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To: Brumar89 who wrote (1389141)	1/29/2023 2:41:30 PM
From: Broken_Clock	Respond to of 1571802

It clearly shows how BigPharma is more concerned about profits than people.

To: Brumar89 who wrote (1389141)	1/29/2023 2:42:28 PM
From: Broken_Clock	Read Replies (1) \| Respond to of 1571802

NIH Failed To Monitor EcoHealth Alliance: Federal Watchdog by Tyler Durden Sunday, Jan 29, 2023 - 02:35 AM After an 18-month audit, a federal watchdog says that the National Institutes of Health (NIH) failed to adequately monitor and address problems involving EcoHealth Alliance, a New York City-based nonprofit that was used to offshore risky gain-of-function research to Wuhan, China after the Obama administration banned the practice in 2014. According to the report from the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS), the "NIH did not effectively monitor or take timely action to address" compliance issues with EcoHealth. In April 2020, after then-President Donald Trump claimed the SARS-CoV-2 virus could have come from the WIV lab, NIH terminated the EcoHealth grant with little explanation. That step was widely condemned by scientists, and OIG’s report now says NIH improperly executed the termination because it did not provide a valid reason or provide EcoHealth with required information for appealing the decision. A few months later, NIH reinstated the award but immediately suspended it, setting conditions for resumption that EcoHealth said it could not meet. NIH permanently terminated the WIV subaward as of August 2022 for compliance issues, including WIV’s failure to provide NIH with laboratory notebooks related to the funded experiments. - Science The audit examined the above grant, as well as two others from 2014 to 2021 which totaled $8 million, but largely focused on $600,000 of it which went to the Wuhan Institute of Virology. The NIH faulted EcoHealth for failing to promptly report gain-of-function results in some experiments, however the company has blamed a computer glitch at NIH for the 2-year delay. Digging into the report is US Right to Know's Emily Kopp, who has broken down various aspects of the OIG report. EcoHealth would like you to believe it had technical issues for four years straight HHS OIG: ?? pic.twitter.com/H0gZjzCWh7 — Emily Kopp (@emilyakopp) January 26, 2023 The 2018 report lists scientific publications including 2019 and 2020 papers The 2019 report lists zero papers pic.twitter.com/CzwHlbqAVu — Emily Kopp (@emilyakopp) January 26, 2023 How does EcoHealth get away with this? Oversight from Fauci’s NIAID was non-existent. NIAID awarded new funds to EcoHealth in 2020 before they received either of these overdue progress reports. The only reason EcoHealth filed the 1st report was because @fastlerner FOIA’d it. pic.twitter.com/Er2fQTLkCV — Emily Kopp (@emilyakopp) January 26, 2023 The line we often hear from NIH is that EcoHealth’s reported gain-of-function research could not have sparked the pandemic. But given (1) the sloppiness of the reports (2) the lateness of their submission to NIH, I do not believe we have a complete picture of EcoHealth’s work. — Emily Kopp (@emilyakopp) January 26, 2023Meanwhile, the audit also found that the nonprofit billed NIH for $89,171 in disallowed costs, including expenses such as alcohol, and a staffer's $3,285 trip to a conference that was miscoded, and should have instead been billed to a non-NIH grant. The OIG recommends that the WIV (but not EcoHealth) be banned from receiving future NIH funds. Meanwhile, EcoHealth just scored a fresh $3 million grant from the Department of Defense. EcoHealth Alliance currently has federal contracts and grants from USAID, DoD-DTRA, DoD-USU, DHS, NIAID, and NSF. — Richard H. Ebright (@R_H_Ebright) January 21, 2023

To: Brumar89 who wrote (1389141)	1/29/2023 2:44:58 PM
From: Broken_Clock	Read Replies (1) \| Respond to of 1571802

