The No Pill Podcast

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Welcome to the inaugural episode of the No Pill Podcast, hosted by Andrew Hoffman, formerly of the Revelations Radio News Podcast. In this episode, we delve into a recent clip from Larry Ellison discussing the potential of AI in developing cancer vaccines. While the promises sound groundbreaking, I explore the skepticism surrounding these claims, particularly focusing on the mRNA technology and its challenges.

We take a critical look at Moderna, a leading company in mRNA technology, examining its past struggles and current market performance. Despite the hype, Moderna's stock has faced significant declines, and the company is grappling with issues such as vaccine pricing, patent violations, and regulatory failures. I discuss why I remain bearish on mRNA technology and why AI might not be the silver bullet for Moderna's challenges.

We also revisit historical concerns about mRNA delivery systems, particularly the safety issues associated with lipid nanoparticles. These concerns were prevalent before the COVID-19 pandemic and remain unresolved. I question the viability of massive investments in AI-driven cancer vaccines and ponder whether these initiatives are genuine or serve other purposes.

Join me as I navigate through these complex topics, offering insights and raising questions about the future of mRNA technology and its implications. Thank you for tuning in to this first episode, and I look forward to exploring more in future episodes.

[00:00:00] Andrew Hoffman:

Welcome, everybody, to the No Pill Podcast episode 1. This is Andrew Hoffman,   formerly of the Revelations Radio News Podcast,   maybe the future Revelations Radio News Podcast. We'll have to see. What I've got for you today is just one clip from Larry Ellison. I'm sure most of you probably heard this recently, but, just wanna go into that clip and then a little history behind it.   It sounds bogus,   and it is,   but go into some of the specific reasons why and why we already know that   that will be 500,000,000,000   or 500,000,000,   whatever it is,   dollars not very well spent.  

So we'll get into the clip. Thanks for listening, and   we'll talk again on the other side. Thank you.  

[00:00:50] Unknown:

One of the most exciting things we're working on, you again, using the tools that's that that Sam and Masa are providing,   is our is a cancer vaccine.   It's very interesting.   Early die turns out I'll be quick. All of our cancers,   cancer tumors,   little fragments of those tumors   float around in your blood.   So you can do early cancer detection. If you can do it with using a you can do early cancer detection   with a blood test.   And using AI   to look at the blood test,   you can find the the cancers that are actually seriously threatening the person. So we can again,   cancer cancer diagnosis   using AI has the promise of just being a simple blood test.  

Then beyond that,   once we   gene sequence, once we gene sequence that cancer tumor,   you can then vaccinate the person,   design a vaccine for every individual person to vaccinate them against that cancer.   And you can make that vaccine, the that mRNA vaccine,   you can make that   robotically again using AI in about 48 hours. So imagine early cancer detection,   the development of a cancer vaccine for the for your particular cancer aimed at you, and have have that vaccine available in 48 hours. This is the promise of AI and the promise of the future.  

[00:02:20] Andrew Hoffman:

Well, that clip raises a lot of questions.   Chief among them is how did that guy how did someone so dumb make so much money?   But that's a,   you know, that's a topic for another day.   Another question,   you know, if there's tumors, why don't you just detect the tumors and not the bits floating around in the bloodstream?   And if there's not tumors, then what exactly is floating around in the bloodstream?   But what I want to talk about is   the mRNA   part of that whole thing. And it's because   clearly they haven't given up on the idea. They've just added AI to it, and magically it's going to work now.   But it's working off the premise that   this mRNA technology   isn't faulty in and of   itself. So one of the chief companies   doing the mRNA stuff is Moderna, and it's got mRNA in the name.  

So let's take   a current look at how the company is doing, and also   look back a little ways and see   if see if the big problems that were hampering Moderna back in 2016,   actually got fixed,   or if COVID was just kind of the Hail Mary that they needed to,   survive and   and make a bunch of people rich.   We'll start here with why I don't believe Larry Ellison's Moderna stock Hype   coming from   the good part of propaganda for dumb people, finance.yahoo.com.   And it talks about how   with that very same Larry Ellison clip, the Moderna stock price surged 7%   this week,   following Oracle   CEOs at Larry Ellison's claims that artificial intelligence could help develop messenger RNA   vaccines to cure cancer. We've heard such blusterous aspirational hype before to be sure, yet his comments represent a rare upward price catalyst for Moderna.  

