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Six Simple Steps to Pharma Reform

By Clayton J. Baker, MD | Brownstone Institute | November 20, 2024

The recent United States elections may have finally produced an administration that is willing – even eager – to reform the Big Pharma juggernaut that has thoroughly dominated life in the United States since Covid. But how might we achieve meaningful, definitive Pharma reform?

Simple.

Before we continue, please allow me to highlight the difference between “simple” and “easy.” Just because something is simple doesn’t make it easy. Lifting a 10-ton weight is no more complicated than lifting a 10-pound weight. But it’s a lot harder to do.

The task of reforming Big Pharma will not be easy. Talk about a heavy lift! Consider that before the 2020 election, the pharmaceutical industry donated funds to 72 senators and 302 members of the House of Representatives. Pfizer alone contributed to 228 lawmakers. At this moment, Big Pharma may be down, but it’s not out. The industry has too much power, money, and influence to be brought under control without a major struggle.

While not easy, should the political will be mustered, the process of breaking the stranglehold Big Pharma has on us would be surprisingly simple. Six changes in Federal law – four repeals of existing law, and two new pieces of legislation – would go a long way toward reining in and even reforming Big Pharma.

From the 1970s onward, US Federal policy consistently trended toward the empowerment and enrichment of the pharmaceutical industry. Since 1980, a series of Federal laws were enacted that created perverse incentives and promoted the rapacious behavior that has characterized Big Pharma over the past several decades, climaxing with the pandemic totalitarianism of the Covid era.

Four of the most problematic of these laws are ripe for repeal. Doing so would constitute vital steps toward reining in Big Pharma. The two other steps proposed here would require new legislation, but fairly simple legislation at that.

The six simple steps are:

• Repeal the 1980 Bayh-Dole Act
• Repeal the 1986 National Childhood Vaccine Injury Act
• Repeal the 2004 Project Bioshield Act
• Repeal the 2005 PREP Act
• Outlaw Direct-to-Consumer Pharmaceutical Advertising
• Encode Medical Freedom into Federal Law

Repeal the 1980 Bayh-Dole Act

The Patent and Trademark Law Amendments Act (Public Law 96-517), better known as the Bayh-Dole Act, was signed into law by Jimmy Carter in 1980.

The Bayh-Dole Act made 2 major changes: it allowed private entities (such as universities and small businesses) to routinely keep ownership and patent rights to inventions made during government-funded research. It also allowed Federal agencies to grant exclusive licenses for use of Federally-owned patents and intellectual property.

The Bayh-Dole Act was intended to encourage innovation within government research. As researchers could now profit directly from their work, it was thought they would make better use of taxpayer support. However, as economist Toby Rogers has argued, this ill-conceived law had the opposite effect.

The ability for government contracted workers to patent their discoveries created a disincentive to share them with other researchers, who might beat them to market. Close guarding of intellectual property and lack of open collaboration had a chilling effect on rapid innovation – hardly what taxpayers would have wanted from their investments.

More importantly, endowing Federal agencies such as the NIH with the power to effectively pick “winners and losers” with whom Federal intellectual property would be granted for commercial use, created a tremendous potential for corruption within these agencies.

The Act did contain a provision for “march-in-rights,” whereby the relevant government agency (such as the NIH) could step in and allow other entities use of the intellectual property if the original patent-holder failed to meet specific requirements to make proper use of them for the public good. However, according to the US Chamber of Commerce, in 44 years since the Act was made law, march-in-rights have never been successfully invoked, despite numerous attempts.

The Bayh-Dole Act itself, coupled with the refusal of agencies such as the NIH to ever invoke march-in-rights, has been frequently implicated in the massive price-gouging problems in US pharmaceuticals. In one remarkable exchange in 2016 between Senator Dick Durbin and then NIH Director Francis Collins, Durbin refuted Collins’ prevaricating defense of never invoking march-in-rights, stating:

… if you cannot find one egregious example where you could apply this [march-in-rights], I would be surprised. And applying it even in one, sends at least the message to the pharmaceutical companies, that patients need to have access to drugs that were developed with taxpayer’s expenses and the research that went into it. I think that doing nothing sends the opposite message, that it’s fair game, open season, for whatever price increases they wish.

By allowing the NIH authority to assign publicly funded intellectual property rights and statutory power to protect exclusive use of them, the Bayh-Dole Act opened the door widely for massive corruption between industry and regulators and greatly enabled the extreme degree of agency capture now present at the NIH and other Federal Agencies.

Bayh-Dole has been a failure. It should be repealed and replaced.

Repeal the 1986 National Childhood Vaccine Injury Act

The toxicity of vaccines was so well-established even decades ago, that a Federal law – the National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34) was passed to specifically exempt vaccine manufacturers from product liability, based on the legal principle that vaccines are “unavoidably unsafe” products.

Since Ronald Reagan signed the 1986 NCVIA Act protecting vaccine manufacturers from liability, there has been a dramatic increase in the number of vaccines on the market, as well as the number of vaccines added to the CDC vaccine schedules, with the number of vaccines on the CDC Child and Adolescent schedule rising from 7 in 1986 to 21 in 2023.

