Saturday, August 26, 2023

Wednesday, August 23, 2023

Surprised?: FEMA officials are staying at $1,000-a-night luxury hotels in Maui amid recovery efforts in Lahaina | Daily Mail Online

EXCLUSIVE: FEMA officials are staying at $1,000-a-night luxury hotels in Maui amid recovery efforts in Lahaina | Daily Mail Online

Bungling U.S. government bureaucrats dispatched to the Maui disaster zone are shacked up in $1,000-a-night luxury hotels on the Hawaiian island, DailyMail.com can reveal.

Officials from the Federal Emergency Management Agency (FEMA) have been slammed by locals over their slow response to the devastating wildfires that have claimed at least 114 lives and left thousands of people homeless after their houses were scorched to the ground.

But that has not stopped the under-fire agency from splashing taxpayer cash to put up more than 1,000 of its personnel at four bank-breaking resorts in Wailea after the deadliest wildfire in the U.S. for more than a century that caused an estimated $5billion in damage.

The beachside resorts are popular among the rich and famous and located about a 45-minute drive away from the fire-ravaged town of Lahaina.

Exclusive DailyMail.com photos show FEMA officials drinking at the cocktail bar at the Grand Wailea hotel on Friday August 18 amid recovery efforts in Lahaina

Exclusive DailyMail.com photos show FEMA officials drinking at the cocktail bar at the Grand Wailea hotel on Friday August 18 amid recovery efforts in Lahaina 

Federal workers dispatched to the Maui disaster zone have been put up at four different luxury resorts in Maui, DailyMail.com has learned. Pictured: FEMA officials man a registration desk at the Grand Wailea hotel on Saturday,  August 19

Federal workers dispatched to the Maui disaster zone have been put up at four different luxury resorts in Maui, DailyMail.com has learned. Pictured: FEMA officials man a registration desk at the Grand Wailea hotel on Saturday,  August 19

The posh, five star hotel is a far cry from the shelters and temporary housing where displaced wildfire victims are living after losing their homes in the blaze

The posh, five star hotel is a far cry from the shelters and temporary housing where displaced wildfire victims are living after losing their homes in the blaze 

FEMA teams have checked in at three five-star hotels, the Fairmont Kea Lani, Four Seasons, and the Grand Wailea Astoria where past guests include members of Hollywood's elite.

Their rooms carry price tags that are well out of reach of most hard-working Americans.

Federal government rates for this week at all three resorts start at an eye-watering $1,000, company sources told DailyMail.com.

But it's unclear how much FEMA actually paid.

In a statement to DailyMail.com from FEMA, following publication of the story: 'In the immediate aftermath of the tragic Maui wildfires, FEMA surged personnel, including hundreds of search and rescue teams, to provide relief to the survivors and support to the state and local governments as quickly as possible. 

'To complete that mission, FEMA selects hotels where all responders can be centrally located to ensure the most effective response possible. Due to the lack of available lodging, FEMA negotiated government rates, at the lowest possible cost, for staff temporarily staying in the available hotels. 

'As we transition into recovery, staff will move to longer term, more affordable responder lodging as they fulfill our commitment to support Maui.'

Meanwhile, the FEMA staff are staying in the lap of luxury.

The Fairmont Kea Lani, Hawaiian for 'heavenly white', boasts on its website about being the 'only all-suite' hotel in Hawaii that once welcomed ex-Bond star Pierce Brosnan and offers 'gourmet dining' to uber-wealthy guests.

The 780 rooms come with either one or two bedrooms, measuring at least 860 square feet, and have private balconies so that visitors can soak up the sunset views of what the hotel calls 'an oceanside paradise.'

Meanwhile, the Four Seasons, another top resort that once hosted Kanye West, spans nearly 15 acres and has a white fountain pool, green trees, 600 square-feet rooms.

FEMA officials are also staying in the Fairmont Kea Lani, another five-star resort in Wailea. Pictured: FEMA workers at a registration desk at the hotel

FEMA officials are also staying in the Fairmont Kea Lani, another five-star resort in Wailea. Pictured: FEMA workers at a registration desk at the hotel 

The upmarket Fairmont resort boasts beautiful ocean views and three different pools

The upmarket Fairmont resort boasts beautiful ocean views and three different pools 

Rooms at the Fairmont hotel start at $870 a night. It is billed as the 'only all-suite' hotel in Hawaii that once welcomed ex-Bond star Pierce Brosnan

Rooms at the Fairmont hotel start at $870 a night. It is billed as the 'only all-suite' hotel in Hawaii that once welcomed ex-Bond star Pierce Brosnan 

The Grand Wailea, where Adam Sandler, Jennifer Aniston and Nicole Kidman filmed their romantic comedy, Just Go With It, has 776 rooms that start at 640 square feet.

