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A Dead Man Speaks...
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Just ahead of tonight's episode of our Yuletide Tale for Our Time, we have
a helpful public-service announcement from the Brit Wanker Coppers: Are we
allow...
1 day ago
Sunday, December 8, 2024
Derrick Max: Your December 8, 2024 Sunday Summary: Election Certified, Bipartisanship in VA, VPAP Index, Republican Infighting, Safety Inspections, Standards, Green Extremism, WMATA...and more!
Current NEWS from Virginia Christian Alliance for 12/08/2024
Prayer and Repentance at the Bell Tower in Richmond, Thursday December 12 at 12 PMBy Virginia Christian Alliance on Dec 07, 2024 09:33 am Please help us bring attention to this crisis! America's Black Robe Regiment is leading one hour of Prayer and Repentance at the Bell Tower in...Read in browser »   |
Saturday, December 7, 2024
You're Invited! Join Fellow Conservatives for AFP's Annual Christmas Gathering @ The English Inn | RSVP Soon!
Merry Christmas Greetings to You!
You are cordially invited to Americans for Prosperity's Annual Christmas Gathering! A great occasion bringing fellow freedom focused citizens together for the holidays.
We're excited to host this year's event at The English Inn of Charlottesville on Sunday, December 15th. Located at 2000 Morton Drive near the Rt 29/Emmett Street interchange next to Bodo's. Feel free to come by anytime 3:30-5:30pm. And, you are welcome to bring a guest.
This is a complimentary event for all to attend. Please RSVP in advance for the event. Contact Flint Engleman at FEngleman@afphq.org or call/text (540)226-4591.
Enjoy good cheer, delicious holiday buffet from Foods of All Nations, festive music, and fun Christmas décor alongside fellow conservatives. Plus, hear from Senior Director Flint Engleman for a preview of AFP's legislative agenda for the 2025 Virginia General Assembly.
RSVP today by contacting Flint Engleman at FEngleman@afphq.org or call/text (540)226-4591
12th Annual Christmas Gathering
Sunday, December 15th 3:30-5:30PM
The English Inn of Charlottesville
2000 Morton Drive, Charlottesville
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Orthomolecular News: A Paradigm Shift in Epidemic and Chronic Disease Management
Richard Z. Cheng, M.D., Ph.D.
Abstract
The COVID-19 pandemic and the American (and global) chronic disease epidemic have exposed critical failures in the current medical system, particularly within institutions like the FDA, CDC, and NIH. Their reliance on outdated approval processes and pharmaceutical-centric approaches has hindered innovation and neglected safe, accessible, and potentially effective treatments. This paper highlights the shortcomings in addressing epidemics and chronic diseases, emphasizing the need for a Toolkit Approach—prioritizing therapies that are safe, effective (or plausibly effective), affordable, and available. A paradigm shift is proposed to foster integrative and inclusive healthcare strategies that address root causes and unmet medical needs.
Introduction
The dual crises of the COVID-19 pandemic and the chronic disease epidemic have revealed the limitations of modern medicine's ability to respond effectively. Despite advancements, many diseases remain without satisfactory treatments, and the institutions responsible for public health, such as the FDA, CDC, and NIH, have failed to adapt to emerging challenges. This failure stems from rigid regulatory frameworks, an overreliance on pharmaceutical interventions, and a lack of support for integrative approaches such as orthomolecular medicine.
This paper summarizes these failures and proposes a new, inclusive healthcare model built on the Toolkit Approach. By emphasizing safe, accessible, and effective solutions, this model addresses gaps in epidemic and chronic disease management while promoting patient-centered care.
Failures of the Current Medical System
1. Epidemic/Pandemic Management Failures
- Slow Response During COVID-19: The FDA and CDC failed to approve or promote promising therapies such as high-dose Vitamin C (HDVC), despite its safety, affordability, and preliminary evidence of efficacy. Instead, they focused solely on vaccines, leaving populations vulnerable for months to years.
- Outdated Regulatory Frameworks: The insistence on lengthy approval processes delayed the adoption of safe and potentially effective treatments during a global emergency.
- Neglect of Integrative Therapies: Nutritional and lifestyle-based interventions, which could bolster immune resilience, were largely ignored despite their potential to reduce morbidity and mortality.
2. Chronic Disease Management Failures
- Pharmaceutical-Centric Approach: Chronic disease management has focused on symptom suppression rather than addressing root causes like oxidative stress, inflammation, and nutritional deficiencies.
- Underutilization of Preventative Strategies: Institutions have failed to prioritize preventative measures, such as promoting nutrient optimization and lifestyle modifications, which could mitigate the rising burden of chronic diseases.
- Economic Barriers: The prioritization of high-cost pharmaceutical treatments has sidelined affordable and accessible options like nutritional therapies.
