Have the Architects of the Covid-19 Pandemic Lost Touch with Reality?

Richard Gale & Gary Null PhD

Progressive Radio Network, May 28, 2021

As the pandemic wages into its second year, two diametrically opposing movements have consolidated in defiance against each other. The dominant contingent, represented by Biden, Congress, Anthony Fauci, Bill Gates and the mainstream media, has decided that any citizen who refuses a Covid-19 vaccine is a de facto enemy of the state. “Ultimately,” Joe Biden declared during another gaff remark about the status of the government’s vaccination campaign, “those who are not vaccinated will pay – end up paying the price.” Despite the dubious claims that the mRNA vaccines are approximately 95 percent effective, the unvaccinated therefore mysteriously pose a health risk to the vaccinated. Consequently, any punitive actions the federal and state governments undertake, including encouraging the social media to publicly shame and censor voices of caution and reason, are justified. 

In an effort to marginalize and socially victimize Israeli citizens who have postponed or refused vaccination, Netanyahu and his right-wing Knesset supporters passed a bill permitting personal information and data about unvaccinated citizens to be shared across government agencies and civil institutions.  Israel was named by Pfizer’s CEO Albert Bourla as the “world’s lab” for the company’s Covid-19 vaccine roll out. Contrary to the government’s response to criticisms, the unvaccinated are theoretically second-class citizens, branded with a “scarlet letter” depriving them of full engagement with Israeli society, including going to a restaurant, attending a movie, concert or athletic event. Many are unable to shop or go to work.  Even the staunch pro-Zionist New York Times indicated the government’s policies are “moving in the direction of a two-tier system for the vaccinated and unvaccinated.” 

An analysis comparing Israeli Covid-19 infection and vaccine-related deaths conducted by Dr. Herve Seligmann, an Israeli-national at Aix-Marseille University of Medicine’s Faculty of Emerging Infectious and Tropical Diseases, concluded that the Pfizer vaccine has caused “mortality hundreds of times greater in young people compare[d] to the mortality from coronavirus without the vaccine, and dozens of times more in the elderly, when the documented mortality from coronavirus is in the vicinity of the vaccine, thus adding greater mortality from heart attack, stroke, etc.”  Seligmann and his co-author Haim Yativ have referred to Netanyahu’s draconian policies with unsafe experimental vaccines as a “new Holocaust.”  A civilian organization, the Israeli People Committee, which includes many health professionals, released a devastating report on the number of injuries and deaths resulting from Pfizer’s vaccine.  It was during the peak of the government’s vaccination campaign that Israel experienced its highest mortality rate, especially among those between 20 and 29 years of age. The Committee reported, “26 percent of all cardiac events occurred in young people up to the age of 40, with the most common diagnosis in these cases being myositis and pericarditis.” Other adverse vaccine reactions included infarction, stroke, miscarriage, impaired blood circulation and pulmonary embolisms.

Nevertheless, Israel has become the poster child for far more than serving as Pfizer’s experimental laboratory for human ferrets. It also models a caste society of haves and have nots, the rewarded and the repressed, the vaccine-anointed and the untouchables, as strategized by the World Economic Forum’s future technological proposals in its Great Reset. Netanyahu is has seemingly fully bought into Schwab’s Fourth Industrial Revolution and it’s re-visioning of the very definition of the human species. Last October, during the WEF’s “Great Reset” virtual session, Netanyahu appeared with Colombia’s far-right president Ivan Dugue – polled as the least popular president during that nation’s history -- and Rwanda’s war criminal Paul Kagame, along with executives in the biotech and financial industries, to advocate on behalf of the Forum’s mantra that the pandemic is an “opportunity” to further mobilize global digital infrastructure systems, including Covid-19 vaccination verification via microchip technology.

Now we are witnessing Canada, the UK and the US aggressively mimicking Israel’s heavy-handed policies to establish full-spectrum social control and make efforts to implement a post-modern, technologically driven caste system. Although Biden stated he does not support a federal mandate on vaccination passports, it has been left to the individual states to decide. Democrat-controlled states, notably New York, are issuing vaccine passports as a ticket to allow the vaccinated to return to a new normal. Republican governors on the other hand have been quick to denounce them, and in the case of Arizona, Florida, Idaho, Montana and Texas to executively ban them altogether. Hopefully some of the bans will challenge many of the over one hundred private colleges and universities that decided to require students to be vaccinated before returning in Fall.

The mainstream corporate-Democrat media, led by the New York Times, Washington Post, the Daily Beast, US News & World Report, CNN, NPR and MSNBC spew volleys of baseless propaganda that the vaccines are effective and wholly safe. However, thousands of medical school professors, physicians and researchers worldwide are challenging this non-consensual assumption. They regularly point out that there is no reliable science to justify any such claims. This raises the question: what are the vaccines effective against? Surely not contracting SARS-CoV-2; thousands of fully-vaccinated people are testing positive with the infection. The CDC has reported “seven percent of those [vaccinated] who have been infected have been hospitalized and 74 have died.”

Government efforts to reach a fictitious herd immunity threshold will inevitably come at a great cost to human life. More recent studies suggest that an exceedingly large percentage of Americans should technically be exempt from Covid-19 vaccines.  The University of Michigan published a recent analysis in JAMA Network Open suggesting that three percent of vaccinated Americans taking immune-weakening drugs have an increased risk of hospitalization. The study is grossly conservative and undermines the breadth of the problem. The researchers only analyzed patients with private insurance, under the age of 65, and who were only prescribed immunosuppressive steroids, such as corticosteroids and prednisone. Other immunosuppressive drugs such “selective immunosuppressants” and calcineurin and interleukin inhibitors were seemingly excluded from the Michigan analysis. Thirty-three percent of the American population was therefore excluded from the study because, according to the CDC, only 66.8 percent of the population has private health insurance. New York University researchers reported in the British Medical Journal that a third of patients receiving methotrexate and TNF-inhibitors for immune-mediated inflammatory illnesses such as rheumatoid arthritis and psoriasis fail to achieve sufficient antibodies from the Pfizer vaccine. We are certain this will be found equally true for many other medications if or when studies are conducted. 

The CDC’s belief that only 4 percent of Americans are immune-compromised is a misleading under-estimation. The agency’s defining criteria is narrow and limited to HIV/AIDS and cancer patients, inherited genetic diseases, and patients who have undergone organ transplants and are prescribed immunosuppressive drugs. On the other hand, there are over 100 different autoimmune conditions, including type-1 diabetes, multiple sclerosis, blood cancers, lupus, fibromyalgia, rheumatoid and other types of arthritis, psoriasis, IgG4 disease, Hashimoto’s and Addison’s diseases, celiac disease, etc. These additional individuals, who account for over 50 million Americans, have malfunctioning immune systems that increase their susceptibility to both severe SARS-CoV-2 infections (if left untreated during its early stage) and a higher probability of vaccine adverse reactions. 

Consequently, a very conservative 17 percent of Americans are at greater risk from either viral infection or vaccine injury or death. This also excludes tens of millions of adults (30 percent) and children (40 percent) with chronic allergies and many of the over 89,000 cancer patients diagnosed annually and prescribed chemotherapeutic drugs. Every year, nearly two-thirds of all Americans require emergency medical care from allergic reactions alone.  Furthermore, those with certain immune weaknesses are less likely to generate sufficient vaccine-induced antibodies thereby making Covid-19 vaccination ineffective. 

Especially disturbing is that the clinical trials the FDA relied upon for Emergency Use Authorization for the past five months of the vaccination campaign were based upon enrollment of healthy participants. Only recently are clinical trials either underway or in recruitment to test the vaccines on participants with weakened immune systems, including small children and infants, and on pregnant women. In the meantime, millions of immunosuppressed people diagnosed with autoimmune conditions or pre-existing comorbidities, from young to old, are being indiscriminately injected. Given the CDC’s previous track record of reckless vaccination policies, upon these trials’ completion, we will surely see vaccination forced upon every infant carelessly. This has been a policy enacted so far on the elderly, the sickly, the immune-compromised, pregnant moms, and the rest of the nation. It is not irrational, therefore, to suspect that past and present Covid-19 trials have been conducted with malice of forethought and with the unconditional approval of our federal health officials. 

During the pandemic, the rapid ascent of our vaccine-addicted culture’s mantra of “vaccination at any cost” truly borders on medical malfeasance and criminal negligence. The overriding emphasis on vaccination and near total disregard for implementing very simple preventative measures to inhibit infections from progressing in severity. If our health policymakers were wise men and women, alternative treatments such as ivermectin, hydroxycholoroquine, and more recent inexpensive off-patent drugs, which have been shown to be highly effective for early stage treatment and being widely prescribed elsewhere in the world, would be permitted and encouraged without reservation. There would be no reason to wait for a novel drug costing thousands of dollars per patient to arrive.  And we still await that magic bullet drug because the previous one, remdesivir, was faulty blank. This is just another example of the institutionalized pathology that infects our health agencies. 

There is no convincing science to support our federal officials belief that a previously infected person requires a Covid-19 vaccine to acquire immunity. In fact, more recent research indicates the opposite and goes directly against the intellectually fetid arguments of the now disgraced financier Bill Gates that every person on the planet should be vaccinated without exception. Johns Hopkins University professor Dr. Marty Makary has put forth the evidence that “natural immunity works.” Makary notes that it is only the rare instance when a person is being re-infected. Washington University School of Medicine reported this month that even mild Covid-19 infections induce long lasting antibody protection. The study’s lead researcher Dr. Ali Ellebedy stated,

"Last fall, there were reports that antibodies wane quickly after infection with the virus that causes COVID-19, and mainstream media interpreted that to mean that immunity was not long-lived… But that's a misinterpretation of the data. It's normal for antibody levels to go down after acute infection, but they don't go down to zero; they plateau. Here, we found antibody-producing cells in people 11 months after first symptoms. These cells will live and produce antibodies for the rest of people's lives. That's strong evidence for long-lasting immunity."

The information we were fed to downplay natural immunity was wrong at best, and more likely a lie, in order to further persuade the public into the importance of the vaccines to return their lives to normal. Another study appearing in this month’s Journal of Infectious Diseases found that “SARS-CoV-2 specific immune memory response [following infection] persists in most patients nearly one year after infection.” The Covid-19 vaccines can’t make the same promise. In fact, more reports show that  fully vaccinated persons are becoming infected. 

But it gets worse.  

The pro-vaccine argument wrongly assumes that anyone who refuses the Covid-19 vaccines is therefore anti-vaxxer. We would argue it is rational caution in the face of a national healthcare system indebted to the pharmaceutical industry and that is rapidly losing public trust. Likewise, if a doctor is successfully treating hundreds of patients without a reported death with cheap, effective drugs, she or he is canceled and ridiculed as a quack. Instead of open dialogue and debate, those who challenge the Medical Church Scientific are censored by Google and from all social platforms, such as Facebook, Twitter and Wikipedia. This is despite the impeccable credentials of many medical professionals abiding by the precautionary principle and who dare to challenge Anthony Fauci and the global vaccine czar Bill Gates, whose faux philanthropy is nothing less than another profitmaking enterprise like Microsoft. 

Conflicts of interests, both financial and non-financial, are endemic in our medical system. Therefore it becomes increasingly more difficult to trust any clinical study or government policy that is based upon flawed evidence submitted by a drug maker that fails to undergo a thorough independent and impartial review by qualified medical experts. There is a clear psychological reason for this. Many psychologists have pointed out over the years that “cognitive bias,” “motivated reasoning” and the heuristics driving the evaluation of clinical trial data and the subsequent institutional regulatory review and decision-making are deeply contrary and undermine the entire evidence-based criteria that should oversee what drugs, vaccines, medical devices, therapeutic protocols should be recommended or approved for use upon the public.  

The late Scott Lilienfeld, a professor of psychology at Emory University, writes, “Clinicians are subject to the same errors in thinking that affect virtually all people. In particular, practitioners must be wary of (a) the misuse of certain heuristics (e.g., availability, representativeness) and (b) cognitive biases (e.g., confirmation bias, hindsight bias) in their everyday work.” Although Lilienfeld is singling out clinical physicians, it applies more rigorously and accurately to the pharmaceutical presidents, CEOs and chief science officers overseeing vaccine development who have stock prices to reach and shareholders to please.  Cognitive bias equally plagues the entire executive hierarchy at the CDC, NIAID, FDA and HHS who are beholden to the gaping revolving door between these agencies and private industry and their revenues. Writing about the deep ethical concerns behind bias in our medical institutions, Dr. Thomas Murray, President of the Hastings Center, states, “For scientists on a panel of the Food and Drug Administration, for example, it isn’t immediately clear to whom they owe their primary loyalty.”  Such biases, Murray believes, have completely destroyed the credibility of the World Health Organization.  

The fact that rates to reproduce medical clinical trials are so poor, according to behavioral economist Susann Fielder at the Max Planck Institute, is that “cognitive biases may be a reason for that.”  It also explains why Stanford University Medical School professor John Ioannidis argues, “most published research findings are false,” and “an estimated 85 percent of research resources are wasted.” Junk science based upon bias should also include every vaccine application submitted to the FDA for regulatory approval, since the vaccine companies are privileged to cherry-pick whichever trials they want to submit to create the most promising portfolio. 

One could review all of the official decisions made during the past 17 months – by Anthony Fauci, Trump and Biden and the naïve stances in both political parties – and should easily observe the frailties of cognitive bias and repeated contradictions throughout. None whatsoever are reliably truthful. And of course, cognitive bias leads to cognitive dissonance, such as denying that one has a bias or resorting to flagrant rejection and disparagement in order to avoid any scientific data that conflicts with one’s unfounded beliefs.

We now live in a nation of medicine by bureaucratic decree rather than by immunological science. This is postmodern cultism at its worst because it hides behind the veneer of being scientific. And it has the full support of a political technocracy that can ordain authoritarian laws. There is a dire need for a collective epiphany. All of us are experiencing the pandemic as a failed experiment orchestrated by institutions that have lost touch with reality. And it has been a very deadly experiment due to the extraordinary incompetence of our medical-degreed bureaucrats. Sadly the decades of institutional ineptitude has had to reach national and perhaps global awareness at this time when the powers that possess every technological tool at their disposal to conduct wide surveillance, pass undemocratic and draconian laws with full impunity, and control the fenced sheep within the mainstream media.

