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Rand Paul Demands Answers After NIH Admits Redacting COVID-19 Origins Emails ‘To Prevent Misinformation’

Rand Paul Demands Answers After NIH Admits Redacting COVID-19 Origins Emails ‘To Prevent Misinformation’

Senator Rand Paul (R-KY) is demanding…

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Rand Paul Demands Answers After NIH Admits Redacting COVID-19 Origins Emails 'To Prevent Misinformation'

Senator Rand Paul (R-KY) is demanding answers from the National Institutes of Health (NIH), after he says the agency "has repeatedly disregarded its responsibilities under FOIA (Freedom of Information Act) and the American people's right to agency records," according to a Wednesday letter from Paul to NIH Acting Director Lawrence A. Tabak.

"For almost two years, public interest groups and media organizations have been forced to engage in protracted litigation to obtain documents related to NIH's involvement in COVID-19," adding "The records NIH has produced have been heavily redacted."

"This suggests NIH is censoring the information it releases to the public about the origins of the pandemic."

Paul cites an article by journalist and former Chuck Grassley investigator Paul D. Thacker, which notes an egregious admission by the NIH in Court that the agency "is withholding portions of emails between employees because they "could be used out of context and serve to amplify the already prevalent misinformation regarding the origins of the coronavirus pandemic.""

In an 18-page declaration to the court, NIH FOIA Officer Gorka Garcia-Malene detailed how the NIH redacts documents in compliance with the law. In the case of Exempt 6 privacy concerns, Garcia-Malene declared:

Exemption 6 mandates the withholding of information that if disclosed “would constitute a clearly unwarranted invasion of personal privacy.” 5 U.S.C. § 552(b)(6). Exemption 6 was applied here due to the heightened public scrutiny with anything remotely related to COVID-19.

Mr. Garcia-Malene also claimed that information had be redacted “because of the amount of misinformation surrounding the pandemic and its origins.” Seriously, the NIH is now arguing in court that because there is so much misinformation about how the pandemic began, they can’t release facts that might clear up misinformation about how the pandemic began.

The NIH was responding to a case brought by US nonprofit Right to Know, after the NIH deleted coronavirus sequences that Chinese researchers added to the NIH's Sequence Read Archive. As Thacker notes, "These datasets involved key studies that virologists were using at the time to promote the now discredited theory that the COVID-19 virus may have passed from pangolins to humans."

In the case at hand, the NIH attempted (and succeeded) at sealing the name of a Chinese researcher which had already been made public.

More via Disinformation Chronicle:

Last week, the NIH filed a motion in a Virginia court to seal portions of documents that reference the Chinese researcher and an NIH official in a lawsuit filed against the agency for redacting and covering up records that might explain how the pandemic began.

“[T]he individuals have a substantial privacy interest in avoiding harassment or media scrutiny that would likely follow disclosure,” wrote a lawyer for the NIH to the judge. “Sealing is therefore necessary to protect this information from any further public dissemination.”

But what is actually being protected? The American public’s right to access public information that may reveal what kicked off the pandemic, or the purported privacy rights of a scientist who lives thousands of miles away in China? This legal ploy further highlights the NIH’s aggressive, haphazard approach to redacting documents and hiding information that might explain how the pandemic started.

Last summer Buzzfeed released an investigation of the NIH’s Anthony Fauci and reported that the documents the agency released were "just a portion of what was requested, and they are filled with redactions, making them an incomplete record of the time period and Fauci's correspondence." Meanwhile, the Intercept reported in February that the NIH continues to withhold critical documents that could shed light on how the epidemic began, noting that the agency sent them 292 pages of fully redacted records.

Among these pages, the NIH fully redacted the 2020 COVID-19 research plan put together by Anthony Fauci.

A week after The Intercept story, The Chief Records Officer for the U.S. Government sent the NIH a letter asking them to investigate allegations that agency personnel are shredding documents related to grant-making decisions and funding for research in China.

Kangpeng Xiao’s name became public in December 2020, when the nonprofit U.S. Right to Know published a report on revisions to coronavirus sequences that Chinese researchers had added to the NIH’s Sequence Read Archive. These datasets involved key studies that virologists were using at the time to promote the now discredited theory that the COVID-19 virus may have passed from pangolins to humans.

“These revisions are odd because they occurred after publication, and without any rationale, explanation or validation,” wrote Sainath Suryanarayanan, in the December 2020 report for U.S. Right to Know. The nonprofit based their report on NIH documents they received from a FOIA request.

According to these documents, several Chinese scientists asked the NIH to alter coronavirus sequences stored on the NIH database, with many of these requests coming from Kangpeng Xiao with the South China Agricultural University. In one case, Xiao asked NIH official Rick Lapoint in March 2020 to delete some coronavirus sequences.

