FDA Proposes New Warning for Tylenol, Other Brands | The Epoch Times

U.S. drug regulators have proposed adding a new warning to Tylenol and other brands of acetaminophen, an analgesic that relieves pain.

If the proposal from the U.S. Food and Drug Administration (FDA) is finalized, companies that produce the medicines will be required to add a warning that states using acetaminophen may cause severe skin reactions.

A scientific review found that Tylenol and other acetaminophen brands, all available over-the-counter (OTC), can cause severe skin problems like Stevens-Johnson syndrome, according to the FDA’s proposed order.

Some 91 cases of the syndrome or toxic epidermal necrolysis, another rare but severe skin disorder, were reported to the FDA Adverse Event Reporting System from 1969 to 2012, the agency found. An additional 25 cases were reported between Feb. 25, 2012, and June 30, 2020.

Both Stevens-Johnson syndrome and toxic epidermal necrolysis are so severe that they frequently require hospital care and can, in certain cases, result in death.

Regulators also combed through the literature and found 21 cases of the syndrome, the necrolysis, or Acute Generalized Exanthematous Pustulosis reported across 18 articles, after excluding cases that lacked enough detail or featured additional products in addition to acetaminophen. Researchers determined six of the cases were probably related to acetaminophen, with the remaining 15 cases possibly related.

Less severe skin reactions such as rashes and blistering have also been recorded after the use of acetaminophen.

To continue to be generally recognized as safe and effective, or include relevant information for consumers, FDA experts say the products “must include a warning about serious skin reactions.”

The warning, if finalized, would tell consumers that acetaminophen “may cause severe skin reactions” with symptoms including skin reddening, blisters, and rash.

“If a skin reaction occurs, stop use and seek medical help right away,” the proposed warning states.

The proposal “helps to ensure the safety and effectiveness of OTC drugs in our marketplace,” Dr. Theresa Michele, director of the FDA Center for Drug Evaluation and Research’s Office of Nonprescription Drugs, said in a statement.

The proposal follows a 2013 FDA alert that informed people acetaminophen was “associated with” serious skin reactions. The FDA in 2017 also issued guidance for manufacturers recommending they add warnings about the reaction. The new step would require the labels to be updated.

People desiring to comment on the proposed order can submit comments via an FDA portal through the end of July 29. All comments must include “OTC000035” and “Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use.”

If you are interested in the inside effects of OTC (Over-The Counter Products. Click here

FDA Proposes New Warning for Tylenol, Other Brands | The Epoch Times

EMF Exposure: Danger Levels, Symptoms, Protection, and More

Should You Be Worried About EMF Exposure?

Not to be confused with EMP (electromagnetic pulse).  An electromagnetic pulse (EMP), also referred to as a transient electromagnetic disturbance (TED), is a brief burst of electromagnetic energy. The origin of an EMP can be natural or artificial and can occur as an electromagnetic field, as an electric field, as a magnetic field, or as a conducted electric current. The electromagnetic interference caused by an EMP can disrupt communications and damage electronic equipment. An EMP such as a lightning strike can physically damage objects such as buildings and aircraft. The management of EMP effects is a branch of electromagnetic compatibility (EMC) engineering.

Types of EMF exposure

Radiation exists across what’s called the electromagnetic spectrum. This radiation ranges from very high-energy (called high-frequency) on one end of the spectrum, to very low-energy (or low-frequency) on the other end.

Examples of high-energy radiation include:

x-rays

gamma rays

some higher-energy ultraviolet (UV) rays

This is ionizing radiation, meaning this energy can affect cells on the atomic level by removing an electron from an atom, or “ionizing” it. Ionizing radiation can damage the body’s DNA and cells, which may contribute to genetic mutations and cancer.

On the other end of the spectrum is extremely low-frequency (ELF) radiation. This is a type of non-ionizing radiation. It can move atoms around in the body or make them vibrate, but most researchers agree that it isn’t enough to damage DNA or cells.

In between ELF radiation and high-energy radiation on the spectrum are other types of non-ionizing radiation, like:

radiofrequency (RF) radiation

visible light

infrared

EMPs created by solar flares interrupt satellite communications and terrestrial radio frequencies.  In some cases, electronic hardware can be damaged or destroyed. The first recorded damage from an electromagnetic pulse came with the solar storm of August 1859 or the Carrington Event.[1]

Image of the July 2012 solar storm, which generated CMEs of comparable strength to the one of 1859. Note the small bright circle in the light baffle which demonstrates the size of the Sun

Large EMPs create significant auroras and can be viewed at lower altitudes.  The earth's gravity influences the aurora display. 

