Things Fall Apart; the Center Cannot Hold
Before the time of COVID, my wife and I had built a quiet life on a Virginia horse farm.
Both of our homeschooled sons were healthy and happy, had graduated from college, and were married. We had one grandchild. The farm and tractor were mostly paid off. We had homesteaded the place, starting with unimproved rolling hay fields purchased directly from the prior owner—no bank loans necessary. Beginning with an old office trailer, we had built up fences, power, well, septic, barn, and both a main and a guest house over five years. Run-down historic outbuildings were being renovated. Years of experience in rebuilding and landscaping small farms had allowed us to create a working operation, our own park and garden.
Our refuge is located in a sleepy Virginia county with about as many residents as before World War II, an hour and a half south of the traffic and bustle of the nation’s capital. Using American political slang, a red county in a purple state, stretching along the western side of the Shenandoah National Park. Internet access is a problem, and television requires a satellite dish. The historic farms of USA founding fathers Thomas Jefferson (Monticello) and James Madison (Montpelier) are only a short drive away. The first Lutheran church built in North America is two miles over the hill as the crow flies. Old established farming families control local politics. Trees pop up if no one mows the grass. Amish and Mennonite communities work nearby farms. Our Portuguese senior stallion was coming along nicely in his dressage training, we had a great string of brood mares, and homebred Australian shepherd dogs were our daily companions. My wife and I planned trips to the Golega Lusitano horse fair in Portugal and a horse competition in Texas. Price and availability of hay was a constant topic. Far from the madding crowd.
Together with Dr. Jill Glasspool, my wife and partner in all things for over forty years, I was maintaining a boutique medical research consulting practice that paid the bills. When we started our lives together, I was working as a short-order cook, farmer, and carpenter; she was a waitress, and we managed to work and pay our way through years and years of university training. This was our fifth small farm rebuild. Our primary challenges at the time consisted of business development, writing, reviewing, and executing contracts, and juggling the very different demands of the consulting business, the farm and gardens, and the horse-breeding operation. Occasionally I was asked to lead an NIH contract study section or review a manuscript for some journal, but that was just about all the contact I still had with the world of academia that I had chosen to leave almost twenty years prior. I had recently picked up a promising new Rockville, Maryland-based client that supported clinical research and regulatory affairs for Chinese pharmaceutical and biotechnology companies seeking to bring their products to the US market. Jill and I were trying to build a more international consulting practice and reduce our dependence on what often seemed like arbitrary and capricious US Government contracts, and we had planned and executed a series of actions toward that goal. It was a quiet and fulfilling life.
The Twin Towers, Pentagon, and anthrax-powder letter attacks had changed both the face of infectious disease research and my professional life as profoundly as had the advent of AIDS at the very beginning of my career. Shortly after the terror attacks, the Norwegian investors in the genetic vaccine company we had helped launch (Inovio) pulled back out of fear of US instability. We were left high and dry with neither clients nor academic appointment, so by necessity I joined a Department of Defense contract management firm called Dynport Vaccine Company (DVC) as assistant director of clinical research. At the time, DVC had recently received the “prime systems contract” for managing all advanced development (clinical and regulatory steps for licensure) for all Department of Defense biodefense-related drugs and vaccines. Little did I know when I took the job that Dynport’s majority owner, Dyncorp, ran one of the two main US-based mercenary armies; that the field of “biodefense” was about to explode; that my career path would be transformed forever; and that I would be catapulted into the shadowy realm that exists between academic biotechnology research and US government-funded infectious disease intelligence, surveillance, and threat mitigation.
While employed at DVC, I had the epiphany that if I really wanted to help people, I needed to leave the cloistered, backbiting, and self-aggrandizing reality of academic discovery research and embrace the world of advanced medical product development. The professional culture around me neither wanted nor needed more “academic thought leaders,” and the true unmet need was for people who understood both the wild west of discovery research as well as the highly regulated world of advanced development— clinical research, regulatory affairs, project management, and all that goes into making licensed medical products. If I really wanted to help people by enabling development and licensing of lifesaving treatments, I had to forget about the ivory tower world of academics and learn the skills necessary to help companies navigate the world of the Food and Drug Administration and the European Medicines Agency. So that became my new career path, and I threw myself into learning all that was required to meet this need. In the ensuing years I exceeded my goals by winning or managing billions of dollars in US federal contracts doing precisely that.
