Volume 79, no. 10 October 2023
Some of us are old enough to remember the Pinto, the first subcompact car manufactured and marketed by Ford in the U.S. Just ahead of a mandatory order, Ford recalled 1.5 million Ford Pintos and Mercury Bobcats, the largest recall in automotive history at the time, because of concerns about fire hazards owing to the placement of the fuel tank. Up to 900 deaths from fire were attributed to this design in the more than 3 million Pintos produced from 1971 to 1980. Ford was accused of cynically deciding that payment of liability claims was cheaper than fixing the problem.
Ralph Nader’s 1965 best-selling Unsafe at Any Speed helped spur the passage of automobile safety legislation, and Nader’s Raiders crusaded as consumer advocates on many issues.
But not on vaccines—presumed to be safe at any speed—even warp speed. Like cars, vaccines are inevitably unsafe. But unlike the auto industry, vaccine manufacturers no longer have to balance concerns about liability.
As “karma” asked in an “X” post, consider what would happen if children were being injured in cars because brakes failed, and that the brakes had not been tested or, worse, the failures had been covered up. Then replace “car” with “vaccine” (tinyurl.com/y8j93b3d). As officials feared, questions about COVID vaccine safety are also being asked about the childhood vaccine schedule.
In 2012, Rep. Bill Posey (R-Fla.) asked Colleen Boyle, director of the CDC’s birth defects and developmental disabilities division, whether a study of vaccinated vs. unvaccinated children had ever been done concerning neurodevelopment disorders, auto immune conditions, and various chronic diseases. After much evasiveness, the answer is apparently “no” (https://tinyurl.com/ya7r94s9).
On the MMR vaccine autism question, the CDC might have tried to destroy 100,000 pages of documents. CDC scientist William Thompson confessed to Brian Hooker, father of an autistic son, that he and coauthors of a 2004 article in Pediatrics had deleted data showing that black boys who had received MMR vaccine before age 36 months had a higher risk of autism (J Am Phys Surg, spring 2017, https://tinyurl.com/eppbeyur). Thompson received whistleblower protection, and more than 10,000 pages of documents were turned over to Rep. Posey, but Thompson has still not been subpoenaed. The issue is just now getting thousands of views on X (formerly twitter, https://tinyurl.com/2zfp5ta2).
The suppression of safety signals on COVID vaccines, previously covered here and in J Am Phys Surg, continues. The CDC states it will release updated data on myo/pericarditis only “when appropriate” (https://tinyurl.com/ywn69ca7). Mark Steyn featured an interview with British cardiologist Aseem Malhotra concerning how truth-telling puts one’s career at risk (https://tinyurl.com/52zyvr7z).
Nader’s and others’ proposals to save the environment and the “climate,” like vaccines and unlike cars, require no cost: benefit analysis. The rationale seems to be that costs are irrelevant in view of an existential, infinite risk. The oceans could boil, so said Al Gore (https://tinyurl.com/y6ecsfza), if we don’t stop using the fuels that power 80% of the world’s economy. Hundreds of thousands or millions of children will die if we impede the vaccination program—of measles, polio, hepatitis b, or even chickenpox. We dare not suggest using single-antigen measles vaccine instead of Merck’s MMR, or delaying the first dose.
With vaccines, the existential threat is to the manufacturers, if they lose their liability protection and if their products are shown to cause significant death and disability.
Just before the National Vaccine Injury Act of 1986 was passed to protect manufacturers from lawsuits that would bankrupt them, the Phil Donahue show featured a panel of physicians and vaccine-injured patients (https://tinyurl.com/mwufvhvf). Such a show could probably not be aired today. (If a tweet disappears, search for it on reSee.it. This one is #15129).
The PREP Act
The Public Readiness and Emergency Preparedness Act, signed in 2005, is a shield of protection in the event of war or public health emergency for “covered countermeasures” purchased by the U.S. Department of Defense under defense production and other transaction authority, on condition that “covered persons” are following the orders of health authorities. It protects against tort liability and is also the source of the sovereign immunity shield for public officials (https://tinyurl.com/4skrfv2f).
