Has some Pharmacists decided to practice medicine without a license ?

In listening to the attached video, remember … that one of the basics of the practice of medicine is the starting, changing or stopping a pt’s therapy. Pay attention to what the pharmacist is saying, telling the prescriber!

This is a video of a recent discussion between a prescriber and a pharmacist, regarding a pt that has lost her regular prescriber because of retirement.  I know who the prescriber is on the phone call, but I do not know who the Pharmacist is,  but suspect because of a few things stated by the Pharmacist… he works for a CHAIN.

Notice that the Pharmacist did not look at the pt’s PDMP history… all he is focused on is either the MME and/or Narxcare score, ignore the pt’s long term history of being on these medications for years.

He seems to be fixated on some arbitrary number and a “line drawn in the sand”  I suspect that this pharmacist works for one of the three chain pharmacies that made an agreement with 50 state AG’s & others. In which they agreed to reduce the opioids and/or controls that they dispense. https://www.pharmaciststeve.com/dea-surrogates-are-trying-to-throttle-the-availability-of-controlled-meds-to-pts/ This Pharmacist seems to be VERY RELUCTANT to explain what and where the criteria behind the “RED FLAG” that he is quoting came from and “hell bent” on refusing to dispense any medications above this seemingly arbitrary MME/day.

Since the Controlled Substance Act was signed into law in 1970, Pharmacists have not been allowed to change a C-II Rx for any reason – including verbal order from the prescriber.  Maybe, part of the lawsuit settlement to reduce the amount of controls those 3 chains dispensed. Gave them a special dispensation on that part of the CSA, as long as they are reducing the number of opioids they dispense?

I find it quite appalling that this Pharmacist had no interest to know if this pt was a confirmed ultra fast metabolizer by pharmacogenomics – which would be justification for the pt to have a higher dose and/or he no concern .. he was happy to enter into his pharmacy computer system a “corresponding responsibility rejection”, which would voided the pt’s C-II Rx and would most likely intentionally the pt into cold turkey withdrawal.

Last week 12 Kansas City area CVS locations close as pharmacists walk out over working conditions  I wonder if these Pharmacists walked out because CVS dictated how they were to practice pharmacy, what meds they can fill, what meds they can’t fill, and they are to limit how many controlled med doses they can provide to a particular pt?

Remember the first sentence of this blog… did the Pharmacist change the pt’s Rx? Was the Pharmacist willing to stop the pts medications? What part of the practice of medicine was this Pharmacist attempting to practice? Is the state board of pharmacy aware of this?  Do they really care … if they are aware?

Some Apple products will not play the above audio/video file

here is a audio only file that seems to play on Apple products

CVS pharmacists that walked out and negotiations with CVS exec and “promises made”

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Two Large Medical Groups Shun Medicare Advantage Plans

Two Large Medical Groups Shun Medicare Advantage Plans

https://www.medpagetoday.com/special-reports/exclusives/106483

MEDICARE OPEN ENROLLMENT STARTS OCT 15th, 2023

here is another Medicare -C (Advantage) announced this week – dropping Humana Medicare-C (Advantage) in Kentucky & Southern Indiana 

Humana-insured patients lose coverage at Baptist Health Medical Group

Signaling what may be an emerging national trend, two influential medical groups with San Diego-based Scripps Health are cancelling their Medicare Advantage contracts for 2024 because of low reimbursement and prior authorization hassles, leaving 30,000 enrolled seniors to look for new doctors, or different coverage.

“Negotiations with the payers for MA with our medical foundation groups and Scripps Health were unsuccessful and we have been forced to withdraw from those plans due to annual losses that exceeded $75 million,” Scripps CEO Chris Van Gorder told MedPage Today in an early morning email.

He said the losses are due to “low reimbursement, denials, and administrative costs to manage high utilization and out of network care.”

Van Gorder emphasized that about 30,000 enrollees will have to make a change in their coverage or pick another doctor. About 1,000 physicians and advanced practitioners such as physician assistants are members of the two groups.