These solar events have been studied.

This image illustrates the solar wind velocity around the Sun as measured by the Ulysses spacecraft. Here’s a detailed explanation:

1. **Central Object - The Sun**:

   - At the center of the image is the Sun depicted in a vibrant red and yellow hue.

2. **Axes**:

   - The image has two primary axes:

     - The vertical axis represents the speed of the solar wind in kilometers per second (km/s).

     - The horizontal axis indicates the distance from the Sun in Astronomical Units (AU), denoting the position measurements.

3. **Graphical Data**:

   - The graph displays four quadrants illustrating solar wind speeds in various directions around the Sun.

   - The y-axis ranges from 0 to 1000 km/s, corresponding to the solar wind speed.

   - The x-axis does not have a numerical scale but represents the spatial direction around the Sun.

4. **Colors and Symbols**:

   - The data lines are differentiated by color:

     - **Blue Symbols**: Represent the inward Interplanetary Magnetic Field (IMF) or solar wind measurements.

     - **Red Symbols**: Represent the outward IMF or solar wind measurements.

   - Each colored line represents the speed of the solar wind in various directions around the Sun.

5. **References**:

   - Key projects and organizations involved in gathering this data are noted in the image:

     - ULYSSES/SWOOPS: Ulysses Solar Wind Observations Over the Poles of the Sun project.

     - ULYSSES/MAG: Magnetic field measurements from Ulysses.

     - Institutions: Imperial College, EIT (NASA/GSFC), Mauna Loa MK3 (HAO), and LASCO C2 (NRL).

6. **Data Interpretation**:

   - The vertical elongation of the lines indicates higher solar wind speeds.

   - The inward and outward IMFs show the solar wind’s expansion and interaction with the Sun’s magnetic field in different hemispheres.

In summary, this image is a graphic representation of solar wind velocities measured by the Ulysses spacecraft, categorizing data into inward and outward flows around the Sun, presenting a comprehensive view of the solar wind dynamics in different directions.

Electric and magnetic fields occur naturally and also come from human-made sources. Scientists and oversight agencies generally agree that low-frequency EMFs pose little danger to human health.

Most of us are used to the electronic conveniences of modern life. But few of us are aware of the possible health risks presented by the gadgets that make our world work.

Our power lines, cellphones, microwaves, Wi-Fi routers, computers, and other appliances send out a stream of invisible energy waves. Electric and magnetic fields (EMFs) are produced anywhere electricity is used, including at home and in the workplace.

Some experts are concerned about the potential health effects of these fields. But should we be worried?

While most researchers don’t believe most EMFs are dangerous, there are still some scientists who question the safety of EMF exposure. Many say there hasn’t been enough research into understanding whether EMFs are safe. Let’s take a closer look.

What are EMFs?

Since the beginning of the universe, the sun has sent out waves that create EMFs, or radiation. At the same time, the sun sends out EMFs, we can see its energy radiating out. This is visible light.

At the turn of the 20th century, electric power lines and indoor lighting spread across the world. Scientists realized that the power lines supplying all that energy to the world’s population were sending off EMFs, just like the sun does naturally.

Over the years, scientists learned that many of the emerging electrical appliances also create EMFs. As the medical world advanced, much of its diagnostic and treatment equipment, like imaging devices for X-rays and CT scans, were also found to make EMFs.

Today, 90 percent of the world’s population has access to electricity and uses electrical appliances. That means lots of electricity and EMFs are created around the world.   

But even with all those waves, scientists generally don’t think EMFs are a health concern.

EMF Exposure: Danger Levels, Symptoms, Protection, and More

The level of EMF exposure varies widely around the world.  The map below reveals the percentage of electrification throughout the world.  There are many countries, especially in Africa where penetration is less than 50%.

If EMF exposure causes health effects the rate of side effects should be apparent by comparing the incidence between countries with a high penetration of electrical devices.

From a practical point, how does this matter for people on Earth?  In general, not much.  Astronauts in orbit on long-duration space flights, or on the moon can be affected, and there is some evidence of the effects on astronauts when they return to terra firma.  

From ChatGPT:

In the context of astronauts, exposure to EMPs during space missions could potentially impact their health and equipment, though the specific effects are not fully understood. Further research and protective measures may be necessary to ensure the safety of astronauts in the face of potential EMP threats.

Recently there has been concern regarding 5G cellular communications. Data speed and capacity indicate the key differences between 5G and LTE. 5G gives faster data speeds than LTE and supports more devices and users on the same network.

Here is how long it would take to download a 1 GB file on different networks:

On a 5G network, it would take about 10 seconds.

