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A team of UC Davis scientists used dynamic total-body positron emission tomography (PET) to provide the first imaging of the human bodys immune response to COVID-19 infection in recovering patients. Their work, published in Science Advances, could lead to a better understanding of how the bodys immune system responds to viral infections and develops long-term protection against re-infection.
The researchers used the uEXPLORER total-body PET scanner. It is an innovative imaging technology developed at UC Davis in collaboration with United Imaging Healthcare.
Dynamic PET involves injecting very small amounts of radiotracers in the patient, followed by continuous imaging over a period of time. It essentially creates a movie showing the radiotracer kinetics (distribution over time) within the body. Mathematical models can then be applied to extract biologically-relevant information.
Total-body PET scanners enable simultaneous dynamic imaging and kinetic modeling in all body organs. They have significantly higher sensitivity than conventional PET systems. This translates into better image quality while enabling the use of lower radiotracer injection doses.
Dynamic total-body PET is currently the only available technology with acceptable radiation dose that allows noninvasive quantitative measurements of immune cell distribution and trafficking (movement) inside all tissues in living humans, said first author Negar Omidvari, assistant project scientist in the UC Davis Department of Biomedical Engineering.
The study presents the first use of dynamic PET and kinetic modeling to measure CD8+ T cell distribution in humans. CD8+ T cells are specific immune cells with CD8 protein on their surface. During a viral infection, nave (non-customized) CD8+ T cells become activated and cytotoxic. This means they find and kill infected cells. Some of these CD8+ cells develop into antigen-specific memory T cells for long-term protective memory against reinfection.
These cells circulate in the blood but mostly reside and function in non-blood tissues, particularly the lymphoid organs, such as the bone marrow, spleen, tonsils and lymph nodes.
There has been a growing interest in studying the critical role of CD8+ T cells in immune response and memory. However, evaluating immunological changes in non-blood tissue is challenging due to the invasive nature of biopsies. In some cases, it is not even practical in certain anatomical regions of living participants, such as the brain, spinal cord, cardiopulmonary tissue and vascular tissue, Omidvari said. So, the challenge was to find noninvasive quantitative methods for measuring CD8+ T cell distribution and trafficking in the body that are safe to also use in healthy people.
For the study, the researchers enrolled three healthy individuals and five patients recovering from COVID-19 infection. The recovering patients had mild or moderate symptoms and were not hospitalized.
The team injected the participants with a small amount of a radioactive liquid that includes an immunoPET radiotracer (89Zr-Df-Crefmirlimab) that targets human CD8. For each participant, the team took a dynamic 90-minute scan, a 60-minute scan at six hours, and a 60-minute scan at 48 hours after the injection. The recovering patients also did the same set of scans four months later.
The researchers measured the activity of the radiotracer in the blood and non-blood tissue on PET images. They did kinetic modeling to separate the effect of blood circulation on tissue. This allowed them to measure the radiotracer uptake in tissues independent of when the imaging was done and differences in the blood of each participant.
With the total-body PET, the researchers could do a noninvasive measurement of the T cell distribution with remarkable image quality throughout the whole body, in all tissue types. Their study showed a high uptake of CD8+ T cells in the lymphoid organs of all participants. The highest uptake was in the spleen, followed by the bone marrow, liver, tonsils and lymph nodes.
The most significant finding was the increased concentrations of CD8+ T cells in the bone marrow of recovering COVID patients compared to the healthy controls. In the follow-up imaging (acquired at 6 months post infection), these concentrations in recovering patients were slightly higher than those acquired at around 2 months post infection (baseline) in all bone marrow regions.
Bone marrow has been identified as a major pool and the preferred site for proliferation of memory CD8+ T cells following a viral infection. This trafficking of memory T cells to certain tissues like the bone marrow is critical to developing immune memory after viral infection, Omidvari explained.
The specificity of the immunoPET tracer combined with the high detection sensitivity of total-body PET provides a new platform for scientists to study the immune response and memory in all organs over the long term in a non-invasive way.
What is fundamentally important about this study is that it showed the potential of total-body PET to assess T-cell distributions across the entire human body, with the image quality necessary for detailed modeling, and with a radiation dose that is low enough to allow its broad application to study the immune response in humans, said Simon R. Cherry, a UC Davis physicist and distinguished professor emeritus of biomedical engineering and radiology. In our case, we were able to characterize the dynamics of this immunoPET tracer in healthy control subjects and in patients with infectious disease (COVID-19), which is an important first.
