RUTHFULLY YOURS

https://issuesinsights.com/2023/07/20/fdas-approval-of-a-new-alzheimers-drug-is-a-real-but-very-modest-advance/

The Food and Drug Administration on July 6 granted full approval to the first therapy for Alzheimer’s that slows the cognitive decline associated with the disease. That “first” is good news, because it validates a therapeutic approach that has long been in doubt, but more important, it benefits patients afflicted with a terrible disease. 

The approval is hardly a breakthrough, however: The benefits of the drug, Leqembi (lecanemab) are meager; it does not restore lost function; it is expensive and administered intravenously every two weeks; and there are occasionally severe side effects. Nevertheless, my neurologist friends tell me that they’re being inundated with inquiries about Leqembi from Alzheimer’s patients and their families.

Alzheimer’s disease is an irreversible, progressive brain disorder that afflicts more than 6.5 million Americans. It slowly destroys memory and cognitive skills and eventually, the ability to perform even simple tasks. Although the specific causes of Alzheimer’s are not fully understood, it is characterized by changes in the brain, including the formation of various abnormal structures that result in loss of neurons and their connections. 

The FDA had previously granted Leqembi accelerated approval based on a “surrogate endpoint” short of demonstrated clinical benefit, based on its ability to reduce amyloid plaques, or clumps, in the brain, a hallmark of Alzheimer’s. As a postmarketing condition of the accelerated approval, the drug manufacturer, Eisai, was required to conduct a clinical trial to confirm the anticipated clinical benefit of Leqembi.  Safety and efficacy were evaluated in a Phase 3 multicenter, randomized, placebo-controlled clinical trial that included 1,795 patients.

That confirmatory trial, which was reported earlier this year in the New England Journal of Medicine, showed that in patients in the early stages of the disease, the drug slowed cognitive and functional decline modestly – perhaps by about five months – over 18 months compared with placebo.

https://www.wsj.com/articles/the-doctor-wont-see-you-now-psychology-white-supremacy-politics-9a3c32b5?mod=opinion_lead_pos5

A patient came to a clinic where I worked a few years ago. He was looking for help with depression but also told his therapist that he was feeling frustrated after having lost out on a research fellowship. The patient, who was white, felt the reason was affirmative action. The therapist was Arab. A group of psychiatrists, social workers and psychologists discussed the case at a clinic-wide meeting and came to an apparent consensus: Confront the patient and tell him that if he didn’t overcome his biases, he would be transferred elsewhere. They argued that it would be unfair for a clinician of color to have to provide therapy to a “racist” patient.

The same ideologies that have infiltrated education, medicine and the legal profession have also invaded mental healthcare. The American Psychological Association has decried “traditional masculinity.” The Journal of the American Psychoanalytic Association published a paper describing “Whiteness” as a “malignant, parasitic-like condition.” Two years ago, a prominent psychiatrist speaking at Yale shared her fantasies of killing white people. Recently, the president of the APA’s division of psychoanalysis said that therapists should “center Palestine . . . as a central working tenet of any clinical praxis.”

These attitudes are more common than one might imagine. The most recent APA psychoanalysis conference, which has in the past focused on the practice of therapy, was absorbed by identity politics, such as “the white supremacist within” and “psychic colonization,” to quote two panel titles.

Emerging empirical research shows the problem is widespread. One forthcoming study charts a more than 500% increase in politically slanted communiques at the APA from 2000-02 to 2017-19. A 2018 study showed that psychology departments, like most of academia, have extreme bias, with almost 17 registered Democratic professors for every one Republican. The bias is larger at higher ranked schools, and most Republican academics report higher rates of self-censorship.

https://www.americanthinker.com/articles/2023/07/biden_trying_to_kill_short_term_health_insurance.html

President Biden has taken to the airwaves to sell his plan to crack down on short-term health insurance policies, which he terms “junk.” Taking away the right to choose is not only bad healthcare policy, it runs counter to the spirit of freedom on which this country was founded. 

The history of short-term, limited duration (STLD) policies is straightforward. In order to coerce Americans to use only government approved (Washington controlled) taxpayer-subsidized policies, the Affordable Care Act of 2010 (ACA) included the individual mandate, an order for all Americans to purchase insurance. Washington restricted STLD policies to non-renewable 3-month plans. The Trump administration expanded public choice by allowing such policies up to 12-months in duration and renewable for three years. Millions of Americans used this affordable vehicle to cover themselves and their families, giving them a viable alternative to expensive and restrictive ACA insurance with its “auto-renewal.”  

Biden wants to quash STLD insurance policies making them illegal, calling them a scam and junk. 

Americans are free to buy junk bonds, including government ones. We are free to buy junk stocks and junk cars. Many happily attend junk events. Shouldn’t the public be able to decide what is junk versus jewel, what is scam and what is savior? Individual Americans are better judges of how to spend their money than Washington. 

