FDA Warns of ‘Disturbingly’ High Levels of Heavy Metals in Kratom Products

FDA Warns of ‘Disturbingly’ High Levels of Heavy Metals in Kratom Products

https://www.medscape.com/viewarticle/905604

Some kratom products contain “disturbingly” high levels of heavy metals, the US Food and Drug Administration (FDA) warned today.

“Among the heavy metals we found were lead and nickel at levels not considered safe for human consumption,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

FDA scientists tested 26 different kratom products. “While the levels of the specific products we’ve tested so far are not likely to result in immediate acute heavy metal poisoning from a single use, some of these products included levels that, with chronic use, could cause some people to suffer from heavy metal poisoning,” Gottlieb said.

The agency is concerned that there may be other kratom products on the market that also contain heavy metals.

No Approved Use

Kratom is derived from the leaves from the kratom tree (Mitragyna speciosa), which is native to Thailand, Indonesia, and Papua New Guinea. The botanical’s popularity has been increasing in the United States, with those who take it and manufacturers claiming it can help treat pain, anxiety, depression, and more recently, opioid withdrawal.

Earlier this year, an analysis of kratom by FDA scientists found that its compounds act like prescription-strength opioids, as reported by Medscape Medical News.

The scientific data and adverse event reports have “clearly revealed” that compounds in kratom make it “not just a plant — it’s an opioid,” Gottlieb, MD, said in a statement back in February. “Claiming that kratom is benign because it’s ‘just a plant’ is short-sighted and dangerous,” he added.

Kratom has been linked to numerous deaths in the United States. There are currently no FDA-approved uses for kratom, and the agency has advised against using kratom or its psychoactive compounds mitragynine and 7-hydroxymitragynine in any form and from any manufacturer. 

The FDA continues to crackdown on companies selling unapproved kratom products with unsubstantiated claims about its purported benefits.

Over the past year, the agency issued numerous warnings about the serious risks associated with the use of kratom, including risks because of the variability in how kratom products are formulated, sold, and used both recreationally and by those seeking to self-medicate for pain or opioid withdrawal symptoms.  

Kratom products have also been found to be contaminated with Salmonella resulting in numerous illnesses and product recalls.

Health providers are encouraged to report any adverse reactions related to kratom products to MedWatch, the FDA’s safety information and adverse event reporting program.

Tonight -11/27/2018- 8pm est THE DOCTOR’S CORNER w/ DR. KLINE & JONELLE ELGAWAY

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Tonight -11/27/2018- 8pm est
THE DOCTOR’S CORNER w/
DR. KLINE & JONELLE ELGAWAY

Topic: How to deal w/ your illness w/out pain meds and questions from the audience.

Tune in on www.cawnation.com and click “Listen.”
OR
YouTube Channel: THE DOCTOR’S CORNER.
Direct link: https://www.youtube.com/channel/UCQk7ewfPvTfo3pleSzvth7A

Call in w/ questions (415) 915-2291

#CAW360Network
#WeR1
#TDCwithDrKline

Anthem among health insurers refusing to pay ER bills, doctors say

https://www.cbsnews.com/news/anthem-among-health-insurers-refusing-to-pay-er-bills-doctors-say/

On Aug., 1, 2017, Brittany Cloyd of Frankfort, Kentucky, said she experienced pain “worse than childbirth.” Her mother — who had been to nursing school — drove her to the nearest emergency room. Brittany thought her appendix had burst, but tests at the ER found she had ovarian cysts. She was given pain medication and told to follow up with her primary doctor.

Cloyd had an Anthem Blue Cross PPO health insurance plan and thought she would get charged just a co-pay for her ER visit. Instead, 15 days later she received a letter from health insurer Anthem. “Your condition does not meet the definition of emergency,” read the letter. She was responsible for the total ER bill — $12,596.

What Brittany endured is becoming more common in the health insurance industry, according to a Doctor Patient Rights Project (DPRP) study. It highlighted Anthem, which through its affiliated networks is the nation’s largest private health insurer. The DPRP contends that Anthem has instituted an organized policy of denial designed to make its subscribers — particularly those who are poor and reside in rural areas — too afraid to go to an ER for fear of receiving a bill like Cloyd’s, or more, for the visit.

“The purpose of this program is to spread fear,” said Dr. Ryan Stanton, a critical care and emergency medical specialist in Lexington, Kentucky.

