Friday, September 23, 2022
FBI hero paying the price for exposing unjust ‘persecution’ of conservative Americans
Bombshell allegations by FBI Special Agent Steve Friend contained in a whistleblower complaint filed late Wednesday with the Department of Justice inspector general reveal a politicized Washington, DC, FBI field office cooking the books to exaggerate the threat of domestic terrorism, and using an “overzealous” January 6 investigation to harass conservative Americans and violate their constitutional rights.
Friend, 37, a respected 12-year veteran of the FBI and a SWAT team member, was suspended Monday, stripped of his gun and badge, and escorted out of the FBI field office in Daytona Beach, Fla., after complaining to his supervisors about the violations.
He was declared absent without leave last month for refusing to participate in SWAT raids that he believed violated FBI policy and were a use of excessive force against Jan. 6 subjects accused of misdemeanor offenses.
This American hero, the father of two small children, has blown up his “dream career” because he could not live with his conscience if he continued to be part of what he sees as the unjust persecution of conservative Americans.
“I have an oath to uphold the Constitution,” he told supervisors when he asserted his conscientious objection to joining an Aug. 24 raid on a J6 subject in the Jacksonville, Fla., area. “I have a moral objection and want to be considered a conscientious objector.”
Friend, who did not vote for Donald Trump in the 2020 election, said he told his immediate boss twice that he believed the raid, and the investigative process leading up to it, violated FBI policy and the subject’s right under the Sixth Amendment to a fair trial and Eighth Amendment right against cruel and unusual punishment.
Multiple violations
In his whistleblower complaint to DOJ Inspector General Michael Horowitz, obtained by The Post, Friend lays out multiple violations of FBI policy involving J6 investigations in which he was involved.
He says he was removed from active investigations into child sexual exploitation and human trafficking to work on J6 cases sent from DC. He was told “domestic terrorism was a higher priority” than child pornography. As a result, he believes his child exploitation investigations were harmed.
He also has reported his concerns about a politicized FBI to Republican members of Congress, among 20 whistleblowers from the bureau who have come forward with similar complaints.
Among Friend’s allegations:
The Washington, DC, field office is “manipulating” FBI case management protocol and farming out J6 cases to field offices across the country to create the false impression that right-wing domestic violence is a widespread national problem that goes far beyond the “black swan” event of Jan. 6, 2021.
As a result, he was listed as lead agent in cases he had not investigated and which his supervisor had not signed off on, in violation of FBI policy.
FBI domestic terrorism cases are being opened on innocent American citizens who were nowhere near the Capitol on Jan. 6, 2021, based on anonymous tips to an FBI hotline or from Facebook spying on their messages. These tips are turned into investigative tools called “guardians,” after the FBI software that collates them.
The FBI has post-facto designated a grassy area outside the Capitol as a restricted zone, when it was not restricted on Jan. 6, 2021, in order to widen the net of prosecutions.
The FBI intends to prosecute everyone even peripherally associated with J6 and another wave of J6 subjects are about to be referred to the FBI’s Daytona Beach resident agency “for investigation and arrest.”
The Jacksonville area was “inundated” with “guardian” notifications and FBI agents were dispatched to conduct surveillance and knock on people’s doors, including people who had not been in Washington, DC, on Jan. 6, 2021, or who had been to the Trump rally that day but did not go inside the Capitol.
Friend says he was punished after complaining to his bosses about being dragged into J6 investigations that were “violating citizens’ Sixth Amendment rights due to overzealous charging by the DOJ and biased jury pools in Washington, DC.”
His top-secret security clearance was suspended last week because he “entered FBI space [his office] and downloaded documents from FBI computer systems [an employee handbook and guidelines for employee disciplinary procedures] to an unauthorized removable flash drive.”
In a Sept. 16 letter from the head of FBI human resources, he was told he was losing his security clearance also because he “espoused beliefs which demonstrate questionable judgment [and demonstrated] an unwillingness to comply with rules and regulations.”
Reprisals from bosses
In his whistleblower complaint, Friend describes “reprisals” from his supervisors after he voiced his conscientious objections.
He says they ignored his complaint about “manipulative casefile practice [which] creates false and misleading crime statistics, constituting false official federal statements.
The hypocrisy and disconnect of the partisan Jan. 6 probe
“Instead of hundreds of investigations stemming from an isolated incident at the Capitol on January 6, 2021, FBI and DOJ officials point to significant increases in domestic violent extremism and terrorism around the United States.
“At no point was I advised or counseled on where to take my disclosure beyond the reprising officials above; the threatened reprisal constituted a de facto gag on my whistleblowing.”
On Aug. 19, he first told his immediate boss, Supervisory Senior Resident Agent Greg Federico, that he believed “it was inappropriate to use an FBI SWAT team to arrest a subject for misdemeanor offenses and opined that the subject would likely face extended detainment and biased jury pools in Washington, DC.
“I suggested alternatives such as the issuance of a court summons or utilizing surveillance groups to determine an optimal, safe time for a local sheriff deputy to contact the subjects and advise them about the existence of the arrest warrant.”
Federico told him it would have been better to just “call in sick” rather than voice his objection and “threatened reprisal indirectly by asking how long I saw myself continuing to work for the FBI.”
Four days later, Friend was summoned to Jacksonville to meet his next-level bosses, Assistant Special Agents in Charge Coult Markovsky and Sean Ryan, about his refusal to join the SWAT raid.
He told them about his concerns over “irregular” case handling of J6 matters that he believed were in violation of a legal rule known as “Brady” that requires prosecutors to disclose evidence that would exonerate a defendant.
They asked if he believed any J6 rioters committed crimes and he replied: “Some of the people who entered the Capitol committed crimes, but others were innocent. I elaborated that I believed some innocent individuals had been unjustly prosecuted, convicted and sentenced.”
Markovsky then asked Friend if J6 rioters who “killed police officers” should be prosecuted, even though no such thing happened. When Friend pointed out that “there were no police officers killed on January 6, 2021,” Markovsky told him he was being a “bad teammate.”
Both agents “threatened reprisal again by warning that my refusal [to go on the SWAT raid] could amount to insubordination. References were made to my future career prospects with the FBI.”
Friend was labeled AWOL the day the raid took place and stripped of his pay.
A week later, he was told to meet the top agent in Jacksonville, Special Agent in Charge Sherri Onks, who told him he needed to do some “soul searching” and decide if he wanted to work for the FBI.
When he told her “many of my colleagues expressed similar concerns to me but had not vocalized their objections to FBI executive management,” she told him his “views represented an extremely small minority of the FBI workforce.”
She then shared the emotional experience of fearing for her own life on Jan. 6, 2021, when she was sitting on the seventh floor of the secure J. Edgar Hoover Building, FBI headquarters, after protesters one mile away “seized the Capitol and threatened the United States’ democracy.”
Agents used as ‘pawns’
Friend says his concerns are shared by large numbers of rank-and-file FBI agents across the country who believe they are being used as pawns to pursue the political agenda of the bosses in Washington, DC.
These kinds of abuses of the law are a “morale killer” for field agents, he says.
