FDA warns of EpiPen device malfunctions

FDA warns of EpiPen device malfunctions

https://www.modernhealthcare.com/safety-quality/fda-warns-epipen-device-malfunctions

The brand name and generic versions of Mylan’s EpiPen devices are vulnerable to malfunctions that can cause them to work improperly or not at all, according to a federal safety alert issued Tuesday.

The EpiPen and EpiPen Jr. devices, which are commonly used to treat emergency allergic reactions, may have delayed injections or fail to inject properly due to design issues or improper administration by users, the U.S. Food and Drug Administration alert said. The agency was made aware of the issues through a letter Mylan recently sent to healthcare workers warning of the problems. Mylan was recently acquired by drug maker Pfizer but continues to use its name.

In a statement, a Pfizer spokeswoman said the company routinely studies and evaluates data regarding administration of its EpiPen devices.

“Although the issues and use errors identified are low, anything that prevents or delays the administration of the intended dose of epinephrine could result in a high risk to patients,” the Pfizer spokeswoman said. “We encourage healthcare professionals, patients and caregivers to review the letter, which includes available training resources, and regularly read the patient information and instructions for use to be prepared in the event of a life-threatening allergic reaction.”

In the letter to providers, Mylan said a “very” limited number of EpiPen devices have blue safety releases that are slightly raised, which can cause the device to activate prematurely. Mylan informs pharmacists, patients and caregivers to inspect the EpiPen prior to use and to call Mylan for a new device if the malfunction is present. Mylan will provide a new EpiPen at no additional cost.

Mylan also said the EpiPen can malfunction if the blue safety release is removed sideways rather than straight up. Mylan advises not using just your thumb to remove the safety release. Instead, hold the device using both hands and remove the safety by pulling it straight out.

In some instances, the EpiPen may also not slide out of its carrier tubes easily or even at all. The carrier tube is the package that holds the auto-injector. The issue is caused by a “slight deformation,” Mylan said. This issue can affect any EpiPen on the market with an expiration label prior to September 2020. Mylan is telling pharmacists, patients and caregivers to inspect the carrier tubes prior to use to ensure they readily slide out.

In response to the FDA safety alert, Mylan’s stock is down about 4%.

 

The enemy of my enemy is my friend

The enemy of my enemy is my friend is an ancient proverb which suggests that two opposing parties can or should work together against a common enemy.

The chronic pain community has basically TWO ENEMIES …  the DEA and the various healthcare corporation.

No one is every going to get a mussel on the DEA.  Whoever believes that they can take on the DEA with the DOJ having “hot & cold running attorneys” to defend the agency – IS A FOOL !

The various healthcare corporations would probably rather not be a enemy of the community, but they fear the consequences of the DEA and how they can fabricate facts and invoke massive fines for the violation of the laws that those fabricated facts alleged.

Most all of those healthcare corporations have “deep pockets” and law firms like to go after corporations that have deep pockets and have done harm to many people.

These corporations are attempting to keep the DEA at bay by providing corporate policies and procedures that they can document that they are following the CDC opiate guidelines… hoping to avoid massive fines.

These corporations are going so far that they are dictating to employee prescribers as to what  controlled substances – in particular – they can/can’t prescribe to pts.  These healthcare corporations encompasses hospitals, office practices, insurance/PBM, chain pharmacies.

How can the community turn these enemies into friends ? Perhaps one way is get them to fear the community as much or more than they do the DEA.  The community does this by SUING THEIR ASSES and get large settlements and make them part with one of their favorite assets – THEIR DEEP POCKETS.

It is reasonable to expect that these corporations spend a lot of money on political elections and lobbying.  If they fear the community… they may chose to spend some/much of that money on influencing Congress, bureaucrats and politicians that the DEA is causing harm and discrimination to the community.

While we may not turn a “enemy” into a friend… most of the community would welcome them to become a ally in our fight to get the DEA out of our healthcare.

It is claimed that there is NINE MILLION/day spent on lobbying the 535 members of  Congress… and this continues to happen every year… so it must work.

These corporations needed to be targeted for discrimination under the ADA and Civil Rights Act. We are never going to talk about MALPRACTICE lawsuit… no one will every find a law firm to represent anyone in the community.

The best pts will be those who have been on stable pain management and per corporate policies the corporate employee has reduced/eliminated their pain management and they have lost a job, became house, chair, bed confined and their quality of life is now in the CRAPPER !  The more pts being impacted by a single corporations the better.