Anthem spokesperson Joyzelle Davis, who said she hadn’t seen the study yet, issued an all-purpose response. “Anthem’s Emergency Department Review aims to encourage consumers to receive care in the most appropriate setting,” Davis said. “Anthem’s review [of claims] aims to reduce the trend in recent years of inappropriate use of emergency departments for non-emergency use.”

Anthem did not provide specific guidelines for what would be an appropriate visit to an emergency room. But in a letter addressed to companies insured by Anthem and obtained by the DPRP, the insurer made it clear that it didn’t want individuals insured by its policies to seek “care right away” at an ER when they could just as easily be treated at a doctor’s office or retail health clinic.

According to Anthem, more than a quarter of its subscribers’ emergency room visits could be treated elsewhere. “If we could reduce unneeded ER visits, we can cut health care costs by $4.4 billion a year,” the letter said. Consequently, Anthem noted, that would cut its member companies’ costs by more than a billion dollars.

“Controversial and dangerous”

Kentucky isn’t the only state where Anthem is rolling out this policy. It’s spreading across the South and Midwest, also. In Georgia, the American College of Emergency Physicians and the Medical Association of Georgia have filed suit in federal court to get Anthem to “rescind its controversial and dangerous … policy that retroactively denies coverage for emergency patients.”

Sen. Claire McCaskill, D-Missouri, sent a letter to both the U.S. Department of Health and Human Services and the Department of Labor asking them to look into whether certain health insurers had violated the “Prudent Layperson Standard” by denying claims. McCaskill is leaving office in January, and her staff did not respond to questions about whether her letter had been answered.

But her question goes to the heart of the matter. Congress enacted the Prudent Layperson Standard for Medicare and Medicaid managed care plans in 1997 and included group and individual health insurance plans in 2010. It defines an “emergency condition” as one in which the average person’s knowledge of health and medicine would dictate that you could go to the ER for treatment of acute symptoms of sufficient severity.

Do you have the ability to diagnose your own pain or injury, and if so, what do you do about it? If you go to the ER, will your insurer deny your claim, leaving you in economic peril? “Patients should never be in the position of correctly diagnosing their … emergency” before seeking help, McCaskill said in her letter.

137 million ER visits annually

But that puts millions of Americans in a vise. In an average year, nearly one in five people report going to the ER, according to the DPRP, for a total of 137 million visits. Doctors, patients and insurers note that statistics from 2012 indicating the average cost of an ER visit, at $1,233, is outdated. One reason for the surge in price since then, according to a University of Maryland study: the increased number of substance abuse cases — particularly among young and middle-aged adults — that now pass through an ER.

Anthem said even a small savings could benefit the health care system, in which Americans spent nearly $3 trillion dollars in 2015. The percentage of patients who leave the ER with no treatment whatsoever is 5 percent according to Anthem, while the Centers for Disease Control and Prevention (CDC) said it’s at least 3.3 percent. Some of these may be psychiatric patients.

But CDC data also appears to show that going to the ER might be the right choice for a serious condition such as chest or stomach pain and high fever. It said 43 percent of all ER cases lead to hospital admissions.

Critics said Anthem will likely keep pushing its policy of denying ER treatment unless it’s stopped. “Anthem is the big boy on the block, but other health insurers are picking up on it,” said Dr. Stanton. “They’re like a child getting into daddy’s wallet. They take a few dollars at a time and, if they don’t get caught, keep going.”

How to file an appeal

Those who feel they’ve been wronged can always appeal. “Patients should first appeal to the insurer,” said Executive Director Stacey Worthy of the Aimed Alliance, a health care coalition dedicated to innovation in medicine. If you get a written denial explaining the reason, then submit documentation and justification for the necessity of the ER treatment.

If you get a second denial, request an external review by an independent party, possibly a state insurance regulator, or someone it appoints. Worthy said it’s labor-intensive for the patient “because the insurer wants you to give up during the process.”

But it often doesn’t get that far, patient advocates said. The Affordable Care Act makes it clear that ER patients have the law on their side, if they can prove a true emergency. “Insurers can’t require you to get prior approval,” the ACA states. And a 2016 study found that 52 percent of retroactive denials were ultimately overturned after independent review.

Brittany Cloyd lost her first appeal, but she refused to take no for an answer. So she sent Anthem a second appeal with documentation and a rebuke.