Many agents, who joined the FBI in the wake of 9/11, are keeping their heads down because they are close to their 20-year retirement with full pension. But he says they are equally disgusted at being forced to take part in the politicization of federal law enforcement.
Other whistleblowers say that disquiet grew after the FBI raid on Donald Trump’s Mar-a-Lago home in Florida on Aug. 8.
Republican Sen. Chuck Grassley of Iowa, who is working with these heroic FBI agents, has been trying to introduce legislation to strengthen the bureau’s woefully inadequate whistleblower protections. Friend’s complaint will be a test case.
In a letter to FBI Director Christopher Wray on Aug. 11, Grassley alleged that a committee of FBI field agents had been to see Wray to express the concerns of agents in all 56 field offices across the country that “the FBI has become too politicized in its decision-making.” Grassley further alleges “those concerns were removed from this year’s final report” of the FBI’s Special Agents Advisory Committee.
Wray ignored Grassley’s letter along with a dozen other letters from the dogged Iowa senator alleging gross malfeasance at the bureau.
But unrest is growing among field agents about the weaponization of the FBI against the Biden administration’s political opponents under Wray. He can’t ignore it for long.
****************************************************
Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)
https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)
**************************************************
Thursday, September 22, 2022
A Covid stocktake: Where are we up to on lockdowns, mandates and vaccines?
In an article in the Epoch Times on 9 September, Julie Ponesse tells Canada’s students that Covid control measures by university administrations ‘will stop as soon as you say “no”’. Moments we should all have said no were when our communities were put under house arrest, citizens were banned from the bedside of dying family members and the healing rituals of funerals (remember a masked Queen sitting all alone at her husband’s service?), police prevented us enjoying health-sustaining access to beaches and parks and governments and corporations mandated facemasks, QR codes and digital vaccine certificates: all self-harms done supposedly for the greater good.
The lockdown and vaccine narratives are falling apart at the seams. Canada’s new opposition leader Pierre Poilievre is staunchly libertarian, anti-lockdown and anti-vaccination mandates who supported the truckers’ Freedom Convoy. My jaw is still on the floor after hearing Jacinda Ardern say ‘we all just need to respect people’s individual decisions’. In the UK, former chancellor Rishi Sunak’s break from official policy led Liz Truss to rule out future lockdowns. On 11 August, the CDC’s revised guidance returned much of the responsibility for risk reduction from institutions to individuals and shifted from sweeping population-wide precautions to targeted advice for vulnerable groups. ‘The effects of lockdown may now be killing more people than are dying of Covid’, says the UK Telegraph, including a rise in the rate of prostate cancer deaths from 7 to 26 per cent. The mainstream Financial Times reports the US decision to roll out new booster shots without clinical testing on humans – already dubbed the mouse vaccine by some – could undermine public trust and deepen vaccine hesitancy.
In Australia the push to end all special Covid measures is led by NSW Premier Dominic Perrotet against stiff resistance from some states and experts who insist there’s ‘no scientific basis’ to end them. What scientific basis was there to introduce them, pray tell? Last year, UK ‘experts’ warned Boris Johnson of catastrophe unless he cancelled his planned ending of restrictions and Anthony Fauci warned of disasters in states that rejected his recommended restrictions. Both were proven dead wrong.
In a press briefing on 6 September, White House Covid response coordinator Dr Ashish Jha explained people can get their flu and Covid booster vaccines in one visit: ‘I really believe this is why God gave us two arms – one for the flu shot and the other one for the Covid shot’. Was this a Freudian slip revealing the religious dogma that lies behind Covid policy? Used in ancient and medieval times, mass closures were discredited in Western epidemiology in the last century and replaced by the concept of herd immunity built through naturally-acquired and vaccine-induced infections. An analysis by Michael Senger concludes that, based on bioterrorism fears in the national security community after 9/11, the CDC had insinuated China’s lockdown measures during the Sars epidemic as US federal policy by January 2004. They called it ‘social distancing’ to disguise its origins.
Debbie Lerman has distilled a lockdown blueprint centred on a relentless fear campaign reinforced by stressing uniqueness, worst-case scenarios, not knowing what to expect and ‘we’re all equally at risk’, on the one hand; and the abandonment of all previous policies in favour of universal mandates to isolate, test, trace, mask up, vaccinate and so on on the other. Based mostly in junk science, they terrified the people into demanding draconian ‘health’ measures whose primary, intended purpose was to cynically exploit emotional distress to ensure compliance with unprecedented, untested, ineffective and destructive policy interventions. They succeeded.
Covid poses such miniscule risk to children that vaccinating them is ‘all risk, no benefit’. Denmark banned vaccines for healthy under-18s from 1 July. Yet on 19 July, Australia’s Therapeutic Goods Administration (TGA) granted provisional approval for administering Spikevax vaccines to children aged 0.5–5 years. NSW Health data show 99.9 per cent of Covid-related deaths in the last six months were among adults despite over 95 per cent being vaccinated and 68 per cent being boosted.
An article in the British Medical Journal shows 12 to 15-year-old healthy boys are four times more at risk of myocarditis after a second Pfizer vaccine than of hospital admission for Covid. A new study in preprint estimates that to prevent just one Covid hospitalisation in 18-29 year olds (university age), 22,000-30,00 previously uninfected must be boosted. But for every one hospitalisation prevented, there are 18 to 98 serious adverse events. A complementary peer-reviewed article in Vaccine seems to suggest, albeit tentatively, that added risks of serious adverse events are 2.4 and 4.4 times higher than the reduced risk of hospitalisation for Moderna and Pfizer vaccines. Some experts point to a worrying trend of rising excess mortality among under-14s in 28 European countries. A study of almost 900,000 5 to 11-year-old children in North Carolina (New England Journal of Medicine) adds to concerns that vaccines don’t just lose their effectiveness within months; they also destroy natural immunity.
The global drug industry has a particularly scandal-ridden history. In an Australian class action case in 2009, court documents revealed Merck had prepared a ‘hit list’ of doctors who criticised Vioxx for its deadly cardiovascular side-effects. On 4 February, 2021, Merck – which makes patent-free low profit ivermectin and has been selling it for years – publicly questioned its safety. How often does a drug company badmouth its own product? The British Medical Journal documented a compromising 96 per cent of the TGA’s 2020–21 budget came from industry sources, raising serious questions about regulatory capture. Last year the TGA banned the use of ivermectin for Covid treatment.
A month later Merck announced the development of a new antiviral drug for which it sought emergency use authorisation from the Federal Drug Administration. This cannot be granted if an existing treatment is available. Banning ivermectin and hydroxychloroquine was essential to grant emergency use authorisation for high-profit Covid vaccines and drugs. Yet a major large-scale study from Brazil published on 31 August found that, compared to regular users, non-use of ivermectin increased the risk of Covid-related mortality by 12.5 times and dying from Covid by seven times.
