Advocates: come and go and SOME ARE JUST RAN OFF

Infighting in the Pain Community Made Me Leave Advocacy

 

 

 

 

 

 

 

Some people in the chronic pain community seem intent to PUSH OUT some of the most vocal and visible advocates…  Another one just announced her departure a couple of days ago.  I don’t blame Caylee from walking away… I have had some of these narcissistic, self-serving, self-centered … so called advocates – come after me.

Fortunately, I have fairly tough skin and I just am able to ignore their “childish attacks”…  I just figure that I just hit a fairly “large nerve”

Maybe it is just me, but I often notice that there seems to be few, if any, of the chronic pain pts has much – if any – support from their spouse  – if the spouse is still around – what about Brothers/Sisters, kids and/or if parents are still around.  OH…they are not advocating for your pain being under/untreated ?  I am sure that they will attend your funeral and they will all agree that you are ” at peace and not in pain any more ”  and they will get on with their life !

There is suppose to be 100 million chronic pain pts … put how many are actually trying to advocate for themselves and others…  I don’t see the numbers … at least being visible ..anywhere on the internet.

I can’t count the number of strong advocates that have thrown up their hands and walked away over the 10 years that I have had my blog. Some I am sure were basically “chased away” …others got tired of the lack of unity within the community and/or the lack of numbers involved with the community.

If you are part of the community – or just a chronic painer standing on the side line – and you see a major advocate – or any chronic painer – being attacked … you need to stand up for the person being attacked.

As prescribers are abandoning more and more pts… no chronic painer need to stand by idle while watching advocates being chased off…  until one day you find yourself with no advocates but the ones who have been chasing off advocates that they don’t agree with – or – feel  that “their power/authority/dominance” is being threatened and those left in the community will have to go along with whatever processes they think is the way to go…. whether it is the right or wrong path.

 

 

Flu season is on the way, and it could be brutal

It is best if people get their flu shot the last of Sept – first of Oct… Flu season typically doesn’t start showing up until Nov and it takes two weeks post shot for blood titters to get to sufficient blood levels.  At some time after that point, blood titters start to fade and “flu season” can continue to be active until March.

Flu season is on the way, and it could be brutal

https://ncpa.org/newsroom/qam/2021/09/09/flu-season-way-and-it-could-be-brutal

NBC News reports that health officials are urging people to get their flu shots now, as two studies warn that this flu season could be a miserable one. Getting the shot now is an attempt to prevent further strain on hospitals already overwhelmed by COVID-19 and other viruses. It is almost impossible to predict what will happen in any flu season, but this year, a combination of factors could make this winter particularly tough, experts say. Children are back in school, often in communities that have eased up on mask mandates and physical distancing measures. And since flu was minimal to nonexistent last year, people were not exposed to the virus, potentially undermining the protection they’d normally have.

Interesting blog that is REALLY NOT FOND of DEA and Pharmacists “who are not comfortable” and refuse to fill Rxs

Someone shared this blog hyperlink ( https://youarewithinthenorms.com/ ) with me… it would appear that it has been around for about two years…  I have only read a few posts but definitive whoever is contributing to this blog… has NO USE FOR THE DEA and that breed of pharmacists who believes that they have the instilled belief that they have the right to basically practice medicine without a license and working on a very limited about of medical information about the pt that they are more than comfortable with refusing to fill a prescription because “I’m not comfortable”…

For the record… “I’m not comfortable” is not a valid clinical reason for refusing to fill a Rx… it is an EXCUSE based on the pharmacist’s person opinion generally based on their own personal biases or phobias.

One of the basics of the practice of medicine is the starting, changing,stopping a pt’s therapy… thus any pharmacist outright refusing to fill a legit Rx without contacting the prescriber… Is, most likely, practicing medicine without a license.

If the Pharmacist believes that there is a potential LEVEL ONE drug interaction, the pt is allergic to the medication and/or the prescribed dose is way outside of what is recommended by FDA. The pharmacist has a duty to explain this to the pt and inform the pt that the pharmacist is unable to fill the Rx until the prescriber has been contacted to clarify his/her concerns.  If the pt elects to take the Rx back and try to get it filled at another pharmacy… that is the pt’s option.

The Pharmacist also has the duty to put notes on the pt’s medical records in the pharmacy’s computer system of the advice provided to the pt… and the pt decided not to have their Rx filled at this particular pharmacy… In healthcare, there is a very important saying “if IT is not documented… it didn’t happen…”  It his type of situation, the pharmacist had some valid clinical reason(s) to HOLD UP the filling of the pt’s Rx(s) and the pt decides not to take the pharmacist’s advice and find another pharmacist that would fill the Rx.

If for some reason, the pt filled a complaint with the Pharmacy board about “denial of care”,  if the BOP followed up with an investigation… in all likelihood that the complaint would be dismissed with no action.

 

https://youarewithinthenorms.com/

Don’t hold your breathe to see this Administration to negotiate medication prices

This is how clueless this administration is about the price of medication.  The graphic at the bottom of this post demonstrates where the BULK of money the pt pays at the counter really goes to…  Over the last few years the major PBM middlemen have been bought/merged/acquired by insurance companies. So the middle of that graphic should be JUST TWO ENTITIES… Some believe that this was done so that their excessive gross profits could be buried within the P&L statement and balance sheet of the insurance company. The PBM industry was founded around 1970 and as they gained control over more and more of the Rx market place their profits have exploded.  Mostly from discount/rebates/kickbacks from the Pharmas to have their particular med on their approved formulary… meaning no PA for the prescriber to deal with.   PA takes time to deal with and time is money.  All medications under Medicare Part D are provided by FOR PROFIT INSURANCE COMPANIES.  I don’t understand how this administration believes that they can negotiate prescription prices from the Pharmas… when the insurance/PBM industry have been manipulating the medication prices that people pay. In 2020, most/all of the part D programs put abt a $435 annual deductible on their programs… Since most Medicare folks were paying abt $30/month premium… they basically OVER DOUBLED the out of pocket expenses for most Medicare folks. $360/yr premium plus $435 deductible…  Medicare folks was now paying $795/yr before the first medication benefit was paid.  Our Part D program estimated that I would not meet my deductible until Nov.  I didn’t hear any large number of Medicare folks RAISING HELL about this cost increase. President Trump has an agreement with insulin makers that as of April 2021 … all type 1 diabetics would only pay abt $30/month for their insulin… instead of the typical $200-$300/month under current pricing structure and President Biden … revoked that as soon as he got into office… and now he is concerned about the cost of medications.  The overall annual cost of treating a Type 1 diabetic is one of the more expensive diseases.  The Insurance/PBM industry has one of the largest “pots of money” to fund lobbying.  The lobbying industry – as a whole – spend $9+ million PER DAY on the 535 members of Congress … to persuade the members of Congress to get them to pass or vote on bills that a particular industry wants it their way.

 

 

White House unveils plan to cut prescription-drug prices

https://www.foxbusiness.com/politics/white-house-unveils-plan-to-cut-prescription-drug-prices

A Biden administration plan to lower prescription drug prices offers the first detailed road map of administrative actions the White House would support in addition to legislation aimed at driving down costs.

The plan, to be released Thursday, backs legislation from congressional Democrats, including a push to empower the federal government to negotiate for drug prices in Medicare and pass those lower costs along to the private sector. The road map goes further, however, by outlining administrative actions by agencies and departments that could come in concert with possible legislative changes.

Administrative measures include testing reimbursement for drugs in Medicare based on the clinical value they provide to patients and offering federal funding for research into new treatments, according to the plan viewed by The Wall Street Journal.

The Biden administration plans to take administrative actions, as well as legislative to lower prescription drug prices. (iStock)

Medicare is the health program for people aged 65 and older and younger people with disabilities.

“The Biden-Harris administration remains committed to making health care more affordable for American families, and this plan outlines one key way we will do that,” Health and Human Services Secretary Xavier Becerra said in a statement. “By promoting negotiation, competition and innovation in the health care industry, we will ensure cost fairness and protect access to care.”

