Billions in Opiate lawsuit settlement: It’s not going to magically end this crisis

Schools, Sheriffs, and Syringes: State Plans Vary for Spending $26B in Opioid Settlement Funds

https://khn.org/news/article/state-plans-opioid-settlement-funds/

A local group that advocates for people affected by the opioid epidemic has expressed similar concerns and is now suing the foundation for a lack of transparency, even though few decisions about funding priorities have been made yet.

The strife in Ohio highlights the tensions emerging nationwide as settlement funds start flowing. The funds come from a multitude of lawsuits, most notably a $26 billion settlement resulting from more than 3,000 cities, counties, and states suing manufacturer Johnson & Johnson and distributors McKesson, AmerisourceBergen, and Cardinal Health for their roles in the opioid crisis. Payments from that case began this summer and will continue for 18 years, setting up what public health experts and advocates are calling an unprecedented opportunity to make progress against an epidemic that has ravaged America for three decades.

But, they caution, each state seems to have its own approach to these funds, including different distributions between local and state governments and various processes for spending the money. With countless individuals and groups advocating for their share of the pie — from those dealing with addiction and their families to government agencies, nonprofits, health care systems, and more — the money’s impact could depend heavily on geography and politics.

“It sounds like a lot of money, but it’s going to a lot of places and going to be spread out over time,” said Sara Whaley, a researcher at Johns Hopkins Bloomberg School of Public Health who tracks state use of opioid funds. “It’s not going to magically end this crisis. But if it’s used well and used thoughtfully, there is an opportunity to make a real difference.”

And if not, it could be just another political boondoggle.

Avoiding the ‘Tobacco Nightmare’

The worst-case scenario, many say, is for the opioid settlement to end up like the tobacco master settlement of 1998.

States won $246 billion over 25 years, but less than 3% of the annual payouts are used for smoking prevention or cessation, according to the Campaign for Tobacco-Free Kids. Most has gone toward filling budget gaps, building roads, and subsidizing tobacco farmers.

But there are stronger protections in place for the opioid settlement dollars, said Christine Minhee, founder of a website that tracks the funds.

Jacqueline Lewis, son Shaun, and his 7-year-old daughter lived together in a family home in Columbus, Ohio, until this fall, when Shaun died of an overdose. (Maddie McGarvey for KHN)

The arrangement specifies that states must spend at least 70% of the money for opioid-related expenses in the coming years and includes a list of qualifying expenses, like expanding access to treatment and buying the overdose reversal medication naloxone. Fifteen percent of the funds can be used for administrative expenses or for governments to reimburse past opioid-related expenses. Only the remaining 15% is a free-for-all.

If states don’t meet those thresholds, they could face legal consequences and even see their future payouts reduced, Minhee said.

“The kind of tobacco nightmare stuff where only 3% of funds were spent on what they were meant for is legally and technically impossible,” she said. Though, she added, “a different nightmare is still possible.”

Experts tracking the funds say transparency around who receives the money and how those decisions are made is key to a successful and useful distribution of resources.

In Rhode Island, for instance, public comment is a regular part of opioid advisory committee hearings. In North Carolina and Colorado, online dashboards show how much money each locality is receiving and will track how it is spent.

But other states are struggling.

In Ohio, the document that creates a private foundation to oversee most of the state’s funds says that “the Foundation shall operate in a transparent manner” and that meetings and documents will be public. Yet the OneOhio Recovery Foundation has since said it is not subject to open-meetings law. It has adopted a policy that meetings can be closed if the board decides the content is “sensitive or confidential material that is not appropriate for the general public.”

The contradiction between the board’s actions and how it was conceived led Dennis Cauchon, president of Harm Reduction Ohio, which distributes naloxone across the state, to sue the foundation. He said he wants the public to have more say in how the funding is spent.

“The board members are in a closed loop, and they’re having a hard time learning what the needs are,” Cauchon said.

The 29-member board includes representatives of local regions, as well as appointees from the governor, state attorney general, and legislative leaders. Many are city- and county-level politicians, and one is the wife of a U.S. senator. They are not paid for this role.

Nathaniel Jordan, executive director of the nonprofit Columbus Kappa Foundation, which distributes naloxone to Black communities in Ohio, has raised concerns about the board’s lack of racial diversity. Since 2017, Black men have had the highest rate of drug overdose deaths in the state, he said, but only one board member is Black. “What gives?”

Kathryn Whittington, chair of the OneOhio Recovery Foundation, said the board is being “very transparent in what we are doing.” The public can attend meetings in person or online. Recordings of past meetings are posted online, along with the agenda, board packet, and policies discussed — including a draft of the diversity and inclusion policy the board is considering.

A “Stay the Course” card that Jacqueline Lewis painted for son Shaun hangs at home in Columbus, Ohio, on Oct. 18, 2022. (Maddie McGarvey for KHN)
Shaun Lewis showed his recovery coin in the room he shared with his daughter at home in Columbus, Ohio, on Oct. 18, 2022. (Maddie McGarvey for KHN)

People who want to provide input “can always reach out to me as the chair or any other board member,” said Whittington, who added that two of her children have struggled with addiction too. But the best option is to contact one of Ohio’s 19 regional boards, she said. Those groups can elevate local concerns to the foundation board.

“We are still at the very beginning,” Whittington emphasized. No money from the 18-year settlement has been spent yet. The board’s operational expenses — including a $10,000-per-month contract with a public relations firm — is being paid from $1 million from a previous opioid-related settlement.

But Lewis, the woman raising her granddaughter in Columbus, worries that the day for families to speak may never come.

“They keep saying it’s not ready, and before you know it, they’ll be handing out money and it’ll be too late,” she said.

Following the Money

Rhode Island is one of the states working fastest to distribute settlement dollars. Its Executive Office of Health and Human Services, which controls 80% of the funds and works with an opioid advisory committee, released a plan to use $20 million by July 2023.

