The original invention of the use of mRNA for drugs and vaccines

From: Jill Glasspool Malone, PhD, President, RW Malone MD LLC

Friends and colleagues:

I am writing to you to ask your assistance in helping to correct a misrepresentation in the mainstream media news - one that is essentially fake news. This in regards to a series of newspaper and scientific review articles about the discovery of mRNA vaccines. I write in the first person because I have been a direct witness to these many events.

By way of introduction, Robert Malone and I have been married for 42 years. Through ups and downs, good and bad, we have always been partners. Is this unique? No. Many people find a life partner; work and play together as a team. What maybe is unique is our commitment to working together for the betterment of society. I am very lucky. Robert is brilliant. More than brilliant – he is someone that can take facts and use them to see into the future. Pattern recognition. As a life partner, I am vigilant in my protection of Robert – both of his reputation, his health and as a person. It is with that sense of needing to help shield him that I write this letter. Our careers are as independent researchers; we don’t have the luxury of an academic institution. There is no infrastructure behind us to place articles, apply for awards and provide institutional support. Our consulting business and our philanthropic research relies on our support of each other, what we have built, and the revenue that we generate through our consulting practice. As most of you know, Robert is a highly accomplished scientist and a foremost expert in RNA technologies and clinical trials development. I write this letter as a way to help tell our friends about a great wrong that has been done to Robert.

As a young scientist, Robert saw into the future. He saw the future of RNA as a drug in 1987. Then in early in 1988, he foresaw the future of the use of mRNA for vaccination, as well as DNA vaccination. He did this in the worst of situations. As a graduate student, without support of his thesis advisor and being in an abusive work/student environment.

But this letter is not about that period so much as now. However, a little back history is needed.

Robert is the inventor of mRNA vaccination and the use of mRNA therapeutics. The documentation is clear, as is the patent record. In 1986, while at the Salk Institute/UC San Diego as a MD (Northwestern)/PhD (Salk/UCSD) student, Robert worked with RNA for his dissertation. His work with RNA had actually begun much earlier while he was working at UC Davis in 1983. That experience taught Robert how to work with RNA and keep it from degrading, at a time when very few scientists were working with RNA. At the Salk, his early work included structure and modeling analysis, but it soon expanded beyond that. In 1987, he invented lipid mediated mRNA transfection and in 1988 at the Salk, he confirmed those results in-vivo. But the situation in the lab was not healthy. The harassment got to the point, where Robert literally was diagnosed with severe PTSD from abuse at the hands of his thesis advisor and institutional attorneys. He knew he had to abandon his PhD, take a masters degree, and go back to Northwestern to finish his medical degree. His thesis advisor was Dr. Inder Verma, whose behavior abusing women and his employees is now legendary and well documented in both the scientific and lay press. In retrospect, the lack of support by the Salk and UCSD is typical of what they did with anyone who complained about Dr. Verma - they made it go away. At the time, the Salk was referred to as “Inder’s Institution.”

Robert left the university knowing that what he had invented would change the world someday. That he has never doubted.

Patent disclosures and a patent application were written and eventually filed on 3/21/89 for these technologies by the Salk. This included not only RNA transfection (RNA as a drug), techniques to stabilize the RNA and increase production. Vical patents filed on the same date include the use of mRNA for vaccination purposes. This patent application be found here. The disclosures and other documents can be found here. Once it became clear that he would be leaving the Salk/UCSD, he stopped filing disclosures. So, he held on to the idea about RNA vaccination until he left the Salk. I have journal entries and he spoke with others about these ideas, so there is some documentation regarding this timeline. This work culminated in a PNAS paper.

When he left, he brought his research, reagents, DNA constructs, RNA constructs, and all the knowledge of these systems that he pioneered, including the use of the luciferase reporter gene with him. He ported them all into a small startup company called Vical. He didn’t really have any other option financially but to take a job at Vical. It wasn’t ideal but we were starving students and had been for over a decade. However, big promises were made by his supervisor (Dr. Philip Felgner) about freedom to continue his research uninterrupted, which was critical to him. He knew that he had to go back and finish medical school, this was just an interim gig to support us and to prove that his discoveries worked, and to continue his research while I finished my BA. For Robert, the only thing that mattered was the science. Not the money, not the fame. It was about saving the world.

Long story short, as the only employee at Vical working in gene therapy and then immunology, he sat down and disclosed all of his ideas for gene therapy and maybe more importantly for mRNA vaccination. He did this almost as soon as he started at Vical. Most of these documents are available on our website. His supervisor at the time, Dr. Felgner then over-signed some of the disclosures on top of Robert’s signature as a co-inventor. Then, because Vical did not have vivisection facilities, a collaboration had been set up by Dr. Felgner with the University of Wisconsin to do the animal studies. Robert sent reagents, DNA, RNA and instructions to the researcher there (Dr. Jon Wolff) via FedEx and animals were injected. The rest is history. “Naked” DNA and mRNA delivery, Science publication, and blowback that this was a fake finding akin to “Cold Fusion”. Time has proven that it was all true, correct, and highly reproducible.