The team pointed to many potential applications for this method. It could be used to study the immune response during viral infection, immune memory after viral infection, and treatment response evaluation in cancer patients. It might also extend to studies of infectious disease, autoimmune disease and transplant, and can be used for prognosis as well as therapeutic and vaccine developments.
Watch Dr. Negar Omidvari explain the study: video
The studys co-authors from UC Davis are Terry Jones, April L. Ferre, Jacqueline Lu, Yasser AbedlHafez, Fatma Sen, Stuart Cohen, Ramsey D. Badawi and Barbara Shacklett. The other co-authors are Ian Wilson and Kristin Schmiedehausen of ImaginAb Inc. and Pat M. Price of Imperial College.
This work was supported by grants from the National Institutes of Health (NIH) (R01CA206187, R35CA197608), NIHs National Cancer Institute (NCI) (P30 CA0933730) and NIHs The National Center for Research Resources (NCRR) (S10 RR12964, S10 RR026825, S10 OD018223-01A1). It was also supported by James B. Pendleton Charitable Trust and ImaginAb Inc.
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What GAO Found
Most COVID-19 relief funds went to the intended recipients in the intended amounts. In other instances, significant funds went to those who engaged in fraud schemes. Federal fraud schemes consist of five key elements: (1) affected program, (2)participants, (3) types of fraud activities, (4)mechanisms to execute fraudulent activities, and (5) impacts. These elements represent the highest-level components in GAO's Conceptual Fraud Model. The model provides a common language and structure for describing fraud schemesincluding those affecting COVID-19 relief programsto support agency efforts to combat fraud.
Key Elements of an Example of a Fraud Scheme Involving Multiple COVID-19 Relief Programs
Federal agencies did not strategically manage fraud risks and were not adequately prepared to prevent fraud when the pandemic began. While eliminating all fraud is not a realistic goal, resources and requirements exist to support strategic fraud risk management. For example, GAO's Fraud Risk Framework and Antifraud Resource provide leading practices and interactive tools, respectively, to help agencies combat fraud. GAO's 142 recommendations to agencies to align their efforts with fraud risk management leading practices also provide a roadmap for action. GAO has also suggested actions Congress can take, such as reinstating agencies' reporting on fraud risk management and enhancing data analytic capabilities. These congressional actions and agencies' use of GAO resources to strategically manage fraud risk would position them to better prevent fraud in both normal operations and in emergencies.
Since March 2020, Congress and the Administration have provided trillions of dollars in COVID-19 relief funding to help the nation respond to and recover from the pandemic. Agencies across the federal government acted quickly to stand up new programs and greatly scale up existing programs.
The unprecedented demand for benefits and the need to quickly implement or expand programs increased the risk of fraud during the pandemic. There have also been cases of funds paid to those who sought to defraud the government. For example, from March 2020 through June 2023, at least 1,399 individuals or entities were found guilty or liable for fraud-related charges in cases involving federal COVID-19 relief programs.
Managing fraud risk is the responsibility of program managers and includes assessing the potential for fraud and implementing strategies to appropriately mitigate related fraud risks. Better understanding the nature of federal fraud schemes and the resources available to combat them can enhance agency efforts to prevent, detect, and respond to fraud risk during normal operations and emergencies.
This testimony discusses (1) key elements of federal fraud schemes and examples of schemes involving COVID-19 relief funds and (2) actions agencies and Congress can take to better prevent fraud during normal operations and emergencies.
GAO reviewed its prior COVID-19 findings and recommendations on internal controls and fraud risk management practices.
For more information, contact Rebecca Shea at (202) 512-6722 or shear@gao.gov.