The hotel is set on 40 acres of tropical gardens and sits right on one of Maui's most beautiful beaches, Wailea Beach.

And there are FEMA 100 officials staying at the four-star Marriott Wailea Beach Resort for $531 per night, a company insider said, but where rooms currently on offer to the general public start at $749.

Among them are search teams who face the horrifying and challenging task of looking for the bodies of the dead and recovering their remains.

But FEMA's choice of accommodation for their officials could raise eyebrows given that there are scores of cheaper hotels in the west of the island.

Kaleo, a local government employee who asked for his surname to be withheld amid fears that he could lose his job, said the revelations about their use of luxury hotels was 'selfish'.

Officials are also shacked up at the Marriott Wailea Beach Resort in Maui (pictured)

Officials are also shacked up at the Marriott Wailea Beach Resort in Maui (pictured) 

The Four Seasons in Wailea, another top resort that once hosted Kanye West, spans nearly 15 acres and has a white fountain pool, green trees, 600 square-feet rooms

The Four Seasons in Wailea, another top resort that once hosted Kanye West, spans nearly 15 acres and has a white fountain pool, green trees, 600 square-feet rooms

Meanwhile, thousands of Lahaina survivors have been left homeless, and hundreds of victims remain missing amid slow recovery efforts. Pictured: Women hug after digging through rubble of destroyed home in Lahaina

Meanwhile, thousands of Lahaina survivors have been left homeless, and hundreds of victims remain missing amid slow recovery efforts. Pictured: Women hug after digging through rubble of destroyed home in Lahaina 

'Shouldn't they stay closer to the site, instead of staying across on the other side of the island?' he asked.

There has also been anger about the $700 'one-time' payment to help survivors get essentials such as clothing, food or transportation.

Bogus claims circulated online last week that the Biden administration had set a cap on any federal handouts to those who survived the deadly blazes at that amount.

The White House has signed off on $7million in emergency funds, meaning FEMA can stump up cash to put those who lost their homes in temporary accommodations such as hotels or condos.

But locals have also fumed over accusations that FEMA has blocked volunteers from delivering aid to the disaster zone.

Volunteers make food and supply deliveries to elderly residents affected by a deadly wildfire in Lahaina, Hawaii, Saturday

Volunteers make food and supply deliveries to elderly residents affected by a deadly wildfire in Lahaina, Hawaii, Saturday

Displaced families are seen picking up some food at a distribution location in a neighborhood of Lahaina, Hawaii

Displaced families are seen picking up some food at a distribution location in a neighborhood of Lahaina, Hawaii

Luz Vargas, mother of Kenyero Fuentes, is embraced as family and friends of Kenyero mark his 15th birthday at Honokowai Beach Park, Lahaina. The boy was found dead in his home which was destroyed by the fire

Luz Vargas, mother of Kenyero Fuentes, is embraced as family and friends of Kenyero mark his 15th birthday at Honokowai Beach Park, Lahaina. The boy was found dead in his home which was destroyed by the fire

Historic town of Lahaina Maui destroyed by wildfires

They blamed U.S. government red tape which means only FEMA-approved supplies can be distributed to those in need.

And Maui's top emergency official Hernan Andaya resigned suddenly on Thursday citing health problems, just one day after he defended his decision not to sound the island's alarm system.

Andaya said he did not activate Maui's 80-alarm, all-hazard outdoor siren system because he feared that residents would confuse the alert for a tsunami warning.

DailyMail.com asked FEMA why those hotels had been chosen and whether they had been offered any additional discounts.

The U.S. government's emergency response agency failed to reply to the request for comment.



~A.

MkCullough paper pre-pub and fyi…

REAL! -Research continues on mask effectiveness - Newsday

Research continues on mask effectiveness 3 years after COVID - Newsday

Research continues on mask effectiveness 3 years after COVID

Three years after the pandemic began, there's still no scientific consensus on how much protection masks offer.

Laboratory studies are clear that masks – especially N95s and KN95s – decrease the number of COVID-19 particles that enter the body, and the less virus that is inhaled, the lower the risk of infection. But research has led to mixed findings on how much masks reduce the spread of COVID-19 in communities, in part because levels of mask-wearing have varied over time and not everyone wears the masks correctly.

