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Wednesday, October 26, 2022

The Rise of the Biomedical Security State

 This essay is adapted from the forthcoming book, The New Abnormal: The Rise of the Biomedical Security State (Regnery Publishing, November 1).

“History doesn’t repeat itself,” said Mark Twain, “but it often rhymes.” This is among the reasons we look to the past, straining as best we can through the deepening fog of time to discern lessons for our own day. Analogies to the events that came before are always imperfect, but nevertheless often useful for understanding our present moment. Thus, only a historical myopia can explain why it’s become so common to describe the events involving the covid pandemic as “unprecedented,” even though pandemics have tended to occur every hundred years or so. This nearsightedness is also perilous given, for instance, the World Economic Forum’s “Great Reset Initiative” and the Bill & Melinda Gates Foundation’s recent pledge to spend $200 million on developing international biometric-based digital identifications. 

Consider prior regimes for which the pretext of “public safety” during an emergency paved the way for excessive state-sanctioned powers and to, in some cases, totalitarianism. Going back centuries, whenever the Roman Republic faced an acute existential threat, such as an invading army, the Senate would appoint a dictator with immense and far-reaching authority. Over a period of three-hundred years, dictators were appointed on ninety-five occasions. Upon termination of the crisis, each was required to quickly relinquish their authority. And they did so every time––except once, and that marked the beginning of imperial overstretch, and, ultimately, the collapse of the Roman Republic.

We should also recall that it was the unabashedly named Committee of Public Safety that carried out the French Revolution’s infamous Reign of Terror. Now I recognize that almost anyone who draws an analogy to the Third Reich is met with the charge of hyperbole. But one would be remiss not to mention Nazi Germany when specifically discussing historical cases of state-sanctioned authoritarian power being used in the name of “public safety.” It remains a sobering, instructive, and undeniable fact that Nazi Germany was governed for virtually the entirety of its existence under Article 48 of the Weimar Constitution, which allowed for the suspension of German law in times of an “emergency.”

If these historical examples seem alarmist, consider that Australia rounded up citizens exposed to covid, including asymptomatic people, and shipped them to detention facilities against their will. Videos of Australian detention centers made their way onto social media before tech censors dutifully scrubbed them from the internet. Canada likewise built detention facilities for infected and exposed persons.

Authoritarian measures during the pandemic went beyond detention of suspected or actual cases. The Medical Indemnity Protection Society (MIPS) is the singular authority for providing medical malpractice insurance in Australia. MIPS published “12 Commandments” to help physicians avoid disciplinary “notifications” by the country’s governing agency. MIPS Commandment #9 ominously warns Australian doctors that mentioning findings of a published scientific study not consistent with “public health messaging” could potentially result in them losing their ability to practice medicine.

Likewise, in the United States, the Federation of State Medical Boards (FSMB), an authority on medical licensure and physician discipline, passed a policy in May 2022 on disciplining physicians for “misinformation” and “disinformation” that will guide all state medical boards and, in turn, the nation’s physicians they license. It might even become state law. Stunningly, the very first example of non-compliance cited involves the FSMB’s October 6, 2020 assertion about the efficacy of cloth masks—an assertion later shown to be false. If the FSMB genuinely wanted to combat falsehoods, it would start by addressing the ones it promulgated during the pandemic. It could then move on to those disseminated by our public health authorities, who routinely flip-flopped on “The Science.”

My home state, California, took up the FSMB’s suggestion to codify its recommendations. I recently traveled to Sacramento to testify against this legislation in the State Senate. The law empowers the state medical board to discipline physicians for spreading “misinformation,” defined as statements that contradict the current scientific consensus (an ill-defined legal standard). Undermining its own central claims, the text of Assembly Bill 2098 made multiple statements about covid that were already outdated by the time I arrived in the capital, because—despite what our bureaucratic overlords posit—science constantly evolves. Alas, the controversial bill was ultimately voted into law last month, passing strictly along party lines.

Fortunately, biomedical authoritarianism is meeting additional resistance. Both physicians and patients in California oppose AB 2098 because they recognize that a doctor with a gag order is not a doctor that can be trusted. They also understand that censorship is anathema to scientific progress. Along with other physicians in California, I will soon file a lawsuit in federal court challenging AB 2098 on First Amendment free-speech grounds. I am confident that this law—which undermines the medical-informed consent process, and, ultimately, harms patients—will not withstand judicial scrutiny. The burgeoning grassroots medical-freedom movement constitutes the necessary corrective to what has with frightening rapidity become the new abnormal.