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Please choose I'm not a medical professional. Allergy and Immunology Anatomy Anesthesiology Cardiac/Thoracic/Vascular Surgery Cardiology Critical Care Dentistry Dermatology Diabetes and Endocrinology Emergency Medicine Epidemiology and Public Health Family Medicine Forensic Medicine Gastroenterology General Practice Genetics Geriatrics Health Policy Hematology HIV/AIDS Hospital-based Medicine I'm not a medical professional. Infectious Disease Integrative/Complementary Medicine Internal Medicine Internal Medicine-Pediatrics Medical Education and Simulation Medical Physics Medical Student Nephrology Neurological Surgery Neurology Nuclear Medicine Nutrition Obstetrics and Gynecology Occupational Health Oncology Ophthalmology Optometry Oral Medicine Orthopaedics Osteopathic Medicine Otolaryngology Pain Management Palliative Care Pathology Pediatrics Pediatric Surgery Physical Medicine and Rehabilitation Plastic Surgery Podiatry Preventive Medicine Psychiatry Psychology Pulmonology Radiation Oncology Radiology Rheumatology Substance Use and Addiction Surgery Therapeutics Trauma Urology Miscellaneous
Posted By: Dan R October 20, 2023
Chaffee County Public Health has finally received its first shipment of Covid vaccine for those who have private insurance and are 12 years old and older.
Public Health also has Covid vaccine for those who are 6 months and older and are uninsured or underinsured.Chaffee Public Health will be offering additional extended clinic hours throughout the fall and winter season to meet local demand.
To make an appointment, call 539-4510.
You can now order free at-home Covid-19 tests.
Danny Dan R Ridenour has been in radio and television broadcasting for over 40 years, starting as a senior in high school in Rogers, Arkansas. His radio career has had stops in Nashville, Memphis, Oklahoma, and eventually, Colorado. Dan enjoys being involved in the community, having been a member of the Upper Arkansas Service Club and is currently on the board of directors for the Salida Community Center and is a member of the Chaffee County Fair Committee. He and his wife Carrie spend their days doing everything the mountains have to offer: hiking, camping, fishing and skiing. They've raised 3 children and have 2 grandchildren.
Pfizer (PFE -1.73%) and Moderna (MRNA -2.39%) have been in agreement on a lot since the beginning of the pandemic. They both recognized the importance of eventually launching combined vaccines -- such as those covering flu and coronavirus -- and consider them the ticket to stronger vaccine uptake. The vaccine leaders also have predicted the coronavirus vaccine market is likely to follow that of the flu market, with many Americans going for an annual jab.
But, in recent days, each company has made a statement showing they don't see eye to eye on one particular point. It has to do with something that offers us clues about long-term vaccine demand -- and revenue potential. Let's take a closer look at what both companies had to say and what that could mean for investors.
Earlier in the year, Pfizer and Moderna both made forecasts for annual vaccine sales. The companies recognized the declines in demand as we head toward a post-pandemic situation, but they still were able to offer an estimate of what the market might look like this year. Both companies collect some revenue from government contracts, but they also now are selling doses directly to healthcare providers in what's known as a commercial market.
Pfizer and Moderna originally launched coronavirus vaccines back in late 2020 and since have generated billions of dollars in earnings. In recent times, though, the big question has been whether these players will continue to bring in significant revenue from their vaccines into the future. Both companies, which recently launched updated vaccines, say this year's vaccination season could offer clues.
Now, let's get to the point that separates Pfizer and Moderna. Pfizer just recently cut its forecasts for sales of its coronavirus vaccine, Comirnaty, this year by $2 billion based on trends it's seeing in the market. It originally had predicted $13.5 billion in vaccine sales for the year. In a call with investors, the company said today it assumes about 17% of Americans will go for a COVID shot this fall.
After Pfizer's move, Moderna issued a statement saying it sticks by its vaccine sales guidance range of $6 billion to $8 billion this year. This is in the context of 50 million to 100 million doses administered, which represents about 15% to 30% of the U.S. population. Moderna also said it's too early in the vaccination season to make a more precise estimate.
At this point, we could say Moderna from the start may have been a bit more cautious by issuing a wide forecast for vaccine sales this year.
Meanwhile, Pfizer's observations so far pushed the company to launch a plan to realign costs with its future revenue opportunity. The big pharma aims to save at least $3.5 billion.
As for costs, Moderna might be in a stronger position because its entire pipeline may benefit from the investments it's made in research and development and infrastructure for the coronavirus program. That's because the mRNA technology used in the vaccine is used across Moderna's pipeline. For example, Moderna aims to build a billion-dollar respiratory vaccine franchise so the investments it's made so far for its coronavirus vaccine are and will be useful for these additional products.