Over the years before COVID, Jill and I had developed a modest network of friends and professional colleagues scattered across the globe. This network was built from our consulting practice, from when I was working on US Government-funded biodefense and influenza vaccine contracts, as well as my prior days as an academic teaching pathology and molecular biology to medical students while doing bench research, writing papers, filing patents, and getting involved in various biotechnology start-up companies. And we had our horse friends of course. LinkedIn, Facebook, occasionally Twitter, and email correspondence allowed us to stay in touch with all of our friends and colleagues. Social media censorship and shadow banning was something that happened to people who lived in China—I could not imagine that it could happen to me. Jill and I simultaneously lived in two very different worlds that rarely touched each other; one in cutting-edge biotechnology and infectious disease medical countermeasure research, and the other immersed in horses, hay, orchards, farm equipment, construction, and the local feed store.
Somewhere between September and December 2019, a novel coronavirus entered the human population and began spreading like wildfire across the globe, turning my world upside down. Maybe it also transformed your life, too? If someone had written a letter describing my life today to the person I was before this outbreak, the old me would have concluded that the author specialized in (improbable) dystopic fiction and should probably be looking for another line of work.
Looking back, I am struck by how sheltered and naive I was (pre-COVID), and how much my worldview and my role in it have been radically shifted by subsequent events.
Will you take a memory walk with me for a moment?
Until COVID, I thought that free speech was a protected fundamental right guaranteed to all citizens of the United States of America by the Bill of Rights. Having been assigned core texts like 1984, Brave New World, Animal Farm, Lord of the Flies, and The Trial and Death of Socrates in fourth and fifth grade as a “gifted and talented” student in the California school system of the time, I believed there was no way anything like what was written in those books could happen here in the USA during the 21st century. Internet censorship and government-controlled propaganda were unfortunate things that happened to those who lived in the People’s Republic of China under totalitarian Communist Party control, but I had been born into a modern Western free society and had the luxury of watching this play out from afar. Social media was a tool that we used to chat with friends, sell horses (Facebook), write about the scientific issues of the day, and look for new biotech clients (LinkedIn).
Trained at one of the top clinically focused medical schools in the United States, Northwestern Feinberg School of Medicine, I believed that physicians were deeply committed to upholding the Hippocratic oath (principle of nonmaleficence), had freedom and responsibility to diagnose and treat patients as individuals, and were guided by a shared core of bioethical principles codified after the Second World War and incorporated into US federal law as the “common rule.” At the center of this training was the practice of taking a detailed history and physical exam, beginning with the “chief complaint”—uncovering the real problem that brought the patient to the physician. Patients had medical autonomy; and “informed consent” for any medical procedure was ethically critical. I knew that corporatized (and computer algorithm-driven) medicine was placing ever-heavier burdens on the daily grind required to maintain a clinical practice—an unfortunate reality that practicing physicians and medical care providers had to endure if they elected to work under those systems. But for my colleagues, there was always the option to leave for private practice. One edgy new frontier for clinical practice was direct payment to physicians, practicing in the new world of outpatient surgical centers, and “doc-in-a-box” group practices, somewhere between the local doctor’s office of my youth and an emergency room setting—thereby bypassing established hospital networks with their huge costs, kludgy bureaucracies, and massive burden of administrative oversight.