Some studies, including some conducted earlier in the pandemic when mask-wearing was more common, concluded masks significantly reduce rates of COVID-19. Others found they only have a small effect, and still others were unable to reach firm conclusions.

A review of studies published in the June Annals of Internal Medicine concluded that "masks may be associated with a small reduction in risk for SARS-CoV-2 infection in community settings."

Another review of previous studies, some completed before the pandemic, looked at community spread of different types of respiratory viruses, including COVID-19, and found "there is uncertainty about the effects of face masks."

Some interpreted that review, published in January in the Cochrane Database of Systemic Reviews, as concluding masks don't work. But the editor-in-chief of the Cochrane Library said that is "an inaccurate and misleading interpretation."

A significant caveat in the Cochrane review illustrates the difficulty in measuring the impact of wearing masks in the real world: "Relatively low numbers of people followed the guidance about wearing masks."

In addition, the CDC warns, masks must fit properly to prevent leaks.

The CDC no longer has a blanket recommendation for mask-wearing, although, the agency says, "Masking is a critical public health tool for preventing spread of COVID-19."

Current CDC guidelines recommend that everyone wear masks in all indoor public spaces only when hospital admission levels are deemed high, and high-risk people do so when hospitalizations are at a medium level. Despite the recent rise in hospitalizations, current levels are considered low on Long Island and in more than 98% of U.S. counties, CDC data as of Aug. 5 shows.

Ali Khosronejad, an associate professor of civil engineering at Stony Brook University, said masks do much more to prevent someone with COVID-19 from spreading the virus than protect someone from contracting it.

"If someone has COVID, wearing a mask is very effective" at stopping that person from passing it on to others, he said.

However, even the best N95 masks don't prevent breathing in some saliva of a nearby person with COVID-19, although they reduce the number of particles that get through, he said. (The amount of virus that a person is exposed to determines whether the individual is infected, studies show.)

Khosronejad said a study he recently led that likely will be published in the coming weeks confirmed his previous research that shows masks significantly reduce how much virus a person with COVID-19 emits. Other researchers have reached similar conclusions.

Tightfitting N95 masks are most effective, followed by KN95s, and then surgical masks and cloth masks, he said.

Even cloth masks can curb the spread of saliva to less than 2 feet, by diminishing the momentum of the "jets" of saliva as someone exhales, Khosronejad said.

"These jets have kinetic energy that can carry the particles far away, and if you have a mask, it reduces the energy of those jets significantly," he said.

With masks more effective at blocking the spread than the inhalation of the virus, if you're the only person in a crowded place wearing a mask — or not wearing one — you have a much greater chance of getting infected than if most people were donning masks, Khosronejad said.


With masks more effective at blocking the spread than the inhalation of the virus,


With masks more effective at blocking the spread than the inhalation of the virus,

With masks more effective at blocking the spread than the inhalation of the virus,

With masks more effective at blocking the spread than the inhalation of the virus,

With masks more effective at blocking the spread than the inhalation of the virus,

With masks more effective at blocking the spread than the inhalation of the virus,

~A.

Pluckers making mods not meds….

Pfizer Documents Show COVID-19 Vaccines Contain Potentially Harmful 'Modified' RNA, not mRNA

Pf=== Documents Show COVID-19 Vaccines Contain Potentially Harmful 'Modified' RNA, not mRNA


Although we've been told Pfizer's COVID-19 vaccine is manufactured with harmless messenger RNA (mRNA), the U.S. Food and Drug Administration's (FDA) product label shows it contains artificially modified RNA—a key ingredient that is not naturally occurring, poses a substantial risk to human health.

According to Pfizer and BioNTech's COVID-19 vaccine label in the FDA's Fact Sheet for Healthcare Providers, each Pfizer vaccine dose for children ages 5 through 11 contains 10 micrograms (mcg) of modRNA, while fully-approved Comirnaty authorized for use in individuals 12 years of age and older contains 30 mcg of modRNA.

Pfizer, on its website, confirms its COVID-19 vaccine contains modRNA: "ModRNA stands for nucleoside-modified messenger RNA and in the synthesis of the RNA used in this vaccine platform, some nucleosides, which are important biological molecules that constitute DNA and RNA, are replaced by modified nucleosides to help enhance immune evasion and protein production." The company says modRNA instructs the cells to produce desired proteins.