The Toolkit Approach
The Toolkit Approach offers a flexible and patient-centered framework for addressing chronic diseases and epidemics. It prioritizes therapies based on three critical criteria:
1. Safety
- Treatments must demonstrate a strong safety record to minimize patient risk.
- High-dose Vitamin C, Vitamin D3, and other nutrient-based interventions have decades of clinical use with minimal adverse effects.
2. Effectiveness or Probable Effectiveness
- Therapies should have demonstrated efficacy or plausible potential through clinical, observational, or historical data.
- Even without large-scale trials, preliminary evidence and historical use justify compassionate application during emergencies or for diseases without satisfactory treatments.
3. Affordability and Availability
- Interventions must be economically viable and scalable for widespread use.
- Nutritional therapies and integrative approaches are cost-effective alternatives to expensive pharmaceuticals, ensuring equitable access.
Key Points from the Toolkit Approach in Action
1. High-Dose Vitamin C (HDVC)
- Proven to reduce oxidative stress and inflammation, HDVC has shown efficacy in managing severe viral infections and improving outcomes in ICU patients.
- Despite its potential, HDVC was sidelined during the COVID-19 pandemic due to regulatory inertia.
2. Nutritional Interventions
- Supplementation with Vitamin D3, zinc, and magnesium strengthens immune function and addresses deficiencies linked to chronic diseases.
3. Detoxification Protocols
- Removing environmental toxins and heavy metals mitigates their role in disease progression.
4. Preventative Care
- Prioritizing lifestyle changes, such as reducing sugar intake and promoting physical activity, can prevent the onset of chronic diseases.
Proposed Paradigm Shift
To overcome the failures of the current medical system, we propose a paradigm shift that emphasizes inclusivity, flexibility, and patient empowerment:
1. Reform the FDA and CDC
- Streamline approval processes for treatments with strong safety profiles, enabling timely access during public health emergencies.
- Broaden the scope of accepted interventions to include integrative and orthomolecular therapies.
2. Expand the Toolkit Approach
- Encourage the use of therapies that meet the criteria of safety, effectiveness, affordability, and availability.
- Promote research and innovation in integrative medicine to complement conventional treatments.
3. Shift Focus to Prevention and Root Causes
- Address underlying mechanisms like oxidative stress, inflammation, and immune dysfunction through holistic approaches.
- Invest in public health initiatives that prioritize nutrition, exercise, and detoxification.
Conclusion
The failures of the FDA, CDC, and NIH in managing both epidemics and chronic diseases highlight the need for a transformative approach. The Toolkit Approach offers a pragmatic, adaptable framework for healthcare, focusing on safe, effective, affordable, and accessible solutions. By adopting this paradigm shift, we can bridge the gaps in chronic disease management and epidemic control, fostering a more inclusive and patient-centered healthcare system that prioritizes prevention and holistic well-being.
Robert W Malone MD from "Who is Robert Malone": AFTER ACTION REVIEW OF THE COVID-19 PANDEMIC: Recommendations From The U.S. House of Representatives
Below is action action review by the Select Subcommittee on the Coronavirus Pandemic. These are the recommendations that the U.S. House of Representatives is making to the Federal Government for further action.
(Note: The document below has not been altered, edited or written by Dr. Robert Malone or Malone.news. This is the review and recommendations of the Select Subcommittee, as written into the Congressional Record on December 4, 2024). Dr. Robert Malone and Malone.news does not endorse and specifically disagrees with some of these conclusions and recommendations, particularly relating to Operation Warp Speed and the discarding of internationally developed regulatory norms and processes.
AFTER ACTION REVIEW OF THE COVID-19 PANDEMIC:
Recommendations (from the Select Subcommittee on the Coronavirus Pandemic.)
December 4, 2024
The Origins of the Coronavirus Pandemic, Including but Not Limited to the Federal Government's Funding of Gain-of-Function Research Recommendations Regarding Investigating the Origins of COVID-19
1. The U.S. Intelligence Community should continue its investigation into the origins of COVID-19.
a. The U.S. Intelligence Community should continue to pursue the origins of COVID-19, to include intelligence collection regarding activities at the Wuhan Institute of Virology and Wuhan Centers for Disease Control and Prevention, specifically regarding activities conducted immediately preceding the COVID-19 pandemic.
b. The U.S. Intelligence Community should continue to pursue the origins of COVID-19, to include intelligence collection regarding the knowledge and actions of the government of the People's Republic of China, including but not limited to local and provincial governments.