The plan aims to bolster support for drug-pricing legislation by showing how administrative action could complement action from Congress. But Democrats remain divided over the scope and speed of the legislation, and the pharmaceutical industry is already ramping up its opposition to a number of the legislative options.

PhRMA, a trade group for drug manufacturers, held a press call Wednesday to criticize plans to enable price negotiation for drugs in Medicare, saying it will reduce funding for the development of new treatments.

“It’s really a smokescreen for implementing new government price controls,” said David Ricks, chairman and chief executive of Eli Lilly & Co. “We cannot and will not support policies that hurt patient access.”

Republicans also have opposed Medicare drug-price negotiations and have called for more bipartisan approaches to lower costs.

The plan, the result of weeks of meetings with industry, patient groups and others, stems from an executive order signed by President Biden in early July that tasked Health and Human Services with developing the road map in 45 days. The report was done but hadn’t been made public yet.

The president called for the plan to include initiatives to combat high drug prices, beef up domestic pharmaceutical supply chains and address what the plan calls price gouging.

The 29-page plan is built around three broad principles: support for price negotiation with drug manufacturers and limits on drug-price increases, promotion of industry competition, and support for public and private research into new treatments, according to a copy of the report.

The plan, for example, says legislation could prohibit pharmaceutical companies from paying generic competitors to hold off on marketing their versions of brand-name drugs. Administratively, the Food and Drug Administration and the U.S. Patent and Trademark Office would then develop solutions so that drug manufacturers can’t unfairly use the patent system to discourage competition, according to the plan.

The plan calls for reducing regulatory barriers that may impede or slow the approval of lower-priced generics or licensing of biosimilars – near-identical versions of drugs that can be made once an original patent expires, as well as promoting the lower-cost alternatives.

To spur new drug innovations, the administration would launch an agency at the National Institutes of Health to drive biomedical breakthroughs. Mr. Biden requested $6.5 billion for three years in his fiscal 2022 budget for the NIH, whose focus would be to “foster medical innovations,” including for diseases such as cancer, diabetes and Alzheimers.

Other administrative measures include drug importation programs that reduce costs. HHS could collect data from insurers and third-party benefit managers to improve transparency about prices, rebates and out-of-pocket spending on prescription medications, according to the plan.

HHS could test models that pay for treatment and care in Medicare based on outcomes, in which payments for drugs are directly linked to the clinical value they provide patients.

Mr. Biden in August urged Congress to move drug-pricing legislation as part of a $3.5 trillion budget package. House and Senate Democrats have largely supported the ideas in concept, with the lawmakers in both chambers currently working on legislation to include provisions aimed at lowering the cost of prescription drugs.

Democrats on the House Energy and Commerce Committee are expected to unveil a proposal based on earlier legislation that passed the House enabling Medicare to negotiate on the price of prescription drugs.

The plan also lays out possible legislative approaches that the administration supports for lowering prices. Measures include legislation to slow price increases over time on existing drugs, a cap on the amount Medicare beneficiaries pay out of pocket for drugs and the speeding up of lower-priced alternatives to patented and name-brand drugs.

Efforts to tackle high drug prices have so far made little progress despite bold announcements. Former President Donald Trump had campaigned on letting Medicare negotiate drug prices but retreated from the idea once in office.

The Biden administration has pulled back from Trump-era plans to align payments for drugs with lower drug prices in other countries and curb drug rebates paid to groups that manage pharmacy benefits for companies and the federal government.

CVS Urges SCOTUS to Bar HIV/AIDS Patients’ Disability Bias Suit

CVS Urges SCOTUS to Bar HIV/AIDS Patients’ Disability Bias Suit

https://consumerwatchdog.org/news-story/hiv-bias-suit-against-cvs-tests-bounds-obamacare-protections

Californians with HIV and AIDS are taking on their drug plan middleman in a fight over how they get the medications they need to survive.

Their proposed class action against CVS Caremark—green-lighted by a federal appeals court last month—is testing the bounds of the Affordable Care Act’s antidiscrimination protections and could open the door to more litigation against powerful pharmacy benefit managers (PBMs) that control how drug benefit plans operate.

The case has the potential to bring more clarity to how Obamacare’s antidiscrimination protections are interpreted, said Elizabeth Pendo, a law professor at Saint Louis University Law School, who specializes in disability discrimination.

“These types of cases are incredibly important, and they are coming at a time when there’s a lot of uncertainty because of multiple legal challenges to the expansive idea of health-care access and nondiscrimination that we had during the Obama administration and a more limited or restricted idea of that during the Trump administration,” she said.

‘Disparate Impact’ 

The plaintiffs argue CVS Caremark, which administers and controls their employer health plan’s drug benefits, threatened their health and privacy by forcing them to get their specialty prescriptions filled by mail order or drop shipment to a CVS pharmacy for pickup. They’d have to pay the out-of-network insurance rates or full price to get their drugs at a pharmacy of their choosing.

One potential member of the nationwide class, who spoke with Bloomberg Law on the condition of anonymity, said they would have to pay over $1,300 out of pocket for a 30-day supply of Biktarvy if they used a pharmacy of their choice. The drug, used to help control HIV infection, otherwise costs $300 for a three-month supply under their health plan. The plaintiffs in the case are listed only as John Doe to protect their privacy. 

CVS Caremark said it treats all of its specialty drugs the same and they include treatments for disabled and non-disabled individuals alike. There are over 300 drugs on the list, including contraceptive devices and drugs that treat osteoporosis, arthritis, and asthma. Even though CVS said its policy is not intentionally discriminatory, the individuals with HIV and AIDS say they are being disproportionately impacted by a program that applies to all plan participants.

“Our goal here is to make sure that people with any pre-existing condition, or chronic illness, or disability can get the life-saving medication in a medically appropriate manner, they can get it in a way that doesn’t undermine their health,” said Jerry Flanagan, litigation director for Consumer Watchdog and one of the attorneys representing the patients’ in the case.

The U.S. Court of Appeals for the Ninth Circuit ruled Dec. 9 that the plaintiffs’ Obamacare bias claims could proceed after they were initially tossed out by the district court. The appeals court said patients can bring a claim of disability discrimination under Section 1557 of the ACA if they are disproportionately impacted by a policy. The ACA provision, which is based on existing civil rights laws, prohibits discrimination on the basis of sex, age, or disability in certain health-care programs. 

CVS Caremark asked the full court of appeals on Dec. 23 to overturn the ruling, arguing any limits on a health plan could be challenged under its reasoning.

“If allowed to stand, the panel decision threatens to open the door to ‘disparate impact’ claims based on any number of commonplace plan designs, with potentially enormous costs to the healthcare system,” CVS Pharmacy Inc. and CVS Caremark warned in their petition for a rehearing.

PBMs play an active role in shaping employee health benefits and could find themselves at a greater risk of being sued for discrimination over other decisions if those decisions hurt some health plan participants and not others, one law scholar said.

“There are lots of reasons why distribution and economics would encourage distribution to the home, but PBMs make a lot of other decisions that affect drugs that are a lot less defensible, at least defensible from a social perspective,” said Barak Richman, professor of law at Duke University School of Law, whose research is focused on health-care policy. 

Plan Design 

In July the Ninth Circuit held in Schmitt v. Kaiser Foundation Health Plan of Washington that Section 1557 of the ACA bars discrimination against people with disabilities in the design of insurance plan benefits.

The complaint filed against CVS Caremark is based on the same idea, “that 1557 specifically bars disability discrimination in insurance and benefit plan design,” Pendo said.

But a CVS spokesman said in a statement that PBMs like CVS Caremark are not plan sponsors and don’t make benefit design decisions for clients.

“We offer clients numerous clinical tools and pharmacy network options, including an option for clients to allow members with HIV to fill HIV-related medications at in-network local independent pharmacies and other national chain retail pharmacies,” Mike DeAngelis, senior director of corporate communications, said. “Each client selects the options that best meet its benefit plan objectives.”