Manufacturers, distributors, program planners, and those who administer, prescribe, or use a “covered countermeasure” are all “covered persons.” The Act has been amended 11 times to accommodate COVID-19—masks, tests, and “all components” (DNA, lipopolysaccharides?) And what sort of proof is needed? “The successful provision of these doses shall establish the effectiveness of a technology capable of potentially providing immediate and long-term solutions to coronavirus infections” [emphasis added] (https://tinyurl.com/4nwu77xm).
President Biden declared that the COVID emergency ended May 11. But FDA determined that certain “guidances” remain as long as it likes and granted more EUAs (tinyurl.com/bd3p9tbf).
“Safety” requirements depend on politics. Unlike the Pinto, the electric vehicle’s lithium battery doesn’t need a low-impact rear-end collision to start a fire that is virtually impossible to extinguish. It can happen in the garage or at a charging station. But it is “rare,” and EVs make the earth greener.
History Lesson
It is always a temptation for a rich and lazy nation,
To puff and look important and to say—
“Though we know we should defeat you, we have not the time to meet you.
We will therefore pay you cash to go away.”
And that is called paying the Dane-geld;
But we’ve proved it again and again,
That if once you have paid him the Dane-geld
You never get rid of the Dane.
Rudyard Kipling (1865-1936)
Florida’s Guidance on COVID Boosters
Florida’s Dept. of Health is recommending against boosters for persons under age 65 and states that patients and providers should be aware of the following (tinyurl.com/w69vdpay):
(1) The mRNA vaccines are associated with negative effectiveness. (2) Studies show that the vaccinated developed an increased risk for infection. (3) The shots present a risk of subclinical and clinical myocarditis and other cardiovascular conditions for healthy people. (4) There is an unknown risk of adverse events with each additional dose. (5) Elevated levels of spike protein persist in some people for an indefinite period of time, which increases health risks by an unknown amount.
Information Gatekeepers
The CIA, FBI, and other intelligence agencies have been deeply involved in online censorship for decades. According to Wikipedia founder Larry Sanger, it “used to be kind of anti-establishment” but “between 2005 and 2012 or so, there was this very definite shift to Wikipedia becoming an establishment mouthpiece…. We do have evidence that, as early as 2008, CIA and FBI computers were used to edit Wikipedia” (https://tinyurl.com/3nwbjsuj).
One way to block researchers’ access to data is to outsource research that supports a policy aim. The Environmental Protection Agency outsources human epidemiology to universities. It even has a double hand-off to the Health Effects Institute. HEI may outsource to Europe, so one has to reach through three organizations to get data—virtually impossible.
Stan Young writes that “an agency can insulate its actions from public scrutiny by funding a grant for controversial research and then basing its action on those findings. As long as the agency does not take possession or control of the records, FOIA requests—or other procedures to facilitate public oversight—will not assist those who wish to challenge the findings the agency relies on to justify its actions” (tinyurl.com/bdh3usxh).
A phone call from the New York Times caused the Cochrane Review editor-in-chief Karla Soars-Weiser to rush out a statement undermining the scientific findings that population masking was useless. It gave the impression that the study was retracted; it was not. Cochrane is “the latest scientific institution ruined by COVID ideology” (tinyurl.com/2x7ubh48). Cochrane has received more than $500,000 from NIH (tinyurl.com/2kmf874v).
“A standing military force, with an overgrown Executive, will not long be safe companions to liberty.” —James Madison
ACPeds Launches Biological Integrity Initiative
The American College of Pediatricians (ACPeds) has announced its Biological Integrity Initiative to combat transgender interventions on minors, offering a wealth of resources at www.biologicalintegrity.org.
ACPeds President Dr. Michael Artigues said: “The massive push we are seeing for children to become the targets of experimental, life-altering drugs and surgeries is ideological in nature, directly opposed to biological reality, antithetical to good medical practice, and deeply disturbing to doctors who have devoted their lives to ethical, compassionate care for their most vulnerable patients—children.”
