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Thursday, September 28, 2023

NIH Doctor Flagged Wuhan Virus Lab Safety Problems As Early As 2017

 by Tom Ozimek via The Epoch Times,

A doctor working for the U.S. government in 2017 visited the China-based virus research facility that may have leaked the pathogen that causes COVID-19, and sounded the alarm on safety issues at the lab earlier than previously reported, according to documents obtained by The Epoch Times.

Dr. Ping Chen, who worked for the National Institute of Allergy and Infectious Diseases (NIAID), visited the Wuhan Institute of Virology (WIV) in October 2017 and prepared a report for her superiors after her visit.

While a version of her report obtained by a Freedom of Information Act (FOIA) request was fully redacted, Sen. Ron Johnson (R-Wis.) and his team were granted an opportunity to carry out an in-camera review of the report that had some of the redactions removed.

“It is clear to me by talking to the technician that certainly there is a need for training support” at the Wuhan lab, Dr. Chen wrote in the report, parts of which were attached to a letter sent by Mr. Johnson to Department of Health and Human Services (HHS) Secretary Xavier Becerra on Sept. 21.

The letter, which was obtained by The Epoch Times, includes fragments of Dr. Chen's report and suggests that HHS and the U.S. National Institutes of Health (NIH) were aware of safety issues at the Wuhan facility as early as October 2017.

Earlier reporting based on two State Department cables and correspondence records obtained by Judicial Watch indicate that NIH was made aware of safety problems at the Wuhan lab in 2018, the year after Dr. Chen's report.

“I think the institute would welcome any help and technical support by NIAID,” Dr. Chen wrote in her 2017 report.

Mr. Johnson wrote in his letter to Mr. Becerra that Dr. Chen's 2017 report partially served as the basis for a Jan. 19, 2018, State Department cable that raised safety concerns about the Wuhan virus lab.

Evidence suggests that SARS-CoV-2, the virus that causes COVID-19, leaked from the Wuhan facility before spreading across the world. According to the so-called lab leak theory, the deadly pathogen that caused the pandemic escaped the Chinese facility, which was conducting risky gain-of-function research on bat coronaviruses that was partially funded by U.S. taxpayer dollars.

Demands

Mr. Johnson demanded that HHS provide a version of Dr. Chen's 2017 report that contains fewer redactions in order to scrutinize its contents more closely and determine how closely it aligned with the cable.

“In the public FOIA document, HHS redacted Dr. Chen’s entire report claiming that it contains privacy and deliberative information,” Mr. Johnson wrote.

“It seems apparent that the only reason that HHS redacted this information was to hide the report’s contents from the American people. Perhaps HHS did not want the public to fully understand the fact that NIH and NIAID officials were aware of safety concerns at the WIV dating as far back as 2017,” he added.

Mr. Johnson also accused NIH and HHS of obstructing his probe.

"HHS and NIH continue to obstruct my oversight efforts," he wrote. "It is unacceptable that HHS and NIH had Dr. Chen's report in its possession and only provided a slightly less redacted version for my staff to review in camera."

He demanded that HHS provide unredacted copies of Dr. Chen's report and all documents and communications relating to the report and to the Wuhan lab.

Mr. Johnson also asked for Dr. Chen to sit before a congressional panel and testify.

He set an Oct. 5 deadline for HHS to comply with his request.

HHS officials didn't immediately respond to a request by The Epoch Times for comment.

Chinese virologist Shi Zhengli is seen inside the P4 laboratory in Wuhan, China, on Feb. 23, 2017. (Johannes Eisele/AFP via Getty Images)

'Preponderance of Evidence' for Lab Leak

In August 2021, a report by Republican lawmakers noted a "preponderance of evidence" that the virus that caused the COVID-19 pandemic leaked from the Wuhan lab.

Chinese officials have denied the lab leak claim, insisting that the virus made a natural jump from animals to humans.

