The mRNA Drug Industry Strikes Back
A Case Study in How Regulatory Capture Happens
Know your enemy.
Today’s essay focuses on the emerging mRNA drug industry, the DC-based lobbying organization that has been formed to support it, push its agenda and interests, and the DC allies that it is cultivating. This industry is the result of massive US government spending, advocacy, subsidies (both financial and regulatory), and promotion through propaganda and censorship. This industry spans academia through small biotech to large Pharma, and of course, big finance and Wall Street. To date, it has been enormously profitable. Like an insatiable spoiled child, it wants still more goodies.
Quoting Secretary Kennedy (May 14, 2025) “When I was a kid, NIH was the premier gold standard scientific institution in the world. Over the years, it was captured by industry.”
By taking the time to understand the “Alliance for mRNA Medicines”, its agenda and interests, how it is being built, and watching as it develops and deploys its propaganda and influence campaign seeking to influence President Trump, as well congressional members, you will gain insight into how the Pharmaceutical Industry has captured NIH, CDC, and FDA. Consider this a case study.
Lately, it has become quite the trendy thing for a subset of MAHA influencers to promote the narrative that the Trump administration is not serious about addressing the widespread malfeasance and harms associated with the COVID genetic “vaccine” products, and in particular, the pseudo-mRNA-based products.
In stark contrast to this divisive and counterproductive narrative, the new mRNA Drug academic-industrial complex is using terms like “existential threat” (ergo, threat of death to the industry) consequent to the appointments of new HHS leadership. In other words, influencers on one side are complaining that not enough is being done fast enough, and on the other side, this new industry seems to be running around saying that the sky is falling.
“This is an existential threat,” according to AMM executive director Clay Alspach, a principal at Leavitt Partners, a health-care consulting firm in Washington DC
Leading the response to this perceived threat to the emerging mRNA drug industry is the new trade industry organization called the Alliance for mRNA Medicines (AMM), which was formed in November of 2023. This lobbying and advocacy organization is headed up by Registered Lobbyist and Foreign Agent Mr. Clay Alspach, a principal at Leavitt Partners, a health-care consulting firm based in Washington DC.
The following is from Mr. Alspach’s corporate bio:
clay.alspach@leavittpartners.com
Former chief health counsel for the U.S. House of Representatives Energy and Commerce Committee.
Clay Alspach is a principal based in Washington, D.C. Clay specializes in health care policy and advocacy related to the Food and Drug Administration, health information technology, Medicare Parts B, C, and D, Medicaid, private health insurance, and the Affordable Care Act.
Prior to joining Leavitt Partners, Clay served as Chief Health Counsel for Chairman Fred Upton of the U.S. House of Representatives Energy and Commerce Committee. During seven years with the committee, he managed, provided strategic direction, and served as the principal representative for the committee on all of its health care-related work. Clay spearheaded legislative initiatives that successfully reformed the SGR (MACRA), reauthorized FDA user fees (FDASIA), and established a national system for drug supply chain security (Drug Quality and Security Act). Clay also led the committee’s legislative accomplishments on biopreparedness and security, public and private medical research, controlled substance and DEA matters, and several other public health initiatives. Most recently, Clay led the committee’s work on the 21st Century Cures Act.
According to Legistorm, Clay Alspach, whose full name is Robert Clayton Alspach, has been registered as a lobbyist/foreign agent. In DC parlance, the term “hired gun” might be used to describe Mr. Alspach's role in this endeavor.
In case you were wondering what companies and academic organizations consider themselves to belong to this new industry, below is the list, each hot-linked to further information. Notably absent are the University of Pennsylvania, Moderna and Pfizer. This lobbying organization currently employs at least 23 people.
A few weeks ago, I was contacted by a reporter from Nature (Elie Dolgin), who asked to speak to me about a new article he had been commissioned to write. With more than a bit of trepidation, I decided to talk to him. To my surprise and relief, my impression was that Mr. Dolgin was doing real journalism and was seeking some balance of opinion in his investigation.
This article was the result of his labors. Based on my prior experience many years ago working as head of business development for an early Bill and Melinda Gates-funded “non-profit” (Aeras Global TB Vaccine Foundation), I suspect that somehow the Alliance for mRNA Medicines provided support or incentive for Nature to publish this article.