Dr. Aaron Kheriaty is a practicing psychiatric physician, Fellow at the Ethics and Public Policy Center, and Senior Fellow at the Zephyr Institute. 

https://www.realclearpolicy.com/articles/2022/10/25/the_rise_of_the_biomedical_security_state_861158.html

Unsafe, Illegal, on the Rise

 “Once we get the pills into the U.S., they can distribute them across the whole country.”

You’d be forgiven for thinking this quote came from a fentanyl kingpin rather than Veronica Cruz Sanchez, the founder of an illegal abortion pill ring, speaking to the Washington Post this week. 

Two years ago, one of us wrote about the abortion industry’s reckless efforts to dispense drugs via telehealth, which would make it impossible to adequately screen or counsel a patient but would still be prescribed by a doctor credentialed by the state and the U.S. Food and Drug Administration (FDA).

Ah, those halcyon days. Thanks to the Biden administration and its media accomplices pushing abortion on demand, we are now confronted with the “spiderweb” of unregulated, unverifiable pills being carried across the Mexican border and sent through the mail without any safeguards.

Dr. Kristyn Brandi, a spokesperson for the American College of Obstetricians and Gynecologists (ACOG), the group that led the de-medicalization of abortion drugs when it sued the FDA to force pills by mail in 2020, assures us that DIY abortion is safe “as long as the pills they receive are clearly labeled.”

The article proceeds to show photographs of broken pills sorted and packaged by volunteers with no medical background. When one “distributor” comments to another that she touched a dog with her pill-sorting gloves, a third replies: “We’re not f---ing doctors, we’re not health-care workers. Everyone is taking some risk in this somewhere along the line…”

One woman’s pills arrived in a cat flea medication bottle leading her boyfriend to question whether she should take them, worried that they could be laced with fentanyl. The organizer admits that sometimes distributors give them pills because they are “about to expire” and presumably could not be sold. We suspect this is not the safe, clear labeling Dr. Brandi has in mind.

These networks do not seem to know—or care—who uses their services, or if men are accessing these dangerous drugs to slip them into a woman’s food or drink and unknowingly cause an abortion. Who could forget when a male New York Times reporter celebrated the ease with which he obtained abortion pills online.

Cruz Sanchez assures us that she has never heard of anyone suffering severe medical complications from her pills, even though a recent peer-reviewed study shows that the rate of emergency room visits following a chemical abortion increased by over 500% between 2002 and 2015. Would you call the internet stranger whose drugs put you in the hospital?

The New Yorker tells a different story, in which Anna (a pseudonym) gave abortion pills to an acquaintance whose health was already “precarious.” When the woman became unreachable, Anna panicked and told a friend, “I don’t know if I can do this anymore. I thought I had killed somebody.” Fortunately, the woman was stabilized after her mother drove her to the emergency room; had she been home alone, the outcome could have been much worse.

The Mayo Clinic, not yet captured by pro-abortion ideology, recognizes the physical risks of chemical abortion, as well as its “emotional and psychological consequences.” It lists screening factors that make a woman ineligible for abortion drugs, including gestational age and ectopic pregnancy, which can only be determined through an in-person medical exam. Mayo Clinic says that “medical abortion isn’t an option if you… can't make follow-up visits to your provider or don't have access to emergency care” [emphasis in original].

No woman receiving drugs in the mail has been screened for medical contraindications, and she probably has not even been told that she should receive screening or follow up care. If she suffers complications, she is left alone to get herself to the emergency room. For women in rural areas, this could be deadly.

It is well-documented that chemical abortions result in four times as many complications as surgical procedures, and outcomes are worse if the abortion is miscoded as a natural miscarriage, which is common as women are increasingly told to “avoid mentioning abortion” in the ER.

Duffel bags of pills carried across the border is not medicine. Chemical abortion is never safe, nor is it anyone’s best option. Women deserve support and compassion, not expired drugs in a Mexican veterinarian’s discarded pill bottle.

Marjorie Dannenfelser is president of SBA Pro-Life America. Katie Glenn is SBA Pro-Life America’s state policy director.

https://www.realclearpolicy.com/articles/2022/10/26/unsafe_illegal_on_the_rise_861292.html

‘SAFE-T Act’ Is the Epitome of Political Hypocrisy

Politicians love to come up with clever acronyms that make bad legislation sound like something voters actually want. That’s exactly what they did with the so-called “SAFE-T Act” in Illinois.

