By Maryanne Demasi, PhD and Tom Jefferson

A recent conversation between popular podcaster Joe Rogan and presidential candidate, Robert F Kennedy Jr ignited an international discussion about placebos in clinical trials. Here, we document the difficulty in determining the details (formulation and testing) of the placebo used in a controversial cholesterol-lowering trial of Crestor (rosuvastatin) – adapted from our earlier publication in JAMA Internal Medicine.

The basis for a “placebo” controlled trial is to reliably assess the safety and efficacy of a therapeutic drug or vaccine against a placebo – they can be active or inactive placebos.

An active placebo can be used to mimic the side effects of the intervention, with no therapeutic effects on the condition being treated.  For example, atropine may be used as a placebo in antidepressant trials to mimic the symptoms of “dry mouth” often experienced after using antidepressants, with no therapeutic effect on depression. The aim is to mitigate the risk of unblinding trial participants.

More commonly, placebos are intended to be inactive or inert. Inactive placebos should ‘match’ the sensory and visual aspects of the experimental drug to maintain blinding throughout the trial. In other words, a placebo needs to be equal in shape, size, colour, texture, weight, taste, and smell.

Drug companies keep details a secret

Drug companies will often manufacture their own placebo for use in clinical trials. The technical data and analytical methods used for the placebo are detailed in the certificate of analysis (CoA), which is part of the dossier submitted to the relevant drug regulator as part of a licensing application.

Drug regulators are expected to analyse the CoA to ensure the placebo and the experimental drug are appropriately matched, to eliminate an unknown variable. However, the details relating to the contents of a placebo are often unknown to independent researchers and remains proprietary information of the drug manufacturers.  For example, the in trials of Gardasil (HPV vaccine), the manufacturer often used a placebo containing amorphous aluminium hydroxyphosphate sulfate (AAHS) – an adjuvant to enhance immune response – and has kept the formulation a proprietary secret.

In fact, the exact formulation of a placebo is rarely disclosed in the peer-reviewed publication of a clinical trial.  Further, medical journals do not require authors, nor drug manufacturers, to disclose the contents of a placebo or publish the CoA. Placebos may contain excipients such as chemicals, dyes, or allergens, which might unintentionally cause side effects, raising concerns about the reliability of trial data and the transparency of important information.

In 2017, Robert Shader, physician and editor-in-chief of Clinical Therapeutics, raised concerns when a study on people with multiple sclerosis published in the New England Journal of Medicine, injected one group of people with a monoclonal antibody (ocrelizumab) and the other group with a ‘matching’ placebo. But what was in the placebo?

“Was it saline? Was it the same vehicle in which the monoclonal antibody was dissolved?” asked Shader.

[…]

Inappropriately matching a placebo to the experimental drug or vaccine can lead to under-reporting of harms or misleading trial outcomes as well as raising ethical questions about whether patients are properly consenting to participate in trials.

Even when one of us (TJ) found evidence that an ‘active’ ingredient in the placebo of a pivotal HPV vaccine trial had been misreported as ‘inert,’ neither the authors nor the editors acted to correct the error.

Placebo in the JUPITER trial

The JUPITER trial investigated the effects of 20 mg rosuvastatin (Crestor) in ‘healthy people’ at low risk of heart disease. It was a highly controversial study because – despite major criticisms – it underpinned the decision to grant regulatory approval for rosuvastatin for the prevention of “a first cardiovascular event.”

One aspect of the JUPITER trial piqued our interest. While, muscle aches were similar in the statin and placebo groups, the reported rate of muscle aches in the placebo group (taking the ‘inert’ pill) was much higher (15.4%) than in the placebo group of other statin trials (<5%).

Therefore, we sought to obtain the CoA of the placebo pill used in the JUPITER trial, in the hope that it might explain why the ‘healthy subjects’ at low risk of heart disease in the placebo group, experienced an unusually high rate of muscle harms.

The process of obtaining the CoA for the placebo used in the trial turned out to be arduous.

The peer-reviewed publication in the New England Journal of Medicine contained no information about the contents of the placebo, nor did the study protocol, which only described it as a ‘matching’ placebo.

We then contacted the lead investigator – Paul Ridker, Professor of Medicine at Harvard University and Brigham and Women’s Hospital – but he did not respond to our emails.

We made enquiries to the European Medicines Agency since it allows access to certain regulatory data. However, the agency informed us that it had not licensed any single statin (only two statin-fibrate combination products) so we turned to the individual member states of the European Union.