2. The Office of the Director of National Intelligence should declassify, to the extent allowable by law, information related to COVID-19's origins. The Office of the Director of National Intelligence must abide by S. 619, the COVID-19 Origin Act of 2023, and declassify "any and all information related to the potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019 (COVID-19)…"
3. The Federal Government should do a holistic review of the origins of COVID-19. The White House should conduct a thorough and comprehensive internal review of all documents and information in the custody and control of the following agencies regarding the origins of COVID-19, EcoHealth Alliance, Inc, and funding of gain-of- function research:
a. U.S. Department of Health and Human Services, to include the U.S. National Institutes of Health and U.S. Centers for Disease Control and Prevention;
b. U.S. Department of State, to include the U.S. Agency for International Development;
c. U.S. Department of Homeland Security;
d. U.S. Department of Justice, to include the Federal Bureau of Investigation;
e. U.S. Department of Defense, to include the Defense Intelligence Agency and the
Defense Advanced Research Projects Agency;
f. U.S. Department of Energy, to include the network of National Laboratories; and the
g. U.S. Intelligence Community, to include the Central Intelligence Agency.
Recommendations Regarding Gain-of-Function Research
1. The Federal Government must take steps to pause and subsequently regulate high- risk pathogen research to increase safety and decrease the risk of an accident. Evaluate pausing all high-risk pathogen research until new regulations and biosafety and biosecurity measures can be designed and implemented.
a. Provide further scrutiny to high-risk pathogen research that involves recombinant or chimeric research, regardless of pathogen host, to include government review and oversight.
b. Evaluate increasing laboratory and fieldwork biosafety and security standards for all life sciences research.
c. Evaluate whether the United States needs a single, unified regulatory scheme governing gain-of-function and dual use research, regardless of funding source.
d. Evaluate removing final approval authority for high-risk pathogen research proposals from the funding agency and instead empower an independent oversight entity to review, approve, and oversee such experiments.
e. Impose increased transparency requirements for high-risk pathogen research so that federal and federally funded entities can no longer withhold critical information from Congress and the public.
2. Using artificial intelligence or machine learning should be encouraged as a substitute for traditional high-risk pathogen research. The Federal Government must encourage the use of artificial intelligence and machine learning in high-risk virology research and restrict the use of live viral research to only necessary uses to reduce the likelihood of a laboratory or research related accident or infection.
Recommendations Regarding EcoHealth Alliance, Inc
1. The Federal Government must ensure that no more U.S. taxpayer dollars go to EcoHealth Alliance, Inc or Dr. Peter Daszak and that they are held accountable. As of December 4, 2024, the U.S. Department of Health and Human Services has preliminarily suspended and proposed for debarment both EcoHealth Alliance, Inc., as an institution, and Dr. Peter Daszak, as an individual. The U.S, Department of Health and Human Services must formally debar both EcoHealth Alliance, Inc. and Dr. Peter Daszak for the maximum time allowable.
2. The Department of Justice must evaluate if Dr. Peter Daszak violated any federal laws, including but limited to violations of:
a. 18 U.S.C. 1001;
b. 18 U.S.C. 1621; and
c. 31 U.S.C. 3729-3733.
Recommendations Regarding the Federal Government.
1. The Federal Government must continue to prioritize grant oversight and compliance efforts. Evaluate the resources allocated to grant oversight and compliance to ensure adequate government-wide grant enforcement and proper investigations of grant compliance.
a. Ensure that the annual grant reporting process is timely, transparent, and streamlined, to include a public repository of all annual reports filed pursuant to taxpayer funded grants.
b. Evaluate policies to ensure federal funded research can be replicated successfully and reward researchers whose research is routinely successfully replicated.
c. Include excessive or unanticipated pathogen growth conditions as a term of award in all high-risk pathogen grants, these terms must include how the grantee should measure growth, when the grantee should measure growth, and how and when that growth is to be reported to the funding agency. Any experiments that exhibit excessive or unanticipated growth must be reported to Congress within 48 hours of the funding agency receiving the report from the grantee.
d. Update applicable U.S. biosafety and security standards to include a biosafety level for research with bat-borne coronaviruses.
e. Include applicable U.S. biosafety and biosecurity standards as a term of award in all high-risk pathogen grants, especially those with a foreign component or collaborator.
f. Evaluate new terms of award, regulations, or grant conditions to ensure the safety and humane treatment of laboratory animals in domestic and foreign labs.
g. Require grantees in all high-risk pathogen grants produce all metadata, underlying data, laboratory notebooks, or other information pertinent to the federal funded activity within 48 hours at the funding agencies request.
2. Restructure the U.S. National Institutes of Health to provide for great accountability and transparency. Consider whether the U.S. National Institute of Allergy and Infectious Diseases should be divided into at least two institutes, one focusing on infectious disease and one focusing on allergies.
a. Evaluate whether leadership of the institutes and centers of the U.S. National Institutes of Health should be subject to term or years of service limits.
