The Way We Were

Guest Post by Doctor Robert Malone

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, were married, and we had one grandchild.  The farm and tractor were mostly paid off.  We 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 that was also a park and a garden.  Our own private Galt’s gulch.

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 bustle of the nations’ capital. Using American political slang, a red county in a purple state, stretching along the northwestern 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 in North America is two miles over the hill as the crow flies.  Old established farming families control local politics.  Trees pop up when no-one mows the grass. Amish and Mennonite communities work the land. Our Portuguese senior stallion was coming along nicely in his dressage training, we had a great string of brood mares, and home-bred Australian Shepherd dogs were our daily companions. Travel planning consisted of trying to figure out how to budget a trip to the Golega Lusitano horse fair in Portugal or attend a horse competition in Texas. Price and availability of hay was a constant topic. Far from the maddening crowd.

Together with Dr. Jill Glasspool, my wife and partner in all things for over 40 years, I was maintaining a small boutique medical research consulting practice that paid the bills.  We had started our lives together when I was working as a short order cook, farmer and carpenter; she as a waitress, and we have managed to work and pay our way through years and years of University training. This was our fifth small farm re-build.  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 had 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 decades before, after the twin towers came down. 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. We 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 this seemed like a great step in that direction. A quiet, fulfilling, intellectually and physically rewarding peaceful life.

The anthrax powder letters had changed both the face of infectious disease research as well as my professional life as profoundly as had the advent of AIDS at the very beginning of my career.  Shortly after the attacks, when the Norwegian investors in the genetic vaccine company Inovio we had helped launch pulled back out of fear of US instability, we were left high and dry with neither clients nor academic appointment, and of necessity I had joined a Department of Defense contract management firm called Dynport Vaccine Company (DVC) as Assistant Director of Clinical Research.  DVC had recently received the “prime systems contract” for managing all advanced development (clinical and regulatory steps for licensure) of all Department of Defense Biodefense-related drugs and vaccines.  Little did I know that DVC majority owner Dyncorp ran one of the two main US-based mercenary armies, that the field of “biodefense” was about to explode, my career path would be transformed forever, and 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. I came to realize that the world really did not want 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 and regulatory affairs.  If I really wanted to help people by enabling development and licensing of life-saving treatments, I should forget about the ivory tower world of academics and focus on learning 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 and developing all that was required to meet this need.  In the ensuing years I exceeded my hopes and ended up winning or managing billions of dollars in US Federal contracts to do 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. Linked-in, Facebook, occasionally Twitter and email correspondence allowed us to stay in touch with all of these. We both lived in two very different worlds that rarely touched each other, one involving cutting edge biotechnology and infectious disease medical countermeasure research, and the other one 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, began spreading like wildfire across the globe, and turned my world upside down.  Maybe it also transformed your life also? If someone had described my life now to 2019 me, I would have assumed that they were a marginal Science Fiction writer specializing in dystopic cyberpunk.

Looking back, I am struck by how sheltered and naïve I was then (when viewed through the lens of my experiences since COVID struck), and how much both my worldview and my role in the world has been radically shifted by subsequent events.

Will you take a memory walk with me for a moment? 

Until the time of 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 that 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, 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 clients (Linked In).  I had been active on Twitter during the prior Presidential election but stopped using it because it just took up too much time and did not seem to be helping with my daily life or business.  I thought that CNN, the Washington Post, The New York Times and Atlantic Monthly were balanced, professional sources of news and opinion, and Fox News was primarily preying on old people who were angry about how fast the world was changing.  “Fact checking” consisted of an occasional article by a professional journalist or ombudsman assigned to review and comment on public relations statements from a professional spokesperson, some politician or (in really edgy cases) by some corporation.  “Russian” disinformation operations were the major threat to social media, and internet trollery was an annoying fact of life that just had to be dealt with in a free society.  I thought that the World Economic Forum was a group of trendy rich people who met annually in the mountains of Davos, Switzerland to hang out, see and be seen, drink expensive wine and watch TED talks. “Podcasts” were something like audio books, a mind candy alternative to AM chat radio when you wanted to distract yourself during a commute to work or a long haul drive to another state. I had never even heard of Joe Rogan, let alone Dr. Bret Weinstein. And I thought the songbirds that gave the world the Laurel Canyon LA sound in the 60s were champions of free speech and the right to protest government overreach, although currently frequently suffering the effects of advanced years combined with various chronic viral infections they picked up during an endless summer of love.