Although the plan doesn’t specify funding for people raising grandchildren, it does allocate $900,000 to recovery supports, which will include community agencies that serve family members, the department said. The single largest allocation, $4 million, will go to school- and community-based mental health programs.

The investment that has sparked the most interest is $2 million for a supervised drug consumption site. Its location and opening date will be determined by organizations that respond to the state’s request for proposals, said Carrie Bridges Feliz, chair of the opioid settlement advisory committee. At a time when fentanyl, a synthetic opioid 50 times stronger than heroin, is infiltrating most street drugs and overdose rates are high, “we were anxious to make use of these funds.”

In contrast, the process of distributing settlement dollars in Louisiana has barely begun. State Attorney General Jeff Landry announced in July 2021 that Louisiana was expected to receive $325 million from the 18-year settlement but has not released any additional information. His office did not respond to repeated inquiries about the status of the funds.

The governor’s office and state health department said they could not answer specific questions about the funds and had not yet been contacted by the attorney general’s office, which negotiated the state’s settlement agreement. Multiple clinicians who treat substance use disorder and advocates who work with people who use drugs were similarly in the dark.

The state’s written plan says it will create a five-person task force to recommend how to spend the money. Kevin Cobb, president of the Louisiana Sheriffs’ Association, said the group had appointed its representative to the task force, but he didn’t know if other members had been selected or when they would meet.

Dennis Cauchon (left), president of Harm Reduction Ohio, has filed lawsuits against the OneOhio Recovery Foundation for a lack of transparency around its handling of the state’s opioid settlement funds. Nathaniel Jordan, who works to prevent overdose deaths among Black communities in Ohio, says the foundation board should reflect the diversity of those affected by the opioid crisis. (Maddie McGarvey for KHN)

One decision Louisiana has made so far is to give 20% of the settlement funds directly to sheriffs — a move that has made some people nervous.

“This plays into an increase in support for an authoritarian response to what are public health issues,” said Nadia Eskildsen, who has worked for syringe service programs and other such groups in New Orleans.

She worries that money will be funneled toward increasing arrests, rather than helping people find housing, work, or health care. Meanwhile, almost 1,400 Louisiana residents died of opioid-related causes last year.

K.P. Gibson, the Acadia Parish sheriff who will represent the sheriffs association on the state task force, said his focus is not on punishment, but on getting people into treatment. “My jail problem will resolve itself if we resolve the problem of opioid addiction,” he said.

Many health and policy experts say using settlement funds to pair mental health professionals with police officers or provide medications for opioid use disorder in prisons could reduce deaths.

States’ choices generally reflect a range of local priorities: While Louisiana has carved out funds for law enforcement, Maine is dedicating 3% of its statewide share for special education programs in schools, and Colorado has allocated 10% to addiction infrastructure, like workforce training, telehealth expansion, and transportation to treatment.

Maine requires that some funds be used for special education because school districts also sued the opioid companies, said state Attorney General Aaron Frey.

Patricia Hopkins is superintendent of a rural school district in Maine’s Kennebec County, which signed on to a lawsuit against opioid companies. She hopes the settlement funds will allow her to hire more social workers to help children whose families have been affected by the opioid crisis.(Elisha Morris)

Patricia Hopkins said she signed on to the lawsuit because she’s seen the impact of the opioid crisis on students over the past decade as superintendent of school district 11, a rural part of central Maine’s Kennebec County with 1,950 students.

A report compiled by her staff in 2019 showed nearly 4% of students have a parent dealing with addiction.

Sixty miles north, in rural Penobscot County, school district 19 social worker Meghan Baker said she knows two siblings who were home when first responders arrived to revive their parents with naloxone, and another set of siblings who lost their mother to an overdose.

Students who experience this trauma often become angry, act out at school, and find it difficult to trust adults. When Baker refers them to counseling services in the community, they encounter waitlists that run six months to a year.

“If we could hire more guidance counselors and social workers, at least we can help some of those kids during the school day,” she said.

It’s clear that many have high hopes for the billions of dollars in opioid settlement funds arriving over the next two decades. But they have questions too, because effectively using this large pot of money requires planning and forethought.

For people like Jacqueline Lewis in Ohio, whose family has lost so much to an epidemic too long ignored, progress feels slow.

As she tries to make do on Social Security, Lewis focuses on the positives: Her granddaughter is a happy child, and her older brother lives with them to help out. But the financial worries gnaw at her. And what if her own health falters before her granddaughter is an adult?

“I might be OK right now, but tomorrow, I never know,” she said.

Did Doctors Overtreating With Opioids Cause the Overdose Crisis? A Soho Forum Debate

 

The above graphic is from PROP’s website and list those involved with this organization. I finally had the opportunity to watch this debate/video and it was between Dr. Fugh-Berman,MD a member of  PROP  Physicians for Responsible Opioid Prescribing and a professor at Georgetown U Medical Center and Jeffrey Singer.MD a  practicing surgeon and part of  The American Council on Science and Health

According to the PROP website it is financially sponsored by Steve Rummler Hope Network

and the The American Council on Science and Health apparently is sponsored by contributions from the general public.

I don’t normally watch to such lengthy videos, but this one was diffidently  was worth my time.

Could NSAIDs Like Ibuprofen, Aleve Make Arthritic Knees Worse?

Could NSAIDs Like Ibuprofen, Aleve Make Arthritic Knees Worse?

https://www.drugs.com/news/could-nsaids-like-ibuprofen-aleve-make-arthritic-knees-worse-109147.html

TUESDAY, Nov. 22, 2022 — Over-the-counter pain relievers like aspirin, Aleve or ibuprofen don’t do a thing to slow the progression of knee arthritis, and might even make things worse, a new study suggests.