A few months later, Xiao published a prominent paper on May 7, 2020, in the journal Nature that argued a coronavirus discovered in pangolins was closely related to COVID-19. But as U.S. Right to Know discovered, Xiao’s request to delete coronavirus sequences from the NIH’s Sequence Read Archive (SRA) was just one of many changes.

Xiao et al. made numerous changes to their SRA data, including the deletion of two datasets on March 10, the addition of a new dataset on June 19, a November 8 replacement of data first released on October 30, and a further data change on November 13 — two days after Nature added an Editor’s “note of concern” about the study.

Eventually, Nature’s “note of concern” attached to Xiao’s 2020 study changed to a very lengthy correction in late 2021 that explained that data “were mislabelled and attributed incorrectly.” That correction also thanked Alina Chan of Harvard and the Broad Institute “for bringing the errors to our attention.” Chan later tweeted that Nature refused to publish her analysis of the viruses and merely folded her study into their correction.

NIH coronavirus database becomes national news

This U.S. Right to Know report was largely ignored, but last summer, coronavirus sequences at the NIH SRA became national news when Jesse Bloom, a virologist at the Fred Hutchinson Cancer Center, published a preprint on NIH sequences that Chinese researchers had deleted. As Bloom explained in an email to NIH leadership at the time, “[T]his can be a good opportunity for the NIH to take the lead by using its remarkable data archives to make progress in resolving some of the important questions about the virus’s origins.”

The NIH would not disclose to reporters the names of Chinese researchers who requested sequence deletions, but the New York Times later identified one of the scientists as Ben Hu at Wuhan University.

Empower Oversight referenced Kangpeng Xiao’s identity in federal court recently on July 11, when the nonprofit charged that the NIH was improperly redacting documents when responding to their FOIA requests. In one case, the NIH had provided Empower Oversight with an October 12, 2021, email from Jesse Bloom to the NIH discussing a scientist’s request to delete NIH SRA sequences. Citing Exemption 6, which covers privacy concerns, the NIH redacted both the names of the requestor and the NIH official that Bloom cited in his email

Read the rest from Thacker here...

Paul has demanded the NIH answer the following questions:

Tyler Durden Thu, 07/28/2022 - 19:30

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Spread & Containment

AI can help predict whether a patient will respond to specific tuberculosis treatments, paving way for personalized care

People have been battling tuberculosis for thousands of years, and drug-resistant strains are on the rise. Analyzing large datasets with AI can help humanity…

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Tuberculosis typically infects the lungs but can spread to the rest of the body. stockdevil/iStock via Getty Images Plus

Tuberculosis is the world’s deadliest bacterial infection. It afflicted over 10 million people and took 1.3 million lives in 2022. These numbers are predicted to increase dramatically because of the spread of multidrug-resistant TB.

Why does one TB patient recover from the infection while another succumbs? And why does one drug work in one patient but not another, even if they have the same disease?

People have been battling TB for millennia. For example, researchers have found Egyptian mummies from 2400 BCE that show signs of TB. While TB infections occur worldwide, the countries with the highest number of multidrug-resistant TB cases are Ukraine, Moldova, Belarus and Russia.

The COVID-19 pandemic set back progress in addressing many health conditions, including TB.

Researchers predict that the ongoing war in Ukraine will result in an increase in multidrug-resistant TB cases because of health care disruptions. Additionally, the COVID-19 pandemic reduced access to TB diagnosis and treatment, reversing decades of progress worldwide.

Rapidly and holistically analyzing available medical data can help optimize treatments for each patient and reduce drug resistance. In our recently published research, my team and I describe a new AI tool we developed that uses worldwide patient data to guide more personalized and effective treatment of TB.

Predicting success or failure

My team and I wanted to identify what variables can predict how a patient responds to TB treatment. So we analyzed more than 200 types of clinical test results, medical imaging and drug prescriptions from over 5,000 TB patients in 10 countries. We examined demographic information such as age and gender, prior treatment history and whether patients had other conditions. Finally, we also analyzed data on various TB strains, such as what drugs the pathogen is resistant to and what genetic mutations the pathogen had.

Looking at enormous datasets like these can be overwhelming. Even most existing AI tools have had difficulty analyzing large datasets. Prior studies using AI have focused on a single data type – such as imaging or age alone – and had limited success predicting TB treatment outcomes.

We used an approach to AI that allowed us to analyze a large and diverse number of variables simultaneously and identify their relationship to TB outcomes. Our AI model was transparent, meaning we can see through its inner workings to identify the most meaningful clinical features. It was also multimodal, meaning it could interpret different types of data at the same time.