A pharma giant currently under the cosh for vaccine pricing, patent violations,   regulatory failures, and transparency issues in recent months. However, despite the colossal potential behind AI and its cross pollination into other sectors,   this stock is more likely to maintain its long down long term downward trend   and fall below $30 per share following a disastrous 12 months in which Moderna shed 62%   of its share price.   That's when a lot of the stock market was going up too.   Alright.   Given the overwhelmingly   bad sentiment surrounding the stock, I'm not going long on the silver bullet theory that AI will rescue Moderna's fortunes   anytime soon. Probably a smart move.  

I remain strongly bearish on mRNA.   Oh, yeah. Okay. And would consider it wise probably not as bearish as me, but, bearish on mRNA, and we'd consider it wiser to short the stock rather than invest   for the short or long term. Short positions could be had at better levels with the stock up 7% over the past 2 days.   That's,   you know, apparently Moderna didn't pay off the Yahoo guy there.   And go back   just a little further,   this is earlier,   earlier, this   this year in January.   After tough year, Moderna CEO confronts challenges for RSV   COVID Businesses and Shareholder Letter.  

So this is January   7th, from fiercepharma.com,   kind of the trade   publication there, online publication.   With COVID vaccine sales in the doldrums and a respiratory syncytial syncytial virus, RSV vaccine market in contraction,   Moderna CEO,   Stephane Bancel, had the unenviable   task of trying to put a positive spin on the, on the sharp stock decline in his annual shareholder letter.   After an unexpectedly limited RSV vaccination recommendation from the CDC   resulted in a contraction in the US market, Moderna will adjust its financial reporting   traditions to   exclude products in their launch here, Bansal said Monday in his annual letter to shareholders.  

The company was too optimistic about our ability to break into the market given the headwinds from a mid year approval on launch.   We are taking those learnings to heart, and going forward, we that's it, the actual quote. We are taking those learnings to heart, and going forward, we will not include revenue from products in their launch year in our financial framework.   Approved by the FDA in May 2024,   Moderna's   mRNA shot, MResvia,   only generated $10,000,000   in sales during the Q3,   its RSV season debut.   Besides the impact of a narrowed CDC policy, RSV incumbents, Glaxo, McLean, and Pfizer   apparently proved to be too difficult to challenge, especially since MResia   is widely viewed as the weakest option   among the offerings from an efficacy perspective.  

That's the worst house   in a   slum there.   So Moderna's stock price   dropped about 60% in the past 12 months. Facing this set of challenges, Moderna   laid out a plan to cut annual R and D spending by more than 20%,   or over $1,000,000,000   by 2027 compared with 2024.   One of the closest to market among the 10 of   their proposed new products is mRNA 1283,   a next generation COVID vaccine. In his Monday letter, Bansal said the FDA has accepted   Moderna's application for the shot.   Assisted by a priority review voucher, a decision is expected by May 31, 2025.   The CEO didn't offer an update on the company's flu COVID combination vaccine,   which the company had aimed to submit to the FDA by the end of 20 20   4. Moderna disappointed investors in September when it said it didn't plan to use a priority review voucher for the combo because it would still not be able to make the 2025 winter season. Another asset that   industry watchers   have been paying close attention to is mRNA 4157,   an individualized cancer vaccine under collaboration with Merck and Co.  

The partners have pushed the immunotherapy into multiple phase 3 trials in what some   analysts view as a high risk, high reward strategy.   Okay. So that's a few weeks ago. It's, you know, not looking good. 60%   stock price is 60% down.   They made a whopping $10,000,000   which when you're spending   when you're   spending $5,000,000,000   a year on,   R and D,   a $10,000,000 product   doesn't go a long ways there. So   we'll go back a little bit further.   This   is COVID era   from the,   one and only Whitney Webb. This was published on Children's Health Defense.   Moderna had a long history of failure, then along came COVID.  

And this is,   yeah, just from   I don't know why the date's not on there, but it is,   fairly recent. We went over this on the Revelations Radio News podcast   a year or 2 ago.   Before COVID 19, Moderna was in danger of hemorrhaging investors as persistent safety concerns and other doubts about its mRNA delivery system threatened its entire product pipeline.   Fear caused by the pandemic crisis made those concerns largely evaporate, even though there's no proof they were ever resolved.   Alright. So   in this article,   she goes back to   she she points out a 2016   article,   published in   stat,   s t a t, by Damien   Gard or   Gardy.  

