Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products | FDA

Historical perspective:

During the 1980s HIV presented a major public health problem.  There were no successful treatments for patients with HIV. It was determined that HIV was prevalent in the 'gay' population.  Their blood was 'tainted' with the Human Immunodeficiency Virus (HIV).  Blood banks were advised to not accept blood donations from anyone who was gay or had sexual encounters with those of the same sex, especially those who engaged in anal sex.

HIV and. AIDS attacks the CD4 white blood cells which form part of the protective immune system of the body.  When these cells are destroyed the immune system is no longer able to recognize and protect against bacterial fungal and protozoa infection. These resulting infections are what kill AIDs patients.

In the last five decades pharmacologic advances produced effective treatments for HIV. A fulminant case of AIDs does occur until well after a person is infected with HIV.  It lies dormant, gradually reducing the CD4 cell count until the immune system is overwhelmed by infectious agents.

The Clinical Guideline for Prevention and Treatment have eliminated AID and HIV as a fatal illness.

Blood Banks have used the above criteria for preventing blood donation by HIV/AIDS patients. 

Changes in FDA Guidance for Blood Donation by Gay Persons

 

US Food and Drug Administration on Thursday paved the way for more gay and bisexual men to donate blood by finalizing new risk-based rules for blood donation. Going forward, prospective donors will be asked the same set of questions regardless of their sex or sexual orientation.

FDA VIDEO COURTESY OF TWITTER

The new criteria are risk-based questions, rather than discriminating against a group of people labeled as gay. This ruling comes as gay people are now in a protected class of people

The new questions are designed to reduce the risk of transmission of HIV, or human immunodeficiency virus, through blood donation. The FDA says it made the changes after reviewing data from other countries that have similar rates of HIV and have already implemented risk-based eligibility for blood donations, information on the accuracy of tests to detect HIV, surveillance information from a system that monitors infections passed by transfusions, and information on individual risk factors gleaned from a government-funded study.

Under the new rules, anyone reporting a new sexual partner, more than one sexual partner, or recent anal sex will be told to wait at least three months to donate blood. This reduces the likelihood that someone with a new or recent infection could donate during a window of time when their infection would not be picked up by lab tests.

Anyone taking medications to treat or prevent HIV, such as PrEP, would also be deferred from donation. The FDA says that while HIV is not transmitted during sex in people whose viral levels are undetectable, the same does not apply to blood donation. Blood is transfused directly into a vein, and involves a larger volume of fluid, making it inherently riskier than sexual contact.

Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products | FDA

DEA buys time on proposed telehealth rules for controlled drugs

This is. Big, Very Big

Fierce Telehealth reports. 

Facing major backlash to its proposed rules released in February, the Drug Enforcement Administration (DEA) is looking to buy some time to reconsider whether it should enforce stricter limits around the prescribing of controlled substances via telehealth. 

The Biden administration said at the time that the new rule seeks to provide safeguards to prevent online over-prescribing of controlled medications. Teleprescribing has been touted as a robust tool for bringing medications for opioid use disorder (MOUDs) to rural areas in the ongoing treatment of the opioid epidemic. 

The agency received a record 38,000 comments on its proposed telemedicine rules, according to a statement from the DEA Administrator 

Last week, the DEA filed a draft temporary rule with the Office of Management and Budget titled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.”

Milgram said further details about the rule will become public after its full publication in the Federal Register.

The DEA issued proposed rules three months ago that would reinstate strict limitations on the virtual prescribing of controlled substances and roll back telehealth flexibilities extended during the COVID-19 pandemic. The proposed rules would once again require patients to be evaluated in person by a doctor to receive prescriptions for some controlled substances (PDF) including stimulants like Adderall and opioids

Provider groups, telehealth advocates, and patients submitted comments largely panning the proposal, arguing that it would create barriers to care. 

Under the proposed rule, Schedule 2 medications or narcotics would require (PDF) an in-person prescription. Schedule 3 or higher medications, including buprenorphine, can be prescribed for 30 days via telehealth but would require an in-person visit before a refill. Non-narcotic drugs like Ambien, Valium, Xanax, and ketamine also fall into this category. If a patient is referred to a provider, an in-person appointment is not required as long as one took place with the referring physician.

