FDA attempts to stop OTC sales of N-acetyle cysteine, an adjunctive treatment for Covid-19
By Meryl Nass, MD | May 16, 2021
Last July, FDA sent out warning letters to supplement companies, informing them that N-acetyl cysteine (NAC) could no longer be marketed as an ingredient in food supplements, using the justification that it was also a licensed drug.
FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been approved as a new drug under section 505 of the Act [21 U.S.C. § 355], then products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.
But other drugs, such as Coenzyme Q10 and Vitamin D, are licensed as drugs but also permitted to be sold as supplements. And the federal government’s PubChem website lists many virtues of NAC.
In the case of NAC, it has been available as a licensed drug for 57 years in the US. It is widely used and very safe. Unlike many supplements, it has been extensively studied. Clinicaltrials.gov lists 541 studies for the search term ‘N-acetyl cysteine.’ Why did FDA suddenly decide its OTC use should be restricted?
This is especially troubling as a number of doctors have said it is useful in the treatment of Covid-19, especially during the late, cytokine storm stage, since it works as an antioxidant and a substrate for the production of glutathione. In fact, there is a growing body of literature on its benefits for Covid. Here is just one review.
Last week, Amazon stopped selling all products containing NAC. While no absolutely final decision has been made by FDA regarding NAC, it might be the third effective Covid treatment that the FDA has attempted to suppress, after the chloroquine drugs and ivermectin. Stay tuned.
Leaked documents prove UK funded anti-Damascus groups: Assad’s top aide
Press TV – May 9, 2021
A senior aide to Syrian President Bashar al-Assad has accused the United Kingdom of funding anti-Damascus groups to stoke further unrest in the Arab country and said Western states were exerting pressure on Syrian officials to dissent from the government.
Bouthaina Shaaban, Assad’s political and media adviser, made the remarks in a video conference organized by the German Schiller Institute on Saturday, entitled “The Moral Collapse of the Trans-Atlantic World Cries Out for a New Paradigm,” Syria’s official news agency SANA reported.
Shaaban said Syria has been waging a “double-edged” war over the past decade, one on the ground against terrorists wreaking havoc in the country and the other against a Western-backed drive for inciting dissent within government ranks.
“All that happened in Syria of destruction, death, and displacement, were because of Western intelligence institutions which, in cooperation with Turkey, trained thousands of terrorists to achieve a single goal which is destroying Syria,” the presidential aide said, adding that the West was dealing with Syria as if it were still under their colonization, ignoring its deep-rooted history and values.
Shaaban also said leaked British documents revealed that the United Kingdom “officially funded” groups of Syrian dissidents who called themselves “witnesses” to launch street movements and provide news for Western media outlets.
Assad’s political and media adviser told the video conference that, “Western governments were pressing Syrian officials to dissent and bribing some of them with money to join those against the Syrian government, assuring them the political system is going to fall and collapse.”
Syrian government troops and their allies have managed to retake some 80 percent of the war-ravaged Arab country’s territory from the Takfiri terrorists.
The Syrian army is fighting to drive out the remaining militants, but the presence of US and European forces in addition to Turkish troops has slowed down its advances.
The United States has also imposed crippling sanctions on Damascus. The Syrian government has repeatedly denounced Washington’s unilateral sanctions as “crimes against humanity,” saying the Western sponsors of terrorism must pay the price for their atrocities against the Syrian nation.
Washington rejected Moscow’s offer of complete reset in Russia-US relations shortly after inauguration of Biden: Lavrov
By Jonny Tickle | RT | April 28, 2021
The Kremlin proposed a complete reset in the strained relationship between Moscow and Washington after the inauguration of US President Joe Biden, but it was turned down by the White House, Russia’s chief diplomat said on Tuesday.
Speaking to journalist Dmitry Kiselyov, Foreign Minister Sergey Lavrov explained that Russia wants to get back on a sound footing in its relationship with the US.
“If it only depended on us, we would return to normal relations,” Lavrov explained, noting that the first step would be to cancel the expulsions of Russian diplomats from Washington, and US diplomats from Moscow.