Flanagan disagrees. CVS designed the benefit plan and can’t provide an option to a client that is discriminatory, he said, noting that Consumer Watchdog sued the employers involved as well. Those claims were dismissed by the district court and the Ninth Circuit.

“What CVS is trying to do here is paint the Ninth Circuit’s decision as doing something that’s brand new,” he said. “The Ninth Circuit found that Section 1557 merely applies existing civil rights laws and the plaintiffs here have met the requirements of existing law.”

The cases are Doe v. CVS Pharmacy, Inc., 9th Cir., No. 19-15074 and Doe One v. CVS Pharmacy, Inc., N.D. Cal., No. 3:18-cv-01031.

To contact the reporter on this story: Lydia Wheeler in Washington at lwheeler@bloomberglaw.com

West Virginia AG sues Biden admin over border policy reversal tied to ‘devastating’ fentanyl flow

West Virginia AG sues Biden admin over border policy reversal tied to ‘devastating’ fentanyl flow

https://www.foxnews.com/politics/west-virginia-ag-sues-biden-admin-border-policy-reversal-fentanyl-flow

West Virginia Attorney General Patrick Morrisey is suing the Biden administration over a key immigration policy reversal he says has fueled a “devastating” flow in the deadly drug fentanyl.

The state is suing over the reversal of the Trump-era “Remain-in-Mexico” policy, which kept migrants in Mexico while they awaited their hearings. The Biden administration began dismantling it in January and ended it in June. 

Critics had called the policy – officially called the Migrant Protection Protocols (MPP) — ineffective and cruel, while the Trump administration had said it ended “catch-and-release” by which migrants were released into the interior, reducing the pull factors bringing migrants north.

The lawsuit accuses Department of Homeland Security (DHS) Secretary Alejandro Mayorkas of having failed to consider “the consequences for the ongoing devastating deadly flood of fentanyl across the Southwest border into this country.”

“When they modified [Remain-in-Mexico], they utterly failed to consider what was going to happen to drug trafficking and didn’t even mention it in their documents,” Morrisey told Fox News in an interview. “And when it comes to immigration issues, it’s not only about stopping undocumented aliens from coming across the border, it’s also critical to be mindful of the drug trade which affects every state in the United States.”

Fentanyl, an opioid for pain treatment, is between 50 and 100 times more potent than morphine. More than 36,000 people died from overdoses involving synthetic opioids like fentanyl in 2019, according to the CDC.

The lawsuit claims that ending MPP burdened and distracted Border Patrol, therefore decreasing border security more broadly against the trafficking of fentanyl “leading directly to both increased numbers of smuggling attempts and increased rates of success in evading Border Patrol.”

It accuses the administration of having violated the Administrative Procedure Act (APA) by not having considered the consequences of the policy on drug trafficking when it ended MPP.

There have so far been 9,337 lbs of fentanyl seized in FY 2021 compared to 4,791 in FY 2020 and 2,804 in FY 2019. While most of those apprehensions take place at ports of entry, it is unclear how much is getting past agents between the ports. NBC reported in June that an increasing amount of the drug is being found in the desert.

Morrisey said that his state has seen an increase in the drug in recent months, although it has been becoming more of a problem for years.

“We are seeing numbers in West Virginia go through the roof in terms of fentanyl rising and while fentanyl has been increasing in recent years, we’ve really seen a lot of growth over the last 6-7 months and that’s very disconcerting,” he said.

He says that when smugglers bring the drug across the border “they make their way up the major highways eventually getting up to Detroit and Columbus and coming into West Virginia so there are a variety of different pathways that the fentanyl is moving in, but it is ultimately making its way up to many of the states across the country.”

The lawsuit is the latest to target the termination of Remain-in-Mexico. A federal judge ordered the Biden administration last week to resume the program after he found in favor of a lawsuit by Texas and Missouri which also accused the administration of violating the APA.

An appeal for a stay was dismissed by an appeals court, but late Friday Supreme Court Justice Samuel Alito issued a temporary stay that will be in effect until Tuesday night so he and the other Supreme Court justices can review the filings submitted in connection with the case.

Morrisey said that the ongoing lawsuit from Texas and Missouri does not affect the lawsuit by his state.

“We think we’re correct on the law, that when you make a major change in policy the way they did by moving away from Remain-in-Mexico you have to use reasoned decision making and you can’t meet the standard of reasoned decision making if you don’t actually consider drug trafficking coming across the border, and they didn’t when they changed the policy,” he said.

How the U.S. lost the war on drugs in Afghanistan

The media has reported over and over again for the last week or so that the war in Afghanistan has been our LONGEST WAR… does that mean that the WAR ON DRUGS…. is not really a WAR ?  The CDC routinely comes up with a “death count” from the war on drugs and we know of countless number of chronic pain pts who have died prematurely from under/untreated pain and/or committed suicide.  Could one say that those deaths are directly the results of actions taken by the DEA and the CDC ?

 

 

Could treating chronic pain help fund terrorism ?

Afghan Shock on Healthcare

https://daily-remedy.com/afghan-shock-on-healthcare

We often explain chaos theory through the butterfly effect, which states a small change can have large consequences later.

Something appearing small and insignificant somewhere or in some point in time can prove immensely consequential later or somewhere else. We have movies about it. We often reference it casually. But we miss it when it appears right in front of us.

Namely, the abrupt departure of the United States from Afghanistan – an event that will impact healthcare domestically for years to come and in ways we have yet to fully understand.

Afghanistan is the world leader in opium production. According to the United Nations Office on Drugs and Crime (UNODC), Afghanistan accounted for 85% of global opium production in 2020.

Now with the United States and its NATO allies gone, the country is run by the Taliban, an Islamic regional power we have trained since the Cold War and currently have a complicated relationship with – to put it mildly.

Initially the Taliban forbade the growth of opium. But in recent decades, the Taliban supported opium growth, even developing sophisticated production and distribution supply chains internationally.

The UNODC reports that Afghan poppy cultivation drifted upward since we began suppressing opium production in 2005 as part of our broader war on drugs.

Regardless of what we tried, Afghanistan remained the primary supplier of the world’s opium and heroin. In fact, our efforts to suppress production actually shifted production towards the Taliban.

The organization then increased opium production and used heroin sales as a revenue stream to support its military efforts. According to the United States Institute of Peace (USIP), a federal institution, we knew as early as 2009 that Afghan politics centered on opium production. And in the last two decades, much of our war efforts in the country centered on negotiating the production and distribution of opium with the Taliban and other regional military powers.

Since we are now gone, we no longer have influence over the supply of opium. This means we have little in the way of curtailing heroin production. Policy experts assume the Taliban will accelerate opium production.

But a RAND report from July 2021 casts doubt on that notion. The curiously prescient report discusses how a sharp decline in Afghan opium production would affect the Afghan economy, suggesting it would produce a humanitarian crisis and foment terrorist activities.

But the report does not suggest our recent withdrawal would lead to a decline. Rather, the authors suggest the increasing demand for fentanyl internationally would prompt a reduced demand for opium.

Fentanyl is a synthetic opiate, manufactured mostly in China or in Mexico with supplies from China. It is more potent and cheaper than opium, because it does not have the same labor costs. With cheaper costs, fentanyl is sold more cheaply on the market.

As a result, much of the heroin currently in the United States is laced with significant amounts of fentanyl. The recent wave of deaths attributed to the opioid epidemic is mostly due to the increased availability of fentanyl.

With the rise in cheap fentanyl, coupled with now unchecked market conditions in Afghanistan, we can only assume the price of heroin will decrease. The Taliban does not have the ability to manufacture fentanyl, and relies heavily on sales from heroin to support its government.

It would be naïve to expect the Taliban, which has invested so heavily in opium production, to simply stop now that the United States has left. Instead, we should assume the Taliban will continue to rely on heroin as a major export. The stability of the Taliban’s government depends on it.