“I’m not sure how one knows if they’re bleeding internally,” she wrote. “But I hope that it’s apparent … perpetuating scare tactics could certainly convince patients not to go the emergency room. I foresee an onslaught of wrongful death suits in Anthem’s future.”

Cloyd said Anthem then paid her entire $12,596 ER bill.

 

CMS FINAL CALL RULES ON OPIOID PRESCRIBING | EVERYTHING YOU NEED TO KNOW

https://youtu.be/lGfQ1YJ4-TM

What the hell is wrong with wanting to feel PAIN FREE ?

We are suppose to live in a country where our Founding Fathers guaranteed us life… LIBERTY.. and PURSUIT OF HAPPINESS…  Who believes that our Founding Fathers perceived that the bureaucracy that they were creating would be controlled by fellow citizens who would be defining just what our individual  “liberty” and “happiness” entailed ?

Our Founding Fathers also gave us the First Amendment that included “freedom of speech” but they did not guarantee that there would not be some sort of consequences for utilizing your rights under the First Amendment.

Pain is a subjective feeling.. it can be either mental or physical or a combination of the two.

Hunger is a feeling… but … does anyone have the right to tell anyone that they must feel a certain degree of hunger or specific hours during the day ?

If you feel hungry outside of normal meal times.. you experience “break thru hunger” and you resolve it with a SNACK –

Thirst is a feeling … but…  does anyone have the right to tell anyone that they must feel a certain degree of being thirsty for specific number of hours during the day ?

If you feel thirsty anytime … you experience “break thru thirst” and you resolve it with getting something to drink

Fatigue/sleepiness  is a feeling … but…. does anyone have the right to tell you that you can only have a certain number of hours of sleep each day/night ?

If you feel tired outside what is considered the normal sleep period  – you experience “break thru fatigue” and if possible, you address it by taking a NAP

We humans have a whole range of feelings/emotions … depression, anxiety, anger, love and on and on … and there is no way to effectively MEASURE the intensity of all of our potential feelings/emotions

There is a lot of talk about getting a new non-addicting pain med… and we have a bunch of non-addicting pain meds… admittedly they may only work for mild-moderate pain… they are collectively referred to as NSAID’s and Acetaminophen and for someone dealing with chronic pain… many people are taking them regularly… some above the recommended dose and everyone is at risk of them causing kidney or liver damage and/or causing a GI bleed… and it is claimed that 15,000 people die from their use of NSAID’s

CMS is suppose to financially “ding” prescribers and pharmacies if they have pts that are not compliant with their medications to treat diabetes, high blood pressure and  cholesterol meds and at the same time they are imposing limits on pain management meds .

It is well documented that under/untreated pain can have adverse complications to comorbidity issues the pt may have, but this valid health data is being ignored by CMS and other Federal agencies as they try to manage the theoretical  opiate crisis.  So… since under/untreated pain can cause Type II diabetes and high blood pressure ..but the last thing that healthcare professionals want to do is to start giving pts additional medications to treat the side effects of treating – or not treating – a pt.  So… CMS is most likely imposing new health issues and their related hospital/doctor/medication costs on to pts – via copays – and our healthcare system… and we wonder why healthcare costs are going up ?

The BOTTOM LINE is we are dealing with a compliance issue with prescribed medication…  If a prescriber tells the pt to take #x doses a day and they take more than what is prescribed… the pt is non-complaint… then either the prescriber has under estimated the number of doses that will get the pt’s pain down to a tolerant level or the pt has some substance abuse mental health issues. Either way, the pt has poor outcomes..

On the other hand if the pt takes less medication than what was prescribed… the pt is non-compliant and if the pt is on Medicare or Medicaid and treating a specific diseases, then CMS is concerned about the bad outcomes for the pt.  The pt may not be taking what is prescribed because of side effects,the cost or some other reason. Again, the pt has poor outcomes.

While the previous and current Surgeon General and the new head of the CDC has stated that substance abuse/addiction is a mental health issue. Shouldn’t we – as a society – be concerned about treating people with mental health diseases or continue to function under the decision of our judicial system in 1917 that opiate addiction is a CRIME and not a DISEASE and throw those into jail/prison for having a mental health issues and all they are trying to do is self-medicate the demons in their head and/or monkey on their back.

What person doesn’t want to feel healthy/normal ? Why are some diseases perceived as not worth treating ? Why are some deaths socially acceptable and others demand action so that no one else dies like that again ?

