The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines

FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

https://www.news-line.com/PH_news30087_enews

The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree.

Basic Reset and Biogenyx products that have been recalled include drugs such as Earth Wash and Ionyte, as well as dietary supplements Mello-Tonin and Body Mass Reset and device Energy FX among others. Basic Reset and Biogenyx issued recall notices by email to their customers on Sept. 23 and Oct. 18, requesting disposal or return to the place of purchase for products sold, purchased or distributed after Nov. 7, 2017. Given these products do not comply with appropriate FDA standards, they have the potential to be unsafe or ineffective for their particular uses, and could lead to adverse health impacts. The FDA is reminding consumers who may still have these products not to use them and distributors not to sell any of the recalled products as they do not meet FDA regulations.

“The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs and medical devices are safe and effective for their intended uses and that dietary supplements are manufactured and distributed appropriately,” said Melinda K. Plaisier, FDA Associate Commissioner for Regulatory Affairs. “All companies must follow the appropriate standards and are given the opportunity to ensure their actions are in accordance with these laws. We will continue to prevent the distribution of products that do not comply with applicable FDA requirements and ultimately place the public health at risk.”

Basic Reset and Biogenyx have not received the FDA’s approval for the sale of their drugs and one device, despite the companies’ claims that these products can be used to diagnose, cure, mitigate, treat or prevent conditions such as inflammation, chronic diarrhea, bacterial infections, head lice, allergies and pain. Consumer use of an unapproved product that claims to treat diseases may cause them to delay seeking appropriate medical care. Additionally, unapproved products have not been reviewed by the FDA for quality, safety or effectiveness. Basic Reset and Biogenyx also unlawfully distributed dietary supplements that are adulterated and misbranded.

This action follows multiple FDA inspections conducted at Basic Reset and Biogenyx between 2012 and 2017 and a 2016 warning letter. Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the companies failed to make the necessary corrections. Basic Reset, Biogenyx and the other defendants cannot receive, label, hold or distribute dietary supplements, drugs or devices until they take certain steps to ensure that all of these products comply with the law. Operations can only resume after receiving written permission from the FDA.

The FDA has not received any adverse event reports related to these products. The FDA encourages patients and health care professionals to report any adverse events to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

Dr. Thomas Kline, MD, PhD: Myth 13: Everyone should go to a pain clinic

https://youtu.be/pIsiSltSYPk

I suppose every one should go to a sore throat clinic, The most frequent reason for a doctor’s visit is pain. If doctors can’t treat pain, they need a new line of work. 80% of docs in the US are too timid to prescript pain medicine, so they send them to pain clinic, where only 1/3 are treating with pain medicine. Most are under treated, or not treated. Only 13% said good treatment, and 25% with little treatment. CDC gave licence to steal by prescription unneeded urine drug tests and dubious injection mills. 90% have said pain medicine are more effect than injects. 44% said care was worse at pain clinic than doc’s office. 92% of patients wouldn’t Recommend pain clinics.

Dr. Thomas Kline, MD, PhD: Myth 12: Alternatives to pain medicine are safe and effective

The center for disease control, aka the CDC,published guidelines, march 15 2016, attempting to override FDA prescription doses. Without proper authorization, CDC attempted to declassification opioids pain medicine as the drug of choice, as it has been for 50 centuries. They admitted this was based on no or low scientific research, and was based on consults from PROP, an anti-opioid pain medicines group. They recommended alternatives that do not work, and have greater cost and side-affects. One of their prime alternatives, Gabapentin, a seizure medicine, now reporting to cause overdose deaths, just recently.

Dr. Thomas Kline, MD, PhD: Myth 11: Addiction and Dependency are the same thing

False, they are not the same thing, by any means. we need a new word for dependency. It’s like snow, and there are many types. The main dependency that is confused is the one that is during drug withdraw. The new word is biochemical interdependence.

Is that a Centipede I see in my Capsule ?

Click on above link to listen – 34 minutes

What’s going on at the FDA? 10 agency updates

What’s going on at the FDA? 10 agency updates

https://www.beckershospitalreview.com/pharmacy/what-s-going-on-at-the-fda-10-agency-updates.html

The FDA is a government agency tasked with protecting public health by making sure prescription drugs are safe and efficient. 

In the last couple of months, several studies have been published questioning how the agency does its job, a new commissioner took over and the agency created a program to improve drug quality. 

Ten FDA updates reported by Becker’s Hospital Review since December: 

Editor’s note: This is not an exhaustive list. Events are listed in order from most to least recent. 