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I Never Trusted Bill Gates, Nor Should You

While leading a Senate investigation, I tracked a corrupt pharmaceutical executive right into the lobby of the much-vaunted Bill and Melinda Gates Foundation—Bill Gates did nothing.

The last year has not been kind to Bill Gates. 

For two decades, Gates has shoveled out buckets of cash through the Bill and Melinda Gates Foundation to transform himself from despised 1990’s software monopolist to a present-day public health intellectual—a miraculous, money-fueled metamorphosis. But that reputational makeover has stumbled, as a series of critical articles have tarnished Gates’ paid-for golden image and cast doubt on his credibility. However, long before these articles came to light, I already knew that Gates could not to be trusted. 

A decade ago, I led a Senate investigation into a multi-billion-dollar diabetes drug sold by GlaxoSmithKline (GSK) that government scientists found to have caused around 83,000 heart attacks. During this federal investigation, I uncovered multiple examples of GSK officials intimidating medical experts who decried the drug’s dangers. A leader in this campaign was GSK’s chairman of research and development, Dr. Tadataka (Tachi) Yamada. 

By the time our committee uncovered GSK’s coercion campaign, Yamada had left the company to run Gates’ global health program. And yet, as the media outlets reported on Yamada’s prior role bullying physicians who tried to warn about the drug’s dangers, the Gates Foundation ignored this public outcry and allowed Yamada to maintain his pulpit as global health protector.

Twenty years back, journalists scrutinized Gates’ foundation as a vehicle to enrich himself and polish his appearance. But over the years, reporters began to forget Gates’ past and provide him a platform to puff himself up as scientific expert, despite his having no medical or scientific credentials. Bill Gates’ sculpted persona as health policy guru began to wobble last summer, however, precisely because of revelations showing the tools he had used to improve his media cachet.

In August 2020, Tim Schwab published an article in the Columbia Journalism Review exposing around $250 million in grants that Gates was throwing at journalism outlets including the BBC, NBC, Al Jazeera, ProPublica, National Journal, The Guardian, Univision, Medium, the Financial Times, The Atlantic, the Texas Tribune, Gannett, Washington Monthly, Le Monde, and the Center for Investigative Reporting. 

A later article in The Nation spotlighted Gates’ potential to profit from investments in companies situated to reap a windfall from the COVID pandemic. And another report in The Nation found that Gates’ funding has stifled debate in public health—described as “the Bill chill”—as organizations are reluctant to bite the hand that feeds them.

These revelations came as little surprise to me. Back in 2007, I was working as an investigator for the Senate Finance Committee and learned first-hand that Bill Gates does not put the public first. That year, I wrote the Senate Finance Committee’s report showing that, shortly after the GSK diabetes drug Avandia came on the market in 1999, the company attacked and silenced several scientists including Dr. John Buse, a professor of medicine at the University of North Carolina. 

GSK began to bully Dr. Buse after he gave talks stating that Avandia might increase cardiovascular problems such as heart attacks. By the time we released the 2007 report, FDA scientists estimated that Avandia had caused approximately 83,000 heart attacks.

When Dr. Buse began warning physicians about the drug, Dr. Yamada was at GSK and contacted Dr. Buse’s department chairman to complain. In an email discussing Dr. Buse with GSK’s CEO and other executives, Dr. Yamada wrote: 

In any case, I plan to speak to Fred Sparling, his former chairman as soon as possible. I think there are two courses of action. One is to sue him for knowingly defaming our product even after we have set him straight as to the facts—the other is to launch a well planned offensive on behalf of Avandia....

In our report, we released a private email that Dr. Buse later sent a colleague detailing this encounter with GSK:

[T]he company’s leadership contact[ed] my chairman and a short and ugly set of interchanges occurred over a period of about a week ending in my having to sign some legal document in which I agreed not to discuss this issue further in public.

Dr. Buse ended the email, “I was certainly intimidated by them.... It makes me embarrassed to have caved in several years ago.”

Multiple media outlets covered Yamada’s actions, including The Guardian (GSK accused of trying to intimidate critic), NBC News (Diabetes drug probe leads to Gates Foundation), and even Bill Gates hometown newspaper, the Seattle Times (Senate committee turns attention to Gates Foundation official).

Months prior to the report’s release, The New York Times also detailed Dr. Yamada’s behavior (Doctor Says He Was Assailed for Challenging Drug’s Safety), as some initial evidence came to light during a hearing in the House. 

In response to all this outcry, Bill Gates did... nothing.

To put this matter directly under Bill Gates’ nose, I then wrote the Senate Committee’s letter demanding that Dr. Yamada come and brief Senate investigators. Just in case Gates was too distracted with saving the world and playing public health saviour to have noticed the bad press, I had the letter sent directly to the Gates Foundation.

When Dr. Yamada showed up for his appointment in Senate Hart, we started with some brief niceties and formalities—typical DC nonsense such as shaking hands, passing out business cards, asking how the plane flight was—before getting down to business. Dr. Yamada’s lawyer then pulled from his briefcase a marked-up copy of a Committee report I had written titled: The Intimidation of Dr. John Buse and the Diabetes Drug Avandia.  

We spent about twenty minutes going over the report, as the lawyer explained what Dr. Yamada had done. He then turned the matter over to Dr. Yamada to detail why, many years prior, he had called Dr. Buse's superiors at the University of North Carolina.

As Dr. Yamada explained, he wasn't trying to intimidate anyone. Ironically, he even offered up the idea that he had called Dr. Buse's dean at North Carolina, because he was concerned that Avandia might actually be harmful. And if the drug was harmful, Dr. Yamada said, he wanted to know.

I almost giggled when he said that.

I then asked, "So this is the only time that you can remember calling a university about one of their faculty?"

"Yes," he replied.

I let him drone on some more, explaining medical research, before I asked him again if he had ever called a university to complain about a professor. Again, he denied doing so, and then started explaining drug development and the regulatory process at the FDA. 

I then asked again, "So during all your time at GSK, this is the only incident you can remember where you placed a call to a university about a researcher who raised concerns about one of your products, correct?” I asked. “It was a singular incident in your time at the company?”

"Yes," he said.

This was the third time that Dr. Yamada had denied making calls to other universities to intimidate academics speaking up about Avandia. I then pulled out copies of GSK emails, showing that Dr. Yamada had called the University of Pennsylvania about physicians there who were worried about drug’s dangers.

“Would you like to explain to us about the call you made to the University of Pennsylvania?” I asked. “One of the physicians involved told me, 'It left a really bad taste in my mouth. After that happened, I said that I would never work for a drug company.’ Another physician who was involved told me, 'It’s the kind of thing you imagine happening on TV.'’’

I then slid the emails across the table to him. Dr. Yamada’s attorney jumped up and grabbed the emails saying, “These emails weren't in the report!”

“No shit, Counselor,” I thought. “I left these ones out, to see if your client might lie to us. Calm down. Everything's going to be A-O-K....”

We then exchanged some more niceties as Yamada “reexplained himself.” Oddly enough, it seems there may have been more than just that one incident at North Carolina, Dr. Yamada said. But I really wasn't interested in listening and started checking my Blackberry.

It took a couple more years to go through hundreds of thousands of GSK’s internal documents before we released our final 342-page report in 2010 titled: Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia. But we redacted the names of the scientists at the University of Pennsylvania who Dr. Yamada had harassed for speaking up, because they were still scared about possible retaliation from the drug industry. 

After reading the report, Yale cardiologist Harlan Krumholz wrote that it "read like a spy novel.” Analysts at UBS predicted that GlaxoSmithKline could face legal liability of up to $6 billion. The New York Times covered the report on its front page and the CBS News put Yamada in its story’s headline: Meet Glaxo's Fixer -- The Man Who Scuttles Drug Critics With One Phone Call.

And still, Bill Gates did nothing.

Five months after the 2010 Senate Finance report, GSK agreed to a $460 million settlement with 10,000 Americans who sued the company for withholding Avandia’s heart attack risks. The New York Times editorialized that GSK and its leaders “can’t be trusted to report adverse clinical results fairly.” 

Nothing at all happened to Yamada. He remained in his role as global health expert at the Gates Foundation, until he left the following year, in June 2011. 

Keeping someone like Yamada to run a global health program has always made me doubt Bill Gates’ commitment to public health. How could anyone have faith in Gates’ judgement after watching him stand idly by as a stream of evidence proved that one of his top lieutenants had a history of corrupt behavior?

Since that time, I have never trusted Bill Gates. And neither should you.

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A natural food supplement may relieve anxiety

Weizmann Institute of Science, May 24, 2021

A natural food supplement reduces anxiety in mice, according to a new Weizmann Institute of Science study. The plant-derived substance, beta-sitosterol, was found to produce this effect both on its own and in synergic combination with an antidepressant known under the brand name Prozac. If these findings, published today in Cell Reports Medicine, are confirmed in clinical trials, they could point the way toward the use of beta-sitosterol as a treatment for relieving anxiety in humans.

Anxiety is not always a bad thing. In fact, in evolutionary terms, feeling anxious about potential threats is critical for survival because it helps us mount an appropriate response. That's precisely why developing antianxiety drugs is so challenging. The circuits for anxiety in the brain are closely related to those responsible for memory, awareness and other functions vital for handling danger, so scientists are on the lookout for compounds that can selectively suppress anxiety without causing unwanted side effects.

The starting point for the present study was research conducted several years ago in the lab of Prof. Mike Fainzilber in Weizmann's Biomolecular Sciences Department. Dr. Nicolas Panayotis and other lab members studied the roles of proteins that shuttle cargoes into the nuclei of nerve cells, and they discovered that in stressful situations, mice lacking a shuttling protein known as importin alpha-five showed less anxiety than the control mice. The researchers then checked how these 'calmer' mice differed from regular ones in terms of gene expression, and they identified a genetic signature of their calmness: about 120 genes with a characteristic pattern of expression in the hippocampus, one of the brain regions that regulate anxiety.

In the new study, Panayotis, now a senior intern in Fainzilber's lab, together with colleagues, searched an international genomic database for existing drugs or other compounds that might mimic the same gene expression signature. He identified five candidates and tested their effects on behavior in mice. That was how the researchers zeroed in on beta-sitosterol, a plant substance sold as a dietary supplement intended mainly to reduce cholesterol levels.

In a series of behavioral experiments, mice given beta-sitosterol showed much less anxiety than the controls. They were, for example, less fearful than the controls when placed in an illuminated enclosure, daring to walk into its brightly lit center, whereas regular mice were careful to stay on the darker periphery, avoiding the stress of the bright light. Moreover, the mice receiving beta-sitosterol did not exhibit any of the side effects that might be expected from antianxiety medications—their locomotion was not impaired, and they did not refrain from exploring novel stimuli.

Next, the researchers tested the effects of beta-sitosterol on mice when given in combination with fluoxetine, a drug belonging to the class of selective serotonin reuptake inhibitors, or SSRIs, and sold under the brand name Prozac, among others. The combination had a synergistic effect: Both beta-sitosterol and fluoxetine reduced the anxiety of mice at lower doses when given together, compared with the doses needed to produce the same effect when they were administered separately.

"One of the major problems with existing antianxiety medications is that they produce side effects, so if beta-sitosterol could help cut down the dosage of such medications, it might potentially also reduce the unwanted side effects," Panayotis says.

A great advantage of beta-sitosterol is that it is naturally present in a variety of edible plants, and it is thought to be safe, as it has been marketed for years as a nutraceutical. It is found in particularly large concentrations in avocados, but also in pistachios, almonds and other nuts, in canola oil, in various grains and cereals and more.

However, this does not mean that eating avocado can induce a calming effect, since it doesn't contain enough beta-sitosterol. "You'd need to eat avocado day and night to get the right dose—and you would be more likely to develop digestive problems than relieve your anxiety," Panayotis says.

The precise mechanism of beta-sitosterol's effect on anxiety remains to be revealed, but the scientists did find that the expression of several genes known to be activated in stressful situations was reduced in mice given the supplement. They also found that these mice had changes in the levels of certain metabolites and neurotransmitters in brain areas involved in anxiety.

Since the study focused on brain regions and neural pathways that are involved in regulating anxiety in both mice and humans, it is likely that the findings will apply to humans as well. This will, however, require further clinical testing.

As Fainzilber points out: "There's a need for a clinical trial to test the use of beta-sitosterol for reducing anxiety in humans. Until then, we recommend that people consult their physicians before taking the supplement for this purpose."

Benfotiamine, vitamin B derivative, intake associated with reduced progression of cognitive decline

Weil Cornell Medicine, May 20, 2021

A randomized phase II trial reported in 2020 in the Journal of Alzheimer’s Disease resulted in positive effects among individuals with amnestic mild cognitive impairment or mild Alzheimer’s dementia who were given capsules that contained benfotiamine, a derivative of thiamine (vitamin B1). 

The trial included 70 cognitively impaired men and women who received physical examinations and completed the Mini-Mental Status Exam (MMSE) prior to enrollment. Prospective candidates received positron emission tomography (PET)/CT scans of the brain to confirm the presence of amyloid plaques that are characteristic of Alzheimer disease) and other general blood tests, an electrocardiogram and neurological exam prior to enrollment. Screening tests commonly used to test for diabetes were also performed prior to enrollment, and participants were required to have a hemoglobin A1c (HbA1c) of less than 8% and/or a fasting glucose of less than 200 milligrams per deciliter to be enrolled in the trial.

APOE genotype was determined upon enrollment in the trial. The presence of one or two copies of the APOE4 variant of the APOE gene is associated with a greater risk of Alzheimer disease in comparison with APOE2 or APOE3.

Blood testing conducted at the beginning and end of the trial measured levels of vitamin B1 and advanced glycation end-products (AGEs), which are formed when fats or proteins react with sugar in the blood. (Research suggests that AGEs are predictive of long-term decline in cognition-related daily living performance in Alzheimer disease patients.) Participants also underwent fluorodeoxyglucose positron-emission tomography (FDG PET) at these time points to assess brain glucose utilization which, when reduced, is associated with cognitive decline. Cognitive tests, including the Alzheimer Disease Assessment Scale-Cognitive Subscale, Clinical Dementia Rating and others were administered at the beginning of the study and at varying time points thereafter. Participants received capsules containing 300 milligrams benfotiamine or a placebo twice daily for one year. 