If a telemedicine relationship was established during the COVID-19 public health emergency, the DEA will extend the in-person exam waiver for an additional 180 days.

DEA buys time on proposed telehealth rules for controlled drugs

Why It is Essential to Review your Electronic Health Record

How often do patients who read open ambulatory visit notes perceive mistakes, and what types of mistakes do they report?

Findings  In this survey study of 136 815 patients, 29 656 provided a response, 1 in 5 patients who read a note reported finding a mistake and 40% perceived the mistake as serious. Among patient-reported very serious errors, the most common characterizations were mistakes in diagnoses, medical history, medications, physical examination, test results, notes on the wrong patient, and sidedness.

In today's world, almost all doctors use electronic health records.  It is difficult to provide an accurate percentage of doctors who do not use an electronic health record (EHR) as it can vary depending on the country, healthcare system, and specialty of the doctor. However, in the United States, where EHR adoption is widely promoted and incentivized, a 2019 survey found that about 9% of physicians still used paper records exclusively, while 84% used EHRs. The remaining 7% used a combination of both. It's worth noting that the percentage of doctors using EHRs has likely increased since then. This figure was given by ChatGPT which is current only to Sept. 2023.

It is estimated 99% of doctors use an electronic health record system. 

Data systems, ie electronic records never forget. 

You must access your EHR via a portal. If you do not know what that is you can learn from ChatGPT or ask someone in your doctor's office or clinic how to go about that.  It is your legal right to be able to obtain your medical record (Federal Law).  

In the United States, there are federal laws that give patients the right to access their electronic health records (EHRs). The two main laws governing access to EHRs are the Health Insurance Portability and Accountability Act (HIPAA) and the 21st Century Cures Act.

The 21st Century Cures Act is a United States law enacted in December 2016 that aims to accelerate medical innovation, enhance research into diseases, and improve patient care. The law includes several provisions related to the development and approval of medical products, including drugs, devices, and biological products, as well as provisions related to mental health and substance abuse.

Some of the key provisions of the 21st Century Cures Act include:

Streamlining the clinical trial process to expedite the development and approval of new drugs and devices

- Promoting the use of real-world evidence in drug approvals

- Encouraging the development of precision medicine and the sharing of genetic and clinical data

- Investing in research on cancer and other diseases

- Providing funding to combat the opioid epidemic

- Improving mental health services and resources

Overall, the 21st Century Cures Act aims to promote innovation and collaboration among researchers, industry, and patient advocates to advance medical treatments and improve patient outcomes.

Under HIPAA, patients have the right to access their protected health information, which includes EHRs, held by covered entities such as healthcare providers, health plans, and healthcare clearinghouses. Covered entities must provide patients with their records within 30 days of the request, and they can charge a reasonable cost-based fee for copying and mailing the records.

The 21st Century Cures Act, which was signed into law in 2016, expands on the HIPAA requirement by mandating that healthcare providers and EHR vendors provide patients with access to their electronic health information in a structured, standardized format that can be easily shared with other healthcare providers and apps. This is known as the "open notes" provision, and it aims to empower patients to become more engaged in their care by giving them greater access and control over their health information.

Overall, these federal laws give patients a legal right to access and control their EHRs, which can help them make more informed decisions about their healthcare and improve the quality of care they receive.

Frequency and Types of Patient-Reported Errors in Electronic Health Record Ambulatory Care Notes | Electronic Health Records | JAMA Network Open | JAMA Network

End of the COVID-19 Public Health Emergency (PHE) Declaration - Public Health Communication Collaborative

The Federal Covid emergency declaration ends on May 11,2023.

What does this mean? COVID-19 is not over. Although the emergency declaration is ending considerable federal resources will remain in effect.

On May 11, 2023, the public health emergency (PHE) declaration will end. Among other policy implications, the end of the PHE will impact health policy measures associated with access to COVID-19 testing and treatment.

How will the end of the public health emergency affect community members?

