Vaccine Nation — Vaccination
The COVID-19 Mass-Injection Campaign and Why the PREP Act Was Never a Good Idea

Unprecedented Magnitude and Speed

     The COVID-19 mRNA, gene-based, vaccine campaign has led to the largest vaccination campaign in history. The resulting vaccines themselves have been the fastest ever developed. This unprecedented magnitude and speed was largely enabled by the Public Readiness and Emergency Preparedness Act (abbreviated PREP Act or PREPA) — on Page 139 at the linked document.  PREPA has empowered a single, unelected government-agency head, the Secretary of the U. S. Department of Health and Human Services (HHS), to exert great control in orchestrating this public-health exercise.

    With one voice, the HHS Secretary can determine that a public health emergency or potential for a public health emergency exists, that a given unapproved drug qualifies as a medical countermeasure, and that anyone associated with developing or dispensing the covered countermeasure during his declared emergency cannot be sued in a court of law. PREPA bestows this power solely to the HHS Secretary, and PREPA provides that no court can challenge the HHS Secretary’s decisions on such matters. COVID-19 mRNA vaccines, thus, came into being as medical countermeasures under the liability protection of PREPA. Ironically, these vaccines that have questionable benefits remain immune to litigation under PREPA.

No Law Defines a Public Health Emergency

     Margaret Barnhorst (2022). Primer: Public Health Emergencies in the United States, American Action Forum.

There is no law or rule that specifies a necessary threshold of urgency or severity, or even a definition, under which to declare a PHE [Public Health Emergency], leaving broad authority to the secretary.

This should cause great concern, because apparently the HHS Secretary can declare almost anything a public health emergency. He can declare almost anything a potential public health emergency — an anticipated emergency that does not actually exist at the time of his declaration but might exist in the future.  Pharmaceutical companies, therefore, can more freely pitch all manner of new formulations or devices as medical countermeasures that initially escape the more stringent regulatory requirements of FDA-approved products.

    The FDA (Food and Drug Administration), as an agency of HHS (Department of Health and Human Services), thus, acts as a relaxed gatekeeper for the HHS Secretary’s single-minded, medical-countermeasure determinations. Even though the HHS Secretary might consult with any number of advisors, still he alone chooses which sources of information to assign greater weight and which sources to reject. The health of every citizen in the United States, therefore, is subject to his individual biases and favoritism.

    A reasonable person has to wonder what Congress was thinking when it gave such broad authority to an unelected government official. Presumably, Congress had the best of human qualities in mind, which required great trust in all people doing the right thing, making the most informed decisions based on research of the highest integrity. Sadly, this most certainly is not the current state of affairs.

Corrupted Societal Landscape Where the PREP Act Was Planted

     Nearly half a century ago, Ivan Illich revealed what was then the state of affairs that has only gotten worse over time:

Ivan Illich. Medical Nemesis: The Expropriation of Health, Calder & Boyars, Ltd., London (1975), then Random House, Inc. (1976). 201 pages.

...  contrary to current conventional wisdom, medical services have not been important in producing the changes in life expectancy that have occurred. A vast amount of contemporary clinical care is incidental to the curing of disease, but the damage done by medicine to the health of individuals and populations is very significant. These facts are obvious, well documented, and well repressed.

The pain, dysfunction, disability, and anguish resulting from technical medical intervention now rival the morbidity due to traffic and industrial accidents and even war-related activities, and make the impact of medicine one of the most rapidly spreading epidemics of our time.

Between 16 and 20 percent of every dollar paid in malpractice insurance went to compensate the victim; the rest was paid to lawyers and medical experts. In such cases, doctors are vulnerable only to the charge of having acted against the medical code, of the incompetent performance of prescribed treatment, or of dereliction out of greed or laziness. The problem, however, is that most of the damage inflicted by the modern doctor does not fall into any of these categories. It [damage inflicted by doctors] occurs in the ordinary practice of well-trained men and women who have learned to bow to prevailing professional judgment and procedure, even though they know (or could and should know) what damage they do.

... medical practice sponsors sickness by reinforcing a morbid society that encourages people to become consumers of curative, preventive, industrial, and environmental medicine.

... the so-called health professions have an even deeper, culturally health-denying effect in so far as they destroy the potential of people to deal with their human weakness, vulnerability, and uniqueness in a personal and autonomous way.