The only way Taliban-produced heroin can compete against fentanyl is by lowering its price. And the only way to lower price is through an increase in supply – which means we can expect opium production in Afghanistan to increase in the coming years, because of the rise in fentanyl, contrary to the RAND report’s conclusion.

This means the United States will be flooded with high quantities and cheaper prices of both heroin and fentanyl. Previously fentanyl was used to lace heroin. Now we can expect more dynamic mixtures of the two drugs.

New combinations or formularies of drugs lead to more overdoses because the drug consuming market has not yet grown accustomed to them. And in the process of acclimating to the new drugs, people will overdose. We saw this with the introduction of crack cocaine in urban America, and with the introduction of vaping in America’s youth.

And we will see this in the years to come with new mixtures of heroin and fentanyl.

Inevitably the government will intensify its efforts to curtail the supply, but the government will continue to falter – because the opioid epidemic cannot be solved through supply-focused intervention.

This is what makes the epidemic unique. On a broad scale the epidemic follows traditional principles of supply and demand. But individually, these principles break down because addiction medicine and addictive behavior cannot be understood rationally or economically. It is a medical disease.

The solution to the epidemic comes out of policies that recognize this dichotomy. But many federal institutions, such as the Drug Enforcement Agency (DEA), refuse to adjust their approach to the opioid epidemic.

They continue to see the opioid epidemic in terms of supply and demand. They criticize de-criminalization by arguing that legalizing drugs would simply flood the market with even cheaper illicit drugs.

This may be true at a broad policy level. But it is not true at an individual level. Those with substance use dependencies or outright addictions will purchase drugs that optimize their high-to-risk ratio. The greater the high relative to the risk, the more likely the drug will be consumed.

Risk comes in many forms. There is financial risk, coming from basic costs of living and other financial expenses. But there is also legal risk, derived from the criminal consequences of consuming drugs that most addicts or patients with a substance dependency prefer to avoid – even at higher financial costs.

Most addiction specialists know that patients with substance dependencies balance risk financially and legally. But federal institutions seem to believe only financial risks matter.

Hence we find a discrepancy in how the clinical and legal worlds perceive the opioid epidemic. We have a unique opportunity to resolve this by examining the recent events in Afghanistan – observe the changes in Afghan opium production and prices post-withdrawal relative to the changes in opioid-based mortality and overdose-related hospitalizations in the United States.

Study the correlative factors between opium production and price internationally, and traditional metrics we use to measure the opioid epidemic. This would elucidate the specific impact of the Afghan opioid trade on the opioid epidemic in the United States.

And more importantly, demonstrate how supply changes, and the commensurate differences in drug prices affect individual behavior among those who consume illicit substances.

We should look the recent events in Afghanistan as a systemic shock to healthcare, and look for discrepancies in the clinical metrics that would indicate stronger or weaker correlations than previously assumed.

We can then understand how addicts perceive risk, and glean whether decriminalization truly lowers the price of illicit drugs.

Such analysis can dispel the prevailing, but false notions that have defined our understanding of the opioid epidemic. And once we properly understand this epidemic, we can finally enact the right solutions.

Guilty until proven innocent and there appears to be no path to appeal the decision.

 It would appear that “BIG DATA” will amass data from just about any place and sell it to anyone and apparently no one seems to validate the data being put into the database and the entity buying the data presumes that the data they have purchased is valid and/or has been validated.  Apparently there is company by the name of ESTEEM does collect data from various employers on their current or previous employees and sells that data to another corporation that someone has applied for a job…  This one person’s experience with this database over what many would consider basically a  NON ISSUE that was reported to the ESTEEM database has basically made him UNEMPLOYABLE in his chosen profession. Some may consider it the most severe type of retaliation from a former employer for 16 yrs.  I have also included hyperlinks from the actions of the SC board of Pharmacy and option from a law firm dealing with issues over various corporations submitting employee information to this database and using this database when considering hiring a new employee and apparently presumes the information provide from ESTEEM as of unquestionable validity.

When we had our own independent pharmacy, we were routinely that there could be severe legal consequences if we share “bad information” when we were called about a former employee that is apply for a job at another business… We were advised that the only thing that we should say about a previous employee to a new potential employer, is that the former employee was eligible to be rehired by us or the former employee was NOT ELIGIBLE to be rehired by us…  and not to elaborate on either statement.

 

publicorderscbop

https://practicesource.com/law-firm-lexis-esteem-database/

PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences

When you look at who was on this CDC committee and their medical qualifications… and they knew or should have known that the VA Hospital system and the DEA had the intention to take these opiate dosing guidelines a lot farther and just guideline.  Those two entities using their ability to coerce medical professionals to consider those guidelines as law and once >50% of medical professional implement these guidelines they would become de-facto standard of care and best practices and the DEA could “go after” prescribers who did not follow these guidelines and charge them with providing controlled substances without a valid medical purpose… thus violating the Controlled Substance Act.  These medical professionals on this committee should have been acutely aware of the possible harm/deaths could result from these guidelines being applied as being black/white law.  There has been numerous medical association that have stated that these guidelines have been GROSSLY MISAPPLIED.  The CDC organized this committee and tried to keep all members anonymous, did not publish the proposed guidelines nor provided for a public comment period and some question if the CDC actually had the statutory authority to generate these guidelines, since the CDC primary charge is dealing with contagious diseases and neither chronic pain nor addiction is considered a contagious disease. Could/should those people on that unconstitutional committee be held individually and collectively legally responsible for all the harm those opiate dosing guidelines have caused. Five years after the fact, would that be like trying to UN-RING A BELL ?

Here is a recent incident where the Supreme Court struck down the CDC’s attempt to extend the pandemic rent moratorium US Supreme Court strikes down CDC moratorium on evictions Apparently, it would appear that once again the lack of unity within the chronic pain community failed to stop the CDC with these unconstitutional opiate dosing guidelines before the DEA & VA were allowed to run amuck in trying to get these guidelines treated as THE LAW.

Here is the definition of

Involuntary Manslaughter

Involuntary manslaughter involves a death due to reckless conduct or criminal negligence. One example of involuntary manslaughter happens in the medical field.

Say there’s a doctor treating a patient for a breathing condition. The patient needs a tube to breathe, and the doctor is responsible for making sure that tube is installed correctly. However, one day, the doctor connects the tube wrong — the patient ends up dying as they’re not getting the air they need.

This is involuntary manslaughter as the doctor didn’t mean to kill their patient. They acted negligently, not ensuring they put the tube in correctly.

PROP’s Disproportionate Influence on U.S. Opioid Policy: The Harms of Intended Consequences

https://www.pallimed.org/2021/05/props-disproportionate-influence-on-us.html?m=1

Introduction

A recent study by the Centers for Disease Control (CDC) has captured the attention of the palliative care and chronic pain communities (1). Published on February 12, 2021, in Morbidity and Mortality Weekly Report (MMWR), it observed that the “age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, heroin, and prescription opioids during 2013–2019” have increased a whopping 1,040% (1). Several critics have attributed this increase in overdose mortality to failed federal opioid policy, particularly the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain and their misapplication (2-4). This criticism has generated recent flurry of activity on social media by the anti-opioid advocacy group (5), Physicians for Responsible Opioid Prescribing (PROP). This commentary will explore how PROP’s flawed policy approach over the last decade has reduced legitimate access to opioid medications and contributed to harms from increases in overdose deaths in the United States (US).

PROP Appears on the Opioid Policy Scene

In 2011, a group of internists, including Michael Van Korff, Andrew Kolodny and Roger Chou, co-authored an article that modern palliative care physicians would recognize as a “warning shot (6)” in the world of opioid policy (7). They announced the creation of Physicians for Responsible Opioid Prescribing (PROP), a “nonprofit organization with no pharmaceutical industry funding or ties,” that would “identify practical approaches to more cautious opioid prescribing in community practice (7).” They declared that “Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone. Rather, experts from general medicine, addiction medicine, and pain medicine should jointly reconsider how to increase the margin of safety (7).”