“We certainly regret any inconvenience to them,” he said, but “that kind and size of loss is unsustainable by Scripps. We will remain in MA with our IPAs [independent physician associations] as those contracts are structured differently and of course, traditional Medicare.”

The two medical groups affected are Scripps Coastal and Scripps Clinic Medical Group. Five other Scripps medical groups will continue to take MA plans, he said. Affected beneficiaries should receive a notice directly from the plans.

Enrollees “can continue to see Scripps through traditional Medicare at all our hospitals and affiliated medical groups or can switch to an independent medical group (IPA) that still maintains a MA contract at Scripps Mercy, Scripps La Jolla, and Scripps Encinitas hospitals,” he added.

Patients can also switch to Kaiser Medicare Advantage during re-enrollment starting Oct. 15, or to another hospital system whose physicians still take MA plans.

However, switching to traditional Medicare without a supplemental plan — also called a Medigap plan — means patients incur 20% of all physician, lab, imaging, and emergency room costs, along with a $1,600 deductible per hospitalization episode this year. In California and in 44 other states, supplemental plans can reject applicants with common health conditions such as cancer, high blood pressure, a prior hospitalization, or joint replacement. In addition, these plans are expensive, with increasing monthly premiums as one gets older.

But Van Gorder said he had no choice. “We are a patient care organization and not a patient denial organization and, in many ways, the model of managed care has always been about denying or delaying care – at least economically. That is why denials, [prior] authorizations and administrative processes have become a very big issue for physicians and hospitals – not to mention that the reimbursement is insufficient in most government programs as we all know.”

“Now with intermediaries taking their profit and offering insurance to beneficiaries for free in many cases [the extra benefits like trips to the doctor], the end of the economic food chain is once again the hospitals and physicians.”

Van Gorder said patients should ask themselves, “‘Am I receiving the care I need if my hospital and physician are not even covering their costs? How long is that sustainable?'”

Where these patients will go is an open question.

More than half of all Medicare beneficiaries are now enrolled in MA plans nationally. In San Diego County, the fifth largest in the country, that percentage is 54%opens in a new tab or window of those eligible.

Nate Kaufman, a San Diego-based health system consultant, wasn’t surprised at Scripps’ news.

“I advise all hospitals to terminate their Medicare Advantage plans with anybody unless they’re getting over 115% of Medicare,” Kaufman told MedPage Today.

The problem is complicated, but in a nutshell the issue is a lack of funds to go around to pay hospitals and doctors the cost of care.

“Medicare’s contracts with Medicare Advantage plans pay less than what Medicare pays for traditional Medicare enrollees on the expectation that the plans will save money,” Kaufman said. “Then, the MA plan takes a piece off the top. The remaining funds go into two buckets. One for MA plan pharmacy benefits and the other for hospital and physicians. And that requires a major reduction in utilization to maintain profitability.”

Kaufman said all of this is made worse by the issue of prior authorization, which is now under Congressional scrutinyopens in a new tab or window.

“It creates hassles for everybody and cost,” he said. “The foundation upon which Medicare Advantage was built, which was that there’s excess money somewhere, has disappeared after the insurance company takes their cut off the top and captures the pharmacy rebates.”

Additionally, providers are seeing delays in getting paid, which carries its own cost. And because enrollees pay very low or no premiums, there are less funds for most of the providers, he said.

The issue is likely to keep many independent insurance agents busy. Christopher Westfall of Senior Savings Network, who is licensed to write Medicare contracts in 47 states, also sees providers ending their MA relationships as a national trend.

He said it can be extremely frustrating for his agents when seniors either don’t check their plan or choose the wrong plan thinking their provider is in network, only to find out after Jan. 1 that their doctors are in different plans, or have dropped out.

Many health systems have announced that they’re terminating their MA contracts, or are strongly considering it.

The Mayo Clinic in Jacksonville, Florida, and Scottsdale, Arizona, told beneficiariesopens in a new tab or window last October that it would no longer take most MA plans. If those patients sought care, it would be considered out-of-network, leaving them with a higher share of the costs.