“We offered this to President Biden’s Administration as soon as he took all the necessary oaths and assumed power,” he continued. “I mentioned this to Secretary of State [Antony] Blinken.”
According to Lavrov, the crisis began when former President Barack Obama took measures against Russia prior to his leaving office. After the election of Donald Trump, Moscow remained patient and waited for the new administration to reverse the “excesses” of the outgoing president, but it never happened.
“I very much hope that Washington, as we do, recognizes their responsibility for stability in the world,” Lavrov continued. “There are not only problems between Russia and the US that complicate the lives of our citizens… but also disagreements that put international security at serious risk, in the broadest sense of the word.”
In recent weeks, relations between Moscow and Washington have become even more strained.
On April 15, Biden signed an executive order imposing further sanctions against Russia. Targeting more than 30 individuals and organizations, the measures are said to be punishment for alleged interference in the US presidential election, as well as the infamous SolarWinds cyber-espionage case, which Washington says was ordered by the Russian government. Biden also announced the expulsion of 10 people from the Russian diplomatic mission.
In response, Moscow sent 10 US diplomats back home.
Lockdowns Devastating For Child Development & Language Skills
By Richie Allen | April 27, 2021
A major survey has concluded that lockdowns are having a devastatingly negative impact on child development. Data from 50,000 pupils and a survey of schools across England, has revealed that an increased number of four- and five-year-olds need urgent help with their language skills.
The Education Endowment Foundation (EEF) research suggests that the lockdowns have deprived the youngest children of social contact and experiences essential for developing their vocabulary. According to the BBC:
Less or no contact with grandparents, social distancing, no play dates, and the wearing of face coverings in public have left children less exposed to conversations and everyday experiences.
Of 58 primary schools surveyed across England:
- 76% said pupils starting school in September 2020 needed more support with communication than in previous years
96% they were concerned about pupils’ speech-and-language development. - And 56% of parents were concerned about their child starting at school following the lockdown in the spring and summer.
Sally Miner, head teacher at Ryder Hayes school in Walsall told the BBC that problems with communication were “really limiting” for young children, particularly if they were unable to express themselves, interact with peers and make themselves understood.
“It’s absolutely key,” she said. “It’s all about a child’s self-esteem and confidence. She went on to say:
“All the research shows that if a child does have issues with language at that age, by adulthood they’re four times more likely to struggle with reading, three time more likely to have mental health issues, twice as likely to be unemployed and have social-mobility issues, so getting this right at such an early age is literally the key to children’s futures.”
Lockdowns are a crime against humanity. Lockdowns are a form of child abuse. If lockdowns are child abuse, the witch doctors and lying politicians responsible for them are child abusers, plain and simple. There must be a day of reckoning for them.
Amid increased tensions in Donbass, Putin invites Ukrainian President Zelensky to Moscow for discussions on ‘bilateral relations’
By Jonny Tickle | RT | April 23, 2021
Russian President Vladimir Putin has revealed that he is ready to welcome his Ukrainian counterpart Volodymyr Zelensky “at any convenient time in Moscow.” The suggestion comes after Kiev offered to meet in war-torn Donbass.
Speaking before talks with Belarusian President Alexander Lukashenko on Thursday, Putin said Zelensky should first discuss the problems of Donbass with the heads of the self-proclaimed Donetsk and Lugansk People’s Republics before speaking with representatives of third countries. He included Russia in this category.
“And if we are talking about the development of bilateral relations, then, please, we will receive the president of Ukraine in Moscow at any time convenient for him,” Putin said. “If President Zelensky wants to start restoring relations, Russia will only welcome it.”
The Russian leader’s statement comes after Zelensky suggested a summit “anywhere in the Ukrainian Donbass where the war is going on,” earlier this week.
“Ukraine and Russia, despite their shared past, look to the future in different ways. We are us. You are you,” Zelensky said. “But this is not necessarily a problem; it is an opportunity. At the very least, an opportunity, before it is too late, to stop the murderous mathematics of future war losses.”