PROP Petition to the FDA on Opioid Labeling

The Petition is Filed
In its first effort to influence national opioid policy, in July 2012, PROP submitted a Petition to the Food and Drug Administration (FDA) calling for a change in labeling of opioid analgesics (8). Signatories to the Petition included PROP President, Andrew Kolodny, PROP Vice-president, Michael Van Korff, and PROP Board Members, Jane Ballantyne, Roger Chou, Stephen Gelfand, and Gary Franklin, among other medical specialists, including American Society of Addiction Medicine (ASAM) President, Stu Gitlow (8). In its petition, PROP requested that the FDA to make three main changes to the labeling process for opioid analgesics:

    1) Strike the term “moderate” from the indication for non-cancer pain (the only clinical indication for using an opioid analgesic would be for severe cancer pain).
    2) Add a maximum daily dose of opioid analgesia, equivalent to 100 milligrams of oral morphine, for treatment of all non-cancer pain.
    3) Add a maximum duration of 90-days for continuous (daily) opioid analgesia use for non-cancer pain, after which opioid analgesia would be discontinued (8).

The FDA acknowledged receipt of the PROP Petition on July 26, 2012 (9), and it simultaneously received a letter of support for its petition on the same date, led by Congress member, Representative Mary Bono Mack from California (10).

The Backlash to the PROP Petition Begins
This unity within the supporters of the petitioning group was short-lived. A representative from within the palliative care community alerted PROP FDA Petition signatory and American Society for Addiction Medicine (ASAM) President, Stu Gitlow, about substantial concerns from the pain management and palliative medicine communities about the potential reduced access to opioid therapy for many patients. In response to concerns that the PROP Petition might have a chilling effect on medically-legitimate opioid prescribing, ASAM released a statement by Gitlow clarifying its position that “the relabeling proposals [were] not intended, in any way, to limit a chronic pain patient’s access to clinically appropriate opioid pain therapy or to impinge upon a pain specialist’s ability to make individual decisions regarding the most effective therapy for their legitimate pain patient (11).”

Several prominent pain management experts echoed important concerns about over-restricting patients’ medically legitimate access to opioid analgesics. Bob Twillman, a pain psychologist and Director of Policy and Advocacy for the American Academy of Pain Management (AAPM), pointed out that “the 90-day limit on use of opioid for [non-cancer pain was] arbitrarily chosen (12).” Because PROP’s Petition had criticized the use of long-term opioid therapy by citing a lack of evidence for opioids’ long-term effectiveness, Twillman also pointed out that “when considering opioid analgesics, FDA has used the standard of a 12-week trial of the medication[;] it has not required longer studies (12).” Similarly, co-chair the New York State Palliative Care Education and Training Council and palliative medicine physician, Russell Portenoy, wrote that in light of “the stunning disconnect between the label changes demanded in the petition and the ‘scientific basis’ presented to justify them, I am concerned that all of the signatories possess an incomplete understanding of opioid pharmacology and pain medicine, and as a result, may pursue regulatory changes that are not in the best interest of public health (13).”

Other PROP critics included several medical professional organizations, like the American Society of Anesthesiologists (ASA), who challenged the clarity of a definition of cancer pain, asking rhetorically, “Who will decide whether the persistent pain, for example, of nerve damage incurred during an otherwise curative course of chemo- and radiation therapy is or is not cancer-related? (14).” Likewise, the American Academy of Pain Medicine (AAPM) stated “we have serious concerns about the petition and believe the rationale for the requested changes is seriously flawed, potentially harmful to patients with debilitating pain conditions for whom opioid therapy is indicated, and without substantive scientific foundation (15).”

The American Pain Society (APS) cited similar concerns about the Petition’s “insufficient scientific evidence base to support [its] recommendations. Further, we are concerned that implementation of these labeling changes which would dictate indications, dosing and duration of opioid treatment will not accomplish the intended goals, but instead have unintended negative consequences for patients including but not limited to untreated pain and loss of access to individualized care (16).”

FDA Response to the PROP Petition

On September 10, 2013, the FDA provided its response to the PROP Petition to change opioid labeling, which was granted in part and denied in part (17, 18). The FDA agreed with PROP that “more data are needed about the safety of long-term use of opioids,” and, to this end, they required “all new drug application (NDA) sponsors of ER/LA opioids to conduct postapproval studies and clinical trials… to assess certain known serious risks of ER/LA opioid use: misuse, abuse, hyperalgesia, addiction overdose and death (17).” Additionally, based on stakeholder input, the FDA determined that “safety labeling changes to the labeling of ER/LA opioid analgesics [were] needed to more effectively communicate to prescribers the serious risks associated with [those] drugs, and to more clearly describe the population in whom these drugs should be used be used in light of these serious risks – thus encouraging better prescribing, monitoring and patient counseling practices involving these drugs (17).” This included a new box warning to disclose risks from ER/LA opioid analgesics and the addition of the phrase, “indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (17).”

Despite calling for these changes, the FDA disagreed with the most important requests from the PROP Petition. It rejected PROP’s separation of non-cancer pain from cancer pain, noting “a patient without cancer, like a patient with cancer, may suffer from chronic pain, and PROP has not provided scientific support for why labeling should recommend different treatment for such patients (17).” The FDA also rejected PROP’s call for a 100 mg/day maximum morphine equivalent (MME) daily dose limitation, noting “the scientific literature does not support establishing a maximum recommended dose of 100 mg MED (17).” Furthermore, the FDA noted that creating a maximum dose of 100 mg MED “could imply a superior opioid safety profile under that set threshold, when there is no data to support that conclusion (17).” Finally, the FDA determined that PROP’s request to limit the maximum duration of treatment with opioid analgesia to 90 days was “not supportable” based on the evidence presented in the Petition (17).

PROP’s Influences the CDC Guidelines

A New Federal Regulatory Target

Although the FDA had rejected the most important changes which PROP had requested, based on a lack of scientific evidence, PROP publicly framed its FDA Opioid Labeling Petition as successful, then repeated its calls for a 100 mg/day MME (19). PROP had also explored other avenues to influence opioid policy and reduce opioid prescribing, reaching out for example to the Federation of State Medical Board (FSMB) to encourage it to make changes in its Revised Model Policy on the Appropriate Use of Opioid Analgesics in the Treatment of Pain (20). Ultimately, PROP identified a more accommodating regulatory agency than the FDA, the Centers for Disease Control and Prevention (CDC), which revealed via engagement webinars on September 16 and 17, 2015, that it had been drafting its own Opioid Prescribing Guidelines (21).

Another PROP Backlash

In the days following these engagement webinars, critics expressed concerns about a lack of transparency in the drafting of the Opioid Prescribing Guidelines, because CDC had failed “to disclose what outside advisors it consulted with during the drafting of its controversial opioid prescribing guidelines for physicians (22).” Additional concerns involved an unusually short, 48-hour period for stakeholders to submit comments about the CDC Pain Guidelines upon their originally planned release in September 2015 (23). Moreover, revelations that at least five PROP Board Members – including PROP President Jane Ballantyne, PROP Vice-President Gary Franklin, PROP Founder Andrew Kolodny, PROP Board Member David Tauben and PROP Board Member David Juurlink – had served on the panels that helped develop the CDC Guidelines, stirred deeper concerns (23, 24). Jane Ballantyne MD, who had succeeded Andrew Kolodny as PROP President, served as the sole clinician from the pain management community to be included in the CDC Core Expert Group (25).

Medical professional organizations joined in criticism of the CDC for a lack of transparency in its policy review process and the scarcity of pain management experts represented in the Core Expert Group (26). The American Medical Association (AMA) wrote that the “review process used to date by CDC, especially the public engagement webinars, [had] generated concern about lack of transparency (26),” and that the “process may have been better served by constructing a more balanced panel that included clinicians from various medical specialty and practice settings (26).” The Patient Quality of Life Coalition (PQLC), an advocacy group that included the American Academy of Hospice and Palliative Medicine (AAHPM), AAPM, the Center to Advance Palliative Care (CAPC), and the Hospice & Palliative Nurses association (HPNA), among others, wrote that “the Guideline in its current form is focused on curbing inappropriate [opioid] use, but seems devoid of empathy for patients who need legally‐prescribed opioid medications for relief from serious and long‐lasting pain that compromises their quality of life and independence (27).”