State medical boards were primarily in place to ensure that physicians and allied medical professionals met educational standards, provided patients with a high standard of care, and did not engage in overtly unethical practices or gross misconduct. Examples warranting medical board review or disciplinary actions included violations of the principles of nonmaleficence, beneficence, patient autonomy, or justice; violations of which would occasionally rise to the level of medical malpractice—usually by physicians who had developed a substance addiction. State medical boards were not generally involved in policing off-label prescribing practices of licensed drugs, or in terminating medical licenses unless a medical care provider was clearly mentally compromised or abusing the right to prescribe a medicine. I had never heard of a medical board policing free speech by a physician, whether it involved politics or prescribing practices. One example of disallowed medical practices that would trigger disciplinary action involved prescribing powerful addictive opioids without a compelling medical indication, typically leading to both patient addiction and high physician revenue. But most medical boards seemed hesitant to even discipline that behavior. Other examples involved physician compromise due to personal drug addiction or inappropriate sexual contact with patients resulting in an abuse of the patient-physician relationship. For those situations as well, the usual medical board intervention involved nothing more than a requirement for remedial training with a possible temporary suspension of medical privileges.
The current practice of “hunting physicians” by filing complaints with medical boards to withdraw their license to practice medicine for trying to help their patients with new therapeutic strategies, or for questioning the safety or effectiveness of a current medical intervention, was unheard of. Dissent and discussion within the medical community was a time-honored tradition with a long history of leading to improvements in medical care. Early in my career, I collected old medical texts as a way to remind myself of how far medical science had come, how far we still needed to go, and how frequently the deeply held medical treatment paradigms of different ages had been proven ineffective or even harmful. One practical consequence of these oversight policies was that for the preceding two decades, medical practitioners were consistently ranked the most trusted professionals by the Gallup Honesty and Ethics poll.
A key part of my consulting practice as a Maryland licensed physician and experienced scientist involved my deep experience in clinical research, with years of training in all of the related disciplines combined with three decades of practical experience in academic and industrial bench research, regulatory affairs, and clinical trials. As a requirement for being allowed to serve as a “Principal Investigator” for both federal biomedical research grants, contracts, and human clinical research trials, I had completed extensive and repeated coursework in medical and research ethics. A few years before, I had completed a prestigious fellowship at Harvard Medical School in Global Clinical Research as a Research Scholar, which rounded out my skills and training in clinical trial design, bioethics, epidemiology, clinical data interpretation, regulatory affairs, and biostatistics. During the winter of 2019, I was completing training for board certification in Medical Affairs, the term applied to the discipline of managing all communications between a pharmaceutical company, physicians, and patients, and for insuring compliance with rapidly expanding legal requirements. I was taking this additional training because so much of my consulting practice involved advising executive-level clients on a wide range of issues involving communication and medical affairs. Clients sought me out because of my deep understanding of FDA-compliant clinical research, my prior experience as an entrepreneurial bench researcher with many issued fundamental patents (including the initial DNA and mRNA vaccine patents from my early work while I was in my late 20s), and my extensive experience and understanding of vaccine and biodefense-related medical countermeasure development. And in particular, they valued my willingness to speak freely, forthrightly, and honestly about whatever issues that they wanted me to look into. Apparently, this has become a rare trait in modern business settings—particularly in the pharmaceutical business.
Late in 2019, working with a scientific friend and colleague, our consulting firm had been awarded a modest pilot subcontract from the Department of Defense (DoD) Defense Threat Reduction Agency (DTRA). The objective was to demonstrate the usefulness of combining the latest computer-based drug screening methods with high throughput robotics to test very large libraries of drug candidates and discover inhibitors of organophosphate-based biowarfare nerve agents. I had previously helped my colleague develop and win a large Department of Defense contract for building and staffing one of the “advanced development” antibody and vaccine production facilities that were built after the Obama White House had realized that the United States had lost much of its biologic drug manufacturing capacity to Europe, India, and China. The scope of work and approach that the DoD had funded was in large part an extension of a prior start-up company that I had founded called “Atheric Pharmaceuticals,” which had been focused on partnering with DTRA and USAMRIID (United States Army Medical Research Institute of Infectious Diseases) to use high throughput robotic screening technology to repurpose drugs for treating diseases caused by viruses such as Zika, Ebola, and Yellow Fever. We had great success in achieving the mission (patents were filed for use of hydroxychloroquine, nitazoxanide, niclosamide, and many others based on our work), but we also learned the hard lesson that the investors had no appetite at that time to fund drug repurposing for emerging infectious diseases and viral biothreats.
Then everything changed, first for me and our DTRA-funded research group, and then for the world.
