Listen Up

Tuesday, January 31, 2023

CDC/FDA - EvuSheld no longer works as a prophylaxis – 61% of circulating variants now XBB.1.5 and 22% BQ.1.1 – what use are C19 mRNA injections targeting BA.4 and BA.5?

Three years later most of the SARS-Covid viral epidemic has dissipated but still remains endemic. In other words, it is with us 'forever'.  Covid is now relegated to the ordinary flu-like syndrome.  The risk of long Covid remains as a small percentage of overall Covid infection. Now we have a risk of adverse reactions to Covid vaccination.

Covid vaccination gave birth to msRNA production of a portion of the virus capsid, in this case, a protein spike. The newer form produces a myriad of complications that are not seen in the classical vaccines produced by attenuated whole vaccines. Covid 19 mutated rapidly through a number of mutations too numerous to elaborate in this article.

As Covid has evolved, so too have vaccinations and treatments. In the world of virology, small things matter (no pun intended) and small things rapidly evolve.  

61% of circulating variants are now XBB.1.5 and 22% BQ.1.1 – what use are C19 mRNA injections targeting BA.4 and BA.5?

“As of January 20, 2023, >90% of circulating SARS-CoV-2 variants in the United States, specifically Omicron BQ.1, BQ.1.1, XBB, and XBB.1.5 sublineages, are unlikely to be susceptible to the combined monoclonal antibodies, tixagevimab and cilgavimab (Evusheld) used for preexposure prophylaxis against SARS-CoV-2 infection (1).

“The FDA pulled Evusheld because it is not effective against 95% of the omicron subvariants circulating in the U.S. This includes the XBB subvariants which are now causing 64% of new cases, as well as the BQ family that is responsible for 31% of reported infections.”

                           The latest variants estimated to be circulating in the US from the CDC

With a tabulation of the current estimated prevalence of each variant here:
  

Information for Persons Who Are Immunocompromised Regarding Prevention and Treatment of SARS-CoV-2 Infection in the Context of Currently Circulating Omicron Sublineages — United States, January 2023

The Food and Drug Administration announced on January 26, 2023, that Evusheld is not currently authorized for preexposure prophylaxis against SARS-CoV-2 infection in the United States (2). It is important that persons who are moderate to severely immunocompromised,* those who might have an inadequate immune response to COVID-19 vaccination, and those with contraindications to receipt of COVID-19 vaccines, exercise caution and recognize the need for additional preventive measures (Box). In addition, persons should have a care plan that includes prompt testing at the onset of COVID-19 symptoms and rapid access to antivirals if SARS-CoV-2 infection is detected         

For those with an immunocompromised system here is a plan:

Personal COVID-19 action plan§ (only for those with compromised immune systems) Not for the general public.
  
Persons should consider how to protect themselves and others around them should they become ill with COVID-19 or if the community's COVID-19 transmission level changes. The plan should include:
ways to protect oneself and others including considerations in case of illness, such as finding a room in which to isolate actions to take in case of exposure or symptom onset, what to do in the event of receipt of a positive SARS-CoV-2 test result

Persons should share their COVID-19 plan with their families, friends, and healthcare providers so they can support prevention and preparation steps. CDC suggests that people consider how others can help them if they get ill. It is important to adhere to treatment plans, keep routine healthcare appointments, and ensure that prescriptions are filled. Persons should make alternative plans for work, child care, and other responsibilities that might cause stress if they become ill.


CDC/FDA - EvuSheld no longer works as a prophylaxis – 61% of circulating variants now XBB.1.5 and 22% BQ.1.1 – what use are C19 mRNA injections targeting BA.4 and BA.5?

Saturday, January 28, 2023

Neurotechnologies for Alzheimer Disease Are Emerging: Here’s What We Know So Far -


One-third of Americans die of Alzheimer's Disease (AD). During the past decade, early diagnosis has improved but can be problematic.  A standard medical workup for Alzheimer's disease often includes structural imaging with magnetic resonance imaging (MRI) or computed tomography (CT). These tests are primarily used to rule out other conditions that may cause symptoms similar to Alzheimer's but require different treatments. There are no specific blood tests, nor imaging test that is diagnostic for AD

How is AD diagnosed?  AD is often a rule-out illness, by eliminating other causes of dementia.