When the public health emergency ends, COVID-19 vaccines will continue to be free for all, as long as the supply of federally purchased vaccines lasts. However, access to and cost of testing and treatment will vary on whether they have public, private, or no health insurance.

Does the end of the public health emergency mean COVID-19 is over?

No. COVID-19 cases are down sharply, but the end of the emergency declarations does not mean the virus is no longer a threat. The virus remains a leading cause of death in the United States, with about 250 daily deaths on average. Visit CDC’s website and your state and local health departments for information about local infection rates and recommended precautions.

CDC continues to advise that everyone stay up to date on COVID-19 vaccinations, use at-home tests if they’ve been exposed or have symptoms, stay home if they’re sick, and wear a high-quality mask when COVID-19 levels are high. These precautions are the best ways to protect yourself and your loved ones.

How will the end of the public health emergency affect community members?

When the public health emergency ends, COVID-19 vaccines will continue to be free for all, as long as the supply of federally purchased vaccines lasts. However, access to and cost of testing and treatment will vary on whether they have public, private, or no health insurance.

Vaccines

Vaccines will remain free for everyone when the public health emergency ends. As long as the supply of federally purchased vaccines lasts, COVID-19 vaccines will remain free.

Testing and Treatment

Coverage for COVID-19 testing and treatment will vary by insurance type.

For people with Medicaid coverage, COVID-19 testing, and treatment will remain covered at no cost through September 2024. For those without insurance, COVID-19 testing and treatment will no longer be covered, and the cost will be determined by individual providers. However, free tests and treatment may be available at local free clinics or community health centers.

State and County Public Health Advisories are available   HERE.  

Requirements for Masking, Indoor Activity, and Distancing will vary according to the incidence of COVID-19 from Low to Medium to High.  In addition, CALOSHA makes recommendations for masking in the workplace

Messaging: End of the COVID-19 Public Health Emergency (PHE) Declaration - Public Health Communication Collaborative

Public Health Turnover Threatens Community Health and Safety - de Beaumont Foundation

Public Health Turnover Threatens Community Health and Safety

According to a recent analysis of data from the Public Health Workforce Interests and Needs Survey (PH WINS), nearly half of state and local public health employees left their jobs between 2017 and 2021, exacerbating an existing workforce shortage and causing a critical lack of skills and experience that puts communities at risk. 

The study, published today in Health Affairs, compared intent to leave or retire in 2017 with actual separations through 2021 among state and local public health staff at agencies that participated in the PH WINS survey in both years. The study authors found that 46% of state and local employees left their organizations during that time – a number that rose to 74% among employees under age 35 and 77% among employees with less than five years. experience.

Public Health is one of those subjects which gain little attention in medical school. Med School students assign it a low priority, such as basket weaving in high school. It is a bit like being an anesthesiologist with long periods of inactivity, boredom, and occasional moments of sheer panic.

COVID-19 amply demonstrated how Public Health works, a slow recognition of an impending catastrophe and a slow ramp-up of an inadequate workforce. The workforce in good times is inadequate.  It is just not an exciting field of healthcare. In fact, the deficit is so bad that the National Guard is often 'called up" by Governors to serve. The private sector and large health institutions have the resources to address the huge increase of patients in emergency departments.

In such situations, testing and vaccination must be accomplished a remote mobile workforce is activated.

The added burden of personnel and medical devices (PPE), and pharmaceuticals (vaccines) requires emergency funding by state and federal governments.

Covid-19 Economic Relief

During such events, other agencies and specialty officials are called in to supplement forward-facing personnel, such as the CDC, DEA, WHO, and the USPHS. Politicians usually become involved as well because it enables them a public forum for recognition. This is not always a good thing, since their announcement has political implications and divides the goals of science to gain political advantage.  This became apparent during the Covid Pandemic.

The future of Public Health lies in the balance.