Yet the Centers for Disease Control and Prevention (CDC) states on its website (pdf) that mRNA COVID-19 vaccines are "made of mRNA," or "messenger RNA."

According to the agency, the mRNA in COVID-19 vaccines such as Pfizer and Moderna is created in a laboratory and teaches cells how to make harmless pieces of spike protein that trigger an immune response inside the body. The mRNA from mRNA-based vaccines is broken down within days after vaccination and eliminated from the body. In its description of mRNA and how COVID-19 vaccines work, the CDC makes no reference to modRNA or indicates that the RNA used in COVID-19 vaccines has been modified.

Messenger RNA occurs naturally and lives in our cells, and it does not last long enough to initiate an immune response before being destroyed by the immune system—it is modRNA that is synthetically created, according to Klaus Steger, a molecular biologist who headed several gene technology laboratories, regularly applying RNA-based technologies.

Unlike mRNA, modRNA modifies one of four compounds in RNA that make it last longer in the body, less immunogenic (reduced stimulation of the innate immune system), and more efficient at producing a protein—in this case, the spike protein. Mr. Steger stated. Since modRNA cannot target specific cells to make viral protein, it can attack perfectly healthy cells and bypass protective barriers in the body, like the blood-brain barrier.

Injecting modRNA into the body may lead to adverse events like strokes, cardiovascular complications, pulmonary embolism, and the formation of blood clots—many of which were disclosed in Pfizer's documents (pdf) but were not attributed to its product.

"It is my opinion that, at a minimum, the intentional use of mRNA—an acronym well-known to stand for messenger RNA along with the endless statements about the vaccines being based on naturally occurring messenger RNA constitute misbranding in violation of a number of laws," Ohio-based attorney Thomas Renz told The Epoch Times in an email.

"There is a legal and moral duty to provide informed consent, and to misrepresent a drug that was intended to be a gene therapy as a vaccine containing "natural messenger RNA" is an apparent violation of both of those duties."

David Wiseman, a research bioscientist with a doctorate in experimental pathology and a background in pharmacy, pharmacology, and immunology told The Epoch Times in an email the FDA uses the term "modRNA" throughout its regulatory documents. Yet the FDA, when it gave emergency use authorization to the Pfizer-BioNTech vaccine, said the vaccine contains messenger RNA, which it described as "genetic material" that contains a "small piece of the SARS-CoV-2 virus's mRNA that instructs cells in the body to make the virus's distinctive 'spike' protein."

The FDA's description is problematic because the SARS-CoV-2 virus doesn't contain mRNA, Mr. Wiseman said. "mRNA is the kind of RNA produced in the copying of instructions from DNA in a process called transcription, so to say this is viral mRNA is inaccurate."

"Understand that, at core, mRNA, modRNA, saRNA, etc.—these are all gene therapies and all about genetic manipulation," Mr. Renz wrote in a recent Substack article. "To suggest that this is high risk is an understatement. We have no idea what we are doing and yet we continue forward trying to control these genes."

Pfizer Is Using Modified RNA Gene Therapy to Develop Other Vaccines

Mr. Renz told The Epoch Times that Pfizer is not only using modRNA for COVID-19 injections but also leveraging gene therapy technology to produce self-amplifying mRNA (saRNA) vaccines and treatments.

"Along with modRNA, Pfizer's website also mentions saRNA (self-amplifying RNA) and numerous other lab-made RNA technologies," he said. "We have discovered that various RNA technologies are in development for various uses, and these technologies, along with new adjuvant technologies, can allow for the introduction of gene therapy products into foods, the air (aerosolized vaccines), and even topical products."

According to Pfizer, saRNA is a platform that uses a much larger molecule that encodes the antigen of interest and four additional proteins, allowing the cell to make more copies of the mRNA, resulting in more protein being expressed from a smaller dose. Pfizer states that it is currently using this gene therapy technology to develop influenza, shingles, and respiratory combination vaccines.

"It will be curious to know if this is going to be disclosed as well," Mr. Renz added.



~A.

Newest (farma-based solutions) Based on a Single Study

FDA Approved 65 Percent of New Drugs in 2022 Based on a Single Study

FDA Approved 65 Percent of New Drugs in 2022 Based on a Single Study

The 21st Century Cures Act (Cures Act), signed into law in December 2016, was created to help accelerate medical product development and "bring new innovations and advances" to patients quicker and more efficiently. Yet some researchers suggest the law is being used to bypass the once rigorous and evidenced-based standards for new drug approvals, allowing novel drugs to flood the market without adequate data and public transparency.

