ISOLATION FOR RESPIRATORY VIRUSES UPDATE
CDC RECOMMENDATIONS ON COVID 19 VACCINATION
WEIGHT LOSS DRUGS
CANCER DETECTION BLOOD TESTS
INSURANCE UPDATE
OFFICE CLOSURE FOR THE SOLAR ECLIPSE
Spring is in the air along with oak and many other pollens. The office has new computers and updated security. We weathered the winter tripledemic of flu, RSV and Covid 19. The first two have peaked and are on the wane, but the latter unfortunately, persists. Every day or two we get reports of new cases. Most of these were diagnosed with home tests. We have been aided this winter by a respiratory pathogen panel that screens for 21 different viruses and 14 bacteria.
In this particular case, the PCR identified a common cold virus for which there is no specific treatment. Even that can be reassuring that there is not a treatable organism that is being overlooked. On a number of occasions a bacteria which was not suspected was identified as the culprit and that prompted treatment with an antibiotic. This technology has assisted us in more precisely treating respiratory infections and limiting the use of antibiotics.
The CDC recently updated their isolation recommendations for patients with Covid 19.
Stay home until you feel better and use caution when you resume normal activities. This summarizes the new recommendations from the CDC. Covid 19 is just as infectious as ever, but deaths have dropped from 21,000 deaths a week to 1,500 a week. Thats still 78,000 people a year! These guidelines are more practical and people weren’t adhering to the old guidelines anyway. Covid is often “just a cold” but can still have strange, severe side effects and that is what continues to concern me. The other news that follows is that older patients can get an additional dose of the present vaccine. It should be 4 months from the fall vaccine if not immunocompromised and 2 months if immunocompromised.
CDC updates and simplifies respiratory virus recommendations
Recommendations are easier to follow and help protect those most at risk
CDC released today updated recommendations for how people can protect themselves and their communities from respiratory viruses, including COVID-19. The new guidance brings a unified approach to addressing risks from a range of common respiratory viral illnesses, such as COVID-19, flu, and RSV, which can cause significant health impacts and strain on hospitals and health care workers. CDC is making updates to the recommendations now because the U.S. is seeing far fewer hospitalizations and deaths associated with COVID-19 and because we have more tools than ever to combat flu, COVID, and RSV.
“Today’s announcement reflects the progress we have made in protecting against severe illness from COVID-19,” said CDC Director Dr. Mandy Cohen. “However, we still must use the commonsense solutions we know work to protect ourselves and others from serious illness from respiratory viruses—this includes vaccination, treatment, and staying home when we get sick.”
As part of the guidance, CDC provides active recommendations on core prevention steps and strategies:
- Staying up to date with vaccinationto protect people against serious illness, hospitalization, and death. This includes flu, COVID-19, and RSV if eligible.
- Practicing good hygiene by covering coughs and sneezes, washing or sanitizing hands often, and cleaning frequently touched surfaces.
- Taking steps for cleaner air, such as bringing in more fresh outside air, purifying indoor air, or gathering outdoors.
When people get sick with a respiratory virus, the updated guidance recommends that they stay home and away from others. For people with COVID-19 and influenza, treatment is available and can lessen symptoms and lower the risk of severe illness. The recommendations suggest returning to normal activities when, for at least 24 hours, symptoms are improving overall, and if a fever was present, it has been gone without use of a fever-reducing medication.
Once people resume normal activities, they are encouraged to take additional prevention strategies for the next 5 days to curb disease spread, such as taking more steps for cleaner air, enhancing hygiene practices, wearing a well-fitting mask, keeping a distance from others, and/or getting tested for respiratory viruses. Enhanced precautions are especially important to protect those most at risk for severe illness, including those over 65 and people with weakened immune systems. CDC’s updated guidance reflects how the circumstances around COVID-19 in particular have changed. While it remains a threat, today it is far less likely to cause severe illness because of widespread immunity and improved tools to prevent and treat the disease. Importantly, states and countries that have already adjusted recommended isolation times have not seen increased hospitalizations or deaths related to COVID-19.
While every respiratory virus does not act the same, adopting a unified approach to limiting disease spread makes recommendations easier to follow and thus more likely to be adopted and does not rely on individuals to test for illness, a practice that data indicates is uneven.
“The bottom line is that when people follow these actionable recommendations to avoid getting sick, and to protect themselves and others if they do get sick, it will help limit the spread of respiratory viruses, and that will mean fewer people who experience severe illness,” National Center for Immunization and Respiratory Diseases Director Dr. Demetre Daskalakis said. “That includes taking enhanced precautions that can help protect people who are at higher risk for getting seriously ill.”
The updated guidance also includes specific sections with additional considerations for people who are at higher risk of severe illness from respiratory viruses, including people who are immunocompromised, people with disabilities, people who are or were recently pregnant, young children, and older adults. Respiratory viruses remain a public health threat. CDC will continue to focus efforts on ensuring the public has the information and tools to lower their risk or respiratory illness by protecting themselves, families, and communities.