I took a call on my cell phone on January 4, 2020, from a fellow physician who had been in Wuhan, China, for some unknown period of time via an academic exchange program with a Chinese university. Dr. Michael Callahan is a brilliant infectious disease and intensive care specialist with both a long history of working at the forefront of biodefense and medical countermeasure development as well as a faculty appointment at Harvard University. Many years before, he had been introduced to me as a CIA employee and key DARPA leader, but his status regarding the CIA as of January 4, 2020, was and remains unknown to me. Michael and I had copublished academic papers in the past (involving the Zika virus outbreak) during my Atheric Pharmaceutical days, and I knew that he was exceptionally well-connected with those who live in the edgy gray zone of global infectious disease outbreaks and the US intelligence community. Of course, he knew that I had previously succeeded in collaborating with leading scientists at USAMRIID, the nation’s biodefense epicenter, to identify repurposed drugs active against the Zika virus. Michael called to warn me that there was a new coronavirus on the loose in Wuhan, China, and to recommend that I get my group spun up to apply our tools, skills, and knowledge to address this new biothreat.
And with that fateful call, our quiet lives on our Virginia horse farm were completely transformed.
Jill and I had been at the forefront of so many of these outbreaks in the past: HIV, the Anthrax spore events, influenza virus (multiple times), West Nile, Ebola, Zika, etc. Our initial response to the alert call from Michael Callahan was a reflexive “here we go again,” with a topper of “time to get going.”
Having a proven ability to make a difference is both a gift and a curse. Chaos reigns early in a potential infectious disease pandemic. As if God’s hand were guided by the words of Shakespeare’s Mark Antony: “Cry ‘Havoc!’ and let slip the dogs of war.” The onset of war is the proper metaphor, and the fog of war descends over everything. For those at the tip of the spear, it gives rise to an addictive sustained adrenaline rush like no other, coupled with constant risk of going overboard if you lose perspective.
Once again, we got to work. Jill is very local community-oriented, and she poured her heart, mind, and soul into writing a kind of survival manual for those at risk and self-published the book via Amazon. An avid reader, she had become a big fan of self-published books and her Kindle. I threw myself into getting the team assembled for the DTRA project spun up and providing direction by diving into the coronavirus literature and selecting a specific protein target to apply the repurposed drug discovery/computational docking tools to. I helped Jill with her book by collecting and expanding some of the thoughts and comments I had been posting on LinkedIn to create content about the virology and immunology and assisted on editing the text. We worked like demons, side by side, day after day, and she was able to self-publish during the first week in February 2020. Within a mere five weeks, she completed the first edition of Novel Coronavirus: A Guide for Preparation and Protection.
Meanwhile, I got my scientific research group motivated, energized, and activated to volunteer their time, skills, knowledge, and abilities to try to discover repurposed drugs able to act as inhibitors of the critical SARSCoV-2 protein known as the papain-like protease, otherwise known to virology experts as the 3-chymotrypsin-like cysteine protease (3CLpro). When the sequence of the “Wuhan Seafood Market Virus” was uploaded to the NIH sequence database, I applied computer software tools developed at UCSF to model the structure of that protein based on publicly available (previously published) crystal structures of the closely related 3CLpro from the SARS coronavirus. With SARS, this protein had been one of the leading antiviral drug targets, so it was reasonable to apply what had been learned with SARS to this new coronavirus. A specific region (binding pocket) of the protein had already been identified for drug development for the original SARS virus. Digital libraries representing detailed models of all known licensed drugs and nutraceutical compounds were obtained. Different software tools were then used to virtually dock each drug into the binding pocket of the modeled 3CLpro, resulting in a ranked list of possible inhibitors, which we then compared to the known safety profile and pharmaceutical characteristics of the leading drugs. This began a monthslong process of testing, refinement, and retesting to optimize a list of drug candidates for further testing as antiviral compounds in the “real world.”
Jill’s book was published February 11, 2020, with a plan to constantly update the editions as more data and information became available. We hoped to create what is known as a “living document” that would be updated as the pandemic evolved. There were no other books available at the time that had been written by medical and scientific professionals. Most people were still unaware of what they were about to be hit with as the virus made its way into Italy, the rest of Europe, and then the United States.