The conflict in Donbass started in April 2014, when two pro-Moscow breakaway republics unilaterally declared independence from Kiev. These regions – the self-declared Donetsk (DNR) and Lugansk People’s Republics (LNR) – are unrecognized by both Russia and Ukraine. However, according to Kiev, they are under the control of the Kremlin, a charge Moscow denies.
Following Zelensky’s invite to Putin, the heads of both the DNR and LNR invited the Ukrainian leader to meet and hold talks in Donbass, suggesting he deals directly with them instead.
“I urge you, Mr. Zelensky, not to invite the leaders of third countries to the line of contact, but rather to go there yourself for an honest and open conversation with us,” said Denis Pushilin, the leader in Donetsk.
The situation in Donbass has escalated in recent weeks, although it now seems to be calming down. Media reports from the region revealed a build-up of both Russian manpower and equipment near the border, following news that the Ukrainian Army was increasing its number of forces in the area. However, on Thursday, Russian Defense Minister Sergey Shoigu announced that troops deployed near the frontier would soon begin returning to base, as military exercises had concluded.
As chemical weapons watchdog’s credibility crumbles, OPCW member states strip Syria’s voting rights
RT | April 21, 2021
Syria has been stripped of most of its rights at the global chemical weapons watchdog for alleged breaches. The OPCW stands accused of suppressing facts reported by its own inspectors in Syria for political purposes.
The vote to penalize Syria took place on Wednesday at the conference of the states that are parties to the Organization for the Prohibition of Chemical Weapons (OPCW) in The Hague. Syria was punished for allegedly violating the Chemical Weapons Convention (CWC), of which the OCPW is the guardian, based on reports by the special Investigation and Identification Team (IIT).
The penalties were imposed at the proposal of France and backed by Western nations who helped pass it overwhelmingly by 87 to 15, with 34 abstentions out of 136 countries taking part.
The mechanism was created last year and was authorized to name perpetrators of chemical weapons attacks. It has on several occasions accused Syria of CWC infractions. Damascus sees the IIT as a “propaganda tool” used by countries seeking to topple its government, and says its reports cannot be considered scientific, as a Syrian representative said at the conference prior to the vote.
The concern is shared by some other countries, including Russia and China. The Chinese representative reminded on Wednesday that the IIT has remarkably less rigorous standards for collecting evidence than the OPCW-UN Joint Investigative Mechanism (JIM) did. The JIM was tasked with investigating incidents of alleged use of chemical weapons in Syria before the ITT.
“The IIT, instead of conducting on-site investigations, gave credence to samples provided by the so-called ‘non-government organizations,’ heeded the opinions of the so-called ‘external experts’ and interviewed the so-called ‘witnesses in third countries’,” Ambassador Jian Tan said, stressing that the work of the IIT went beyond the mandate under the CWC and couldn’t guarantee impartiality of the results.
Skepticism about the IIT and the OPCW in general has been growing among member states since 2019, when the organization was accused of covering up evidence discovered by its own inspectors after an incident in the Damascus suburb of Douma, which happened in April 2018. The US, the UK and France swiftly responded to the highly-publicized incident with retaliatory missile attacks against Syria.
The watchdog’s final report in 2019 all but accused Damascus of dropping chlorine gas canisters on the area as part of its effort to capture it from jihadist forces. But several whistleblowers came up after the report’s release with documents and testimonies indicating a different scenario.
They said the evidence collected by a JIM mission on the ground pointed to possible staging of the scene to blame the Syrian army. The OPCW allegedly suppressed the contradictory evidence and brought in external experts, who helped it arrive at the conclusions favorable to the three countries, which launched the strikes at Syria.
The OPCW leadership responded to the allegations by painting the whistleblowers as rogue elements disgruntled at the organization and ignoring calls for a rigorous scientific examination of how the final report on Douma was penned. Western governments and media treat their testimonies as a conspiracy theory peddled by Russia.
However this attempt to brush aside the dissenting voices seems to be hurting OPCW’s credibility. Earlier this month, members of the UN Security Council held an informal meeting to discuss the issue, and during the events India for the first time openly criticized the watchdog’s recent Syria reporting issued under the IIT mechanism.