On an LTE network, it would take about 2 minutes.

5G operates at a higher frequency than 4G or LTE and therefore has a shorter range. Because of these limitations, more cell towers are necessary and the antennas are positioned to face downward from the towers.  The power levels on smart device such as smartphones are very low.  Despite concerns about brain tumors being induced by smartphones.There is no credible scientific evidence that 5G technology causes brain tumors or other health issues. The safety of 5G has been extensively studied, and major health organizations have concluded that 5G radio frequency (RF) exposure is not harmful to human health.

Some key points about the safety of 5G:

- The radio frequencies used for 5G are similar to those used for previous cellular networks, which have been in use for decades without proven health effects.

- Numerous studies and reviews by organizations like the World Health Organization have found no adverse health effects from exposure to the RF energy levels used in wireless communications, including 5G.

- 5G uses higher frequency millimeter waves, but these do not penetrate the body deeply and the power levels are well below safety limits.

- There is no mechanism by which 5G could plausibly cause brain tumors or other health problems. The energy levels are simply too low to damage cells or DNA.

So in summary, the scientific consensus is that 5G technology is safe and does not pose a risk of brain tumors or other health issues when used normally. Claims linking 5G to cancer are not supported by scientific evidence.

Leaked documents reveal patient safety issues at Amazon’s One Medical - The Washington Post

So much  for Amazon's One Medical

Since Amazon acquired the primary-care service One Medical, elderly patients have been routed to a call center — staffed partly by contractors with limited training — that failed on more than a dozen occasions to seek immediate attention for callers with urgent symptoms, according to internal documents seen by The Washington Post.

When one patient reported a “blood clot, pain, and swelling,” call center staff scheduled an appointment rather than escalating the matter for medical evaluation, according to a note in an internal incident tracking spreadsheet dated Feb. 19.

Over the following two days, clinical staffers flagged four more call-center errors involving elderly patients with urgent complaints, including stomach pain and blood in stool, a spike in blood pressure, an insect bite, and sudden rib pain, according to the internal spreadsheet.

The call-center incidents were among dozens flagged by doctors, nurses, and assistants at One Medical Seniors between Feb. 19 and March 18 in the documents, a year after Amazon acquired the primary-care service. One Medical began routing elderly patients to the call center in Tempe, Ariz., staffed partly by newly hired contractors with limited training and little to no medical experience, according to internal documents seen by The Post and interviews with four current and former One Medical workers.

Since Amazon formally acquired One Medical in February 2023 in a $3.9 billion deal, the company has alarmed patients and employees by eliminating free rides, shortening appointments, and laying off staff. Now evidence of potentially life-threatening situations at the Tempe call center is raising fresh concern that Amazon’s frugal approach to health care may be imperiling patient safety.

One Medical

Prime member benefit: Get 24/7 virtual care with One Medical membership

$9.00$9.00/mo

Amazon Prime One Medical clearly states on its website it is "Virtual Care"

They no longer have a brick-and-mortar practice, It is all virtual care

Amazon-owned One Medical has confirmed that it is closing several of its offices in a move intended to cut costs, with offices in New York, New York, Minneapolis, Minnesota, and St. Petersburg, Florida set to shutter their doors by the end of February.  The move comes less than a week after parent company Amazon said it would be cutting more than 100 jobs at One Medical and Amazon Pharmacy. Roughly 115 positions may be eliminated within the healthcare division in a bid to decrease One Medical's operating losses. Seeking Alpha reported that the job cuts could amount to several hundred as part of a company-wide effort to save $100 million this year. 

Amazon acquired One Medical last year and offered the announcement of the acquisition in July 2022. The deal was valued at $3.9 billion. Amazon had agreed to acquire One Medical in July 2022.

The deal was another example of a company outside of traditional healthcare provided by hospitals and physician practices making inroads into the primary care market.

While the realization of healthcare is seen as a competitive threat to traditional hospital and physician services, these deals have not always run smoothly. Experts have said there is a learning curve to healthcare and its low operating margins.

It becomes obvious that the corporate model does not work well, and profit motives fly in the face of quality of care.  Corporate models such as HCA (Health Care of America) were founded by physician Dr. Thomas Frist, Sr. also a U.S. Senator who emphasized quality over profits.

A critical key to corporate medicine success is real physician leadership, not just titles such as Medical Director.

Leaked documents reveal patient safety issues at Amazon’s One Medical - The Washington Post

 Health Train Express has been published for almost 20 years.  We would appreciate your answering the  survey

 

 

Are physician scientists and other part-timers good doctors?

Do you ever wonder if your doctor does research?