Understanding the size and composition of the state and local governmental public health workforce in the United States is critical for promoting and protecting the health of the public. Using pandemic-era data from the Public Health Workforce Interests and Needs Survey fielded in 2017 and 2021, this study compared intent to leave or retire in 2017 with actual separations through 2021 among state and local public health agency staff. We also examined how employee age, region, and intent to leave correlated with separations and considered the effect on the workforce if trends were to continue. In our analytic sample, nearly half of all employees in state and local public health agencies left between 2017 and 2021, a proportion that rose to three-quarters for those ages thirty-five and younger or with shorter tenures. If separation trends continue, by 2025 this would represent more than 100,000 staff leaving their organizations, or as much as half of the governmental public health workforce in total. Given the likelihood of increasing outbreaks and future global pandemics, strategies to improve recruitment and retention must be prioritized.

Public Health Turnover Threatens Community Health and Safety - de Beaumont Foundation

Health Misinformation

With the abundance of health information available today, it can be hard to tell what is true or not. We all need access to trusted sources of information to stay safe and healthy.

Why health misinformation matters

We can all benefit from taking steps to improve the quality of the health information we consume. Limiting misinformation helps us make more educated decisions for ourselves, our loved ones, and our communities.

Health misinformation is a serious threat to public health. It can cause confusion, sow mistrust, harm people’s health, and undermine public health efforts.”

Dr. Vivek H. Murthy

Vivek Mirthy M.D.Surgeon General of the United StatesThe Rest of IT

Physician Unionizing How, Why, Who? SMHS residents and fellows vote to unionize – The GW Hatchet

Medical residents and fellows at the School of Medicine and Health Sciences voted overwhelmingly to unionize Thursday.

SMHS residents and fellows voted 253-16 Wednesday and Thursday join the Committee of Interns and Residents — a subsidiary unit of the Service Employees International Union. Maryssa Miller, a physician who helped organize the unionization effort, said the union will form a bargaining committee in the coming weeks representing residents’ departments like internal medicine, emergency medicine, and obstetrics and gynecology.

Every year some group of physicians organizes to form a union. Most often they are not successful. The reasons are many.

George Washington University School of Medicine and Health Sciences is no worse than any other academic center.

1. Trainees have a limited time span 1-3 years in a position where they are subject to abuse.

2. A moral and ethical imperative to care for a patient, no matter the circumstance in hospital.

Always a point of contention is the long hours and difficulties for physician trainees.

COVID-19 exacerbated the intense work and long hours for all caregivers, including physicians.

Physicians' Unions have rarely gained strength in the United States.  Perhaps the worst working conditions exist in academic settings.

Trainees are in a captive and at times abusive environment.  This has been a never-ending story. Forty years ago when I was a trainee it was even worse.  At times I would work 36-hour shifts.  Today in 2023 Academic residency programs are required to abide by rules regarding training hours, limiting the work week to no more than 80 hours.

Medical residents and fellows at the School of Medicine and Health Sciences voted overwhelmingly to unionize Thursday.

SMHS residents and fellows voted 253-16 Wednesday and Thursday to join the Committee of Interns and Residents — a subsidiary unit of the Service Employees International Union. Maryssa Miller, a physician who helped organize the unionization effort, said the union will form a bargaining committee in the coming weeks representing residents’ departments like internal medicine, emergency medicine, and obstetrics and gynecology.

A recent report from the American Council for Graduate Medical Education reveals that despite the rules many institutions are being cited for infractions. 

Some specialties were cited more often, Internal Medicine, Family Practice Transitional year (Internship). It is common practice for trainees in the initial year of training to be expected to carry a disproportionate workload.  The reasons are a subordinate position as related to superiors, and the necessity to acquiesce to unreasonable demands to ensure being advanced to the next level of training.

What is the ACGME 16-hour rule?

In July 2011, the Accreditation Council for Graduate Medical Education (ACGME) reduced the consecutive number of hours that post-graduate year-1 residents can work in a single shift, from 30 to 16. This rule was intended to improve patient safety by reducing residents' fatigue.

It has been over ten years since this guideline was recommended by the ACGME.  Ongoing examination reveals there has been considerable resistance to the ACGME guidelines. 

Why is this? 

The demands of clinical care are ongoing, 24/7/365/. It is a bit like 7-11.   The relative shortage of physicians creates an undeniable demand for those working in the system.  There is no reasonable solution for this confounding fact.  The result would be a lack of physicians for a considerable portion of patients in the hospital.  Can you imagine a patient needing emergency surgery at night and there would be no surgeon available?

