicitly clear to your audience. I'm not talking about any approved in the United States. This is approval in Saudi Arabia and we happened to do that call right after that. So now at least out of the country in lung cancer. I have no idea why your podcast was highlighted.