Microscopy image of rod-shaped TB bacteria stained green
Mycobacterium tuberculosis spreads through aerosol droplets. NIAID/NIH via Flickr

Once we trained our AI model on the dataset, we found that it could predict treatment prognosis with 83% accuracy on newer, unseen patient data and outperform existing AI models. In other words, we could feed a new patient’s information into the model and the AI would determine whether a specific type of treatment will either succeed or fail.

We observed that clinical features related to nutrition, particularly lower BMI, are associated with treatment failure. This supports the use of interventions to improve nourishment, as TB is typically more prevalent in undernourished populations.

We also found that certain drug combinations worked better in patients with certain types of drug-resistant infections but not others, leading to treatment failure. Combining drugs that are synergistic, meaning they enhance each other’s potency in the lab, could result in better outcomes. Given the complex environment in the body compared with conditions in the lab, it has so far been unclear whether synergistic relationships between drugs in the lab hold up in the clinic. Our results suggest that using AI to weed out antagonistic drugs, or drugs that inhibit or counteract each other, early in the drug discovery process can avoid treatment failures down the line.

Ending TB with the help of AI

Our findings may help researchers and clinicians meet the World Health Organization’s goal to end TB by 2035, by highlighting the relative importance of different types of clinical data. This can help prioritize public health efforts to mitigate TB.

While the performance of our AI tool is promising, it isn’t perfect in every case, and more training is needed before it can be used in the clinic. Demographic diversity can be high within a country and may even vary between hospitals. We are working to make this tool more generalizable across regions.

Our goal is to eventually tailor our AI model to identify drug regimens suitable for individuals with certain conditions. Instead of a one-size-fits-all treatment approach, we hope that studying multiple types of data can help physicians personalize treatments for each patient to provide the best outcomes.

Sriram Chandrasekaran receives funding from the US National Institutes of Health.

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International

IVI starts technology transfer to Biological E. Limited to manufacture oral cholera vaccine for India and global markets

  Credit: IVI IVI will complete the technology transfer by 2025 Oral Cholera Vaccine to be manufactured by Biological E. Limited for India and international…

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Credit: IVI

  • IVI will complete the technology transfer by 2025
  • Oral Cholera Vaccine to be manufactured by Biological E. Limited for India and international markets

 

March 20, 2024, SEOUL, Republic of Korea and HYDERABAD, India — The International Vaccine Institute (IVI), an international organization with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health, today announced that it has commenced a technology transfer of simplified Oral Cholera Vaccine (OCV-S) to Biological E. Limited (BE), a leading India-based Vaccines and Pharmaceutical Company.

 

Following the signing of a technology license agreement in November last year, IVI has begun providing the technical information, know-how, and materials to produce OCV-S at BE facilities and will continue to support necessary clinical development and regulatory approvals. IVI and BE entered this partnership during an unprecedented surge of cholera outbreaks worldwide and aim to increase the volume of low-cost cholera vaccine in India as well as the global public market.

 

IVI will complete the technology transfer by 2025 and the oral cholera vaccine will be manufactured for India and international markets by Biological E. Limited.

 

Dr. Jerome Kim, Director General of IVI, said: “In an era of heightened risk of poverty-associated infectious diseases such as cholera, the world needs a sustainable source of high-quality, affordable vaccines and committed manufacturers to supply them. We are pleased to partner with Biological E., a company with a proven history of making life-saving vaccines accessible globally, to address this supply gap and protect communities from this deadly, though preventable, disease.”

 

Ms. Mahima Datla, Managing Director, Biological E. Limited, said: “We are glad to be in collaboration with IVI for the manufacture of simplified Oral Cholera Vaccine. Our efforts are aimed to not only combat the disease but to also be part of a sustained legacy of innovation, collaboration, and health stewardship. Together with IVI, we are happy to be shaping a healthier and more resilient future by making this vaccine accessible globally.”

 

This technology transfer and licensing agreement is the sixth of its kind for IVI, transferring such technology to manufacturers in India, the Republic of Korea, Bangladesh, and South Africa. All these partnerships have led to or seek to achieve, pre-qualification (PQ) from the World Health Organization, a designation that enables global agencies such as UNICEF to procure the vaccine for the global market. BE already has 9 vaccines with WHO PQ in its portfolio, and IVI and BE will pursue WHO PQ for OCV-S as well, following national licensure in India.

 

Dr. Julia Lynch, Director of IVI’s Cholera Program, said: “The cholera situation is dire, and the availability and use of oral cholera vaccine is an essential part of a multifaceted approach to cholera control and prevention, especially as outbreaks increase and the global vaccine supply remains strained. With more manufacturers like BE entering the market, the future supply situation looks strong. IVI remains committed to ensuring the availability of the oral cholera vaccine and to developing new and improved vaccines that are equally safe, effective, and affordable and made around the world, for the world.”