Knee arthritis patients who regularly took nonsteroidal anti-inflammatory drugs (NSAIDs) wound up with worse knee inflammation and weakened cartilage, compared to a “control” group not taking the medications, researchers report.

“We found that the participants who were taking NSAIDs regularly for four years showed worse results with regard to synovitis,” which is inflammation within the knee, said lead researcher Dr. Johanna Luitjens, a postdoctoral scholar with the University of California, San Francisco’s department of radiology and biomedical imaging.

“Also, we saw that the composition of the cartilage was worse in the group of NSAID users compared to the controls,” Luitjens added.

NSAIDs block the production of body chemicals that cause inflammation. People regularly pop these pills to provide short-term relief of arthritis pain.

Aspirin, ibuprofen (Motrin, Advil) and naproxen sodium (Aleve) are the most common NSAIDs, available over the counter at any pharmacy or grocery store.

For this study, Luitjens and her colleagues analyzed data gathered from more than 1,000 participants in a federally funded long-term observational study of knee arthritis. Participants entered the study between February 2004 and May 2006.

The researchers compared 277 people who were prescribed NSAIDs regularly for at least a year with 793 people not treated with the drugs.

All of the participants received knee MRI scans at the beginning of the study and then four years later.

The researchers looked over the MRIs to see if NSAID treatment helped or hurt, adjusting their findings using a graded arthritis measurement to provide a better apples-to-apples comparison between the two groups, Luitjens said.

The results showed that NSAID users had worse joint inflammation and cartilage quality at the beginning of the study compared to the control group, and their knee health had deteriorated even more after four years.

“There were no protective mechanisms from NSAIDs in reducing inflammation or slowing down progression of osteoarthritis of the knee joint,” Luitjens said. “The use of NSAIDs for their anti-inflammatory function has been frequently propagated in patients with osteoarthritis in recent years and should be revisited, since a positive impact on joint inflammation could not be demonstrated.”

NSAIDs might not be effective in controlling the sort of inflammation that comes with knee arthritis, Luitjens suggested. It’s also possible that NSAIDs cause cartilage to become weaker, similar to the way that steroids affect cartilage.

It also might be that people taking NSAIDs tend to be more active, using the meds so they can be pain-free while they play, Luitjens added. That sort of activity could cause more wear and tear and create more knee inflammation.

A randomized, controlled clinical trial will be needed to confirm what was observed in this study, Luitjens noted.

Orthopedic surgeon Dr. Nicholas DiNubile said he won’t be changing his practice based on these findings.

“This study raises an interesting question, but I don’t think it answers it. Not even close,” said DiNubile, who practices in Havertown, Pa., and serves as an expert for the American Academy of Orthopaedic Surgeons.

DiNubile agreed that a clinical trial is needed to confirm these results, but he added that the type of NSAID use documented in this study doesn’t really happen anymore.

“The days of taking NSAIDs chronically are pretty much over. We really try to avoid that at all costs because NSAIDs have a wide range of other issues associated with them,” including ulcers, bleeding and damage to the liver, kidneys and heart, DiNubile said.

“The days of popping them like M&Ms are over,” he added.

People living with knee arthritis — or who hope to avoid it — would do best to lose weight and exercise, DiNubile said.

“They’ve shown that even an 8- to 10-pound weight loss can significantly lower your risk of getting a knee replacement,” DiNubile said. “Small amounts of weight loss are always recommended.”

Exercise also creates stronger muscles that can take pressure off the knee joint, he added.

“Exercise and weight loss are two things that have strong data behind them,” DiNubile said. “Everything else is that holy grail we’re waiting to come one of these days.”

The study is scheduled to be presented Sunday at a meeting of the Radiological Society of North America, in Chicago.

Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.

MARC MOORE: THE DIRTY COP OF MANTIS, IN THE TRIAL OF LESLY POMPY, MD. (MICHIGAN)

youarewithinthenorms

MARC MOORE: THE DIRTY COP OF MANTIS, IN THE TRIAL OF LESLY POMPY, MD. (MICHIGAN)

You’re Within The Norms

Nov 21

https://www.facebook.com/watch/?v=3708394616116679

REPORTED BY 

youarewithinthenorms.com       

  https://youarewithinthenorms.com/2022/11/22/blacked-own-pharmacies-under-attack-raid-on-at-cost-pharmacy-ft-meyers-florida/

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT BS., MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CLINTON BATTLE, JR., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., IN THE SPIRIT OF GIOVAN MBEKI, RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

https://www.facebook.com/watch/?v=3708394616116679

THE DIRTY COP OF MANTIS

In November 2015, Marc Moore of MANTIS ( Monroe Area Narcotic Team Investigation Service) teamed with then prosecutor William Paul Nichols and James Stewart, aka James Howell of Blue Cross Blue Shield of Michigan Mutual  Insurance Company, to extort doctors first,  and then you the members of the general public.  

MANTIS was formerly known as OMNI and was funded by the DEA.  OMNI  has a history of raiding people and seizing the cars, assets, and money of the people of Monroe. Marc Moore was promoted to the head of MANTIS. William Paul Nichols was promoted to a judge position.

Deputy USA Attorney General Kenneth Polite leads DOJ misguided campain of “Junk opioid Science

Dan Loepp, the president of Blue Cross Blue Shield of Michigan Mutual insurance company, makes over $15 million in bonuses yearly. In contrast, your premium for health insurance goes up every year.  Please don’t take our word for it; Google Dan Loepp and find out for yourself.  The State of Michigan disbanded OMNI but sealed court records such that those records would not be revealed.

Dan Loepp, President Blue Cross Blue Shield of Michigan

https://www.facebook.com/watch/?v=3708394616116679

When you see Marc Moore or one of  Molly Moore’s tweets, look at them in the eyes, and ask them about unsealing those court records hiding the seized properties.   Ask them how  Joshua Cangliosi and Victoria Evans died.