And that's the article I want to focus on, then we'll come back to Whitney's article there.   So this, again, 2016,   so almost 10 years ago at this point.   And the   article,   it's a very long article.   If I can figure out how to make show notes, it will be in the show notes. So you can check that out.   And, ego, ambition, and turmoil inside one of Biotech's most secretive startups.   Alright.   And this,   a large part of the article is focusing on just   Stefan   Bansal being a a terrible boss and kind of a psycho to work for. I don't really care about that.   So we're going to kind of focus on the actual   talk about their   their amazing mRNA products.  

At the center of it all is Stefan Bansal, a first time biotech CEO with an unwavering belief that Moderna Science will work,   and that employees who don't live the mission have no place in the company.   Confident and intense, Bansal told Stat that Moderna's science is on track, and when it is finally made public, that it will meet the brash goal he himself has set. The new drugs will change the world.   We'll skip over a little bit there. As he pursued a complex and risky strategy for drug development, Bansal built a culture of recrimination at Moderna. Former employees said,   failed experiments have been met with reprimands and even on the spot firings. They recalled abusive emails, dressing down at company meetings, exceedingly long hours,   and unexplained terminations.  

Lower ranking employees   said they've been disappointed and confused by Moderna's pivot to less ambitious and less transformative treatments. Moderna has pushed off projects meant to upend the drug industry and focus first on the less daunting   and most likely far less lucrative   field of vaccines,   although it is years behind competitors in that arena.   Then talks goes on to talk about how a bunch of money coming in, but not many actual products going out.   It's a case of Emperor's New Clothes, said a former Moderna scientist. They're running an investment firm, and then hopefully it also develops a drug that's that's   successful.  

Moderna just moved   its first two potential treatments.   Remember, this is back 2016. Both vaccines into human trials.   In keeping with the culture of secrecy though, executives won't say which diseases the vaccines   target, and they have not listed the studies on the public federal registry, clinicaltrials.gov.   Listing is optional for phase 1 trials, which are meant to determine if a drug is safe, but most companies voluntarily disclose their work.   Investors say it'll be worth the wait when the company finally lifts the veil.   We think that when the world does get to see Moderna, they're going to see something far larger in its scope than anybody's ever seen before, said Peter Kolchinsky,   whose RA Capital Management owns a stake in the company.  

Alright. Goes on, talks about how   talks about Bansal a lot.   He peppers his speech with Silicon Valley buzzwords, most of which are scrawled on a giant whiteboard in his office space. Messenger RNA   is like software, he explained. If it works in one disease, it should work for 1,000.   Well, that's an interesting premise. If it works in one disease,   it should work for 1,000.   But does it work for 1?   That's that's the question.   And,   interesting, the connection between   Silicon Valley and Moderna   back in 2016.   So this is   not a new a new connection. It's not like Silicon Valley just now got involved there.  

Get back get back down to the vaccine trial part.   First are the 2 vaccine trials for undisclosed infectious diseases.   Coming next   next is a one time treatment for heart failure developed in partnership with AstraZeneca,   followed by another experimental vaccine for Zika virus.   I remember Zika.   Which several other pharma companies are also working to develop. And after that, Moderna is planning a human trial of personalized cancer vaccine   using mRNA,   something it just came up with last year.   The choice to prioritize vaccines came as a disappointment to many in the company.   Yadayada.  

Alright.   This is   one of the main reasons I wanted to look at this article.   Delivery,   actually getting into actually getting RNA into cells,   has long bedeviled the whole field.   Not just Moderna, the whole field.   On their own, RNA molecules have a hard time reaching their targets. They work better if they're wrapped up in a delivery mechanism, such as nanoparticles made of lipids.   Lipid nanoparticles.   But those nanoparticles can lead to dangerous side effects, especially if a patient has to take repeated doses over months or years.   Novartis have abandoned the related realm realm of RNA interference over concerns about toxicity,   as did Merck and Roach.  

Now, as we're going to human trials, it's pretty clear no one else is going to catch us. That's one way to look at it. Moderna's most advanced competitors,   CureVac and Biointech   Biointech,   have   I believe they're the ones who worked with Pfizer,   have acknowledged the same challenge with mRNA.   Each is principally focused on vaccines for infectious disease and cancer,   which the companies believe can be attacked with just a few doses of mRNA.   And each has already tested its technology in 100 of patients.   I would say that mRNA is better suited for diseases where treatment   is for short duration is sufficiently curative,   so the toxicities caused by the delivery materials are less likely to occur, said Cataline Carrico, a pioneer in the field who serves as a vice president at Biointech.  

