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Judge’s Abortion Pill Opinion Tells The Truth About ‘Unborn Humans,’ And The Left Can’t Stand It


BY: MARGOT CLEVELAND | APRIL 10, 2023

Read more at https://thefederalist.com/2023/04/10/judges-abortion-pill-opinion-tells-the-truth-about-unborn-humans-and-the-left-cant-stand-it/

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In his 67-page straight-talking opinion, Judge Matthew Kacsmaryk stuck to the facts — something Americans desperately need to hear after decades of euphemistic discussions about abortion.

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“Unborn humans.” “Eugenics.” “Head, hands, and legs, with defined fingers and toes.” “Shame, regret, anxiety, depression, drug abuse, and suicidal thoughts.”

Federal Judge Matthew Kacsmaryk’s Friday decision freezing the FDA’s approval of the abortion-pill combination, mifepristone and misoprostol, included these phrases and more. And while the left is already attacking Kacsmaryk’s 67-page straight-talking opinion in Alliance for Hippocratic Medicine v. FDA by framing it as filled with anti-abortion rhetoric, the Trump appointee stuck to the facts — something Americans desperately need to hear after decades of euphemistic discussions about abortion.

After a brief introduction in which Kacsmaryk highlighted the FDA’s two decades of stonewalling that delayed a legal challenge to the 2000 approval of the abortion drugs, the court opened with the basic facts. The plaintiffs — doctors and medical associations that provide health care to pregnant and post-abortive women and girls — sued the FDA, challenging several administrative actions related to the approval of the chemical abortion drugs. 

‘Unborn Humans’

The court then explained the drugs and their functioning: “Mifepristone — also known as RU-486 or Mifeprex — is a synthetic steroid that blocks the hormone progesterone, halts nutrition, and ultimately starves the unborn human until death.” But “because mifepristone alone will not always complete the abortion,” the court continued, “the FDA mandates a two-step drug regimen: mifepristone to kill the unborn human, followed by misoprostol to induce cramping and contractions to expel the unborn human from the mother’s womb.”

Calling an unborn human an “unborn human” immediately triggered abortion activists, but as Kacsmaryk explained in a footnote, such terminology is scientifically correct, whereas the lawyers and courts “often use the word ‘fetus’ to inaccurately identify unborn humans in unscientific ways.”

“The word ‘fetus,’” Kacsmaryk explained, “refers to a specific gestational stage of development, as opposed to the zygote, blastocyst, or embryo stages.” And because the FDA’s approval of the abortion drugs applies at multiple “gestational stages,” the word “fetus” would be inaccurate.

It is understandable that abortion activists want to hide the humanity of unborn humans, but that doesn’t make the science less real: It just means girls and women who have bought the “clump of cells” narrative will suffer when faced with the truth, which chemical “at home abortions” force. 

“The mother seeing the aborted human ‘appears to be a difficult aspect of the medical termination process which can be distressing, bring home the reality of the event and may influence later emotional adaptation,’” the court wrote, based on the record evidence. “For example, one woman was surprised and saddened to see that her aborted baby ‘had a head, hands, and legs’ with ‘[d]efined fingers and toes.’” 

Another woman alleged that “she did not receive an ultrasound or any other physical examination before receiving chemical abortion drugs from Planned Parenthood.” According to the record, “The abortionist misdated the baby’s gestational age as six weeks, resulting in the at-home delivery of a ‘lifeless, fully formed baby in the toilet,’ later determined to be around 30-36 weeks old.” 

Harm to Women

Beyond exposing the reality that abortion kills an unborn human, Kacsmaryk’s opinion also refuted the “popular belief and talking points” that using the abortion pill is “as easy as taking Advil.” Here, the federal judge detailed the factual evidence. Among other things, “bleeding from a chemical abortion, unlike surgical abortion, can last up to several weeks,” and by being done at home, “without physician oversight,” it can lead “to undetected ectopic pregnancies, failure of rH factor incompatibility detection, and misdiagnosis of gestational age — all leading to severe or even fatal consequences.” 

The opinion also countered the claim that side effects are rare by highlighting evidence that “over sixty percent of women and girls’ emergency room visits after chemical abortions are miscoded as ‘miscarriages’ rather than adverse effects to mifepristone.” 