What causes dementia?

Common causes of dementia are:

Alzheimer's disease. This is the most common cause of dementia.
Vascular dementia. This may occur in people who have long-term high blood pressure, severe hardening of the arteries, or several small strokes. Strokes are the second most common cause of dementia.
Parkinson's disease. Dementia is common in people with this condition.
Dementia with Lewy bodies. It can cause short-term memory loss.
Frontotemporal dementia. This is a group of diseases that includes Pick's disease.
Severe head injury.
Less common causes of dementia include:

Huntington's disease.
Leukoencephalopathies. These are diseases that affect the deeper, white-matter brain tissue.
Creutzfeldt-Jakob disease. This is a rare and fatal condition that destroys brain tissue.
Some cases of multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS).
Multiple-system atrophy. This is a group of degenerative brain diseases that affect speech, movement, and autonomic function.
Infections such as late-stage syphilis. Antibiotics work well to treat syphilis at any stage, but they can't reverse the brain damage already done.
Inherited dementia
Some disorders that cause dementia can run in families. Doctors often suspect an inherited cause if someone younger than 50 has symptoms of dementia.

The classical pathologic signs are the neurofibrillary tangle and the senile plaque. The neurofibrillary tangle consists of abnormal accumulations of abnormally phosphorylated tau within the perikaryal cytoplasm of certain neurons. Tau is an abnormal protein that accumulates within the neurons. 

Microtubules in neurons

Amyloid plaques are aggregates of misfolded proteins that form in the spaces between nerve cells. These abnormally configured proteins are thought to play a central role in Alzheimer's disease. The amyloid plaques first develop in the areas of the brain concerned with memory and other cognitive functions.   Amyloid plaques form one of the two defining features of Alzheimer’s disease, the other being neurofibrillary tangles.


Amyloid Plaques


Neurofibrillary tau

The impact of AD is enormous in terms of caregiving, and support services.  Many families cannot afford the full-time support necessary for a parent or loved one.  Assisted living and/or memory support units are expensive, and most health insurance does not reimburse for those services. 

Unlike heart disease where progress has been significant in diagnosis and treatment, AD presents other challenges, such as being difficult to diagnose and a lack of proven treatments.

Can Alzheimer's Disease Be Prevented?  We know that control of blood pressure, lowering blood lipids, and regular exercise can reduce the risk of atherosclerotic heart disease.

The Alzheimer's Association has these suggestions for 10 Ways to Love your Brain

Which came first?  The chicken or the egg?   Are the tangles and amyloid the result of dementia, or do tangles and amyloid cause dementia?  

Financial repercussions for the health system (Medicare/Medicaid)

In 2015, the costs to all payers for the care of people living with Alzheimer's disease and other dementias will total an estimated $226 billion, with Medicare and Medicaid paying 68 percent of the costs. Without a treatment, costs are projected to increase to more than $1.1 trillion in 2050.

A treatment introduced in 2025 that delays the onset of Alzheimer's would cut the number of people in 2050 who have the disease by 42 percent — from 13.5 million to 7.8 million. The Alzheimer's Association's report also shows the positive impact of adequate funding and the potential consequences of underfunding.

Reaching the 2025 goal would save payers $220 billion over the first five years and $367 billion in 2050 alone. Savings to Medicare and Medicaid would account for nearly 60 percent of the savings.


Notwithstanding the financial advantages, there is another and perhaps more important item, quality of life


        Therapeutics 1, 2 , 3

The alternatives to alleviate suffering are

Death with dignity (A euphemism for death by suicide.)


    Short of finding a successful treatment, advanced directives are proactive and allow for seniors to instruct their surviving children and relatives as to what you want.  The Advanced Directive must be filed with your physician and/or hospital.


Neurotechnologies for Alzheimer's Disease Are Emerging: Here’s What We Know So Far - Ophthalmology Advisor: Mehdi Jorfi, Ph.D., discusses the array of techniques in different technologies that can help identify potential interventions for Alzheimer's disease.