Based on the title, you might expect that this law would have something to do with keeping people safe, right? Think again. What the SAFE-T Act really does is eliminate cash bail for people who commit heinous felonies such as second-degree murder, arson, drug-induced homicide, robbery, kidnapping, aggravated battery, burglary, intimidation, aggravated driving under the influence, fleeing and eluding, drug offenses, and threatening a public official.

And just in case you were wondering – no, that doesn’t mean that people who commit those crimes will be sitting in jail until their trial. Just the opposite, in fact. Under the SAFE-T Act, starting on January 1, 2023, accused murderers, arsonists, kidnappers, and other violent criminals will not be in jail at all before their trial. They will be free to roam the streets as before, despite the fact that they are potentially dangerous and undoubtedly desperate.

The only exception is if a prosecutor can prove to a judge with “clear and convincing evidence” that the defendant is either a flight risk or presents a “specific” threat to the community. The charges against them, in other words, are not enough to keep them jailed – the prosecutor must find substantial additional evidence that they are likely to commit another crime.

Our communities deserve better than this. The country is currently experiencing a crime wave of historic proportions, characterized by an explosion of violent crime that is primarily affecting urban areas.

So far this year in Chicago alone, there have been over 6,500 robberies; over 4,600 aggravated batteries; and over 5,700 burglaries – all crimes that will no longer involve pre-trial incarceration. In just one year, vehicle thefts have nearly doubled, while murder is up 30% since 2019. And that’s with two whole months left to go in 2022.

The victims of these crimes are disproportionately black and brown Americans, which means that the so-called SAFE-T Act is directly endangering communities of color.

That’s not what the politicians say, though. They say they’re protecting us from the criminal justice system, which is not only a scathing indictment of a system they themselves control, but also an insult to all law-abiding citizens.

If the politicians want to correct the inequities in policing and criminal justice that exist in our society – and they should – they are going about it all wrong. Instead of addressing bias against black and brown people, they are treating that bias like a foregone conclusion. Then, to make matters worse, they are telling us that because they feel (sort of) remorseful that the criminal justice system is biased against black and brown folks, they are going to release people they believe are violent criminals into our communities.

We do not deserve to be forced to live with potentially dangerous criminals in our midst. Would the politicians who voted for the SAFE-T Act want accused murderers wandering the streets of their subdivisions and gated communities? Of course not! But since those criminals will be concentrated in the inner cities, where our communities are located, they can pretend to be social justice warriors while sleeping easy in their beds at night, while we lie awake worrying because our children aren’t safe.

The SAFE-T Act is the ultimate example of how “politics as usual” fails communities of color. Politicians could take action that would actually make a positive difference in our communities, but it’s cheaper and easier to pass laws like the SAFE-T Act and pawn the problems off on us instead.

DaQuawn Bruce is the executive director of Concerned Communities for America, a 501(c)3 advocacy group.

https://www.realclearpolitics.com/articles/2022/10/26/the_safe-t_act_is_the_epitome_of_political_hypocrisy_148373.html

War Over 'Transgender' Kids: A Pre-Election Battlefield Update

 America is in the throes of a cultural and political war over gender ideology, featuring high-profile conflicts over everything from school curricula to athletics to pronouns.  

But among the most explosive battles unfolding within the broader war is that over transgender children. In an inhospitable election year for the left, Democrats, far from being on the back foot, have pushed ahead on this front, including this fall in California, New York, and Virginia with moves to curb parental rights. 

Days from the election, President Biden made clear the party’s broader position, telling a transgender activist that no state should be able to bar “gender-affirming healthcare” for kids. 

That can include puberty blockers, cross-sex hormones, and surgeries to remove or replace breasts and genitalia. Promoting such treatment  for the growing number of kids identifying as transgender are, on one side, the Biden administration; blue state governmentsmuch, though not all, of the medical establishment; educators; and activists. Opposing them are red state governments acting on behalf of outraged or concerned parents and other constituents, and buoyed by dissenting doctors.  

Divisions have deepened despite, as Reuters recently reported, a lack of “strong evidence of the efficacy” of the treatments at issue and despite their possible long-term consequences. Here is a timeline of major developments this year: 

February 2022

  • Attorney General Ken Paxton of Texas issued an opinion concluding that “performing certain ‘sex-change’ procedures on children, and prescribing puberty-blockers to them, is ‘child abuse’ under Texas law.”  