The evidence also shows emotional and psychological injury, Kacsmaryk stressed, with 77 percent of women who underwent a chemical abortion reporting “a negative change” after the at-home abortion, and 38 percent of women reporting issues “with anxiety, depression, drug abuse, and suicidal thoughts because of the chemical abortion.” 

While the abortion industry prefers to cite its own evidence, as Kacsmaryk noted, those studies are flawed both because of the miscoding of chemical abortions as miscarriages and because the FDA stopped requiring the reporting of non-fatal adverse reactions.

Eugenic Roots

The left also didn’t like Kacsmaryk exposing the eugenic beliefs of the Population Council, which had sought FDA approval for the abortion drugs. John D. Rockefeller founded the Population Council in 1952, “after he convened a conference with ‘population activists’ such as Planned Parenthood’s director and several well-known eugenicists,” the court wrote. Attendees of that conference discussed “the problem of ‘quality,’” and concluded that “[m]odern civilization had reduced the operation of natural selection by saving more ‘weak’ lives and enabling them to reproduce,” thereby resulting in “a downward trend in … genetic quality.”

“[m]odern civilization had reduced the operation of natural selection by saving more ‘weak’ lives and enabling them to reproduce,” thereby resulting in “a downward trend in … genetic quality.” …….. “Natural Selection”????? Can you say, “disciples of Margarete Sanger”?

Many Americans remain oblivious to the historical backdrop eugenics played to the abortion movement, and activist groups prefer they remain in the dark. The sunlight Kacsmaryk shined upon that truth infuriates them.

Political Pressure

Judge Kacsmaryk also exposed the political pressure placed on the FDA to approve the abortion drug — something Americans are likely to appreciate more today in the aftermath of the FDA’s hasty approval of the Covid mRNA shots. 

In the case of the abortion pill, the FDA took the unprecedented step of arranging a meeting between the French pharmaceutical company that owned the patent rights and the eventual drug sponsor, the Population Council. “The purpose of the FDA-organized meeting was ‘to facilitate an agreement between those parties to work together to test [mifepristone] and file a new drug application.’” 

Evidence further shows the Department of Health and Human Services “initiated” another meeting to determine how the Clinton administration “might facilitate successful completion of the negotiations” between the French firm and the Population Council to ensure the group secure patent rights and eventual FDA approval.” In fact, Clinton’s HHS secretary “believed American pressure on the French firm was necessary.”

Then after the Population Council submitted a new drug application, the FDA proposed detailed restrictions to address safety concerns, including that the drug be administered by doctors “trained and authorized by law” to perform surgical abortions; trained in administering mifepristone and treating adverse events; and able to provide treatment at a medical facility that had the equipment necessary to perform surgical abortions, resuscitation procedures, and blood transfusion, within one hour’s drive. The FDA’s restrictions were leaked to the press, prompting a political firestorm. 

So Much for Safety

The FDA later abandoned the above safety mandates and approved the drug for use to kill unborn humans aged seven-weeks gestation or younger. The FDA further required three “in-person office visits: the first to administer mifepristone, the second to administer misoprostol, and the third to assess any complications and ensure there were no fetal remains in the womb.” All adverse events were also required to be reported. 

In 2002, the FDA removed even more of the safety restrictions, increasing the maximum gestational age from seven-weeks gestation to 10-weeks gestation, reducing the number of office visits from three to one, increasing the drug dosage, allowing non-doctors to prescribe and administer chemical abortions, and eliminating the requirement for non-fatal adverse reactions to be reported. Then in 2019, the FDA approved a generic version of the abortion pills, and on April 12, 2021, the FDA announced it would allow abortion pills to be dispensed through the mail. 

“Whether FDA abandoned its proposed restrictions because of political pressure or not,” the court wrote, “one thing is clear: the lack of restrictions resulted in many deaths and many more severe or threatening adverse reactions.” But “due to FDA’s lax reporting requirements, the exact number is not ascertainable,” Kacsmaryk stressed. 

Straight Facts

But it was not on politics that Kacsmaryk based his decision to freeze the FDA’s approval of the abortion pill. Rather, in his methodical opinion, the federal judge explained that the FDA lacked the authority to accelerate approval of the drug under what is called “Subpart H” of the FDA. That subpart only allows for accelerated approval of drugs that treat “serious or life-threatening illnesses” — something pregnancy is not. 