As an OPCW state party, India expects the organization to conduct “impartial, credible and objective investigation into any use of chemical weapons,” in line with the convention principles, Indian envoy K. Nagaraj Naidu said. “The current report falls short of these expectations”.
The report in question details three alleged chemical weapons attacks in the town of Ltamenah in March 2017, which the IIT attributed to the Syrian Air Force. It updates an earlier version explaining OPCW’s findings, which was released last year and which New Delhi didn’t publicly comment on.
India was among the countries that voted against the creation of the IIT, citing its concerns over ‘mandate creep’. It abstained in July 2020, when the OPCW Executive Council voted to condemn Syria for IIT-reported use of chemical weapons.
Syria joined the OPCW in 2013 and declared massive stockpiles of chemical weapons, which were subsequently destroyed. The move was taken after Washington said it was considering military action against Syria after an alleged chemical weapons attack. The OPCW received the 2013 Nobel Peace Prize for bringing Syria into the CWC fold.
Use of J&J’s Hazardous Covid Vaccine Suspended in US
By Stephen Lendman | April 14, 2021
In response to potentially life threatening blood clots showing up in individuals jabbed with J & J’s experimental, hazardous covid vaccine, the CDC, FDA, and HHS recommended suspension of its use, a joint statement saying the following:
“As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the US.”
The “CDC and FDA are reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine.”
“In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).”
“All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.”
Reported numbers of blood clots and other serious adverse events may be the tip of the iceberg.
Mass-jabbing for covid since last December with experimental, rushed to market drugs pose serious — potentially irreversible — harm to millions of unwitting people.
Suspending use of AstraZeneca’s covid vaccine earlier in Europe and J & J’s in the US isn’t good enough.
Use of these hazardous drugs should be permanently halted.
The same goes for Pfizer/Moderna’s mRNA covid drugs.
Growing numbers of individuals have already been harmed. Countless thousands died.
As long as these drugs continue to be used, adverse events and death will keep increasing exponentially.
Knowing the hazards these drugs pose, the FDA and European Medicines Agency (EMS) OK’d their use under “emergency” conditions that don’t exist.
On Wednesday, the CDC will convene an Advisory Committee on Immunization Practices meeting to further review serious blood clots from use of J & J’s covid vaccine.
It advised individuals experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after being jabbed with the vaccine to seek medical care.
After the European Medicines Agency suspended use of AstraZeneca’s covid vaccine because of blood clots earlier, the agency once again OK’d its use —falsely claiming benefits outweigh the risks.
Since use of J & J’s covid drug began in late February, various sites in four US states halted use because of severe reactions.
An earlier article discussed what the Corporate Research Project called J & J’s disturbing “rap sheet.”
In August 2019, Cleveland County, Oklahoma District Court Judge Thad Balkman ruled for the state against Johnson & Johnson, saying:
J&J “caused an opioid crisis that is evidenced by increased rates of addiction, overdose deaths and neonatal abstinence syndrome, in Oklahoma,” adding:
“(M)isleading marketing and promotion (of the company’s opioids) compromised the health and safety of thousands of Oklahomans.”
“We have proven that Johnson & Johnson have built its billion dollar brand out of greed and on the backs of pain and suffering of innocent people” — despite warnings from its scientific advisors.
Oklahoma’s Attorney General Mike Hunter called J & J an “opioid kingpin.”
Lead state attorney Brad Beckworth said “(w)e’ve shown that J & J was at the root cause of this opioid crisis,” adding:
“It made billions of dollars from it over a 20-year period (yet) always denied responsibility” for selling hazardous to health drugs to unwitting consumers.
Court rulings against the firm forced it to pay billions of dollars in damages.
Former Attorney General Eric Holder earlier accused the company of “recklessly put(ting) at risk the health of some of the most vulnerable members of our society — including young children, the elderly and the disabled.”
Its hazardous covid vaccine is produced by its Janssen division.
Earlier, it produced the anthrax vaccine administered to around 150,000 US forces deployed to the Persian Gulf for the 1990-91 Gulf War — even though concerns were raised about adverse longterm health consequences.