BETH DARNALL PH.D STANFORD SCHOOL OF MEDICINE

STANFORD UNIVERSITY SCHOOL OF MEDICINE EXPOSES DEA’S FALSE OPIOID EQUIVALENCES (SEE ZOOM LINK BELOW)

https://stanford.zoom.us/rec/play/1PKq1NUwL-uGPncKXuPHdR9FmcHt35ovcoXNb_VDJtuwqvgC4VQSxFTs81SzmX40MwpTzaaP2HDuQfLu.e776mKCV966GDIQ2?continueMode=true&_x_zm_rtaid=2HMP-fdbRlepfK8jCQ566g.1667470243087.999a3e4f2bc4eda927b09465b4fe0d61&_x_zm_rhtaid=804

MORPHINE MILLIGRAM EQUIVALENT AND INVALID GUIDELINE (MME) USED BY DEA-DOJ

DEA CLEAR AND PRESENT DANGER TO

LICENSE PROFESSIONAL PEOPLE OF COLOR

BY JACK FOLSON RPh, WALTER R. CLEMENT, NORMAN J. CLEMENT RPh., DDS 

https://www.facebook.com/watch/?v=3708394616116679

NOVEMBER 18, 2019

DEA’s mission is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.

However, the Office of the Inspector General reports the inadequacies of the DEA in combating diversion; The major issues are the illicit drugs and not the prescribed medications.  So again, the DEA is off target by targeting Healthcare Providers while largely ignoring the low-level diversion actors in the street.  

https://www.facebook.com/watch/?v=3708394616116679

We’re measuring opioid strength the wrong way

According to authors Drs. Jefferey Singer and Josh Bloom;

“Over the past several years, our government has taken control of doctors’ prescription pads. In an attempt to reduce opioid overdose deaths, lawmakers placed hard quantitative limits on the maximum daily dose of painkilling drugs doctors can prescribe.

These dose limits 90 MME (morphine milligram eqquivalent)were calculated from a conversion table that was the crux of the Centers for Disease Control. and Prevention (CDC) 2016 opioid prescribing guidelines. But a review of the scientific literature shows that the evidence upon which the table is based is either flimsy or non-existent. Even if the CDC recants its 2016 prescribing guidelines when it updates them later this year, the damage has already been done.”

“… When junk science is enacted into law, innocent people become “guilty.” In many cases, innocent physicians have ended up in prison for exceeding the 90 MME law, even though this number was never properly determined. And innocent chronic pain patients fared even worse.

Many of them who had been on long-term high-dose opioid therapy found themselves in unbearable pain after their pain meds were cut, sometimes sharply, because their doctors were afraid of the consequences of exceeding the 90 MME limit — even when medically appropriate. In desperation, an increasing number have turned to street drugs or worse, to suicide.”

https://www.facebook.com/watch/?v=3708394616116679

THE DEA’S RED FLAG GUIDELINES

Healthcare Providers are assumed by DEA to be lacking due diligence if they don’t prove beyond a shadow of a doubt that they have addressed any red flags, but in court hardly ever produce evidence of real diversion but rely on suspicions and glitzy presentations.  

DEA is the single most government agency whose tactics have increased the cost of medication and healthcare all across America by misinterpreting the purpose and roles of medications needed to treat acute, chronic, neuropathic, and psychological pain. The DEA has been waging a campaign of disinformation to sway the public to the point that prescribed narcotic analgesic medications are indeed drugs, dangerous drugs whose dosages are red flags indicating abuse and trafficking contributing to the so-called Opioid crisis around America.

Notably, DEA’s shreds of evidence always realize upon execration on numbers of “pills” and street language such as “pill mills,” “Holy Grails,” and “Cocktails,” not on medical disease states or clinical conditions. Prosecutors have found these forms of distortion and redefinition of medical procedures effectively sell juries.  Further, Judges often instruct the juries to ignore any clinical presentation or will not allow such testimony on the record.  

The damage to Healthcare Providers and the chronic pain patient populations is devastating, and the DEA never takes into account the clinical needs of the patients.  It’s as if they have criminalized pain management without the benefit of clinical knowledge.

Remember, your body, choice, and pain to suffer and cry as one wishes.   

https://www.facebook.com/watch/?v=3708394616116679

FOR NOW, YOU ARE WITHIN

THE NORMS

reference:

https://stanford.zoom.us/rec/play/1PKq1NUwL-uGPncKXuPHdR9FmcHt35ovcoXNb_VDJtuwqvgC4VQSxFTs81SzmX40MwpTzaaP2HDuQfLu.e776mKCV966GDIQ2?continueMode=true&_x_zm_rtaid=2HMP-fdbRlepfK8jCQ566g.1667470243087.999a3e4f2bc4eda927b09465b4fe0d61&_x_zm_rhtaid=804

LOW HANGING FRIUT

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Four different methodologies in calculating MME numbers

https://stanford.zoom.us/rec/play/uyYgp63aAQtvTBakjWN2Pe5bl4ZTlfEeG_9bWPLDnkFbBzO0tiYdd3qnE1JQcL1nPPvuOinIf8ue89uJ.mTrktYay_HfzOcD7?continueMode=true&_x_zm_rtaid=ewmMRXkaS_i-N9Ap-xIojw.1669070308746.1ad6844ea0715e64e4dadc8fa76e0840&_x_zm_rhtaid=98

 

DOJ Attack on Telemedicine

Is it just me, or does it seem like the SCOTUS Ruan/Kahn ruling – which basically told the DEA that they could not use objective criteria in judging prescribers when they were treating pts with subjective diseases –  has caused the DEA to step up their actions against prescriber for exceeding some undefined or vague “exceeding standard of care and/or best practices” that the DEA uses to charge prescribers with prescribing/providing opiates and controlled substances without a valid medical need ?