At the end of the treatment period, thiamine levels were significantly elevated in the benfotiamine-intake group. The 12 month increase in Alzheimer Disease Assessment Scale-Cognitive Subscale scores (indicating increased cognitive dysfunction) was lower among those who received benfotiamine compared to the placebo group. Benfotiamine intake participants additionally experienced 77% less deterioration in Clinical Dementia Rating scores compared to the placebo group; however, the effect seen with benfotiamine was stronger among participants who did not have the APOE4 variant. Benfotiamine was also associated with a significant reduction in the increase in AGEs compared to the placebo, which again was stronger in noncarriers of APOE4. FDG PET data suggested that participants without APOE4 were more responsive to benfotiamine intake.

“Benfotiamine is safe and cost effective, and the results of this pilot study are encouraging, providing preliminary evidence of efficacy,” authors Gary E. Gibson of Weil Cornell Medicine and colleagues concluded. “Our next step is to propose a larger clinical trial appropriately powered to replicate our findings. We believe that further studies would be very valuable to determine whether benfotiamine may be helpful in delaying onset or treating Alzheimer disease.”

'45 is the new 50' as age for colorectal cancer screening is lowered

Dana Farber Cancer Institute, May 21, 2021

BOSTON - Prompted by a recent alarming rise in cases of colorectal cancer in people younger than 50, an independent expert panel has recommended that individuals of average risk for the disease begin screening exams at 45 years of age instead of the traditional 50. 

The guideline changes by the U.S. Preventive Services Task Force (USPSTF), published in the current issue of JAMA, updates its 2016 recommendations and aligns them with those of the American Cancer Society, which lowered the age for initiation of screening to 45 years in 2018.

Colorectal cancer (CRC) is one of the most preventable malignancies, owing to its long natural history of progression and the availability of screening tests that can intercept and detect the disease early. Overall incidence of CRC in individuals 50 years of age and older has declined steadily since the mid-1980s, largely because of increased screening and changing patterns of modifiable risk factors.

"A concerning increase in colorectal cancer incidence among younger individuals (ie, younger than 50 years; defined as young-onset colorectal cancer) has been documented since the mid-1990s, with 11% of colon cancers and 15% of rectal cancers in 2020 occurring among patients younger than 50 years, compared with 5% and 9%, respectively, in 2010," said Kimmie Ng, MD, MPH, first author of an editorial in JAMA accompanying the article about the guideline change of the USPSTF. Ng is the director of the Young-Onset Colorectal Cancer Center at Dana-Farber Cancer Institute. 

The causes of the increase in young-onset CRC aren't currently known. 

Lowering the recommended age to initiate screening "will make colorectal cancer screening, which is so important, available to millions more people in the United States, and hopefully many more lives will be saved by catching colorectal cancer earlier, as well as by preventing colorectal cancer," said Ng.

The USPSTF is an independent panel of experts funded by the U.S. Department of Health and Human Services. It systematically reviews the evidence of effectiveness of preventive services and develops recommendations. American health insurance groups are required to cover, at no charge to the patient, any service that the USPSTF recommends with a grade A or B level of evidence, regardless of how much it costs.

The task force recommendation means that insurers will be required to cover preventive procedures such as colonoscopies and stool tests designed to detect colon cancer in early stages.

The task force selected age 45 based on research showing that initiating screening at that age averted more early deaths than starting at age 50, with a relatively small increase in the number of colonoscopy complications. There is no change to the USPSTF 2016 recommendation to only selectively screen individuals aged 76 to 85, as research shows only small increases in life-years gained.

The accompanying JAMA editorial asked rhetorically whether the age of screening should be lowered even younger than age 45. While the majority of young-onset CRC diagnoses and deaths occurs in persons 45 to 49, the rate of increase in young-onset CRC is actually steepest in the very youngest patients. Colon cancer incidence is increasing by 2% per year in 20 to 29-year-olds, compared with 1.3% in 40 to 49-year-olds. Rectal cancer incidence is increasing by 3.2% per year in 20 to 29-year-olds and 30 to 39-year-olds, versus 2.3% in 40 to 49-year-olds.

"We are now seeing patients even younger than 45 - in their 20s and 30s - who are being diagnosed with this cancer and often at very late stages," said Ng. "Clearly the USPSTF recommendation to start screening at age 45 will not be enough to catch those young people who are being diagnosed."

Ultimately, optimal prevention and early detection of CRC in people younger than 45 will require further research into the underlying causes and risk factors of young-onset CRC, which have thus far remained elusive, said the editorial authors. 

The authors also called for "bold steps" to translate the lowered age of beginning screening into meaningful decreases in CRC incidence and mortality, noting that despite the preventive benefits of colorectal cancer screening, only 68.8 percent of eligible individuals in the United States undergo screening. The rate is lower among the uninsured and underinsured, those with low incomes, and racial and ethnic minorities. Barriers include lack of knowledge of the importance of screening, concerns about the invasive nature of colonoscopy, and lack of access to and provider recommendations for screening.

The editorial lists examples including public awareness campaigns, including those aimed at gaps in CRC incidence and mortality between Black and white Americans, and specific actions. Employers could provide 45-year-old employees with a paid "wellness day" to undergo CRC screening, or offer day care or transportation vouchers to overcome the logistical hurdles of colonoscopies. Health systems could offer weekend or after-hours appointments for colonoscopies.

The new recommendation "represents an important policy change," the authors wrote, "to drive progress toward reducing colorectal cancer incidence and mortality."

Study Finds New and Effective Treatment for Vitamin D Deficiency

Boston University School of Medicine, May 20, 2021

There are several million people worldwide with various fat malabsorption syndromes including those who have undergone gastric bypass surgery and those with obesity. These patients often have a difficult time absorbing vitamin D and both groups of patients are at an increased risk for vitamin D deficiency and therefore at higher risk for osteoporosis and osteomalacia (softening of the bones). Patients with obesity are also susceptible to vitamin D deficiency as vitamin D derived from intestinal absorption and cutaneous synthesis is diluted in a larger body pool of fat. Now a new study demonstrates 25-hydroxyvitamin D3 is an effective treatment for vitamin D deficiency for these specific patients.

According to the researchers, approximately one third of adults are obese and require much larger doses of vitamin D to satisfy their requirement. "This vitamin D metabolite is better absorbed in patients with fat malabsorption syndromes and since it is not as fat soluble, it does not gets diluted in the body fat and is effective in raising and maintaining blood levels of 25-hydroxyvitamin D in obese people," explained corresponding author Michael F. Holick, PhD, MD, professor of medicine, physiology and biophysics and molecular medicine at Boston University School of Medicine.

Healthy adults, adults with a fat malabsorption syndrome and obese adults were compared to evaluate if a more water-soluble form of vitamin D3 known as 25-hydroxyvitamin D3 was more effective than the same dose of vitamin D3 in improving their vitamin D status. The researchers observed that compared to healthy adults only about 36 percent of orally ingested vitamin D3 was found in the blood of patients with fat malabsorption syndromes including patients who had gastric bypass surgery. When the same adults ingested 25-hydroxyvitamin D3 the patients with fat malabsorption syndromes were able to absorb it as well as the healthy adults thereby raising their vitamin D status to the same degree. A similar observation was made in the obese subjects compared to the healthy controls. "Therefore using 25-hydroxyvitamin D3 could be a novel approach for treating vitamin D deficiency in patients with fat malabsorption syndromes and obese adults," added Holick.

Vitamin D deficiency not only results in bone loss increasing risk for fracture but causes the painful bone disease osteomalacia. Patients who are vitamin D deficient with osteomalacia have unrelenting achiness in their bones and muscles. Vitamin D deficiency has been associated with an increased risk of many chronic illnesses including multiple sclerosis, type 1 diabetes, heart disease, type 2 diabetes, depression, neurocognitive dysfunction and Alzheimer's disease as well as infectious diseases including COVID.

These findings appear online in the American Journal of Clinical Nutrition.

Young teens should only use recreational internet and video games one hour daily

Rutgers University, May 24, 2021

Middle-school aged children who use the internet, social media or video games recreationally for more than an hour each day during the school week have significantly lower grades and test scores, according to a study from the Center for Gambling Studies at Rutgers University-New Brunswick.

The findings appear in the journal Computers in Human Behavior. 

Researchers say the findings give parents and children a moderate threshold for using entertainment-related technology -- no more than one hour daily on school days and four hours a day on weekends. 

"Interactive technology is widely used to promote children's educational access and achievement," said lead author Vivien (Wen Li) Anthony, an assistant professor at the School of Social Work and research associate at the Rutgers Center for Gambling Studies. "During the COVID-19 pandemic, technology has been essential to facilitating remote learning. At the same time, there is a growing concern that excessive technology use, particularly for entertainment, may adversely affect children's educational development by facilitating undesirable study habits and detracting from time spent on learning activities." 

The researchers, which include Professor Lia Nower of the Rutgers Center for Gambling Studies and a researcher from Renmin University of China, analyzed the China Education Panel Survey data, a national survey of educational needs and outcomes of children in China. Approximately 10,000 first-year middle school students were surveyed and followed. Their average age was 13.5 years.

The results showed that children who used the internet, social media or video games for entertainment four or more hours daily were four times more likely to skip school than those who did not. Boys used interactive technology for entertainment significantly more than girls. Boys also performed worse and showed lower school engagement levels than girls.

"Such findings are critical, particularly in light of the recent movement toward online learning in countries throughout the world," said Anthony. "In a learning environment that integrates the internet, it is easy for children to move across educational and entertainment platforms during learning without alerting teachers or adults to alternate activities."

Anthony said children in the study who used technology in moderation (i.e., less than one hour per day on weekends) experienced less boredom at school, potentially due to the positive effects of participation in social media, video games and video streaming such as peer bonding and relationship building. Using interactive technology for entertainment in moderation advanced children's cognitive development. 

The findings suggest that parents place time limits on their children's interactive technology use, and that parents and teachers should help children to develop effective time management and self-regulation skills to reduce their reliance on technology.

Do people aged 105 and over live longer because they have more efficient DNA repair?

University of Bologna (Italy),  May 19, 2021

Researchers have found that people who live beyond 105 years tend to have a unique genetic background that makes their bodies more efficient at repairing DNA, according to a study published in eLife.

This is the first time that people with ‘extreme longevity’ have had their genomes decoded in such detail, providing clues as to why they live so long and manage to avoid age-related diseases.

“Aging is a common risk factor for several chronic diseases and conditions,” explains Paolo Garagnani, Associate Professor at the Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Italy, and a first author of the study. “We chose to study the genetics of a group of people who lived beyond 105 years old and compare them with a group of younger adults from the same area in Italy, as people in this younger age group tend to avoid many age-related diseases and therefore represent the best example of healthy aging.”

Garagnani and colleagues, in collaboration with several research groups in Italy and a research team led by Patrick Descombes at Nestle Research in Lausanne, Switzerland, recruited 81 semi-supercentenarians (those aged 105 years or older) and supercentenarians (those aged 110 years or older) from across the Italian peninsula. They compared these with 36 healthy people matched from the same region who were an average age of 68 years old.

They took blood samples from all the participants and conducted whole-genome sequencing to look for differences in the genes between the older and younger group. They then cross-checked their new results with genetic data from another previously published study which analysed 333 Italian people aged over 100 years old and 358 people aged around 60 years old.

They identified five common genetic changes that were more frequent in the 105+/110+ age groups, between two genes called COA1 and STK17A. When they cross-checked this against the published data, they found the same variants in the people aged over 100. Data acquired from computational analyses predicted that this genetic variability likely modulates the expression of three different genes.

The most frequently seen genetic changes were linked to increased activity of the STK17A gene in some tissues. This gene is involved in three areas important to the health of cells: coordinating the cell’s response to DNA damage, encouraging damaged cells to undergo programmed cell death and managing the amount of dangerous reactive oxygen species within a cell. These are important processes involved in the initiation and growth of many diseases such as cancer.

The most frequent genetic changes are also linked to reduced activity of the COA1 gene in some tissues. This gene is known to be important for the proper crosstalk between the cell nucleus and mitochondria - the energy-production factories in our cells whose dysfunction is a key factor in aging.

Additionally, the same region of the genome is linked to an increased expression of BLVRA in some tissues - a gene that is important to the health of cells due to its role in eliminating dangerous reactive oxygen species.

“Previous studies showed that DNA repair is one of the mechanisms allowing an extended lifespan across species,” says Cristina Giuliani, Senior Assistant Professor at the Laboratory of Molecular Anthropology, Department of Biological, Geological and Environmental Sciences, University of Bologna, and a senior author of the study. “We showed that this is true also within humans, and data suggest that the natural diversity in people reaching the last decades of life are, in part, linked to genetic variability that gives semi-supercentenarians the peculiar capability of efficiently managing cellular damage during their life course.”

The team also measured the number of naturally occurring mutations that people in each age group had accumulated throughout their life. They found that people aged 105+ or 110+ had a much lower burden of mutations in six out of seven genes tested. These individuals appeared to avoid the age-related increase in disruptive mutations, and this may have contributed in protecting them against diseases such as heart disease.

“This study constitutes the first whole-genome sequencing of extreme longevity at high coverage that allowed us to look at both inherited and naturally occurring genetic changes in older people,” says Massimo Delledonne, Full Professor at the University of Verona and a first author of the study.

“Our results suggest that DNA repair mechanisms and a low burden of mutations in specific genes are two central mechanisms that have protected people who have reached extreme longevity from age-related diseases,” concludes senior author Claudio Franceschi, Professor Emeritus of Immunology at the University of Bologna.

Your Risk of Dying Hinges on Well-Being Not Diseases

University of Chicago, May 18, 2021

A new study has yielded a radically different picture of aging in America, finding that how old you are plays little or no role in determining differences in health and well-being.

The researchers say the results suggest the medical community is focusing on the wrong set of factors to determine risk of dying. Rather than rely on a checklist of infirmities—heart disease, cancer, diabetes, high blood pressure, and cholesterol levels—perhaps it’s time to consider a new “comprehensive model” that looks at factors such as psychological well-being, sensory function, and mobility.