If a pt calls a law firm.. do not even discuss MALPRACTICE… that is a no winner… it becomes a he said/she said… the defendant will hire a expert to testify that the pt’s care was meeting standard of care and best practices and the plaintiff will hire a expert that said they didn’t.  Besides, most states have caps on malpractice awards that most law firms will not come out financially when taking a case on a contingency basis even if they win.

 

 

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: Myth 18: PDMP will help doctors

PDMP was made by a grant of 14 million dollars from the DoJ/DEA signed by an important PROP member and anti-opioid member. It is a national police computer system that uses its own invalid information system to profile every doctor and patient that is pro-scripted more than one opioid pain medicine pill. the systems have caught only a handful of doctor shoppers per year, its use. Instead, physicians are being rounded up using analytics as the new weapon against crime, dragging off hundreds of legit pain treated doctors. who violate this bizarre system that is rigged against them. As far as we know at JATH, we have yet to see a real criminal in the drag net.

Dr Mark Ibsen -after 7 yrs – trying to get justice from the MT medical licensing board

Mandams Dr Ibsen

The above link is a 20 page *.pdf of the legal paperwork that Dr Ibsen has filed against the MT medical license board and some of its ancillary staff.  They have been dragging out justice for Mark for abt 7 yrs.  By just about anyone who has witnessed this from the very beginning… the board has been dragging their feet in coming to a conclusion and taking the necessary actions to exonerate and liberate Mark’s medical license.

 

walgreens apparently implementing “hard stops” on their computer system for particular meds- practicing medicine ?

The practice of medicine can be basically defined as follows: Do a in person physical exam, diagnose the pt’s health issues, create a plan of treatment that will cure the health issue or manage the health issue..  As well, the practice of medicine involves the starting, changing, stopping a pt’s plan of treatment, which includes medications.

The question is… is Walgreen’s practicing medicine without a license, restricting interstate commerce or some other issue that they have no legal authority to do ?

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: Coronavirus (COVID-19)

https://youtu.be/SjCIP1dZG4o

A lot of what I read on how to prevent becoming sick is confusing. So I think the best way to prevent the virus is to always assume that you are infected.

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: RED FLAGS can be destructive

One mechanic to discriminate against anyone is a red flags. a red flag is a made-up suspension to say that just because someone has a pony-tail or tattoos, they are a criminal. In our world, the pharmacists are delaying the people prescriptions just because they are a opioid user and have traveled a large distance. We need to protect people from the prejudice of pharmacists refusing to fill a legitimate prescriptions.

 

We have signed PAIN WARRIORS -the movie – to Gravitas Ventures distribution , USA and our official worldwide release is- May 25/ 2020

Dear Pain Warriors ~ Its OFFICIAL !

We have signed PAIN WARRIORS to Gravitas Ventures distribution , USA and our official worldwide release is- May 25/ 2020- across all Video on Demand platforms, cable tv, and other venues.

Please feel free to SHARE on your FB page, in pain groups, journalists, Local newspapers, on line bloggers etc . Feel free to be interviewed in * local papers
( in your capacity as an interview subject) sharing your involvement in the film and its important message.

Dont forget to mention our DISTRIBUTOR: Gravitas Ventures USA.

PLEASE PLEASE SHARE OUR SOCIAL MEDIA LINKS and help us build a following!

FB: Painwarriorsmovie
TWITTER @painwarriorsdoc
Instagram : painwarriorsmovie

Thanks so much.

death panels: U.S. Hospitals Prepare Guidelines For Who Gets Care Amid Coronavirus Surge

U.S. Hospitals Prepare Guidelines For Who Gets Care Amid Coronavirus Surge

https://www.npr.org/2020/03/21/819645036/u-s-hospitals-prepare-guidelines-for-who-gets-care-amid-coronavirus-surge

As COVID-19 spreads rapidly through the United States, many American doctors could soon be making the decisions that overwhelmed health care workers in Italy are already facing: Which patients get lifesaving treatment, and which ones do not?

Every accredited hospital in the U.S. is required to have some mechanism for addressing ethical issues like this — typically, an ethics committee made up of not just medical professionals but often also social workers, pastors and patient advocates. Sometimes in partnership with hospital triage committees, they create guidelines for prioritizing patient care if there’s a resource shortage.

As the number of coronavirus cases rises in the U.S., hospitals have a new urgency in revisiting and updating those guidelines.