The Therapeutic Goods Regulation (1990) restricts provisional approvals to medicines for ‘the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition’. This would appear to rule out provisional vaccine approval for children below five. On this basis, a group of lawyers is aiming to file a crowd-funded case in the High Court against the TGA’s decision. On past form, don’t hold your breath for the courts to uphold citizens’ autonomy over the health bureaucracy’s infinite if inscrutable wisdom.
https://spectator.com.au/2022/09/a-covid-stocktake
***************************************************Simple steps to treat that distressing loss of smell
As many as 1.2 million people in the UK are estimated to have persistent smell disorders due to infection with Covid-19.
The problem typically lasts at least six months and, for some, their sense of smell will never fully return, according to a report in the BMJ in July.
Initially, it may be due to the infection causing inflammation in nasal tissue. But chronic cases may arise from nerve damage.
Covid can interfere with the sensitivity of our olfactory receptors, proteins on the surface of nerve cells in our noses that detect molecules associated with odours, reported researchers at Columbia University in the U.S. in the journal Cell in February.
The problems Covid can cause range from smelling things that are not there (phantosmia) to a complete loss of smell (anosmia).
Our sense of smell often diminishes naturally with age, with an estimated third of over-80s affected, but thanks to Covid there is an impetus to find ways to cure it.
Scientists are vying to produce the first ‘robot nose’ — an implant that picks up smell signals and transmits them into the brain.
As many as 1.2 million people in the UK are estimated to have persistent smell disorders due to infection with Covid-19
+4
View gallery
As many as 1.2 million people in the UK are estimated to have persistent smell disorders due to infection with Covid-19
At Virginia Commonwealth University in the U.S., surgeon Daniel Coelho is developing a device to bypass our normal smell system, in which sensory nerve cells at the top of our nose detect odour molecules and send signals via the olfactory nerve to the olfactory bulb, the area in the brain that processes smell.
The new device aims to detect chemical odours from the air via a sensor that’s worn on spectacles and sends the information to the olfactory bulb (at the bottom of the brain, near the back of the nose).
Carl Philpott, a professor of rhinology and olfactology at the University of East Anglia, is working on a simpler approach, involving vitamin A (retinoic acid) nose drops.
The hope is the vitamin will encourage natural repair in the smelling cells in the lining of the nose.
A study of 170 patients suffering loss of smell, published in the journal European Archives of Oto-Rhino-Laryngology in 2017, showed that 37 per cent treated with the vitamin drops could identify more smells correctly, compared with 23 per cent of patients given a placebo. For his new study, 38 patients will receive a 12-week course of daily nasal vitamin A drops. He hopes to have results early next year.
Meanwhile, stem cells are being suggested as a future therapy, says Graham Wynne, a chemist who is on the scientific advisory board of Fifth Sense, a charity dedicated to smell and taste disorders.
‘A healthy human olfactory system has an efficient and well-known repair system, where the tissues lining the nose replace themselves every few weeks,’ he says.
The repair mechanism can break down, however, due to viral attack or age-related wear and tear. It’s hoped that stem cells may kickstart the repair mechanism.
Marianna Obrist, a professor of multisensory interfaces at University College London, is the co-founder of a company pioneering a high-tech smell-training therapy.
Smell training involves sniffing and identifying four scents — usually rose, eucalyptus, lemon, and clove — for 15 seconds, twice a day, over several months. This trains people to use their remaining smell sense more accurately and hopefully strengthen it.
You can do smell training at home, by spending 20 seconds sniffing four strong scents.
Professor Obrist’s OWidgets system, currently being trialled, consists of a computer-controlled smell-delivery box (which can emit up to six scents) and a smartphone app that controls the device and reminds you to do the next session.
****************************************************
Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)
https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)
**************************************************
Wednesday, September 21, 2022
Scientists on alert as new Covid strain tears through ’multiple countries’
A new Covid variant is ripping through “multiple countries”, with experts fearing it could be even more transmissible than the BA. 5 Omicron strain.
Named BF. 7 – short for BA. 5.2.1.7 – the new variant is spreading faster than most other variants of interest that scientists are currently tracking in the US.
While it accounted for 1.7 per cent of sequenced infections in America last week, it now represents 25 per cent of cases in Belgium, while Denmark, Germany and France have each recorded 10 per cent of the world’s identified cases, Fortune reports.
Dr Stuart Ray, vice chair of medicine for data integrity and analytics at Johns Hopkins’ Department of Medicine, told the publication the US Centres of Disease Control (CDC) recently named it as a separate strain after cases hit one per cent, with that figure expected to grow.
“The same growth advantage in multiple countries makes it reasonable to think that BF. 7 is gaining a foothold,” Dr Ray said, adding that it could prove to be more transmissible than parent strain BA.5.
The rise of the new variant is of particular concern as it’s growing steadily compared to other Omicron subvariants, and because the northern hemisphere is heading towards winter, when Covid is most worrying.
And Dr Ray said there was also a chance an entirely new variant could soon emerge. “It’s been a while since we went from Alpha to Beta to Gamma to Delta, then to Omicron,” he said. “We may be complacent. This may be feeding into the notion that this is behind us.”
The news is all the more concerning given US President Joe Biden this week stated that the “pandemic is over” – despite a daily death toll in the hundreds in America. He told CBS’s 60 Minutes on Sunday US time that while Covid was still a concern, the worst had passed.
“We still have a problem with Covid. We’re still doing a lotta work on it. But the pandemic is over,” he said. “If you notice, no one’s wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.”
Mr Biden’s surprising comments came after the World Health Organisation declared the end of the pandemic was “in sight” last week, after announcing weekly deaths had dropped to the lowest level since March 2020.
“We have never been in a better position to end the pandemic,” WHO chief Tedros Adhanom Ghebreyesus told reporters. “We are not there yet, but the end is in sight.”
But the world needed to step up to “seize this opportunity”, he added. “If we don’t take this opportunity now, we run the risk of more variants, more deaths, more disruption, and more uncertainty.”
However, that message did not go down well in China, where an aggressive Zero Covid category is still being pursued via mass testing and brutal lockdowns months after the rest of the world moved on.
The WHO announcement was originally reported by some local news outlets and shared on social media, but was then quickly censored, given Covid Zero is inextricably bound to President Xi Jinping’s Covid strategy.
Xi is widely expected to secure a historic third term in power in October, with some speculating the country’s Covid rules might potentially be relaxed after that point.
According to WHO’s latest epidemiological report on Covid-19, the number of reported cases fell 28 per cent to 3.1 million during the week ending September 11, following a 12 per cent drop a week earlier.
***************************************************
Drug Companies Test New Booster on Eight Mice and Zero Humans, FDA Approves It Anyway. With no efficacy or safety data, the agency is enthusiastically promoting a fifth COVID shot
On Aug. 31, 2022, the Food and Drug Administration authorized bivalent boosters reformulated to target the BA.4 and BA.5 omicron subvariants. At the authorization meeting, FDA officials announced the approval of these new boosters for emergency use based on data from eight mice in a Pfizer study. At the same time, the FDA revoked authorization for the original monovalent boosters—meaning anyone subject to a booster or “up-to-date” mandate will have to take the bivalent booster, which has no proven safety or efficacy data in human beings.