This updated guidance is intended for community settings. There are no changes to respiratory virus guidance for healthcare settings.
THEY ALSO UPDATED VACCINE RECOMMENDATIONS:
Older Adults Now Able to Receive Additional Dose of Updated COVID-19 Vaccine
Today, CDC Director Mandy Cohen endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for adults ages 65 years and older to receive an additional updated 2023-2024 COVID-19 vaccine dose. The recommendation acknowledges the increased risk of severe disease from COVID-19 in older adults, along with the currently available data on vaccine effectiveness.
Previous CDC recommendations ensured that people who are immunocompromised are already eligible for additional doses of the COVID-19 vaccine.
Data continues to show the importance of vaccination to protect those most at risk for severe outcomes of COVID-19. An additional dose of the updated COVID-19 vaccine may restore protection that has waned since a fall vaccine dose, providing increased protection to adults ages 65 years and older.
Adults 65 years and older are disproportionately impacted by COVID-19, with more than half of COVID-19 hospitalizations during October 2023 to December 2023 occurring in this age group.
CDC and ACIP will continue to monitor COVID-19 vaccine safety and effectiveness. CDC continues to recommend that everyone stay up to date on their COVID-19 vaccines, especially people with weakened immune systems.
The following is attributable to Dr. Mandy Cohen:
“Today’s recommendation allows older adults to receive an additional dose of this season’s COVID-19 vaccine to provide added protection,” said Mandy Cohen, M.D., M.P.H. “Most COVID-19 deaths and hospitalizations last year were among people 65 years and older. An additional vaccine dose can provide added protection that may have decreased over time for those at highest risk.”
THE WILD, WILD WEST OF WEIGHT LOSS
I asked a patient who returned to San Antonio after 10 years what change was most apparent to here. “People are thinner”, she observed.
We have some very effective medications for diabetes which are also approved for weight loss. Semaglutide is marketed as Ozempic for diabetes and as Wegovy for weight loss. Likewise, tirzepatide is marketed as Mounjaro for diabetes and Zepbound for weight loss. The drugs are classified as GLP 1 agonists (tirzapeptide has an additional mechanism of action) which work by activating glucagon-like peptide 1 receptors which increases insulin secretion, lowers glucagon secretion, increases insulin sensitivity and delays gastric emptying. They are once a week injections which cause patients to lose their appetite and eat less. The side effects are mainly gastrointestinal: nausea, vomiting, abdominal pain, constipation and diarrhea are common side effects. They are very effective and very expensive costing over $1000 per month. They are also hard to come by and frequently patients have to call multiple pharmacies to find them. That has led to the rise of compounded substitutes which are chemically similar, but not identical leading to the FDA to issue a warning which will follow. But people will do anything to lose weight and these drugs are being offered by a wide variety of entities. Medical spas are dispensing them and there is a home IV service which will send a nurse to your house to administer them weekly for a price of $1000-$2000 a month depending on the Cocktail selected. There is a website where you can enroll in a plan to access these drugs for $145 a month which does not include the cost of the drugs.
Here is the FDA’s warning on compounded semaglutide:
Medications Containing Semaglutide Marketed for Type 2 Diabetes or Weight Loss
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar). GLP-1 in higher amounts also interacts with the parts of the brain that reduce appetite and signal a feeling of fullness.
There are currently three FDA-approved semaglutide products:
- Ozempic injection and Rybelsus tablets are approved to lower blood sugar levels in adults with type 2 diabetes mellitus, in addition to diet and exercise. Ozempic is also approved to reduce the risk of heart attack, stroke, or death in adults with type 2 diabetes mellitus and known heart disease.
- Wegovy injection is approved to help adults and children aged 12 years and older with obesity or some adults with excess weight (overweight), who also have weight-related medical problems, to lose weight and keep the weight off, in addition to diet and exercise.
All three medications are only available with a prescription, and there are no approved generic versions.
Can semaglutide be compounded?
When a drug is in shortage, compounders may be able to prepare a compounded version of that drug if they meet certain requirements in the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, Ozempic and Wegovy are both listed on FDA’s Drug Shortages list.
Are there concerns with compounded semaglutide?
FDA has received adverse event reports after patients used compounded semaglutide. Patients should not use a compounded drug if an approved drug is available to treat a patient. Patients and health care professionals should understand that the agency does not review compounded versions of these drugs for safety, effectiveness, or quality.
Additionally, FDA has received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate. The salt forms are different active ingredients than is used the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded.
On April 27, 2023, FDA wrote to the National Association of Boards of Pharmacy expressing the agency’s concerns with use of the salt forms in compounded products. On Oct. 10, 2023, FDA sent additional letters to the National Association of Boards of Pharmacy and the Federation of State Medical Boards expressing similar concerns. The letters also explain the conditions under which compounded semaglutide products may be permissible under the law, and note that compounded drugs are not FDA-approved or evaluated for safety and effectiveness.
What should patients know about compounded semaglutide drugs?