Quoting from the Nature magazine news feature article, which you can read here:
The day after Donald Trump moved back into the White House in January, he celebrated a US$500-billion private-sector investment in artificial intelligence (AI) with a high-profile announcement in the Roosevelt Room. The new president looked on as technology billionaire Larry Ellison highlighted one of the initiative’s most transformative goals: using messenger RNA vaccines to transform cancer treatments.
By harnessing AI to analyse tumour genetics, Ellison explained, researchers could rapidly design personalized vaccines tailored to an individual’s cancer. “This is the promise of AI and the promise of the future,” he said.
Biotechnology executives were elated. Trump had, just five years earlier, propelled mRNA medicines into the spotlight through his signature effort to fast-track the development of a coronavirus vaccine. Now, just one day into his second term, he was once again elevating the technology to the national stage.
“Then the bottom fell out,” says Deborah Day Barbara, co-founder of the Alliance for mRNA Medicines (AMM), a trade group representing more than 75 companies and academic institutions that are advancing mRNA research, development and manufacturing.
A prominent vaccine critic who had vilified the mRNA-based COVID-19 jabs, Robert F. Kennedy Jr, was appointed to lead the country’s top health agency, and long-time champions of immunization science in the civil-service sector were shown the door. Research grants tied to HIV prevention and pandemic preparedness were abruptly cancelled, including many involving mRNA. And numerous other projects that were focused on mRNA vaccine technology were compiled into a list, potentially signalling their impending termination.
At the same time, legislators in several states have been pushing to ban or restrict the use of mRNA-based medicines for infectious diseases. None of these measures has become law, but the efforts threaten to destabilize the mRNA industry, creating uncertainty and potentially limiting patient access to emerging treatments.
The anti-mRNA sentiment — coupled with the sweeping shake-up of science funding across the United States — has sparked fears that this once-celebrated technology, widely seen as a major engine of next-generation vaccines and therapeutics, could soon find itself on the chopping block.
For AMM executive director Clay Alspach, a principal at Leavitt Partners, a health-care consulting firm in Washington DC, the message has been unmistakable: “This is an existential threat,” he says.
By mid-March, the AMM was holding regular conference calls to strategize. Members swapped intelligence, compared notes on delayed grants and tried to anticipate what might come next. Amid the uncertainty, a few questions loomed large: how far would the clampdown on mRNA go? Would it stop at COVID-19 jabs? Would it extend to all vaccines in development for influenza and other infectious threats? Or reach even into mRNA-based drug therapies in the works for cancer, autoimmune disorders, rare genetic diseases and more?
The initial meeting of the AMM has already been completed, and was held November 13–15, 2024 in Boston, MA. Notable keynote speakers included the two senior FDA personnel with direct regulatory responsibilities relating to this industry.
The second annual meeting is now scheduled for September 16-18, 2025
at the Coronado Island Marriott Resort and Spa, 1500 Orange Ave, Coronado, CA. You can find further information concerning this meeting here. Per AMM, the scope and structure will be as follows:
The Alliance for mRNA Medicines (AMM) brings together senior executives and top decision-makers in the mRNA industry to advance pioneering research into vaccines and therapies for patients.
The annual meeting, AMM ASCENT (Advancements in mRNA Science, Commercialiation, Education, and Novel Technologies), features one-on-one partnering opportunities for companies and investors, dedicated networking, keynotes and fireside chats featuring KOLs and industry visionaries, as well as engaging plenary and panel discussions among biotech, pharma, and academic leaders.
The AMM held lobbying meetings on Capitol Hill during September 2023. This AMM “sizzle reel” attached below documents that, at that time, they met with Director, Center for Biologics Evaluation and Research (FDA) Dr. Peter Marks, Louisiana Senator Bill Cassidy, and Kentucky Congressman Brett Guthrie.
Readers of this substack are familiar with the vaccine-industry-friendly concessions extracted from HHS Secretary Kennedy during the Senate Confirmation process by Senator Cassidy, and with the central role that Dr. Peter Marks has played in expediting and defending the mRNA platform and COVID “vaccines”.