DOJ Attack on Telemedicine

http://  https://doctorsofcourage.org/attack-on-telemedicine/

Last Friday, November 18, two doctors and three pain clinic operators in Detroit, MI were charged with illegal opioid distribution for providing legal telemedicine to patients in Michigan.  The doctors are Dr. Juan Bayolo, 48, of Lake Mary, Florida and Dr. Renee Gonzalez Garcia, 62, of Henderson, Nevada. Pain clinic operators were Angelo Foster, 33, of Detroit, Michigan; Brandy King 33, of Detroit, Michigan; Edward King, 33, of Northville, Michigan.

The government’s press release makes the treatment provided at these clinics sound illegal, but it isn’t. The problem is that just what is written in this press release, although all lies and fabrication, perverts the minds of the community. Hopefully the community will come here and learn the truth. The other problem is simply that the government agencies—whose bread and butter depend on indicting doctors for doing their job, fabricating a case against them, spreading propaganda against opioids, convicting doctors and sending them to prison to satisfy agreements with prison owners—are ignoring the SCOTUS decision of Ruan/Kahn, and will continue to do so.

Not being too sure of the law in this situation, I called upon the Chapman Law Group as they have a compliance division. I received a response from Mike Staples to post.

Mike Staples of Chapman Consulting Group:

Government press releases concerning healthcare practitioners are always issued in the darkest light for the accused and meant to stir public outrage and negative opinions towards the accused practitioner even before the actual evidence is presented in a court of law and ignore the fact that in America all people are innocent until proven guilty. 

While it’s not possible for me at this time to review all facts and evidence of this particular telemedicine prescribing case, I would like to point out the following laws and guidance concerning the prescribing of controlled substances via telemedicine.

Firstly, due to the Covid19 Federal Health Emergency declared and still valid. Federal laws pertaining to telemedicine prescribing, such as the Ryan Haight Act, have been suspended to allow greater access to healthcare practitioners for patients while minimizing health risks for all and that includes controlled substance prescribing.  The DEA itself issued the following guidance concerning the prescribing of controlled substances via telemedicine during this federal health emergency:

DEA COVID-19 Telemedicine Guidance

Question: Can telemedicine now be used under the conditions outlined in Title 21, United States Code (U.S.C.), Section 802(54)(D)?

Answer: Yes

While a prescription for a controlled substance issued by means of the Internet (including telemedicine) must generally be predicated on an in-person medical evaluation (21 U.S.C. 829(e)), the Controlled Substances Act contains certain exceptions to this requirement. One such exception occurs when the Secretary of Health and Human Services has declared a public health emergency under 42 U.S.C. 247d (section 319 of the Public Health Service Act), as set forth in 21 U.S.C. 802(54)(D). Secretary Azar declared such a public health emergency with regard to COVID-19 on January 31, 2020. On March 16, 2020, the Secretary, with the concurrence of the Acting DEA Administrator, designated that the telemedicine allowance under section 802(54)(D) applies to all schedule II-V controlled substances in all areas of the United States. Accordingly, as of March 16, 2020, and continuing for as long as the Secretary’s designation of a public health emergency remains in effect, DEA registered practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met: The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice; The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and the practitioner is acting in accordance with applicable Federal and State laws. Provided the practitioner satisfies the above requirements, the practitioner may issue the prescription using any of the methods of prescribing currently available and in the manner set forth in the DEA regulations. Thus, the practitioner may issue a prescription either electronically (for schedules II-V) or by calling in an emergency schedule II prescription to the pharmacy, or by calling in a schedule III-V prescription to the pharmacy. The term “practitioner” in this context includes a physician, dentist, veterinarian, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which s/he practices to prescribe controlled substances in the course of his/her professional practice (21 U.S.C. 802(21)).

Important note: If the prescribing practitioner has previously conducted an in-person medical evaluation of the patient, the practitioner may issue a prescription for a controlled substance after having communicated with the patient via telemedicine, or any other means, regardless of whether a public health emergency has been declared by the Secretary of Health and Human Services, so long as the prescription is issued for a legitimate medical purpose and the practitioner is acting in the usual course of his/her professional practice. In addition, for the prescription to be valid, the practitioner must comply with applicable Federal and State laws. (Exhibit A: DEA COVID-19 Chart).

Secondly, the State of Michigan also allows the prescribing of controlled substances via telemedicine both before, during (with less regulations during the state declared COVID19 health emergency via  Michigan EO 2020-86 https://content.govdelivery.com/attachments/MIEOG/2020/05/14/file_attachments/1451862/EO%202020-86%20Emerg%20order%20-%20telehealth.pdf ) and after the COVID19 health emergency.

Michigan law permits a healthcare professional to prescribe a patient a drug via telemedicine if the healthcare professional is acting within the scope of his or her practice in prescribing the drug, and meets certain additional requirements, such as referring the patient for geographically accessible health care services (including emergency care services) if medically necessary, and either referring the patient or making the healthcare professional (or a person acting under his or her delegation) available to provide follow-up health care services.

If the healthcare practitioner is prescribing a controlled substance, the healthcare practitioner must meet the Public Health Code’s requirements applicable to the healthcare professional for prescribing a controlled substance (e.g., controlled substance license, establishing a bona fide prescriber-patient relationship, obtaining and reviewing the patient’s MAPS report, etc.).

So to sum all of this up, it is absolutely legal from a compliance viewpoint to prescribe controlled substances via compliant telemedicine practices and even more so during the declared state and federal covid-19 emergency declarations.

If you are a healthcare professional facing state or federal make sure you have an attorney well versed and established in healthcare law with a team of compliance professionals to help you build the best possible defense against an overzealous government that will even ignore their very own guidance and laws just to make a name for themselves and to pretend they are doing something to fight the opiate epidemic, even though studies have shown that legitimately prescribed pain medications were never the issue.