Pfizer also is working on other mRNA candidates -- but this technology isn't the backbone of its entire pipeline. And that means the investments in the coronavirus vaccine platform won't necessarily serve all of its programs -- and Pfizer is right to realign costs.
Pfizer sees now as the moment to make initial observations about this fall's vaccine demand -- and take action. Moderna says it's too early to draw any conclusions. Considering each company's business, as I talked about above, they both are right.
So, as an investor, there's reason to be confident about Pfizer and Moderna and the way they're handling the current situation. And both of these companies offer solid long-term prospects beyond the vaccine. They aim to launch several new products over the next few years that should translate into billions of dollars in revenue.
Of course, shares of Pfizer and Moderna probably won't recover overnight as investors focus on vaccine trends and sales. But, the investors who decide to get in on these stocks today, while they're down, may reap rewards over time -- once the focus shifts from the vaccine to the companies' entire pipeline.
Adria Cimino has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Pfizer. The Motley Fool recommends Moderna. The Motley Fool has a disclosure policy.
In a recent study published in Emerging Infectious Diseases, researchers used dogs to investigate the histopathologic alteration caused by the severe acute respiratory syndrome coronavirus 2 (SARSCoV2) on mammalian neurological systems.
Study:Neurologic Effects of SARS-CoV-2 Transmitted among Dogs. Image Credit:el-ka/Shutterstock.com
Their findings reveal that infection by SARS-CoV-2 results in significant damage to the brain, especially concerning the blood-brain barrier.
They further discovered the presence of phosphorylated tau, a protein linked to neurodegenerative alternations in mitochondria. Researchers observed these changes in both symptomatic and asymptomatic dogs.
Given the similarity between the histopathology of SARS-CoV-2 across both human and non-human hosts, these findings may provide insights into the neurological effects of the coronavirus disease 2019 (COVID-19) on the brains of its human survivors.
Since the emergence of the coronavirus disease 2019 (COVID-19) in late 2019, most severe acute respiratory syndrome coronavirus 2 (SARSCoV2), its causative pathogens hosts, have been human.
However, given that the angiotensin-converting enzyme 2 (ACE2) receptor of many mammals is highly conserved and very similar to those of humans, animals such as cats, non-human primates, rodents, and dogs have been infected.
The World Health Organization (WHO) reports almost 750 million confirmed cases of COVID-19 in humans, 7 million of which were lethal.
Scientific and clinical studies conducted on cohorts of survivors reveal that, in addition to COVID-19 symptoms that persist for months or even years following infection (long COVID), some survivors present neurological symptoms, including fatigue, headaches, and cognitive dysfunction.
Magnetic resonance imaging (MRI) of some of these individuals brains has revealed white matter hyperintensities indicative of blood-brain barrier (BBB) damage.
Other research has identified markers of neuroinflammatory responses, damage to the brains coagulatory systems, and microglial cell activation. Similar patterns of ARs-CoV-2 pathology have been reported in murine models.
The etiology of neuropathologic changes following COVID-19 infection, however, remains elusive. Protein modeling has confirmed that ACE2 in dogs can bind to human SARS-CoV-2, which epidemiological and genetic studies have discovered allows cross-species transmission from humans to their four-legged friends.
Mutant strains of SARS-CoV-2 in dogs cause histopathologic changes in lung tissues and increased expression of muscle damage markers in the blood.
Given their close similarity, the patterns of neuropathologic damage in humans and dogs are hypothesized to be alike. Studies on the effects of COVID-19 on dogs may provide glimpses into the mechanisms underpinning SARS-CoV-2-induced neural damage in humans.
In the present study, researchers used canine transmission models to elucidate dogs susceptibility to the Delta variant of SARS-CoV-2. Fifteen 6-month-old beagles (female) were divided into three cohorts Control (n = 3), infection (n = 6), and contact (n = 6).
Dogs in the infection cohort were intranasally inoculated (105 PFU of Delta variant) and subsequently placed in cohabitation with a dog from the contact cohort to mimic natural transmission models in humans.
Once the infection in the contact cohort was established, researchers used quantitative reverse-transcription PCR to investigate SAR-CoV-2 nucleic acid in the dogs brains and immunofluorescence assays to observe the presence of viral particles.