Brett Guthrie is the U.S. Representative for Kentucky's 2nd congressional district. He has not held a specific policy position related to mRNA. However, he has been involved in discussions and legislation regarding healthcare and medical policies, including those that could affect healthcare providers and pharmaceutical companies involved in mRNA technology. For instance, he has been pushing for changes to Medicaid, which could impact the funding and availability of medical treatments and technologies, including mRNA-based therapies.
We should all be asking Senator Cassidy and Congressman Brett Guthrie whether their campaigns or affiliated political action committees have accepted any funding or support from the AMM. And specifically asking Senator Cassidy whether AMM lobbying influenced his actions during Secretary Kennedy’s confirmation process. The Senator’s contact information is linked above.
FDA Guidance for Industry Benefits the mRNA Drug Industry
During May 2024, the FDA issued a draft guidance for “Platform Technology Designation Program for Drug Development” which you can review here. The AMM sees this new regulatory position as a great opportunity for the mRNA drug development industry and has developed a summary of its analysis, which can be viewed here.
In a virtual meeting presentation focusing on the new FDA platform technology guidance, the Alliance for mRNA Medicines discussed the potential of mRNA product development, the benefits of platform technology, and the challenges associated with mRNA delivery. The panelists also discussed the implications of the FDA's draft guidance on platform technology designation, the potential of using a platform technology for various applications, and the need for broader understanding of who could be the sponsor. The conversation ended with an invitation for further discussions and the announcement of the registration for the annual meeting of the Alliance for mRNA Medicines.
Sara Singleton, Managing Director of the Alliance for mRNA Medicines, welcomed attendees and outlined the agenda for the webinar. The speakers included Andrew from Replicate Bioscience, Alana Goldberg from Replicate, Dave Schmickel from CSL, Bearing, Yi Zhang from Arcturus Therapeutics, and Sean Semple from Acuitas Therapeutics. The webinar aimed to discuss the history of mRNA product development, the promise of mRNA as a platform, the FDA's platform designation program, delivery technology, and AMM's comments on the FDA's draft guidance. The meeting also covered the implications for the future of product development and mRNA. Development of this guidance was required by the Congressional Pandemic Act of 2022. A transcript of this webinar, which includes insights into the current status of the industry and products in the pipeline is available at this link.
Top AMM Policy Lobbying Focus and Issues
Let’s take a look at the top policy issues and agendas that the AMM will be lobbying to address and advance.
AMM advisors plan to engage with governments, policymakers, regulators, and other stakeholders in North America, Europe, and Asia Pacific to advocate for the following policies that AMM asserts will encourage innovation, define regulatory standards, support manufacturing, and promote access of mRNA medicines to patients.
The text cited below has been lightly edited to remove misspellings.
Regulatory framework for vaccines and therapeutics
To realize the promise of mRNA across its many potential applications, AMM believes regulators should develop a specific regulatory framework for mRNA Why? The areas in which the field needs clarity for mRNA development and manufacturing are different than the issues most pressing for small molecules and other biologics (including cell and gene medicine). The development of a specific framework for mRNA would provide certainty for the community as well as help FDA as it they consider issues from pre-clinical to post-approval.
This regulatory environment would enable continued flexibility and speed in development of mRNA vaccines and therapeutics around the world.
AMM is also promoting international harmonization and cooperation among regulatory authorities across the globe to propel mRNA technology forward in all its potential uses and to move smoothly between discovery, development and deployment stages.
Interpretation: Essentially, AMM is striving to establish a globalized, frictionless business model for mRNA development, enabling them to expand into a worldwide market for their products. They are using the regulatory process to achieve this goal.
Standards Development
With some of the most recognized innovators in mRNA, AMM will help overcome the obstacles to mRNA medicine development stemming from uncertainty about standards. We are convening our members and partnering with relevant organizations to develop, where needed, or improve upon standards for the field.
Interpretation: Regulatory standards benefit large corporations, as a strong regulatory environment captured by big business keeps the competition at bay.
Education (combating mRNA vaccine misinformation and explaining mRNA therapeutics)
AMM is playing a role in combating mRNA vaccine misinformation and demystifying the technology by explaining how mRNA works. We are educating policymakers, payers, and the public about the great potential of mRNA across many different applications so that as they move from bench to bedside, there is greater awareness of it.
Interpretation: This is all about getting the government, insurance companies, and hospitals to foot the bill for these new products.