3. Increase accountability, security, and transparency in the federal grant peer review process. Consider granting the Director of the U.S. National Institutes of Health or the Secretary of the U.S. Department of Health and Human Services, in consultation with the Office of the Director of National Intelligence and the Director of the funding Institute, authority to immediately suspend, pending investigation, a grant determined to be a threat to national security.
a. Incorporate a national security or Office of the Director of National Intelligence review into the grant making process for grants that involve, in any way, countries of particular concern or special watch list countries.
b. Provide transparency and accountability to the grant process by assigning one funding agency official to be accountable for approving federal funding for grants and making those decisions, and the peer review process more transparent to Congress and the public.
c. Allow federal funded research peer review process to be more open to include more researchers and scientists to ensure research is being thoroughly and impartially reviewed.
The Efficacy, Effectiveness, and Transparency of the Use of Taxpayer Funds and Relief Programs to Address the Coronavirus Pandemic, Including Any Reports of Waste, Fraud, or Abuse
1. Federal Agencies Cannot Rely on "Self-Certification" and Must Implement Modern Digital Identification Programs: Whether for regular, recurring government benefits or for the extraordinary benefits that were disbursed during the pandemic, federal agencies must verify eligibility of applicants through either commercially available or government-developed identification verification applications. Federal agencies should implement proper cross-matching of applicant data with available databases immediately to be effective in the scenario of future emergency relief funds. Update legacy systems within federal agencies to give them the ability to perform cross-matching for such a large volume of claims.
2. Office of Management and Budget (OMB) Effective Control Measured Should be Implemented: Require OMB to provide detailed guidance for federal agencies to develop internal control plans that can be put to immediate use for future emergency funding and require agencies to report such plans to OMB and Congress. These internal control plans should be standardized across all agencies and include procedures for verifying eligibility, monitoring fund usage, and detecting fraud.
3. SBA Should Implement a Fraud-Risk Program: When SBA is engaged in contingency operations to disburse funds as it was during the pandemic, it needs to assign trained staff to focus on fraud risk management and oversee improper payments and fraud. This includes leveraging analytics programs to identify patterns of fraud or abuse across applications.
4. SBA Must Instruct Lenders on How to Combat Fraud and Require Internal Controls: During the disbursement of various pandemic relief funds and loans, SBA assumed lenders had prior internal control measures in place for mitigating waste, fraud, and abuse in loans. While some lenders may have some controls, not all did. SBA should develop uniform guidance and minimum levels of internal controls in order for lenders to be eligible to administer relief loans.
5. Require Sole Proprietors and Contractors to Provide Employer Identification Numbers (EINs): EINs must be provided when applying for future emergency relief programs, such as EIDL loans. Do not allow applicants to self-certify the number of employees at their company to receive additional relief funds based off a falsified SSN or EIN.
6. Federal Agencies Must Integrate Frad-Risk Assessments Before Disbursing Funds to Applicants: Federal agencies should not disburse funds to applicants without proper implementations of fraud risk assessments outlined by the Select Subcommittee, and the agency's IGs. Fraud risk assessments should involve identifying, analyzing, and mitigating potential vulnerabilities in the program's funding process.
7. Establish Agreements with Other Agencies to Securely Share Data and Streamline Eligibility Verification: For example, make the U.S. Department of Treasury's do-not- pay list available to all agency's OIGs to verify identities and the eligibility of individuals and organizations seeking emergency relief funding prior to issuing payments.
8. Amend the Social Security Act to Allow full Death Data to be Shared Between the Social Security Administration and Treasury. Authorize the SSA to share the Full Death Master File (DMF) with the Treasury and other federal agencies for program integrity purposes. Sharing complete death records ensures that federal agencies can quickly identify and stop payments made to deceased beneficiaries. Ensure timely updates to federal databases, reducing overpayments and the risk of fraud. Minimize financial losses due to improper payments, which cost taxpayers billions.
The Implementation or Effectiveness of Any Federal Law or Regulation Applied, Enacted, or Under Consideration to Address the Coronavirus Pandemic and Prepare for Future Pandemics
1. Expand and Improve the Office of Pandemic Preparedness and Response: Created after the COVID-19 pandemic, the Office Pandemic Preparedness and Response (OPPR) is a good start, but only focusses on two of five biodefense strategy objectives.
The current National Biodefense Strategy has five objectives. Those are:
(1) enable risk awareness to inform decision making,
(2) ensure capabilities to prevent incidents,
(3) ensure preparedness to reduce impacts,
(4) rapidly respond to limit impacts, and
(5) facilitate recovery.
The OPPR is currently only responsible for (3) preparedness and (4) response.
The OPPR should be renamed the Office of Biodefense Surveillance, Prevention and Response because "pandemic" is too limited a focus in a world of biodefense threats.
The Office should be responsible for 'biological hazards' as naturally occurring or bioengineered and 'biological incidents' as natural or accidental occurrences, a crime involving a biothreat, and an act of biological terrorism or warfare. More important, the Office should be expanded to cover all of the National Biodefense Strategy objectives. As the leading public health officer, the Surgeon General should be consulted and briefed regularly on the Office's activities. Finally, the Office should be removed from the Executive Office of the President to emphasize the apolitical nature of the office and its responsibilities.