Samaritan Health Services in Corvallis, Oregon, endedopens in a new tab or window its MA contracts with UnitedHealthcare, one of the largest Medicare Advantage contractors in the country.

Regional Medical Center in Cameron, Missouri terminatedopens in a new tab or window contracts with Cigna’s MA plans in 2023, and planned to drop Aetna and Humana MA contracts in 2024. Cameron’s Regional CEO Joe Abrutz blamed the plans’ practice of “delaying any action on reimbursement.”

Stillwater Medical Center, a 117-bed hospital in Oklahoma, called it quitsopens in a new tab or window last year with all of its in-network MA plans, blaming rising operating costs and a 22% prior authorization denial rate, compared with a 1% denial rate for traditional Medicare.

Brookings Health System, a 49-bed hospital in South Dakota, won’t be in networkopens in a new tab or window with any MA plan starting in January to preserve its financial sustainability.

St. Charles Health System in Oregon encouragedopens in a new tab or window its seniors not to enroll in MA this year as it re-evaluates its participation in Medicare Advantage contracts.

And Baptist Health Medical Group in Louisville, Kentucky failed to agree on termsopens in a new tab or window by its deadline with Humana’s Medicare Advantage plan and alerted their patients to seek other options.

Officials for the Medicare Advantage industry had not returned requests for comment as of press time.

 

Pharmacy desert coming to a town near you ?

CVS is permanently closing hundreds of stores for a surprising reason

https://www.thestreet.com/retailers/cvs-is-permanently-closing-hundreds-of-stores-for-a-surprising-reason

The drugstore and health-care chain announced a slew of changes planned before the end of 2024.

It’s no secret that U.S. drugstore landscape has been consolidating at a jarring pace now that the pandemic has passed. 

Rite Aid  (RAD) – Get Free Report has been reportedly toying with the possibility of filing Chapter 11 bankruptcy and liquidating many of its stores. It currently has some $3.3 billion in debt. The proposed deal would permanently shutter 400 to 500 of the chain’s current 2,100 stores and hand them over to creditors or other interested buyers. 

With the the pandemic now firmly behind us and brick-and-mortar retail at a crawling recovery pace compared with more robust corners of the market, drugstores have been ripe for change and, perhaps inevitably, consolidation. 

Walgreens  (WBA) – Get Free Report recently parted ways with its intrepid covid-era chief executive, Rosalind Brewer, who abruptly left on Sept. 1. The drugstore is now seeking someone with “deep health-care experience to lead in today’s dynamic environment,” according to Executive Chairman Stefano Pessina. 

It’s clear that if a U.S. drugstore isn’t implementing change, change is being forced on it, and more often than not that spells trouble. And that’s before accounting for the sharp spike in shoplifting and other retail crime, which has cut deeply into drugstores’ bottom lines and forced some to either shutter or chain up frequently stolen goods. 

CVS  (CVS) – Get Free Report is one chain that has managed to weather the post-covid recovery with as much ease and grace as is possible in the sector. The largest drugstore in America said in mid-September that it would launch a new company, called Cordavis, which would aim to bring down drug prices for customers by producing biosimilar medications and negotiating directly with drugmakers. 

The prospect is exciting for both customers and investors because CVS has not only market opportunity but also the scale to compete with the large drugmakers.

But it’s been active not only on the partnership and growth front. CVS is also consolidating, thanks to a recent policy change that will shutter hundreds of locations at a rapid clip. 

Walgreens Pharmacy and store closing sign at entrance, Queens, New York. (Photo by: Lindsey Nicholson/UCG/Universal Images Group via Getty Images)

CVS is shuttering hundreds of stores

A policy change first put forward in 2021 meant that hundreds of CVS locations would close as the chain worked to cut costs and get ahead of losses. 

“The company has been evaluating changes in population, consumer buying patterns and future health needs to ensure it has the right kinds of stores in the right locations for consumers and for the business. As part of this initiative, CVS Health will reduce store density in certain locations and close approximately 300 stores a year for the next three years,” the company said in late 2021. 