Experimental anthrax vaccines contained squalene-based adjuvants that caused severe autoimmune diseases and deaths among Gulf War veterans years later.
Illnesses included rheumatoid arthritis, multiple sclerosis, neuritis risking later paralysis, uveitis risking blindness, neurological harm, congenital disabilities in offspring, cognitive impairment, and systemic lupus erythematosus, among other health issues.
From 1990 to 2001, over two million doses of anthrax vaccine were administered to US military personnel.
Squalene adjuvants are a key ingredient in many vaccines.
J & J uses them in its covid vaccine.
There’s nothing remotely safe and effective about mass-jabbing with hazardous, experimental Pfizer/Moderna’s DNA altering mRNA technology or J & J/AstraZeneca’s covid vaccines.
Using them as directed risks serious near-or-longer-term harm to health and no protection from seasonal flu-now called covid.
Danish drug regulator FAINTS at press conference announcing AstraZeneca vaccine halt
RT | April 14, 2021
Denmark will completely abandon the rollout of AstraZeneca’s Covid-19 vaccine due to a risk of rare blood clots. One of the country’s top drug officials passed out at a press conference delivering the news.
As National Health Board Director Soeren Brostroem announced the decision, the Danish Medicines Agency’s acting director of pharmacovigilance, Tanja Erichsen, fainted and collapsed to the ground.
Erichsen’s fall sparked panic, as Brostroem and other officials rushed over to check on her. The medicines agency later announced that she had regained consciousness, but was taken to hospital for a checkup. No explanation was given for her fainting.
Denmark was the first country in the world to suspend the rollout of AstraZeneca’s Vaxzevria shot in March, though a number of other countries followed suit, among them France, Germany, Italy and Spain. Denmark, however, is the first country in the world to permanently ditch the British-Swedish developed jab.
“In the midst of an epidemic, it has been a difficult decision to continue our vaccination program without an effective and readily available vaccine against Covid-19,” Brostroem said at the press conference. “However, we have other vaccines at our disposal, and the epidemic is currently under control.”
The suspension is expected to push the country’s vaccination timeline back by “some weeks,” according to a report from Danish broadcaster TV2.
Denmark began vaccinations in December, and has to date approved four vaccines – from AstraZeneca, Johnson & Johnson, Moderna and Pfizer/BioNTech. Only two shots, from Moderna and Pfizer, are currently available to Danes, after Johnson & Johnson delayed its own European rollout on Tuesday, due to several cases of blood clots being reported in the US.
FDA Says Stop the Johnson & Johnson Coronavirus Vaccine Shots
By Adam Dick | Ron Paul Institute | April 13, 2021
On Tuesday, the United States government’s Food and Drug Administration asked states to temporarily halt the giving of Johnson & Johnson’s experimental coronavirus vaccine shots, pointing to the developing of blood clots in people who have received the shots as the justification for halting.
For more information about the blood clots and other issues related to the Johnson & Johnson experimental vaccine, check out the Tuesday article “5 Reasons Johnson & Johnson Is Having A Very Bad Month” by Megan Redshaw at the Children’s Health Defense website.
One thing that is odd is that the Johnson & Johnson experimental vaccine shots have been subjected to this temporary halt, but shots of the experimental vaccines of Moderna and Pfizer-BioNTech have not. Many reports of injury and death after Moderna and Pfizer-BioNTech experimental vaccine shots, from the early days onward, have come in as well. Could the different regulatory outcomes be because the Moderna and Pfizer-BioNTech shots use mRNA technology and are not even vaccines under the normal meaning of the term while the Johnson & Johnson shot is more in line with the traditional vaccines approach? Are we seeing regulatory favoritism for the new mRNA shots?
Copyright © 2021 by RonPaul Institute
Argentine Government to Launch Legal Action Against Ex-President Over IMF Loan
Sputnik – 10.04.2021
Argentina’s President Alberto Fernandez issued a decree instructing the country’s special legal body to act as a plaintiff on behalf of the state in a case against his predecessor Mauricio Macri, stemmed from his decision to take a loan from the International Monetary Fund (IMF) in the amount of $50 billion.