While the flu vaccine is also approved on a yearly basis without full trials, the mRNA COVID vaccines do not share the flu shot’s decadeslong track record of observed safety. The population most likely to be mandated to take a bivalent booster consists largely of college students. The young men in this population are the exact demographic that face heightened safety concerns, specifically around myocarditis, as documented in multiple peer-reviewed studies. In fact, during a meeting of the Centers for Disease Control and Prevention to recommend the bivalent boosters, the agency presented updated myocarditis data that confirmed the rates of myocarditis in young men were about 2-to-3.5 times higher (slide 35) than the agency had claimed last year (slide 13). Nevertheless, the FDA and CDC moved to recommend the bivalent boosters for anyone over the age of 12 without human clinical trials.
This is just the latest episode in the FDA’s less-than-thorough approach to new COVID vaccine approvals. For example, in May 2022, the FDA authorized monovalent Pfizer boosters for children ages 5-11 based on laboratory data that showed heightened antibody response levels in just 67 children.
During the opioid crisis, the FDA famously failed to demand adequate research, disregarded safety concerns, and allowed Purdue Pharma to promote oxycodone for uses that were never borne out by testing. Later, it was revealed that the agency had been plagued by ethical issues: When the FDA convened advisers to address mounting oxycodone safety concerns, for instance, five out of 10 of these advisers had received payments from Purdue, and another three had received payments from other opioid manufacturers.
The continuation of unchecked conflicts of interest, and several recent authorizations for uses of new medical products that are in many ways unproven, demonstrate that the FDA is essentially unresponsive to public outrage, culminating in the bizarre spectacle of the agency promoting bivalent boosters on social media through unsubstantiated claims of efficacy, acting not as a neutral regulator but actively advertising on behalf of pharmaceutical companies with government purchase contracts. The FDA’s disregard for its congressional mandate is not unique to this moment—it is a symptom of its decadeslong transformation into an agency captured by the corporations it is tasked with regulating.
When Kelley Krohnert, a mother and career IT expert from Georgia, watched the CDC’s Advisory Committee on Immunization Practices meeting held on June 17, 2022, she noted a slide that listed COVID as the fourth-leading cause of death for children under 1 and the fifth-leading cause for children aged 1-4 in the United States. This same slide was originally used at the FDA’s June 15 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, when FDA advisers voted to authorize vaccines for children under 5. Krohnert immediately recognized that the slide was citing a preprint by researchers in the United Kingdom. This preprint not only used death statistics that included deaths where COVID was not an underlying cause—it also compared a 26-month cumulative total for COVID deaths to a 12-month total for other deaths. In Krohnert’s analysis, COVID fell to ninth place for children under 1 and into a four-way tie for eighth place for children aged 1-4. When the researchers corrected their preprint to adjust for some of the errors Krohnert found, COVID fell below influenza and pneumonia as a cause of death for children under 5.
“I didn’t have to do a complex statistical analysis to find these errors,” Krohnert told me. “If this is the standard for what goes into these presentations, what kind of vetting is going into that data?”
This lack of vetting is a central issue in the FDA’s approval process. The key question for any drug authorization is, “Do the benefits outweigh the risks?” When a disease’s risks are exaggerated, one side of this equation is skewed, and the equation is also affected by exaggerating the benefits of a treatment or ignoring the potential risks of that treatment. The data presented in recent FDA meetings has been consistently nonobjective and skewed to favor drug approval.
For the authorization of vaccines for children under 5, boosters for children 5-11, and the new bivalent boosters, the FDA has relied heavily on measures of antibody levels as the main “benefit” side of the equation. This is despite the fact that Pfizer has admitted that there is “no established correlate of protection” between antibody levels and immunity. Both the CDC and the FDA already advise against the use of antibody testing to determine levels of immunity. Essentially, this metric has been deemed inadequate by the very regulatory agency that is now consistently accepting it as a substitute for clinical trials.
This lack of real efficacy data has been accompanied by a disregard for potential safety issues. European Union regulators have already warned that frequent boosters can weaken the immune system; the FDA is apparently unconcerned. The FDA also disregarded the fact that for pediatric vaccines, Pfizer observed a higher rate of severe COVID in its vaccine group (table 5). Furthermore, the FDA allowed the company to ignore 365 symptomatic cases in its trial, and to use only the last 10 symptomatic cases after the third dose to claim 80% efficacy (tables 19 and 20). This is significant because Pfizer saw negative efficacy between doses 1 and 2. In a vaccine meant to prevent illness for an age group that is already at extremely low risk, this data should have been a red flag for the FDA. Why, then, has the body charged with protecting Americans from inadequately tested products been so eager not just to authorize these products for emergency use, but to enthusiastically recommend them?
Dr. Paul Offit, director of the Vaccine Education Center and attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, was one of only two advisers who voted against VRBPAC’s recommendation for reformulated boosters in June. I asked him about his vote as an FDA vaccine adviser and longtime advocate for vaccination. He told me he believed the thinking behind the bivalent boosters was sound. “The problem for me,” he said, “was I just didn’t think the data that were presented on June 28th to our committee made that case compellingly.”
I asked Offit if he felt there was political pressure to vote a certain way. “I never feel pressure when I cast my vote,” he answered. “I voted no.” However, he said, “I think the way that they were presented, I think it was clear that the FDA and the World Health Organization wanted to go in this direction.” It was notable that the day after the FDA’s vote, the White House announced its purchase of 171 million bivalent booster doses from Pfizer and Moderna for $4.9 billion. “You felt that the train sort of had left the station,” Offit said.
In 2020, the Trump administration was widely criticized for rushing vaccines and pressuring the FDA. Although the Biden administration has exerted similar, if not more pressure, it has enjoyed a conspicuous absence of criticism. Before the FDA’s expert panel could even meet to discuss vaccines for children under 5, for example, the White House’s COVID czar, Ashish Jha, publicly announced a precise date for when they would become available. In other words, Jha appeared to know the FDA’s decision before it had allegedly made one.
Notably, President Joe Biden’s election campaign reversed a long-standing trend of Republican candidates receiving far more campaign donations from the pharmaceutical industry: In 2020, Biden outraised Trump from Big Pharma by a margin of 2 to 1. Several political appointees in the Biden administration, moreover, have ties to vaccine manufacturers, including the president’s chief campaign strategist, Anita Dunn, who worked for Pfizer before joining his team. Biden also ran his election campaign on the promise to “shut down the virus”; it turned out that there were more U.S. COVID deaths in 2021, when vaccines were widely available, than in 2020, when they were not. Rather than reckon with this fact and readjust its strategy, the administration has doubled down by putting increased political pressure on an already compromised FDA.
If your primary job occupation is to work for the firm across the table, how can you be an effective regulator?
****************************************************
Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)
https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)
**************************************************
Tuesday, September 20, 2022
Why even mild Covid is now being linked to long-term heart trouble
Two weeks after falling ill with Covid TV doctor Xand van Tulleken thought he was on the mend, when he suddenly took a turn for the worse.
‘I woke at 3am with my heart rate rushing at 170 beats per minute [it should have been about 60] and in a chaotic rhythm. I felt bad: faint, sweaty, breathless, panicky,’ he says.
This was March 2020, at the start of the pandemic, when little was known about the typical course of the infection.