Pros of Unionization

Unions provide an integrated and time-proven methodology of negotiations between employees and employers by an experienced third party

Cons

A Union introduces factors and dues whether you decided or not that prospective union members may not have factored into their voting.

The GWUMS provided some insights into unions

SMHS residents and fellows vote to unionize – The GW Hatchet

Where is the Pain ?

 

Why do we reduce humans who suffer from chronic pain to simple molecules and receptors? Pain psychologist Rachel Zoffness, P.h.D. returns to talk about fibromyalgia, stomach pain, anxiety, the role of trauma, and much more.

Dr. Rachel Zoffness is a Health and Pain Psychologist, international speaker, author, and thought-leader in pain medicine. She is an Assistant Clinical Professor at the UCSF School of Medicine, a Stanford lecturer, and a Mayday Fellow. Her podcast episodes on The New York Times Ezra Klein Show, Ologies (Dolorology), and The Jordan Harbinger Show are viral sensations with more than 6 million views and downloads.

Dr Zdogg, as he is known is Zubin Damania MD a graduate of UC San Francisco. His background is in intensive care and primary care.  ZdoggMD is well known on the YouTube circuit. 

Dr. Z's book, links to our prior interview, audio podcast, and full transcript:

The Pain Management Workbook: Powerful CBT and Mindfulness Skills to Take Control of Pain and Reclaim Your Life

Rachel Zoffness, P.h.D. examines the segments of the pain mechanism in this video.

Key Topics:

0:00 Intro

1:14 The bio-psycho-social nature of pain: phantom limb pain, the limbic system & emotion-pain connection, social contributors

9:00 The stigma of “psychological” pain and holistic approaches to managing it

16:15 The concept of “pain volume” and how emotional states affect it

18:56 Releasing negative emotion: the idea of “tea-kettling”

26:21 Fibromyalgia & trauma, pain amplification and “central sensitization”

33:14 The importance of desensitization practices for chronic pain

36:14 The benefits and risks of narcotics, the danger of removing them too fast

40:41 Sympathetic nervous system, the interaction of trauma and adverse childhood experiences (ACEs)

47:44 Placebo & the mind-body connection

53:34 Anxiety/Depression and Overmedicalization by Big Pharma

1:00:00 Non-pharmacologic treatments for pain, anxiety, and depression

1:04:06 The mind-gut connection: Irritable Bowel Syndrome, performance anxiety, and more

1:11:14 Emotional repression, fear of speaking and exposure therapy, PTSD

1:18:28 Imposter Syndrome and Dunning-Kruger effect, gender roles (vocal fry/uptalk)

1:25:00 The Problem of emotional repression, and Solutions

1:28:37 How biofeedback works

Why do people experience pain in a limb that is missing? (Phantom Limb Pain)

Pain causes angst, anxiety, and physiological effects.  What is the connection between the psycho-biological-emotional aspects of pain?

CMS cracks down on prior authorization requirements in MEDICARE ADVANTAGE plans

Tension has developed between CMS and their Medicare Advantage Plans.

Whose prior authorization is it anyway? MA plans are contracted to provide insurance benefits via a private contract. Strictly speaking, MA plans are not the same as fee-for-service Medicare. The goal was to reduce Medicare costs by contracting with groups and/or private insurers (ie, Humana. Aetna and smaller insurance entities (local). These MA plans are paid a contract amount for covering the same benefits as FFS Medicare.  In some cases, this is an FFS arrangement with the MA plan.

In order to contain costs prior authorizations are used to filter out unnecessary tests, or procedures.

In real life, this serves to deny coverage, and at the least increases costs for the providers. (more personnel to process prior authorizations.  In some cases, additional insurance billers are required for at least 1 FTE, or more in some cases for group practices. The cost has been absorbed by the provider.

Medicare Advantage (MA) plans will find it harder to require prior authorizations for their coverage under a new final rule from the Centers for Medicare and Medicaid Services (CMS).