“The new comprehensive model of health identifies constellations of health completely hidden by the medical model and reclassifies about half of the people seen as healthy as having significant vulnerabilities that affect the chances that they may die or become incapacitated within five years,” says Professor Martha McClintock, a biopsychologist and lead author of the study in the Proceedings of the National Academy of Sciences.

“At the same time, some people with chronic disease are revealed as having many strengths that lead to their reclassification as quite healthy, with low risks of death and incapacity,” adds Professor Linda Waite, a demographer and study coauthor.

The study is a major longitudinal survey of a representative sample of 3,000 people between the ages of 57 to 85 conducted by the independent research organization NORC at the University of Chicago.

SOME OF THE FINDINGS INCLUDE:

• Cancer itself is not related to other conditions that undermine health.
• Poor mental health, which afflicts one in eight older adults, undermines healthin ways not previously recognized.
• Obesity seems to pose little risk to older adults with excellent physical and mental health.
• Sensory function and social participation play critical roles in sustaining or undermining health.
• Breaking a bone after age 45 is a major marker for future healthissues.
• Older men and women have different patterns of healthand well-being during aging.
• Mobility is one of the best markers of well-being.

The comprehensive model reflects a definition of health long advanced, but little studied, by the World Health Organization, which considers health to include psychological, social, and physical factors in addition to the diseases that are the basis for the current medical model of health.

THE HEALTHIEST 22%

Twenty-two percent of older Americans were in the model’s healthiest category. This group was typified by higher obesity and blood pressure, but had fewer organ system diseases, better mobility, sensory function, and psychological health. They had the lowest prevalence of dying or becoming incapacitated (six percent) five years into the study.

A second category had normal weight, low prevalence of cardiovascular disease and diabetes, but had one minor disease such as thyroid disease, peptic ulcers, or anemia. They were twice as likely to have died or become incapacitated within five years.

Two emerging vulnerable classes of health traits, completely overlooked by the medical model, included 28 percent of the older population. One group included people who had broken a bone after age 45. A second new class had mental health problems, in addition to poor sleep patterns, engaged in heavy drinking, had a poor sense of smell, and walked slowly, all of which correlate with depression.

The most vulnerable older people were in two classes—one characterized by immobility and uncontrolled diabetes and hypertension. A majority of people in each of these categories were women, who tend to outlive men.

“From a health system perspective, a shift of attention is needed from disease-focused management, such as medications for hypertension or high cholesterol, to overall well-being across many areas,” says William Dale, associate professor of medicine and a member of the research team.

“Instead of policies focused on reducing obesity as a much lamented health condition, greater support for reducing loneliness among isolated older adults or restoring sensory functions would be more effective in enhancing health and well-being in the older population,” says Edward Laumann, also a collaborator and sociology professor.

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Western diet may increase risk of gut inflammation, infection

Diet rich in sugar, fat damages immune cells in digestive tracts of mice

Washington University School of Medicine in St. Louis and Cleveland Clinic

Eating a Western diet impairs the immune system in the gut in ways that could increase risk of infection and inflammatory bowel disease, according to a study from researchers at Washington University School of Medicine in St. Louis and Cleveland Clinic.

The study, in mice and people, showed that a diet high in sugar and fat causes damage to Paneth cells, immune cells in the gut that help keep inflammation in check. When Paneth cells aren't functioning properly, the gut immune system is excessively prone to inflammation, putting people at risk of inflammatory bowel disease and undermining effective control of disease-causing microbes. The findings, published May 18 in Cell Host & Microbe, open up new approaches to regulating gut immunity by restoring normal Paneth cell function.

"Inflammatory bowel disease has historically been a problem primarily in Western countries such as the U.S., but it's becoming more common globally as more and more people adopt Western lifestyles," said lead author Ta-Chiang Liu, MD, PhD, an associate professor of pathology & immunology at Washington University. "Our research showed that long-term consumption of a Western-style diet high in fat and sugar impairs the function of immune cells in the gut in ways that could promote inflammatory bowel disease or increase the risk of intestinal infections."

Paneth cell impairment is a key feature of inflammatory bowel disease. For example, people with Crohn's disease, a kind of inflammatory bowel disease characterized by abdominal pain, diarrhea, anemia and fatigue, often have Paneth cells that have stopped working.

Liu and senior author Thaddeus Stappenbeck, MD, PhD, chair of the Department of Inflammation and Immunity at Cleveland Clinic, set out to find the cause of Paneth cell dysfunction in people. They analyzed a database containing demographic and clinical data on 400 people, including an assessment of each person's Paneth cells. The researchers found that high body mass index (BMI) was associated with Paneth cells that looked abnormal and unhealthy under a microscope. The higher a person's BMI, the worse his or her Paneth cells looked. The association held for healthy adults and people with Crohn's disease.

To better understand this connection, the researchers studied two strains of mice that are genetically predisposed to obesity. Such mice chronically overeat because they carry mutations that prevent them from feeling full even when fed a regular diet. To the researchers' surprise, the obese mice had Paneth cells that looked normal.

In people, obesity is frequently the result of eating a diet rich in fat and sugar. So the scientists fed normal mice a diet in which 40% of the calories came from fat or sugar, similar to the typical Western diet. After two months on this chow, the mice had become obese and their Paneth cells looked decidedly abnormal.

"Obesity wasn't the problem per se," Liu said. "Eating too much of a healthy diet didn't affect the Paneth cells. It was the high-fat, high-sugar diet that was the problem."

The Paneth cells returned to normal when the mice were put back on a healthy mouse diet for four weeks. Whether people who habitually eat a Western diet can improve their gut immunity by changing their diet remains to be seen, Liu said.

"This was a short-term experiment, just eight weeks," Liu said. "In people, obesity doesn't occur overnight or even in eight weeks. People have a suboptimal lifestyle for 20, 30 years before they become obese. It's possible that if you have Western diet for so long, you cross a point of no return and your Paneth cells don't recover even if you change your diet. We'd need to do more research before we can say whether this process is reversible in people."

Further experiments showed that a molecule known as deoxycholic acid, a secondary bile acid formed as a byproduct of the metabolism of gut bacteria, forms the link between a Western diet and Paneth cell dysfunction. The bile acid increases the activity of two immune molecules -- farnesoid X receptor and type 1 interferon -- that inhibit Paneth cell function.

Liu and colleagues now are investigating whether fat or sugar plays the primary role in impairing Paneth cells. They also have begun studying ways to restore normal Paneth cell function and improve gut immunity by targeting the bile acid or the two immune molecules.

Glutathione precursor gamma-glutamylcysteine may represent novel strategy for treatment and/or prevention of cognitive impairment

University of New South Wales(Australia), May 12, 2021

According to news originating from Sydney, Australia, research stated, “The accumulation of oxidative stress, neuroinflammation and abnormal aggregation of amyloid beta-peptide (A beta) have been shown to induce synaptic dysfunction and memory deficits in Alzheimer’s disease (AD). Cellular depletion of the major endogenous antioxidant Glutathione (GSH) has been linked to cognitive decline and the development of AD pathology.”

Our news journalists obtained a quote from the research from the University of New South Wales, “Supplementation with gamma-glutamylcysteine (gamma-GC), the immediate precursor and the limiting substrate for GSH biosynthesis, can transiently augment cellular GSH levels by bypassing the regulation of GSH homeostasis. In the present study, we investigated the effect of dietary supplementation of gamma-GC on oxidative stress and A beta pathology in the brains of APP/PS1 mice. The APP/PS1 mice were fed gamma-GC from 3 months of age with biomarkers of apoptosis and cell death, oxidative stress, neuroinflammation and A beta load being assessed at 6 months of age. Our data showed that supplementation with gamma-GC lowered the levels of brain lipid peroxidation, protein carbonyls and apoptosis, increased both total GSH and the glutathione/glutathione disulphide (GSH/GSSG) ratio and replenished ATP and the activities of the antioxidant enzymes (superoxide dismutase (SOD), catalase, glutamine synthetase and glutathione peroxidase (GPX)), the latter being a key regulator of ferroptosis. Brain A beta load was lower and acetylcholinesterase (AChE) activity was markedly improved compared to APP/PS1 mice fed a standard chow diet. Alteration in brain cytokine levels and matrix metalloproteinase enzymes MMP-2 and MMP-9 suggested that gamma-GC may lower inflammation and enhance A beta plaque clearance in vivo. Spatial memory was also improved by gamma-GC as determined using the Morris water maze.”

According to the news editors, the research concluded: “Our data collectively suggested that supplementation with gamma-GC may represent a novel strategy for the treatment and/or prevention of cognitive impairment and neurodegeneration.”

This research has been peer-reviewed.

Study led by NTU Singapore finds that microbes work as a network in causing lung infection

Nanyang Technological University (Singapore) May 21, 201

Traditionally, an infection is thought to happen when microbes - bacteria, fungi, or viruses - enter and multiply in the body, and its severity is associated with how prevalent the microbes are in the body.

Now, an international research team led by Nanyang Technological University, Singapore (NTU Singapore) has proposed a new way of understanding infections. Their study of close to 400 respiratory samples from patients with bronchiectasis, a chronic lung condition, has shown that microbes in the body exist as a network, and that an infection's severity could be a result of interactions between these microbes.

Through statistical modelling of data from these respiratory samples, the scientists found that flare-ups of coughs and breathlessness (known as exacerbations) occurred more often when there were 'negative interactions' between communities of bacteria, viruses and fungi in the airways. A negative interaction occurs when the microbes compete rather than cooperate with one another.

These findings, published in one of the world's leading scientific journals Nature Medicine in April, bring the scientists one step closer to developing a new way of tackling infections, by targeting microbial interactions rather than the specific microbes.

Assistant Professor Sanjay Haresh Chotirmall from the NTU Lee Kong Chian School of Medicine, who led the study, said: "Our current understanding of infections is that they occur when harmful microbes enter our bodies. This model of understanding, however, fails to account for resident microbes or explain why some patients with infection respond to antibiotics to which the microbe is resistant in laboratory testing. We are therefore proposing that microbes exist as networks, where interactions happen and that the resistant antibiotic in this case targets another microbe with which the culprit is interacting. We therefore can potentially improve clinical outcomes by breaking such crosstalk. 

"The findings of our study are the first steps in providing a more holistic view of how infections occur. While our study looked at patients with bronchiectasis, we believe this concept applies to all forms of infection - whether skin, lung, or a gastrointestinal infection. This way of looking at infections potentially changes our understanding of infection and may offer fresh ways of treating them." 

Associate Professor John Abisheganaden, co-author of the study and Head of Department of Respiratory & Critical Care Medicine at Tan Tock Seng Hospital, said: "By applying an integrated and holistic method, this study provides a new and fresh approach to our understanding of respiratory infection. Applying this precision-medicine approach can help the managing physician better understand and choose the most appropriate antibiotic or other therapy to confer clinical benefit - in short, to guide us to the right treatment at the right time, and for the best outcome."

Microbial interactions and infection 

For their study, the scientists looked at patients with bronchiectasis, a disease of high Asian prevalence, where airways dilate irreversibly and, where infection promotes progression. Targeting bacteria with antibiotics reduces bacterial load and accompanying inflammation, which in turn alleviates symptoms and improves clinical outcomes.

To investigate interactions between microbes in the airways of patients with bronchiectasis, the team collected respiratory (sputum) samples from 383 patients from Singapore, Malaysia, Italy, and Scotland, including samples before, during and after bronchiectasis flare-ups.

After analysing the genetic material from bacteria, fungi and viruses in the samples, the scientists assessed for possible microbial interactions and found that patients with frequent flare-ups had more negative interactions, where microbes compete rather than cooperate, and that the number of such negative interactions increased even further during a flare-up. While changes to interactions between microbes during flare-ups was detected, there was surprisingly minimal change to the type and quantity of microbes present during a flare-up, and even after antibiotics were administered. 

New treatment possibilities

The scientists believe that these findings suggest that microbial interactions potentially drive frequent flare-ups in patients.

Using these findings, the scientists have developed an online tool to help other researchers and physicians analyse microbial interactions in their own patient samples through the microbes' genetic sequences. 

Asst Prof Chotirmall, who is also NTU Provost's Chair in Molecular Medicine, said: "We are proposing a fresh way to view infection, as networks rather than individual microbes. Targeting microbial interactions within an established network may promote more judicious antibiotic use and help curb rising antimicrobial resistance."

The team is currently exploring the use of probiotics to treat bronchiectasis by regulating microbiomes within the air passages.

Pea flour helps malnourished children regain weight and restores gut flora

Imperial College London, May 21, 201

Adding pea flour to foods for severely malnourished children helps them gain weight and restores the balance of microbes in their gut.

In a small study of severely malnourished children in Uganda, researchers found that providing them with a mix containing cowpea flour improved their ability to absorb nutrients and gain weight, while maintaining their gut microbiome comparable to healthy children.

According to the researchers, the findings, published today in the journal Cell Reports Medicine, lay the foundations for larger trials with cowpea-based supplements and highlight the critical role of gut health in restoring nutrition in children with severe acute malnutrition.

Acute malnutrition is a major contributor to child mortality around the world. It remains a leading cause of death in children under five years of age and increases their risk of life-threatening events such as pneumonia, diarrheal disease or infections. Children with severe acute malnutrition can be treated with nutrient-rich, milk-based formulas to restore weight and nutrition, but despite treatment many will later go on to die.

Professor Gary Frost, head of the Center for Translational Nutrition and Food Research at Imperial College London, said: "These are children who have been admitted to hospital and often have other disease, such as bacterial sepsis, which complicates the picture—so they are very fragile.

"High quality feeds are lifesaving for many thousands of children. But sadly, when children are severely malnourished they can struggle to absorb nutrients and despite initial improvements in hospital, many remain very weak and will later go on to die."

"We have been able to show that legume-enriched feeds are well tolerated by these very sick children, and they may also protect their 'good' gut microbes, compared to traditional feeds. Our hope is that this kind of intervention will help them to grow stronger by enabling their bodies to absorb more of the nutrients from the feed."

More than 'calories in'

Researchers at Imperial College London have been exploring the links between gut health and nutrition, with the aim of improving outcomes for severely malnourished children. Growing evidence suggests that gut microbes feed on carbohydrates from our diet, releasing nutrients which maintain the lining of the gut. Without this regular supply of nutrients, the gut lining deteriorates and becomes 'leaky," reducing our ability to absorb nutrients and increasing the risk of bugs entering the bloodstream where they can cause infection.