  1. FDA approvals relying on weaker evidence, study finds
    While the FDA has gotten faster at approving new drugs, it is relying on weaker evidence in granting those approvals.
  2. FDA warning letters to devicemakers down nearly 90 percent
    The number of warning letters the FDA sent to medical devicemakers fell by almost 90 percent between 2015 and 2019, and it could be because the FDA is too focused on pleasing the device industry.
  3. FDA, NIH allowed clinical trial sponsors to keep results secret
    Institutions that conduct clinical trials — such as pharmaceutical companies and universities —  do a poor job following a law that requires them to post clinical trial results on a government website, and the government agencies that are supposed to enforce that law are ignoring it.
  4. JAMA editorial blasts FDA’s reporting of medical device problems
    The FDA needs to do more to quickly and substantially reform its system for reporting adverse events caused by medical devices, two researchers wrote in an editorial published in JAMA Internal Medicine.
  5. FDA rush to meet drug approval deadlines doubles adverse patient effects, study finds
    More drugs are approved in December than any other month, but end-of-year approvals are associated with twice the number of adverse effects, including hospitalizations and deaths.
  6. FDA creates Center of Excellence program to improve compounded drug quality
    The FDA formed the Compounding Quality Center of Excellence program to mitigate quality issues with compounded drugs.
  7. Senate confirms Dr. Stephen Hahn as FDA chief
    Stephen Hahn, MD, became the latest FDA commissioner after the Senate voted 72-18 to confirm him.
  8. Decline in number of FDA inspections raises concerns about safety of pharma supply chain
    The number of FDA inspections of drug manufacturing facilities has declined, partly because of a lack of inspectors, raising concerns about the safety of the global pharmaceutical supply chain.
  9. Rapid FDA drug approvals raise patient safety concerns
    The FDA has been approving new drugs so quickly that some patient safety advocates are voicing concerns.
  10. Serious drug side effects likely underreported to FDA, study finds
    Underreporting prescription drug side effects may be much more common than previously thought.

Government-sanctioned medical torture, pain treatment, the health care industry, and bodily autonomy

Recorded by the Libertarian Party on 6-23-19. Press release referenced in video: https://www.lp.org/libertarians-suppo… Dr. Kyle Varner is a practicing hospitalist and expert in health care policy. In his upcoming book, White Coat Cartels, Dr. Varner uncovers the dark side of the US healthcare market. Dr. Varner passionately stands for freeing the market and advocates cash-based services and medical tourism as the prevailing alternatives to the compromised healthcare system we are faced with today. He is a highly sought-after writer and speaker, and has spoken at a number of conferences around the world. He shares his insider’s knowledge on the website DrVarner.com to give people the tools they need to take back control of their lives and start making informed decisions about their health. Cara Schulz is a Stage 4 cancer survivor and advocate for humane pain management for cancer patients and chronic pain patients. She has testified on their behalf at the Minnesota State Legislature and is a co-founder of Minnesota Pain Initiative. The Libertarian Party hosts a series conference calls on topics ranging from outreach, activism, current issues, and important updates on our party’s progress. After visit on Health Blog you will get all the details related to health.

 

Dr Thomas Kline: Myth #10 PALLIATIVE CARE

https://medium.com/@ThomasKlineMD/when-does-pain-treatment-become-protected-palliative-care-treatment-339d29024b57

Many think Palliative Care Status Z51.5 doesn’t apply to patients in pain. Then what else is it for? Refusing to make this diagnosis is in the category of refusing to make a diagnosis of cancer. Only medical people can make this diagnosis and treat accordingly. Google “medium palliative exemption” send it to doc in the mail. All this can be found on our master web site “JATHeducational.com

 

Dr Thomas Kline: Myth 9: Milligram phobia “this is way too much”

South FL: transitioned from “pill mills” to untold number of questionable “sober houses”

Opioid Treatment Scam May Be Coming to Your State

https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2019/10/07/opioid-treatment-scam-may-be-coming-to-your-state

FREDERICK, Md. – Donna Johnson, a working mother of four who lives in a quiet upscale neighborhood in suburban Maryland, is determined to thwart an insidious addiction treatment scam that’s spreading across the country.

It ensnared her son, then 21, in Florida five years ago when he was desperate for treatment for his addiction to opioid painkillers and heroin —and she was desperate to get him help.

Prompted by a man whom Johnson met online, she agreed to sending her son to South Florida, where he cycled through more than two dozen sober homes and treatment facilities over four years, receiving little actual therapy. He relapsed every time he was discharged, only to be picked up by another facilitator and admitted to another sober living program.