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 non-maleficence), doctors 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” – what was 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 which practicing physicians and medical care providers had to endure if they elected to work under those systems, but there was always the option to leave for private practice.  One edgy new frontier for clinical practice was direct payment to physicians who often operated 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 and kludgy bureaucracies.

State medical boards were primarily in place to ensure that physicians and allied medical professionals met educational standards, provide 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 non-maleficence, beneficence, patient autonomy, or justice.  Violations which could potentially rise to the level of medical malpractice. 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 which would trigger disciplinary action involved providing ready patient access to powerful addictive opioids without a compelling medical indication, typically leading to 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 consequent to an abuse of the patient-physician relationship.  Even in those situations, the usual medical board intervention involved a requirement for remedial training with a possible temporary suspension of medical privileges.  The practice of “hunting physicians” by filing complaints with medical boards seeking to withdraw their license to practice for trying out new therapeutic strategies or criticizing 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 professions 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 together 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 and 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, which is the discipline responsible for managing all communications between a pharmaceutical company, physicians and patients, and for insuring that all of the rapidly expanding legal requirements are complied with.  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 fundamental DNA and mRNA vaccine patents from my early work while I was in my late 20s), and my deep experience and understanding of vaccine and biodefense 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 contract 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 the same colleague develop and win a large Department of Defense contract for building and staffing one of the “advanced development” antibody and vaccine production facilities assembled 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.

During the last months of 2019, while SARS-CoV-2 was beginning to circulate in human beings, we had assembled a small group of experts and were beginning work on this new contract. At about the same time, Event 201, a remarkably prescient table-top simulation of an outbreak of a novel zoonotic coronavirus transmission leading to a severe pandemic, was being held at Johns Hopkins University Center for Health Security in partnership with the World Economic Forum and the Bill and Melinda Gates Foundation.

In terms of national politics, Donald Trump was President of the United States, and the US Congress was fixated on the issue of whether he had acted to coerce or bribe Ukrainian president Volodymyr Zelensky (who I had never heard of before) to reopen an investigation into Hunter Biden (who I had also not heard of, other than as the lesser son of Joe).  As the Presidential election campaign started to heat up, the US House of Representatives voted to impeach the President over the topic, but the Senate did not convict.  For the first time in U.S. history, the economy had avoided a recession for an entire calendar decade, but in a harbinger of the future 9,300 retail stores would still close by the end of the year.  The CDC reported a historic decline in life expectancy (to 78.6 years for a baby born in 2017, down from 78.7 years in 2016), driven in part by a 72% increase in overdoses in the last decade (including a 30% increase in opioid overdoses from July 2016 to September 2017), a ten-year increase in liver disease (men 25 to 34 increased by 8%; women by 11%), and a 33% increase in suicide rates since 1999.

Then everything changed, first for me and our DTRA-funded research group, and then for the world.

I got a call on January 04, 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 a long history of working at the forefront of biodefense and medical countermeasure development, as an advocate for gain of function research, and 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 04 2020 was not known to me. Michael and I had co-published academic papers in the past involving the Zika virus outbreak, and I knew him to be exceptionally well connected in the edgy gray zone of global infectious outbreaks and the US intelligence community.  Over the years that I had known him, he had told me story after story of figuratively parachuting into “hot zone” outbreaks all over the world, the Boeing 707 maintained with a hyperbaric chamber waiting on the tarmac at Boston Logan airport for some future transportation of a high-profile US citizen who had been infected with the latest infectious nasty, his work as an advisor to multiple White House administrations, and he had shared many medical battlefront stories during the original West African Ebola outbreak. He knew that I had previously succeeded in collaborating with leading scientists at the nations biodefense capital, United States Army Medical Research Institute of Infectious Diseases (USAMRIID) 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 lives were completely transformed.

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