March


Gov. D
  • Florida Governor Ron DeSantis signed a bill into law that forbids instruction on sexual orientation and gender identity in kindergarten through third grade, a measure that opponents dubbed the "Don't Say Gay" bill.

  • The Justice Department’s Civil Rights Division issued a letter to all state attorneys general emphasizing its position that restrictions on transgender medical treatment could violate federal constitutional protections. 

  • After Idaho's House passed a bill prohibiting gender reassignment surgeries, puberty blockers, and hormone therapy in connection with transitioning, the Senate killed the bill claiming it undermined parental rights. 
  • Republican Governor Doug Ducey of Arizona signed into law a bill prohibiting sex reassignment surgery for those under 18 years old. 

April

  • The Justice Department challenged Alabama’s Vulnerable Child Compassion and Protection Act (VCAP), which prohibited doctors from performing surgeries on children in connection with transitioning, or providing children with puberty blockers and hormones. Days after the law went into effect, a federal judge in May temporarily halted the provisions pending an appeal by Alabama supported by 15 other states. 

May

  • Legislators in 19 states committed to introducing so-called “trans refuge state” bills to protect transgender children and families facing restrictive legislation from other states. 

June

  • Republicans in the Senate and House introduced companion pieces of legislation that would “allow individuals who suffered from an irreversible and potentially sterilizing gender-transition procedure as a minor to seek justice in court.” 

August  



  • A leaked State Department memo reveals the administration could classify countries permitting conversion therapy as human rights abusers, City Journal reported. 
  • The Department of Justice issued a sweeping subpoena to Eagle Forum of Alabama, a nonprofit advocate for Alabama’s contested VCAP law – a move seen by some as chilling since the subpoena required the organization to produce extensive information regarding its promotion of the legislation. Eagle Forum took the Justice Department to court to quash the subpoena, and the Justice Department backed down, dramatically scaling its subpoena to “1%” of its original demands, in the words of the judge presiding over the case.  
  • Georgia Republican Rep. Marjorie Taylor Greene introduced legislation that would make providing transgender medical treatment to minors a felony punishable by up to 25 years in prison. 

September

  • Democratic Governor Gavin Newsom of California signed into law a bill making the Golden State the nation’s first “sanctuary state” for children seeking transgender treatment without the knowledge or consent of their parents. The governor also signed into law a bill co-sponsored by Planned Parenthood that, according to the California Family Council, “prohibits insurance companies from revealing to the policyholder  the ‘sensitive services’ of anyone on their policy, including minor children ... ” – such services including transgender treatment. 

October

  • New York State state Senator Sen. Brad Holyman, a Democrat, introduced a bill that would similarly make New York a sanctuary state for transgender children. 

  • Virginia state delegate Elizabeth Guzman, a Democrat, announced she would introduce legislation under which parents could be criminally prosecuted for child abuse should they refuse to affirm their kids’ transgenderism. Amid national blowback over the bill, Guzman quickly recanted. 

  • Republican Governor Gov. Kevin Stitt of Oklahoma signed legislation conditioning $108.5 million in federal stimulus funds for the University of Oklahoma’s Children’s Hospital on its ceasing “gender reassignment medical treatment” for minors. The governor also called on Oklahoma to bar “irreversible gender transition surgeries and hormone therapies on minors” during the 2023 legislative session. Gov. Stitt finds himself in an unusually close race with Joy Hofmeister – the state superintendent of education – who switched parties from Republican to Democrat in 2021 to challenge him. 

  • Michigan Republican state Rep. Ryan Berman introduced a bill under which doctors, as well as parents or guardians, could face child abuse charges if they “knowingly or intentionally consent to, obtain, or assist with a gender transition procedure for a child” – with a maximum penalty of life in prison. 

  • The American Medical Association, American Academy of Pediatrics, and Children’s Hospital Association called on the Department of Justice to police purported social-media threats to doctors and medical facilities by opponents of transgender treatment. 
  • 13 state attorneys general, led by Republican Tennessee Attorney General Jonathan Skrmetti, responded to the AMA’s letter to the Justice Department with a letter of their own to Attorney General Merrick Garland, calling for the department to “stand down and allow the national conversation to continue,” citing medical data calling into question the efficacy of transgender treatment.  

Context 

  • 24 states and Washington D.C. prohibit transgender exclusions from health insurance coverage, whether involving a minor or an adult.