The Dutch drug regulator – i.e. Medicines Evaluation Board (MEB) – had licensed rosuvastatin and confirmed that it held the data relating to the JUPITER trial. But after multiple emails over several months requesting access to the CoA, the regulator finally conceded that it did not have that particular document in its possession.

We also lodged a request with the Australian drug regulator – the Therapeutic Goods Administration (TGA) – which informed us that the information we requested was “not publicly available and the TGA would not be in a position to release this information…without the permission of the sponsor (AstraZeneca Pty Ltd)”.

The TGA also stated that we could apply through a formal Freedom of Information (FOI) process, however it would not guarantee the release of any information “if the sponsor raised valid objections” or if the documents were classified as exempt under the FOI Act. The TGA suggested that we approach the drug manufacturer directly, so we did.

After multiple emails and lengthy delays, we finally obtained a response from AstraZeneca stating that we could ‘apply’ for access to the information but that we could not share the data with any third parties without restrictions.  The company stipulated in its conditions that we could not publish the CoA in the peer reviewed literature and that any analysis of the CoA by us, would have to be “pre-reviewed” by the drug company since they were owners of the information.

We refused to abide by AstraZeneca’s conditions of access. This type of oversight, whereby research needs to be vetted by drug companies or where researchers are required sign confidentiality agreements, can stifle open science.

[…]

Via https://maryannedemasi.substack.com/p/whats-in-the-placebo

By Ivan Penchoukov
Epoch Times

Former President Donald Trump said that he received a letter on July 16 informing him that he is a target of the special counsel investigation of the Jan. 6 Capitol breach.

Mr. Trump said the Sunday letter from special counsel Jack Smith gave him four days to report to a grand jury. In a message posted on his social media platform, Truth Social, on July 18, the former president suggested that the short deadline may mean he would be arrested and indicted.

Mr. Trump called the letter “HORRIFYING NEWS for our country” and framed it with the backdrop of the two other indictments he is facing amid a heated presidential reelection campaign in which he is dominating the GOP field.

Mr. Trump was charged earlier this year in connection to payments for a non-disclosure agreement in a state case in New York. He was later charged in a federal case in Miami in connection to his handling of classified documents after leaving the White House.

“THIS WITCH HUNT IS ALL ABOUT ELECTION INTERFERENCE AND A COMPLETE AND TOTAL POLITICAL WEAPONIZATION OF LAW ENFORCEMENT,” Trump wrote.

Mr. Trump’s campaign did not immediately respond to The Epoch Times’ request for a copy of the target letter. The Epoch Times has also asked Mr. Trump’s campaign to answer whether he would present himself to the grand jury as the letter reportedly ordered.

The Department of Justice has indicted hundreds of people for participating in the breach of the Capitol on Jan. 6, 2021. In two of the most prominent cases, the government convinced juries in Washington that members of the Oath Keepers and the Proud Boys, two right-wing groups, were guilty of seditious conspiracy.

Legal experts had previously suggested that the successful prosecution of the Oath Keepers and the Proud Boys cases spelled trouble for Trump, who could be snarled with seditious conspiracy charges over parts of the speech he delivered on Jan. 6 and other remarks he made leading up to that day.

Defense attorneys maintained that their clients exercised their First Amendment rights to free speech.

The Proud Boys were convicted even though an FBI informant testified that, to his knowledge, there was no organized plan to storm the building. Instead, he said, “a herd mentality” took hold.

Peter Carr, a spokesman for the special counsel’s office, declined to comment.

Trump was found not guilty in a Senate impeachment trial over his remarks on and before the Jan. 6 events. The charges against him hinged largely on selective quotations from his speech in the capital that day.

A massive crowd of Trump supporters gathered in Washington on Jan. 6, 2021, at the behest of Mr. Trump to protest election irregularities. By that day, nearly every legal election challenge by Mr. Trump’s team had failed in the courts. After hearing Trump speak, the attendees started making their way to the Capitol, where a joint session of Congress was in the process of certifying Joe Biden as the winner of the 2020 election. The ensuing breach of the Capitol briefly interrupted the Congressional session.

Democrats have framed the events of Jan. 6 as an “insurrection” and, beginning with the impeachment, have ceaselessly used the attacks to paint Republicans and Trump followers as extremists. Republicans, including Trump, immediately condemned the violence and vandalism and drew a distinction between the largely peaceful crowd of protesters and the small group which engaged in egregious lawbreaking.

More than 1,000 people from 25 states have been indicted on charges related to Jan. 6, according to data maintained by Look Ahead America. Some defendants were detained for more than 800 days before their trials.