Furthermore, this special protection afforded to vaccines has prompted Big Pharma to attempt to sneak other types of therapeutics under the “vaccine” designation to provide them with blanket liability they would not otherwise enjoy.

For example, the Pfizer and Moderna Covid mRNA injections, while commonly called vaccines, are not true vaccines, but rather a type of mRNA-based gene therapy. In effect, they are what I refer to as Vaccines-In-Name-Only, or “VINOs.” As pointed out by Rep. Thomas Massie (R-KY) and others, the CDC’s definition of “vaccination” was altered during Covid to allow new types of drugs to be labeled as vaccines.

We have now reached the previously unimaginable state where Big Pharma is touting potential “vaccines” for cancer. As the National Cancer Institute admits on its website, these are actually immunotherapies. The purpose of employing this misleading nomenclature is clear: to slide even more therapies under the tort-protected “vaccine” umbrella.

The bloom is off the rose for vaccines. The alarming toxicity of the Covid vaccines caused a worldwide reexamination of this entire class of medicines. Multiple Covid vaccines, including the Johnson & Johnson and AstraZeneca products, once brazenly touted as “safe and effective,” have now been pulled from the market. And the literally millions of VAERS reports implicating the mRNA Covid products have not gone away.

The National Childhood Vaccine Injury Act (NCVIA) of 1986 should be repealed, returning vaccines to the same tort liability status as other drugs.

Repeal the Project Bioshield Act of 2004

The Project Bioshield Act, signed into law by George W. Bush in 2004, introduced the Emergency Use Authorization avenue for pharmaceutical products to be brought to market. Among other things, this law empowered the FDA to authorize unapproved products for emergency use, in the event of a public health emergency as declared by the Department of Health and Human Services (HHS).

By its very design, this law is ripe for abuse. It places immense power in the hands of the unelected Director of HHS, who can declare an emergency activating the law, and who simultaneously oversees the FDA.

This power was egregiously misused during Covid. Shockingly, the FDA issued nearly 400 EUAs related to Covid for pharmaceutical and medical products, the Covid “vaccines” being only the best known. The FDA even went so far as to grant “umbrella” EUAs for entire categories of Covid products such as test kits, often without reviewing specific products at all. The immense amounts of fraud related to test kits and other Covid-era medical products should come as no surprise.

With regard to Covid-related pharmaceuticals, to this day EUAs continue to be misused to the benefit of Big Pharma and to the detriment of citizens. For example, when the FDA announced the “new” formulations of the Covid boosters for 2024-25, they still released these new products under Emergency Use Authorization. In other words, a full four-and-one-half years after the start of the Covid pandemic, these products are still rushed to market after ludicrously inadequate safety and efficacy trials, based on a purported “emergency” now approaching a half decade in length.

The 2004 Project Bioshield Act should be repealed and the EUA designation it created should be eliminated.

Repeal the PREP Act of 2005

The NCVIA already provided vaccine manufacturers with a blanket tort liability shield beyond the wildest dreams of other industries, but apparently that was not enough. In 2005, at the height of the “War on Terror,” George W. Bush signed the Public Readiness and Emergency Preparedness Act (42 U.S.C. § 247d-6d), better known as the PREP Act.

The PREP Act, which was heavily lobbied for by vaccine manufacturers, provides an unprecedented level of blanket tort liability to Big Pharma and other medical-related industries in the event of declared bioterrorism events, pandemics, and other emergencies. Again, tremendous power is placed in the hands of the Director of HHS, who has broad discretion to declare such an emergency.

The PREP Act was controversial from the outset – any act that can spark vigorous, simultaneous opposition from both Phyllis Schlafly’s conservative Eagle Forum and Ralph Nader’s left-wing Public Citizen for its unconstitutional nature is surely pushing the envelope.

In effect, the PREP Act has allowed Big Pharma and its captured regulatory friends to completely circumvent routine FDA standards for safety and efficacy under the guise of an emergency, which as noted above, can conveniently last half a decade or more.

Furthermore, in the aftermath of Covid, the PREP Act has been broadly invoked in the legal defense of countless defendants now sued for the excesses, harms, and violations of human rights perpetrated at all levels of government and society. It will take decades in the courts to sort out where the PREP Act’s broad protections begin and end.

This is both absurd and insane. At its inception, the PREP Act was broadly recognized as one of the most overreaching and unconstitutional Federal laws in modern times. The Covid era has tragically revealed the PREP Act to be a murderous failure. The PREP Act must be repealed.

During Covid, government at nearly every level used the specter of a pandemic to blatantly suspend, deny, and even attempt to permanently eliminate numerous fundamental civil rights that are clearly encoded in the Constitution. Furthermore, the well-established and time-honored pillars of Medical Ethics were dismissed wholesale in the name of public safety.

In addition to repealing the deeply flawed laws discussed above, two pieces of straightforward legislation are needed to limit Big Pharma’s undue influence on society.