Notional organizational chart for the Office of Biodefense Surveillance, Prevention, and ResponseThis office will inform biodefense strategy and policy, assign biodefense roles and responsibilities across the interagency, direct biodefense activities, and advise on biodefense budgetary matters
.
Recommendations Regarding The WHO
2. Reform the WHO as a Condition of Continued U.S. Support: The WHO stood by while China lied about the severity of the novel COVID-19 virus and obstructed investigations within China. Honesty is a non-negotiable, especially in a once in a lifetime global pandemic, and within any public health intuition. If the WHO cannot be reformed to better manage its membership the U.S. should commence withdrawing support.
3. Support Taiwan's Inclusion into the WHO to Replace China's Membership: The next Administration should endorse Taiwan's membership as a consequence for the manner in which China misled the international community regarding COVID-19. The United States and other like-minded developed countries must hold China to account, and excluding China from international bodies, such as the WHO, should be considered as means to bring China into compliance with shared international norms and practices between responsible nations.
Recommendations Regarding The Supply Chain and Strategic National Stockpile
4. A U.S. Pandemic Quick Response Team and Supporting Infrastructure Needs to be in Place Before the Next Pandemic: This is crucial for rapid containment, effective response, and mitigation of societal and economic impacts. This would be part of a larger national pandemic response infrastructure that includes enhanced disease surveillance, dispersed supply stockpiles, rapid development of medical countermeasures, and securing public trust through effective communication.
5. States Need to Acquire and Maintain Their Own Strategic Stockpiles: Stockpiles should be designed to address pandemics, natural disasters, chemical/biological threats, and other emergencies. State stockpiles should supplement the Strategic National Stockpile (SNS), reducing reliance on federal resources. Ensure stockpiles are appropriately sized for state populations and potential risks.
6. Better Management of National Stockpile: More and multiple diverse sites – even with the states acquiring their own products. Use digital inventory systems to track stock levels, expiration dates, and maintenance schedules. Set up alerts for replenishment needs and approaching expiration dates. Ensure systems can communicate with federal and regional databases for seamless coordination. Regularly rotate stock to prevent expiration, especially for perishable items like medications. Partner with manufacturers or distributors to maintain "just-in-time" replenishment capabilities.
7. U.S. Must Move Toward a 100 Percent Domestic Production of Vital medical Supplies and Pharmaceuticals: Provide tax credits, grants, and low-interest loans to companies investing in domestic production. Offer guaranteed government procurement contracts to incentivize U.S.-based production. Partner with private companies to develop next-generation medical supplies and pharmaceuticals. Fund educational initiatives and apprenticeships in pharmaceutical manufacturing, biomedical engineering, and related fields. Maintain a strategic reserve of critical materials to buffer against supply disruptions.
8. U.S. Must Develop a Manufacturing Ready Reserve (MRR): This would be a forward-thinking strategy to ensure the U.S. can rapidly produce critical medical supplies, pharmaceuticals, and other essential goods during emergencies. The MRR would act as a "standby force" of manufacturing capacity, ready to be activated when needed. Focus areas would include: Medical Supplies: PPE, ventilators, syringes, and diagnostic tools. Pharmaceuticals: Vaccines, antiviral drugs, antibiotics, and essential medications. Critical Technologies: Items like microchips and other essential components used in healthcare devices.
Recommendations Regarding Public Health Mitigation Measures
9. Ensure Proposed Policies, Such as Social Distancing, are Considered Wholistically. The economic, mental, and social impacts of these policies must be weighed with the public health considerations.
10. The CDC and Administration must Conduct Gold Standard Scientific Studies before Suggesting Wide-Spread use of Masks: The government should be more transparent with their understandings. Let people know if what they are discussing is a hypothesis. Show if trials eventually prove something to be false
11. Public Health Lockdowns Must Be Designed to Protect the Most Vulnerable While Preserving the Status Quo For As Much of the Population as Possible: A robust discussion of the costs and benefits is critical. We must not ever again attach "zero value" to the collateral damage that may be caused by interventions such as lockdowns.
12. The Collateral Damage of COVID-19 Lockdowns Should be Robustly Studied: These studies may help inform cost-benefit analysis during a future pandemic or provide guidance toward what present problems need to be addressed.
Recommendations Regarding Surveillance and Testing
13. Support Wastewater Surveillance Efforts. During COVID-19, efforts to surveil wastewater proved to be an effective early-warning tool. The federal government should consider bolstering these efforts to prepare for a future pandemic.
14. Public-Private Partnerships to Develop Testing Must be Put in Place Now to Prepare for Future Pandemics: Having agreements, contracts, etc. and infrastructure in place with industry and academia for testing. Government development of its own kits did not work. Incorporate lessons learned for failures in developing tests. Office of Pandemic Preparedness Readiness and Response should have the lead.