“For example, myocarditis, it’s an extremely strong signal that you can see without doing statistics.” === Authored by Zachary Stieber via The Epoch Times (emphasis ours), The U.S. Food and Drug Administration (FDA) has changed the end date for a key study on post-vaccination heart inflammation without notifying the public. A sign for the U.S. Food and Drug Administration outside of the headquarters in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images) Pfizer was supposed to complete a study on the occurrence of subclinical myocarditis, or heart inflammation, after receipt of its COVID-19 vaccine. The completion date was listed by the FDA in 2021 as June 20, 2022. Pfizer was also supposed to submit the results of the study to the FDA by the end of 2022 as part of a list of requirements the FDA imposed as a condition of approving Pfizer’s jab. But after the deadline passed, the FDA quietly changed the date. Under a list of postmarketing requirements for the Pfizer-BioNTech vaccine, the FDA now says the same study has an “original projected completion date” of June 30, 2023. The current status of the study is listed as “pending.” The FDA and Pfizer did not respond to requests for comment. Jessica Adams, a former regulatory review officer at the FDA, said the wording amounts to misinformation. “By definition, ‘original’ dates can’t change,” she wrote on Twitter, tagging the agency. “Please correct this ‘misinformation.'” Dr. Vinay Prasad, who has increasingly criticized the FDA over its decisions during the pandemic, said the new timeline “is so slow it will be entirely moot.” “Another FDA failure,” he said on Twitter. StudyThe study is one of nine Pfizer was to complete to examine post-vaccination adverse events. The study is designed to “prospectively assess the incidence of subclinical myocarditis” after receipt of a third dose, or a booster, in people aged 16 to 30. Pfizer submitted a timetable to the FDA stating the company would submit a final protocol by Nov. 30, 2021, and complete the study by June 30, 2022, according to the FDA’s approval letter for the company’s vaccine. The final report was due to the FDA by the end of 2022. The study was one of several examining myocarditis and pericarditis, a related condition. Both are caused by the Pfizer and Moderna vaccines, according to U.S. officials and other experts. Some of the vaccine-caused myocarditis cases have led to death. FDA officials expressed concern about the post-vaccination heart inflammation when considering whether to approve Pfizer’s vaccine. Signal for Myocarditis After New BoosterThe bivalent Pfizer vaccine triggered a safety signal for adults aged 18 to 35, Richard Forshee, an FDA official, told the agency’s vaccine advisory committee on Jan. 26. Regulators cleared that bivalent and one from Moderna in the fall of 2022 despite there being no clinical data for either shot. The adverse event happened at a concerning rate after a Pfizer bivalent in recent months, according to analyses of data from the FDA’s Biologics Effectiveness and Safety initiative, which pulls from systems such as one managed by CVS Health. “The only signal we have detected so far is for myocarditis/pericarditis following the Pfizer bivalent vaccine among adults 18 to 35 years old,” Forshee told the panel. Safety signals indicate a vaccine may cause events but don’t establish causality. But officials have stressed that the bivalents are similar to the original vaccines in defending the authorization without clinical data, and have acknowledged a causal link between the original messenger RNA vaccines and the heart inflammation. Most of the meeting presentations that went over adverse events focused on ischemic stroke, which triggered the threshold for a safety signal following Pfizer’s bivalent booster in the elderly and following receipt the original Pfizer and Moderna vaccines in all adults. Officials said that the stroke has happened in many people who received a flu vaccine on the same day as a COVID-19 vaccine. They’re studying whether there’s a connection, though they noted there was no signal for the stroke after a flu shot alone. Dr. Nicola Klein, a Kaiser Permanente researcher who helps the CDC monitor vaccine safety, said that the signal for stroke wasn’t as strong as that for myocarditis. “This is a cluster but … it doesn’t stand out as extremely striking, unlike some other signals which we have seen,” Klein said. “For example, myocarditis, it’s an extremely strong signal that you can see without doing statistics.” Panel Notified of CDC AnalysesDuring the public comment portion of the meeting, any panel members watching were notified that the CDC’s analyses of reports to a different surveillance system concluded hundreds of adverse events met the safety signal threshold, including approximately 500 with a signal larger than that for myocarditis. Read more here...