Following this outcry for transparency and expanded clinical representation regarding content, the CDC announced a second, 30-day open-comment period on its proposed 2016 Pain Guidelines, effective December 14, 2015 (28, 29). This delayed the roll out of the CDC Pain Guidelines past its originally anticipated implementation in January 2016, and prompted PROP founder, Andrew Kolodny to complain, “Opening a docket will tack months on to the process [and also] increases the likelihood that the guideline may never be released. This is an enormous win for the opioid lobby (30).” Interestingly, Kolodny co-authored a subsequent article examining the role of pharma funding and support of the CDC Pain Guidelines, and found that “of the 158 organizations that commented on the CDC’s draft guidelines, approximately 80% supported them either with or without recommendations, including many that received funding from opioid manufacturers (31).”

The CDC Guidelines are Published, Despite Ongoing Concerns

Notwithstanding PROP-founder Kolodny’s fears that the guidelines “may never be released (30),” the CDC Pain Guidelines were published via MMWR on March 18, 2016 (4). While most pain experts generally felt that the Pain Guidelines would be useful for those prescribing opioids in primary care settings, many expressed concerns that the Guidelines could be misapplied and affect a much broader group of patients than intended. For example, AMA board chair-elect, Patrice Harris, said that while the AMA shared the goal of reducing harm from opioid abuse, it remained concerned “about the evidence base informing some of the recommendations, conflicts with existing state laws and product labeling, and possible unintended consequences” including insurance coverage limitations for non-pharmacotherapeutic options for chronic pain (30). Similarly, Bob Twillman, executive director of the AAPM, said the CDC guidance “leaves much to be desired,” particularly regarding the limitations on dose, duration of treatment and arbitrary dosing threshold (32, 32). “Our concern is that, based on experience when states have implemented similar guidelines, some clinicians will interpret these ‘soft limits’ and thresholds as absolute ceiling doses, and that people with pain will suffer needlessly as a result,” Twillman said (32).

On August 29, 2016, a group of scientists from the CDC itself expressed integrity concerns about the agency’s data and its “the current state of ethics,” noting that “[i]t appears that our mission is being influenced and shaped by outside parties and rogue interests (34),” without specifically identifying PROP as one of those forces. Calling themselves the “CDC Spider Group (CDC Scientists Preserving Integrity, Diligence and Ethics in Research),” they reached out to Carmen S. Villar, MSW Chief of Staff, Office of the Director for the CDC, plainly stating that CDC “data were clearly manipulated in irregular ways” for political purposes (34). In October 2016, an article echoed similar concerns regarding CDC’s manipulation of data in a variety of projects, again alleging that the CDC was being influenced by corporate and political interests in a way that compromised its data collection (34). Despite these warnings, the 2016 CDC Opioid Prescribing Guidelines were implemented as planned.

Unintended Harms and the Backlash Against Misapplication of the CDC Guidelines

Just two years later, yet another article authored by CDC scientists was published in April 2018, again calling into question the methodology used by CDC to estimate opioid overdose deaths (35). The authors alleged that the CDC traditional method for calculating opioid overdose deaths overestimated deaths due to prescription opioids because the CDC failed to account for the emergence of illegally-manufactured fentanyl (IMF) as a cause of overdoses in its methodology (35). The authors proposed a method that would exclude IMF-related deaths for a more accurate estimate of total opioid overdose deaths (35). Using its traditional method, the CDC “estimated 32,445 prescription opioid–involved deaths occur[ing] in 2016.” Using these authors’ proposed “more conservative method, 17,087 prescription opioid–involved deaths occurred in 2016.” The concerned scientists concluded that “obtaining an accurate count of the true burden and differentiating between prescription and illicit opioid-involved deaths [was] essential to implement and evaluate public health and public safety efforts (35).”

In addition to concerns about the accuracy of CDC’s overdose data, by 2018 it had become clear that misapplication of its Pain Guidelines had begun to contribute to deaths from “suicides within and outside of the Veterans Affairs Healthcare System in the United States” from forced or involuntary tapers off of opioid analgesics (36). Although the CDC had designed the Guidelines “as non-mandatory guidance for primary care physicians[,] legislators, pharmacy chains, insurers, and others [had] seized on certain parts of its dosage and supply recommendations and translated them into blanket limits in law[s] and mandatory policy (37).” These misapplications and unintended consequences prompted the passage of an AMA Resolution against ongoing, widespread misapplication of the CDC Pain Guidelines in November 2018 (38). Adopted by the AMA House of Delegates at its November 2018 Interim Meeting, the new AMA policy affirmed that:

    1) “Some patients with acute or chronic pain [may] benefit from taking opioid pain medications at doses greater than generally recommended in the CDC Guideline for Prescribing Opioids for Chronic Pain and that such care may be medically necessary and appropriate,”

    2) The “AMA advocate against misapplication of the CDC Guideline for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit patients’ medical access to opioid analgesia,” and,

    3) “No entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the MME thresholds found in the CDC Guideline for Prescribing Opioids (38).”

In the months after adoption of this AMA policy change, more clinical professionals and medical societies would actively seek to reverse the harms of the CDC Pain Guidelines’ misapplication.

In December 2018, a group of clinical leaders and international stakeholders in the pain management community signed an open letter calling for urgent action against forced tapering of opioids (36). On February 13, 2019, the National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) sent a joint letter to Debra Dowell, Chef Medical Officer of the CDC Opioid Response Coordinating Unit, to follow up on a stakeholder meeting that was held on November 8, 2018, during which those professional organizations called for CDC “to address unintended implementation and reimbursement consequences that have been occurring in practice” because of the misapplication of CDC’s Pain Guidelines (39). On February 19, 2019, Dowell answered back in a letter that stated, “The Guideline is not intended to deny any patients who suffer from chronic pain from opioid therapy as an option for pain management (40).” She also wrote, “CDC encourages physicians to continue to use their clinical judgment and base treatment on what they know about their patients, including the use of opioids if determined to be the best course of treatment (40).” This response letter was embargoed for release until April 9, 2019 (40), to coincide with other anticipated press releases related to federal actions regarding misapplication of the Pain Guidelines (see below).

Similarly, on March 6, 2019, a group identified as Health Professionals for Patients in Pain (HP3) called upon “the CDC to follow through with its commitment to evaluate the impact by consulting directly with a wide range of patients and caregivers, and by engaging epidemiologic experts to investigate reported suicides, increases in illicit opioid use and, to the extent possible, expressions of suicidal ideation following involuntary opioid taper or discontinuation (41).” HP3 also urged “the CDC to issue a bold clarification about the 2016 Guideline – what it says and what it does not say, particularly on the matters of opioid taper and discontinuation (41).” The CDC responded on April 10, 2019, noting that “the Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm (42).”

FDA Warning and CDC Clarification About the Pain Guidelines

FDA Warning Against Rapid Tapers

One day prior to the CDC response letter to HP3 (42), on April 9, 2019, the FDA posted a safety announcement warning against sudden discontinuation of opioid pain medications (43). In the announcement, the FDA noted that it had “received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide (43).” This information was also released via a special FDA podcast on 4/17/2019 (44).

CDC Warns Against Misapplication of its Pain Guidelines; PROP Gets Defensive

In view of the embargo for release of the CDC response to the NCCN-ASCO-ASH, which occurred on April 9, 2019 (40), and the CDC response to HP3 (42) on April 10, 2019, it seems likely that the FDA and CDC coordinated their communications to response to the Pain Guideline backlash. CDC then released another embargoed statement on April 24, 2019, in which it advised against the misapplication of its Guideline for Prescribing Opioids for Chronic Pain (45). More explicitly, CDC sought to raise “awareness about the following issues that could put patients at risk:

     – Misapplication of recommendations to populations outside of the Guideline’s scope.
     – Misapplication of the Guideline’s dosage recommendation that results in hard limits or ‘cutting off’ opioids.
     – The Guideline does not support abrupt tapering or sudden discontinuation of opioids.
     – Misapplication of the Guideline’s dosage recommendation to patients receiving or starting medication-assisted treatment for opioid use disorder (45).”

