Health
US FDA plans overhaul of decades-old medical device system
WASHINGTON — US health officials say they plan to overhaul the country’s decades-old system for approving most medical devices, which experts have long criticized for failing to catch problems with risky implants and medical instruments.
The Food and Drug Administration announced plans Monday aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing.
The FDA’s pledge came one day after the publication of a global investigation into medical device safety by more than 50 media organizations, including The Associated Press. The probe, led by the International Consortium of Investigative Journalists, analyzed more than 8 million device-related health records, including death and injury reports and recalls.
Matthew Perrone, The Associated Press
From LifeSiteNews
Contrary to initial reporting from corporate media, the WHO, and the apocalyptic mutterings of Dr. Peter Hotez, there continues to be no evidence indicating the circulation of a highly pathogenic version of bird flu in either animal or human populations.
What is the current threat assessment for Avian Influenza, and has it changed?
I previously established and published a brief baseline threat assessment for Avian Influenza on July 2, 2024. Four dominant parameters must be considered when assessing a potential infectious disease threat to human populations:
- Disease severity (a measurable objective truth)
- Mechanism of transmission and observed transmissibility (an experimentally testable objective truth)
- Evidence of sustained human-to-human transmission (a measurable objective truth)
- Assessment of anticipated future risk (subjective, speculative, and hypothetical)
Politicians and their allies (in BioPharma, academia, and other sectors) have a variety of conflicts of interest and agendas which are not aligned with objective, dispassionate assessment and response to public health and infectious disease issues, and cannot be relied upon to analyze and respond to these key parameters objectively.
An assessment of the conflicts of interest and political agenda(s) of California’s Gavin Newsom is beyond the scope of this analysis. Still, please remember that Governor Newsom clearly mismanaged and overreacted to the COVID threat, as did the World Economic Forum that trained and coached (coaches?) him as a “Young Leader” and clearly continues to influence his political postures.
Although California has remained under Democrat party control – in significant part consequent to “rank choice” voting policies – during the recent presidential election there was a clear shift and momentum toward the Republican party across the majority of the state.
California has a very large dairy industry, and I know that a leader in and representative of that industry has close connections to Newsom. The presence of the virus in Southern California dairy farms is widespread, with over 300 dairy herds testing positive in the last 30 days
Has the threat assessment circa July 2024 changed? Let’s revisit the basics:
Disease severity, December 2024
Disease severity continues to be mild, with the exception of one new case which apparently triggered Newsom to declare a state of emergency in California.
According to Newsweek, “A person in Louisiana was hospitalized in critical condition with severe respiratory symptoms from a bird flu infection, according to state health officials. The patient had been in contact with sick and dead birds in a backyard flock, according to the CDC. Louisiana health officials said the patient is older than 65 and has underlying medical conditions.”
Here is the current CDC threat summary
- H5 bird flu is widespread in wild birds worldwide and is causing outbreaks in poultry and U.S. dairy cows with several recent human cases in U.S. dairy and poultry workers.
- While the current public health risk is low, CDC is watching the situation carefully and working with states to monitor people with animal exposures.
- CDC is using its flu surveillance systems to monitor for H5 bird flu activity in people.
The CDC charts above document that the risk of H5 in humans is low, disease severity is low, and although massive testing has occurred, there are only 61 total “exposure” sources found from cattle, birds, and other mammals.
There are a total of three human cases picked up from the CDC flu surveillance program since February 25, 2024, and a total of 58 cases in the U.S., after testing almost 10,000 people who were exposed to infected animals.
In sum, the profile of disease severity has not changed since July 2024. As opposed to initial reporting from corporate media, dark warnings from the WHO and Dr. Tedros, and the apocalyptic mutterings of Dr. Peter Hotez, there continues to be no evidence indicating the circulation of a highly pathogenic version of this virus in either animal or human populations.
Mechanism of transmission and observed transmissibility
All reported U.S. transmission events involve human exposure in the context of intensive contact during animal husbandry or other known animal hosts, indicating that the mechanism of transmission remains intensive exposure to infected animals and animal carcasses. No change from July 2024.
Evidence of sustained human-to-human transmission
No evidence of sustained human-to-human transmission, now or in the past with this currently circulating variant.
Assessment of anticipated future risk
This appears to be the crux of Newsom’s alarmist response involving the declaration of a “State of Emergency” for bird flu in California. A statement from the governor’s office characterized the move as a “proactive action to strengthen robust state response” to avian influenza A (H5N1), also known as bird flu.
“This proclamation is a targeted action to ensure government agencies have the resources and flexibility they need to respond quickly to this outbreak,” Newsom said in a statement. “Building on California’s testing and monitoring system – the largest in the nation – we are committed to further protecting public health, supporting our agriculture industry, and ensuring that Californians have access to accurate, up-to-date information.”
He added, “While the risk to the public remains low, we will continue to take all necessary steps to prevent the spread of this virus.”