The drugstore has already shuttered locations in Des Moines, Iowa; Berkeley, Calif.; San Francisco; Albany, N.Y., Houston, Kansas City, Mo., and Tallahassee, Fla.

“We consider many factors when making store-closure decisions, including maintaining access to pharmacy services, local market dynamics, population shifts, a community’s store density, and ensuring there are other geographic access points to meet the needs of the community,” a spokesperson said of the decision. 

As many as 900 stores are expected to close through the end of 2024. 

Walgreens also said during its Q3-earnings call in June that it planned to close as many as 450 stores across the U.S. and U.K. to simplify the business. 

 

Humana-insured patients lose coverage at Baptist Health Medical Group


This is another example of a Medicare Advantage prgm… that is being provided by a FOR PROFIT insurance company and providing a Medicare-C (Advantage) insurance. Baptist Healthcare is a large hospital & office practices in Kentucky & southern Indiana. According to this article, the Baptist hospitals are still in-network with Humana. In 2024, it will cost us abt $750/yr each before we get the first PENNY IN COVERAGE for our medications. “We” have Humana Part D and we have already been given a “heads-up” that if we elected to stay with Humana for 2024, our “out of pocket costs” is increasing abt 45%. Of course, as of Jan 1, 2024… Humana is merging with United Health – who is endorsed by AARP.. don’t know if this has anything to do with these out of pocket cost. When I turned 65 y/o in 2012, United Health Medicare Supplement was $20/month more for the same supplemental policy that we ended up signing up for.  Maybe the difference between this year Medicare Part D and will be for 2024… was what it cost United Health – and other businesses – to have AARP’s endorsement?

Humana-insured patients lose coverage at Baptist Health Medical Group

https://www.whas11.com/article/news/health/humana-baptist-health-contract-patients-uninsured-medicare/417-294109f0-13d5-45aa-9f8d-b591c0e97c4c

The two companies were unable to reach an agreement Friday, leaving some patients little to no options.

LOUISVILLE, Ky. — Baptist Medical Health Group is no longer accepting some patients insured through Humana, after the companies were unable to reach an agreement Friday.

After months of negotiations, there was no agreement on a new contract – meaning Baptist Health Medical Group will be out of Humana’s network for Medicare Advantage and employer-sponsored commercial plans.

Patients, like Amy Derby, are now left frantic and unsure of where to turn next.

“Everybody’s lost,” Derby said. “And you try and talk to a social worker or a healthcare advocate here at the hospital and they don’t even know.”

Derby has been insured through Humana for 13 years. She tells WHAS11 that she was notified in late August of the negotiation problems between Baptist, Humana and Medicare. 

She received a letter from Baptist printed on Sep. 13, but delivered Sep. 18, stating that her doctor at Baptist was dropping her as a patient because of her Humana Medicare Advantage Plan. That change went into effect Sept. 22. 

What does this all mean? Higher out-of-pocket costs for medical services.

“Now that I’m out of network, I can’t get any actual answers on what copays, hospitalizations, or procedures are going to be,” Derby said.

Derby is now tasked with finding a new general practitioner cardiologist and hematologist oncologist.

“I’m just in a tizzy like everybody else,” she said. 

In a statement sent to WHAS11, Baptist Medical Health Group stated, in part: “As caregivers, nothing is more important than ensuring our patients have access to the care they need, when they need it. We understand this process has been frustrating for our community, but we will continue to advocate for those we serve.”

The change only effects Baptist Health Medical Group, Baptist Health hospitals are still in-network for Humana.

Baptist Health is encouraging patients to call Humana at the number on the back of your insurance card to learn about your plan’s out-of-network benefits. 

Humana has not responded to our requests for comment.

‘No question my mom was addicted to opioids,’ McCaskill reflects during roundtable

U.S. Sen. Claire McCaskill, who is an attorney, “There’s no question my mom was addicted to opioids near the end of her life, ..“And frankly some of the times she was in the most pain was when she was going through withdrawals. She wanted the drugs because she was coming off of the drugs”

Marc Larsen, the chair of emergency medicine at St. Luke’s, told McCaskill the medical community “created this epidemic by saying we have to treat the pain.”