As more and more people became aware of the threat posed by this novel coronavirus, the book began to sell. Although sales were modest, charts from the Kindle Direct Publishing website showed steady increases in February and March. The Amazon reviews were all five stars, and Jill felt a strong sense of pride. Her first book!
Little did we know we were about to encounter the new reality of government-corporate cooperative censorship, which would become a major theme throughout the entire history of the COVID-19 public health event.
Jill’s book was censored by Amazon. No explanation, no appeal. When we went to upload the most current edition in March, we received messages stating that Kindle Direct Publishing was “experiencing a temporary delay in publishing some titles.” On the phone we were told this was a normal delay due to lack of editors.
We then received multiple messages, stating that the book did not meet “community standards”—which many of us have come to recognize as the standard phrase used to justify censorship in the time of COVID. We spoke with multiple people at KDP, who assured us that the reviewers would speak to us about why, as that was standard Amazon policy. That usually such problems could be worked out.
A few days later, people at Amazon told us by phone that the reviewers would not speak with us and that the book didn’t meet community standards. They stated they did not know the reason the book was banned, and they were “very sorry.” Multiple phone calls produced the same results. They refused to pass on our wish to speak with a supervisor, and they refused to answer our questions. At no point did we lose our temper or raise our voice. They just refused all inquiries and stated that the reviewers did not wish to speak with us. We could find nothing in the “community standards” statements that applied to anything we had written.
And at that moment, we knew that something very dark was happening, something we had never seen before. Little did we realize that this was just a very early example of what was to become a large movement over the next two years, a global movement involving collusion between government, corporatized legacy media, social media, big technology, big finance, and nongovernmental organizations to completely control and shape all information and thought concerning the public health response to the novel coronavirus.
Publications and social media posts about the coronavirus began being removed from all over the Internet. Although the original intent was to remove books that promoted “snake oil,” or were out to make a quick profit, this censorship quickly turned into something far more insidiously dangerous. That is, books that didn’t share the messaging of the US government were removed. Amazon represents the biggest bookseller in the USA. When Amazon censors reading material—where does this leave us as a nation? Apparently, the government believed that we as a nation must give up our precious freedoms of free speech and a free press due to declaration of a public health emergency. I will write it as clearly as I can: censorship and its “big brother”—propaganda—is not the answer.
The ramifications of these choices by our government to censor, lie, and obscure will go down in history. If the truth-tellers—scientists, writers, journalists, and authors—are not allowed to document the true story, a revisionist history will emerge. The alternative history being provided by the US government and promulgated by tech giants will allow such outbreaks to occur more easily in the future and allow those who failed us to remain in control of our governmental functions.
In the short span of three months, Jill and I had gone from a peaceful life on our farm, to receiving an alert from an American physician and intelligence operative operating in a region of China that I had never even heard of before, to self-publishing a modest guide for preparing and protecting yourself from the coming wave of infection, to directly experiencing the effects of an emerging Orwellian collusion among an international nongovernmental organization (WHO), a US Government (which appeared to have casually cast aside the First Amendment enumerated in the Bill of Rights), and the largest bookseller and retailer in the world.
I am often asked, “What made you decide to speak out about what you saw going on during this ‘pandemic?’” I have been told that I have become radicalized (by Steve Bannon, no less!) or “red-pilled” over the ensuing many months. The truth is, my quest to understand how, why, and by whom this global public health event has been weaponized against all of us began with a simple and inexplicable book banning. Many have since reviewed Jill’s book looking for some subtle offense and found nothing. The incredible effort and work product of my treasured wife and companion had been taken from her and thrown away with neither rationale nor explanation.