According to a research letter published on August 8 in the Journal of the American Medical Association Network Open (JAMA), 24 of the 37 drugs approved in 2022 by the U.S. Food and Drug Administration (FDA) were based on a single study, with only four drugs having more than three studies to support their approval.

"I'm not surprised," David Gortler, a pharmacologist, pharmacist, and FDA reform advocate at the Ethics and Public Policy Center, told The Epoch Times in an email. As a former senior advisor to the FDA commissioner, Mr. Gortler said he saw the agency grant expedited approval to a medication called aducanumab—used to treat Alzheimer's disease "based on zero positive studies."

"They did the same with other monoclonal antibodies for Alzheimer's disease," Mr. Gortler said.

According to the research letter, most of the 413 studies evaluating the 37 drugs approved in 2022 were sponsored by the industry—meaning they were manufactured, funded, and analyzed by the company producing the product, seeking FDA approval, and standing to benefit financially from the drug.

Of the studies available for analysis, only 25 percent of study results have been made publicly available, with the results of six percent of those studies published after the FDA had already approved the drug for use.

Furthermore, researchers found that only 55 percent of studies evaluating drugs in 2022 consisted of randomized clinical trials—the "gold standard" of evidence-based medicine—despite the FDA justifying most approvals based on randomized clinical trial data.

For comparison, only 20 percent of medical products in 2016 were approved based on a single study, and 55 percent were approved based on three or more studies, whereas 65 percent of drugs in 2022 were approved based on a single study, with only 11 percent having three or more studies.

"We believe consumers deserve access to the full range of evidence for the drugs they are considering, not just from the selected studies released to the public," the authors wrote.

The researchers say their results "highlight a trend toward less rigorous standards for novel drug approvals that has evolved over the past few decades" and are consistent with other reports showing a widespread decrease in the number of trials used for drug approvals.

"The authors point to the deterioration of the quality and rigor of the regulatory review and approval of new drugs over time," Sasha Latypova told The Epoch Times in an email. Ms. Latypova is a retired pharmaceutical industry executive with 25 years of experience in pharmaceutical research and development and co-founder of several organizations that work with pharmaceutical companies to design, execute, collect data, and submit clinical trial data to the FDA.

Your Health Matters

Ms. Latypova says this trend began with a "fast track" designation implemented in 1988 that increased the number of special regulatory programs available by the FDA and decreased the evidentiary requirements for approval. In the 2000s, Ms. Latypova said many blockbuster drugs became generic medicines, which started a "patent cliff" where industry investments began to focus on narrower niches in an effort to get patent exclusivity—which is more profitable for a pharmaceutical company.

"For example, approvals receiving an 'orphan' designation or what is considered rare disease increased to over 50% percent," Ms. Latypova said. "These products are sometimes approved on as little as a single observational study with fewer than 20 subjects, however, once approved, the drug's price increased one million to three million dollars per treatment and was fully covered by the taxpayer and private insurance—driving the costs of premiums."

Thus, the "regulatory requirements are minimal, but the profits are outsized," she added.

FDA Cures Act Made It Easier for Pharma and Regulatory Agencies to Cut Corners

The FDA, on its website, states the intent of the Cures Act (pdf) passed by Congress in December 2016  was to "incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision-making process" and enhance its ability to "modernize clinical trial designs," including the use of "real world evidence" to speed up the development and review of novel medical products, including emergency and preparedness response countermeasures used to justify rapid authorization of COVID-19 vaccines.

Allowing the FDA to consider real-world evidence instead of randomized trials previously required under its strict methodological standards used to evaluate the safety and efficacy of a drug relaxed requirements for pharmaceutical companies and opened the door for bias.

The Cures Act gave new authority to the FDA to "recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs" and directed the agency to create one or more intercenter institutes to assist with coordination of activities between the drug, biologics, and device centers to improve the regulation of combination products.

The 312-page Act provided $500 million U.S. tax dollars to help the FDA implement the law over nine years and provided $6.3 billion in funding, mainly to the National Institutes of Health (NIH), a major funder of American universities and research institutions.

According to the National Center for Health Research (NCHR), the Cures Act dramatically benefits pharmaceutical and medical device companies, lowers the standards for drugs and devices, and makes it difficult for patients and physicians to decide whether to try a new treatment without knowing if it is safe or effective. This may explain why the Act was originated and promoted by major pharmaceutical companies, universities, and other organizations that hired more than 1,455 lobbyists to advance the bill.