 

 

 

 

Southwest Florida Journalists Patricia Borns setting up interviews

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Operation Starburst is for all Americans to FIGHT BACK against violations to the 5th & 14th Amendments

https://youtu.be/4DjAILJVFCM

Operation Starburst is for all Americans to FIGHT BACK against violations to the 5th & 14th Amendments. If we do not make a stand now, what will be targeted next? Insulin? Only because addicts can use the needles to inject ILLEGAL heroin. Together we will take back that which has been stolen from us — OUR LIVES! Much luv, soft hugs and many prayers! Robert D. Rose Jr. BSW, MEd. USMC Semper Fidelis (423) 794-8241 four.of.hearts@comcast.net

Please share these VIDEOS from the Cato institute far and wide

Fellow Pain Warriors, may I present the explanation of the TRUE cause fueling the OVERDOSE EPIDEMIC……

Please share these VIDEOS from the Cato institute far and wide. Post on ALL policy makers and media sources Facebook & Twitter pages as well as other PAIN GROUPS in order to make this go viral!

https://youtu.be/tyeTq3OXp9A

https://youtu.be/OkTpAc0xLGI

We’re being SILENCED – We have 2 separate “crises” happening:

#1 HEROIN/FENTANYL OVERDOSE EPIDEMIC Addiction Rate ~2% of US Population

#2 UNTREATED PAIN CRISIS DUE TO ALTERED STATISTICS

100+MILLION Americans SUFFER from chronic pain. Chance of addiction: .06%

We all know what’s really fueling the OVERDOSE EPIDEMIC yet legitimate doctors & pain patients are taking the fall for people who CHOOSE to ABUSE illegal drugs.

MILLIONS are SUFFERING for no justifiable reason!
Who will champion our cause?
Why are our VOICES being SILENCED?
Please help us!
#EndPainPatientAbuse #FENTANYLCRISIS #INHUMANE

Will The Feds Ban Your Pain Meds?

What if you were injured and developed severe pain that wouldn’t go away? Would your government let you take the kind of pain medication you need? If federal officials follow the recommendation of a Food and Drug Administration panel, many of the most effective prescription painkillers—including Vicodin, Percocet, and countless generics—would be banned. Scott Gardner says that kind of a move would be “intensely cruel.” “I took Vicodin for three years,” says Gardner. “I needed it. It got me through a very tough period of my life.” The tough period began after a cycling accident shattered the left side of his body. After eight surgeries and countless hours of physical therapy, Gardner’s once active life is now filled with limitations. He suffers from chronic pain that prevents him from sleeping more than a few hours at a time, and yet his pain today is nothing compared to the agonizing days and months following his accident. “When there’s nothing but pain, there’s no reason to live,” says Gardner. “There were times where the only way I could stay sane and civil was because I could take painkillers.” The fear of addiction and abuse already makes many suspicious of pain medication. Media reports about celebrities like Rush Limbaugh or Matthew Perry suggest that it’s common for people to become addicted to medications they once took for legitimate medical conditions. And countless public service announcements remind us of the dangers of prescription drug abuse. Now the old fear of prescription drug abuse takes a new twist. The FDA panel is targeting drugs like Vicodin and Percocet because they contain acetaminophen, a popular painkiller also found in many over-the-counter drugs. Panel members warn that some Americans ingest too much acetaminophen, and overdoses can lead to liver damage, even death. But maybe the FDA panel isn’t putting this threat into context. After all, mundane threats like falling down stairs claim more lives than acetaminophen overdoses. And it turns out the more common fear—that patients will become addicted to prescription drugs—is also overblown. In fact, the barrage of warnings we hear about prescription drugs obscures an important point—people saddled with severe chronic pain need these painkillers. Says Gardner, “I think people who haven’t dealt with pain don’t really know what it’s like.” “Don’t Get Hurt” is written and produced by Ted Balaker, who also hosts. The director of photography is Alex Manning, the field producer is Paul Detrick and the animation in the piece is from Hawk Jensen. Approximately five minutes. Go to Reason.tv for downloadable versions of all videos, more links, and other related materials.

Reach out to this reporter and share THE TRUTH about the proper/appropriate use of opiates in chronic pain

I was contacted by a chronic painer in S Florida and apparently this reporter just regurgitated this article from what she was told by a ER doc…  Apparently, after talking to a local chronic painer she has been “enlightened” to the plight of those in the chronic pain community and perhaps some more positive stories might get generated if those in S Florida reached out to her… Here is her email  pborns@news-press.com

 

Doctors are rethinking pain management – should you?

https://www.news-press.com/story/news/2018/11/20/doctors-rethinking-pain-management-should-you/1897236002/

A uterine cancer diagnosis changed Lyla Whitson’s world several years ago, but the oxycontin prescription that helped manage her pain shattered it.