The age of great discoveries in pharmacology lies behind us. According to the present director of FDA, the drug age began to decline in 1956. Genuinely new drugs have appeared in decreasing numbers, and many which temporarily glittered in Germany, England, or France, where standards are less stringent than in the United States, Sweden, and Canada, were soon forgotten or are remembered with embarrassment. There is not much territory left to explore. Novelties are either " package deals"— fixed-dose combinations — or medical "me-toos" that are prescribed by physicians because they have been well promoted.

     Fast forward (from 1976) to 2012 (36 years later), when Marc A. Rodwin, Professor of Law at Suffolk University Law School, described precisely how bad the state of affairs had gotten:

Marc A. Rodwin (2012). Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform, Journal of Law, Medicine and Ethics, 40:511-524.

We expect drug firms to develop innovative therapies that improve patient care and public health, and to promote drug safety.  But today the pharmaceutical industry neglects many of these goals, and sometimes even engages in activities that undermine them.

Drug firms often develop products that have minor value, and neglect investing in significant innovative therapies. They often behave as if they have no responsibility for how physicians prescribe or patients use drugs. They sometimes promote drugs in ways that endanger the public’s health. They market drugs for uses where risks outweigh the benefits. They fuel inappropriate prescribing while earning income from improper drug use. Worse, drug firms have slanted the information available to public officials who decide whether to authorize the sale of drugs and who monitor the risks of drugs on the market. They bias the information available to physicians, hospitals, policy makers, and insurers and thereby corrupt the practice of medicine.

It [the FDA Center for Drug Evaluation and Research] found that among the 1,284 new drugs approved from 1990 to 2004, only 22 percent offered a significant improvement over marketed products and just over 14 percent were new molecular entities.

From 1962 to 1980, congressional hearings revealed the high risk of bias, fraud, and failures to disclose risks when drug firms conduct clinical trials as part of an application to market a new drug.

Since 1980, scholarly literature has revealed that drug firms can design trials that bias the results, and interpret the data to assess the drug more favorably than warranted; they can also report data selectively to distort the evidence available to the FDA.

By 2000, drug firms funded 70 percent of clinical drug trials, allowing them to influence the questions posed, research design, protocol, and methods.

It is no surprise, then, that several reviews have found that when an interested party pays for a clinical trial, the trial tends to produce results that favor the interest of the funder.

A Congress Captured by Pharma Lobbyists, and an FDA Captured by User Fees From Companies It Regulates

     The full extent of corruption has been documented well before COVID-19, yet the body of lawmakers empowered to make change is itself captured by the very industry where corruption looms. Regulators empowered to guard public health are also captured by the pharmaceutical companies that support those regulators with user fees. What exists is nothing less than a congressional/regulatory/pharmaceutical-company mafia that remains beyond the reaches of law, because the ultimate lawmaking body is part of it. The following excellent article explains much of this in no uncertain terms:

Donald W. Light, Joel Lexchin, and Jonathan J. Darrow (2013). Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs, Journal of Law, Medicine and Ethics, 14(3):590-610.

Pharmaceutical companies continuously emphasize how deeply society depends on their development of innovative products to improve health. But in fact, these companies are mostly developing drugs that are mostly little better than existing products but have the potential to cause widespread adverse reactions even when appropriately prescribed.

We present evidence that industry has a hidden business model to maximize profits on scores of drugs with clinically minor additional benefits.

The industry measures “innovation” in terms of new molecular entities (NMEs), but most NMEs provide at best minor clinical advantages over existing ones and may lawfully be approved by the FDA even if they are inferior to previously approved drugs.

From the mid-1970s through the mid-1990s, multiple assessments have found that only 11 to 15.6 percent of NMEs provide an important therapeutic gain.

These facts provide evidence that companies are using patents and other protections from market competition primarily to develop drugs with few if any new therapeutic benefits and to charge inflated prices protected by their strong IP [Intellectual Property] rights. 

Most new drugs approved and promoted since the 1970s lack additional clinical advantages over existing drugs and — as with all drugs — they have been accompanied by harmful side effects.

Of priority drugs that were reviewed in slightly more than half the normal time, at least one in three of them caused serious harm.

In fact, evidence suggests that commercial distortions of the review process and aggressive marketing contribute to both undermining beneficence as health care’s raison d’être and to the epidemic of harm to patients.

But as Malcolm Salter, at the Harvard Business School emphasizes, companies institutionalize corruption by getting legislative and administrative rules shaped to serve their interests, either directly or by crafting rules in ways they can game.

... allowing companies to test their own products has led them — as rational economic actors — to design trials in ways that minimize detection and reporting of harms and maximize evidence of benefits.

Approvals based on scientifically compromised trials underlie the large number of heavily marketed new drugs with few or no new therapeutic benefits to offset their under-tested risks of harm.