  • 26 states and Washington D.C. have Medicaid policies covering such transgender treatment, while 15 states have no explicit policy regarding such coverage and care—but do not prohibit it.   

  • Nine states have Medicaid policies explicitly excluding transgender treatment. 

Biogen upped to Buy from Neutral by Goldman

 Target to $370 from $220

https://finviz.com/quote.ashx?t=BIIB&ty=c&ta=1&p=d

FDA delays panel meet on Perrigo's OTC birth control pill

 The U.S. Food and Drug Administration has delayed a meeting of its advisory panel to discuss Perrigo Co Plc's over-the-counter (OTC) contraceptive, the drugmaker said on Wednesday.

The meeting, scheduled for Nov. 18, was delayed to review additional information, and no new date has yet been set, in a setback for what was expected to be the first approved daily OTC birth control pill in the United States.

Contraceptives have been in focus since abortion rights were sharply curtailed by the U.S. Supreme Court's decision about four months ago to overturn the landmark Roe v Wade ruling.

The health regulator had also extended the decision date for a possible approval decision by 90 days, Perrigo said.

The FDA did not immediately respond to a request seeking more information.

The drug, Opill, has been used with a prescription since its approval in 1973.

https://finance.yahoo.com/news/1-u-fda-delays-panel-124531963.html

Oncopeptides Sees Redemption with Positive Multiple Myeloma Data

 Oncopeptides released positive data Wednesday from the Phase III LIGHTHOUSE trial of Pepaxto (melflufen) in relapsed refractory multiple myeloma (RRMM) patients.

This comes one month after the FDA’s Oncologic Drugs Advisory Committee (ODAC) meeting in late September that resulted in a 14-2 vote against Pepaxto.

Pepaxto has been on the market in the U.S. since 2021 for multiple myeloma under an accelerated approval pathway. However, the OCEAN confirmatory study demonstrated mixed benefit results.

Although the drug is no longer on the market in the U.S. “due to regulatory hurdles,” the European Medicines Agency approved the drug on Aug. 18. This is in combination with dexamethasone to treat adults with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have shown disease progression on or after the last therapy.

The LIGHTHOUSE trial studied the efficacy and safety of the drug in combination with daratumumab subcutaneous (sc) plus dexamethasone compared to daratumumab sc with supportive dexamethasone. It was a confirmatory study in addition to the OCEAN trial.

LIGHTHOUSE was launched in Dec. 2020 and was expected to include 240 patients. But the FDA requested a partial clinical hold of all trials with the drug in July 2021. As a result, after 54 patients had been randomized, patient recruitment was halted.

In each treatment arm, 27 patients were randomized, with patient characteristics roughly equivalent between the two study arms. The efficacy and safety of the daratumumab sc control arm in the study were consistent with the approved labels in Europe and the U.S., with numerically higher PFS and overall response rate (ORR).

Even with the smaller number of patients enrolled, the PFS in the intent-to-treat (ITT) population was superior for the melflufen treatment arm compared to the control arm.

Maria-Victoria Mateos, M.D., Ph.D., lead investigator of the LIGHTHOUSE study, called the LIGHTHOUSE data "very encouraging," adding that the data "clearly indicate that the combination of melflufen and daratumumab has a clinical benefit in patients with RRMM."

Safety of the drug combination was consistent with what was seen in the Phase I/II ANCHOR trial, with clinically manageable cytopenias. ANCHOR assessed the melflufen plus dexamethasone combination with either daratumumab sc or bortezomib in RRMM patients.

Holding Out Hope for Another Chance with the FDA

In discussing the ODAC meeting with BioSpace in September, Jakob Lindberg, CEO of Oncopeptides, noted that in June, the drug received full approval in Europe for an earlier line of therapy. The company felt the earlier puzzling data had to do with confounding results related to the comparator drug, Bristol Myers Squibb’s Pomalyst (pomalidomide).

“We realized that the OS result was highly heterogeneous — astonishingly heterogeneous — that Papaxto almost doubled survival in the elderly compared to pomalidomide, while pomalidomide almost doubled survival in the young patients,” Lindberg told BioSpace. “Our point of this is this is driven primarily by pomalidomide.”

This also appears to be the perspective of the EMA, but so far, not the FDA.

“We wanted to have a dialogue with the FDA about this,” Lindberg said. “Because if we were right, it has large implications for how we treat patients.”

https://www.biospace.com/article/oncopeptides-lighthouse-trial-confirms-benefit-of-myeloma-drug/