Questions and Answers:

The dialog raises several adjacent questions

Are physician scientists— people who mostly run labs and see patients 1/2 a day a week in clinic and 2-4 weeks a year in the hospital — good doctors?

Is the doctor who specializes in just one disease better at that disease than a doctor who sees a range of problems?

Is there a minimum amount of clinical work below which a doctor is out of practice? (the part-timer question)

Average Vacation Time for Doctors: 5 Ways to Make the Most of It

Most physicians work extremely long hours, week after week, and are at risk of suffering from job burnout. Taking the time for a little rest and relaxation can go a long way toward helping them reduce stress levels, enjoy more family time, and stay at their best to deliver quality patient care. But how many vacation weeks do doctors take? Is it enough to help them recharge and maintain a healthy work-life balance?

The 2018 Medscape Physician Lifestyle and Happiness Report, which surveyed more than 15,500 doctors across the United States, found that a third of the physicians surveyed take just 2 weeks of annual vacation or less.

The full survey results showed the following average vacation times for doctors:

6% of physicians take less than 1 vacation week annually

27% of physicians take 1-2 weeks of vacation

49% of physicians take 3-4 weeks of vacation

11% of physicians take 5-6 weeks of vacation

7% take more than 6 weeks of vacation

                                            Alternatives for Vacations:

The dialog raises several adjacent questions

Are physician scientists— people who mostly run labs and see patients 1/2 a day a week in the clinic and 2-4 weeks a year in the hospital — good doctors?

Is a doctor who specializes in just one disease better at that disease than a doctor who sees a range of problems?

Is there a minimum amount of clinical work below which a doctor is out of practice? (the part-timer question)

Twenty part-time jobs for physicians

Part-time doctors also include other duties that have clinical exposure., and many physicians in practice spend time (protected status) in clinical research as well as basic science. Some physicians also have PhDs in a basic science that serves them well in their specialty and they can offer patients alternative or breakthrough treatments.

Are physician-scientists and other part-timers good doctors?

Mediterranean Diet

How particular variations in diet influence health and the course of the disease remain largely undefined. The authors review the spectrum of types of diets and describe some attributes of the various types.

 This is a statistically valid study.

What is a '4-STAR' diet? seeds, fruits and vegetables, and protein source foods. for 4- stars on your plate at every meal. nutrients from their meals.

What are the three types of diets?

Let's define the 3 levels:

A Therapeutic Diet. This is a way of eating that's designed to treat or heal a disease or medical symptom. ...

A Maintenance Diet. This kind of fare is the staple fare used in everyday life, the business-as-usual diet.

An Experimental Diet.

What is the 4 4 4 12 diet?

Benefits of Intermittent Fasting and The 4 4 12 Fasting Schedule

The 4-4-12 method has a shorter fasting window—12 hours—but eliminates snacking between meals. The goal here is to fast for at least four hours between breakfast and lunch, four hours between lunch and dinner, and at least 12 hours between dinner and breakfast the next day.

What diet loses the most weight fastest?

Very Low-Calorie Diet (VLCD)

On a VLCD, you may have as few as 800 calories a day and may lose up to 3 to 5 pounds (1.5 to 2 kg) week. Most VLCDs use meal replacements, such as formulas, soups, shakes, and bars instead of regular meals. This helps ensure that you get all of the nutrients you need each day.

What is the caveman diet?

Paleo Diet Foods

• Leafy vegetables.
• Fresh fruit.
• Seafood.
• Grass-fed meat.
• Root vegetables, such as sweet potatoes.
• Free-range poultry and eggs.
• Nuts and seeds, plus unsalted butter made from them.
• Healthy oils, such as olive oil, avocado oil, flaxseed oil, coconut oil, macadamia oil, and walnut oil.

The underlying feature is calorie restriction and walking several times a week or daily.

Weight loss is a function of calories in vs calories out.  Walking burns the most calories for effort.  The amount depends on you weight X distance walked.  It is a simple formula of physics.  

Good luck, and enjoy your walk with the smartphone, Spotify or Apple Music.

The Future of Health Care Wearables

The Story has not yet been written

The Future of Health Care Wearables

Unpatched Security Bugs in Medical Wearables Allow Patient Tracking, Data Theft

How will Artificial Intelligence (AI) support remote monitoring and telemedicine?

As AI technology continues to advance, we can expect to see even more innovative and transformative uses of this technology in the healthcare industry.

How will Artificial Intelligence (AI) support remote monitoring and telemedicine?

The addition of artificial intelligence to wearables will. facilitate automated monitoring, and notifications of vital signs, and blood glucose determination in the background. and in real-time.