This statement demonstrates either a profound ignorance of the mechanism by which animal influenza viruses spread, including avian influenza, or the presence of a hidden agenda. With a wide range of animal reservoirs, including migratory waterfowl, there is no way that the state of California can prevent the spread of this virus.
READ: Australian doctor who criticized COVID jabs has his suspension reversed
Conclusion
There has been no significant change in the current threat assessment associated with Avian Influenza relative to July 2024. The CDC, which has recently been implicated in industrial-scale “PsyWar” deployment of psychological bioterrorism regarding COVID and has an organizational conflict of interest in promoting vaccines and vaccine uptake, characterizes the current public health risk as low.
My conclusion regarding the Newsom declaration of a “State of Emergency” for bird flu in California is that it is being driven by a hidden agenda. There are multiple hypotheses regarding what that hidden agenda may be, but Newsom’s statement that, “Building on California’s testing and monitoring system – the largest in the nation – we are committed to further protecting public health, supporting our agriculture industry, and ensuring that Californians have access to accurate, up-to-date information,” suggests that this declaration may, at a minimum, reflect advocacy by and for California’s infectious disease testing industry, which includes both academic and commercial components.
Reprinted with permission from Robert Malone.
Alberta
Province says Alberta family doctors will be the best-paid and most patient-focused in the country
Dr. Shelley Duggan, president, Alberta Medical Association
New pay model, better access to family doctors |
Alberta’s government is implementing a new primary care physician compensation model to improve access to family physicians across the province.
Alberta’s government recognizes that family physicians are fundamental to strengthening the health care system. Unfortunately, too many Albertans do not currently have access to regular primary care from a family physician. This is why, last year, the government entered into a memorandum of understanding with the Alberta Medical Association (AMA) and committed to developing a new primary care physician compensation model.
Alberta’s government will now be implementing a new compensation model for family doctors to ensure they continue practising in the province and to attract more doctors to choose Alberta, which will also alleviate pressures in other areas of the health care system.
This new model will make Alberta’s family doctors the strongest-paid and most patient-focused in the country.
“Albertans must be able to access a primary care provider. We’ve been working hard with our partners at the Alberta Medical Association to develop a compensation model that will not only support Alberta’s doctors but also improve Albertans’ access to physicians. Ultimately, our deal will make Alberta an even more attractive place to practise family medicine.”
“We have worked with the Alberta Medical Association to address the challenges that primary care physicians are facing. This model will provide the supports physicians need and improve patient access to the care they need.”
The new model is structured to encourage physicians to grow the number of patients they care for and encourage full-time practice. Incentives include increases for:
- Maintaining high panel numbers (minimum of 500 patients), which will incentivize panel growth and improve access to primary care for patients.
- Providing after-hours care to relieve pressure on emergency departments and urgent care centres.
- Improving technology to encourage using tools that help streamline work and enhance patient care.
- Enhancing team-based care, which will encourage developing integrated teams that may include family physicians, nurse practitioners, registered nurses, dietitians and pharmacists to provide patients with the best care possible.
- Adding efficiencies in clinical operations to simplify processes for both patients and health care providers.
As a market and evidence-based model, it recognizes and pays for the critically important work of physicians, including the number of patients seen and patient complexity, as well as time spent providing direct and indirect care.
“Family medicine is the foundation of our health care system. This model recognizes the extensive training, experience and leadership of primary care physicians, and we hope it will help Alberta to attract and retain more family medicine specialists who provide comprehensive care.”
Additionally, family physicians who are not compensated through the traditional fee-for-service model will now receive higher pay rates under their payment model, known as the alternative relationship plan. This includes those who provide inpatient care in hospitals and rural generalists. Alberta’s government is increasing this to ensure hospital-based family physicians and rural generalists also receive fair, competitive pay that reflects the importance of these roles.
“This new compensation model will make Alberta more attractive for physicians and will make sure more Albertans can have improved access to a primary care provider no matter where they live. It will also help support efforts to strengthen primary care in Alberta as the foundation of the health care system.”
“Family physicians have been anxiously awaiting this announcement about the new compensation model. We anticipate this model will allow many primary care physicians to continue to deliver comprehensive, lifelong care to their patients while keeping their community clinics viable.”
Quick facts
- Enrolment in the primary care physician compensation model will begin in January with full implementation in spring 2025, provided there are at least 500 physicians enrolled.
- The alternative relationship plan rate has not been updated since it was initially calculated in 2002.
- The new compensation model for family doctors is the latest primary health care improvement following actions that include:
- A $42-million investment to recruit more health providers and expand essential services.
- A new rural and remote bursary program for family medicine resident physicians.
- Additional funding of $257 million to stabilize primary care delivery and improve access to family physicians.
- Implementing the Nurse Practitioner Primary Care Program, which expands the role of nurse practitioners by allowing them to practise comprehensive patient care autonomously, either by operating their own practices or working independently within existing primary care settings.
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