Kacsmaryk also concluded the evidence the FDA supposedly relied upon to approve the abortion drugs failed to support the conclusion that they were “safe and effective under particular conditions of use.” And finally, Kacsmaryk held the FDA’s approval of mail distribution violated the 1873 Comstock Act, which makes it illegal to use the mail to deliver any “article or thing designed, adapted, or intended for producing abortion.” 

The Biden administration has already filed a notice of appeal with the Fifth Circuit Court of Appeals, and in issuing his opinion in Alliance for Hippocratic Medicine v. FDA, Kacsmaryk entered a temporary stay, which he or the court of appeals will likely make permanent pending resolution of the case. Thus, abortion pills will remain available for now. 

How the Fifth Circuit and eventually the Supreme Court will rule remains to be seen, but what is clear now is the abortion-loving left is desperate to keep the truth about abortion from the public and is furious that Kacsmaryk dared to expose the reality: Abortion kills unborn humans.

Margot Cleveland is The Federalist’s senior legal correspondent. She is also a contributor to National Review Online, the Washington Examiner, Aleteia, and Townhall.com, and has been published in the Wall Street Journal and USA Today. Cleveland is a lawyer and a graduate of the Notre Dame Law School, where she earned the Hoynes Prize—the law school’s highest honor. She later served for nearly 25 years as a permanent law clerk for a federal appellate judge on the Seventh Circuit Court of Appeals. Cleveland is a former full-time university faculty member and now teaches as an adjunct from time to time. As a stay-at-home homeschooling mom of a young son with cystic fibrosis, Cleveland frequently writes on cultural issues related to parenting and special-needs children. Cleveland is on Twitter at @ProfMJCleveland. The views expressed here are those of Cleveland in her private capacity.

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Biden Admin Pushes Transgender Medical ‘Care’ While Quietly Bankrolling Research Showing Its Risks


BY: ANONYMOUS | FEBRUARY 28, 2023

Read more at https://thefederalist.com/2023/02/28/biden-admin-pushes-transgender-medical-care-while-quietly-bankrolling-research-showing-its-risks/

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NIH is funding many studies premised upon how little research has been conducted on the long-term health risks of cross-sex hormones. Yet HHS is pushing for more transgender ‘care.’

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As the Biden administration pushes the Department of Health and Human Services to make “gender-affirming health care” more widely available, HHS’s own National Institutes of Health is funding multiple studies premised upon how little research has been conducted on the long-term risks of taking cross-sex hormones and whether they improve mental health. The NIH research on transgender issues also emphasizes intersectionality and about half has been on HIV prevention. 

The NIH Reporter database, which lists active federally funded research projects, shows 74 with “transgender” in the title, totaling more than $26 million of taxpayers’ money annually. Several NIH-funded studies examine specific health risks of cross-sex hormone treatment — such as associated bone loss and possible increased risk of thrombosis, drug overdose, heart attack, and stroke.

Only a few studies evaluate the risk of infertility, even though “the impact of long-term cross-sex hormone therapy on reproductive health is largely unknown,” as one such project states and experts have warned. In contrast, seven studies examine stigma and disparities in health care for transgender people, in response to NIH’s Notice of Special Interest in understanding the role of alleged intersectional stigmas and how they harm health.

Many studies address higher incidence of sexually transmitted infections in transgender people, and whether hormone therapy might increase that risk. About half of all NIH-funded research on transgender health, including that which has been completed, relates to HIV prevention among the transgender population, totaling approximately $80 million since 1985.

Transgender males “have some of the highest concentrated HIV epidemics in the world, with a pooled global prevalence of 19% and a 49-fold higher odds ratio of acquiring HIV than non-transgender adults,” according to one project summary. Behavioral factors contribute, another project says, but the role of sex hormones needs further study, since they “are known to modulate the immune response, resulting in changes in host susceptibility to pathogens, vaccine efficacy and drug metabolism.”

Many Ongoing Projects Highlight Lack of Research

While suicide prevention is often cited as a major reason to give dysphoric children puberty blockers and cross-sex hormones, only one of the current studies is focused specifically on suicide risk, although several emphasize the lack of long-term studies of cross-sex hormones administered to children and their relation to mental health.

Medical professionals “say more specific research is needed to determine whether medically transitioning as a minor reduces suicidal thoughts and suicides compared with those who socially transition or wait before starting treatment,” according to Reuters.

One NIH-funded project summary acknowledges that the long-term effect of puberty suppression on mental health needs further study and will evaluate children already taking puberty blockers.