As time went on, it became clear to me that the World Health Organization, as well as senior members of the US Government Department of Health and Human Services, were repeatedly lying to the world. Almost daily, the official “leaders” speaking to the world, using the megaphone of mass media, were substituting their own personal opinions and biases for what was being presented to the general population as fact or data-based information. The phrase “Follow the Science” became a global joke, compounded by the amazing self-own statement of Dr. Fauci in which he told MSNBC’s Chuck Todd during June of 2021 that attacks on him were “attacks on science.” I began feeling an almost overwhelming sense of vertigo while struggling to find truth in the middle of this sea of mis(mal?)-information, “factcheckers,” gaslighting, defamation, and chronic falsehoods. Then, while I was participating with other physicians in an effort to support two of our colleagues who were being threatened with loss of job and medical license for merely voicing concerns about the genetic vaccines and support for early interventions with repurposed licensed drugs, I was presented with an amazing document titled “The Malone Doctrine.” The authors told me that they had listened to everything I had said in my various public statements up to that point, had read everything I had written, and had developed a declaration based on the “white space between the lines” of all that I had spoken or written. They asked us to read and sign the declaration that they had prepared.
As Jill and I began to read their work, a smile crept across each of our faces and grew into outright joy. This was a first step toward recovery from the trauma and darkness that so many of us were experiencing. A new dawn. At that moment, we began to see the outlines of a better future coming, a future worth fighting for.
The Malone Doctrine
A Declaration of Independence
From the Decisions of Institutions That Lack Integrity
We the Undersigned:
Demand that all underlying data that contributes to a body of work under consideration must be made available and must remain accessible for analysis.
Proclaim the value of knowledge to society is not determined by any given creator of information. Instead, that it is the beneficiaries of knowledge who assign value to a proposition only through thorough critique and relentless scrutiny.
Establish the free and open exchange of information and establish as a duty the authority to serve as the custodians of all data forming the basis of our decisions.
Require the full disclosure of all sources of funding regarding any citation noted or references made pertaining to any matter under consideration.
Commit to impartiality in consideration of all analytical information and data brought before us and expect the same from all others.
Foster rigorous open debate and scrutiny in consideration of and for any matter of concern.
Shall promptly make the discovery of intellectual dishonesty or professional irresponsibility known to all.
Ensure the health, welfare, and safety of any whistleblower, bringing forth and/or making public an abrogation of the beliefs held herein.
Stand in opposition to censorship and will not accept representations of parties holding within themselves values that conflict with principles of free expression.
Deny no person the right to challenge, debate, petition, redress, examine, or protest with facts and evidence any decision of this body.
In one sense this book documents a personal journey, a long effort to get to the bottom of the fundamental questions that have dominated every waking moment of my life ever since. It includes a series of essays composed during late 2021 through 2022, each of which addresses some aspect of the enormity of what we have all experienced. Who is responsible for all the globally coordinated propaganda, information management, mind- control efforts, lies, and mismanagement we have experienced? How has it been globally coordinated, and what can we do to stop this sort of thing from ever happening again? What are the root causes of this incredibly dysfunctional “public health” response that frequently seems to have nothing to do with public health? Has there been a truly nefarious agenda, or is this dysfunction merely the unintended consequence of interactions between separate, random events amplified by incompetence and exacerbated by hubris?
During this journey, I have seen, experienced, and learned so many new things, met so many people, made many new friends, and listened to so many stories. What follows in this volume is an attempt to process and comprehend the incomprehensible human tragedy and horror of what has occurred during this “pandemic,” and to find some path forward that could lead to a better future for all of us. A future that will require people who still believe in the core principles that form the bedrock upon which Jill and I have built our lives: acting with integrity, respecting the fundamental dignity of other human beings, and making a commitment to community. The principles that formed the foundation of the American Enlightenment, resulting in the US Constitution and Bill of Rights.
I am firmly committed to a belief that the American experiment in self-governance, forged in another crucible, the tyranny of a mad king, remains relevant today. I reject the twisted logic of those who assert that these principles are obsolete, antiquated, and must be replaced with a system built upon a collectivist and globalist totalitarian vision, a system of government and command-and-control economic activity that have consistently failed every time they have been tried throughout history.
Jill and I have lived our lives as free and honest people. It has not been an easy path to walk, but as we begin to approach the end of our journey, we would have it no other way. This commitment and belief system form the subtext that is woven throughout the following chapters. A commitment to integrity, dignity, and community, tempered with empathy, offered without apology.