15. Clear and Concise Communications: The FDA's evolving guidance on testing types, usage, and interpretation of results led to some confusion. For instance, there were changing recommendations about the use of PCR vs. antigen tests, which affected public understanding and trust in testing. As the understanding of the virus evolved, updating guidelines and communicating changes promptly would have kept testing strategies aligned with the latest scientific knowledge.
16. Streamline Testing Processes (from Production to Delivering Results):
a. Reducing Bottlenecks: The testing process often faced delays due to bottlenecks in sample collection, processing, and reporting. Improving logistics and increasing the speed of processing and reporting could have accelerated response times.
b. Decentralization: Enhancing the ability for more decentralized or local testing, including at pharmacies and clinics, might have alleviated pressure on centralized testing facilities and made testing more accessible.
c. Prioritize development of at-home testing for future pandemics, especially if symptoms could be asymptomatic and human-to-human transmission is the means of spreading the virus.
17. When There is Any Doubt about a New Virus of Concern Emerging in a Foreign Country, Travel Restrictions Should be Immediately Enacted: It is far easier to undo the restrictions that may have been unneeded than it is to take a "wait and see" approach once the unknown virus of concerned has entered our borders and thoroughly spread.
18. Continue to Build upon and Augment International Partnerships. The CDC and USAID have established effective programs in less capable nations to conduct overseas surveillance to provide early detection of diseases of concern.
19. Exercise Closing the Borders and Ports of Entry: The Department of Homeland Security, in consultation with the CDC and Office of Pandemic Preparedness and Response, should develop an operational plan (or, if they exist, refine existing plans) to close the borders and all ports of entry within 24 hours' notice and routinely exercise the plan in order to prepare for the next pandemic.
General Recommendations
20. The Constitution Should Never be Put on Hold in Times of Crisis: Free speech is of vital importance and the federal government should never seek to suppress content it disagrees with on social media, or elsewhere. The government should never be the arbiter of truth, especially not when it has a conflict of interest.
21. Doctors Frequently and Responsibly Prescribe Off-Label Treatments and Should Never be Demonized for Doing so in Exercising Their Sound Medical Judgment: Doctors were repudiated for prescribing off-label treatment. This was shameful and should not be repeated. Off-label medications are a critical tool for physicians, both in times of normalcy and during a pandemic. Stigmatizing this commonplace practice is counterproductive. For federal health agencies to regain trust, they must avoid patronizing the American people. The American people want to be educated, not indoctrinated. In the face of a novel virus for which there is little or no available treatments, federal policy should seek to support doctors' efforts to repurpose drugs which are already known to be very safe.
22. Federal Health Agencies Must Trust the American People with the Whole Truth - Speaking in "Generalities" and Using Rules of Thumb is Not Good Enough: Full transparency is necessary for ensuring trust. Federal health agencies must avoid unnecessarily inflating or exaggerating the power of vaccines or other interventions.
The Development of Vaccines and Treatments, and the Development and Implementation of Vaccination Policies for Federal Employees and Members of the Armed Forces
1. Operation Warp Speed Should Serve as a Blueprint to be Used to Quickly Develop Vaccines and Therapeutics. The federal government should evaluate whether certain aspects of Operation Warp Speed can be integrated permanently to more rapidly develop vaccines and therapeutics for diseases which currently afflict the American people. If this evaluation necessitates legislation, Congress should pass legislation which facilitates these goals.
2. The Government should not Promise Approval of a Drug or Treatment Before its Approval. The White House should not promise a particular regulatory action, such as a booster recommendation, prior to the regulatory agency making its decision.
3. Greater Congressional Oversight of FDA Decisions. Congress should consider legislation which requires the FDA Commissioner and CDC Director to notify Committees of jurisdiction prior to overruling its advisory committees such as VRBPAC and ACIP.
4. Naturally Acquired Immunity Should not be so Quickly Discarded in the Future until there is Ample Scientific Data to Support or Refute the Value of Natural Immunity to a New Virus. Official public health guidelines should acknowledge that individuals who have recovered from an infection may possess natural immunity, which can provide protection against reinfection. Public health authorities should adopt a nuanced perspective, recognizing that while natural immunity exists, it may vary in strength, duration, and effectiveness across different individuals. Decisions regarding natural immunity should be grounded in robust, peer-reviewed scientific research, not assumptions or generalizations.
5. Vaccine Mandates—Particularly at the Federal Level—Should be Avoided, Especially for Vaccines which do Not Prevent the Spread of a Virus. Vaccine policy should leave room for individual choice and tailored medical advice from individual's doctors. One's vaccination status should not preclude them from earning a wage or pursuing a happy and fulling life.