They vary from hospital to hospital, but their overall goal is usually to save the most lives. So hospitals consider a combination of factors: age, life expectancy, how severe a patient’s illness is, how likely treatment is to help and whether a patient has additional illnesses that could shorten the person’s life span, such as cancer or heart disease. Hospitals can then use those factors to develop scoring systems or clinical scores to prioritize care.

In early March, as the coronavirus outbreak worsened in Italy, an Italian medical association issued guidelines finding that doctors might have to prioritize younger COVID-19 patients over older ones. “It may be necessary to place an age limit” on access to intensive care, the guidelines advised, with the goal of preserving limited health care resources for patients more likely to survive.

But age is rarely the only factor in such decision-making. For example, a 20-year-old will not always get priority over a 60-year-old, especially if that 20-year-old has additional health problems that could mean the 60-year-old is likely to live longer anyway. Scoring systems can disadvantage older patients, because as people age they become more susceptible to disease, which can hurt their clinical scores.

“Some people think that people who are in a position to help address a crisis in the future if they were to recover, like health care workers and first responders, maybe should receive some sort of priority in triaging scarce resources,” said Emily Rubin, a pulmonary and critical care physician at Massachusetts General Hospital in Boston and a co-chair of the hospital’s ethics committee.

Could other professions also be a factor, meaning that a hospital might prioritize, say, a hedge fund manager over a landscaper? That’s unlikely, according to Dr. Matthew Wynia, an infectious disease and public health specialist who directs the University of Colorado’s Center for Bioethics and Humanities.

Wynia said most hospitals should operate on the principle that every human life has equal worth, so patients are clinically evaluated the same regardless of their employment, gender, race or insurance, or whether they have children.

“So if you had someone who was an upstanding member of the local community or a big donor to the hospital or a well-known politician versus a clerk at the 7-Eleven or a homeless person,” Wynia said, each of those patients should be evaluated equally.

There’s already evidence that when it comes to coronavirus testing, rich and powerful people are getting greater access than ordinary Americans.

But ideally, hospital decision-makers would have “blinded” information that prevented them from knowing details about a patient’s source of payment, race, gender and other personal details, unless it were clinically relevant, Wynia said.

Hospitals could adopt a lottery or first-come-first-served system for triaging patients, but that might mean someone less sick is treated before someone more sick, potentially failing to achieve the goal of saving the most lives. Hospitals could treat worse-off patients first, but if those people are unlikely to survive, doctors might be better off focusing on people who are less ill.

“A million intricacies” could come into play in a real-world setting, Rubin said.

Numerous doctors interviewed by NPR said the U.S. lacks an exact historical comparison for how the coronavirus pandemic could play out but said guidelines at least offer general principles for steering hospital decision-making.

They also said guidelines must be transparent so the public has faith that the guidelines are fair and ethically justifiable. Wynia predicts that many hospitals will soon begin releasing their triage guidelines in case the U.S. ends up in an Italy-like situation.

And guidelines are needed not just for determining which patients to treat but how long to treat them. Nancy Berlinger, a research scholar at the Hastings Center, a nonprofit bioethics think tank in Garrison, N.Y., posed an ethical dilemma.

“Let’s say a patient is on a ventilator but isn’t improving, and this patient might — might — do better if they were allowed to stay on the ventilator longer, but there are people waiting for that ventilator,” Berlinger said. “Do you withdraw the ventilation earlier than you might normally do? So it’s not just who gets the vent — it’s also who stays on it.”

For now, U.S. hospitals are unsure whether their triage guidelines will be needed in the coronavirus pandemic, but they must brace for the possibility.

“This is a worst-case scenario that we’re talking about,” Wynia said. “We hope we never get there, but we have to get ready for the worst. And it would be irresponsible not to be getting ready right now because of what we’re seeing in other places around the world where things really have gone very, very badly and where they have run out of equipment, supplies, staff, space, people. So we need to be prepared for that.”

New blood test for fibromyalgia is 99% accurate Everyone needs to know if it is a mold fungus treatment.

New blood test for fibromyalgia is 99% accurate Everyone needs to know if it is a mold fungus treatment.

http://daily.allabouthealtips.com/2020/01/01/new-blood-test-for-fibromyalgia-is-99-accurate-everyone-needs-to-know-if-it-is-a-mold-fungus-treatment/

A new blood test for fibromyalgia is more accurate than expected and will not confuse the chronic pain disorder with other diseases such as lupus and rheumatoid arthritis, according to the doctor who developed the test.