In the 2012 challenge to the ACA, NFIB v. Sebelius, the Supreme Court struck down Obama’s individual mandate saying it was unconstitutional to force Americans to purchase what the government commanded them to buy. Now Biden wants to do an end-run and force the public to buy only what Washington allows. If Americans want to have medical insurance, Washington wants to mandate what Americans must purchase. 

Health insurance, any insurance for that matter, is a way to manage risk. A person pays an insurance company a comparatively small amount of money to hedge against the chance the person will need to expend a large amount of money when something unexpected happens, such as a housefire, a flood, or an automobile accident with injuries. Never mind that insurance premiums are already a very large expense, with the average family set to expend $30,065 on healthcare costs this year. More than 80 percent will go to insurance companies. 

https://justthenews.com/government/federal-agencies/cdc-admits-not-including-diagnostic-codes-showing-covid-vax-cause-some

The CDC’s explanation for leaving certain diagnosis codes off Minnesota death certificates that cite COVID-19 vaccines as a cause of death, allegedly hiding vaccine injuries in federal records, shows “intent to deceive,” according to a person who helped analyze the death certificates for the Brownstone Institute, a think tank that challenges the scientific basis for COVID conventional wisdom and policy.

John Beaudoin Sr., who is suing Massachusetts for submitting “fraudulent” death certificates to the feds falsely labeling COVID as a cause of death, says CDC spokesperson Kristen Nordlund’s comments on the matter to Just the News will be incorporated in an “affidavit to petition for a grand jury investigation of the CDC” in its home of Georgia.

Beaudoin’s law school expelled him for refusing its vaccine mandate, which he says was based on federal COVID guidance devised in part from Massachusetts death certificate data. 

The suit includes a 123-page exhibit analyzing death certificates Beaudoin claims either wrongly omit vaccine-induced deaths or falsely attribute them to COVID. And in May he requested a hearing in response to the state’s motion to dismiss his January amended complaint. His website includes legal filings.

File
Massachusetts-motion-to-dismiss-Beaudoin.pdf

The Minnesota analysis is part of three years of questions about the reliability and integrity of federal and state governments’ COVID-related statistics.

The New York Times found up to 90% of COVID-positive tests officially recorded in Massachusetts, New York and Nevada in summer 2020 were based on SARS-CoV-2 viral loads too small to be infectious.

Oregon lawmakers similarly sought a federal grand jury investigation into COVID statistical manipulation nearly two years ago, claiming the Center for Disease Control and Prevention employed a “double-standard exclusively for COVID-19 data collection” that inflated cases and deaths starting early in the pandemic.

https://www.wsj.com/articles/covid-censorship-proved-to-be-deadly-social-media-government-pandemic-health-697c32c4?mod=opinion_lead_pos8

In the wake of the 1986 Challenger space-shuttle explosion, Nobel Prize-winning physicist Richard Feynman knew that the truth would both fuel progress and soothe the nation’s sorrow. “For a successful technology,” he said, “reality must take precedence over public relations, for Nature cannot be fooled.”

For three years, pandemic public relations mocked nature, generating fear, illness, inflation and excess death beyond what the virus caused. Digital censorship supercharged the effort to hide reality, but reality is getting its day in court.

On July 4, U.S. District Judge Terry Doughty temporarily blocked numerous federal agencies and the White House from collaborating with social-media companies and third-party groups to censor speech.

Discovery in Missouri v. Biden exposed relationships among government agencies and social-media firms and revealed an additional layer of university centers and self-styled disinformation watchdogs and fact-checking outfits.

Elon Musk’s release of some of Twitter’s internal files revealed that up to 80 Federal Bureau of Investigation agents were embedded with social-media companies. The agents mostly weren’t fighting terrorism but flagging wrongthink by American citizens, including eminent scientists who suggested different paths on Covid policy.

The results of these relationships? Twitter blacklisted Stanford physician and economist Jay Bhattacharya for showing Covid almost exclusively threatened the elderly, severely reducing the visibility of his tweets. When Stanford health policy scholar Scott Atlas began advising the White House, YouTube erased his most prominent video opposing lockdowns. Twitter banned Robert Malone, a pioneer of mRNA vaccine technology, for calling attention to the vaccines’ dangers. YouTube demonetized evolutionary biologist Bret Weinstein, who suggested the virus might be engineered and predicted vaccine-evading variants. And those are only a few examples.

https://www.city-journal.org/article/the-association-of-american-medical-colleges-selective-research

Early last month, the Association of American Medical Colleges (AAMC)—the organization that oversees the Medical College Admission Test (MCAT) and cosponsors the accrediting body for all medical schools— published a story claiming that black patients fare better with black doctors, an idea that has become popular across the health-care establishment. That it was being amplified just as the Supreme Court prepared to hand down its landmark ruling on affirmative action was neither subtle nor coincidental. Woke activists are determined to sell the idea that race-based medical school admissions are noble and sensible to justify skirting bans on affirmative action. Justice Ketanji Brown Jackson even paid lip service to the purported benefits of doctor-patient race concordance in her dissent.