Patients should be aware that some products sold as ‘semaglutide’ may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations. Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective.
Patients should only obtain drugs containing semaglutide with a prescription from a licensed health care provider, and only obtain medicines from state-licensed pharmacies or outsourcing facilities registered with FDA.
What should health care professionals know?
Health care professionals who are considering working with compounders to obtain semaglutide products should be aware that compounders may be using salt forms of semaglutide. FDA is not aware of any basis for compounding a drug using semaglutide salts that would meet federal requirements.
Has FDA found illegally marketed semaglutide online?
Yes. FDA vigilantly monitors the internet for fraudulent or unapproved products and has issued warning letters to stop the distribution of illegally marketed semaglutide. These drugs may be counterfeit, which means they could contain the wrong ingredients, contain too little, too much or no active ingredient at all, or contain other harmful ingredients.
Has FDA found counterfeit Ozempic in the U.S.?
FDA is aware and is investigating reports of counterfeit Ozempic being marketed in the U.S. The agency investigates any report of suspect counterfeit drugs to determine the public health risks and the appropriate regulatory response, and remains vigilant in protecting the U.S. drug supply from these threats.
How should patients protect themselves?
While we understand certain drugs are in short supply and patients are having difficulty obtaining their medication, FDA urges patients to obtain prescription drugs only from state-licensed pharmacies that are located in the U.S., where FDA and state authorities can assure the quality of drug manufacturing, packaging, distribution and labeling. FDA’s BeSafeRx campaign helps consumers learn about how to safely buy prescription medicines online. FDA recommends patients to talk to their doctor if they have questions about their medicines.
Reporting issues to FDA
FDA encourages health care professionals, patients, and compounders to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
More Resources
Multi-cancer detection tests — Multi-cancer detection (MCD) tests have the goal of detecting cancer at early stages [44]. MCD tests analyze blood samples for molecular signals (eg, DNA, proteins) that are produced by cancer cells. Although they are intended to serve as adjuncts to standard cancer screening tests, MCDs can result in substantial downstream testing, which can be costly. A positive test result requires additional imaging and diagnostic work-up, particularly since MCD tests often do not specify the type of cancer or the organ(s) that are involved.
Although some MCD tests are commercially available and may detect cancer signals across a wide diversity of malignancies [45], their clinical utility for cancer screening remains uncertain. Results from studies to date are generally not reflective of test performance in larger populations who typically undergo screening (ie, asymptomatic individuals in primary care). Most importantly, no studies have shown that MCD testing improves clinical outcomes, such as cancer-related deaths, particularly in comparison with existing screening methodologies [46,47]. Representative studies include:
●A prospective cohort study (PATHFINDER) performed MCD testing in a convenience sample of 6621 asymptomatic adults aged 50 years or older, 31 percent of whom had a known cancer predisposition or prior cancer (a high-risk population). A cancer signal was detected in 1.4 percent of participants, of whom 38 percent were diagnosed with cancer (true positives) and 62 percent were not (false positives) [48]. Of the true positives, 17 percent had recurrence of previous disease. The median time to diagnostic resolution was 57 days in true positives, and longer (162 days) in false positives. Most participants had further work-up with laboratory tests and imaging, and procedures were done in 30 percent of participants with false-positive results and 82 percent of those with true-positive results. In this high-risk study population, the overall sensitivity of MCD testing was only moderate (29 percent), suggesting that MCD testing would need to occur in conjunction with standard cancer screening methods in order to be effective [47].
●A multicenter cohort study of 6238 participants in England and Wales evaluated the utility of an MCD test in adult patients who were referred for urgent investigation of non-specific symptoms that were possibly caused by lung, gastrointestinal, or gynecologic cancers [49]. This study population was therefore not typical of an asymptomatic screening population. In this cohort of symptomatic patients, the test was highly specific (98 percent) but only moderately sensitive (66 percent). Test sensitivity was lower for early stage cancers (24 percent for Stage I cancers), and only 43 percent of all cancers diagnosed were stages I-II.
Given the current limitations of MCD tests, no national organization has recommended their use for cancer screening.
I will comment on the total body MRIs recommended by Kim Kardashian at a later time.
INSURANCE REMINDER
INSURANCE REMINDER
While we take a variety of insurances, we do not take HMOs and cannot accept patients on HMO plans. We do not foresee that changing. HMOs require us to get insurance authorization every time someone needs to see another physician, have an x ray or procedure. We don’t have the staff to accommodate all of their requirements while also being accessible to our patients. Insurance lists of providers are often outdated and inaccurate. If you have any questions, please call the office.
SOLAR ECLIPSE
I hope my photos of the eclipse will be better than this one from October 14th, 2023. We will be closed after noon on Monday April 8th for the eclipse. Make sure you use proper eyewear for the event. Here is a link to a JAMA patient page on safe viewing. https://jamanetwork.com/journals/jama/fullarticle/2816227
I wish you the best of health,
Mark L. Thornton, M.D., F.A.C.P.