To monitor the continuous spectrum of changes accompanying COVID-19 infection, nasopharyngeal, fecal swab, oropharyngeal, and blood samples were collected at 10, 12, 14, 38, 40, and 42 days postinfection (dpi) for use in experiments across day 4 through 35 dpi.
The complete cohort of tests included immunohistochemistry, immunofluorescence staining, quantitative reverse transcription PCR, enzyme-linked immunosorbent assay (ELISA), and the plaque reduction neutralization test. All experiments were conducted in triplicate. Finally, statistical analyses involved using plotted dose-response curves and Student t-tests.
The present research found no significant change between dogs body weight and temperature before and after Delta variant infection. All of the dogs were neurologically and respiratorily asymptomatic for COVID-19 infection.
Quantitative reverse-transcription PCR and immunofluorescence assays detected the presence of viral particles in the brain during the early- but not late stages of the infection period.
Our observations indicate that SARS-CoV-2 may infect the brain during the early infection period and may be cleared by the later infection period.
Modified immunofluorescence assay using antibodies specific to the blood-brain barrier (BBB) compartments revealed loss of matrix (laminin and collagen IV) and tight junction (claudin 5) proteins.
Platelet-derived growth factor receptor-beta (PDGFR- ) densities were lower during the late stages of viral infection, suggesting damage to the BBB.
Last, infiltration of CD4+ T cells was found in the brain by trespassing into the BBB matrix protein layer, suggesting severe damage to the BBB integrity and subsequent recruitment of these cells into the brain. Those observations indicate that SARS-CoV-2 infection could induce pathologic changes in the structural and functional integrity of the BBB.
Together, these damages would allow immune cells and peripheral molecules to cross the BBB, resulting in small vessel disease (SVD).
Glial activation investigative staining revealed significant increases in the brain white matter of dogs from the infected cohorts compared to the controls, suggesting the COVID-19 infection could instigate neuroinflammatory responses, thereby promoting neurodegenerative pathology.
Tau is a family of major microtubule-associated proteins (MAPs) of a normal mature neuron and a hallmark of the Alzheimers condition. To evaluate tauopathy in COVID-19-infected brains, phosphorylated tau staining was employed.
we detected phosphorylation of tau at Ser202/Thr205 by using an AT8 antibody in the brains of dogs in the infection group during the early period and dogs in the infection and contact groups during the late period. Those results suggest that SARS-CoV-2 infection could induce accumulation of the pathologic form of tau in a site-specific manner.
Finally, decreases in the number of neuronal cells in the infected cohorts during later infection periods reinforce damage to the BBB and SVD.
The present research uses canine models to gain insight into the neurodegenerative changes occurring in mammalian brains as a proxy for human neuronal impairment.
Their findings reveal that the Delta variant of SARS-CoV-2 can infect dogs by direct contact and dog-to-dog transmission. This study also suggests that long-COVID-19-like symptoms may plague canine survivors.
Their findings highlight viral damage to the BBB and that neuroinflammatory responses are prominently localized to the white matter, not the grey matter.
Overall, these data can be used as translational research data to interpret the potential neuropathologic changes that may be observed in humans.
The president of a Silicon Valley-based medical technology company was sentenced today to eight years in prison and ordered to pay $24 million in restitution for participating in a scheme to defraud investors and a scheme to commit health care fraud and pay illegal kickbacks in connection with the submission of over $77 million in claims for COVID-19 and allergy testing.
A Silicon Valley executive exploited the pandemic for profit, ultimately endangering patients with unproven COVID-19 tests, said Acting Assistant Attorney General Nicole M. Argentieri of the Justice Departments Criminal Division. The Department of Justice is committed to protecting the people of this nation by investigating and prosecuting those who put public health at risk and use global emergencies to line their own pockets.
Schena put profit over public safety. He used the global pandemic as a backdrop to fuel a kickback scheme and a massive fraud upon investors and people searching for better health care during a time of great uncertainty, said U.S. Attorney Ismail J. Ramsey for the Northern District of California. Even in times of national crisis, our office will ensure that Silicon Valley remains a place where innovation and ingenuity and not fraud and deceit fuel vibrant markets for investors and inventors.