But Xand’s training as a public health doctor left him in little doubt that he had developed atrial fibrillation, a dangerous heart rhythm disorder where abnormal electrical impulses cause an irregular and often racing heartbeat. It can lead to stroke and, in extreme cases, heart failure.
‘I believed that my heart-rhythm problem arose most likely as a result of the virus inflaming my heart,’ he says. Realising the seriousness of the situation he raced by taxi to University College Hospital in London.
‘The emergency doctors shocked my heart to stop it temporarily, allowing it to restart in a normal rhythm, a process called cardioversion,’ he adds.
With his heart beating more normally, Xand was prescribed bisoprolol, a type of beta-blocker — medication that alters the heart’s response to nerve impulses, slowing its rate to reduce the risk of further heart-rhythm problems. But it didn’t.
‘My heart went into atrial fibrillation several times after that, meaning I had to go through the cardioversion process repeatedly,’ he says.
A year after his original infection, in 2021 Xand had to return to hospital for an ablation, a procedure that uses freezing liquid nitrogen to ‘burn’ heart tissue, creating scarring that disrupts the electrical signals that cause irregular heartbeats.
‘Surgery took about 90 minutes and I was awake throughout,’ he recalls. ‘It wasn’t painful but it definitely wasn’t enjoyable. When it got to the bit where they froze the heart tissue with liquid nitrogen in a balloon threaded through my artery, I was gripped by a sense of impending doom.’
Xand now feels recovered, mercifully. But millions of fellow Britons have been left facing similarly dangerous and debilitating heart problems in the wake of Covid.
Some 23 million Covid infections have been recorded in the UK, although it’s estimated that many more cases have gone unrecorded because those affected weren’t tested.
Two million people in the UK are living with long Covid, data from the Office for National Statistics (ONS) revealed in June. It classified long Covid as experiencing symptoms more than four weeks after a coronavirus infection.
Fatigue is the most common, followed by shortness of breath, loss of sense of smell and difficulty concentrating, according to the ONS, but more worryingly there are also significant reports of long-term heart-related problems.
In March, the potential scale of such problems was revealed by a paper in the BMJ. The study of more than 47,000 people who’d been hospitalised with Covid-19 showed that they were about three times more likely than uninfected people to face major cardiovascular problems within eight months of being taken to hospital.
It’s not only people who were hospitalised who have been affected. A study in March of 150,000 Americans found serious heart complications can occur in people who seem to have recovered from a mild infection. The report in the journal Nature Medicine, led by Dr Ziyad Al-Aly, an epidemiologist at Washington University, St Louis, in the U.S., found that people who’d had Covid faced substantially increased risks for 20 conditions, including heart attacks and strokes, in the following 12 months.
In patients who’d been admitted to intensive care the risk of conditions, such as myocarditis (inflammation of the heart that reduces its pumping ability) and blood clots in the lungs, was at least 20 times higher than in uninfected people. But even those who had not been hospitalised had increased risks of many conditions, ranging from an 8 per cent increase in heart attacks to a 247 per cent increase in myocarditis.
Scientists have long known that respiratory infections such as flu can trigger heart disease. This is because they cause inflammation, which plays a major role in cardiovascular illnesses.
However, a Covid infection seems to cause a much higher incidence of problems, and following much milder levels of initial illness.
‘It is not only surprising but also profoundly consequential that the risk is evident even in those [who had mild infections],’ says Dr Al-Aly. ‘That’s what makes this likely a serious public health problem.’
But why? One possibility is that the virus’s spike protein — which it uses to invade human cells — can cause an outbreak of localised inflammation in heart tissue that is so intense that it damages the muscle. Dr Zhiqiang Lin, an assistant professor of cardiology at the Masonic Medical Research Institute in New York, exposed human heart tissue in the lab to spike proteins from Covid-19 and HCoV-NL63, a coronavirus that infects the respiratory system without harming hearts.
He found Covid-19 sparks an immune response in heart cells whereas the other coronavirus did not. He believes that causes excessive inflammation which damages heart cells and causes myocarditis.
But Covid may also harm cardiovascular health in another way, according to a study by Houston Methodist Academic Medical Centre, Texas, published in August. This found that patients with long Covid heart symptoms may have double the normal risk of having unhealthy endothelial cells, which line the inside of the heart and blood vessels.
Endothelial cells play a key role in dilating the arteries and helping to get blood to the heart when we do physically strenuous activities. Patients with unhealthy endothelial cells, a condition known as microvascular dysfunction, are at higher risk of heart failure and death.
Dr Mouaz Al-Mallah, a cardiologist who co-authored the paper, explains in the journal JACC: Cardiovascular Imaging: ‘When a patient exercises they need more blood delivered to the heart to be able to provide blood to the entire body ... But in some patients with Covid, we noted it’s not increasing to the degree it should be.’
Dr Al-Mallah’s team scanned the hearts of nearly 400 patients with long Covid. The scans showed they were twice as likely to have unhealthy endothelial cells inside the heart and blood vessels. ‘This may potentially explain why some patients are having chest pain and shortness of breath because their heart is not getting that extra blood,’ Dr Al-Mallah wrote.
Not everyone is convinced that the dangers are widespread, however. In a small study of 52 people, Professor Gerry McCann, a cardiac-imaging specialist at the University of Leicester, found that people who had recovered after being hospitalised with Covid-19 had no greater rate of heart disease than people who had similar underlying cardiovascular conditions such as high blood pressure, but who had remained uninfected by the virus.
He is working on a larger study with around 1,200 participants. ‘The more data we’re acquiring, the less impressed we are with the degree of myocardial injury,’ he told Good Health.
‘There is no doubt Covid is associated with heart problems in hospitalised patients, although it is relatively uncommon. Those who are hospitalised tend to have other risk factors such as older age, obesity and pre-existing cardiovascular disease.’
He adds: ‘There are mixed reports on the extent of heart problems from researchers using imaging techniques. Some of the abnormal findings are of uncertain clinical significance and we are not sure how much of the changes are related to pre-existing conditions.’
Other British researchers disagree that the extent of cardiovascular dangers are exaggerated.
Colin Berry, a professor of cardiology and imaging at the University of Glasgow, said: ‘Professor McCann’s study has serious limitations because it only studied 52 patients. I would concentrate on much larger studies that have greater statistical power such as the American ones, which do show widescale problems.’
Professor’s Berry’s own study, published in Nature Medicine in May, covered 1,306 former Covid patients. It found that one in eight people who had been hospitalised with the virus between May 2020 and March 2021 were later diagnosed with myocarditis.
‘Prior to Covid they had been fit and healthy,’ he says. ‘I think that the damage is more than just to these patients’ hearts but to their wider cardiovascular systems.
‘It may also involve their blood vessels, which helps to explain why such long Covid patients are showing physical problems and loss of quality of life.’
Dr David Strain, a senior clinical lecturer at the University of Exeter who specialises in viral infections, also believes Professor McCann’s results may not represent the whole picture.
‘The patients he studied are generally being followed up after they have left hospital, when the main danger period has passed,’ he says. ‘Beyond three months there seems to be a negligible risk of bad cardiovascular things happening.’