Rep. Michael McCaul (R-Texas) said in testimony before the Coronavirus Select Subcommittee Republicans that evidence points to a lab leak as the likely origin of the virus, saying that "it's time to completely dismiss the wet market as the source of the outbreak" and "the preponderance of the evidence that it came from the lab is very convincing."

U.S. intelligence agencies later said in a report that a natural origin and a lab leak are both plausible hypotheses but that a lack of evidence makes a definitive conclusion either way impossible.

It's a sentiment echoed by Mr. McCaul in his testimony.

"Unfortunately, we may never know for certain because the Chinese Communist Party went to great lengths to cover up this outbreak," he said. "They detained the doctors in order to silence them. They disappeared journalists. They destroyed lab samples. They hid the fact there was clear evidence of human-to-human transmission. And they have refused to allow a real investigation into the origins."

Wuhan Lab Funding Controversy

The U.S. Agency for International Development awarded a total of $1.1 million to the WIV between October 2009 and May 2019, the agency wrote in a May 2021 letter (pdf) to Rep. Guy Reschenthaler (R-Pa.).

Mr. Reschenthaler alleged that the funding was used for a study that used gain-of-function research to create "a hybrid, man-made virus by inserting a spiked protein from a wild coronavirus into a mouse-adapted SARS-CoV backbone, which could infect human airways."

The agency said the funds were channeled through EcoHealth Alliance and were meant for the purpose of advancing research on critical viruses that could pose a threat to humans. It also denied claims that the money was used for gain-of-function research, which seeks to boost viral lethality for the purpose of studying it.

In June 2022, the House Appropriations Committee approved a ban on sending any further funding to the Wuhan Institute of Virology.

More recently, the NIH quietly removed the WIV from a list of foreign facilities that are eligible to receive U.S. taxpayer funds to conduct animal experiments.

https://www.zerohedge.com/covid-19/nih-doctor-flagged-wuhan-virus-lab-safety-problems-early-2017

Philip Morris develops zero-tobacco heat stick that may avoid regulations

 Philip Morris International (PMI) on Thursday unveiled a zero-tobacco stick for use with its "heat-not-burn" device IQOS, which may help the company avoid tax and other regulations that affect its tobacco products in some markets.

IQOS heats up small packets of ground up tobacco resembling cigarettes but does not burn them, a process the company says potentially results in fewer health risks compared to smoking.

Now, PMI has developed a range of sticks, which it calls LEVIA, that do not contain tobacco but a "non-tobacco substrate" infused with nicotine, with flavours including tobacco, menthol with blueberry and peppermint.

Chief Executive Officer Jacek Olczak said during an investor day presentation that as well as offering another alternative to consumers who may not wish to use tobacco, the product may avoid the heavy taxes or other controls imposed on its other products.

LEVIA "may not be subject to flavour regulations in some jurisdictions" and "doesn't fit" in existing fiscal categories, Olczak continued, adding PMI was in discussions with regulators in some target markets on how they would approach it.

The company advocates for lower taxes for products referred to by the industry as "reduced risk" compared to traditional cigarettes.

The U.S. Food and Drug Administration has authorised PMI to market IQOS as offering reduced exposure to harmful chemicals versus smoking, though the World Health Organisation says there is currently no evidence that heated tobacco has lower health risks than other tobacco products.

A PMI spokesman declined to provide additional details on when and where LEVIA could launch, or what substance replaces the tobacco.

Some niche companies have developed heat sticks made from tea leaves instead of tobacco, which they sell for use with major players' "heat-not-burn" technology - a headache for big companies that want only their own sticks to be compatible with their devices

https://finance.yahoo.com/news/philip-morris-develops-zero-tobacco-160342496.html

Detroit casino workers to vote on authorizing strikes this Friday

 Workers who staff the majority of operations at the three casinos in Detroit will vote on Friday to authorize potential strikes, the United Auto Workers (UAW) union said.

The union, in a release on Thursday, said workers staffing operations such as slots and table games, as well as restaurants at MGM Grand Detroit, MotorCity Casino and Hollywood at Greektown, will cast ballots on whether to authorize strikes as they negotiate for a new contract.