“When the prescription stopped after my hysterectomy, I went to the doctor thinking I had a bad case of the flu,” said the Cape Coral woman who turned to heroin. “My doctor said, ‘You don’t have the flu. You’ve been taking pain pills for three years.”

But it doesn’t take nearly that long for opioid withdrawal symptoms to set in from pain pill use, said Lee Health Emergency Room Dr. Aron Wohl. 

Some hospital patients report the most common signs – nausea, diarrhea and chills – after three or four days’ use.

“What they are becoming is physically dependent,” Wohl said. “That can lead to addiction if you continue use.”

An alarming number of people do continue. The Centers for Disease Control found 24 percent of people who were given a 12-day supply of opioid pills were still taking the medication a year later. Six percent were still taking them having only been given a one-day supply.  

At the Lee Health ER and across the country, a growing practitioners’ movement wants to prevent dependency before it begins. 

“For the last 15 to 20 years we wanted you to be at pain level 0,” Wohl said. “The pharmaceutical industry promoted and lobbied for that. We do not need to be at 0 pain.”

The overprescription of opioids is leveling off, but deaths continue rising, says Dr. Marc Fishman of the Maryland Treatment Centers. He talks about addiction, treatment and bootleg fentanyl with USA TODAY Editorial Page Editor Bill Sternberg. USA TODAY

The pendulum of pain management is swinging back to techniques like elevation, compression, ice and heat that fell by the wayside decades ago. 

Say you broke an arm or sprained a tendon and it’s acutely painful. Doctors who in the past might have prescribed hydromorphone or oxycodone now say that aspirin or non-steroidal anti-inflammatories like Ibuprofen are best, Wohl said.

Following recommendations of the CDC, a consensus is growing to treat episodes of acute pain with opioids for three days at most.    

“After just five days of prescription opioid use, the likelihood that you’ll develop long-term dependence on these drugs rises steeply,” Mayo Clinic’s new guidelines say. 

Florida healthcare providers adopted three-day limits for opioid prescriptions based on a new definition of acute pain signed into law by Gov. Rick Scott in March. (Pain from cancer or a terminal condition is excluded from that rule.)                

Providers are also expected to come up with recommended pill counts for specific medical procedures that would reduce pill counts dramatically. 

A pioneering group, the Michigan Opioid Prescribing Engagement Network has already published a model prescribing guide

For a hysterectomy like Whitson had, its recommended dose of hydrocodone is 20 to 35 tablets at 5 mg strength, for example. 

For a breast biopsy, 10 tablets. 

Until recently there was no definitive recommended guide for pill counts at all.

“The answer today is Tylenol and Motrin in many cases,” Wohl said. “For a severe injury – a  tibial lower leg fracture, for example – an opioid used sparingly would probably be recommended. The key is sparingly and with understanding of the risk.”

While doctors are becoming more vigilant, consumers have the most to gain by being their own advocates. The good feelings you have on opioid medications are tempting to continue, but they won’t last, Wohl said.  

Just ask Whitson, who lost her home and family and is still on the street seeking drugs to feed her addiction.

Southwest Florida’s Ramona Miller gives opioid users the overdose antidote Narcan for free. “The best person to help an addict is an addict,” she says. Patricia Borns, pborns@news-press.com

What you can do

  • If your doctor prescribes one of the common opioid medications for your pain (below), ask if it’s OK to take Tylenol, Motrin or Advil instead. 
     
  • Don’t keep using opioids when your pain subsides. Wait longer between doses and stop as soon as the pain does.  
     
  • If you stop taking opioids after three to five days, you may feel body aches, nausea, vomiting, diarrhea or constipation. Recognize them as withdrawal symptoms that will pass in one to a few days. Don’t take more opioids to try to feel better.

Pain-free is a pharma myth, Wohl said; an idea seeded by a marketing campaign called Pain is the 5th vital sign, complete with pain scales, that spread through groups such as the Joint Commission and American Pain Society. 

An entire generation was led to believe they should be pain-free.

The re-learning process is just beginning, Wohl said.

Follow this reporter on Twitter @PatriciaBorns.