6. Consider Whether Vaccines which are not Eligible for VICP Compensation should be Eligible for a Vaccine Mandate. Some vaccines, particularly those approved for emergency use (e.g., COVID-19 vaccines during the pandemic), may not be eligible for VICP compensation. Mandating such vaccines raises concerns about their safety, as they have not undergone the same long-term testing as vaccines covered by VICP. Vaccines not covered by VICP may still be safe and effective, but their long-term safety profile might not be fully known at the time of mandate. Continuous monitoring and post-market surveillance are necessary to ensure that any adverse effects are identified early and addressed. Mandating vaccines that do not offer VICP protection could lead to legal challenges, particularly if individuals feel they are being forced to take a vaccine without adequate recourse in the event of harm. This could also damage public trust in vaccination programs. If vaccines are not eligible for VICP compensation, it may be appropriate for Congress to explore alternative mechanisms to provide compensation or remedy for individuals who suffer serious adverse reactions to mandated vaccines.
7. DOD Should have Considered Testing Servicemembers' Antibody Levels for a More Targeted Approach to Vaccination Policy, Rather than Mandating it for All Troops. The DOD or other entities may consider taking blood samples to test for antibody levels for more tailored vaccine policy. The DOD has a long history of requiring certain vaccines, however COVID-19 vaccines were very new and controversial, and the unintended consequences must be considered when weighing new mandates
8. The System used by Federal Health Agencies for Vaccine Safety Surveillance Must be Reformed. The federal government should consider establishing a personnel reserve consisting of appropriate public and private sector experts, which could be activated during a public health emergency to evaluate reports of adverse events and seek to establish causality. Rather than maintaining a "separate back-end system" The FDA and CDC should evaluate the feasibility of publicly publishing all updates and corrections to VAERS reports.
9. The Federal Government Should Robustly Investigate Reports of Neurological Issues Associated with COVID-19 vaccines. The federal government should consider establishing dedicated programs to study these conditions. The federal government must take neurological issues associated with COVID-19 vaccines seriously, given the potential concerns and the need to maintain public trust in the vaccination process. Investigating reports of adverse events, especially neurological side effects, should be done in a transparent, rigorous, and scientific manner. This is essential not only to ensure public safety but also to demonstrate the government's commitment to thorough monitoring and accountability.
10. HRSA Should Work Rapidly to Establish an Injury Table for COVID-19 Vaccines and Other Covered Countermeasures: HRSA plays a crucial role in administering the VICP, which compensates individuals who suffer serious injuries from vaccines and other covered countermeasures. Given the introduction of COVID-19 vaccines and other emergency countermeasures (such as therapeutics and diagnostic tools), there is a pressing need for HRSA to rapidly establish an injury table specific to these vaccines and countermeasures to ensure timely support and transparency.
11. Establish a Personnel Reserve Consisting of Appropriate Public and Private Sector Subject Matter Experts: The federal government should consider establishing a personnel reserve consisting of appropriate public and private sector experts, which could be activated during a public health emergency to assist in the adjudication of compensation claims. This personnel reserve may also be established in conjunction with a personnel reserve analyzing overall reports of vaccine adverse events.
12. Move COVID-19 Vaccines from CICP to VICP: Congress should also consider reforming these programs such that any future vaccine which is mass-distributed or mandated vaccine is covered under VICP rather than CICP.
13. Emergency Use Authorization should Only Be Used for the Most Vulnerable Americans with the Greatest Risk: EUA process was created to allow for the rapid deployment of medical interventions—such as vaccines, diagnostics, and therapeutics— during public health emergencies, including pandemics. However, there is a growing concern that EUA should only be applied to the most vulnerable Americans who face the greatest risk during a health crisis, rather than being broadly extended to all populations.
14. Americans Need to Hear From Trusted Messengers: During the next pandemic or public health emergency, Americans need to hear more from trusted messengers such as doctors treating patients, who are also better equipped to provide advice that is tailored to a particular region or locality's situation.
15. During a Future Pandemic, the Government Should Craft Response Policies which Prioritize Maintaining Normalcy in the Healthcare System: During the COVID-19 pandemic, far too many Americans were encouraged or forced to forgo medical treatment that was deemed to be "elective" or was deprioritized. The Select Subcommittee has heard personal stories of individuals who died from diseases other than COVID-19 because crucial medical procedures were put on hold.
16. In the Interest of Pandemic Preparedness and General Public Health Resiliency, Congress and the Executive Should Consider Enacting Legislation or Policies which Broadly Bolster the Health of the American People: Comorbidities were a critical determinant of an individual's risk for COVID-19.
The Economic Impact of the Coronavirus Pandemic and Associated Government Response on Individuals, Communities, Small Businesses, Health Care Providers, States, and Local Government Entities
1. Faster Distribution of Aid: Delays in distributing unemployment benefits and stimulus checks caused financial strain. Implementing a more streamlined system for disbursing funds quickly, possibly using existing tax infrastructure or direct deposit systems, could have reduced delays.