The announcement comes as labor unions are taking advantage of low unemployment to push for higher pay and better working conditions in their talks for new labor agreements.

About 18,300 UAW members working at the Detroit Three automakers are already on strike, which has led to the shutdown of one assembly plant at each of the three carmakers and 38 parts distribution centers at General Motors and Chrysler parent Stellantis.

Should casino workers authorize a strike in Friday's vote, the Detroit Casino Council, the negotiating committee for workers, could call for strikes as soon as mid-October when contracts expire, according to the union.

https://finance.yahoo.com/news/detroit-casino-workers-vote-authorizing-212730471.html

UAW makes new counter proposal to Chrysler-parent Stellantis -union

 The United Auto Workers made a new counter-proposal to Chrysler-parent Stellantis on Thursday, just one day before the union is set to strike additional Detroit Three automotive facilities without serious progress in ongoing labor negotiations.

A union official confirmed the new proposal as talks remain active with Stellantis, General Motors and Ford Motor in the strike's fourteenth day.

UAW President Shawn Fain plans to disclose the union's next steps Friday at 10 a.m. ET (1400 GMT) in an online address.

https://finance.yahoo.com/news/uaw-makes-counter-proposal-chrysler-185152718.html

'Biden warns Trump's MAGA 'extremist movement' is a threat to democracy'

 President Joe Biden launched a blistering personal attack on "extremist" Donald Trump Thursday, accusing his likely 2024 challenger of plotting to subvert the US constitution if he wins a return to power next year.

The Democrat said in a speech in the battleground state of Arizona that Republican frontrunner Trump was driven by "vengeance and vindictiveness", and he urged Americans to stand up for democracy before it was too late.

The speech came as House Republicans launched impeachment inquiry hearings into the 80-year-old president, based on unproven allegations that he lied about his son Hunter’s business dealings.

"We should all remember: democracies don't have to die at the end of a rifle," Biden said. "They can die when people are silent, when they fail to stand up, or condemn threats to democracy."

In this speech Biden finally took off the gloves after months in which he has largely steered clear of any direct comment on the multiple criminal indictments against his hard-right populist predecessor.

Biden has sought to avoid any appearance of interference in the cases stemming from Trump's efforts to overturn his 2020 election loss -- culminating in the attack by a mob of his supporters on the US Capitol on January 6, 2021.

But in Arizona Biden took the unusual step of addressing Trump by name, accusing him and his followers of attacking the free press and the rule of law and planning to gut US institutions if he wins a second term.

- ' Vengeance' -

"Trump says the constitution gave him 'the right to do what he wants'," said Biden, referring to statements by Trump about how he saw his powers in office.

"I've never even heard a president say that in jest -- not guided by the constitution or by common service and decency towards our fellow Americans, but by vengeance and vindictiveness."

In a dark warning, Biden said there was "something dangerous happening in America" and that the Republican Party was "driven and intimidated" by Trump's MAGA (Make America Great Again) fringe.

He criticized Republicans for failing to speak up after Trump recently accused America's top military officer of treason, and lashed out at hardline Trump allies for pushing the United States towards a government shutdown this weekend.

The president sounded a still more personal note when he recalled how Trump had reportedly referred to service members captured or killed in action as "suckers and losers".

A fired-up Biden asked if that referred to John McCain, the late Arizona senator and Vietnam war hero whose legacy the speech honored -- or Biden's own son Beau, who served in Iraq and died of brain cancer in 2015 aged 46.

"Was he (Beau) a sucker for volunteering to serve his country?" asked Biden.

- 'Never easy' -

Biden also touted his bipartisan credentials by hailing the legacy of his frequent political opponent and close friend McCain, who was an outspoken critic of Trump.

The feeling was mutual, with Trump mocking McCain's his war hero status in 2015, criticizing the fact that he had been taken prisoner.

Biden described McCain, who died in 2018, also of brain cancer, as a "proud Republican who put country first."

The president was interrupted at one point by a climate change heckler, before quipping to the audience: "Democracy is never easy -- as was just demonstrated."