During puberty, hormones change the structure and organization of the brain. Puberty blockers “may also disrupt puberty-signaled neural maturation in ways that can undermine mental health gains over time and impact quality of life in other ways,” the Nationwide Children’s Hospital project summary says. “The overall impacts” of puberty blockers “have not been systematically studied,” the summary says.

One of the larger NIH-funded transgender studies, funded at $743,000 annually, is at Boston Children’s Hospital. It notes, “Little is known [emphasis added] about how pubertal blockade, the first step in the medical management of a young transgender adolescent, affects bone health and psychological well-being. … In an exploratory aim, we will also consider the effect of pubertal blockade on anxiety, depression, and health-related quality of life.”

Another research project, “Psychological consequences of medical transition in transgender youth,” begun last year at Princeton University and anticipated to end in 2025, notes the lack of quality research in this area:

Five studies to date have longitudinally examined the relationship between one or both of these interventions [puberty suppression and hormone therapy] and mental health in transgender youth. However, these studies have had relatively small samples, none have been able to isolate the effects of endocrine interventions, none have included a cisgender [non-transgender] comparison group, and none have examined the mechanisms by which endocrine interventions might improve mental health.

A longitudinal study that began in 2015 and will run through at least 2026 acknowledges, “Transgender children and adolescents are a poorly understood and a distinctly understudied population in the United States. … Continuing our current research is imperative to expand the scant evidence-base currently guiding the clinical care of TGD [transgender and gender diverse] youth and thus, is of considerable public health significance.”

As the summary of one ongoing NIH-funded research project on sex hormones’ effects on the developing brain says, “There is little to no empirical data guiding clinical practices” of cross-sex hormone therapy in early pubertal adolescents, “highlighting the need for further research to address the critical knowledge gap.” The research, funded at $3 million so far to Stanford University, “will provide a much-needed foundation for understanding the longitudinal impact of treatments that are already being used [emphasis added] in clinical settings.”

The project will elucidate “how sex hormone therapy alters sex-specific risk for disease … and [its] impact on neural networks implicated in psychiatric disorders.” The research proposed “has never been conducted in early pubertal adolescents,” the summary reads.

NIH Acknowledges Limited Evidence, FDA Hasn’t Approved

The NIH, the largest public funder of biomedical research in the world, told Reuters that “the evidence is limited on whether these treatments pose short- or long-term health risks for transgender and other gender-diverse adolescents.” Additionally, the Food and Drug Administration has not approved puberty blockers and sex hormones for children’s transgender medical interventions. As Reuters reported:

No clinical trials have established their safety for such off-label use. The drugs’ long-term effects on fertility and sexual function remain unclear. And in 2016, the FDA ordered makers of puberty blockers to add a warning about psychiatric problems to the drugs’ label after the agency received several reports of suicidal thoughts in children who were taking them. More broadly, no large-scale studies have tracked people who received gender-related medical care as children to determine how many remained satisfied with their treatment as they aged and how many eventually regretted transitioning.

Countries such as Finland, Sweden, and the United Kingdom have begun to limit children’s access to transgender health interventions. Early, foundational research from 2011 on transgender medical interventions has been criticized as failing to meet basic research standards.  

Before 2012, “there was no scientific literature on girls ages eleven to twenty-one ever having developed gender dysphoria at all,” according to Abigail Shrier’s book “Irreversible Damage.” Studies show most children grow out of gender dysphoria, Shrier says.“There are no good long-term studies indicating that either gender dysphoria or suicidality diminishes after medical transition,” according to Shrier.

Yet Biden Administration Pushes Transgender ‘Care’

Meanwhile, despite all the possible health risks, President Joe Biden has issued executive orders charging “HHS to work with states to promote expanded access to gender-affirming care.” The administration has issued directives that federal health insurance benefits must “provide comprehensive gender-affirming care.” The administration also opposes “conversion therapy — efforts to suppress or change an individual’s sexual orientation, gender identity, or gender expression.”

Taxpayers are already paying for transgender procedures, as they are covered by some insurers and Medicaid in some states. 

I’ll ask again. WHY ARE THESE MENTAL PATIENT LEFTEST SO HYPER ABOUT MUTILATING AMERICA’S CONFUSED CHILDREN? WHAT IS THEIR END GAME?