Access
As more mRNA based therapies and vaccines are developed, AMM will lead the field in communicating to government and private sector payers on access issues to ensure patients receive the benefits of these products.
Interpretation: Again, this agenda is to find a way for governments, insurance companies, and hospitals to pay for these very expensive treatments.
Pandemic preparedness
The versatility and agility of mRNA technology combined with the high level of coordination between industry and regulators enabled development, approval and distribution of the COVID-19 vaccine in record time. Looking forward, AMM is pursing development of a framework that will enable rapid deployment of mRNA vaccines for new pathogens as need arise.
Interpretation: More lobbying efforts are underway to integrate this technology into existing pandemic response technologies through the lobbying process, which involves giving money to Congress members.
Industry Website
I am often asked why there has been so much pressure to rapidly advance the authorization of mRNA drugs and vaccines. My standard answer is that the pharmaceutical industry sees this as a whole new unexplored area of pharmacology that can be exploited in developing and marketing new drug and vaccine products.
In other words, this is a gold rush.
When I first conceived the idea of using RNA as a drug in 1988, as the sole author, I initially published this concept in a small trade magazine called Focus after a patent disclosure in 1989. The article is linked here.
Vical, was the company that I then worked for in the early 1990s, and this company was once featured in the CIA-associated magazine “Wired” with the breathless headline that it would be the next Microsoft - due to the DNA and RNA technologies that I had pioneered. Under the direction of my old boss Dr. Philip Felgner, Vical turned away from mRNA as a platform and focused on lipid-based plasmid DNA delivery, spent well over a billion investor dollars, completely failed to bring any significant products to market, and went bankrupt. Felgner eventually landed a plum academic position at the University of California, Irvine.
Just for the record, I have never received any inquiries from this industry concerning my experience, observations and conclusions concerning the technology platform that I launched with my inventions and invention disclosures in the late 1980s while working on my PhD at the Salk Institute (pre-Vical).
But now this new industry hopes that the old “Wired” prophecy will finally come true. The truth is that they really don’t care if it is “safe and effective” as long as they all make a killing on the increased stock valuations and/or IPOs generated from the new bio-opportunities. And if the tech doesn’t turn out so well, then “pump and dump” is always an option. Either way, the biotech investors win.
If you wish to better understand how industry insiders see the issues and prospects that they believe are opening up to them, I recommend the following article authored by AMM staff member Deborah Day Barbara, and review the other articles at the “Advancing RNA” website.
Trouble in Pharmaceutical Paradise
Getting back to the Nature magazine news feature article quoted at the start of this essay, and which you can read here, despite all of the rosy projections, the fledgling mRNA drug industry is facing unexpected challenges. And these are the direct consequence of Peter Marks’ “Operation Warp Speed” (with a strong boost by biodefense spook Bob Kadlec and the notorious Dr. Anthony Fauci), which jammed the technology through product development, manufacturing and testing by bypassing almost all applicable regulatory hurdles and directly into the arms of much of the worlds adults, adolescents, children, and pregnant women with profound disregard for the consequences.
You might say that “the industry” is now being hoisted with its own petard. Returning to the Nature article, what jumps out is that there is neither acknowledgement nor even entertainment of the idea that the industry has destroyed its own credibility out of greed and its own mis- and disinformation about the technology and its risks.
Five years ago, the US government was spending billions of dollars to support the development, manufacturing and roll-out of mRNA vaccines, which played a major part in curbing the COVID-19 pandemic. Pharmaceutical companies were pouring in capital and building ambitious pipelines centred on mRNA. The technology was feted with a Nobel prize. Investor confidence was sky-high.
Now, in the span of just a few months, the mood across the industry has grown darker — chilled by a newly hostile political climate.
One contract manufacturer of mRNA products has seen a substantial decline in business as government-backed vaccine programmes have their funding pulled, according to a senior company executive. Another biotech executive says that his mRNA-focused company is considering relocating planned clinical trials for anti-viral vaccines to outside the United States — or scrapping them entirely, shifting the firm’s focus to less politically volatile therapeutic areas. “It’s all just a commercial and regulatory risk now,” he says.