Previous research by the Imperial team has shown that increasing dietary fiber can help to overcome this 'leaky gut' syndrome and improve the absorption of nutrients, so they designed and tested a new feed fortified with cowpea—which contains a source of easily fermentable carbohydrates and fiber, both known to be key in maintaining gut health.

In a small proof of concept trial, researchers recruited 58 hospitalized children in Uganda with severe acute malnutrition to receive one of three feeds: a conventional feed; a feed containing the plant compound inulin; and a feed fortified with cowpea flour. Children in all three groups received antibiotics and other medical treatments, as needed, in addition to the feed.

Led by Ph.D. candidates Nuala Calder and Kevin Walsh, the team measured changes to weight after seven days of treatment, along with fecal sampling to look at changes to the makeup of their gut microbiome. The children were also followed up at 28 days.

The researchers found that overall, all feeds resulted in comparable weight gain after one week, and duration of hospital stay did not vary between groups. However, the cowpea feed limited the damage to gut microbes associated with antibiotic treatment—which can reduce the richness of the microbiome by killing off key groups of bugs. The same effect was not seen in conventional feeds or those enriched with inulin—a compound derived from plants—highlighting the role of fiber and other elements in the legume feed.

Following 28 days, there was limited difference in mortality between the groups, and sadly, despite treatment 12 children died (3, 6 and 3 from the respective groups). But analysis suggested that across the groups, children that died had higher levels of gut dysfunction and altered levels of short chain fatty acids, indicating reduced diversity of gut microbes.

Protecting gut bugs

Professor Frost said: "Our major finding was that the cowpea enriched feeds actually protect the gut bugs when these children are given antibiotics, so we know that the feed is actually helping the microbiota to survive some of the concurrent medical therapy these children are receiving.

"We also found that the children that died tended to have a worse gut problem than those who survived, so it has highlighted that the gut is very important in rescuing children from severe malnutrition. These legume enriched feeds may be a small step towards improving outcomes for those children."

Professor Kathryn Maitland, Professor of Tropical Pediatric Infectious Disease at Imperial and based in Kenya, said: "This is a very small study, but it's an important first step. The role the gut actively plays in the pathology of severe malnutrition has not been fully appreciated, and there are multiple parameters that need fixing. Fortifying feeds with legumes can go some way towards that. Many of these children may receive multiple antibiotics, which kills the microbiota, leaving only the microbes that are bad for human health, and these legume enriched feeds may actually help to resist that."

Future trials are now planned to test the legume-enriched feeds in larger numbers of children with severe acute malnutrition in more regions. The team believes that if the feeds could be produced regionally, using legumes such as cowpea which can be grown and milled in East Africa, it could help to reduce the dependency on internationally produced feeds which may be more expensive and less effective.

Professor Maitland added: "Many feeds which are imported to East Africa are based on cow's milk, or a dried form of it. They can contain a lot of sugars, such as sucrose and lactose, and these children can't absorb this. In fact, quite a lot of these malnourished children may develop severe diarrhea from these feeds as they are lacking the enzymes to properly digest and absorb them, so our next steps are to tackle that as well.

"We think that the next iterations of our feed will include legumes, but will also not include any aspect of cow's milk, replacing the sucrose with other carbohydrate sources. This also means that they can be produced locally."

Professor Frost added: "We know that we can reverse the malnutrition, but this isn't really fixing the whole problem. This approach is a radical change for these children. It's taking a very different view of feeding. It's not just about the nutrients flowing in, it's about how compounds in plants are metabolized, and underlying gut health."

Why blueberries are an effective weapon in the war against Alzheimer’s disease

University of Cincinnati,  May 21, 2021 

Could a plump, little blueberry really hold colossal promise in the fight against Alzheimer’s disease?  New research adds to the growing evidence that blueberries, bursting with antioxidants, could help diminish the devastating defects of dementia.

Blueberries are already known as a “super fruit,” thanks to their documented contribution to lowering the risk of heart disease and cancer. But now, newly released study findings show that certain flavonoids found in blueberries could also hold the key to lessening the effects of Alzheimer’s disease.

Over 5 million Americans suffer from Alzheimer’s disease, a number that is expected to continue to rise as the population ages. The Alzheimer’s Association estimates that as many as 7 million could fall prey to the disease by 2025, and that the number could triple by 2050.  In fact, Alzheimer’s has become the sixth leading cause of death in the United States, with one out of every three elderly persons dying of complications from Alzheimer’s or some other form of dementia.

But Alzheimer’s takes a toll on more than just human life. It is an extremely costly disease as well. Experts estimate that Alzheimer’s will cost the nation $236 million and that caregivers will spend more than $5,000 a year trying to care for their loved one.

Hope for Alzheimer’s disease patients: Blueberries found to improve cognition and memory

As scientists work to slow this alarming trend, researchers out of the University of Cincinnati Academic Health Center have released promising results of two human studies conducted in follow up to their earlier clinical trials. Lead author Robert Krikorian, Ph.D., stated that the new findings corroborate those from previous human and animal research.

The researchers, led by Krikorian, believe that blueberries’ beneficial effects against Alzheimer’s could be due to certain flavonoids found in the berries. Known as anthocyanins, they have been shown to improve cognition in tests with animals.

In one study, 47 adults, aged 68 and older, exhibiting mild cognitive impairment – a risk factor for Alzheimer’s disease – were given either freeze-dried blueberry powder or a placebo powder once a day for 16 weeks. The blueberry powder was equivalent to one cup of fresh blueberries.

Those receiving the blueberry powder were found to exhibit improved brain function and cognitive performance compared to those in the control group, with better memory and improved access to words and concepts.  In another study, 94 people, aged 62 to 80, were divided into four groups. The subjects did not have diagnosed early-onset Alzheimer’s, but did report feelings of having their memory decline.

In the trial, stated above (with 94 people), cognition was somewhat better for those consuming powder or fish oil only, but there was little improvement with memory. Also, researchers report that the MRI results were not as definitive for those receiving blueberry powder.

Even with somewhat less striking results from the second study, the scientists believe the two studies show that blueberries may be more effective in treating patients with cognitive impairments. Next up, the researchers want to conduct a study involving younger subjects, all with risk factors for Alzheimer’s.

Reaping the benefits of blueberries from your regular diet can be easy. Blueberries are an extremely popular berry and can be found in many stores (and farmers’ markets) throughout the world.  Naturally, to avoid excess consumption of chemicals, it’s best to eat organic varieties only.

As a matter of convenience and potency, the best way to incorporate blueberries into your diet is through a powder of pure (organic) blueberry extract or by eating whole, organic berries.  Baking or cooking blueberries will diminish the nutritional value of this powerful fruit.

Oxidative Stress, Vitamin D Deficiency and Male Infertility: An Under-Looked Aspect

Aga Khan University (Pakistan), May 21, 2021

Infertility is a known source of distress among couples worldwide. This agony significantly stems from the concern of not having an identifiable cause leading to infertility. With male factors accounting for 20-30% of the total causes of infertility (1), a thorough evaluation of both the partners is done.

Upon evaluation, Vitamin D deficiency was noticed significantly in males coming to infertility centres. However, its functions and how it impacted reproduction was not known until the research led to the discovery of Vitamin D Receptor (VDR) in many organs of the male reproductive tract. It is now known that vitamin D deficiency decreases male fertility by contributing to oxidative stress and gonadal insufficiency, disrupting spermatogenesis, affecting sperm morphology and normal calcium haemostasis. (2)

Oxidative stress, caused by an imbalance between oxidative and antioxidative mechanisms, is believed to be a well-known mechanism underlying idiopathic male infertility. Reproductive health professionals and researchers fittingly started searching for antioxidants to combat this imbalance. A study concluded that adding vitamin D to a cryopreserved semen sample reduced oxidative stress and resulted in better fertility outcomes (3). Animal trials have shown that Vitamin D supplementation reduced oxidative stress and improved semen DNA integrity (4).

As Vitamin D exerts its effects by binding to Vitamin D receptors, it was noted that vitamin D receptor null mutant mice had a significant reduction in successful reproductive outcomes due to gonadal insufficiencies. Reduced levels of oestrogen and testosterone were seen along with low sperm count, reduced motility, abnormal spermatogenesis and histological abnormalities in testes of mutant mice. These insufficiencies were attributed to a decreased CYP2R1, CYP27B1 and CYP24A1 expression, lower aromatase activity, secondary to suppression of CYP19 gene and calcium supplementation improved fertility in such cases. (5)

There is limited human data available on how Vitamin D deficiency causes gonadal insufficiency, which is important to maintain normal reproductive physiology. More studied are needed to clarify the role of vitamin D in gonadal physiology. Considering the importance of Vitamin D on reproductive functions, its role in causing Oxidative stress and gonadal dysfunction, we suggest randomized control trials in pre-pubertal phase.

Want to escape Alzheimer's disease? Run for your life and exercise

Tel Aviv Sourasky Medical Center (Israel), May 20, 2021



Exercise slows down aging of the brain and can reduce risks of Alzheimer's disease and other dementias by about half.







There is a growing amount of medical evidence that exercise slows down the aging of the brain and can reduce the risk of Alzheimer's disease and other dementias by about half, according to Prof. Nir Giladi, chief of neurology at Tel Aviv Sourasky Medical Center.


He said that the modern sedentary way of life reduces the amount of body movement. Long-term epidemiological and physical studies show that exercise can improve memory, concentration and mood and minimize pain, as well as reduce the risk of cognitive damage, stroke, Parkinson's disease and depression.


The connection between exercise and brain function was first disclosed from animal studies two decades ago, said Giladi. Brains of rats that ran on a wheel for three months at a time had many more neurons and synapses through which electric signals connect. Exercise causes these to multiply, said Giladi.


"These findings flew in the face of the belief that over the age of 30, the neurons decline irreversibly. Today we know that the adult brain has many stem cells that when stimulated can differentiate and turn into ripe neurons that know how to create synapses." The neurologist added that for some unknown reason, the best potential for differentiation exists in brain regions responsible for memory.


Exercise promotes the secretion of trophic factors -- including brain-derived neurotrophic factor that encourage the growth of stem cells that turn into adult nerve cells. he added. These factors activate genes responsible for the development of stem cells in the hippocampus and other brain regions involved in memory, storage and processing of data. They are available in large quantities during a baby's first years when the brain develops at a rapid pace, but the amounts decline during adolescence and aging.


The greater the amount, the more the brain grows and holds more nerve cells, especially in the hippocampus, he said. Exerting the muscles activates unique genes that encourage the muscle cells and apparently others to create proteins that increase the synthesis of trophic factors. "This is why those who exercise regularly look and have younger brain function -- and their cells are more protected from diseases, trauma and natural aging."


Giladi said it was best to do aerobic exercise (causing the heart and lungs to exert themselves) along with non-aerobic exercise (strengthening the muscles on the skeleton) at least three times a week. Even if you exercise just as an adult and the cognitive decline has begun, your physical activity will slow down the rate of decline.


A study published in the journal PNAS  using MRI to see the effect of regular exercise on the brain showed that the brains of healthy 75-year-olds who performed physical activity at least three times a week declined slower in the regions of memory, concentration, planning, initiative and management abilities. The same thing was noted in studies of teenagers, Giladi said. Exercise influences the brain cell in deciding which genes will function and contribute to this and which will be neutralized. This is thus epigenetics, in which the environment actually affects the genes, the neurologist said.


Exercise also increases the supply of blood to the organs, including the brain, he continued, and encourages the growth of alternate blood vessels to take over functions from clogged vessels.


He bemoaned the fact that many Israelis don't exercise regularly. An average of 150 to 300 minutes per week -- half aerobic and half non-aerobic -- can improve the abilities of the brain and protect it from disease, Giladi concluded.

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Vegan and omnivorous diets promote equivalent muscle mass gain, study shows

University of São Paulo (Brazil), May 19, 2021

Protein intake is more important than protein source if the goal is to gain muscle strength and mass. This is the key finding of a study that compared the effects of strength training in volunteers with a vegan or omnivorous diet, both with protein content considered adequate. 

In the study, which was conducted by researchers at the University of São Paulo (USP) in Brazil, 38 healthy young adults, half of whom were vegans and half omnivores, were monitored for 12 weeks. In addition to performing exercises to increase muscle strength and mass, the volunteers followed either a mixed diet with both animal and plant protein, or an entirely plant-based diet, both with the recommended protein content (1.6 gram of protein per kilogram of body weight per day). At the end of three months, there was no difference between vegans and omnivores in terms of muscle strength and mass increase. 

“Like any other protein in our organism, such as the proteins in our skin and hair cells, which die and are renewed, our muscles undergo synthesis and breakdown every day. Diet [protein intake] and exercise are the main protein balance regulators, favoring synthesis over breakdown,” said Hamilton Roschel, last author of the published study. Roschel is a University of São Paulo professor affiliated with both USP’s Sports and Physical Education School (EEEE) and Medical School (FM). He also heads the Applied Physiology and Nutrition Research Group jointly run by EEEE-USP and FM-USP.

Protein sources are characterized primarily on the basis of essential amino acids, especially leukin, which plays a key role in anabolic stimulation of skeletal muscles. “Animal protein has more leukin than plant protein. Leukin is an essential amino acid in the anabolic stimulus signaling process. A plant-based diet is often thought to contain less leukin and hence trigger less anabolic stimulation, potentially affecting vegans’ capacity for muscle mass gain,” Roschel said.

The study is published in Sports Medicine and resulted from the master’s research of Victoria Hevia-Larraín, with support from FAPESP. 

The study innovated by including a clinical analysis of the effects of protein source quality on muscle adaptation in vegans as compared with omnivores, since most research on the topic to date has focused on the acute anabolic response of muscles to protein intake under laboratory conditions and not on muscle mass as such. “Our findings show that there is no impairment of muscle mass gain for young adult vegans if they ingest the right amount of protein. In fact, the outcome of both diets was the same in this respect,” Roschel said. 

However, the researchers stress that, for the purposes of experimental control, protein intake was made the same in both diets by means of protein supplements. Omnivores and vegans were given milk serum protein isolate or soy protein respectively in accordance with individual dietary needs in order to attain the targeted protein intake. 