 

OCV-S is a simplified formulation of OCV with the potential to lower production costs while increasing production capacity for current and aspiring OCV manufacturers. IVI’s development of OCV-S and ongoing technology transfers are part of an institutional strategy to confront cholera with 3 main goals: 1) Ensure supply of OCV 2) Improve cholera vaccines 3) Support OCV use and introduction. The Bill & Melinda Gates Foundation has been supporting IVI’s cholera program since 2000 and is funding this latest technology transfer to BE.

 

###

 

About the International Vaccine Institute (IVI)

The International Vaccine Institute (IVI) is a non-profit international organization established in 1997 at the initiative of the United Nations Development Programme with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health.

IVI’s current portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases that disproportionately affect low- and middle-income countries, such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV, COVID-19, and more. IVI developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO), and developed a new-generation typhoid conjugate vaccine that also achieved WHO prequalification in early 2024.

IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden, an Africa Regional Office in Rwanda, a Country Office in Austria, and a Country and Project Office in Kenya. IVI additionally co-founded the Hong Kong Jockey Club Global Health Institute in Hong Kong and hosts Collaborating Centers in Ghana, Ethiopia, and Madagascar. 39 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, Finland, and Thailand provide state funding. For more information, please visit https://www.ivi.int.

 

 

About Biological E. Limited

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India, the USA and Europe. BE currently has 8 WHO-prequalified vaccines and 10 USFDA approved Generic Injectables in its portfolio. Recently, BE has received Emergency Use Listing (EUL) from the WHO for CORBEVAX®, the COVID-19 vaccine. Recently, DCGI has approved BE’S 14-Valent Pneumococcal Conjugate vaccine.

In recent years, BE has embarked on new initiatives for organizational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

Please follow us on Facebook, LinkedIn and Twitter

 

 

MEDIA CONTACTS

IVI

Aerie Em, Global Communications & Advocacy Manager
+82 2 881 1386 | aerie.em@ivi.int

 

Biological E. Limited

K. Vijay Amruth Raj
Email: Vijay.Kammari@biologicale.com
www.biologicale.com/news


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Government

Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Federal police in Brazil have indicted former President Jair…

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Bolsonaro Indicted By Brazilian Police For Falsifying Covid-19 Vaccine Records

Federal police in Brazil have indicted former President Jair Bolsonaro for falsifying his Covid-19 vaccine card in order to travel to the United States and elsewhere during the pandemic.

Federal prosecutors will review the indictment and decide whether to pursue the case - which would be the first time the former president has faced criminal charges.

According to the indictment, Bolsonaro ordered a top deputy to obtain falsified Covid-19 vaccine records of himself and his 13-year-old daughter in late 2022, right before he flew to Florida for a three-month stay following his election loss.

Brazilian police are also waiting to hear back from the US DOJ on whether Bolsonaro used said cards to enter the United States, which would open him up to further criminal charges, the NY Times reports.

Bolsonaro has repeatedly claimed not to have received the Covid-19 vaccine, but denies any involvement in a plan to falsify his vaccination records. A previous investigation by Brazil's comptroller general concluded that Bolsonaro's vaccination records were false.

The records show that Bolsonaro, a COVID-19 skeptic who publicly opposed the vaccine, received a dose of the immunizer in a public healthcare center in Sao Paulo in July 2021. [ZH: hilarious, Reuters calling the vaccine an 'immunizer.']

The investigation concluded, however, that the former president had left the city the previous day and didn't leave Brasilia until three days later, according to a statement.

The nurse listed in the records as having applied the vaccine on Bolsonaro denied doing so and was no longer working at the center. The listed vaccine lot was also not available on that date, the comptroller general's office said. -Reuters

"It's a selective investigation. I'm calm, I don't owe anything," Bolsonaro told Reuters. "The world knows that I didn't take the vaccine."

During the pandemic, Bolsonaro panned the vaccine - and instead insisted on alternative treatments such as Ivermectin, which has antiviral properties against Covid-19. For this, he was investigated by Brazil's congress, which recommended that the former president be charged with "crimes against humanity," among other things, for his actions during the pandemic.

In May, Brazilian police raided Bolsonaro's home, confiscating his cell phone and arresting one of his closest aides and two of his security cards in connection to the vaccine record investigation.

Brazil's electoral court ruled that Bolsonaro can't run for public office until 2030 after he suggested that the country's voting system was rigged. For that, he has to sit out the 2026 election.

Tyler Durden Tue, 03/19/2024 - 11:00

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