That makes vaccines the lowest hanging fruit in mRNA,   said Franz Werner Hass,   CureVac's chief corporate officer. From our point of view, it's obvious why Moderna started there.   So there's problems everywhere with that. Let's go back to,   Whitney's article   and kind of talking about those issues.   Concerns about the safety and efficacy of the company's products, which were publicly reported beginning in 2017,   17, evaporated in the wave of panic surrounding COVID nineteen and the simultaneous   warp speed race for a vaccine that would end the pandemic.   Yet, there is little, if any, evidence that these once well recognized concerns were addressed prior to the US government's emergency use authorization   of Moderna's COVID 19 vaccine and its now widespread use in many countries around the world.  

To the contrary, there is evidence that these concerns were covered up both prior to and during the development of its vaccine.   The reports that emerged in January 2017   noted that Moderna had run into troubling safety problems with its most ambitious therapy,   and the company was now banking on a mysterious new technology to keep afloat.   The ambitious therapy in question was meant to treat,   Crigler Najjar Syndrome and was to be the first therapy using audacious new technology that Bansal promised would yield dozens of drugs in the coming in the coming decade.   Bansal had specifically used   the Crigler Najjar therapy as a major selling point to investors,   particularly in 2016, where he touted it at the JPMorgan Healthcare Conference.  

Yet employees of Alexia on the company, co developing the drug with Moderna, blew the whistle on the project in 2017,   revealing that it never proved safe enough to test in humans, and that the failure of this therapy and the technology platform   it it sought to use   had been responsible for prompting Moderna to abandon the class of drug therapies that for years had justified its sky high valuation   and attracted 100 of 1,000,000 in investor cash.   As a result of the problem with Crigler Najjar, the Crigler Najjar drug, media outlets asserted that Moderna was now in need of a Hail Mary   that would keep its valuation from imploding   and its investors from fleeing.  

The specific problem Moderna encountered with the Crigler Najjar treatment was related to the lipid nanoparticle delivery system it was using.   According to former Moderna employees and their collaborators at Alexion,   the safe dose was too weak, and repeat injections of a dose strong enough to be effective had troubling effects on the liver,   the target organ of this particular therapy, in animal studies.   This was an issue Moderna had apparently run into with its nanoparticle delivery system in other cases too,   according to reports published at the time.  

Per stat,   the delivery system employed by Moderna had consistently created a daunting challenge. Dose too little, you don't get enough enzyme to affect the disease. Dose too much, the drug is too toxic for   patients. So that is   that was the issue with Moderna   products   2016,   2017.   That is still the issue today.   It doesn't matter whether you   do you tag AI onto it   or you, you know,   try to   use it to treat cancer as opposed to,   you know, COVID,   it's still toxic.   There's no evidence.   Obviously, if they had figured out a way to make it safe, they would talk about that.   So   this is a $500,000,000,   was it 500,000,000,000?  

500, I don't know. The   it's just all Monopoly money at this point. But,   I believe 500,000,000,000   going into this Project Stargate, it's an interesting name,   it's a dead end.   I I don't know. I mean,   Larry Ellison sounded sincere, like he thought this stuff could actually work.   But this is,   I mean, this is even more obvious than back in the COVID   time   when, you know, there were a lot of people saying, hey. The vaccine's not gonna work. And there's a lot of terrain theory reasons and just   problems with vaccines in general. None of them work.   We could move I'm sure we'll talk about that on later episodes. But,   you know, you   just because you want something to work or spend a lot of money on it or or tag AI   onto the front of it, it, doesn't mean it's gonna work. So this is,   you know, fairly obvious that it's not going to work.  

Are there other reasons why money's being poured into it? Is it a cover for something else?   Is it just intended to poison people, people the way the the COVID vaccines were? That I don't know. Open question there.   But I I   would like to thank everyone for listening.   This was episode 1. Maybe you   are listening to this in the near future. Maybe you went back   and heard some future episodes and are listening to episode 1.   So I I do appreciate it, and hopefully I will,   be putting some more stuff out relatively soon.   Again, thank you for listening.  

Have a great day, and   just remember, it's okay to be an anti vaxxer.