“In clinical practice, we know foods of animal origin generally have a higher protein content,” Roschel said. “Meat, milk and eggs contain more protein per gram than rice and beans, for example. In a clinical application with plant-based foods as the sole protein source, vegans would need to ingest a large amount of food to obtain the same amount of protein. In some specific cases, this could be a major challenge.”

The protein source (mixed or plant-based diet) made no difference, provided each subject received an adequate amount of protein. “This result corroborates other data in the literature showing that a vegan diet can absolutely be complete if it is properly planned and executed,” Roschel said. “Previous studies suggest it can even be healthier than an omnivorous diet. For this to be the case, however, it requires appropriate nutritional counseling and education regarding people’s choices in restricting their intake to plant-based sources.” 

Another point noted by Roschel is that the subjects were healthy young adults, and the results might be different for older people or subjects with health problems. “Aging entails a phenomenon known as anabolic resistance, meaning a suboptimal anabolic response to the stimuli provided by diet and exercise compared with young people. Optimal response is possible in older people only if their protein intake is higher than that of the average healthy youngster. So we should be cautious about generalizing our findings for the entire population.”

Yoga and breathing exercises aid children with ADHD to focus

Ural Federal University, May 17, 2021

Yoga and breathing exercises have a positive effect on children with attention deficit hyperactivity disorder (ADHD). After special classes, children improve their attention, decrease hyperactivity, they do not get tired longer, they can engage in complex activities longer. This is the conclusion reached by psychologists at Ural Federal University who studied the effect of exercise on functions associated with voluntary regulation and control in 16 children with ADHD aged six to seven years. The results of the study are published in the journal Biological Psychiatry.

"For children with ADHD, as a rule, the part of the brain that is responsible for the regulation of brain activity - the reticular formation - is deficient," said Sergey Kiselev, head of the Laboratory of Brain and Neurocognitive Development at UrFU, head of the study. "This leads to the fact that they often experience states of inadequate hyperactivity, increased distraction and exhaustion, and their functions of regulation and control suffer a second time. We used a special breathing exercise based on the development of diaphragmatic rhythmic deep breathing - belly breathing. Such breathing helps to better supply the brain with oxygen and helps the reticular formation to better cope with its role. When the reticular formation receives enough oxygen, it begins to better regulate the child's state of activity".

In addition to breathing exercises, psychologists used body-oriented techniques, in particular, exercises with polar states "tension-relaxation". The trainings took place three times a week for two to three months (depending on the program).

"Exercise has an immediate effect that appears immediately, but there is also a delayed effect. We found that exercise has a positive effect on regulation and control functions in children with ADHD and one year after the end of the exercise. This happens because the child's correct breathing is automated, it becomes a kind of assistant that allows better supply of oxygen to the brain, which, in turn, has a beneficial effect on the behavior and psyche of a child with ADHD," says Sergey Kiselev.

This technique was developed by the Russian neuropsychologist Anna Semenovich as part of a neuropsychological correction technique. UrFU psychologists tested how well this approach helps children with ADHD. But the study is pilot, says Kiselev. It showed that these exercises have a positive effect. However, more work needs to be done, involving more children with ADHD. This will also take into account factors such as gender, age, severity of the disease, concomitant problems in children (speech, regulatory, etc.).

Study findings suggest vitamin D deficiency may be associated with reduced arterial elasticity

Guizhou Medical University (China), May 17, 2021

According to news reporting out of Guizhou, People’s Republic of China, research stated, “There is evidence that serum 25-hydroxyvitamin D [25-(OH) D] levels may be associated with cardiovascular disease and its risk factors. This study aimed to investigate the relationship between 25-(OH) D levels and blood pressure (BP), blood lipids, and arterial elasticity in middle-aged and elderly cadres in China.In this retrospective study, we included 401 civil servants and cadres aged >42 years who underwent medical examinations at Guiyang Municipal First People’s Hospital, China in 2018.”

Our news journalists obtained a quote from the research from Guizhou Medical University, “The participants were assigned to deficiency ( 20 ng/mL), insufficiency (20-30 ng/mL), and sufficiency ( 30 ng/mL) groups according to 25-(OH) D levels in their blood. Demographics, brachial-ankle pulse wave velocity (baPWV), BP, ankle-brachial index (ABI), and blood lipids were compared among groups. The associations between 25-(OH) D and other parameters were evaluated using linear regression analysis.Median (range) 25-(OH) D levels in the deficiency (n = 162), insufficiency (n = 162), and sufficiency (n = 77) groups were 15.32 (2.93-19.88), 25.12 (20.07-29.91), and 33.91 (30.23-82.42) ng/mL, respectively. There were significant differences in systolic BP, pulse pressure, baPWV (left and right sides), ABI (left side), high-density lipoprotein-cholesterol, and triglycerides (TGs; all P< .05) among groups.”

According to the news editors, the research concluded: “Multivariate linear regression revealed that TG, left baPWV, and right baPWV were significantly negatively correlated with 25-(OH) D levels (all P< .05).In this study, 25-(OH) D levels were found to be associated with TG, left baPWV, and right baPWV values. 25-(OH) D deficiency may be associated with reduced arterial elasticity.”

Icing muscle injuries may delay recovery

Kobe University and Chiba Institute of Technology (Japan), May 19, 2021

A study using a mouse model of eccentric contraction (*1) has revealed that icing injured muscles delays muscle regeneration. The discovery was made by a research group including Associate Professor ARAKAWA Takamitsu and then PhD. Student KAWASHIMA Masato from Kobe University's Graduate School of Health Sciences, and Chiba Institute of Technology's Associate Professor KAWANISHI Noriaki et al. In addition, the researchers illuminated that this phenomenon may be related to pro-inflammatory macrophages' (*2, 3, 4) ability to infiltrate damaged cells. This research raises questions as to whether or not severe muscle injuries (such as torn muscles) should be iced.

These research results were published online as one of the Journal of Applied Physiology's Articles in Press on March 25, 2021.

Main points

• The research results revealed that applying an ice pack to a severe muscle injury resulting from eccentric contraction may prolong the time it takes to heal.
• The cause of this phenomenon is that icing delays the arrival of pro-inflammatory macrophages, which are responsible for the phagocytosis (*5), or removal, of damaged tissue. Furthermore, this makes difficult for the macrophages to sufficiently infiltrate the damaged muscle cells.

Research Background

Skeletal muscle injuries encompass a range of damage to muscles; from a microcellular level to a severe level. These injuries include not only those that happen during sports or schools' physical education lessons but also external injuries that occur as a result of accidents and disasters.

'RICE treatment' is a common approach for skeletal muscle injuries, regardless of the extent of the injury. This acronym stands for Rest, Ice, Compression and Elevation and is often used in physical education, sports and even medicine. Ice is commonly applied regardless of the type of muscle injury, yet little is known about the long-term effects of icing.

Ice is used to suppress inflammation, however, inflammation in response to tissue injury is one of the body's healing mechanisms. This has come to be understood as a vital response for tissue regeneration. In other words, suppressing inflammation with ice may also inhibit the body's attempt to repair itself.

Experiments investigating the effect of icing muscles after injury have produced conflicting results. Some have reported that it delays muscle regeneration while others have stated that it doesn't inhibit this process. However, none of the research up until now has investigated the effects of icing using an injury model that mimics common sports injuries caused by muscle contraction.

Using a mouse model of eccentric contraction injury, the current research team decided to observe the effects of post-injury icing. In this mouse model, injuries were induced to resemble severe torn muscles.

Research Methodology and Results

Eccentric contraction was induced by electrically stimulating the leg muscles of the mice and then exerting a stronger force during this stimulation to make the leg muscles move in the opposite direction. After this, the muscles were harvested. Icing was performed by placing polyurethane bags of ice on top of the skin over three 30 minute sessions per day, with each session being 2 hours apart. This was continued until two days after the injury. The icing was based on the usual clinically recommended method.

The researchers investigated the regenerated skeletal muscle two weeks after injury, comparing the icing group with the non-icing group. A significantly higher percentage of smaller regenerated muscle fibers were found in cross-sections from the icing group, with a greater number of medium to large fibers in the non-icing group (Figure 1). In other words, this revealed that skeletal muscle regeneration may be delayed as a result of icing.

Next, the researchers periodically took samples of muscle from the icing and non-icing groups of animals in order to investigate what was happening in the regeneration process up until this point.

In the regeneration process, inflammatory cells gather at the site of the injury, remove the debris from the damaged muscle and then begin to build new muscle. However, the results revealed that it is harder for inflammatory cells to enter the injured muscle cells if ice is applied (Figure 2).

Macrophages are typical of the inflammatory cells that enter the injured muscle. These consist of pro-inflammatory macrophages, which phagocyte damaged tissue thus causing inflammation, and anti-inflammatory macrophages (*6), which suppress the inflammatory reaction and promote repair. It is thought that pro-inflammatory macrophages change their characteristics, becoming anti-inflammatory. The results of this research team's experiments showed that icing delays the arrival of pro-inflammatory macrophages at the site of the injury (Figure 3).

These results indicate the possibility that macrophages are unable to sufficiently phagocyte the damaged muscle when ice is applied after severe muscle injuries caused by eccentric contraction, consequently delaying the formation of new muscle cells.

Comment from Associate Professor Arakawa

In sports, the mantra of immediately applying ice to an injury is commonplace, regardless of the injury's severity. However, the mechanism that we illuminated through this research suggests that not icing a severe muscle injury may lead to faster recovery. The idea of immediately cooling any type of injury is also entrenched in schools' physical education classes. I hope that in the future, the alternative option of speeding up recovery by not cooling severe muscle injuries will become known.

However, even though icing may disrupt the recovery process for severe muscle injuries, there is no denying the possibility that there are degrees of mild muscle injuries that can be iced. The next issue is to work out where to draw the line. We are now in the middle of investigating what effect icing has on slight muscle injuries.

Next, we will continue to investigate how icing should be carried out according to the extent of the muscle injury. We aim to contribute guidelines that will enable people in sports and clinical rehabilitation to make accurate judgements about whether or not to ice an injury.

Probiotics associated with fewer respiratory symptoms in overweight and older people

Findings provide further evidence of relationship between the gut and lungs

Imperial College London, May 14, 2021

Daily probiotic use was associated with fewer upper respiratory symptoms in overweight and older people, according to a study that suggests a potential role for probiotics in preventing respiratory infections. The study was selected for presentation at Digestive Disease Week® (DDW) 2021. 

"This is not necessarily the most intuitive idea, that putting bacteria into your gut might reduce your risk of respiratory infection," said Benjamin Mullish, MD, a lead researcher on the study and clinical lecturer in the Division of Digestive Diseases, Imperial College London, England, "but it's further evidence that the gut microbiome has a complex relationship with our various organ systems. It doesn't just affect how our gut works or how our liver works, it affects aspects of how our whole body works."

Researchers re-analyzed detailed daily diaries of 220 patients who participated in an earlier double-blind placebo-controlled study on probiotics and weight loss. Reviewing the entries for common symptoms of upper respiratory infection, including cough, sore throat and wheezing, researchers found that participants who took probiotics during the six-month study had a 27 percent lower overall incidence of upper respiratory tract symptoms compared to the placebo group. The effect was largest among participants who were aged 45 years or older, as well as those with obesity.

People with obesity are at higher risk for respiratory infections. Previous research has shown that probiotics reduce upper respiratory infections in healthy adults and children, but little data exists on this vulnerable population of older, overweight and people with obesity.

"These findings add to growing interest in the gut-lung axis -- how the gut and the lungs communicate with each other," Dr. Mullish said. "It's not just the gut sending out signals that affect how the lungs work. It works in both directions. It adds to the story that changes in the gut microbiome can affect large aspects of our health."

The researchers did not measure immune response, only respiratory symptoms. Future randomized clinical trials could help identify the mechanisms related to the reduction in respiratory symptoms and explore the possible impact of probiotics on the immune system, Dr. Mullish said.

Fruit discovery could provide new treatments for obesity, type 2 diabetes and cardiovascular disease

University of Warwick (UK), May 11, 2021 

A combination of two compounds found in red grapes and oranges could be used to improve the health of people with diabetes, and reduce cases of obesity and heart disease. The find has been made by University of Warwick researchers who now hope that their discovery will be developed to provide a treatment for patients.

Professor Thornalley who led research said: "This is an incredibly exciting development and could have a massive impact on our ability to treat these diseases. As well as helping to treat diabetes and heart disease it could defuse the obesity time bomb."

The research 'Improved glycemic control and vascular function in overweight and obese subjects by glyoxalase 1 inducer formulation' has been published in the journal Diabetes, and received funding from the UK's innovation agency, Innovate UK. The project was a collaboration between the University of Warwick and University Hospitals Coventry and Warwickshire (UHCW) NHS Trust.

A team led by Paul Thornalley, Professor in Systems Biology at Warwick Medical School, studied two compounds found in fruits but not usually found together. The compounds are trans-resveratrol (tRES) - found in red grapes, and hesperetin (HESP) - found in oranges. When given jointly at pharmaceutical doses the compounds acted in tandem to decrease blood glucose, improve the action of insulin and improve thehealth of arteries.

The compounds act by increasing a protein called glyoxalase 1 (Glo1) in the body which neutralises a damaging sugar-derived compound called methylglyoxal (MG). MG is a major contributor to the damaging effects of sugar. Increased MG accumulation with a high energy diet intake is a driver of insulin resistance leading to type 2 diabetes, and also damages blood vessels and impairs handling of cholesterol associated with increased risk of cardiovascular diseases. Blocking MG improved health in overweight and obese people and will likely help patients with diabetes and high risk of cardiovascular disease too. It has already been proven experimentally that blocking MG improves health impairment in obesity and type 1 and type 2 diabetes.

Although the same compounds are found naturally in some fruits, the amounts and type required for health improvement cannot be obtained from increased fruit consumption. The compounds that increase Glo1 and are called a 'Glo1 inducer'. Pharmaceutical doses for patients with obesity, diabetes and high risk of heart disease could be given to patients in capsule form.

Professor Thornalley increased Glo1 expression in cell culture. He then tested the formulation in a randomised, placebo-controlled crossover clinical trial.