... companies have created what can be characterized as the trial-journal pipeline because companies treat trials and journals as marketing vehicles. They design trials to produce results that support the marketing profile for a drug and then hire “publication planning” teams of editors, statisticians, and writers to craft journal articles favorable to the sponsor’s drug.

In sum, testing and FDA criteria approval provide little or no information to clinicians on how to prescribe new drugs, a vacuum filled by company-shaped “evidence” that misleads physicians to prescribe drugs that are less safe and effective than indicated by evidence that the FDA possesses.

The FDA’s obligation to serve the public is being corroded by pressures to serve the companies it regulates.

A 15-month investigation by the Committee on Government Reform [see link below] of the U.S. House of Representatives found “a growing laxity in FDA’s surveillance and enforcement procedures, a dangerous decline in regulatory vigilance, and an obvious unwillingness to move forward even on claims from its own field offices.”
LINK: United States House of Representatives Committee on Government Reform — Minority Investigations Division (2006). Prescription for Harm: The Decline in FDA Enforcement Activity, Washington DC.

Over the years, expert bodies and prominent scientists have called for an independent institute to test drugs because commercial trials were so poor, biased, and conflicted. Yet this bedrock reform has never been accomplished, as the industry’s lobbying of Congress and its contributions to Congressional campaigns have soared.

Hearings through the 1960s and 1970s documented how frequently the FDA fails to adhere to its own rules and protocols.

What Lobbying Is and What Lobbyists Do

     In general, lobbyists are paid, professional advocates who push the agendas of the companies that hire them. They might conduct highly technical policy research that they use to influence lawmakers. As experts in these issues, they might throw fund-raising dinner parties, where they mingle with important guests to influence opinions. Often times, lobbyists are former elected officials.

     Lobbyists schedule face-to-face meetings with members of congress or their staff, offering research findings and sometimes helping to draft the actual legislation. They might write news-media editorials, appear on political talk shows, or organize letter-writing campaigns. According to Dave Roos (19 June 2012), in … How Lobbying Works:

The best lobbyists are highly effective communicators with solid people skills, a strong command of the issues, a broad network of contacts and a flair for fundraising.

Lobbying and Advertising by the Pharmaceutical Industry

     In 2022, the pharmaceutical and health-product industry spent over $ 375 million on lobbying. Of the top twenty companies that spent the most in this area, Pfizer ranked second, with lobbying expenditures exceeding $ 14 million.

     Oliver Wouters has noted that the pharmaceutical and health-product industry spent more on lobbying than any other industry, during the years from 1999 to 2018:

Olivier J. Wouters, PhD (2020). Lobbying Expenditures and Campaign Contributions by the Pharmaceutical and Health Product Industry in the United States, 1999-2018, JAMA Internal Medicine, 180(5):688-697:

This observational study, which analyzed publicly available data on campaign contributions and lobbying in the US from 1999 to 2018, found that the pharmaceutical and health product industry spent $4.7 billion, an average of $233 million per year, on lobbying the US federal government;

$414 million on contributions to presidential and congressional electoral candidates, national party committees, and outside spending groups; and $877 million on contributions to state candidates and committees. Contributions were targeted at senior legislators in Congress involved in drafting health care laws and state committees that opposed or supported key referenda on drug pricing and regulation.

     The following source sums up the power that pharmaceutical companies exert through advertising:

Russell L. Blaylock (2022). COVID Update: What is the Truth?, Surgical Neurology International, 13(167):

We are now witnessing a growing number of excellent scientific papers, written by top experts in the field, being retracted from major medical and scientific journals weeks, months and even years after publication. A careful review indicates that in far too many instances the authors dared question accepted dogma by the controllers of scientific publications—especially concerning the safety, alternative treatments or efficacy of vaccines. These journals rely on extensive adverting by pharmaceutical companies for their revenue. Several instances have occurred where powerful pharmaceutical companies exerted their influence on owners of these journals to remove articles that in any way question these companies’ products.

Worse still is the actual designing of medical articles for promoting drugs and pharmaceutical products that involve fake studies, so-called ghostwritten articles.

Proven fraudulent “ghostwritten” articles sponsored by pharmaceutical giants have appeared regularly in top clinical journals, such as JAMA, and New England Journal of Medicine—never to be removed despite proven scientific abuse and manipulation of data.

As concerns the information made available to the public, virtually all the media is under the control of these pharmaceutical giants or others who are benefiting from this “pandemic”.

Television media receives the majority of its advertising budget from the international pharmaceutical companies—this creates an irresistible influence to report all concocted studies supporting their vaccines and other so-called treatments.