At least a half-dozen Jan. 6 defendants have been convicted of seditious conspiracy. The underlying law has been on the books since the end of the Civil War and was intended for use against Southerners bent on rebelling against the federal government.

As defined, a seditious conspiracy means that at least two people worked together to “overthrow, put down, or to destroy by force” the U.S. government, oppose its authority, or prevent a law from being executed.

Judicial Watch President Tom Fitton, a Trump ally, said he was questioned for hours by Mr. Smith’s grand jury about challenges to the outcome of the 2020 election.

“Having witnessed firsthand their abuse of power, no surprise these partisans now want to arrest Trump on political charges. This is a dire threat to the rule of law,” Fitton wrote on Twitter on Tuesday.

In a Rasmussen Reports poll released on Tuesday morning, two in three likely voters said they expect Trump to be the Republican 2024 nominee. Mr. Trump was 33 percentage points ahead of his closest GOP challenger, Florida Gov. Ron DeSantis, in an average of polls maintained by RealClear Politics.

Mr. DeSantis on Tuesday issued a mixed reaction in response to news of the target letter. The governor condemned the political weaponization of the prosecution while faulting Trump for not doing enough on Jan. 6 to thwart the violence.

Nikki Haley, one of Mr. Trump’s Republican challengers in the race for the White House, did not defend the former president in an appearance on Fox News.

“It’s going to keep on going,” said Ms. Haley, who served as Mr. Trump’s United Nations ambassador. “It’s just going to continue to be a further and further distraction.”

“And that’s why I’m running,” she continued. “It’s because we need a new generational leader. We can’t keep dealing with this drama.”

Former Arkansas Gov. Asa Hutchinson, a White House hopeful with less than one percent Republican support on average, used the news to mount an attack on Mr. Trump.

“I have said from the beginning that Donald Trump’s actions on January 6 should disqualify him from ever being President again,” Hutchinson said in a statement posted on Twitter.

Rep. Elise Stefanik (R-N.Y.) told reporters during a House GOP press conference on July 18 on Capitol Hill that “We have yet again another example of Joe Biden’s weaponized Department of Justice targeting his top political opponent, Donald Trump.”

[…]

Via https://www.theepochtimes.com/trump-received-letter-stating-he-is-target-of-january-6-investigation_5405674.html

Dr Eddy Betterman

A “rare” vaccine injury called Guillain Barré syndrome (GBS) has caught the attention of Peruvian health authorities. Peruvian President Dina Boluarte declared a 90-day national emergency after an “unusual increase” in GBS was detected in hospitals across Peru.

At least 18 of the country’s 24 departments have seen at least one case of GBS in June, which is unprecedented. Since June of 2023, 182 cases have been reported across Peru, of which 147 have been discharged, 31 remain hospitalized, and four have died.

Peruvian health authorities are taking alarming spike in GBS seriously

Boluarte’s latest decree sends $3.2 million to the hospitals to improve patient care and increase GBS detection and control measures. Though GBS is not contagious, Peruvian health authorities are moving quickly to acquire human plasma to manufacture intravenous immunoglobulin and human albumin to help treat GBS.

The government’s decree, published in the El Peruano (Official Gazette), warns of an “unusual increase” of a rare disease in a short period of time that threatens the nation’s health services. The rise in GBS “negatively affects the continuity of health services, as there are not enough strategic resources to respond to the volume and complexity of the cases in the different health facilities,” warned the decree.

GBS is a neurological disorder where the immune system attacks part of the peripheral nervous system. It often starts with tingling in the hands, feet, and face, before progressing to muscle weakness and paralysis across the body. In severe cases, GBS can leave one “unable to breathe independently.”

In GBS, immune cells do not function properly and mistakenly attack the myelin sheaths of the peripheral nerves. According to Medical News Today: “The damage prevents the nerves from sending certain information, such as touch sensations, to the spinal cord and brain. This causes a feeling of numbness. In addition, the brain and spinal cord can no longer transmit signals back to the body, leading to muscle weakness.”

GBS can cause lingering issues such as blood pressure fluctuations and irregular heart rhythms as well as sluggish bowel function and urine retention. About one third of patients will experience severe nerve pain. With the right treatment, most people will recover from GBS but they will likely have some form of reoccurring weakness in their muscles.

GBS is a well-known injury for many vaccine types

GBS may show up in individuals who have a compromised immune system after recovering from an infection. According to the Mayo Clinic, symptoms of GBS may appear weeks after an infection from the influenza virus, the cytomegalovirus, the Epstein-Barr virus, the Zika virus, or Hepatitis A, B, C and E.