The NCHR says the bill has had the following effects:

  • Allowed anecdotal, unreliable, and easily manipulated health data to be used to approve new drugs.
  • Allowed pharmaceutical and device companies to bypass public reporting requirements related to funding and gifts provided to physicians.
  • Weakened patient safety by lowering the evidentiary standards required to prove a new drug or medical device is safe and effective.
  • Allowed companies to disseminate potentially inaccurate scientific information not evaluated as part of the FDA approval process, opening the door for widespread use of drugs and treatments not FDA-approved.
  • Reduced the FDA's authority to regulate electronic health records systems and other medical software, which, if defective, can lead to deaths and permanent harm.
  • Encourages smaller and shorter-term studies that are less likely to measure product safety and effectiveness for excluded parts of the population who may rely on them.

FDA Is Not Enforcing Reporting Requirements for Clinical Trials

Problems with clinical trial reporting go back to a law passed in 2007 requiring companies, universities, and other institutions to publish most clinical trial data in a federal database so that doctors and patients can determine whether a new product is safe or effective, according to a Science analysis. After trial sponsors failed to follow the law, the NIH and FDA attempted in 2017 to enact a final rule explaining the requirements and penalties for failing to disclose clinical trial results. Yet many sponsors ignored the requirements, and federal officials have done "little or nothing" to enforce the law.

The analysis of more than 4,700 clinical trials that should have been published on the NIH database ClinicalTrials.gov under the 2017 rule showed improved compliance rates of most large pharmaceutical companies and some universities. Yet the performance of many other sponsors, including the NIH, was "lackluster."

ClinicalTrials.gov is an online registry of clinical trials run by the National Library of Medicine at NIH, where researchers, doctors, and patients are supposed to be able to see data on trial outcomes from peer-reviewed publications and can compare results across trials. Yet according to the analysis, thousands of trials are never published, especially when treatments are shown to be ineffective.

The Science analysis showed roughly 67 percent of studies from 30 of the 184 sponsor organizations with at least five trials failed to report any results on ClinicalTrials.gov, reinforcing the 2022 data published in the JAMA research letter.

Perhaps even more concerning is that these organizations consisting of pharmaceutical companies, universities, and medical centers failed to meet a single deadline. Those considered "habitual violators" didn't report results in 67 percent of their trials and were an average of 268 days late disclosing data past their original deadlines.

These institutions included Harvard University, the University of Minnesota, and Baylor College of Medicine—leading recipients of NIH grants in 2019. Researchers found that The University of Texas MD Anderson Cancer Center and Mayo Clinic both failed to report results on time, or at all, in nearly two-thirds of their clinical trials. Yale University did not report results in 84 percent of its trials.

The NIH is tasked with reporting results when they sponsor studies done by agency staff or certain grantees, and the top four NIH institute sponsors reported results late or not at all in more than six of every ten trials assessed by Science. In addition, the Science analysis found the sponsors violated the reporting law more than 55 percent of the time and identified hundreds of cases where sponsors were credited for reporting results where the results themselves were not publically posted.

Despite the 2017 rule promising "aggressive enforcement and stiff penalties," the NIH and FDA have not penalized sponsors who have not followed the requirements. The FDA in 2019 said it would not enforce penalties of up to $12,103 a day for failing to report a trial's results until the agency issues further guidance on how it will exercise its power.

The FDA and NIH did not respond to requests for comment at the time of press.

Megan Redshaw

Megan Redshaw is an attorney and investigative journalist with a background in political science. She is also a traditional naturopath with additional certifications in nutrition and exercise science.



~A.

Cures???

The 21st Century Cures Act (Cures Act), signed into law in December 2016, was created to help accelerate medical product development and "bring new innovations and advances" to patients quicker and more efficiently. Yet some researchers suggest the law is being used to bypass the once rigorous and evidenced-based standards for new drug approvals, allowing novel drugs to flood the market without adequate data and public transparency.

According to a research letter published on August 8 in the Journal of the American Medical Association Network Open (JAMA), 24 of the 37 drugs approved in 2022 by the U.S. Food and Drug Administration (FDA) were based on a single study, with only four drugs having more than three studies to support their approval.


~A.

Karen’s Aug.