Dr Strain argues instead that the majority of heart problems emerge in a period that lasts from six to eight weeks after Covid infection. ‘This is the period when we see rates of heart attacks, strokes and blood clots going up,’ he says. ‘During this post-infection danger period, Covid picks on your weakest parts, such as your heart and arteries.’ Over the longer term Dr Strain says worrying evidence is mounting to suggest that the virus can hide dormant in our bodies for months or even years.
‘If the virus can hide in the body then anything that weakens a person’s immune defences — such as physical stress, infection or reinfection with another strain of Covid — may allow the virus to re-emerge,’ he says. ‘There is evidence to suggest long Covid can be caused by the virus persisting, and having surges subsequently may cause cardiovascular disease.’
This, Dr Strain says, is why it is crucial people getting over Covid take things very easy when recuperating from the virus. ‘From what we see, people who return to work early are more likely to get post-Covid problems,’ he warns.
Professor Berry agrees. ‘I advise long Covid patients to keep active, but to stay within their own limit,’ he explains. ‘Go for short leisurely walks and if you can do that well, try brisk walks — but don’t overdo it.’
Xand van Tulleken wishes he had taken things more slowly two years ago in the wake of his Covid infection. ‘I did not try to take it easy,’ he says. ‘Even on the day I suffered the first bout of atrial fibrillation, I went straight into work.’
As a result, ‘I went into a downward spiral. Being post-Covid and with heart worries, I felt depressive, miserable,’ he says.
‘Lots of people have gone through this stuff. Fortunately I had the support of my parents, who encouraged me to exercise gently and cooked for me. My twin brother Chris has been hugely helpful with recovering my health by getting me to eat well, not eating junk food and ultraprocessed foods to aid my general health.’
He adds: ‘Professor Toby Hillman was my doctor at the clinic for people with Covid complications. He said his best advice for anyone with long Covid is to rest.’
Thanks to a combination of Xand taking this on board, and having the successful cardioversion op, he says: ‘I now feel amazing. ‘I can go for a run every morning and feel healthy.
‘Convalescence is what we all need after Covid. It sounds such an old-fashioned word, but as a nation we have lost the concept of convalescence. We need to get it back.’
****************************************************
Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)
https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)
**************************************************
Monday, September 19, 2022
Scurrilous journalism award in Australia
At least it cost the lying media a bundle. Dr Laming has an account here telling how grievously the media lie hurt him. He shares there what it's like be the centre of a media stitch-up. Australia's defamation laws have their problems, but in Laming's case they ensured that some justice has been done him.
Had the journalists concerned just checked with Laming before rushing into print the story would never have been published -- as it was an easily refuted story.
But the opportunity of sliming a prominent conservativre was just too juicy to miss. Leftists hate those dreadful conservatives who keep puncturing their balloons so horror stories about conservatives seem obviously correct to them
The contentious entry criteria for the Walkley Awards could be overhauled as part of the independent review into a reporting prize given to a since-discredited story about former federal MP Andrew Laming.
Last Wednesday, Dr Laming won a defamation case against Nine in relation to one key element of its award-winning report, after the network accepted that it was untrue.
On Friday evening, the foundation directors announced a review into the Walkley Award won earlier this year by Nine journalists Peter Fegan and Rebeka Powell for their March 2021 reports about Dr Laming, one of which falsely claimed the then politician had committed the criminal act of “upskirting” – taking a sexually intrusive photograph of someone without their permission.
In one of three reports about Dr Laming’s alleged misconduct in March last year, Nine quoted a witness who said he’d seen the MP take an inappropriate “upskirting” photo of a female staff member while she was stacking a bar fridge at her Brisbane workplace.
The woman was wearing shorts, not a skirt, at the time. The photo was deleted before anyone from Nine could view it. Dr Laming was questioned by police about the alleged incident, but was never charged.
Dr Laming has always strenuously denied any wrongdoing in relation to the matter.
Fegan and Powell won the 2021 Walkley Award in the television/video news reporting category for their report on Dr Laming’s alleged misconduct; the pair also won a Clarion (at the Queensland media awards) for their investigation into the MP.
In its statement on Friday, the Walkley Foundation said it would commission an independent review of the “particular award” given to Fegan and Powell, but it is widely expected that the review will also scrutinise the wider issue of whether journalism that is the subject of ongoing legal proceedings should have caveats attached as part of its conditions of entry.
Currently, entries for major journalism awards in Australia, such as the Walkleys, require a disclosure if the reporting is the subject of ongoing legal action.
But there are no rules governing the overturning of awards if subsequent legal action finds the story to be untrue, as was the case with the Laming “upskirting” claim.
Dr Laming has claimed that Walkley organisers had known for “nearly a year” of his complaint that a story submitted for the awards had made “baseless” upskirting claims against him.
Dr Laming told The Australian on Sunday that he wants to play a key role in the review. “Through my lawyers I have notified the Walkley Foundation that I wish to submit materials to it for their consideration,” he said.
Dr Laming is unhappy that the Walkleys – which he describes as “Australian journalism’s highest honour” – lent weight to the Nine story by publicising comments that lauded the story when it won the prize.
“The comments made by the judges at that time lauding the network and journalists for their work in the face of ‘legal pushback’ is hard to reconcile with the complete abandonment of Nine’s defences and its subsequent unconditional public retraction and apology to me,” he said.
“Despite being on notice at the time of a legal dispute and the waves of retractions, apologies by others over republications of Nine’s story, the Media, Entertainment and Arts Alliance (which oversees both the Walkleys and the Clarion Awards) persisted with both a state and a federal award – and as of right now, even despite announcing a review, they continue to refuse to rescind what is now an award for effectively a story that been withdrawn, deleted and has been accepted by all as a work of fiction.”
Dr Laming said that he initially made allegations to the MEAA in October last year.
“We first notified the MEAA of baseless allegations in the Nine TV news story in October 2021, so they have been made aware of our complaint for nearly a year,” he said. “The MEAA would know that Nine publicly abandoned its unmeritorious truth and honest opinion defences last month, and in my view, from that moment the awards … became completely untenable.”
Dr Laming says he has so far received no response to a letter he addressed to Walkley Foundation chief executive Shona Martyn last week. He asserted in the letter that the Walkleys needed to do more than simply leave it in the hands of award recipients to return them.
“There is already sufficient evidence at hand to rescind the award, and leaving it in the hands of recipients to return awards is weak,” he wrote. “By continuing to promote these awards, the Walkley Committee further harms my reputation through imputation that the stories were true. Nine now admits they were not, and these court documents are public.”
He concluded his letter to the Walkleys: “I reserve my rights in this regard.”
Dr Laming’s former LNP colleague James McGrath has also written to the Walkley Foundation, calling for Nine’s award to be withdrawn.
“The broadcaster has admitted the allegations against Dr Laming were untrue,” Senator McGrath wrote.
“Why haven’t you withdrawn the Walkley Award from Ch9? In light of the above admission from Ch9 I ask you to withdraw the associated Walkley Award.
“If you are not prepared to withdraw I would ask you justify your reasoning.”