Outlaw Direct-to-Consumer Pharmaceutical Advertising

The United States is one of only 2 countries in the world that allows direct-to-consumer advertising of pharmaceuticals. The scale of this advertising is monumental. Total Pharma advertising spending topped $6.58 billion in 2020. The dangers of this are multiple.

First, as we can all see by turning on the television, Big Pharma abuses this privilege by aggressively hawking almost any product it feels it can profit from. The “pill for every ill” mindset shifts into hyperdrive on TV, with an expensive, proprietary, pharmacological cure for everything from your morbid obesity to your “bent carrot.”

Direct-to-consumer television advertisements heavily target the elderly. This is an important component of Big Pharma’s push to promote the Covid and RSV vaccines as routine shots, piggybacking on the wide acceptance of influenza vaccines. Not content to profit off the traditional fall flu vaccine, Big Pharma seeks to create a subscription model for a bevy of seasonal shots against numerous, generally mild, viral respiratory infections.

Even more importantly, direct-to-consumer advertising provides Big Pharma with a legal way to capture media. Pharma was the second-largest television advertising industry in 2021, spending $5.6 billion on TV ads. No legacy media outlet dares to speak out against the interests of entities providing that level of funding. This muzzles dissenting voices and eliminates open discussion about safety issues in mainstream media.

In short, through direct-to-consumer advertising, Big Pharma has bought the media’s silence.

A free society requires freedom of the press and media. The Covid era has demonstrated that direct-to-consumer pharmaceutical advertising stifles freedom of the press and media to a dangerous and unacceptable degree.

Somehow, the rest of the world has managed to survive without direct-to-consumer pharmaceutical advertising. In fact, many countries do better with respect to health measures than the Pharma-ad-riddled USA. In 2019, just before Covid, the United States ranked only 35^th in terms of overall health in the Bloomberg National Health Rankings. Meanwhile, the United States pays more for its middling health rankings than any other nation on Earth.

Encode Medical Freedom into American law

The Founding Fathers would be scandalized to find that the United States needs explicit laws stating that the Bill of Rights is not null and void in the event of a “pandemic,” (or during other emergencies, for that matter), but here we are.

The Founders were well acquainted with episodic infectious disease. In fact, they faced epidemics at a level we cannot imagine. George Washington survived smallpox. Thomas Jefferson lost a child to whooping cough. Dr. Benjamin Rush, signer of the Declaration of Independence and surgeon general of the Continental Army, promoted inoculation of the troops against smallpox.

Despite those experiences, the Founders inserted no health-emergency-based escape clauses in the Constitution permitting government to deny citizens the inalienable rights protected therein.

As I have written previously, the excesses of the Covid era have sparked a movement toward encoding “medical freedom” into law, to protect our civil rights against medical and public health overreach. (To be fully effective, this may need to be expanded to include any declared emergency – e.g. “climate” emergencies – although that is beyond the scope of this essay.)

Given the excesses of the Covid era, many of which have now been demonstrated to have been pre-planned and deliberate, and given rapid technological advancement of both medicine and surveillance, it is advisable to encode into law assertions regarding medical freedom. While the exact wording may vary, the 2 key points of focus would be explicitly protecting bodily autonomy and limiting the power of public health declarations. Here are two examples:

• Citizens shall not be deprived of any rights protected in the US Constitution, or of their ability to fully participate in society, on the basis of their acceptance or refusal of any medical treatment(s) or procedure(s).
• Citizens shall not be deprived of any rights protected in the US Constitution, or of their ability to fully participate in society, on the basis of a medical or public health emergency.

Encoding such statements into law would accomplish two goals. First, it would substantially rein in the power-seeking element of the public health industry that became such a menace to human freedom during Covid, and which incidentally is tightly entwined with Big Pharma. Second, it would significantly thwart the efforts of Big Pharma to push their wares through a herd-based and mandate-driven approach.

Should someone oppose such explicit statements of our God-given rights, on the basis of “But what if there is another pandemic?”, I would reply as follows: Only once in human history did the world lock itself down due to a disease. It turned out to have been done mostly under false pretenses, and it turned out to be a deadly and disastrous mistake. We are not doing that again.

Conclusion

Big Pharma is a Leviathan, in both the biblical and Hobbesian senses of the word. To truly control it, other measures will surely be necessary. Other needful actions are beyond the scope of this article. Some of these may be very complicated. For example, it is imperative that the gain-of-function bioweapons research be halted. However, this is a worldwide issue, so outlawing it in the US alone will not solve the problem.

However, these six simple steps are an important start. Members of the incoming administration have already spoken about some of them. Success breeds success, and successfully implementing these solutions will help free ourselves from the tentacles of the monstrosity that Big Pharma has become.

Clayton J. Baker, MD is an internal medicine physician with a quarter century in clinical practice. He has held numerous academic medical appointments, and his work has appeared in many journals, including the Journal of the American Medical Association and the New England Journal of Medicine. From 2012 to 2018 he was Clinical Associate Professor of Medical Humanities and Bioethics at the University of Rochester.

November 24, 2024 Posted by aletho | Civil Liberties, Corruption | Human rights, United States | Leave a comment