Both executives requested anonymity to avoid drawing political attention to their companies — but their experiences reflect a broad upheaval that is now rippling through the industry. In a survey released this month by the AMM, nearly half of 106 senior biotech and pharma executives reported direct impacts from US policy shifts this year — including project downsizing, budget cuts, delayed investments, terminated partnerships, job losses, hiring freezes, and planned relocation of operations overseas.
Even the term ‘mRNA’ has become a political lightning rod; its charged connotations now influence scientific discourse and health policy far beyond the vaccine debate. “That paranoia has gotten wrapped into mRNA as a word,” says Jeff Coller, an RNA biologist at Johns Hopkins University in Baltimore, Maryland, who is also involved in several small biotech firms.
Seeking to reframe the narrative, Coller and others are mobilizing around a strategic communications offensive, emphasizing mRNA’s potential not just in thwarting infectious threats but also in treating many of the same chronic conditions targeted by Kennedy’s ‘Make America Healthy Again’ initiative. The campaign to rehabilitate mRNA’s reputation starts at the top: with appeals to Trump’s legacy as a champion of medical innovation.
AMM leaders are preparing to publish a series of editorials that make the case that Trump’s decisive leadership during Operation Warp Speed — the 2020 programme that delivered COVID-19 vaccines in record time — marked the beginning of a new chapter in biotechnology and positioned the United States at the forefront of what many see as the fourth great wave of pharmaceutical innovation, after small-molecule drugs, biologics and cell and gene therapies.
Framing it as a chance for Trump to cement his place in medical history, they are urging the president to build on the foundation that he helped to lay. In particular, they pointed out that, by supporting mRNA-based cancer treatments, he could achieve a major unmet goal that was advanced by his predecessor Joe Biden, who had made “ending cancer as we know it” a signature priority. Trump “could be the president who is a true visionary on cancer”, says Coller, a leading academic voice at the AMM.
Such messaging just might resonate. Although Trump criticized the roll-out and mandates surrounding the COVID-19 vaccines in the period between his two terms, allies say he remains proud of the part he played in accelerating the technology’s development. “President Trump believes that Operation Warp Speed was a roaring success, and that the COVID mRNA vaccines were his great achievements,” says Robert Malone, a scientist involved in foundational mRNA research and a high-profile voice in conservative-leaning health-policy circles.
“But leading the charge against mRNA technology are individuals in the ‘medical freedom movement’ — Kennedy chief among them. They contend that COVID-19 vaccines were rushed through approval without adequate long-term testing, alleging that safety corners were cut in the name of speed, and that the risks of mRNA platforms continue to be deliberately downplayed.
At his confirmation hearing earlier this year, for example, Kennedy — who previously described an mRNA-based COVID-19 jab as the “deadliest vaccine ever made” — persisted in claiming that the vaccine was recommended for young children “without any scientific basis”, despite published clinical-trial evidence to the contrary.”
Public-health researchers and vaccine scientists emphasize that mRNA vaccines have consistently demonstrated robust safety and effectiveness in preventing severe COVID-19 outcomes, supported by extensive data from rigorous clinical trials and real-world studies. Yet, with trust in institutions and in the biomedical establishment crumbling, some argue that pulling back from mRNA is the only responsible course of action — not because the science is flawed, but because the damage to public confidence is too deep.
“If mRNA has a chance to have impact in the future, there needs to be a restoration of public trust around it,” says David Mansdoerfer, a political consultant in Fort Worth, Texas, and a former senior HHS official in the first Trump administration. To that end, he, like many associated with Kennedy, would support federal regulators withdrawing approval for all COVID-19 vaccines that initially entered the market under emergency-use provisions — including the mRNA-based ones that later won full approval. Mansdoerfer advocates re-evaluating the jabs under a standard review process.
The problem of mRNA’s reputation isn’t just a communications challenge — it’s a systemic liability. “I fear the brand is damaged for most uses,” wrote Vinay Prasad, a haematologist–oncologist at the University of California, San Francisco, in a Substack post in March. A vocal critic of COVID-19 vaccine mandates under Biden, Prasad was selected this month to lead the division of the US Food and Drug Administration that oversees vaccines and other biological products.