As of September 2023, there are 23 states that have passed legislation protecting minors from transgender interventions. The majority of laws protect minors from the harms of puberty blockers, cross-sex hormones, and transgender surgeries. The protective laws have been temporarily or permanently blocked by judges in four states (Arkansas, Florida, Indiana, and Oklahoma).
Nobel Prize for mRNA Work
The 2023 Nobel Prize for Physiology was awarded to Katalin Karikó and Drew Weissman for the nucleotide base modifications used in the mRNA in COVID vaccines. Pseudouridine replaces uridine throughout in the synthetically produced mRNA. The resulting molecule is quite different in many key biological properties from natural mRNA, but it can still be translated into protein. Dr. Weissman, however, said that the mRNA is identical to the RNA in your cells, which is rapidly degraded and gone within a week (https://tinyurl.com/yc5aj2c9). In fact, the pseudouridine makes the mRNA resistant to degradation and also reduces the inflammatory response (tinyurl.com/4r9rr3ay).
The Nobel Committee of the Karolinska Institute, to which Pfizer is a major donor, asserted that this modification “enabled the development of effective mRNA vaccines against COVID-19.” Dr. Robert Malone states that the effectiveness trials and interpretation of them were both fraudulent (https://tinyurl.com/yc4cwm9p).
Mass Production Process Untested
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) said that no corners had been cut in authorizing the Pfizer COVID vaccine, but the safety of the up-scaled mass manufacturing process has not been assured. The vaccine tested in clinical trials was made by Process 1. The product made by a significantly different Process 2 was approved without comparative data (tinyurl.com/8jvwd94j, tinyurl.com/3w47zrk7).
AAPS Calendar
Oct 26-28. 80th Annual Meeting, Fort Worth, TX. – https://aapsonline.org/2023am
ACTION OF THE MONTH
Even if you are still trapped in Medicare or third-party contracts, if you’d like to see cash-paying patients, be sure you are listed on our website, https://aaps.pub/cashlist.
6th Circuit Protects Children from Castration
The Sixth Circuit Court of Appeals has overturned the lower court’s injunction against enforcing a Tennessee law that prohibits “gender-affirming care” for minors, including puberty blockers and cross-sex hormones (https://tinyurl.com/bdhcf3uj). Matt Walsh explains how the ruling thoroughly dismantles “every disingenuous argument from trans activists” (tinyurl.com/4t7vh338).
Voters have the right to ban procedures they consider immoral or dangerous, the Court ruled. There is good reason to believe the treatments are dangerous, and many countries have started banning them. An independent reanalysis of UK data shows that a third of youth suffered mental health problems after taking puberty blockers. Walsh concludes that “being a parent doesn’t give you the right to mutilate your child.”
Watts Family Challenges PREP Act
The only case challenging the constitutionality of the PREP Act is Watts v. Austin. The case is brought by the family of George Watts, a 24-year-old man who died of myocarditis after being administered two doses of the Pfizer-BioNTech COVID vaccine, which was required for attendance at Corning Community College (https://tinyurl.com/3khydban).
Watts’s family first sought compensation for his death under the Countermeasures Injury Compensation Program (CICP) established under the PREP Act. As of Aug 1, only four CICP claims totaling $8,592.55 have been paid out for injuries related to COVID-19. According to a Plaintiff’s memorandum, “Not only is the CICP insufficient to satisfy due process, but here due process is further offended when a Plaintiff, upon exiting the CICP program, has absolutely no remedy against willful misconduct—the only possible claim—against federal agencies and actors hiding behind the shield of sovereign immunity.”
The only exception to PREP Act immunity is if a countermeasure-related injury is caused by “willful misconduct” by a covered person or entity. The complaint alleges the DOD engaged in willful misconduct when it propagated the idea that the experimental versions of the COVID-19 vaccine were “safe and effective,” while fully aware that the FDA’s EUA does not meet that standard. Granting sovereign immunity would violate the family’s Fifth Amendment right to just compensation.