HHS’s Office of Population Affairs, which is overseen by transgender Dr. Rachel Levine, states there’s no debate: “Research demonstrates that gender-affirming care improves the mental health and overall well-being of gender diverse children and adolescents.” Other proponents acknowledge a lack of research on these hormones’ effect on brain development, but say the pros outweigh the cons.

Growing Transgender Identification

The number of transgender adults in the U.S. is estimated at 1.4 million to 2 million, with an estimated 150,000 to 300,000 transgender children. The number of American children who started on puberty blockers or hormones totaled 17,683 from 2017 to 2021 and has been increasing, according to Reuters.

From 2019 to 2021, at least 56 patients ages 13 to 17 had genital surgeries, and from 2019 to 2021, at least 776 children that age had mastectomies, not including procedures that weren’t covered by insurance, according to Reuters.

The transgender surgery industry grosses more than $2 billion annually and expects to double that by 2030.

Debate Among Medication Providers

“Puberty delay medications are safe and effective,” according to the World Professional Association for Transgender Health (WPATH), a pro-transgender organization that sets standards for trans medical interventions. “Every person, including every TGD person, deserves an opportunity to be their true selves and has the right to access medically-necessary affirming care to enable this opportunity,” WPATH says.

When WPATH recently updated its guidance, authors “were acutely aware that any unknowns that the working group acknowledged — any uncertainties in the research — could be read as undermining the field’s credibility and feed the right-wing effort to outlaw gender-related care,” The New York Times reported. The newspaper is in the midst of an internal fight about its coverage of transgender issues, with some saying it has been too critical of transgender medical interventions.

A draft of the WPATH chapter for adolescents included minimum recommended ages for hormone treatments and breast removal or augmentation, but after criticism from providers and transgender activists, “it was determined that the specific ages would be removed to ensure greater access to care for more people,” WPATH said.

The final guidelines also walked back a recommendation that preteens and teenagers should provide evidence of several years of persistently identifying as transgender, to differentiate from kids whose change in identification is recent, and changed it to a vaguer “sustained” gender incongruence. “In the end, the chapter sided with the trans advocates who didn’t want kids to have to wait through potentially painful years of physical development,” according to the Times.

The final guidelines acknowledged that because of the limited long-term research, treatment without a comprehensive diagnostic assessment “has no empirical support and therefore carries the risk that the decision to start gender-affirming medical interventions may not be in the long-term best interest of the young person at that time.”

Reuters found that gender facilities across the country are not conducting recommended months-long assessments before administering hormones to children. Parents of 28 of 39 minors who had sought transgender interventions told Reuters they “felt pressured or rushed to proceed with treatment.” Gender-care professionals also said some of their peers are “pushing too many families to pursue treatment for their children before they undergo the comprehensive assessments recommended in professional guidelines.”

Studying Causes of Gender Dysphoria

Some of the taxpayer-funded studies may bring clarity to the issue of gender dysphoria by examining its causes. One study will examine social media’s influence on children becoming transgender. A second will study “the life history calendar to examine young transgender women’s trajectories of violence, mental health, and protective processes.”

Another government-funded study will help determine how chromosomes, sexual organs, and hormones combine to create sex differences. Another will “uncover genetic underpinnings of female sexual orientation.”

This byline marks several different individuals, granted anonymity in cases where publishing an article on The Federalist would credibly threaten close personal relationships, their safety, or their jobs. We verify the identities of those who publish anonymously with The Federalist.

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12 Ways the New Congress Should Hold Big Pharma Accountable for Covid Evils


BY: DAVID THALHEIMER | NOVEMBER 29, 2022

Read more at https://thefederalist.com/2022/11/29/12-ways-the-new-congress-should-hold-big-pharma-accountable-for-covid-evils/

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We need to recognize what contributed to the insane pandemic response and implement solutions to make sure nothing like it ever happens again.

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The Covid-19 pandemic has exposed a crisis of confidence in our so-called elites and technocrats, who are supposed to serve the public but instead appear to have been serving themselves. So, what do we do to restore sanity and medical freedom and make sure a public health disaster never happens again? Some suggest “amnesty” for those who went to extremes during the pandemic. Absolutely not. What we need is to recognize what contributed to the insane pandemic response and implement solutions to make sure nothing like it ever happens again.

Now that the GOP has a majority in the House and some members want to hold Anthony Fauci, the director of the National Institute of Allergy and Infectious Disease (NIAID), and others accountable, here are 12 steps Congress can take to curb future pharma corruption and malfeasance.