Thirty-two overweight and obese people within the 18-80 age range who had a BMI between 25-40 took part in the trial. They were given the supplement in capsule form once a day for eight weeks. They were asked to maintain their usual diet and their food intake was monitored via a dietary questionnaire and they were also asked not to alter their daily physical activity. Changes to their sugar levels were assessed by blood samples, artery health measured by artery wall flexibility and other assessments by analysis of blood markers.

The team found that the highly overweight subjects who had BMIs of over 27.5 with treatment displayed increased Glo1 activity, decreased glucose levels, improved working of insulin, improved artery function and decreased blood vessel inflammation. There was no effect of placebo.

Professor Thornalley said: "Obesity, type 2 diabetes and cardiovascular disease are at epidemic levels in Westernised countries. Glo1 deficiency has been identified as a driver of health problems in obesity, diabetes and cardiovascular disease."

"Diabetic kidney disease will be the initial target to prove effective treatment for which we are currently seeking commercial investors and partners. Our new pharmaceutical is safe and expected to be an effective add-on treatment taken with current therapy.

"The key steps to discovery were to focus on increasing Glo1 and then to combine tRES and HESP together in the formulation for effective treatment.

"As exciting as our breakthrough is it is important to stress that physical activity, diet, other lifestyle factors and current treatments should be adhered to."

Professor Martin O Weickert, Consultant in Diabetes and Endocrinology at UHCW NHS Trust, and co-applicant for the grant, said: "We were really excited to participate in this study with Warwick Medical School, as taking part in world-leading research makes a real difference to our patients both now and in the future.

"As well as the positive effects for the UHCW patients who took part in the trial, we hope this study will lead to new treatments to help patients with diabetes and cardiovascular diseases all over the world."

Prof. Thornalley and his team are now hoping manufacturers will want to explore the use of the compound as pharmaceutical products.

Vitamin D supplementation associated with less time spent in ICU among critically ill patients

Lishui People’s Hospital (China), May 18, 2021

According to news originating from Lishui, People’s Republic of China, research stated, “Vitamin D deficiency is a common scenario in critically ill patients and has been proven to be associated with poor outcomes. However, the effect of vitamin D supplementation for critically ill patients remains controversial.”

Our news correspondents obtained a quote from the research from Lishui People’s Hospital: “Thus, we conducted a meta-analysis to evaluate the effect of vitamin D supplementation among critically ill patients. Electronic databases PubMed, Embase, Scopus, and the Cochrane Library were searched for eligible randomized controlled trials between 2000 and January 2021. The primary outcome was overall mortality, and the secondary ones were the length of intensive care unit stay, the length of hospital stay, as well as the duration of mechanical ventilation. Subgroup analyses were performed to explore the treatment effect by type of admission, route of administration, dose of supplemented vitamin D, and the degree of vitamin D deficiency. A total of 14 studies involving 2,324 patients were finally included. No effect on overall mortality was found between vitamin D supplementation and control group [odds ratio (OR), 0.73; 95% CI, 0.52-1.03; I2 = 28%]. The vitamin D supplementation reduced the length of intensive care unit stay [mean difference (MD), -2.25; 95% CI, -4.07 to -0.44, I2 = 71%] and duration of mechanical ventilation (MD, -3.47; 95% CI, -6.37 to -0.57, I2 = 88%). In the subgroup analyses, the vitamin D supplementation for surgical patients (OR, 0.67; 95% CI, 0.47-0.94; I2 = 0%) or through parenteral way (OR, 0.42; 95% CI, 0.22-0.82, I2 = 0%) was associated with reduced mortality.”

According to the news reporters, the research concluded: “In critically ill patients, the supplementation of vitamin D has no effect on overall mortality compared to placebo but may decrease the length of intensive care unit stay and mechanical ventilation. Further trials are necessary to confirm our findings.”

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Western diet found to impair function of immune cells in the gut

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After receiving a bachelor’s degree from Baylor University, Dr. McCullough completed his medical degree as an Alpha Omega Alpha graduate from the University of Texas Southwestern Medical School in Dallas. He went on to complete his internal medicine residency at the University of Washington in Seattle, cardiology fellowship including service as Chief Fellow at William Beaumont Hospital, and master’s degree in public health at the University of Michigan. Dr. McCullough is a consultant cardiologist and Vice Chief of Medicine at Baylor University Medical Center in Dallas, TX. He is a Principal Faculty in internal medicine for the Texas A & M University Health Sciences Center. Dr. McCullough is an internationally recognized authority on the role of chronic kidney disease as a cardiovascular risk state with > 1000 publications and > 500 citations in the National Library of Medicine. His works include the “Interface between Renal Disease and Cardiovascular Illness” in Braunwald’s Heart Disease Textbook. Dr. McCullough is a recipient of the Simon Dack Award from the American College of Cardiology and the International Vicenza Award in Critical Care Nephrology for his scholarship and research. Dr. McCullough is a founder and current president of the Cardiorenal Society of America, an organization dedicated to bringing cardiologists and nephrologists together to work on the emerging problem of cardiorenal syndromes. His works have appeared in the New England Journal of Medicine, Journal of the American Medical Association, Lancet and other top-tier journals worldwide. He is the co-editor of Reviews in Cardiovascular Medicine, and associate editor of the American Journal of Cardiology and Cardiorenal Medicine. He serves on the editorial boards of multiple specialty journals. Dr. McCullough has made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), European Medicines Agency, and the U.S. Congressional Oversight Panel. 

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The FDA, Shock Troops for the Pharmaceutical Industrial Complex

Richard Gale and Gary Null PhD

Progressive Radio Network, May 17, 2021

As of this week, over 194 million doses of the Covid-19 vaccines have been administered in the US. Consequently, a growing majority of Americans are delighted that life may return to normal because most believe they are now protected from infection. Clearly that is not the case. Bill Maher tested positive for Covid last week and had to cancel his television show for his first time since 1993. This was despite Maher having been fully vaccinated. Moreover the vaccines’ serious adverse effects are being downplayed by health officials and the media. Who will experience an adverse effect appears to be arbitrary; therefore, it is a game of Russian Roulette as to whether a person will be critically injured or be protected from the virus. One of the world’s most accomplished rock guitar musicians Eric Clapton received both doses of AstraZeneca’s Covid vaccine and had such severe reactions he feared he might never play the guitar again.  Clapton posted a message:

“About six weeks later [after receiving the first shot] I was offered and took the second AZ shot, but with a little more knowledge of the dangers. Needless to say the reactions were disastrous, my hands and feet were either frozen, numb or burning, and pretty much useless for two weeks, I feared I would never play again, (I suffer with peripheral neuropathy and should never have gone near the needle.) But the propaganda said the vaccine was safe for everyone.”

However it is not simply a miniscule few who are suffering undesirable Covid-vaccine events such as blood clots and other cardiovascular complications, anaphylaxis, severe allergic reactions, various neuropathies, abnormal menstrual bleeding and suspected miscarriages, extreme muscle weakness, fatigue, etc.  If this were the case, an argument could be made for siding with benefits over risks. Covid vaccines have only been administered for less than six months, and it is becoming increasingly clear that the risks may outweigh the benefits. Suspected numbers of miscarriages following Covid vaccines is especially worrisome. A government study published in the New England Journal of Medicine attempted to analyze and downplay the risk. Yet at the same time, the study observed a trend of 11.6% of spontaneous abortions occurring less than 13 weeks after the mRNA vaccination.  It is becoming increasingly obvious that these vaccines’ safety profiles is far less than Anthony Fauci, the FDA and the CDC are touting

More younger adults are experiencing adverse vaccine symptoms than from the risks due to acquiring a wild coronavirus. Worldwide reported adverse effects and deaths are escalating dramatically. In the CDC’s Vaccine Adverse Events Reporting System (VAERS), reported Covid-19 vaccine deaths have now reached 4.434 as of May 13^th 2021 which is more vaccine-related deaths from conventional vaccines recorded in VAERS during the past 21 years.  Since VAERS is a passive reporting system, the actual serious adverse effect rate may be as high as 1in 10 shots. No other vaccine on the CDC’s vaccination schedule has such a poor record of safety.

As with Bill Maher, fully vaccinated people are still being infected and testing positive. Younger healthy adults, who earlier had an insignificant chance of becoming sick or dying from the SARS-CoV-2 virus, are now being injured and in some cases dying from the vaccines. 

A recent study published in JAMA observed delayed hypersensitivity vaccine reactions well after injections. The University of Pennsylvania estimates that between 5 to 10 percent of recipients of the mRNA vaccines have “severe adverse reactions” – an inordinately high percent compared to every other non-Covid vaccine. And a group of medical institutions including the University of Greifswald School of Medicine, and the Medical University of Vienna are proposing a new medical condition, “vaccine-induced prothrombotic immune thrombocytopenia,” now be associated with the AstraZeneca and Johnson and Johnson vaccines.

A recent paper warns about the dangers of vaccine-induced prion disease. The list of adverse effects continues to mount.  Pfizer document refers to the possibility of Covid vaccine shedding to the unvaccinated.  Doctors are coming forward and accusing the CDC of scrubbing the statistics of actual vaccine-related deaths. The risks were quite obvious in the vaccine makers’ own clinical trial documents before the FDA awarded Covid vaccines with emergency use approval to launch a nation-wide vaccination program. Whether or not health officials at the CDC or FDA thoroughly deliberated on the many warnings or simply ignored them is open to debate.  But the evidence strongly leans towards the latter.

Earlier, we presented the historical evidence of widespread corruption at the CDC; however, the FDA is far more influential because it is the final watchdog that determines a drug’s efficacy and safety profile. In the most perverse scenario, the FDA relies upon outside experts to sit on its advisory committees to review a drug’s or a vaccine’s safety. Many of these experts have a gross conflict of interests with the pharmaceutical industry.  This institutional dilemma is steeped into the FDA’s very DNA. As far back as 2006, Public Citizen discovered that 1 out of 3 of outside consultants and advisory members to the FDA had financial conflicts. The situation has only worsened over the years.

A Pogo investigation in October last year, uncovered several advisers on the FDA’s Vaccines and Related Biological Products Advisory Committee who had direct ties with the Covid-vaccine companies, including direct payments for consulting fees. Dr. Archana Chatterjee, for example, has received over $200,000 from agreements with these companies. The same is true for the Committee’s chairman, University of Michigan Dr. Arnold Monto who received fees from the largest vaccine firms including  Pfizer, Sanofi, GlaxoSmithKline and Novartis. The previous chair, Dr. Hana El Sahly from Baylor University, had to recuse herself due to her role in supervising Moderna’s Covid-19 vaccine clinical trials. Earlier, Monto was the principal investigator for Sanofi’s influenza vaccine. Another is the president of Meharry Medical College where coronavirus clinical trials were conducted. Three other Committee members likewise held close conflict-of-interest relationships with vaccine makers.  Shortly before issuing emergency use approval, a second Pogo analysis concluded that the FDA Committee whitewashed the warnings indicated by the Covid-19 vaccine trials. The meeting was adjourned by the FDA director for the Office of Vaccines Research and Review in favor of green-lighting the vaccines before Committee members suspicious of the clinical results could weigh-in. Prof. Carl Elliott, a medical ethicist at the University of Minnesota, summarized the problem of corporate bias now plaguing the FDA. “You do something positive for a company that you feel confident is going to pay you back for it later on,” Elliot stated. “And they do.”  The FDA‘s current rules regarding conflict of interest is strictly limited to the honor system.  In Europe, on the other hand, the European Medicines Agency strictly prohibits experts with ties to private industry from sitting on its advisory committees. 

Even with FDA efforts to crack down on conflicts of interests due to Congressional pressure, the industry has found other means to get their representatives onto advisory panels. And the heads of the agency willingly turn a blind eye.  A Science exposé reported on the growing strategy of “pay after” conflicts of interests. Outside advisors will declare no conflicts but then rule in favor of a drug or vaccine only to be reimbursed afterwards. The journal’s review of compensation records uncovered “pay after” schemes for the approval of 28 psychopharmacologic, arthritis, cardiac and renal drugs.” The investigation also uncovered:

“Of the more than $24 million in personal payments or research support from industry to the 16 top-earning advisers—who received more than $300,000 each—93% came from the makers of drugs those advisers previously reviewed or from competitors.”

Probing still deeper, the Pacific Legal Foundation released an analytical review of 2,952 rules issued by the Department of Health and Human Services over a 17-year period. The Foundation determined that 75 percent of these rules were unconstitutional and “issued by low-level officials and employees with no authority to issue rules.” With respect to the FDA dozens had no democratic controls and involved tens of millions of dollars ruled over by career bureaucrats.  

Every American who is prescribed a drug by a physician has the belief that the pill has undergone rigorous trials to scrutinize its safety and will be effective. And when there are known potential adverse effects, we blindly assume the attending physician knows these dangers. However, this is a myth perpetuated not only by drug makers but also by our own federal health agencies.

As we have reported on many occasions, iatrogenic deaths, deaths caused by medical error and prescribed medications is now the third leading cause of mortality in the US. The Institute of Medicine has warned about “the nation’s epidemic of medical errors.” A large percent of these errors are related to adverse drug events (ADEs). The FDA states, “ADRs are one of the leading causes of morbidity and mortality in healthcare.” Dr. Curt Furburg published an article in the Archives of Internal Medicine proposing sweeping changes throughout the FDA.  Furburg and his colleagues wrote, “We see eight major problems with the current system of assessment and assurance of drug safety at the FDA.” A fundamental problem is the FDA’s initial review for drug approval that often fails to detect serious ADRs: “A study by the US General Accountability Office (GAO) concluded that 51% of all approved drugs had at least one serious ADR that was not recognized during the approval process.”

A 2003 investigation published in The Independent in the UK reported “under pressure from the pharmaceutical industry, the FDA routinely conceals information it considers commercially sensitive, leaving medical specialists unable to assess the true risks [of approved drugs].” One case involved a very popular over-the-counter drug, the painkiller ibuprofen. The investigators’ search uncovered concealed data showing that ibuprofen increased heart attack risks by 25 percent. Even Freedom of Information (FOI) filings to the FDA do not produce all the information being requested. For example, a group of Swiss investigators filed an FOI to procure trial data about the musculoskeletal pain drug Celecoxib and received back only 16 of the 27 trials conducted on it. A separate FOI concerning a similar drug, Valdecoxib, had pages and paragraphs deleted because sections of the document were marked as “trade secrets.” An even worse case involving a leaked report concerning internal memos and secret FDA reports provided detailed evidence that the FDA approved 9 different antidepressants, representing a total of 22 studies enrolling 4,250 children, while knowing full well that the risk of “suicide-related events” was twice as high as children taking a placebo. These are just several examples among numerous others, which may best be summarized by a Forbes article entitled “The FDA is Basically Approving Everything.”