Despite repeated requests from The Australian for further clarification around the parameters of the independent review, the Walkley Foundation declined to comment.
Nine also declined to comment.
The terms of Dr Laming’s settlement with Nine, which included an apology, were confidential but the network is understood to be liable for more than $1m in damages and legal costs.
In its apology, which was read to the court, Nine said: “9News unreservedly withdraws those allegations about Dr Laming and apologises to him and his family for the hurt and harm caused by the report.”
************************************************
Pervasive media censorship of Covid skepticism
Facebook groups that criticise any aspect of the official response to the pandemic have their own history of sudden death. On 26 April 2021, for example, Facebook deleted a group with 120,000 members who posted accounts of adverse vaccine reactions.
In May, Republican attorneys general Eric Schmitt of Missouri and Jeffrey Landry of Louisiana brought a suit against the Biden administration for alleged violations of the First Amendment. They accuse top officials of using social media giants Meta (publisher of Facebook and Instagram), Twitter, YouTube (owned by Google) and LinkedIn, of using the tech titans to censor critics of government policy. Instead of Russian collusion, the lie Democrats threw at Trump for most of his term, Schmitt and Landry accuse Dr Anthony Fauci, Director of the National Institute of Allergies and Infectious Diseases, White House Press Secretary Karine Jean-Pierre, and former Disinformation Governance Board executive Nina Jankowicz amongst others, of Big Tech collusion.
In July, US District Judge Terry Doughty ordered various federal agencies to produce records requested by the plaintiffs which resulted in a trove of damning documents exposing an army of at least 50 administration officials and 12 agencies engaged in either censorship as Landry and Schmitt put it or ensuring that the American people have access to ‘factual, accurate, science-based information’ as the Administration claims. The government says it supports freedom of speech but claims it is important to ‘combat misinformation and disinformation that can cost lives’. Fauci and Jean-Pierre refused to provide their communications with the social media companies claiming they were protected by executive privilege, but Judge Doughty was not persuaded and has given them 21 days to hand over the records by 27 September.
Examples of the cosy relationship between the administration and the social media giants are evident in the documents provided so far. CEO of Meta, Mark Zuckerberg gave Fauci his personal phone number, and a parody Fauci account was pulled down within minutes of Facebook receiving a request from Clarke Humphrey, the White House digital director of the Covid response team.
A Facebook official emailed White House officials on 23 July 2021 reporting that Facebook had removed 39 profiles, pages, groups, and Instagram accounts tied to the ‘Disinformation Dozen’ – a group that was targeted by the government which includes Robert F Kennedy junior, founder of Children’s Health Defence, and son of former US attorney general Senator Bobby Kennedy. Kennedy junior said he was ‘astonished that any elected Democrat would be so estranged from our nation’s history and values as to consider it acceptable for a president to pressure publishers to censor his critics’.
The picture of Democrat-friendly censorship fits with other recent revelations. On 25 August Zuckerberg revealed to podcaster Joe Rogan that his employees had been told by the FBI to be wary of Russian disinformation, so they suppressed the New York Post’s scoop on Hunter Biden’s laptop which showed how Hunter leveraged his father’s position as vice president to make lucrative business deals. Republicans will use subpoena powers to further investigate what happened if they win a majority in the House of Representatives in the mid-term elections in November. Others who have joined the lawsuit include epidemiologists Martin Kulldorff, Professor of Medicine at Harvard University and Jay Bhattacharya, Professor at Stanford Medical School, two of the three original authors of the Great Barrington Declaration, which they launched on 4 October 2020 opposing lockdowns and calling for a standard scientific response to the pandemic, protecting the vulnerable while allowing the rest of society to function as normal.
Emails obtained in January via a Freedom of Information request revealed that Francis Collins, Director of the National Institutes for Health emailed Fauci in horror when he read the declaration, describing the authors as ‘fringe epidemiologists’ and fretting that their proposal was ‘getting a lot of attention’. ‘There needs to be a quick and devastating published take down of its premises,’ he schemed. When Bhattacharya read the emails he tweeted, ‘Now I know what it feels like to be the subject of a propaganda attack by my own government. Discussion and engagement would have been a better path.’
How the case launched by Schmitt and Landry is decided we will know in due course, what seems ominously prescient is the quote from George Washington with which they opened their complaint in which Washington warned, in 1783, if ‘the Freedom of Speech may be taken away’ then ‘dumb and silent we may be led, like sheep, to the Slaughter’.
https://spectator.com.au/2022/09/death-by-carrot/
****************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)
https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)
**************************************************
Sunday, September 18, 2022
The Ivermectin saga
Its big fault: It was too cheap. I pointed out some months ago that the big study which purported to discredit Ivermectin was not a true test of it
The story of Ivermectin is a story of the pandemic that might have been.
There are doctors around the world, including Australia, who believe that, far from Covid being an unusual disease for which expensive new therapies had to be found, there were existing medicines, which could markedly reduce the chance of ending up in hospital or dying from the infection.
They say one of these is Ivermectin and another is Hydroxychloroquine. These are tried-and-tested drugs that have been used to treat illnesses like scabies and rheumatoid arthritis, respectively, for decades. Their safety profiles are well known because millions, or even billions, of people worldwide, have taken them.
It’s important to note that we know a lot more about the safety profiles of these two drugs than we do about the new Covid antivirals, simply because these established drugs have been used in so many people for such a long time.
And what’s more, they are cheap! They have been ‘off patent’ for decades and so can be made by any reputable pharmaceutical company, with competition keeping prices low.
You would think the government would jump at such saviour drugs. But the TGA banned GPs from prescribing these medicines for Covid.
I’m a medical journalist trained in science with over a decade of experience trawling medical literature and writing up important studies for busy doctors and the public.
Ivermectin was first championed by Dr Pierre Kory, a US specialist critical care physician treating Covid patients.
In December 2020, Dr Kory testified to the US senate on behalf of the Front Line Covid-19 Critical Care Alliance (FLCCC), advocating for Ivermectin to be made available for prevention and early treatment of Covid. He showed graphs demonstrating the effect of the use of the drug in eight states in Peru.
In January 2021, Dr Tess Lawrie, an independent medical research consultant in the UK, who counts the World Health Organisation (WHO) among her clients, independently reviewed the studies gathered by the FLCCC. She sent a video message to the then UK Prime Minister, Boris Johnson, telling him the good news that Ivermectin was effective in treating Covid.
Both Dr Kory and Dr Lawrie thought their message of a solution to the pandemic would be welcomed. They were wrong.
Instead, there were a lot of stories in the media last year, telling us that Ivermectin was something that should not be used for early treatment of Covid.
In February 2021, I edited a piece that drew on a Reuters news story which was in turn based on a press release from the pharmaceutical company, Merck, the original developer of Ivermectin.
Merck said it had concerns about the safety of the use of its drug, Ivermectin, for Covid, and that there was ‘no meaningful evidence for clinical activity or clinical efficacy’ in Covid patients.
As I edited the story, I remember saying to myself: ‘Good heavens, that’s the first time I’ve ever seen a press release from a drug company rubbishing its own drug!’ I put it in the ‘surprised’ bucket and thought about it no more.