The bitter political divide that Biden lamented in his speech was underscored by the Republican impeachment inquiry hearings that began in Washington shortly before he spoke.

Republicans have accused Biden of trading on the power of his office when he was vice president under Barack Obama to help his younger son Hunter secure lucrative foreign business deals, and of benefiting personally from alleged corruption.

Democrats have dismissed the hearings as a stunt but they will add to the pressure on Biden as he battles poor approval ratings and polls showing him neck-and-neck with Trump.

The current and former presidents were in campaign mode this week despite the election being more than a year away, with both men making visits to the swing state of Michigan to speak to auto workers.

https://news.yahoo.com/biden-democracy-speech-fueling-2024-090813758.html

Wegovy, other weight-loss drugs scrutinized over reports of suicidal thoughts

Dawn Heidlebaugh felt trapped in a disturbing pattern while taking Ozempic, the popular drug used to treat diabetes and obesity.

Each Sunday for more than a year, the 53-year-old Ohio real estate agent took her weekly injection to help control her blood sugar. Then every Tuesday, she felt lethargic, depressed and sometimes suicidal, thinking her husband and four children might be better off without her. These feelings would last a few days, and the cycle repeated every week — except when she skipped a dose.

“I knew it was the drug,” said Heidlebaugh, who said she had not previously suffered from depression.

Heidlebaugh is one of four U.S. patients who told Reuters about experiencing suicidal thoughts while taking Novo Nordisk’s popular Ozempic drug, approved to treat type 2 diabetes, or Wegovy, another Novo top-seller approved for weight loss. A fifth patient said he experienced depression and suicidal thoughts after taking Mounjaro, a similar diabetes medicine from Eli Lilly, which is also used for weight loss. All three drugs are GLP-1 receptor agonists, which slow digestion and reduce hunger.

The U.S. Food and Drug Administration has received 265 reports of suicidal thoughts or behavior in patients taking these or similar medicines since 2010, Reuters found in an examination of the agency's adverse-event database. Thirty-six of these reports describe a death by suicide or suspected suicide. The FDA monitors such reports to help decide whether to further investigate a drug’s safety and take action to protect patients, such as mandating a warning label.

Accounts of suicidal thoughts linked to this class of drugs are drawing increasing scrutiny, including an investigation by European regulators announced in July. In a statement to Reuters, the FDA said it is evaluating such reports and will decide on what action, if any, to take after a thorough review.

Many beneficial drugs have rare and sometimes dangerous side effects that have to be carefully assessed by regulators and managed by physicians, making clear warnings essential in such cases, said Thomas J. Moore, faculty associate at the Johns Hopkins Bloomberg School of Public Health, who has studied the incidence of rare psychiatric side effects.

https://finance.yahoo.com/news/insight-wegovy-other-weight-loss-100000581.html

Amicus Drug Scores FDA Approval For Rare Inherited Pompe Disease

 The FDA has approved Amicus Therapeutics' FOLD Pombiliti (cipaglucosidase alfa-atga)+Opfolda (miglustat) 65mg capsules for Pompe disease.

It's a disease in which the body can't make a protein that breaks down a complex sugar called glycogen for energy. Too much sugar builds up and damages muscles and organs.

This two-component therapy is indicated for adults living with late-onset Pompe disease (LOPD) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).

Pombiliti is a recombinant human GAA enzyme (rhGAA) naturally expressed with high levels of bis-M6P (Mannose 6-Phosphate), designed for increased uptake into muscle cells. Once in the cell, Pombiliti can be properly processed into its most active and mature form to break down glycogen. 

Opfolda is an enzyme stabilizer designed to stabilize the enzyme in the blood.

The FDA approval was based on clinical data observed from the Phase 3 pivotal study (PROPEL), the only trial in LOPD to study ERT-experienced participants in a controlled setting.

https://www.benzinga.com/general/biotech/23/09/34979628/amicus-therapeutics-drug-scores-fda-approval-for-rare-inherited-pompe-disease