“Prosecutors representing the state as the claimant are ordered to pursue the case, ‘Mauricio Macri and others, fraud against state bodies’ … and to facilitate the advancement of the criminal process in order to determine those responsible for the crime,” the decree says.
The document further states that the case is related to Marci’s decision to take a loan from the IMF in the amount of $50 billion in 2018. The current government has repeatedly spoken about the difficulties surrounding paying off the debt and began negotiations with the IMF on a new assistance program.
In addition, lawyers were instructed to initiate actions leading to compensation for possible losses incurred as a result of the actions of the previous authorities.
The decree was signed by the country’s current president, prime minister, and ministers of economy and justice.
Iran will in no way enter negotiations beyond JCPOA: Security chief
Press TV – April 6, 2021
Secretary of Iran’s Supreme National Security Council (SNSC) Ali Shamkhani says the Islamic Republic will under no circumstances enter negotiations beyond the nuclear agreement it clinched with six major world states in 2015.
“Regardless of whether Europe has the will or ability to persuade #USA to lift all sanctions at once & Washington’s return to its commitments, there will be no possibility for Iran entering the talks in the new fields, more than JCPOA, under any circumstances,” he said.
The security chief posted the tweet with the hashtag #activeresistance in his tweet.
Shamkhani’s tweet followed remarks by the US administration’s special envoy for Iran, Rob Malley, who is based in a hotel near the venue of talks in the Austrian capital of Vienna between representatives of Iran and the remaining signatories to the JCPOA.
In an interview with the American National Public Radio, Malley was asked about a “follow-up” agreement in case the JCPOA gets back on track.
“What we would pursue is, first of all, a longer agreement. Even though this one lasts quite some time and some of its provisions last forever, of course, it would be better, as in any arms control agreement, to see whether we could get a follow-on deal that extends the timelines,” he replied.
Earlier in the day, representatives of Iran and the P4+1 group of countries — Britain, France, Germany, Russia and China — began a new round of talks in Vienna over a possible return of the United States to the JCPOA, which abandoned by the US under former president Donald Trump some three years ago.
The Vienna negotiations took place within the “in-person” and expert-level formats.
Ahead of the talks, Iran’s Foreign Ministry reaffirmed in a statement that no representatives from the US are to attend the nuclear talks in Vienna, and that the Iranian delegation’s agenda does not feature any direct or indirect negotiations with Americans either.
Mexico President Says ‘Pass’ on Coronavirus Vaccine
By Adam Dick | Ron Paul Institute | April 6, 2021
Mexico President Andrés Manuel López Obrador has distinguished himself among top national political leaders across the world by not freaking out over coronavirus. Instead, López Obrador has gone his own way with actions including choosing to usually not wear a mask and criticizing other nations’ political leaders for “acting like dictators” in their imposing of coronavirus-related mandates.
Now comes news of López Obrador again going directly against the worldwide coronavirus political tide. He decided not to take one of the experimental coronavirus vaccines.
Many government leaders across the world have, in contrast, made a big show of their publicly taking experimental coronavirus vaccine shots.
While United States President Joe Biden is out spreading blatantly fraudulent propaganda that experimental coronavirus vaccines are safe and everyone should take them, south of the border President López Obrador is pretty much saying “I’ll pass.”
As reported Monday by the Associated Press, López Obrador, who had refused to take a shot earlier because he did not want to become a “spectacle,” chose again not to take a shot when, based on his age and where he lives, his turn recently came up. Why? López Obrador explains that doctors advised him he already has sufficient antibodies due to having been infected with coronavirus in January.
Instead of allowing himself to be corralled like livestock into a mass vaccination pen, López Obrador did what people have long done as a matter of course, he obtained medical advice focused on his own unique circumstances and then made up his own mind about his healthcare. His conclusion: Taking shots is not the right course of action for him.
How normal. How not “new normal.” What a breath of fresh air.
Copyright © 2021 by RonPaul Institute
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