Robert then wrote more patent disclosures, which included more on RNA vaccination and stabilization. Vical set up talks with the Salk to license Robert’s technology. These Vical patents all have a priority date of 3/21/1989. Important because this is also the date that the Salk filed their patent, demonstrating that the Salk and Vical were working together in this. At that point, Robert was assured that Vical would license the Salk patent – as this was prior art.

As Robert’s supervisor soon took credit for much of his inventions, it was almost immediately clear that this short-term solution was just that and was not sustainable. In August 1989, Robert went back to Northwestern to finish up medical school. He continued to support/consult for Vical without pay. He helped design the animal studies to prove that polynucleotide (DNA/RNA) worked in animal models.

These experiments were conducted in 1989 and 1990 and there is documented immunologic data embedded in the patents. Another experiment showed clear antibody responses with viral challenge. THESE ARE THE FIRST mRNA vaccine experiments. These experiments are written out of history by the newspress.
But more than that, the actual data that was sent to the USPTO can be found on the webpage (links to the PDF).

This seminal work, which occurred over five years (1986-1990), is what has spawned the mRNA vaccination technologies now saving the world from COVID-19. There are papers and TEN issued patents, all with a priority date of 3/21/1989. THOSE PATENTS INCLUDE claim mRNA vaccination. The data include an experiment documented that NEF (an HIV protein) mRNA vaccination in mice, followed by HIV challenge reduced positively stained cells by 2-fold and p24 expression was reduced by 50% at eight weeks. There were vaccines studies to support the patent claims of mRNA vaccines. The record is crystal clear.

For more on this topic and to view the papers and patents, click here and scroll down this webpage.

So, Vical and the Univ of Wisconsin originally took credit, cutting Robert out of the writing of the papers, as soon as he resigned. Then Vical licensed the technology to Merck and Merck set up an agreement whereby Merck scientists would repeat the experiments and then took credit for the DNA/RNA vaccination discoveries. Literally, Robert’s work was given to someone else to claim as their own.

BUT… Vical and Merck didn’t have the expertise to make RNA after Robert left. Robert had pioneered tech to increase RNA production yield; these protocols came off of his bench. Without Robert there, Vical couldn’t make RNA and we have been told, neither could Merck. Remember this was the early 1990s, Robert had spent a decade perfecting his techniques working with RNA. This was not a fluke or “one-off,” this was a solid research platform that he had created de-novo.

The main reason why mRNA vaccines took an additional 30 years to develop was that these original patents were used by Vical and Merck to block development and commercialization of mRNA vaccines by any other company. They did this even though they had chosen to only develop DNA vaccines. These original mRNA vaccine patents comprehensively disclosed and therefore blocked any others from developing and commercializing an mRNA vaccine until the patents expired.

All this said, this mRNA vaccine discoveries were so amazing, Robert’s passion for the work so far reaching, that the ideas still pour out of him when discussing it. It is this enthusiasm and curiosity that make it so fun to be around Robert and what drives people to want to work with him. When working on a project, it is always about the project, the science, the problem to be solved. Egos are left at the door.

The work at the Salk, at UCSD and at Vical was always about collaboration. Ideas, discussions, writings, editing, data, reagents, constructs – freely made, given and exchanged. That is when science is set free. When minds share – develop, expand, evolve ideas, generate hypotheses. This is what drove Robert and I then and now. So many people worked on developing mRNA technologies and mRNA vaccines. Long after Robert left Vical, he still collaborated with people there. That is how good science works. It is what kept him tethered to Vical. Frankly, it is one reason why he never pursued legal counsel in all of this. It is why he was consulted on data, why Dr. Gary Rhodes, who carried out the initial mRNA vaccination studies, later worked with Robert in the 1990s at UC Davis. Science is one of the highest callings for man. There is always more to know, more to discover.

Over the coming decade, Vical pressured Robert to stop work on mRNA therapies and vaccinations. Cease and desist letters, phone calls were made. Grants were blocked by people at Vical sitting on peer review committees at NIH. I lived it with Robert. This happened. Much of it is documented and we have that documentation.

Fast forward 30 years…

So, imagine how disheartening it is over the course of the last year, to see others take credit for his work in the lay press. First a well-placed article in STAT news. Then a New England Journal review article, written by University of Pennsylvania, extolling their researchers as being up there with Edward Jenner due to their discoveries of mRNA vaccines. Other national newspaper stories followed suit. Any complaints that the news stories were not accurate, were stone walled. It felt like the fix was in. Then to see this article as the headliner by CNN this week was extremely upsetting:

Vaccines

“The story of mRNA vaccines dates back to the early 1990s, when Hungarian-born researcher Katalin Kariko of the University of Pennsylvania started testing mRNA technology as a form of gene therapy….
Kariko was unable to drum up much interest in this idea for years. But for the past 15 years or so, she's teamed up with Dr. Drew Weissman, an infectious disease expert at Penn Medicine, to apply mRNA technology to vaccines.”