None of these should be considered partisan since both parties should share the objective of avoiding another pandemic disaster. However, the pharmaceutical and health industry makes substantial contributions to elected officials on both sides of the aisle, with more than $361 million spent on lobbying in 2021 and an all-time high of $92 million in political contributions in 2020 (62 percent to Democrats and 38 percent to Republicans), so implementing reforms will be a challenge no matter who controls the House or the Senate.

Early in 2022, Sen. Rick Scott, R-Fla., published a 12-point plan to rescue America. Curiously, not a single point of his plan addressed the pandemic even though it was the worst health catastrophe in a century that also triggered authoritarian medical mandates and censorship never before seen in this country.

What is the common denominator between the pharmaceutical companies, the public health bureaucracy, medical associations, the corporate media, and Big Tech companies when it comes to censorship and medical misinformation? Money, of course.

According to Statista, the pharmaceutical and medical industry spent $5.6 billion on U.S. television advertising in 2021, second only behind the life and entertainment industry at $10.1 billion. For reference, total U.S. TV ad spending is expected to exceed $68 billion in 2022. According to eMarketer, pharmaceutical and health care companies combined spent an estimated $9.5 billion on digital media in 2020, with 56 percent going toward search advertising, dominated by Google and Facebook, which have aggressively censored medical information that deviated from the official public health narrative. This accounted for about 7.1 percent of all U.S. digital ad spending.

The pharma industry pays, in the form of user fees, for 75 percent of the FDA’s drug review budget, according to Forbes, and 45 percent of its overall budget. One investigation showed that 40 of 107 physician advisers on the FDA committees examined “received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms.”

According to an analysis by the Journal of American Physicians and Surgeons, the Centers for Disease Control and Prevention (CDC) has numerous conflicts of interest, including openly accepting private gifts through the CDC Foundation, accepting supposedly “prohibited” donations, and “automatic” conflict of interest waivers for advisory committee members. In 2010, the CDC inspector general noted a “systemic lack of oversight” of its ethics program. The CDC uses taxpayer money to develop patents and then receives money from pharma companies in the form of licenses and royalties.

The NIAID, headed by Fauci, also accepts donations, such as a $100 million pledge by Bill Gates for work on gene therapies.

Individual public health officials and scientists, including Fauci and former NIH Director Francis Collins, receive royalties on patents used by the industry, teaching hospitals accept industry donations, and doctors accept “consulting fees,” and other travel and meals payments from pharma companies when they promote their products. Medical associations, such as the American Medical Association, accept pharma money while promoting drug-based medicine and discrediting alternative medicine and other competitors. Some professional societies that are involved with the development of clinical practice guidelines also have financial conflicts of interest.

Is it any wonder why the public health authorities, medical associations and hospitals, the news media, and Big Tech have attempted to censor any information that contradicted the pro-pharma narratives?

Congress could pass one comprehensive law to effectively undercut the corruption behind the censorious Big Tech companies, the corporate media, and the corrupt public health establishment. Such a law would consist of several simple common-sense reforms to combat financial incentives that promote corruption and tyrannical behavior.