Merck made another press release in March 2021. Good news! They were re-purposing an antiviral they had been developing and it was doing well in phase 2 trials as an early treatment for Covid. The drug’s name – Molnupiravir.
Merck, and other companies, were hurrying to develop new, patented therapies for early treatment of Covid. They were aiming to get an Emergency Use Authorisation (EUA) that would make their path to regulatory approval faster, easier and cheaper.
But a condition of the US Food and Drug Administration’s EUA is that ‘there are no adequate, approved, and available alternatives’.
I was astounded when, on September 10, 2021, the TGA banned GPs from prescribing Ivermectin for Covid, though perhaps I shouldn’t have been, since similar restrictions on the use of Hydroxychloroquine had been put in place in March 2020.
The ban attacked something doctors and patients hold dear – the doctor-patient relationship.
It is a long-held tradition that a doctor can use their judgment to prescribe a medication for a condition other than the one it has been approved for, as long the doctor believes it to be in the best interests of the patient. This is called prescribing ‘off-label’.
By that stage, the media worldwide were disparaging Ivermectin as a Covid therapy, including in a tweet from the US Food and Drug Administration emphasising its use as a dewormer in horses and cows. Some Australian journalists were busy running an Ivermectin witch hunt, exposing GPs who were breaking the TGA’s ban.
Let’s examine the statement the TGA wrote when they banned our GPs from prescribing Ivermectin for Covid.
They gave three reasons.
First, they were worried that people might choose to use Ivermectin rather than be vaccinated. ‘Individuals who believe that they are protected from infection by taking Ivermectin may choose not to get tested or to seek medical care if they experience symptoms. Doing so has the potential to spread the risk of Covid infection throughout the community,’ they said.
How laughable this seems, especially in the light of what has happened: multiply-vaccinated people everywhere are catching and spreading Covid!
‘Secondly, the doses of Ivermectin that are being advocated for use in unreliable social media posts and other sources for Covid are significantly higher than those approved and found safe for scabies or parasite treatment.’ But remember, Ivermectin was going to be prescribed by qualified GPs, not Facebook!
Finally, they said that the increased use of Ivermectin for Covid might lead to shortages for its TGA-approved uses such as for scabies. ‘Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities.’
What a lack of faith this shows in the free market, particularly considering that the drug is off-patent and can be made by many pharmaceutical companies! If demand were to increase, so would production.
Back in September 2021, how could the TGA, have responded rationally and scientifically to the reports of Ivermectin’s effectiveness for Covid? Let’s consider the evidence.
First, the drug had an exemplary safety record. Dr Kory says 3.7 billion doses have been distributed over its 35 years of use. The WHO has Ivermectin on its list of essential medicines and its discoverer, Japanese scientist Dr Satoshi Omura, received the Nobel prize in 2015 for the drug, which has dramatically reduced river blindness and other diseases caused by roundworms.
There was never a question about safety – providing a doctor prescribed the drug properly – there was only a question about whether it worked.
Furthermore, there was no body of evidence showing Ivermectin made Covid worse – instead there were numerous randomised controlled trials showing it made it better. Physicians like Dr Kory were saying it had turned patients around and there were reports that some states in Mexico, Peru, and India had found it to be very effective.
One has to ask – what was to be lost by trying it? And what was to be gained – if it really worked as Drs Kory and Lawrie suggested – was a markedly reduced number of people getting seriously ill and dying from Covid.
Here’s a possible alternative approach. Instead of banning Ivermectin, the TGA could have allowed GPs to prescribe Ivermectin for Covid but require them to report on the outcome. In other words, proactively collect data on its effectiveness.
One year on, we may reflect on what the outcome of such a decision might have been.
And if you are wondering what happened about Mulnupiravir, Merck got its EUA and reports sales of USD 4.4 billion for the first half of 2022. Molnupiravir (sold as Lagevrio) is now being used to treat early Covid in Australia. The other new antiviral being used in Australia, Paxlovid, which also got its EUA last year, has been forecast by its developer, Pfizer, to bring in USD 22 billion in sales in 2022.
https://www.spectator.com.au/2022/09/today-is-a-significant-anniversary/
***********************************************************Adverse Effects of mRNA Vaccines Were Known Before COVID-19: Medical Doctor
Complications and adverse reactions occurring after administering mRNA COVID-19 vaccines have been anticipated by doctors based on data and studies going back 15 years, said Dr. Elizabeth Lee Vliet.
When the COVID-19 vaccines were rolled out, it was already known that the toxicity of the spike protein and the toxicity of another component of the vaccine could cause complications such as inflammation, blood clots, and disruption of the immune system, Vliet said in a recent interview for EpochTV’s “Crossroads” program.
“Over the first six months after the rollout of COVID-19 shots, I had a whole gamut of patients with all kinds of problems they had not had before,” she said, adding that the only common denominator of these cases was that they all had the COVID-19 vaccines.
Vliet runs an independent medical practice.
“Most of these people are people that have been my patients for 20 or 25 years. I even have some that I’ve seen for 30 years. And I knew their medical history,” she said.
Among disorders that Vliet observed in her patients were cognitive issues, memory loss, brain fog, mini strokes, dizziness, vertigo, tinnitus, and falling episodes.
The doctor mentioned two of her patients, a couple in their 70s who were healthy and fit and exercised regularly, walking 7 miles a day. They got the COVID-19 shot so they could travel to see their children and grandchildren.
Since then, the woman’s heart arrhythmia has been out of control and the man began having falling episodes that resulted in a broken hip, Vliet said.
Vliet said that in her medical practice, she abides by a basic principle she learned in medical school: If what you’re doing is working, keep doing it. If what you’re doing isn’t working, stop doing it.
“And if the patient has new health problems, right after you’ve given them a treatment or a medicine or a shot, then consider that as the connecting link,” she said.
“Those principles are common sense. It’s basic medicine 101 … and it’s been true my whole career.”
Doctors generally stop administering a medicine when a patient shows side effects that they didn’t have before, to see if those reactions resolve, Vliet said. “The same is true with any vaccine.”
“I’ve seen patients over my career who’ve had adverse reactions to all the different vaccines,” Vliet said, adding that she herself has had vaccines in the past and has not experienced any adverse reactions.
“I’ve recommended them appropriately for patients over my career. But there are also times when vaccines simply aren’t needed. COVID was one of those.”
COVID-19 was not a lethal illness for those under 50 with no medical comorbidities, Vliet said. And for those over 50 or with medical comorbidities, Vliet used early treatment, and the disease “was very treatable,” she said.
Vliet said she used a combination of older, safer medicines recommended by Drs. Vladimir Zelenko and Peter McCullough beginning in March 2020.
“I didn’t have any of my patients go in the hospital. I didn’t have anyone die,” she said. She did have some older patients with diabetes, obesity, and other medical conditions who were pretty sick with COVID-19, but she kept them out of the hospital with an aggressive combination of drug therapies recommended by McCullough.
“So vaccines are not always the answer to every problem,” she said, adding that for COVID-19, the best answer was early treatment.
****************************************************
Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)
https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)
**************************************************
Subscribe to:
Posts (Atom)