Bio-Preparedness Workforce

Bio-Preparedness Workforce Pilot Program

Watch: A conversation on the health preparedness workforce

On Thursday, June 15, in Washington, D.C., Axios health care editor Tina Reed hosted conversations examining ways to bolster the health workforce and improve pandemic preparedness. Guests included HRSA administrator Carole Johnson, Howard University Hospital vice president and chief nursing officer Dr. India Medley, and Sen. Tina Smith (D-Minn.). A View from the Top sponsored segment featured Infectious Diseases Society of America treasurer Dr. Jeanne Marrazzo.

 

Contact IDSA and HIVMA staff to learn how to get involved.

Learn About the Bio-Preparedness Workforce Pilot Program

Sign-On Letter to House Appropriators to Fund the Bio-Preparedness Workforce Pilot Program
121 organizations signed a letter urging Congress fully fund the Public Health Workforce Loan Repayment Program and the newly authorized Bio-Preparedness Workforce Pilot Program. These programs will provide needed financial incentives to bring public health and ID and HIV health care professionals into settings where they are crucially needed.

Bio-Preparedness Workforce Pilot Program – Implementation Update (January 2023)
This informational brief provides background on the legislation and the need for a loan repayment program for infectious diseases and emergency preparedness health care professionals.

ID and Public Health Groups Call for Funding for ID and Public Health Loan Repayment Programs
IDSA and the National Association of County and City Health Officials led a sign-on letter urging the Administration to include $100 million for the Public Health Loan Repayment Program and $50 million for the Bio-Preparedness Workforce Pilot in the president's budget.  

Sign-On Letter to Congressional Leadership to Advance the BIO Act
More than 900 infectious diseases professionals across the country signed this letter urging congressional leadership to advance the Bio-Preparedness Workforce Pilot Program, as part of the PREVENT Pandemics Act, by the end of 2022. The pilot program would incentivize health care professionals to pursue careers in ID/HIV and practice in underserved communities through targeted loan repayment.

Multi-Organization Letter Urging Passage of the PREVENT Pandemics Act
More than 100 organizations signed this letter successfully urging Congress to enact the PREVENT Pandemics Act, including the Bio-Preparedness Workforce Pilot Program.

Learn More About Bio-preparedness & Infectious Diseases Workforce Shortages

Where Is the ID in COVID-19? Annals of Internal Medicine (2020)
A national study evaluated the density of infectious diseases physicians by county and found that 208 million Americans live in counties with no or below-average ID physician coverage.  

HIV-Experienced Clinician Workforce Capacity: Urban-Rural Disparities in the Southern United States Clinical Infectious Diseases (2021)
This study found that more than 80% of counties in 14 Southern states have no HIV-experienced clinicians.

The American Society for Clinical Pathology's 2018 Vacancy Survey of Medical Laboratories in the United States American Journal of Clinical Pathology (2019)  
This study documented serious shortages of medical laboratory department staff across the U.S.

In the News

Protecting Rural Washington Against the Next Pandemic (2/15/2022)
Rachel Bender Ignacio, MD, MPH, discussed the importance of the BIO Preparedness Workforce Act to Washington and surrounding states in an op-ed published in The Spokesman-Review

Let's Talk ID: The Bolstering Infectious Outbreaks (BIO) Pre-preparedness Workforce Act (11/19/2021)
IDSA President Dan McQuillen, MD, FIDSA, discussed the importance of the bill with one of the lead House sponsors, Rep. Lori Trahan (D-MA), and IDSA member Kinna Thakarar, DO, in this podcast episode.  

Energy & Commerce Committee Health Subcommittee Hearing (10/26/21)
IDSA Treasurer Jeanne Marrazzo, MD, MPH, FIDSA, testified at a hearing detailing the importance of the bill to improve health equity in Alabama and communities across the country.

IDSA and HIVMA Support BIO Preparedness Workforce Act (10/25/2021) 
In a news release, IDSA and HIVMA urged Congress to move swiftly to advance H.R. 5602, the Bolstering Infectious Outbreaks (BIO) Preparedness Workforce Act.



~A.

‘Scientific’ Data to Support Mask Narrative….

Secret Letter to CDC: Top Epidemiologist Suggests Agency Misrepresented Scientific Data to Support Mask Narrative

Secret Letter to CDC: Top Epidemiologist Suggests Agency Misrepresented Scientific Data to Support Mask Narrative


Documents recently obtained from the National Institutes of Health suggest public health officials used inaccurate information and misrepresented medical research to advance their policy objective that masks prevent severe COVID-19 and virus transmission—despite opposing scientific evidence received from experts.