According to court documents, Mark Schena, 60, of Los Altos, California, was the president of Arrayit Corporation. Schena engaged in a scheme to defraud Arrayits investors by claiming that he had invented a revolutionary technology to test for virtually any disease using a single drop of blood from a finger stick sample. In meetings with investors, Schena and his publicist claimed that Schena was the father of microarray technology and that he was on the shortlist for the Nobel Prize. Schena also falsely represented to investors that Arrayit could be valued at $4.5 billion.
Todays outcome illustrates HHS-OIGs unwavering commitment to protecting federal health care programs under any circumstance especially when a public health emergency presents opportunities for bad actors to exploit, said Deputy Inspector General for Investigations Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). We continue to work tenaciously with our law enforcement partners to bring to justice those who have constructed schemes to take advantage of the COVID-19 pandemic for personal gain.
Every time theres a disaster of some type, scammers climb out of the woodwork with schemes to bilk people out of their money, said Postal Inspector in Charge of Criminal Investigations Eric Shen of the U.S. Postal Inspection Service (USPIS). In this case, Mark Schena and the Arrayit Corporation were already involved in deceiving the public before the COVID-19 pandemic hit. When the pandemic hit, the company then attempted to develop a COVID-19 antibody test but were unsuccessful. Despite having no product and on the verge of bankruptcy, Schena continued to defraud investors, claiming to have multimillion-dollar contracts and other business developments that all proved to be bogus.
In furtherance of the scheme, Schena failed to release Arrayits financial disclosures as required by the Securities and Exchange Commission (SEC) and concealed that Arrayit was on the verge of bankruptcy. Schena lulled investors who were concerned that the company was a scam by engaging in television appearances and filming videos that fraudulently portrayed the laboratory as busy and high-tech. Schena also issued false press releases and public statements on social media that Arrayit had entered into lucrative partnerships with companies, government agencies, and public institutions, including a childrens hospital and a major California health care provider. The press releases and statements falsely claimed that such entities had agreed to use the Arrayit technology, when in fact no such agreements existed or were of minimal value.
Those who used the pandemic for illicit profit by engaging in health care fraud and defrauding investors must face the consequences of their actions, said Assistant Director Luis Quesada of the FBIs Criminal Investigative Division. The FBI and its partners will work relentlessly to protect the American people from abuses to our financial and health care systems, and this sentencing reflects those efforts.
Schena also orchestrated an illegal kickback and health care fraud scheme that involved submitting fraudulent claims to Medicare and private insurance for unnecessary allergy testing. Arrayit ran allergy screening tests on every patient for 120 different allergens regardless of medical necessity. To obtain patient blood specimens, Schena paid kickbacks to marketers in violation of the Eliminating Kickbacks in Recovery Act and orchestrated a deceptive marketing plan that falsely claimed that the Arrayit test was highly accurate in diagnosing allergies, when it was not, in fact, a diagnostic test. The Health Care Fraud Units Data Analytics Team supported the prosecution and, as the evidence at trial showed, Arrayit billed more per patient to Medicare for blood-based allergy testing than any other laboratory in the United States.
This sentence holds the defendant accountable for his large-scale fraud scheme that impacted multiple federal agencies and robbed the taxpayers of millions of dollars, said Inspector General Michael J. Missal of the Department of Veterans Affairs Office of Inspector General (VA-OIG). The VA-OIG will continue to work zealously with our law enforcement partners to ensure schemes like this are uncovered, investigated, and prosecuted to the fullest extent of the law.
Mr. Schenas sentencing is a fitting resolution that holds him accountable for a multimillion-dollar fraudulent scheme driven purely by greed and devoid of fiscal responsibility or concern for the patients that would ultimately use his nearly useless products, said Director Kelly P. Mayo of the Department of Defense (DoD) Office of Inspector General, Defense Criminal Investigative Service (DCIS). DCIS remains committed to working with its partners to identify and eliminate fraudulent schemes that potentially endanger patient safety and corrupt the integrity of TRICARE, the DoDs health care program.
In early 2020, Schena falsely announced that Arrayit had a test for COVID-19. Schena told federal agents that it was simple to develop a test for COVID-19 because the switch from testing for allergies to testing for COVID-19 was like a pastry chef who switches from selling strawberry pies to selling rhubarb and strawberry pies. Seeking to capitalize on the nationwide shortage of COVID-19 testing, Schena orchestrated a deceptive marketing scheme that falsely claimed that Dr. Anthony Fauci and other prominent government officials had mandated testing for COVID-19 and allergies at the same time, and required that patients receiving the Arrayit COVID-19 test also be tested for allergies. Schena also concealed from investors and patients that the Food and Drug Administration had informed him that the Arrayit test was not accurate enough to receive an Emergency Use Authorization for use in the United States.