CMS says the new rule, announced on April 5, is intended to address MA member complaints that the plan’s prior authorization requirements restrict their access to care. In response, the rule will:

limit the use of coordinated care MA plans’ prior authorization policies to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary,

prohibit coordinated care MA plans from requiring prior authorizations for an active course of treatment for at least 90 days when a patient switches MA plans, require all MA plans to establish utilization management committees to ensure consistency with Traditional Medicare’s national and local coverage decisions and guidelines, and require that prior authorization approvals remain valid “for as long as medically reasonable and necessary to avoid disruptions in care in accordance with applicable coverage criteria, the patient’s medical history, and the treating provider’s recommendation.”

“Together, these changes will help ensure enrollees have consistent access to medically- necessary care while also maintaining medical management tools that emphasize the important role MA plans play in coordinating medically-necessary care,” CMS said.

The rule comes in the wake of a 2022 report from the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services that found that some MA plans have been denying prior authorization requests even though the requests met Medicare coverage rules.

The OIG report also found that plans were denying payments to providers for some services that met both Medicare coverage and the MA plan’s own billing rules.

Physicians’ groups hailed the rule. “Family physicians know first hand how this will help ensure timely access to care while alleviating physicians’ administrative burdens and patients’ care delays,” American Academy of Family Physicians President Tochi Iroku-Malize, MD, FAAFP, said in a tweet.

 

CMS rule cracks down on prior authorization requirements in MA plans

Abortion A Tale of Two Lawsuits - by Jessica Valenti

Politics has no place in healthcare.  How the world turned.

 

Congress, when it formed Medicare inserted a message that Medicare could not practice medicine and would not interfere with professional judgment.  That did not last very long.  Soon new regulations imposed restrictions on treatments.  

When Medicare in 1965 went into effect professional medical organizations warned that open and free access to medical care would bankrupt the country in short order.  

It is a conundrum to deliver health care to all who need it since demand is infinite and supply is limited. Health care has its own algorithm outside of the free market enterprise.

NHE Fact Sheet.  (National Health Expenditure Data)

As decades have passed the percentage of the GDP has risen to 18%, although at a slower rate due to balanced budget restrictions.

Historical NHE, 2021:

NHE grew 2.7% to $4.3 trillion in 2021, or $12,914 per person, and accounted for 18.3% of Gross Domestic Product (GDP).

Medicare spending grew 8.4% to $900.8 billion in 2021, or 21 percent of total NHE.

Medicaid spending grew 9.2% to $734.0 billion in 2021, or 17 percent of total NHE.

Private health insurance spending grew 5.8% to $1,211.4 billion in 2021, or 28 percent of total NHE.

Out-of-pocket spending grew 10.4% to $433.2 billion in 2021 or 10 percent of total NHE.

Other Third Party Payers and Programs and Public Health Activity spending declined 20.7% in 2021 to $596.6 billion, or 14 percent of total NHE.

Hospital expenditures grew 4.4% to $1,323.9 billion in 2021, slower than the 6.2% growth in 2020.

Physician and clinical services expenditures grew 5.6% to $864.6 billion in 2021, slower growth than the 6.6% in 2020.

Prescription drug spending increased 7.8% to $378.0 billion in 2021, faster than the 3.7% growth in 2020.

The largest shares of total health spending were sponsored by the federal government (34 percent) and the households (27 percent). The private business share of health spending accounted for 17 percent of total health care spending, state and local governments accounted for 15 percent, and other private revenues accounted for 7 percent.

Projected NHE, 2021-2030:

On average over 2021-30, National Health Expenditures (NHE) and Gross Domestic Product (GDP) are both projected to grow 5.1 percent per year; as a result, the projected NHE share of GDP in 2030 (19.6 percent) is similar to 2020 (19.7 percent).

Near-term NHE patterns are significantly influenced by the COVID-19 pandemic.  NHE growth in 2021 is projected to have slowed to 4.2 percent (down from 9.7 percent growth in 2020) as federal COVID-19 supplemental funding declined substantially. 

Following the declines observed in 2020, healthcare utilization is expected to rebound starting in 2021 and normalize through 2024.  By 2024, the government's (federal and state & local) share of health spending is expected to fall to 46 percent as COVID-19 supplemental funding is expected to wane, down from an all-time high of 51 percent in 2020.