Now, Johnson fears that some of the same people who preyed on her son are setting up shop in Maryland, and she wants state elected officials to outlaw the deadly business scheme before it takes root.

Florida enacted an anti-kickback law in 2017 that gave police the authority to crack down on drug treatment fraud, and since then, similar laws have been enacted in Arizona, California, New York, Tennessee and Utah.

Here’s how the scam works: Seemingly caring people join recovery-related online chat groups, answer addiction hotlines advertised online or show up at fundraisers for addiction recovery. They typically say they’re in recovery themselves and are therefore uniquely qualified to help.

People with addiction and their families often don’t want to ask their doctors or pastors for help because they’re ashamed and want to hide their illness. So, turning to a stranger can be appealing.

To attract victims, “patient brokers,” as the scammers are known, typically offer free airline tickets and pocket money, according to prosecutors. They waive insurance deductibles and copays and tout the camaraderie and beach life the patients will enjoy in a place such as Florida. Parents, relieved that their son or daughter has finally consented to treatment, are eager to go along.

Past legal cases show the brokers can make initial commissions of as much as $2,000 per patient — and then rake in additional fees when they re-enroll the same patients after they relapse.

Opioid Treatment Programs Gear Up to Provide Suicide Care

Within two to four weeks of a patient checking into a sober home where treatment is subpar or nonexistent, insurers may stop paying claims under standard protocols for that type of service, and the fraudulent operators dump their young clients on the street, prosecutors say.

That’s when the shuffle begins.

The patients, mostly in their 20s, typically start using drugs again, sometimes aided by cash they’ve received as a goodbye gift from the treatment provider. Some die of an overdose because their tolerance for the powerful drugs has plummeted. Many become homeless.

Others might be picked up by a friendly recruiter who helps them get into another sober home, where their insurer is obliged by recent federal laws — the Affordable Care Act of 2010 and the Mental Health Parity and Addiction Equity Act of 2008 — to start paying again after they’ve relapsed.

Past cases show that the cycle can continue until the insurance company stops paying on the patient’s 26th birthday, when the Affordable Care Act allows insurers to drop dependent care coverage under a parent’s policy.

For Johnson, one of the first clues that something was amiss with the addiction treatment center she sent her son to in Florida was a $13,000 charge to her insurance company for drug testing that her son said he never received.

Excessive numbers of urine drug tests and widely varying prices for them are just part of the insurance fraud schemes perpetrated by many of the same operators who pay patient brokers to deliver customers, prosecutors say.

In Maryland, state Rep. Karen Lewis Young, a Democrat who represents Frederick, is drafting a patient brokering bill that she plans to propose in the next legislative session with Republican cosponsor Rep. Jesse Pippy, she told Stateline in an interview. The idea for the law, she said, came from Johnson.

“These marketers are looking for young people with good insurance and vulnerable parents who want to do anything they can for their children. They’re targeting them,” Young said.

“Who could be against outlawing patient brokering?” she asked.

Model Law

Dave Aronberg, the Palm Beach County, Florida, state attorney known for the nation’s first crackdown on patient brokering in 2016, said he and assistant state attorney Alan Johnson have been talking to advocates in Georgia, North Carolina, New Jersey, Ohio and Pennsylvania about enacting similar laws in their states. 

They also worked with California officials to help craft a patient brokering law enacted there last year.

Initially, advocates for people with addiction opposed California’s law, worried it could be used to discriminate and concerned it could dampen a much-needed expansion in the addiction treatment business.

Local property owners said the bill didn’t go far enough to restrict the sober homes that were proliferating in their neighborhoods. And treatment companies and their attorneys wanted to make sure that handing out small freebies to their patients wouldn’t get them in hot water.

By describing how the patient brokering law worked in Florida, Aronberg and Johnson said, they were able to illustrate that the California law would improve the health and safety of people with addictions, while boosting relations between sober homes and their surrounding neighbors.

Aronberg also testified before Congress as it developed a 2018 federal anti-kickback law aimed at the addiction treatment industry.

In July, the National Alliance for Model State Drug Laws, which is funded by the U.S. Department of Justice, released a template for a patient brokering statute based on Florida’s 2017 law.

“We’re seeing patient brokering and other unscrupulous forms of marketing show up all over the country now,” said Gary Tennis, president of the model drug law group.

“Even if it hasn’t hit your state yet, it’s coming,” he cautioned. “States need to be prepared with the right tools to combat it.”