2. Targeted Support for Hard-Hit Sectors: Some sectors, like hospitality, retail, and small businesses, were disproportionately affected. More targeted aid and relief packages tailored specifically to the needs of these sectors could have preserved more jobs.
3. Enhancing Digital Infrastructure: Many state unemployment systems were overwhelmed due to outdated technology. Federal investment in modernizing state unemployment systems before or early in the pandemic could have ensured more efficient processing of claims.
4. Improved Communication and Guidance: Mixed messages and changing guidelines created confusion among businesses and workers. Clearer and more consistent communication from federal and state governments might have helped businesses and workers make better-informed decisions.
5. Increased Federal Reserve Reporting on Risks of Prolonged Low Interests Rates: The Federal Reserve could have produced more detailed and frequent reports on financial stability, focusing on the risks associated with prolonged low interest rates and rising government debt. These reports should have included analyses of asset price bubbles and credit risk within the financial system. Furthermore, implementing robust monitoring systems to track risks across different sectors, including housing, corporate debt, and financial institutions, could have helped identify vulnerabilities early. The Federal Reserve should have conducted regular analyses of government debt sustainability, including assessing the potential impact of rising debt on future interest rates, inflation, and fiscal policy.
6. The Federal Reserve Must Provide Clear Forward Guidance on How and When it Plans to Normalize Interest Rates and Unwind Unconventional Monetary Policies: Communicating a well-defined exit strategy would help manage expectations and reduce market uncertainty about future policy changes. Being transparent about the potential risks associated with low interest rates and high government debt would help market participants and policymakers understand the challenges and prepare for potential adjustments. This includes publishing detailed analyses of how current policies could impact future economic conditions.
The Societal Impact of Decisions to Close Schools, How the Decisions Were Made and Whether There is Evidence of Widespread Learning Loss or Other Negative Effects as a Result of These Decisions
1. School Closures should be reviewed under the highest level of scrutiny: In the event of a declared national health emergency, School closures should be temporary measures and subject to the highest scrutiny.
2. Comprehensive Analysis Impacts of School Closures: In the context of school closures, analyzing its effects should not be limited to public health considerations. Federal public health authorities should consider effects including but not limited to student academics, mental health, and physical health.
3. Establishment of a Temporary Interagency Task Force: In the event of a declared national health emergency, the federal government should establish a temporary interagency task force that identifies and analyzes risks associated with the health emergency to coordinate and communicate targeted mitigation measures. The Secretary of Education should appoint a temporary officer to serve as a liaison to the public health agencies—specifically, HHS and CDC—to a continually review evolving science. While respecting federalism interests, the interagency task force should be communicating risk assessment and guidance to state and local stakeholders.
4. Communicating and Consulting on Public Health Guidance: Public health authorities—specifically the CDC—should be encouraged to consult with stakeholders related to the practicality of health guidance. However, these agencies should be discouraged from sharing and accepting feedback from stakeholders that are not based on science and could harm the public trust of federal health agencies.
5. Transparency in public health guidance. The CDC must be more transparent regarding published guidance, guideline, reference, or recommendation documents. This must include acknowledge any non-governmental groups the CDC consulted in the formulation of the documents.
6. Addressing Pandemic-Era Learning Loss: The federal government should encourage states to establish programs to identify and assess pandemic-era learning loss and encourage targeted programs for addressing learning loss.
7. Reducing Chronic Absenteeism: The federal government should collaborate with public and private stakeholders to identify, assess, and establish programs aiming to reduce the rate of chronic absenteeism that has occurred since the pandemic.
8. Improving School Infrastructure: Encourage school districts to identify, construct, and maintain infrastructure, including but not limited to ventilation systems, that could further impact transmission in school environments.
Cooperation By the Executive Branch and Others with Congress, the Inspectors General, the Government Accountability Office, and Others in Connection with Oversight of the Preparedness for and Response to the Coronavirus Pandemic
Recommendations Regarding the Federal Government
1. The Executive Branch must comply with Congress. The Executive Branch's standard operating posture must be to comply with authorized congressional oversight requests fully, transparently, and timely to the fullest extent allowed by law.
3. The Federal Government must review employees' record retention practices and ensure accountability for any violators. Conduct a federal government wide review of federal employees' use of personal email for official, government business.
a. Conduct a federal government wide review of federal employees' deletion and destruction or potential deleting or destruction of official, government records.
b. Conduct a federal government wide review of agencies compliance with the Freedom of Information Act to ensure it is consistent with the law and Congressional intent.
c. The Department of Justice must evaluate if Dr. David Morens violated any federal laws, including but limited to violations of:
I. 18 U.S.C. 1001;
II. 18 U.S.C. 1621; and
III. 18 U.S.C. 2071.
Below is the link for the PDF of the
"AFTER ACTION REVIEW OF THE COVID-19 PANDEMIC: RECOMMENDATIONS"
(from the Select Subcommittee on the Coronavirus Pandemic.)
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