  1. Re-impose the ban on direct-to-consumer pharmaceutical advertising. Pharmaceutical companies spend billions of dollars on advertising, which has made both Big Tech and corporate media companies vulnerable to influence, leading to censorship and search engine result manipulation.
  2. Prohibit pharmaceutical companies from contributing to the campaigns of any political candidate or any political action committee for a period of 25 years if they have been fined or agreed to settlements of more than $100 million for violations of the False Claims Act, Medicare fraud, kickbacks, failure to disclose safety data, making misleading statements about drug safety, poor manufacturing practices, or off-label promotion. Since most pharma companies have been fined from hundreds of millions to billions of dollars, this would effectively prohibit them from making political contributions to suppress government oversight and regulation.
  3. Prohibit state medical boards and associations that accept state or federal funds from accepting funds from pharmaceutical companies. Those donations are a corrupting influence on the entire medical establishment, which has backed medical discrimination and tyrannical mandates. Instead, allocate public funds, paid for by higher taxes on pharma products, to support reputable medical boards and professional associations and enforce strict conflict-of-interest policies.
  4. Prohibit medical journals that accept state or federal funds from accepting funds from pharmaceutical companies. Such funding is a corrupting influence on the journals, some of which have censored truthful medical studies or published fraudulent studies designed to suppress alternative treatments or challenge pharmaceutical company safety and efficacy claims. Instead, allocate public funds, paid for by higher taxes on pharma products, to support reputable journals that publish federally funded medical research and enforce strict conflict of interest policies.
  5. Revoke laws granting pharmaceutical companies’ immunity from liability for vaccines or other products that cause death or harm. Pharmaceutical companies will no longer have an incentive to offer products that are improperly tested or do not meet reasonable safety standards and will need to pay more attention to safety. People who are harmed will be able to file lawsuits for financial restitution and bring public attention to the harm that is being done. Also prohibit the government National Vaccine Injury Compensation Program from requiring victims to agree to a non-disclosure (gag) agreement when they settle an injury claim, thus providing public transparency to vaccine injuries.
  6. Require pharmaceutical companies that supply products to deal with a declared public health emergency, or produce products developed with federal research and development funding, to sell at a limited profit margin of, for instance, 5 percent. Pharmaceutical companies should not be allowed to use public funds in a public health emergency to make billions of dollars in profits. This should mitigate any incentive to exaggerate the threat of future pandemics, engage in unsafe gain-of-function research, or push for medical mandates to force the use of pharmaceutical products.
  7. Pass a medical professional bill of rights that prohibits discrimination against medical professionals who do not agree with public health authorities on treatments. This includes threats of firing or decertification and attempts by public officials and medical associations to prevent doctors from lawfully treating patients using off-label medications or questioning the safety, efficacy, and need for pharmaceutical products. Impose civil or criminal penalties for public officials, private organizations, or medical professionals that engage in such discrimination.
  8. Pass a medical consumer bill of rights that prohibits medical coercion and discrimination, including medical mandates that abrogate the doctor-patient relationship without consent or a complete disclosure of risks. Impose civil or criminal penalties for public officials, private organizations, or medical professionals that engage in such discrimination.
  9. Limit corruption in the federal public health establishment by creating independent medical and scientific advisory commissions appointed by state legislatures that can override decisions made by the FDA, CDC, NIAID, and other federal public health bureaucracies. Doctors and scientists appointed to such commissions must be free of financial conflicts of interest with medical industries over which they provide oversight.
  10. Create an independent, publicly funded drug safety monitoring organization that accepts no funding or royalties from pharmaceutical companies and has no role in the promotion or approval of pharmaceutical products. Oversight of this organization will also be provided by scientific advisory commissions appointed by state legislatures, whose members must be free of financial conflicts of interest with the medical industries over which they provide oversight.
  11. Prohibit public health officials from holding investments in medical companies and receiving income from patents related to work conducted while in government service.
  12. Limit terms of office for senior officials in public health to four years and impose a lifetime ban on employment by or representation of a medical company that they previously regulated.

These comprehensive reforms would help to remove corrupting financial incentives and decentralize federal public health oversight. The current environment rewards corruption and tyrannical behavior, which must be fought by eliminating bad incentives and replacing them with higher standards of personal integrity and transparency. There should be no amnesty for bad decisions that resulted in violations of human rights — only accountability and solutions designed to prevent them from ever being made again. As we have long been told, “those who fail to learn from history, are doomed to repeat it.”

David Thalheimer is a graduate of George Washington University, Harvard University, the Air War College, and the National Intelligence University. He retired from the U.S. Air Force as a colonel and now works as an engineer in the field of cybersecurity.

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Biden’s FDA Has Reportedly Not Proven Any Babies Died From Baby Formula


REPORTED BY DYLAN HOUSMAN, HEALTHCARE REPORTER | May 13, 2022

Read more at https://dailycaller.com/2022/05/13/fda-baby-formula-shortage-abbott-bacteria-plant/

Biden's FDA May Have Played A Huge Part In The Baby Formula Shortage
(Photo by Drew Angerer/Getty Images)

President Joe Biden’s Food and Drug Administration (FDA) may have directly contributed to the ongoing nationwide baby formula shortage without proving any babies died from baby formula.

The FDA announced Feb. 17 that a major Abbott Nutrition plant in Michigan, responsible for producing massive quantities of baby formula, was under investigation for links to bacterial outbreaks, including salmonella. The agency helped Abbott initiate a recall of its baby formula. Yet neither the Centers for Disease Control and Prevention (CDC) nor the FDA have been able to prove that any babies got sick from Abbott’s formula, according to The Wall Street Journal.