Wednesday, January 25, 2023

Congress eliminates need for waiver to treat opioid use disorder



In its year-end omnibus legislation passed on December 23, 2022, Congress took steps to a expand access to medication-assisted treatment for opioid use disorder. Under the new law, physicians no longer must obtain a special federal waiver to prescribe buprenorphine, which is used to treat patients with opioid use disorder.

The California Medical Association (CMA) supports efforts to increase access to much-needed medication-assisted treatment for opioid use disorders. Across the country, many people suffering from opioid use disorder are unable to access medication-assisted treatment for their condition due to a lack of nearby physicians with waivers to prescribe buprenorphine.

Going forward, all prescriptions for buprenorphine only require a standard U.S. Drug Enforcement Agency (DEA) registration number. Additionally, there are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.

Section 1263 of the Omnibus spending bill (the Medication Access Training Expansion Act) also establishes new training requirements for all prescribers of controlled substances, which will take effect June 21, 2023. The new law requires all prescribers of schedule II – V controlled substances to meet a one-time eight-hour training requirement on identifying, treating, and managing patients with opioid or other substance use disorders. (Certain physicians – including those board certified in addiction medicine – will be deemed to have met this training requirement through their specialty training and/or board certification. Click here for more details.)

DEA and the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) are actively working to provide additional guidance on these requirements.















Congress eliminates need for waiver to treat opioid use disorder: In its year-end omnibus legislation, Congress took steps to a expand access to medication-assisted treatment for opioid use disorder. Under the new law, physicians no longer must obtain a special fed...

Tuesday, January 24, 2023

CLINICAL TRIALS

 The number and scope of clinical trials is daunting. 

NEW! NATIONWIDE LISTINGS!


There are currently multiple studies recruiting for the following conditions.

Alzheimer's Disease Clinical Trials

Arthritis Clinical Trials

Asthma Clinical Trials

Back Pain Clinical Trials

Cancer Clinical Trials

COVID-19 Clinical Trials

Chronic Cough Clinical Trials

Cluster Headaches Clinical Trials

Constipation Clinical Trials

Crohn's Disease Clinical Trials

Cytomegalovirus Clinical Trials

Depression Clinical Trials

Diabetes Type 1 Clinical Trials

Diabetes Type 2 Clinical Trials

Eczema Clinical Trials

Endometriosis Clinical Trials

Fatty Liver Disease Clinical Trials

Fibromyalgia Clinical Trials

Healthy Volunteer Clinical Trials

Heart Attack Clinical Trials

Heart Disease Clinical Trials

High Blood Pressure Clinical Trials

High Cholesterol Clinical Trials

Hodgkin's Lymphoma Clinical Trials

Irritable Bowel Syndrome Clinical Trials

Kidney Disease Clinical Trials

Knee Pain Clinical Trials

Lupus Clinical Trials

Lymphoma Clinical Trials

Migraine Clinical Trials

Melanoma Clinical Trials

Myelofibrosis Clinical Trials

Narcolepsy Clinical Trials

Obesity/Weight Loss Clinical Trials

Osteoarthritis Clinical Trials

Parkinson's Disease Clinical Trials

Pediatric Healthy Volunteers Clinical Trials

All Pediatric Clinical Trials

Psoriasis Clinical Trials

Prurigo Nodularis Clinical Trials

Remote Clinical Trials

Schizophrenia Clinical Trials

Smoking Clinical Trials

Stress Urinary Incontinence Clinical Trials

Stroke Clinical Trials

Traumatic Brain Injury Clinical Trials

Ulcerative Colitis Clinical Trials

Vaccine Clinical Trials


If you have found a clinical trial that you are interested in, simply follow the instructions listed below the clinical trial posting. Some clinical trial postings allow you to complete an interest form which is located at the bottom of the study posting. Other clinical trials will require you to complete an online questionnaire, which is also at the bottom of the posting. If you are interested in contacting the clinic directly you must fill out the contact form to receive an email containing the phone number if the investigator opted to include one.

Also, remember that you may always refer your friends and family members to clinical trials that they may be interested in.

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