On the heels of this media release, the CDC referenced a companion article published in New England Journal of Medicine (NEJM), co-authored by PROP member and CDC Core Group member, Roger Chou, which was available online on April 24, 2019, and in print on June 13, 2019 (46). Those authors also admitted that “some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations (46).” But in contrast to the contrite note struck by the CDC media release, the NEJM article vigorously defended the Pain Guidelines, noting that “the medical and health policy communities [had] largely embraced its recommendations” and that “the guideline was rated as high quality by the ECRI Guidelines Trust Scorecard (46).” The NEJM article also dismissed allegations about the lack of transparency in the Guideline creation, noting that the CDC had “engaged clinicians, health systems leaders, payers, and other decision makers in discussions of the guideline’s intent and provided clinical tools, including a mobile application and training, to facilitate appropriate implementation (46).” Notably, the article ended with this disclaimer: “The views expressed in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (46).”

Undeclared Conflicts of Interest

Less than a month after the printed publication of the Chou’s NEJM article defending the Pain Guidelines, the US Department of Justice (DOJ) announced obtaining a record-setting $1.4 billion settlement against Reckitt Benckiser, the manufacturer of Suboxone, an opioid addiction treatment drug (47). For years, critics had alleged financial connections between PROP members and Reckitt Benckiser, with suspicions driven by comments by PROP’s Kolodny, who in 2005 – when asked about his financial relationship with the company – replied, “They are not a pharmaceutical company. They make Lysol (48).” In 2015, Reckitt Benckiser had spun off its Suboxone manufacturing to a subsidiary that it named Indivior (49), more commonly identified as its manufacturer currently. Additionally, in recorded testimony during government hearings, Kolodny had encouraged the use of Suboxone as a measure to combat the opioid crisis. In 2011, at a New York State Senate Hearing, then-PROP President Kolodny testified, ““If we want to see a decline in overdose deaths, you have to [sic] provide effective treatment for people who are opioid-addicted. And for this epidemic, that’s probably going to mean buprenorphine (50).” Likewise, during a US Senate Hearing in 2018, Kolodny testified, “The first-line treatment for opioid addiction is buprenorphine, also called ‘’Suboxone.’ Access to this treatment is not sufficient (51).”

Testimony from hearings encouraging the use of Suboxone and deflective comments, like Kolodny’s dismissal about his relationship with Reckitt Benckiser, were less suspicious as betraying conflicting interests before it was revealed that PROP members failed to disclose relevant conflicts of interest when authoring several articles printed in medical journals. Kolodny failed to disclose conflicts of interest pursuant to his executive directorship of PROP and provision of expert witness testimony in malpractice cases involving opioids when he published two articles in the Journal of the American Medical Association (JAMA) in October 2017 and April 2018 (52). Similarly, PROP President, Jane Ballantyne, failed to disclose her affiliation with PROP in an “Ideas and Opinions” article, co-authored with PROP members, Anna Lembke and Roger Chau, in Annals of Internal Medicine in 2019 (53, 54). Moreover, PROP’s Mark Sullivan failed to declare a conflict of interest regarding his work on a opioid tapering device, which occurred during his participation in the drafting of the CDC Pain Guidelines, until he was participating in a CDC-sponsored Clinical Outreach and Community Activity, after the Guidelines’ publication (55). More recently, the British Medical Journal (BMJ) updated a “Rapid Response” that accused the AMA of a pharmaceutical industry bias when creating opioid policy, written by several members of PROP, when it was revealed that one of the co-authors, PROP’s Sullivan, did not disclose his competing interest related to his work as an expert witness in cases in Maryland and Missouri (56).

Despite their collective tendency to under-report relevant conflicts of interest in publications, PROP members continued to place themselves successfully in key positions to enhance their ability to shape opioid policy. In early April 2020, the Agency for Healthcare Research and Quality (AHRQ) disclosed for the first time the identity of the authors of the controversial report, “Opioid Treatment for Chronic Pain,” which had concluded “opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose, especially at high doses (57).” The lead author of that report was revealed to be Roger Chou, a PROP member who has been described as “a vocal critic of opioid prescribing for years (58).” This revelation was especially concerning at the time, because CDC had announced its plans to review and possibly revise the 2016 CDC Pain Guidelines, which were co-authored by Chou, and because the AHRQ study had reaffirmed many of CDC’s still-disputed conclusions about opioid therapy (58).

CDC Begins a Reassessment of the 2016 CDC Pain Guidelines

Open Docket for Comments

On April 17, 2020, the CDC announced “the opening of a docket to obtain comment concerning perspectives on and experiences with pain and pain management, including but not limited to the benefits and harms of opioid use, from patients with acute or chronic pain, patients’ family members and/or caregivers, and health care providers who care for patients with pain or conditions that can complicate pain management (59).” Eventually, it received 5,392 comments from patients, physicians, medical organizations, and other stakeholders with feedback about its 2016 Pain Guidelines (60).

The AAHPM did not mince words when commenting about its concerns of misapplication of the CDC Pain Guidelines: “The 2016 Guideline has been broadly misapplied, with devasting effect on patients and prescribers. Forced tapering of patients’ opioid prescriptions has been incentivized and/or mandated, violating ethical and evidentiary norms of medical practice. This has resulted in many patients’ medical deterioration, loss of care relationships, turning to illicit substances/alcohol, and suicidality. Swapping products and formulations to reduce opioid prescriptions where not medically necessary has also led to medical errors. At the same time, prescribers have faced professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above the morphine milligram equivalent (MME) thresholds included in the CDC Guideline (61).”

The AMA echoed these concerns, writing “It is clear that the CDC Guideline has harmed many patients—so much so that in 2019, the CDC authors and HHS issued long-overdue, but greatly appreciated, clarifications that states should not use the CDC Guideline to implement an arbitrary threshold (Italics mine, 62). It also noted that “the CDC Guideline has been misapplied as a hard policy threshold by states, health plans, pharmacy chains, and PBMs,” and that “these policies, moreover, have not withstood any meaningful evaluation or data analysis as to whether they have improved pain care or reduced opioid-related harms (62). There also are no data to suggest that payers have increased access to non-opioid pain care options. If one of the goals of the CDC Guideline was to increase access to non-opioid pain care, that has not been realized (62). Rather, there is evidence that payers continue to erect and support barriers to non-opioid pain care (62).” The AMA urged the CDC to rescind policies employed by “many health insurers, pharmacy chains, and PBMs” based on the concept of a hard MME threshold to avoid “harms done to patients as a result of inappropriate tapering or denials of care (62, 63).

In its comments, PROP conceded that reduced opioid prescribing was associated with downward trends in “prescription opioid related morbidity and mortality (64),” but did not acknowledge a concomitant, upward trend in total opioid-related morbidity and mortality from illicit drug, including illegally manufactured fentanyl. They further argued, “For some patients, continued opioid use is necessary not because it effectively manages the pain that prompted opioid prescribing initially, but because continued use averts the negative effects of opioid discontinuation (64),” a claim advocates for patients with chronic pain have labeled as a gaslighting strategy (65). Furthermore, as discussed later in the article, PROP also incorrectly predicted, “The downward trends in new starts of chronic opioid treatment achieved by the 2016 guideline should be seen as a positive development that will encourage people to find alternative means of controlling chronic pain, which though harder to employ than the prescription pad, will ultimately result in better outcomes and less distress (65).”