GBS is also linked to several vaccines. The latest mRNA vaccines, including those made with an adenovirus (Johnson & Johnson, AstraZeneca) and those designed to protect against RSV (respiratory syncytial virus) have been flagged by regulators for causing an uptick in GBS. The J&J covid-19 vaccine was slapped with an FDA warning label in 2021, alerting consumers to the increased risk of developing GBS up to 42 days after vaccination.

Additionally, the US Food and Drug Administration noted that GBS is a possible risk from Pfizer’s new RSV vaccine for older adults. There were two cases of GBS out of 20,000 recipients who took the experimental jabs. The FDA now recommends that doctors monitor for GBS after a patient takes a Pfizer RSV shot. The long list of childhood vaccinations are also known to cause GBS in rare instances.

The U.S. Centers for Disease Control and Prevention (CDC) is aware of the deadly and debilitating vaccine-GBS risk and stated that “very rarely, people have developed GBS in the days or weeks after getting certain vaccines.” However, like every other serious health issue related to vaccination, the CDC claims that the “benefits of vaccination far outweigh risks.” Of course, this is not true for the vaccinated individuals who come down with GBS and aren’t treated in time or perish from this most serious vaccine injury. At least one nation — Peru — is now taking this issue seriously.

[…]

Via https://dreddymd.com/2023/07/19/rare-vaccine-injury-becomes-national-health-emergency-in-peru/

Episode 15 Brahmanic Synthesis

A History of India

Michael Fisher (2016)

Film Review

From the 3rd century BC to the 8th century AD, Brahmanism (the precursor to modern Hinduism) absorbed many features of Buddhism and Jainism (especially their emphasis on nonviolence and asceticism). This would require revision of the traditional Veda.* With the movement of the merchant class into cities in 500 BC, many of its original precepts no longer applied.

Brahman priests also composed a number of Shastras applicable to urban life.

• The Dharmastrastras – a manual focused on morality and the history of the Varna and Jatis,*
• The Arthashastras – a manual of material power
• The Kamashastras – a manual of sensual pleasure
• The Natyashastras – a manual of performing arts
• The Vastushastra – a manual for architecture
• The Shilpashasera – a manual for sculpture

The Dhamashastras

These describe three levels of Brahman priests:

• Some perform vedic rituals
• Some withdraw from society into the forest to contemplate
• Some practice asceticism

According to the Dhamashastras, individuals born into higher varna (Brahman, Kshatrya and Vaishya) process through four stages of life: student life, household life, retired life and renounced life. Each is associated with a specific samskara or rite of passage. Children are initiated into student life by donning a sacred thread to signify being twice born. Only about 10% of modern India qualifies as being twice born.

After being twice born, higher caste members attach themselves to a guru for a 36-year period to learn the Veda. The student must remain celibate, live on donated food and be totally obedient to his guru.

The next rite of passage is marriage to a healthy virgin from a religious family with a history of producing sons.

Retiring into the forest, the third stage of life, is open to women as well as man.

The final stage, renounced life, follows a symbolic cremation after which devotees leave their family and only eat when fed.

The Arthrashastras

The Arthrashastras address the interests of a rising merchant class, with an emphasis on marriage and the role of kings. While it stresses the obligation of brides to pay a dowry, it allows women more control of their dowries. It also allows a woman to divorce her husband if he stays abroad too long and a man to divorce his wife if she fails to produce a son after eight years.

It also describes how low born individuals can become debt slaves but must be set free if they pay their debt. It forbids masters from forcing slaves to perform “polluting” work or sexually abusing female slaves.

It describes the role of craft guilds to set wages, prices and working conditions, as well stipulating how much color fading subjects launderers to a fine and prescribing fines for medical ma;practice.

The Kamashastras (aka the Kama Sutra)

This manual is mainly directed at courtesans, guiding them in controlling their senses to improve their ability to derive profit from sensual pleasure. It lists 64 arts courtesans should become adept in, including seduction, kissing, touching, intercourse, music, art, carpentry, singing, gymnastics, archery, chemistry and magic.

Film can be viewed free with a library card on Kanopy.

*See The Vedic Origin of India’s Castes

https://www.kanopy.com/en/pukeariki/video/366254/366201

Seemorerocks

Shocking data from Israel’s largest healthcare organization shows a staggering increase in cardiac arrest diagnoses.

and number of people dying post vaccination.

Credit: BBC

The Blogging Hounds

United States officials have confirmed that one of their soldiers was detained in North Korea this morning. He has also reportedly defected.

CBS News reported that the soldier in question is Private 2nd Class Travis King. Before his detainment, he was being escorted back to the United States from South Korea for disciplinary reasons.