This case has the potential to force Defendants to answer many questions, including the role of the Department of Defense
(https://tinyurl.com/yftt3rd5).
Tip of the Month: Noncompliance by patients is a consideration worth raising with a state medical board if a physician faces discipline. Tens of millions of Americans reject the approach of Fauci, CDC, and FDA to treat COVID and other conditions. Some medical boards have sought to discipline physicians for not insisting that their patients comply with these federal directives, even though only physicians, not a federal agency, are authorized to practice medicine. When patients came to you because they disagree with federal guidelines, then their noncompliance with those guidelines could be a strong defense against a medical board action—for example an attempt to discipline a physician not for prescribing an off-label drug but for not prescribing the federally recommended one, which the patient would not have taken.
AB 2098 Repealed
California’s medical censorship law has been repealed by the very people who wanted it in the first place, writes Azadeh Khatibi, M.D., who with others won a preliminary injunction against the law (https://tinyurl.com/2v722jmh).
Attorney Rick Jaffee proposes a proper epitaph: “Here lies the dead carcass of the California Covid misinformation law. Misconceived in fear, constitutional obtuseness, anti-science and hubris. Siblings include the late societal lockdowns, including the especially nefarious shut down of schools, the comatose but perhaps soon to be revived mask mandates, and the most notorious sibling of them all, the dormant perhaps soon to be revived fifth booster mandate (or whatever is the current iteration).
“Section 2270 date in effect: 1/1/2023.
“Date of the legally induced coma by Judge Schubb: 1/23/2023, for a total of 22 days in effect.
“Expected date of death, via SB 815: 1/1/2024.”
The last straw, he thinks, was the 9th Circuit’s panel’s question to the attorney general: “Assume we find that strict scrutiny applies to the case, does the law pass strict scrutiny?” A finding that a law is subject to strict scrutiny is the kiss of death in constitutional litigation. “Rational relationship” is the breath of life to a law. No laws are struck down if they have any real, speculated, or hypothetical relationship to a government interest or function (https://tinyurl.com/yeytf6mw).
Agency Authority Threatened
Since 1984, FDA has enjoyed deference from the courts under the Chevron doctrine, from Chevron U.S.A. v. Natural Resources Defense Council. “But mounting judicial skepticism, which reached a new height in the 2022 case, West Virginia v. Environmental Protection Agency, has weakened this norm and now threatens to upend it” (NEJM 3/16/23). Conservative justices, write Lawrence O. Gostin, J.D., et al., have reinvigorated the “major questions” doctrine, which hold that Congress must explicitly grant authority to act on matters of vast social or economic significance, including vaccine mandates. This “bedrock principle of public health law” faces “legal uncertainty that only a few years ago seemed inconceivable” (JAMA 8/15/23).
Loper Bright Enterprises v. Raimondo this session threatens Chevron, the principle requiring courts to defer to “experts” when a law is unclear, as long as the experts are “reasonable.” This could “spell doom for power of federal regulators,” warns Politico (https://tinyurl.com/bdhpf9jj).
AAPS Petitions SCOTUS Again Re: Ruan
Despite the unanimous Supreme Court decision in Xiulu Ruan v. U.S. overturning convictions of pain physicians who were denied a good-faith defense, courts are still using an administrative agency’s wording that a prescription “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice” instead of the Court’s wording, “was acting in an unauthorized manner, or intended to do so.” Nearly every physician inevitably acts outside the usual course of practice in order to properly treat an unusual patient. AAPS amicus is posted here: https://tinyurl.com/yr45u7d3.
Correspondence
Immune to Truth and Facts. Even though top epidemiologists informed the CDC and the Infectious Diseases Society of America (IDSA) that “misrepresenting the evidence” on their websites would “damage the credibility of science and endanger public trust” (https://tinyurl.com/2p9hb4mn), mask mandates are being imposed again. The woke don’t care that the evidence shows that masks do not prevent or mitigate the spread of COVID. They are going to try to force them on people anyway.