The BSC/NCIPC Workgroup

On July 6, 2020, the CDC announced the formation of a new Opioid Workgroup and the Board of Scientific Counselors, National Center for Injury Prevention and Control Centers for Disease Control and Prevention (The BSC/NCIPC Workgroup), which would “review the Opioid Workgroup’s report, discuss, deliberate, and provide advice and recommendations for CDC to consider as part of the potential update and/or expansion of the Guideline. The updated and/or expanded Guideline is anticipated to be released in 2022 (66).” This announcement was followed by the release of a PowerPoint Presentation entitled, “Update on the BSC/NCIPC Workgroup,” on July 22, 2020, which elaborated on the process of choosing the new Opioid Workgroup (67). An additional update from October 13, 2020, identified the membership of the Opioid Workgroup – NCIPC BSC Committee Members (68). The updated and/or expanded Pain Guideline was anticipated to be released in 2022 (66), but that timeframe was projected before the full impact of the COVID-19 Pandemic.

Increases in Overdose Deaths and CDC Data Flaws

The February 2021 MMWR Report

While the world anxiously awaited word on any new or revised CDC Pain Guidelines, on February 12, 2021, the MMWR Report (1) mentioned at the top of this commentary quickly captured the attention of those already hungry for news from the CDC, including patients with chronic pain and clinicians who manage that pain. In the setting of a 1,040% increase in “age-adjusted overdose death rates involving synthetic opioids, psychostimulants, cocaine, heroin, and prescription opioids during 2013–2019 (1),” it seemed prudent to critically question PROP’s assertion that “The downward trends in new starts of chronic opioid treatment achieved by the 2016 guideline should be seen as a positive development that will encourage people to find alternative means of controlling chronic pain, which though harder to employ than the prescription pad, will ultimately result in better outcomes and less distress (64).”

On February 16, 2021, in what felt like an effort to draw attention away from the stark reality of the MMWR Report, PROP wrote a letter to AMA President, Susan R. Bailey, regarding “AMA’s Opposition to Dose & Duration Guidance for Opioid Prescribing (69),” based on AMA’s comments to Dr. Deborah Dowell in the CDC Open Docket (61). PROP concomitantly published this letter to the AMA as a “Rapid Response” to an article entitled, “UK recommendations on opioid stewardship (70, 71).” The letter alleged that AMA Opioid Policy was inappropriately influenced by donations from the pharmaceutical industry (69, 70). AMA President, Susan Bailey, quickly responded back to PROP, in a letter dated February 19, 2021, saying “With respect to the issue you raise in your letter, it might be helpful to point out that the CDC authors of the 2016 CDC Guideline themselves have recognized it has been misapplied (Italics mine; 72, 73).” Additionally, Bailey pointed out, “When policies or organizations focus only on the restriction of a legitimate pharmacologic option to help patients with pain, they miss the chance to address the complexity of policies needed to truly help patients with pain. That misguided focus also has led to harmful stigmatization and other stressors. That is why the AMA provided comprehensive recommendations on the 2016 CDC Guideline and why we continue to advocate for policies that support comprehensive, multidisciplinary, multimodal pain care, including opioid therapy when appropriate. If you choose to cite the AMA’s policies in the future, we encourage you to cite them in their entirety to ensure accurate context (72),” and Bailey provided the link for the AMA’s comments to Deborah Dowell to guide PROP when referencing AMA policy in the future (62).

Inaccurate CDC Data on Opioid Deaths

Just a few weeks later, PROP’s troubles worsened, with the publication of an article by John Peppin and John J. Coleman in Pain Therapy (74) that detailed fundamental methodological shortcomings in CDC’s data on prescription overdose deaths (35). The authors held that “CDC erroneously reported prescription opioid overdose deaths in 2016 and for more than a decade before (74)” in a way that overestimated overdose deaths due to prescribed opioids. They further assert that “the CDC ignored the problem until 2016 data showed serious inconsistencies with other, more reputable, data for prescribing volumes of opioids (74).” Furthermore, in “2018, the U.S. Congress mandated the CDC to ‘’modernize’’ its system for reporting drug overdose deaths but this has not yet occurred (74).” They concluded: “For more than a decade, millions of Americans were misled into believing that—as a White House report once characterized it— ‘opiate overdoses, once almost always due to heroin use, are now increasingly due to abuse of prescription painkillers.’ Little did they know or suspect that the CDC’s coding of prescription painkillers included non-prescribed illicitly manufactured fentanyl and fentanyl analogs and non-prescribed methadone administered or dispensed to patients being treated for opioid use disorder (74).”

This report again exposed PROP’s and CDC’s false narrative that overprescribing of opioid analgesics had driven the US overdose crisis (74). In a predictable response, Andrew Kolodny reacted quickly to soften the crushing blow and establish some semblance of plausible deniability for PROP’s culpability. On March 22, 2021, Kolodny produced a webinar during which he “refuted” several alleged “myths and false narratives” about the opioid crisis (75). This presentation was swiftly characterized as “a rambling dialogue by Kolodny that gaslighted pain sufferers, doctors, patient advocates and anyone else critical of the CDC guideline (76).” For example, in a clear example of a Straw Man Argument (77), Kolodny alleged a myth that the “CDC Guideline forced millions of patients off opioids resulting in an epidemic of suicides (75),” when in fact both the CDC and FDA had publicly acknowledged the potential harms of forced tapers, acknowledging that the extent of the harm was not yet known (Italics mine, 42-45). In response to legitimate concerns about harms from polices influenced by PROP’s advocacy, one of its individual members had responded with gaslighting (75), informal fallacies (77) and deflection, aimed apparently at creating plausible deniability for their contribution to those harms.

Conclusion

Despite being turned back from an effort to bluntly reduce opioid prescribing by the FDA in 2013 based on a lack of scientific evidence for its position (17,18), PROP has had a disproportionate effect on opioid policy in the Untied States for almost a decade. PROP found a willing federal regulatory partner in the CDC, and while PROP may not have “secretly written” the 2016 CDC Pain Guidelines (75), they certainly enjoyed disproportionate representation on CDC’s review panels and Core Expert Group (23-25) in a process that lacked transparency (22, 23, 26, 27). When the CDC admitted that its Pain Guideline had been widely misapplied (40) and joined the FDA in a call against forced opioid tapers (42, 43, 45), PROP doubled down on its rhetoric (46), dismissing legitimate concerns about potential harms in a performative manner (75) that encouraged their ongoing misapplication, while assailing PROP’s critics (76, 77). All of this has occurred as PROP members have repeatedly concealed relevant conflicts of interest, including key conflicts that should have been disclosed during the process of drafting the CDC Pain Guidelines (48-54).

Given this, at a minimum, PROP should no longer enjoy a prominent role in guiding future opioid policy in the United States. This is a particularly urgent concern, as Roger Chou has been linked to authorship of CDC’s New Pain Guidelines, which have not yet been released to the public (78). Chou’s involvement in yet another set of Guidelines and CDC’s recurrent lack of transparency (79) in identifying the new Guidelines’ authors should alarm all advocates who support access to pain medications for all patients with a medically legitimate indication for opioid therapy.

Beyond limiting PROP’s role in developing future, potentially harmful opioid policy, a reasonable individual would be justified in wondering to what extent PROP bears culpability for the harms that arose from misapplications of the 2016 CDC Pain Guidelines. In our country, civil suits – like class action lawsuits, for example – only require a preponderance of the evidence – that is something is “more likely than not” – as the burden of proof for liability. It is more likely than not that PROP’s efforts to affect opioid policy helped shape the CDC Guidelines, which CDC has admitted were misapplied harmfully (40). It is also more likely than not that PROP’s performative advocacy efforts contributed to misapplication of the CDC Guidelines. And it is more likely than not that widespread misapplication of the CDC Guidelines resulted in harms with attendant civil liability. This would expose PROP to civil liability with a potentially enormous settlement if a class action suit were to arise from those harmed by the misapplication of the CDC Guidelines. Perhaps that is why PROP member, Andrew Kolodny, and others have worked so hard recently to create plausibly deniability (75) in the wake of the damaging February 12, 2021, MMWR Report (2).

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