There were two types of infections initially reported to the FDA, and linked back to the Abbott facility: Cronobacter sakazakii and salmonella. FDA inspectors found bacteria at the Abbott plant, but the company has strongly denied that it’s actually responsible for the reported infections, according to the outlet.

The company claims the evidence is on their side. The places at the facility where FDA inspectors found bacteria were not in contact with formula products, and genetic tests performed by the CDC determined that the cronobacter strains in the facility did not match those which caused the infections, according to The WSJ, citing Abbott. That hasn’t stopped the Biden administration from blaming Abbott for the shortage. White House press secretary Jen Psaki said that the cause of the shortage was not anything to do with the Biden administration, but was caused by Abbott making “unsafe” baby formula. (RELATED: Lawmaker Says Migrants Are Getting ‘Pallets’ Of Baby Formula Amid Nationwide Shortage)

“The issue here is that a manufacturer was taken offline because they did not produce a safe baby formula,” Psaki said Thursday. “I think it’s also important to note that the reason we’re here is because the FDA took a step to ensure that babies were taking safe formula. There were babies who died from taking this formula, so they were doing their jobs.”

Abbott said it will begin ramping production back up next week, if approved by the FDA, the WSJ reported. But it will take weeks for the facility to get fully back online, the company said, meaning the shortage intensified by supply chain woes and inflation could continue. 

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After FDA says it can release COVID-19 vaccine data by 2097, federal judge orders all info to be shared this year


Reported by PAUL SACCA | January 07, 2022

Read more at https://www.theblaze.com/news/fda-vaccine-data-release-judge/

The Food and Drug Administration was told that it can’t take 75 years to release COVID-19 vaccine data. On Thursday, a federal judge in Texas ordered the FDA to greatly increase the number of documents it releases each month that pertain to the agency’s approval process for the Pfizer-BioNTech COVID-19 vaccine.

Public Health and Medical Professionals for Transparency launched a Freedom of Information Act suit against the FDA in August. The international group consists of “public health professionals, medical professionals, scientists, and journalists,” including academics and medical experts from Yale, Harvard Medical School, and UCLA.

The nonprofit organization “exists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines” and “takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses.”

The FOIA request asked the FDA to expedite the release of roughly 450,000 pages of material regarding the COVID-19 vaccine that was used by the health agency during the process of Pfizer’s COVID-19 vaccine licensing approval. The FDA said it could only release 12,000 pages by the end of January and a “minimum” of 500 pages a month thereafter – which means it could be the year 2097 before all of the documents are made public. The FDA blamed staffing issues as the reason for the slow pace of the release of the documents, claiming that it only has 10 employees to review FOIA requests.

“It is important for the FDA to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request,” Suzann Burk – who heads the FDA’s Division of Disclosure and Oversight Management – said in a declaration filed with the court.

Burk noted that it takes a worker eight minutes per page to perform a close review of the documents.

U.S. District Judge Mark Pittman in Fort Worth ordered the FDA to significantly increase the output of the data release.

“The Court concludes that this FOIA request is of paramount public importance,” Pittman – who was appointed to the bench by former President Donald Trump in 2019 — declared.

In his four-page order, Pittman quoted a statement that James Madison wrote in a letter to W.T. Barry in 1822, “A popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which knowledge gives.”

Pittman also cited a 1962 quote from former President John F. Kennedy, “A nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”

Pittman ordered the FDA to produce 55,000 pages every 30 days, “with the first production being due on or before March 1, 2022, until production is complete.” This forces the FDA to release all of the Pfizer vaccine data by the end of the summer instead of by 2097.

Attorney Aaron Siri – who represents Public Health and Medical Professionals for Transparency – reacted to the federal judge’s decision.

“This is a great win for transparency and removes one of the strangleholds federal ‘health’ authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission,” Siri wrote on his Substack account.

“No person should ever be coerced to engage in an unwanted medical procedure,” he added. “And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead. That form of governance is destructive to liberty and antithetical to the openness required in a democratic society.”

Reuters reported, “The Justice Department, which represented the FDA in the litigation, did not immediately respond to a request for comment on Thursday evening. Pfizer, not a party to the suit, also did not immediately respond to a request for comment.”

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