The branding issue for mRNA is not just a problem in the United States either. An analysis of social-media data across 44 countries, published last year, found “widespread negative sentiment and a global lack of confidence in the safety, effectiveness and trustworthiness of mRNA vaccines and therapeutics”
For anyone interested in 2023, The Malone Institute compiled a list of nearly 800 peer-reviewed papers on the adverse events associated with the mRNA Covid-19 vaccines. That list could now easily be tripled. So, Nature may choose to overlook the adverse events associated with this technology, but the rest of us know better.
Of course, the magazine “Nature” is fooling itself, and maybe fooling its readership, but it is not fooling the new Commissioner of the FDA, as we reported in a previous substack essay or any of us in MAHA.
Transcript of FDA Commissioner Dr. Makary:
"Look, I'd love to see the evidence to show that giving young, healthy children another Covid shot, you know, a sixth Covid booster, would help them. But that evidence does not exist. And so, we're not just gonna rubber-stamp things at the FDA, and I don't think you're going to see a push at the CDC to be pushing Covid shots in young, healthy children.
That is something that's being discussed right now.
I think you're gonna see some announcement on that in the coming weeks, but I know they are trying to review all of the scientific data, and guess what? There's no data. There are no good randomized control data that the current version, the latest formulation of the Covid shot is necessary for young, healthy children.
Other countries have already recommended against it. Other, leading countries in Europe have recommended against it for young, healthy children.
So, I think you're gonna see this, and you're gonna hear something forthcoming."
FDA - Dr Makary on Real America's Voice
Lately, we have heard a lot from the nattering nabobs of negativity within the MAHA base. Secretary Kennedy has betrayed them, they say. Marty Makary is not moving fast enough. On and on. The vaccine injured must be heard, acknowledged, and somehow made right- they shall not be denied!
But get real. Do people really think that Secretary Kennedy is going to abandon this issue because - well, why? “Because the pharmaceutical industry has co-opted him?” Not likely!
Then said Jesus unto him, Put up again thy sword into his place: for all they that take the sword shall perish with the sword.
Matthew 26:52
The mRNA medicines industry exists because the United States Government, and in particular DARPA, DTRA, NIAID, USAID, and, in particular, Dr. Anthony Fauci, willed it into existence.
Now the worm has turned, and the carelessness, hubris, disregard for established regulatory and bioethical norms, and general sense of entitlement of the industry and its supporters have backfired, and champions have risen to defend the population from these entitled academics and biopharmaceutical industry types. The politics have shifted, and those who abused public trust are now running for cover.
As well they should. And who is it that they are most afraid of?
HHS Secretary Robert F. Kennedy Junior.
Let that sink in for a moment.
And then, the next time you hear someone blathering on about how RFK jr. has betrayed them, gently invite them to relocate to Canada. Because he is on the front line, taking the heat, and 99.999% of those detractors are armchair quarterbacking, and the majority of those are hiding behind pseudonyms.
DC politics is a blood sport. Just ask the President. And patience is a virtue. I have faith in Secretary Kennedy and his team to get the job done. Maybe you could consider joining me in that?
Yes the worm has turned. I remember when I found your sub stack years back Drs. Malone. I at that time felt isolated, how things have changed! The gangs of charlatans with complete disregard for the people came together, tried to silence the public, push their untested poisons, made billions and billions of dollars but ruined their reputations. Mark 8:36 and Mathew 16:26, “What shall it profit a man, if he shall gain the whole world, and lose his own soul?”For now whatever good that could have possibly come from their failed technology has been killed by their own greed, and their own actions. Truth has prevailed.
The AMM sounds a lot like the line from a Firesign Theater album in the 1970s: "Keep the problem in the pockets of the businessmen". I support RFK.jr and the humongous task he is facing. MAHA and MAGAs work is like trying to change the course of an oncoming freighter with a rowboat. I am amazed how much has been done already.
One thing that need to change is the immunity for liability the pHarma companies have. Then they might not be so willing to have shortened clinical trials and obfuscate data that they don't like in those trials. Right now trust is gone for most people in the whole medical field from the bottom to the top. I did not take the Covid injections, and I will never take an mRNA injection. The last several years have shown so many alternatives to what the medical system are pushing which is why my wife and I subscribe to substacks such as this one, Pierre Kory's, A Midwestern Doctor's Steve Kirsch's Jessica Rose's, Walter Chesnut's and other information sources.