The percentage of the population with health insurance is expected to peak in 2022 at 91.1% (mainly due to Medicaid enrollment) before falling back towards pre-pandemic levels as the public health emergency is assumed to end.  The 2030 rate is projected to be 90.5%.

For 2025-2030, factors that typically drive changes in health spending and enrollment, such as economic, demographic, and health-specific factors, are again expected to primarily influence trends in the health sector.

Federal Spending on Major Health Care Programs Grows Faster Than GDP  

The Judicial Branch has now stepped in to overrule Congress and the Federal Drug Administration attempting to overrule scientific decisions.  Not only that they are conflicting rulings between state jurisdictions.  Legal maneuvering delays treatment plans.

 

Two federal courts —one in Washington and one in Texas—issued conflicting rulings on mifepristone, one of the two drugs used for medication abortions. Matthew Kacsmaryk, the Trump-appointed federal judge in Texas, ruled to invalidate the FDA approval of mifepristone (with a stay of 7 days)—a decision we anticipated after the hearing earlier this spring. But a Washington federal judge, who also has the power to bind the FDA, ruled that the FDA shouldn’t restrict mifepristone and that the role of an Article III judge is not to second guess the expertise of the FDA.

This is important: Both have equal bearing over abortion access going forward. And medically-safe sources of medication abortion pills, including mifepristone, are still available, despite the ruling out of Texas. Fear is just as strong of a tool in the anti-abortion movement as any legal ruling.

To get a clearer picture of what the two conflicting federal opinions mean and what the FDA and the Biden administration can do to protect mifepristone, Abortion, Every Day went to law professors Greer Donley and Rachel Rebouche—who have been leading the national conversation on abortion medication and the FDA approval process since Roe fell.

A Tale of Two Lawsuits - by Jessica Valenti

Line up children, the COVID sniffing dog is here to judge you

A recent paper in JAMA Pediatrics shows how badly adults dehumanized children.

Commentary from the author:

                                   Commentary :  Ten hours of dog sniffing

 

A recent paper in JAMA Pediatrics shows how badly adults dehumanized children. Before I explain, as background, I work as a health care provider in California. During the pandemic, I never had to asymptomatically test even during hospital work. No dog ever smelled me. Keep that in mind as I tell you about this. Because these CA kids have more restrictions than doctors working in the hospital with the sickest patients!

It strikes me as a bit dehumanizing to treat children like this. Especially since ~100% would later go on to develop COVID. The vast majority would get COVID without getting a vaccine. Seems that lining them up in the schoolyard, and having a dog sniff them— something I have only been subject to in airports, where I assume they are sniffing for bomb residue or drugs— is a bit extreme.

I worry how a child might feel if they go to school feeling fine, and the dog sits down beside them. Their classmates— even though they are told to face away— will still know. The dog will stop moving. And let’s be honest, kids will look around. Did they pull the kid from school then? Did any kids start crying? Seems messed up to me. Why did they have to do this with children?

Why do I note this: isn’t it something that not a single person flagged this idea and said: if we are going to do this, let’s do it for doctors or nurses, or at least adults. It is kinda fucked up to treat children like this, and future generations may look at us like we are out of our minds. When they look back at the IFR in kids, they may think we are actually insane.

Regardless of a pandemic emergency, this sort of behavior is unconscionable.  These children are in the protective custody of the school.  There is no mention of parental consent for involuntary testing.  Were the parents even notified beforehand?

The article also did not mention what was done if a child tested as positive. 

What I don't know is whether individual parents complained or protested about this event.  I assume if the testing was done in the schoolyard (probably in the morning) the child wouldn't be permitted to enter the school.

If this was done during the masking mandate why would they still test if kids were masked?

This procedure raises many more questions than answers.

The article was published by authors in California so I assume the testing was done there.

This was obviously done for deriving data for a public health study rather than protecting innocent children.

I am also certain the authorities used the Public Health Emergency Order by the State of California, the Governor, and all others who use immunity as a protection against legal action.

What do you think? Reasonable or messed up?

I predict it will only get worse.