Guest Author Michael Staples, CMBI
Chapman Consulting Group

Michael Staples is a former police detective, former State of Ohio Medical Board Investigator, Certified Medical Board Investigator (CMBI), former Director of Compliance for two large Greater Cincinnati pain clinics, CME presenter, healthcare regulatory expert witness, and healthcare regulatory consultant. He has spent the majority of his life dedicated to investigating, enforcing, educating, and maintaining healthcare compliance with a focus on controlled substance prescribing and diversion risk analysis.

As a police detective, he actively was involved in drug investigations- including diversion, trafficking, doctor-shopping cases, fraud, and undercover operations.

As a State Medical Board of Ohio Investigator, he has investigated hundreds of cases involving the standard of care, “pill mills”, and controlled substance prescribing. He has participated in, had training on, and consulted on undercover operations regarding physician practices accused of illegally trafficking in controlled substances.

As a public speaker and CME presenter, he has taught law enforcement officers at the Ohio Chapter of the National Association of Drug Diversion Investigators about the difference between naive and criminal prescribers and was previously the education and training coordinator for the Ohio chapter of NADDI. He has educated Doctors, Nurse Practitioners, and Physician Assistants at CME and private events on aberrant behaviors, detecting diversion, and documentation.

As Director of Compliance for two large Greater Cincinnati area Pain Management Practices,  he has have personally observed, formulated, and implemented policies and procedures to reduce drug diversion and address aberrant behaviors. He has screened and vetted new patients for intake at the practices, including making sure the patients had the proper pain management referral. He has personally witnessed and monitored patients being treated with controlled substances for pain for compliance.

As a healthcare regulatory consultant, he has helped healthcare practices, including pain clinics and pharmacies, improve regulatory compliance, detect and address diversion, improve documentation, and more.

 

Pieces of the puzzle on how the DEA really functions

Like a lot of puzzles, one cannot see what the final picture is going to look like until you get more and more pieces in place.  The same seems to be the same how about all the “things” that the DEA has done basically “behind the curtain”…  as people retire, some are starting to talk about what they did and what they saw while working in law enforcement, DEA or within our judicial system.

Richard A. Lawhern recently published a article A Good Man Speaks Truth to Power

Because I write and speak widely on public health issues and the so-called “opioid crisis”, people frequently send me references to others’ work.  One of the more startling articles I’ve seen lately was published November 20, 2018 in Pharmacy Times.  It is titled “Should We Believe Patients With Pain?”.  The unlikely author is Commander John Burke, “a 40-year veteran of law enforcement, the past president of the National Association of Drug Diversion Investigators, and the president and cofounder of the International Health Facility Diversion Association.”

The last paragraph of Commander Burke’s article is worth repeating here.

“Let’s get back to dealing with each person claiming to be in legitimate pain and believe them until we have solid evidence that they are scamming the system. If they are, then let’s pursue them through vigorous prosecution, but let’s not punish the majority of people receiving opioids who are legitimate patients with pain.”

This seems a remarkable insight from anyone in law enforcement — especially from one who has expressed this view in both Pain News Network, and Dr Lynn Webster’s video “The Painful Truth”.   Recognizing Commander Burke’s unique perspective, I followed up by phone to ask several related questions.  He has granted permission to publish my paraphrases of his answers here.

  1. “Are there any available source documents which establish widely accepted standards for what comprises “over-prescription?” as viewed by diversion investigators?”Burke’s answer was a resounding “NO”.  Each State and Federal Agency that investigates doctors for potentially illegal or inappropriate opioid prescribing is pretty much making up their own standards as they go.  Some make reference to the 2016 CDC Guidelines, but others do not.
  2. “Thousands of individual doctors have left pain management practice in recent years due to fears they may be investigated, sanctioned, and lose their licenses if they continue to treat patients with opioid pain relievers.. Are DEA and State authorities really pursuing the worst “bad actors”, or is something else going on?Burke’s answer:  “Regulatory policy varies greatly between jurisdictions.  But a hidden factor may be contributing significantly to the aggressiveness of Federal investigators.  Federal Agencies may grant financial bonuses to their in-house diversion investigators, based on the volume of fines collected from doctors, nurse practitioners, PAs and others whom they investigate.“No law enforcement agency at any level should be rewarded with monetary gain and/or promotion due to their work efforts or successes. This practice has always worried me with Federal investigators and is unheard of at the local or state levels of enforcement.”

Commander Burke’s revelation hit me like a thunder-clap.  It would explain many of the complaints I have heard from doctors who have been “investigated” or prosecuted.  It’s a well known principle that when we subsidize a behavior, we get more of it. Financial rewards to investigators must inevitably foster a “bounty hunter” mentality in some.  It seems at least plausible that such bonuses might lead DEA regulators to focus on “low hanging fruit” among doctors who may not be able to defend themselves without being ruined financially.  The practice is at the very least unethical. Arguably it can be corrupting.

I also inquired concerning a third issue:

  1. “I read complaints from doctors that they have been pursued on trumped-up grounds, coerced and denied appropriate legal defense by confiscation of their assets – which are then added to Agency funds for further actions against other doctors. Investigations are also commonly announced prominently, even before indictments are obtained – a step that seems calculated to destroy the doctor’s practice, regardless of legal outcomes.  Some reports indicate that DEA or State authorities have threatened employees with prosecution if they do not confirm improper practices by the doctor. Do you believe such practices are common?”Burke’s answer:  “I hear the same reports you do – and the irony is that such tactics are unnecessary.  Lacking an accepted standard for over-prescribing, the gross volume of a doctor’s prescriptions or the dose levels prescribed to their patients can be poor indicators of professional misbehavior.  Investigators should instead be looking into the totality of the case, which can include patient reports of poor doctor oversight, overdose-related hospital admissions, and patterns of overdose related deaths that may be linked to a “cocktail” of illicit prescribing.  Especially important can be information gleaned from confidential informants – with independent verification – prior patients, and pharmacy information.”