The illegal crossing reportedly occurred at 3.27pm local time (2:37 AM ET) according to the Daily Mirror. King was visiting the Military Demarcation Line (MDL) at Panmunjom with a civilian tour group before leaving their sight.

The MDL marks the border between North and South Korea. The line is surrounded by a demilitarized zone and is one of the most heavily guarded areas in the entire world.

The United States maintains a presence of approximately 28,500 forces along the North Korea-South Korea border.

The United Nations command, which operates the Joint Security Area (JSA) within the demilitarized zone between North and South Korea, released the following statement:

A U.S. National on a JSA orientation tour crossed, without authorization, the Military Demarcation Line into the Democratic People’s Republic of Korea (DPRK). We believe he is currently in DPRK custody and are working with our KPA (North Korean army) counterparts to resolve this incident.

Newsweek revealed that the Korean -language version of the message said that King “had defected to North Korea.” This news has not been confirmed by American authorities at this point.

A witness, who was part of the tour group with King, gives credibility to the report that King was trying to defect. He explained to CBS News that they had just visited one of the buildings at the site before King laughed and disappeared from the group.

[…]

Via https://theblogginghounds.com/2023/07/18/developing-american-soldier-captured-by-north-korean-forces-crossed-border-without-authorization-and-has-reportedly-defected-to-north-korea/

The Blogging Hounds

The International Atomic Energy Agency (IAEA), an international organization within the United Nations system, just approved a large Fukushima discharge into the Pacific Ocean. The pending discharge, which includes over 500 Olympic-sized swimming pools of “treated” radioactive water, will be released from the infamous Fukushima Daiichi Nuclear Power Plant. Chinese customs and food safety regulators are warning against the move and are threatening to block seafood imports from Japan.

The Fukushima disaster is not over

Back on March 11, 2011, the Daiichi Nuclear Power Plant was struck by 15-meter tsunami from a catastrophic 9.0 earthquake. Immediately, eleven reactors at four nuclear power plants shut down. In the first three days, all three cores largely melted down, releasing radioactive material, especially through days 4-6. The three units were no longer able to maintain proper reactor cooling and water circulation functions, and their electrical switch gear was disabled. For weeks, operators worked to restore heat removal from the reactors.

All four Fukushima Daiichi reactors were decommissioned due to extensive damage from the meltdown. For years, the basic ongoing task was to prevent the release of radioactive materials, particularly in contaminated water that leaked from the three units.

Related: Japan begins secret discharge of RADIOACTIVE WATER from Fukushima nuclear plant into the ocean.

The Fukushima controversy continues over a decade later

Over a decade later, “treated” radioactive water is set to be released directly form the Fukushima plant into the Pacific Ocean. Hong Kong’s Environment and Ecology Department is not on board with the decision. The Department head, Tse Chin-wan, issued a warning for Japan. If Japan discharged the “treated” water into the Pacific Ocean, Tse Chin-wan said China would ban all imported, frozen, refrigerated, and/or dried seafood products, including unprocessed or processed seaweed and sea salt. This impacts China’s supply of scallops, shrimp, tuna, and Japanese rice wine sake, all of which are popular staples in China. China is the largest buyer of Japan’s seafood exports, so the confrontation has enormous implications.

As Japan gets international approval to dump the treated radioactive water into the Pacific Ocean, Hong Kong warned that they will crack down on Japan’s seafood exports and ban products from a “large number” (10) of Japanese prefectures. China’s General Administration of Customs said the ban is to prevent “contaminated food” from hitting Chinese supermarkets. Chinese Customs lambasted IAEA’s report, claiming it “failed to fully reflect expert opinions” and that China will take “all necessary measures” to ensure that Chinese consumers are safe from radioactive waste.

Wang Wenbin, a Chinese Foreign Ministry spokesperson addressed the issue in a recent press briefing: “If some people think that the nuclear-contaminated water from Fukushima is safe to drink or swim in, we suggest that Japan save the nuclear-contaminated water for these people to drink or swim in instead of releasing it into the sea and causing widespread concerns internationally.”

Chinese Customs added: “Since the Fukushima nuclear disaster in 2011, China’s customs have attached great importance to the issue of radioactive contamination of Japanese food imported to China. It has closely monitored the relevant measures taken by the Japanese government, continued to assess the risk, and responded promptly.”

The IAEA maintains that the treated radioactive water conforms with international safety standards.

[…]

Via https://theblogginghounds.com/2023/07/17/un-approves-large-fukushima-discharge-into-pacific-ocean-prompting-china-to-ban-japanese-seafood-imports/