Just remember,  "We're doing this for your protection"

Line up children, the COVID sniffing dog is here to judge you

AskAnExpert: Anesthesia 101 SCIENCE FRIDAY NPR

AskAnExpert: Anesthesia 101 (SciFri Zoom Call-in)

Your surgeon recommends you have surgery. He gives you an informed consent form and asks you to sign it.  

Are you signing your life away? He/she explains the risks and benefits of the procedure and should also tell you what can happen if you don't have the surgery.

What other risks do you face ? If general or local anesthesia is necessary you should be aware of those risks as well.  They can be substantial and usually, the anesthetist should explain them in an informed consent separate from the consent form given to you by the surgeon's office. But caution is advised because some hospitals or ASCs do not do this.  If there is an adverse event or even death if this has not b been explained the perpetrators are open to clear-cut malpractice/negligence, separate from the surgeon's liability.

Contrary to what most people think, going to sleep is not the same as anesthesia.

This video clearly explains those risks. 

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov

HJR 7 - Relating to a national emergency declared by the President on March 13, 2020. Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That, pursuant to section 202 of the National Emergencies Act (50 U.S.C. 1622), the national emergency declared by the finding of the President on March 13, 2020, in Proclamation 9994 (85 Fed. Reg. 15337) is hereby terminated.   https://www.whitehouse.gov/briefing-room/legislation/2023/04/10/bill-signed-h-j-res-7/

What does this mean?

There are other laws passed by Congress that leaves in place certain actions.

Biden rescinding Trump-Biden Proclamation 9994 under the 1976 National Emergencies Act does not terminate Azar Becerra’s Public Health Emergency authorities under the 1983 PHE amendment to the 1944 PHSA.

Under the terms of. 1944PHSA, U.S. Congressional law still permits emergency quarantines for ensuing epidemics, or results of biological warfare or terrorism.

President Joe Biden on April 10 signed a measure that immediately ended the COVID-19 national emergency more than three years after it was enacted, the White House announced.

HJ Res 7 passed through the Senate on March 29 by a 68-23 margin, with 21 Democrats joining 47 Republicans to support the measure. 

Four Republicans and five Democrats did not cast a vote—and 23 Democrats voted against the short resolution—which was introduced by Rep. Paul Gosar (R-Ariz.) last month and passed by the House 229-197 on Feb. 1.

Concerned citizens should be aware that the terms of declaring a national emergency due to infectious disease outbreaks remain vague, leaving it open to interpretation by politicians, and local, tribal, and state government officials.

According to law the CDC (Communicable Disease Center)

There are certain rules regarding the roles of Federal, State, and local government which introduce possible competing and adversarial roles for quarantine and enforcement.

If a quarantinable disease is suspected or identified, CDC may issue a federal isolation or quarantine order.

Public health authorities at the federal, state, local, and tribal levels may sometimes seek help from police or other law enforcement officers to enforce a public health order.

U.S. Customs and Border Protection and U.S. Coast Guard officers are authorized to help enforce federal quarantine orders.

Breaking a federal quarantine order is punishable by fines and imprisonment.

Federal law allows the conditional release of persons from quarantine if they comply with medical monitoring and surveillance.

In the rare event that a federal order is issued by CDC, those individuals will be provided with an order for quarantine or isolation. An example of a Quarantine Order for Novel Coronavirus (print-only) [PDF – 5 pages] is provided. This document outlines the rationale of the federal order as well as information on where the individual will be located, quarantine requirements including the length of the order, CDC’s legal authority, and information outlining what the individual can expect while under federal order.

COVID 19 QUARRANTINE ORDER. 

The United States was ill-prepared for COVID-19.  Conflicting advice from individuals, governors, and others led to confusion and a lack of trust on the part of the American people.

In addition to the above the First Amendment allowed mis- information to be propagated by social media. This has and will continue in the future without strict guidelines to monitor misinformation via the internet. This will require massive monitoring of internet traffic, using Artificial Intelligence. The First Amendment could be used to strike down internet monitoring.  Who will set the standards for what is correct or not?  Will there be penalties for internet abuse?

There are many issues to be decided before the next epidemic.