Lawrence R. Huntoon, M.D., Ph.D., Lake View, NY
‘They’re the Most Studied Vaccines in History.’ When CDC director Mandy Cohen makes this claim for COVID vaccines, she is correct. There are thousands of studies on COVID vaccine hesitancy (not safety) and what types of propaganda, nudging, neurolinguistic programming, and behavioral modifications work best to elicit compliance. This was taxpayer-funded marketing research, to try to spur 100% global compliance.
Robert W. Malone, M.D., https://tinyurl.com/56hy625x
FOIA Reveals White House Complicity in COVID Vaccine Cover-up. Forty-six pages inserted into the CDC’s 472-page response to a Freedom of Information Act request about myocarditis, although 80% redacted, revealed that they contained confidential communications with the President’s office and his most senior advisors, as Naomi Wolf explained to Steve Bannon (https://tinyurl.com/ym967pwv, start at 3:45 mark). This means that the Biden Administration knew about the reports of thrombotic thrombocytopenia and myocarditis, just as vaccine mandates were being imposed.
Joseph Guarino, M.D., Reidsville, NC
It’s Not ‘All or None.’ You do not have to eschew all vaccines to question each one. It is not “anti-vax” to investigate the safety or efficacy data we have on shots the CDC keeps adding, such as RSV—or to inform the public that CDC-recommended shots have no product liability (“take at your child’s own risk”). Not every disease needs to be prevented. Careful scrutiny of vaccine risks versus the disease risk in the targeted population should be undertaken in studies free of conflict of interest.
Jane L. Hughes, M.D., San Antonio, TX
The Curse of the Enlightenment. All its axioms are false, yet we believe them all. These are: secularism, egalitarianism, and the utilitarian axiom, that the test of morality is the greatest happiness of the greatest number. From secularism comes nihilism, anarchy, and eventually tyranny. Equality, the most insidious belief, leads to communism. From utilitarianism come Experts. To escape our predicament we need to purge all three axioms, in their totality.
William Briggs, Ph.D., https://tinyurl.com/39rc4e6r
SDOH Means Less Medical Care. The new CMS rule on payment policies (CMS-1784-P) has 36 mentions of Social Determinants of Health in its 936 pages. SDOH initiatives rely on intrusive data collection on all areas of an individual’s life, creating extensive profiles on American citizens through their medical records. Most patients are likely to feel pressured to provide the data, and may believe (falsely) that HIPAA protects their privacy. The SDOH drum beat is growing, posing an ever-increasing threat to freedom in and outside the exam room.
Twila Brase, R.N., P.H.N., https://tinyurl.com/2s7ccvxb
‘Lost’ Civics Education and COVID. Dr. Harvey Risch zeroed in on the violations of Constitutional liberties during COVID, stating that because Americans have become “culturally uneducated” regarding the “foundational ideas of our country,” many liberties protected by the Constitution were violated without complaint. Although there were frequent smallpox epidemics at that time, nothing was written into the Constitution about abrogating rights in the event of a public health emergency.
Susan Berry, Ph.D., https://tinyurl.com/mr2c7zzp
Freedom of Speech, Ended. As my compatriot Ezra Levant observed, one day the Danish Mohammed cartoons would come to be seen as a more consequential event than 9/11 in its lessons for a free society’s enemies. The Danish Government, 18 years later, proposes to criminalize the burning of the Koran and make it an offense punishable by fines and/or imprisonment. The Danes, gelded, are now the ones paying the Dane-geld.
Mark Steyn, https://tinyurl.com/2u75rdhp
CME Update. UCSF is offering a CME “intensive group workshop” on white racism, privilege, and power (https://tinyurl.com/358zxc78). The course should come with a warning: Caution, this course can be harmful to your intelligence. One goal of such courses, which are permeating major institutions, is to change language. An example from an email to USC faculty, staff, and students: “We have decided to remove the term ‘field’…and replace it with ‘practicum’…. Language can be powerful, and phrases such as ‘going into the field’ or ‘field work’ may have connotations for descendants of slavery and immigrant workers that are not benign.”
Craig J. Cantoni, Tucson, AZ