A federal jury convicted Schena on Sept. 6, 2022.
The HHS-OIGs San Francisco and Detroit Regional Offices, USPIS, FBI, VA-OIG, and DCIS investigated the case.
Principal Assistant Chief Jacob Foster and Trial Attorney Laura Connelly of the Criminal Divisions Fraud Section and Assistant U.S. Attorney Christina Liu for the Northern District of California prosecuted the case.
The Fraud Section leads the Criminal Divisions efforts to combat health care fraud through the Health Care Fraud Strike Force Program. Since March 2007, this program, comprised of 15 strike forces operating in 25 federal districts, has charged more than 5,000 defendants who collectively have billed federal health care programs and private insurers more than $24 billion. In addition, the Centers for Medicare & Medicaid Services, working in conjunction with HHS-OIG, are taking steps to hold providers accountable for their involvement in health care fraud schemes. More information can be found at www.justice.gov/criminal-fraud/health-care-fraud-unit.
The Fraud Section uses the Victim Notification System (VNS) to provide victims with case information and updates related to this case. Victims with questions may contact the Fraud Sections Victim Assistance Unit by calling the Victim Assistance phone line at 1-888-549-3945 or by emailing Victimassistance.fraud@usdoj.gov. To learn more about victims rights, please visit www.justice.gov/criminal-vns/victim-rights-derechos-de-las-v-ctimas. If you believe you are a victim who has invested in Arrayit, or you have taken a COVID-19 test prepared or marketed by Arrayit, please visit www.justice.gov/criminal-vns/case/Arrayit.
Transit agencies nationwide have led a historic response to the COVID-19 pandemic. As the industry continues to recover and adapt, transit agencies are implementing new and enhanced measures to ensure the safety of their employees and passengers and increase public confidence in transit. FTA is committed to helping the public transportation industry in the U.S continue to recover and adapt.
The Bipartisan Infrastructure Law requires that transit agencies subject to the Public Transportation Agency Safety Plans (PTASP) regulation include strategies in Agency Safety Plans (ASP) to minimize exposure to infectious diseases, consistent with guidelines from the Centers for Disease Control and Prevention (CDC) or a State health authority.
FTA encourages each transit agency to consider identifying mitigations or strategies related to exposure to infectious diseases and other respiratory hazards such as smoke or residue from controlled substances through the Safety Management System (SMS) Safety Risk Management process described in the agencys ASP.
Transit agencies may find the following resources useful as sources of hazard identification data and potential mitigations to inform the Safety Risk Management process. This list is non-exhaustive and is provided for technical assistance only.
The content linked below is available for historical purposes. FTA is no longer updating this content and it may not reflect current COVID-19 guidance.
From March 2020 to September 2022, FTA collected information from FTA recipients and subrecipients on the impacts of COVID-19, including transit workforce counts, service impacts, and transit worker positives, fatalities, and recoveries. All agencies that provided transit service and submit reports to the National Transit Database as urban reporters or tribal transit agencies reported this information directly. State recipients of Section 5311 grants are reported on behalf of their applicable subrecipients. FTA used this data to inform FTA actions in support of the transit industrys COVID-19 response and recovery efforts and implementation of the federal mask requirement for public transportation.
While reporting is no longer required, agencies may access previously submitted baseline and recurring forms on FTAs Transit Integrated Appian Development Platform for information and to update any previous responses as needed.
From January 2021 to April 2022, the federal government required masks on public transportation conveyances and at transportation hubs. As a result of a court order, effective April 18, 2022, the CDC's January 29, 2021 Order requiring masks on public transportation conveyances and at transportation hubs is no longer in effect. As of April 18, 2022, the CDC stopped enforcing its Order, and the Transportation Security Administration (TSA) stopped enforcing its mask-related security directives.
This does not preclude transit agencies or local governing bodies from implementing their own requirements for face masks. Transit agencies may continue to recommend or require face masks on public transit. The CDC continues to recommend that people wear masks in indoor public transportation settings.