In 2020 alone the pharmaceutical industries spent 6.56 billion dollars on such advertising. Pharma TV advertising amounted to 4.58 billion, an incredible 75% of their budget.

     A trio of doctors from Boston, MA add further clarity:

Michael S. Sinha, Aaron S. Kesselheim, and Jonathan J. Darrow (2018). Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship, Chest, 153(1):9-11.

Traditional print-based advertising in medical journals remains particularly attractive to pharmaceutical manufacturers because print versions of such journals reach 90% of physicians, a figure that rises to 96% when print and digital versions are considered together.

Advertisements enable pharmaceutical manufacturers to target physicians precisely and try to sway prescribing practices in favor of the product being advertised, regardless of whether it is the most efficacious or cost-effective option for a patient.

   In one of his books, Robert F. Kennedy Jr. confirms what the above authors and others have reported:

Robert F. Kennedy Jr. (2021). The Real Anthony Fauci, Skyhorse Publishing, New York, NY, page 891.

Big pharmaceutical companies are the biggest advertisers on news and television outlets. Their $9.6 billion annual advertising budget buys more than commercials—it buys obeisance.

In 2014, network president Roger Ailes told me he would fire any of his news show hosts who allowed me to talk about vaccine safety on air. “Our news division,” he explained, “gets up to 70 percent of ad revenues from pharma in nonelection years.”

     Put another way, pharmaceutical companies are in a position to buy the good favor of medical-journal editors and to sell doctors on their products. Questioning the use of a particular product becomes a threat to the financial survival of the medical journals, a threat to news media, and a threat to the medical practitioners who endorse the product.

News Media Control by the Pharmaceutical Industry

     In 2019, a group of the world's largest news publishers established an industry partnership named the ... Trusted News Initiative … . This large group of publishers collectively promoted widespread COVID-19 vaccination, while demonizing the use all other proven treatments. The Trusted News Initiative (TNI), thus, helped generate hundreds of billions of dollars in profits for vaccine manufacturers and other large pharmaceutical companies. These profits, in turn, enabled those vaccine manufacturers and pharmaceutical companies to pay $ billions to TNI publishers for advertising.

     By suppressing information (news) that could have undermined hundreds of billions of profits from new, expensive COVID-19 vaccines, TNI pleased its largest advertisers. It enabled these advertisers to buy even more advertising, further increasing the revenue of TNI publishers.

Political Contributions by the Pharmaceutical Industry

     Pharmaceutical companies routinely contribute large sums of money to help fund the campaigns of political candidates. This includes contributions to presidential candidates, to members of congress, and to judges.

     In 2020, for example, the pharmaceutical and health-products industry contributed over $ 8,000,000 to the presidential campaign of Joe Biden. In 2021, Pfizer was the second largest of all pharmaceutical-company contributors to political candidates.

A Liability Free Pass

     The Public Readiness and Emergency Preparedness Act (PREPA), thus, has enabled the stability of a massive economic engine critically dependent on continued success of the pharmaceutical industry. Drug companies shielded from the pressure of injury lawsuits have been free to pursue higher risk/lower reward products, whose development is heavily influenced by a militarized mindset hell-bent on producing war-fighter countermeasures along unrealistic timelines. 

     Interestingly, the passage of PREPA did not arise from a loud lobbying campaign by a pharmaceutical industry threatening to halt vaccine production, as some sources have claimed. Any such pressure was more informal and directed toward key lawmakers already aligned with the biodefense mindset that had overtaken public‑health logic. With public health reframed as a national‑security function, and vaccines elevated to countermeasures against bioterrorism, PREPA was quietly slipped into a must‑pass defense appropriations bill during a period when biodefense priorities dominated federal thinking. Heavy lobbying came later, when PREPA’s sweeping liability‑immunity provisions finally drew public and congressional criticism, and the pharmaceutical industry mobilized to protect what it had tacitly secured.

     Without PREPA, drug companies could not operate at the same profit level, which would result in less money for everyone involved. Without PREPA, application fees for new vaccines would drop, advertising dollars to publishers would drop, political contributions would drop, clinical trial contracts and related employment would drop. In short, an entire network of economic exchange would be throttled, along with associated career advancement opportunities, patent pursuits, and reputation-building endeavors.

     It seems reasonable to suggest that PREPA has created a world addicted economically to drugs, and this is not an outcome compatible with managing public health. PREPA has put humanity on the wrong path towards that goal.

.pdf copy of this article

<< BACK TO MAIN PAGE