In a recently obtained letter (pdf) sent in November 2021 to the Centers for Disease Control and Prevention (CDC), top epidemiologist Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, and seven colleagues informed the agency it was promoting flawed data and excluding data that did not reinforce their narrative.

The letter warned the agency that misrepresenting data on trusted websites such as the CDC and the COVID-19 Real-Time Learning Network—jointly created by the CDC and Infectious Diseases Society of America (IDSA)—would "damage the credibility of science," endanger public trust by "misrepresenting the evidence," and give the public "false expectations" masking would protect them from the SARS-CoV-2 virus that causes COVID-19.

"We believe the information and recommendations as provided may actually put an individual at increased risk of becoming infected with SARS-CoV-2 and for them to experience a serious or even life-threatening infection," Mr. Osterhom wrote.

The authors urged the IDSA to remove the suggestion that masking prevents severe disease from its website and asked the CDC to reconsider its statements about the "efficacy of masks and face coverings for preventing transmission of SARS-CoV-2."

Osterholm also noted a pattern of selectively choosing data that supported the desired narrative that masks prevent severe COVID-19 disease and transmission—claims he said are unsupported by the scientific evidence provided by the CDC and IDSA on their websites.

The IDSA "Masks and Face Coverings for the Public" webpage appears to "focus on the strengths of studies that support its conclusions while ignoring their shortcomings of study design," Mr. Osterholm wrote. "Studies that do not support its perspective are similarly downplayed."

The COVID-19 Real-Time Learning Network was created in 2020 to share "accurate, timely information about COVID-19." According to its website, the IDSA's editorial team of infectious disease and public health experts synthesize clinical guidance, identify emerging scientific consensus and areas of ongoing uncertainty, and tackle "misconceptions and disinformation."

Although partly funded by the CDC, the IDSA collaborates with numerous medical professional organizations that publish medical journals and make recommendations based on agency guidance, including the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, the Society of Critical Care Medicine, the Society for Healthcare Epidemiology of America, and the Society of Infectious Diseases Pharmacists.

The letter was sent to CDC officials, the associate medical and associate digital editors of the COVID-19 Real-Time Learning Network, and IDSA board members, which included Dr. Rochelle Walensky, the former director of the CDC during the COVID-19 pandemic.

Experts Ask CDC and IDSA to Address 'Serious Errors' on Website

In his letter to the CDC, Mr. Osterholm asked the CDC and IDSA to address the "serious errors" published on its website regarding the efficacy of masks as soon as possible and strongly urged the IDSA to remove the suggestion that masking prevents severe COVID-19 from its website and a podcast where such "irresponsible claims were made."

Furthermore, Mr. Osterholm recommended the IDSA reconsider statements about the efficacy of masks and coverings for preventing SARS-CoV-2 transmission, noting the IDSA's website falsely suggests evidence of mask efficacy has strengthened throughout the pandemic.

"We do not agree that the evidence for their efficacy has strengthened throughout the pandemic, as the website suggests," Mr. Osterholm said. "In fact, contrary to the conclusion on this website, the November 2020 Cochrane Review cited states this: 'Compared with wearing no mask, wearing a mask may make little to no difference in how many people caught a flu-like illness (9 studies; 3,507 people); and probably makes no difference in how many people have flu confirmed by a laboratory test (6 studies; 3,005 people).'"

Osterholm said he and his colleagues are not "anti-mask" but wanted to see a more careful scientific review of the data showing the role masks may play in preventing SARS-CoV-2 transmission. They offered to help the IDSA update its review of the science. Instead, the IDSA and CDC modified their website to promote masking, stating: "Masking is a critical public health tool for preventing the spread of COVID-19, and it is important to remember that any mask is better than no mask."

The letter was part of documents obtained through the Freedom of Information Act (FOIA) by The Functional Government Initiative (FGI), an organization dedicated to "improving the American public's awareness about the officials, decisions, and priorities of their government."

"The story of official masking guidance should trouble the American public. Recall that Dr. Fauci at first said there was no need for masks. The cloth masks were all that stood between you and COVID. But as evidence against cloth masks appeared, the premiere scientific health organizations dug in their heels and refused to follow the science or listen to their trusted outside advisors," FGI said in a statement (pdf).

"That Dr. Osterholm and his colleagues felt compelled to raise concerns about cherry-picked data and the danger it presented to the credibility of public health officials and the health of the public says that something was deeply dysfunctional in these agencies," FGI stated.

The Epoch Times contacted the CDC for comment but did not receive a response.


Go Minnesota!
~A.