The notion that patients benefit from seeing doctors who share their race is dubious to the majority of us who know better than to essentialize race in our encounters with others. So is the implicit claim that lowering standards and elevating race in medical school admissions maximizes patient welfare. Indeed, the quality of the studies that AAMC cited to support these claims are as poor as one might expect.

Take, for example, a recent study published in JAMA Network Open. It observes that black life expectancy is longer in counties with higher proportions of black primary care providers (PCPs). But the researchers make no allowance for how their results are shaped by their modeling of the relationship between black representation among PCPs and life expectancy—including a curious decision to omit the roughly 50 percent of counties that don’t have any black PCPs. Data can be manipulated to reach just about any conclusion. The researchers’ failure to demonstrate that their results are robust, and not dependent on their very specific parameters, should leave readers deeply skeptical.

https://issuesinsights.com/2023/06/28/senate-democrats-take-one-more-step-toward-socialized-medicine/

It’s been less than a year since Democrats enacted the Inflation Reduction Act, which gives Medicare the power to set the prices of certain medicines. 

Those price controls have yet to go into effect. But Democrats already want more. They’ve introduced new legislation that would amp up those price controls — and even permit the government to refuse to cover drugs in order to drive a harder bargain with pharmaceutical companies.

As for the patients who would benefit from those drugs — or may even need them to stay alive? They may end up being collateral damage.

The Democrats’ new price control gambit is the SMART Prices Act, introduced by Sens. Amy Klobuchar, D-Minn., Peter Welch, D-Vt., and 23 of their colleagues. They say their bill would “build on” the IRA. 

That law, which President Biden signed last August, subjects 10 medicines to price controls under Medicare in January 2026. The government will set the prices for 15 more in 2027, another 15 in 2028, and 20 more per year in 2029 and beyond.

The SMART Prices Act would take things even further. It would empower Medicare to set prices for 20 drugs in 2026, instead of the current 10 under the IRA. In 2027, that number would jump to 40 — many more than the IRA stipulated.

The new bill would also subject medicines to price controls five years after approval by the Food and Drug Administration. That’s up to eight years quicker than under the IRA and significantly sooner than when generic or biosimilar competitors can enter the market.  

This provision would gut the generics industry. Generic firms face substantial upfront costs. They must create medicines that are bioequivalent to the innovative branded drugs they’re copying. And they have to build facilities in which to manufacture them. 

They recapture those investments by underpricing their wares relative to branded drugs and capturing a small margin on each sale. Patients, of course, benefit from those lower prices. 

But if Washington sets a rock-bottom price on a brand-name drug, there will be no incentive for a generics manufacturer to enter the market.

That’s problematic for several reasons. For starters, the government’s mandated price may not be as low as a competitive market could generate. So patients may end up paying more than they should. 

https://sciencebasedmedicine.org/update-on-gmos-and-health/

There is a lot of competition for our attention, and many issues that seem urgent and controversial. Sometimes important issues just fall off the radar because of this competition. Part of our goal at SBM is to keep tabs on relevant issues – antivaccine efforts, promotion of pseudoscience in medicine, weakening consumer protection laws, and many others. That is when a lot of harm occurs, when the public is not paying attention, and fanatics are tirelessly working in the background to subvert science and public health. So when an important issue has not been in the news recently, I like to take a look and see what’s going on.

GMOs (genetically modified organisms) is one of the topics I try to track carefully, even when it’s not making headlines. The first GMO food was approved in 1994 (a GMO tomato that is no longer on the market), so we are getting close to 30 years of GMOs. Opponents of GMOs falsely claim that they have not been studied enough (there is more evidence for their safety than other food products) and that there may be long term unknown risks. They were wrong 30 years ago, but it was at least true that GMO introduction into the food market and animal feed was new. But the “new” argument, by necessity, doesn’t age well. By now, if there were any actual risk to GMO foods, we would likely be seeing the result – and we are not.

The labeling of GMOs have been updated in the US, and while there is no evidence that this is useful information to consumers, there has been a reasonable improvement. The USDA now uses the term “bioengineered” to refer to any food product that has detectable levels of altered genetic material – genes that could not have results from usual breeding techniques. The term “GMO” now is restricted to those organisms with foreign DNA introduced, usually transgenic, from distant organisms, not possible with breeding. Whereas bioengineered can refer to a host of processes, such as using CRISPR to alter existing genes without introducing new genes.

As an aside, I find it ironic that a large number of available crops were produced over the last century through mutation breeding. This technique uses chemical or radiation to dramatically increase the rate of mutation (a thousand to a million fold) to increase the number of varieties to select from. But mutation breeding is not considered GMO or bioengineered. Many other crops are hybrids, even forced hybrids that would not occur in nature. But labeling such crops would be pointless, and banning them impossible, and they constitute virtually our entire agricultural industry.