This very long CNN article extolls the “discoveries” by Katalin Kariko, while at the University of Pennsylvania and then BioNTech. Unfortunately, this is just another egregious but highly successful endeavor whereby Dr. Kariko is cited as having invented these technologies. Because after interviewing her, the reporter somehow came away believing that she invented mRNA vaccination! Oh, but now her fame grows, with this article strongly suggesting that she also invented RNA as a drug! Each article becomes more strident in these assertions. Google “mRNA vaccine inventor” and guess whose name comes up, with her own Wiki page and all. Wiki… yes, wiki is all about her also. This publicity didn’t happen in a vacuum. This is an active campaign by institutions to sway public opinion and to convince a very large, international awards committee that Dr. Kariko is deserving.

So, what does one do when someone’s work is not cited, when they are erased from history?

It turns out there is nothing one can do. When a national newspaper gets it wrong, over the course of months – they won’t correct it. Even if one goes to the editor, the magazine, the newspaper or the journalist. Even if one writes about it on social media, etc. Yes, I and to some extent, Robert did all that. I have written, begged, pleaded, informed – all to no avail. Basically, we hit a stone wall. Either journalists denied it (“well, I said “others” worked on these technologies”) or we were ignored. For instance, the New England Journal of Medicine 175 word letter of rebuttal that Robert wrote about an article written by a professor conflating Jenner with Dr. Kariko. The rejection letter below:

With time, each article seems to get more and more exaggerated about the Dr. Kariko “discoveries.” The more this gets cited as truth, the more embedded it becomes in the web.

So, why am I writing this?

I guess at the very least to set the record straight with our friends.

This was and is Robert’s work, his passion. He is thrilled that all these technologies are working. He is thrilled for his part in that. He freely credits that other people have worked to develop this. And there are lots and lots of people! But to have poured his heart and soul into this – decades of work and to have someone else get credit for his work in the national press is demoralizing and disheartening. As this isn’t the first time, credit for his work has been taken from him, it literally makes me panic. To note, Dr. Kariko has responded to us and admitted that she did not make these discoveries, only “improvements” to the technology. Improvements, which many companies, like CureVac are not even using. Dr. Kariko now refers to a term that Robert coined and used in the patents- “transient gene therapy” to describe her early work - showing that she is well aware of prior work. She says that she tells reporters that “many, many” people helped make these discoveries, but “they don’t listen to her”… Which reminds me of the quote:

“A truth that's told with bad intent

Beats all the lies you can invent.”

― William Blake, Auguries of Innocence

We literally have nothing to lose in this. Robert never received the money that Vical owed him. Heck, they never even admitted to owing him anything but a silver dollar. They never licensed his work from the Salk. The Salk dropped the patent applications without telling him. Vical threatened Robert with “cease and desist” letters, if he continued working in the field commercially or if he helped a commercial company with these technologies. We never were able to capture a single NIH or government grant for this work. This all happened thirty years ago, it is a terrible but old story. One that Robert likes to forget. It is not worth dredging up.

But now, we kind of have to.

So, I write this to our friends. Understand that Robert is grieving. He invented the field of mRNA vaccination and the use of RNA as a drug. But the credit goes to others. This is painful. It is the erasing of an important part of his life’s work.

As someone who has been supporting him in this endeavor for eons, I know what developing these technologies has brought us. It is the opposite of what one might think. The legacy of these technologies for us has been: abuse, poverty, angst and being disempowered. From there, Robert and I have built successful scientific careers, but it has not been easy and there has been no institutional support.

To move on, Robert will most likely stop writing and speaking about it. This is his way. He is embarrassed to “make a fuss.”

I am not. I know that the American media has a “poster child,” in Dr. Kariko, who is actively being promoted to win a Nobel. There is a campaign going on. I know that Robert has no institutional support, no one to nominate him and no one nominated him (nominations were due in Feb). So, Dr. Kariko, BioNTech and the University of PA do not have to worry. She has no competition from these quarters. She most likely has won. But her win must be cheapened by the fact that that she did not invent these technologies, that the campaign to promote her has misrepresented her contributions to the field, with the press having been misled into believing that she these discoveries came off of her lab bench. But the truth is, they didn’t. The fundamental discoveries and invention of mRNA as a drug and for vaccines were completed, disclosed, published and patented before she began her work.

Thank you for reading through to this point. I hope you will add your voice to those who speak the truth about this.

But in the end, I am afraid that the reality is…

“If you tell a big enough lie and tell it frequently enough,

it will be believed.”

― Walter Langer