The federal anti-kickback law only applies to federal health care programs and is not broad enough to address the full range of false marketing, insurance fraud and patient brokering that is occurring in the industry, Tennis and others say.

According to Aronberg, Palm Beach County police have arrested 95 allegedly fraudulent treatment operators and patient brokers in the past two years. The arrests and investigations, along with the local media attention they have garnered, have stanched the flow of vulnerable, young drug-addicted patients to South Florida, primarily from out-of-state, he said. 

As a result, drug overdose deaths in Palm Beach County declined from 647 in 2017 to 400 in 2018, nearly a 40% drop, according to the state’s medical examiner.

Aronberg stressed that states need to take a multi-layered approach to beating addiction fraud. In 2017 and 2018, the Florida Legislature appropriated roughly $300,000 to help create a sober home task force to improve law enforcement strategies, develop new treatment industry ethics policies and inform the public about addiction treatment fraud. Those groups have been invaluable, he said.

“Forcing the addiction treatment industry to change its marketing approach made a huge difference,” Aronberg said. “That’s what lured unsuspecting people down to South Florida to ostensibly go through rehab.

“More than 75 percent of Palm Beach patients came from out of state, only to leave in an ambulance or a body bag,” he said.

“We believe we’ve cleaned up well over a majority of the problem here. Unfortunately, some of it has moved to other states,” he said. “Florida may now be the safest place you can send your loved one for treatment.”

Supply and Demand

In an opioid epidemic that is killing at least 130 U.S. residents every day, the demand for addiction treatment started rising sharply about a decade ago.

And with private insurers newly required to pay for behavioral health services to help people quit, the addiction treatment industry started booming.

The drug treatment industry became fertile ground for fraud once insurance money started rolling in, because unlike the rest of the medical profession, it historically had consisted of mostly small companies whose owners were in recovery themselves and were only lightly regulated by federal or state licensing and accreditation agencies, explained Peter Thomas, quality assurance officer for the National Association of Addiction Treatment Providers.

“In the past, most treatment providers were in the business because they wanted to help others, not because they wanted to make money,” Thomas said.

In the past several years, though, investors who cared more about profits than patients have gotten into the business, he said. Insurance companies were taken advantage of and by 2016, they responded by tightening up their claims processing and authorization procedures, Thomas said.

“These changes have also challenged ethical treatment providers. But the scrutiny will be worth it if it weeds out the bad actors.”

Insurance providers argue that addiction treatment fraud not only puts patients’ lives in danger, but that it also raises overall health system costs and increases premiums for everyone, not just those sent to sober homes.

“These ‘sober homes’ are often associated with providers that do not provide evidence-based addiction treatment, frequently bill excessively for urine drug screening tests, and may be fraudulently billing multiple insurers for one patient’s services,” said Cathryn Donaldson, communications director for insurance industry trade group America’s Health Insurance Plans, in a statement to Stateline.

“Even more alarming, there are reports of ‘sober homes’ that may perpetuate access to drugs that keep people addicted rather than assisting them in recovery, exacerbating the crisis,” she said.

Helping Hand

Addicted since he was 17 after taking the opioid painkiller Percocet at a party, Marc had completed a 28-day intensive residential treatment program at a Maryland addiction center. But soon after he left treatment, it became clear he needed more help.

In an online group called The Addict’s Mom, Johnson found a young man who told her he was in recovery and would be willing to help her son get the treatment he needed. He told Johnson he’d look after her son and even gave him a free plane ticket to Florida.

“He seemed genuinely concerned about Marc, so I trusted him,” Johnson said. “He promised me he wouldn’t leave him on the street.”

But that’s exactly what happened.

Johnson had heard about fraudulent treatment centers in Florida that discharged kids when their insurance ran out, leaving them with nowhere to live and vulnerable to relapse.

But back then, she said she put too much trust in what she now realizes was a patient broker, and she didn’t fully understand how the scam worked.

Now she does. And she’s educating anyone who will listen, including state lawmakers, local county officials and state agencies.

Johnson’s son moved in and out of Florida treatment centers for four years and then got recruited to a California rehab center. That’s when Johnson intervened and brought him back home.

When Johnson talks to Maryland government officials and parents, she shares her worries that some of the charlatans she and her son encountered in Florida have moved to other states and may be running the same kind of scams there.

“I feel like I’m starting to make progress,” Johnson said on a recent warm afternoon as the sun poured through her office window.

“There are days when I can’t look at my computer or even engage with anyone on the phone. But that’s usually only for a day, and then somebody will call and I’m right back at it.”