Isn't it time for real truth telling? The FDA, which was budgeted for $5.9 billion in FY 2019, is ruled and governed by a small group of political scientists who have abdicated their ethical responsibilities as physicians and medical professionals. With all the controversy and debate over the efficacy and safety of new mRNA vaccines and the aggressive emergency approval of the ineffective anti-Covid drug remdesivir, we may consider a Harvard University article published in the Journal of Law, Medicine and Ethics entitled “Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs.”  For the past four decades, the paper states, 

“patients have suffered from a largely hidden epidemic of side effects from drugs that usually have few offsetting benefits. The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency.”  

We are witnessing the pharmaceutical industry increasing its demands for shorter than average times for the FDA to review new drug submissions; alternatively they have an option to pay the FDA costly fees to have these drugs fast-tracked under its Accelerated Approval Program, thereby jumping over many regulatory hurdles to bring their products to market more quickly. According to a 2019 review of the Program, conducted by the University of Nebraska’s Institute for Operations Research, “from 1992 to 2008, 36% of post-market studies had not been completed, and 50% of the uncompleted studies took on average of 5 years to even begin.”  Yet throughout the duration of years, these drugs continued to be prescribed and reap enormous profits for the companies benefiting from the FDA’s loopholes. 

As a consequence, the FDA’s entire regulatory protocol has consistently deteriorated with each passing year. From a system originally mandated to function as a guardian to protect patients from dubious industry commercial interests, it has been transformed into an anti-preventative pipeline favoring drug companies’ bottom line and their shareholders. 

In 2013, the Union of Concerned Scientists released its investigative report, four years after the Obama administration launched a process to increase transparency in the federal sciences agencies --- another well-meaning Obama initiative that failed to make any fundamental change. The Union concluded that the  FDA had created a culture lacking scientific integrity, including no formal procedures for investigating scientific misconduct. 

The FDA’s serious failures to carry out its duties to monitor and regulate drug companies are well exemplified in the case of the North Carolina outsourcing firm Cetero.  After several years of gross negligence to thoroughly review pharmaceutical drugs, mostly generic knock-offs submitted for licensure, the agency finally uncovered Cetero’s five-year history of faking documents and data or early clinical trials and bioanalytics.  While we expect contractors who carry out clinical trials for large drug companies to be busy at work conducting research on the recorded trial data, on over 1,900 occasions there were no personnel in the Cetero facilities. Approximately 1,400 trials for roughly 100 drugs were faked. Whereas the FDA did little to conduct a thorough investigation, the European Medicines Agency on the other hand discovered that Cetero and its Big Pharm partners, including Roche and Genentech, failed to submit 80,000 reports on American approved drugs that killed over 15,000 Europeans. We need to consider that the Mayo Clinic is on record stating that the last ten years of cancer research are utterly useless due to systemic fraud, 

To understand the systemic rot eating away the FDA, we may take note of the research of Dr. Charles Seife and his students at New York University. Seife and his team undertook the task to investigate and analyze the extent to which the FDA covers up evidence of fraud and corruption in medical drug trials. They reviewed FDA documents for about 600 clinical trials. One of Seife’s primary questions was the frequency that FDA officials discover flagrant and intentional misconduct and subsequently decide to bury the evidence and prevent it from becoming public to the medical community.  He discovered such actions to be an official pattern within the agency. Given the high rate of content deleted or blacked out from the documents the FDA provided, the investigators could only determine which pharmaceutical company or drug was involved in 1 of 6 of the reviewed trials. For one trial alone, where FDA inspectors found significant fraud and misconduct, 78 different medical publications printed articles based upon that single study.  In an article for Slate, Seife writes, 

"Nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers."

In one case, a new anti-blood clotting drug, rivaroxaban, involved four large trials recruiting thousands of patients in clinical sites in over a dozen countries. According to Seife, one of the trials "was a fiasco."  In half of the sixteen clinical sites, the FDA discovered "misconduct, fraud, fishy behavior or other practices so objectionable that the data had to be thrown out." One Colorado site falsified data. At the Mexican site, there was "systematic discarding of medical records." Despite these overwhelming problems, the drug trial was published favorably in the prestigious British journal The Lancet. The FDA found similar problems in the three other trials; in one the data was ruled "worthless." The FDA advisory committee of "expert" reviewers were only informed that inspectors discovered only "significant issues" at two sites in one of the trials. Rivaroxaban was nevertheless approved in 2011. Since then lawsuits for wrongful death from the drug continue to increase. 

One of the deeper flaws within the FDA’s mode of operations is that it solely relies on the studies and clinical trials conducted by drug makers without conducting any studies of its own. Consequently these private firms have complete control over the clinical data and can provide such data or not at their own discretion. For example, if a company conducts 20 clinical trials on a potential new drug and15 trials conclude it is absolutely useless or results in serious reactions and deaths, the company is only required to submit documentation for the 5 trials that are favorable. 

Over the years, Congressional subcommittees have voiced warnings to FDA officials to clean up their act. A House Government Reform Committee reported that both the CDC’s and FDA’s advisory committees for vaccines were thoroughly compromised with pharmaceutical conflicts of interest.  

One of the most glaring examples of FDA misconduct, deceit and cover-up to protect pharmaceutical interests in the agency’s history was the federal case against Merck and its anti-inflammatory drug Vioxx. Dr. David Graham, a former Associate Director for Science and Medicine in the FDA’s Office of Drug Safety, testified before the US Senate. Dr. Graham has impeccable credentials qualifying him as an expert on the failures of pharmaceutical drugs. He graduated from the Johns Hopkins University School of Medicine, and trained in Internal Medicine at Yale and in adult Neurology at the University of Pennsylvania. 

Dr. Graham told the Senate:

“During my career, I believe I have made a real difference for the cause of patient safety. My research and efforts within the FDA led to the withdrawal from the US market of Omniflox, an antibiotic that caused hemolytic anemia; Rezulin, a diabetes drug that caused acute liver failure; Fen-Phen and Redux, weight loss drugs that caused heart valve injury; and PPA (phenylpropanolamine), an over- the-counter decongestant and weight loss product that caused hemorrhagic stroke in young women.

“My research also led to the withdrawal from outpatient use of Trovan, an antibiotic that caused acute liver failure and death. I also contributed to the team effort that led to the withdrawal of Lotronex, a drug for irritable bowel syndrome that causes ischemic colitis; Baycol, a cholesterol-lowering drug that caused severe muscle injury, kidney failure and death; Seldane, an antihistamine that caused heart arrhythmias and death; and Propulsid, a drug for night-time heartburn that caused heart arrhythmias and death. . . .

“I have done extensive work concerning the issue of pregnancy exposure to Accutane, a drug that is used to treat acne but can cause birth defects in some children who are exposed in utero if their mothers take the drug during the first trimester. During my career, I have recommended the market withdrawal of twelve drugs. Only two of these remain on the market today—Accutane and Arava, a drug for the treatment of rheumatoid arthritis that I and a co-worker believe causes an unacceptably high risk of acute liver failure and death.”

The Los Angeles Times reported that witnesses told the Senate panel that Merck and the FDA knowingly had data well before the approval and licensure of Merck’s Vioxx painkiller that proved the drug’s serious cardiovascular health risks. Nevertheless, the FDA granted it approval without resolving the risks, and Vioxx was aggressively marketed.

Testifying about Merck’s Vioxx, Dr. Graham states:

"Today . . . you, we, are faced with what may be the single greatest drug safety catastrophe in the history of this country or the history of the world. We are talking about a catastrophe that I strongly believe could have, should have been largely or completely avoided. But it wasn’t, and over 100,000 Americans have paid dearly for this failure. In my opinion, the FDA has let the American people down, and sadly, betrayed a public trust."

According to Dr. Graham. “Not only did the FDA ignore known risks from Vioxx and related drugs but . . . it tried to prevent Graham and others from publicizing their own research that proved the extent of these risks.”

Members of Congress have echoed Graham’s concerns. Charles Grassley (R–Iowa) said he was concerned that the FDA “has a relationship with drug companies that is too cozy.”  Sen. Jeff Bingaman (D–New Mexico) said the problem was within the FDA’s own culture.“ This culture is one whereby the pharmaceutical industry, which the FDA is mandated to regulate, is the FDA’s most favored and lucrative client.

Sixteen years have passed since Dr. Graham’s public statements exposing the life-threatening policies and corruption that infest the FDA. It’s difficult to comprehend why the agency has been unable to clean up its act. Instead the FDA’s culture of deceit has only worsened. Nevertheless, the evidence clearly shows that our government health officials would rather support pharmaceutical profiteering than the health and safety and American citizens. In fact, 45 percent or $2.7 billion of its budget derives from private pharmaceutical “user fees.”

The disturbing data suggest that the FDA’s evaluation of pharmaceuticals for safety and efficacy may be so flawed that only 4% of all trial results are identified as such. As a result, FDA scientists and officials responsible for approving drugs to the market are kept largely uninformed about the egregious scientific misconduct involved in obtaining study data. Further, these erroneous and fraudulent studies are published in peer-reviewed scientific literature and accepted as valid science. The American public is ‘virtually defenseless’ if another medication proves to be unsafe after it is approved.

But it gets worse.  The agency has been warning against highly effective off-patent drugs to treat early SARS-CoV-2 infections such as hydroxychloroquine (HCQ) and ivermectin.  Shortly after the pandemic was formally announced, and with no promising treatment in sight, the FDA recommended HCQ but then reversed its decision in June after Anthony Fauci publicly announced the coming arrival of Gilead’s novel drug remdesivir. The FDA’s approval of remdesivir baffled many scientists, according to the journal Science, who were keeping a close watch on the drug’s clinical reports, which showed a “disproportionally high number of reports of liver and kidney problems”Nor did remdesivir lessen hospital stays or lower mortality rates.

Two months ago the agency issued a warning statement against the use of ivermectin. “The very next day,” reported the Alliance for Natural Health, “Merck announced positive results from a clinical trial on a new drug called molnupiravir in eliminating the virus in infected patients.”  Again, the FDA had been working in concert with the pharmaceutical industry to advance expensive experimental drugs rather than cheaper and proven drugs with decades of research to back their safety records. 

In addition, the FDA has waged a war against alternative medical systems for many decades, including natural supplements. Last September, the agency attempted to ban N-acetylcysteine (NAC) after it showed promise to reduce cytokine storms associated with SARS-CoV-2 infection. The supplement had already been shown to improve lung problems due to respiratory infections such as pneumonia and acute respiratory distress symptom. Three years ago, an FDA advisory committee met to consider banning five supplements made by specialized compounding pharmacies: alpha lipoic acid, CoQ10, pyridoxal-5-phosphate, creatine monohydrate  and quercetin dehydrate. Earlier the FDA had banned curcumin, boswellia and aloe vera from pharmacologic compounding. One of the key executors of the agency’s revitalized assault against supplements and the natural health industry was Trump’s appointment of Scott Gottlieb as FDA Commissioner. Following his two years at the FDA’s helm, Gottlieb quit and joined Pfizer’s Board of Directors.

The FDA’s argument is rather straightforward, albeit dubious; since supplements, including Vitamin C and D, Omega-3 fatty acids, and even minerals such as magnesium and zinc have not been formally submitted to the FDA for evaluation to be registered as “approved drugs,” it is against the law to make any health claims about their health benefits.  This is despite the thousands of peer-reviewed studies in the National Library of Medicine to support their efficacy. The average median cost to conduct clinical trials to meet FDA standards for approval, according to a Johns Hopkins University evaluation, is $19 million and upwards to $2-3 billion. In other words to get Vitamin D officially recommended as a viable preventative defense against Covid-19 would require a minimum of $19 million in addition to numerous fees and other legal costs prior to and after submission. And that doesn’t even address the problem of ownership since Vitamin D is a natural substance and excluded from patenting. In the meantime, supplement manufacturers are prohibited from stating the vitamin’s benefit to the public thereby contributing to a gross disservice. 

“Clearly these are the actions of an agency looking to restrict the supplement market,” according to the Alliance for Natural Health, “and remove as many products as possible in as many ways as possible.”  One reason is that if a vitamin or supplement were to go through the FDA licensure treadmill, the agency could potentially require a supplement’s access by prescription only. It would no longer be available over the counter. And this in turn would be another boon for the drug industry, which is already developing synthetic supplemental knock-offs that are patentable. 

Much of the blame lies on the shoulders of politicians on both sides of the aisle and the mainstream media who have enabled the FDA and CDC to run amok and then propagate the pharmaceutical industry’s nonsense. A recent Harvard University and Robert Wood Johnson Foundation survey reported that public trust in America’s health care system has rapidly fallen during the pandemic to 34 percent. Only 37 percent stated they had much trust in the FDA. 

This trend may very likely continue as a growing number of physicians and medical experts are sounding alarms over the flagrant incompetence of our federal officials leading the national efforts against Covid-19 and the approval vaccines with highly questionable safety records and expensive novel drugs that fail to warrant use. Worldwide, tens of thousands of otherwise orthodox medical professionals are charging Anthony Fauci, the CDC, FDA and the World Health Organization with gross mishandling of the pandemic.  Lawsuits are underway against national health ministries around the world for deceiving their populations with fraudulent PCR testing, fake mortality rates and unwarranted public health policies that have produced extreme harm and suffering.  As the situation deteriorates more suits will be anticipated. 

Sadly there is no reason to expect the FDA to undergo a structural change. For decades Congressional committees have warned the agency about it’s ignoring the public health of Americans and its revolving door policies with drug makers. Yet matters continue to worsen. A complete overhaul by adopting policies similar to the European Medicines Agency such as independent leadership divorced from the pharmaceutical complex and full public funding, would be a decent start. Another  solution could be the creation of separate and independent National Drug Safety Board without ties to private industry or overlapping conflicts of interest with the existing health agencies in dire need of reform. However that tipping point has not been reached to expect any of our politicians to switch sides and for once serve the public’s health interests

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