No formal legal prosecution should ever proceed from the testimony of only one witness — even one as well informed as Commander John Burke.  But it seems to me that it is high time for the US Senate Judiciary Committee to invite the testimony of others in open public hearings, concerning the practice of possible bounty hunting among Federal  investigators.

for years Commander John Burke contributed a monthly op-ed in Pharmacy Time – one of the two major pharmacy magazine sent to all pharmacies in the country.  As I remember, just about every article that Burke wrote, seemed to be from the perspective of law enforcement that suggested that everyone taking prescribed opiates were doing so because they were addicted or selling the meds  to supplement their income.  Once I wrote Pharmacy Times and suggested that they discontinue publishing Burke’s biased op-eds…   Of course, they continued to publish his one-sided point of view..  Here is a list of various organization that he was affiliated with and his titles within these organizations:

  • Executive Director @ International Health Facility Diversion Association
  • President @ International Health Facility Diversion Association
  • Commander @ Warren County Drug Task Force
  • Past President @ Ohio Task Force Commanders Association

I guess that should help explain the contents of all the articles that he published in various medias. I did a search for his Pharmacy Times articles and her is a link to what I found  https://www.pharmacytimes.com/authors/cmdr-john-burke?page=17Apparently he stopped a few years back.

Here is a blog post from 5 yrs ago about a job posting by the DEA   Forfeiture Financial Specialist Supporting the DEA    and within the job description:  Provides support in conducting pre seizure analysis.   This would seem to validate what the previous DEA employee stated in the above video.

Here is a more recent blog post  wonder how many members of Congress is aware of this – and have turned a blind eye and deft ear to how corrupt the DEA is ?    A  DEA agent who is going to jail for 12 yrs and who “spills the beans” on all the diversion of confiscated money, drugs and what many of these agents spent the money on themselves. According to this article some agents that were involved, where allowed to just retire with out any legal consequences.  A quote from the agent in the article ….“You can’t win an unwinnable war. DEA knows this and the agents know this,” Irizarry said. “There’s so much dope leaving Colombia. And there’s so much money. We know we’re not making a difference.”

Here is another recent blog post  Is this why 90%+ of people taken to Federal Court – ARE FOUND GUILTY ?      Judge denial all the NINE expert witnesses from testifying for the physician/defendent and the only witness for The prosecution was expert, Dr. Timothy King, is an Indiana anesthesiologist who makes large amounts of money testifying for the federal government.  The 85 y/o physician, is currently serving a five-year prison term in a minimum security prison

Here is just one blog  post head of Suboxone mafia: testified at J&J opiate crisis trial  on the J&J trial in OK in the summer of 2019 where the judge decided that J&J COULD NOT HAVE A TRIAL BY A JURY … it was to be a BENCH TRIAL – where the judge acts as JUDGE, JURY & EXECUTOR  and J&N was being sued for being a PUBLIC NUISANCE because they were basically the WHOLESALER of raw opiate powder to the pharma industry. 

Doc’s office raided: purportedly treating addicts with a drug called buprenorphine

The “BAD AND THE UGLY – there is NO GOOD” of the PDMP’s and Narxcare and the INACCURATE CONCLUSIONS from those databases

The “BAD SIDE” of Epidural Spinal Injections

Who said that dead bodies DON’T TALK ?

How DEA does a UNDER COVER INVESTIGATION

The FOUR DIFFERENT WAYS MME’S CAN BE CALCULATED

 

 

 

comment: CDC’s Updated Opioid Guidelines Are Necessary, but Not Sufficient

CDC’s Updated Opioid Guidelines Are Necessary, but Not Sufficient

 

You had better believe the Guidelines need work. CORRECTION: They need to be totally erased and gotten rid of. I arrived in California from my home in Virginia for an appt with my Pain Management Physician. Upon arrival, my wife turned on her phone and we were greeted by a text message from a friend, telling us that the previous day, my doctor had been “visited by the DEA-holes” and was handed an immediate order to stop all schedule 2 Rxs of any opioid pain meds. This unjustified action has already caused a double-suicide. This doctor is a very compassionate and caring doctor that hates to see people suffer. In his 52 years of practice, he has never had a single complaint or black mark on his record with the California Board of Medicine. Now my supply of legitimately prescribed pain meds are running low and soon I will not only be in agony from my pain caused by two incurable and painful diseases AND I will be facing painful and dangerous withdrawals from my medications. The DEA has forced my doctor to abandon his intractable pain patients, something the CDC has said repeatedly not to do. This abandonment will cause more deaths as immediate stoppage of pain medicine can cause blood pressure to spike and cause death by heart failure or stroke. This is our government executing people and the blood will be on the hands of the DEA for their murder of innocent, intractable pain patients. We called around to virtually all Los Angeles area Pain Management Doctors and NONE, I repeat NONE have returned any calls. Doctors are justifiably afraid to take on abandoned intractable pain patients because they know they will also be “visited” by the DEA. The DEA should be working to take down dealers of deadly street fentanyl but instead they are taking out doctors who are veritable “sitting ducks.” Am I angry? Yes, I am! These actions HAVE to stop b4 causing more needless deaths of some of the sickest people in our country.

CDC’s Updated Opioid Guidelines Are Necessary, but Not Sufficient

CDC’s Updated Opioid Guidelines Are Necessary, but Not Sufficient

https://www.medpagetoday.com/opinion/second-opinions/101825

Additional steps are needed to calibrate opioid access and undo harm

Before the CDC suffered a loss of trust over its handling of the COVID-19 pandemic, the agency had fumbled its response to the overdose crisis. Under its leadership, overdose deaths have continued to spiral, as people living with pain have lost access to vital medications.

One of its key missteps was the formulation and implementation of its 2016 prescribing guideline for chronic pain. On November 3 this year, the agency took partial corrective action, revising its approach that contributed to so many harms to people with pain.