“We found no overlap between biomarkers of fibromyalgia and the immune system profiles of patients with rheumatoid arthritis or lupus. This has the effect of exhaling the minds of opponents, “said Bruce Gillis, MD, founder and CEO of EpicGenetics, a bioresearch company based in Santa Monica, California.

A new blood test for fibromyalgia is more accurate than expected and will not confuse the chronic pain disorder with other diseases such as lupus and rheumatoid arthritis, according to the doctor who developed the test.

“We found no overlap between biomarkers of fibromyalgia and the immune system profiles of patients with rheumatoid arthritis or lupus. This has the effect of exhaling the minds of opponents, “said Bruce Gillis, MD, founder and CEO of EpicGenetics, a bioresearch company based in Santa Monica, California.

EpicGenetics launched the FM test in March, calling it the first definitive blood test for fibromyalgia, a misunderstood condition characterized by deep tissue pain, fatigue, headache, depression and lack of sleep. Test results are usually available in about a week.

The FM test looks for protein molecules in the blood, the so-called chemokines and cytokines, which are produced by white blood cells. According to Gillis, fibromyalgia patients have fewer chemokines and cytokines in their blood and therefore have a weaker immune system than normal patients.

Critics have indicated that the same biomarkers of the immune system can be found in people with other diseases, such as rheumatoid arthritis, making the blood test unreliable.

In a new research involving more than 300 patients with fibromyalgia, lupus or rheumatoid arthritis, Gillis said only fibromyalgia patients had lower chemokines and cytokines than normal.

“They do not have the same biomarkers of the immune system. Not at all, “Gillis told the National Pain Report. “The models we see in lupus and rheumatoid arthritis, we see this inflammatory process. However, we do not see the same biomarkers in fibromyalgia. “

Gillis said the research is complete and he hopes that it will be published in a medical journal in the coming months.

When the FM test was introduced, EpicGenetics said it was 93% accurate in diagnosing fibromyalgia. Gillis says the sensitivity of the test is now estimated at 99%, which is about the same as the test used to diagnose HIV.

Dr. Bruce Gillis

According to estimates by the National Institutes of Health, 5 million Americans suffer from fibromyalgia – and millions worldwide – but so far only a few hundred have signed up for the FM test. According to Gillis, the cost of $ 744, which is not normally covered by health insurance, could be an obstacle for many patients.

“Many people diagnosed with fibromyalgia do not work. And because they do not work, they can not afford to pay for a test. They are not health insured, “Gillis said, adding that some insurers paid the test in compensation cases for employees.
“When we started it cost us $ 12,500 to analyze the parameters of a patient’s immune system. So we lowered prices, very low. “

Gillis hopes to lower the price of the FM test by allowing other laboratories with analytical balances to collect blood and send blood samples to EpicGenetics.

Regardless of the cost, patients with fibromyalgia are excited that eventually a simple test is available to diagnose a disorder in which their physicians and relatives are often skeptical. The diagnosis of an average patient with fibromyalgia takes three to five years.

“Having a reliable blood marker will more than just confirm us as a patient. It will open a field full of dreams and opportunities for compassionate researchers to define this terrible disorder, “said Celeste Cooper, a fibromyalgic patient.

“Once we have a biological test, we will know that the study participants have fibromyalgia. There will be no twisted results and the discussion of the mental illness will take place in our examination mirror. It’s a tasty thought. “

There have been several potential breakthroughs in fibromyalgia research in recent months.

Ohio state researchers are in the early stages of developing another type of blood test for fibromyalgia. Using a high-power infrared microscope, they identified a model of molecules in the blood that seems unique to fibromyalgia patients.

Another research team in the state of New York has discovered that fibromyalgia has excessive sensory nerve fibers in the blood vessels of their hands that can disrupt blood flow throughout the body.

“In less than six months, we have received two studies that report a successful analysis of fibromyalgia using blood markers. Now he appears to be entering an area that transcends more than one debate,” says Cooper.

“This is a victory for the scientific community and a victory for the patient. I doubt that this is the last one. Expect more research during the race and what a glorious race it will be for those of us who live with fibromyalgia every day. “

The research could also lead to the discovery of a genetic marker for fibromyalgia – a gene that increases the likelihood of disease in some people.

EpicGenetics is rescuing numerous blood samples from patients who have passed the FM test, hoping one day to examine them for RiboNucleicAcid (RNA), molecules involved in protein synthesis, and the transmission of genetic information.

reference: http://usahealthynews.online/2019/01/05/new-blood-test-for-fibromyalgia-is-99-accurate-everyone-needs-to-know-if-it-is-a-mold-fungus-treatment/