In its update, the 2022 Clinical Practice Guideline for Prescribing Opioids for Pain, the CDC emphasizes flexibility in pain pharmacotherapy. It also rejects controversial dose and duration limits that had been widely misinterpreted by policymakers. For this welcome change to have meaning, however, the CDC must work proactively with regulators to rescind harmful policies that resulted from its prior guideline.

What Went Wrong in 2016?

Recommendations in the 2016 CDC opioid guideline included concrete thresholds related to opioid dosing and the number of days opioids should be prescribed for acute pain. Regulators, eager for a ready solution to the overdose crisis, adopted these thresholds as one-size-fits-all laws and mandates.

The uptick was fast and far-reaching. State and federal lawmakers, quality metric agencies, pharmacy benefit plans, state medical boards, and the Drug Enforcement Agency, among others, embraced the thresholds, which had a chilling effect on providers. Patients who’d been placed on opioids were transformed into liabilities. Far too many lost access to care, creating “opioid refugees” with nowhere to turn. Nearly half of primary care providers, according to studies, will refuse to take on such patients.

People with pain were also subjected to dangerous opioid cessation practices — actually increasing their risks of overdose and suicide by three to five times, and needlessly destabilizing their health and lives.

What began as an appropriate call for caution in opioid prescribing turned into a crisis of under-treated pain.

To be fair, the problem can’t be laid entirely at the CDC’s door. The U.S. has undergone a rapid pendulum swing in opioid prescribing, which began to drop in 2012 and is now roughly at levels last seen in the early 1990s.

Further, opioids are not generally considered a first line of treatment for chronic pain. The updated 2022 guideline rightly urges careful balancing of benefits and risks and the expanded use and coverage of other treatments.

But some people do need opioids, one size does not fit all, and the CDC, as the agency in the proverbial driver’s seat issuing guidelines, is in the best position to undo ongoing harm and effect a course correction.

Taking the 2022 Prescribing Guidelines a Step Further

For many patients who have already lost access to care, the 2022 update is too little too late. But the issue still stands to affect millions. While it’s difficult to pinpoint exact numbers, given recent drops in prescribing, an estimated 5 to 8 million Americans, or up to as many as 13 million, use opioids to manage pain.

In light of documented harms and ongoing risks, the CDC must close the gap between rhetoric and action. In 2019, the agency came out publicly against misapplications of its 2016 guideline, but we witnessed no slowing in the number of patients suffering harm.

The language in the 2022 update is stronger; it repeatedly emphasizes clinician discretion and individualized care, and stridently warns regulators not to implement its provisions strictly. It also recognizes that people of color are at heightened risk of having their pain under-treated and spotlights equity.

But the 2022 update could still be misapplied. While dose benchmarks are notably absent from its recommendations, qualified dosage “guideposts” in the text remain. Numbers, history tells us, are temptingly easy for policymakers to adopt as mandates.

Furthermore, the urgency of this problem has not abated. Just recently, patients were abandoned when their provider was raided by the DEA. Desperate, one patient has sought help in a methadone clinic, even though she has no history of a use disorder. Another, who had recently experienced repeated impediments to care, died by suicide alongside his wife.

What Should the CDC Do?

In proactively working with regulators to undo harm, the CDC can begin in its own house at the Department of HHS. It should work with the Centers for Medicare and Medicaid Policy to rescind quality payment metrics based on dose thresholds. Moreover, it should offer technical assistance to the National Committee for Quality Assurance, payers, and pharmacy benefit plans to encourage similar redactions.

Likewise, the CDC should actively engage the DEA and state medical boards so that they cease policing providers based on the dosages they prescribe, and encourage the DEA to arrange transitional care for patients who fall through the cracks.

While the agency can’t tell state or federal lawmakers which laws to rescind or pass, they should conduct active outreach with regulators to educate them about what went wrong with strict thresholds and the genuine risks to patient safety that have resulted. As the nation’s premier public health agency, the CDC has the data and expertise to conduct empirically-based outreach to these decision makers.

The agency has developed implementation tools for providers. It must also disseminate those tools to policymakers, so it can help them understand how key presumptions in opioid regulation — that cutting the medical supply of opioids would reduce overdoses and that cutting people off medication will ensure their safety — have proven wrong with disastrous effects.

How Will the CDC Monitor and Prevent Misapplication?

Fortunately, the CDC already seems poised for vigilance. In a perspective piece in the New England Journal of Medicine, authors of the 2022 update state that the CDC will “monitor” against misapplication. We strongly urge the CDC to remediate past harm, in addition to engaging in forward-looking monitoring.

Monitoring is especially important because the 2022 update represents a significant expansion that now covers the full spectrum of pain from acute, to subacute, to chronic. Typically, it’s good practice to check safety equipment on an aircraft before you expand the fleet. Given the well-acknowledged misapplication of its prior guideline, proper implementation of this expanded guideline is essential.

The health and lives of tens of millions of Americans depend on it.

Facebook Makes Unexpected Trump Announcement that Will Have Liberals ABSOLUTELY Freaking out

The first amendment really only applies to the federal government https://mtsu.edu/first-amendment/page/things-you-need

“Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.” – The First Amendment to the U.S. Constitution

Our Founding Fathers could never conceive that any private entity could have sufficient influence to sway public opinion.   This survey of people claimed  79% say ‘truthful’ coverage of Hunter Biden’s laptop would have changed 2020 election

Elon Musk’s acquisition of Twitter could change  how the other entities, that has a major internet presence, are able to influence what people believe because certain news/information can no longer be throttled.  Facebook/Meta change may be a direct result of Musk’s acquisition of Twitter. Hopefully, other major internet news medias will follow suit.

Only time will tell how all of this shakes out.  If we are lucky, some of the media will not longer just regurgitate what the DEA pushes out via press releases https://www.dea.gov/