McCaskill, got her law degree in 1978, when the DEA was just gaining some some momentum and in 1999 Congress passed the Decade of Pain Law than when in came to be renewed in 2009-2010, the political majority of Congress had flipped since the law was signed into law and it was not renewed.

If Senator McCaskill, wanted to take her Mom off her pain management, at her in a life… no matter how much she suffered with untreated pain and withdrawal. All she seemed to care about is the possibility of her Mom being “addicted ” to a opioid when she died.

Those of you who live in Missouri and have written to or talked to Senator McCaskill about the fabricated opioid crisis. If she threw her elderly Mom into withdrawal and untreated pain… do you think that you can get thru to her?  To change her mind?

‘No question my mom was addicted to opioids,’ McCaskill reflects during roundtable

https://www.kansascity.com/news/politics-government/article199431699.html

U.S. Sen. Claire McCaskill thinks her mother was addicted to opioids before she died. McCaskill, a Missouri Democrat, hosted a health care roundtable Friday afternoon at St. Luke’s Hospital. The roundtable with Kansas City physicians and other medical professionals covered topics including the cost of emergency room care, the impact of Missouri’s decision to not expand Medicaid and problems in the state’s mental health system. McCaskill also devoted several minutes to the highly personal topic of opioid addiction. “There’s no question my mom was addicted to opioids near the end of her life,” said McCaskill, whose mother, Betty Anne McCaskill, died in 2012 at age 84. She recalled how her mother often told her doctors that her pain was at a 10 on 1-to-10 scale to get the strongest dose of medication during her final years. “It was one of those gut-wrenching things because it felt like I knew it was not helping her. On the other hand, to try and get her off those drugs at that point in her life also seemed like a cruel and sometimes painful thing to get done,” McCaskill elaborated to reporters after the event. “And frankly some of the times she was in the most pain was when she was going through withdrawals. She wanted the drugs because she was coming off of the drugs … and all of them were prescribed with her doctors.” Marc Larsen, the chair of emergency medicine at St. Luke’s, told McCaskill the medical community “created this epidemic by saying we have to treat the pain.” McCaskill, who has led an investigation into opioid manufacturers, floated the idea of broadening her investigative efforts into the rest of the pharmaceutical industry. She repeatedly expressed her concern about the links between drug companies and research organizations that tout the benefits of medication. U.S. Sen. Claire McCaskill offered an alternative to President Donald Trump’s proposed military parade. By Bryan Lowry and Leah Becerra Another area of focus during the discussion was the state of mental health care in Missouri. McCaskill was shocked to learn that the largest mental health care provider in the state is the Department of Corrections. She was also surprised to learn that Missouri incarcerates women at a higher rate than any other state. “Are women meaner in Missouri?” she quipped. After the meeting, she blamed both of these statistics on the state’s “failure to have wrap-around health services, mental health services, behavioral health services for many of the underinsured and uninsured in our state.”

 

 

Abbott issues warning for 155K pain relief devices

Abbott issues warning for 155K pain relief devices

https://www.beckershospitalreview.com/supply-chain/abbott-issues-warning-for-155k-pain-relief-devices.html

Abbott has received reports of 73 injuries concerning its Abbott Proclaim and Infinity neurostimulation systems, which deliver low-intensity electrical impulses and are used for chronic pain, the FDA said Sept. 13. 

The devices are indicated for spinal cord and deep brain stimulation. The product can be controlled through a mobile app, including halting therapy to begin magnetic resonance imaging. Abbott said some patients have reported being unable to exit the MRI mode from the app, which could require surgery to replace the device. 

Customers for about 155,000 Proclaim and Infinity systems have been notified after Abbott recorded 73 injuries and 186 incidents. The company instructed implanting surgeons to advise patients to not delete bluetooth connection between their phone and the device.

Prescription opioid shipments declined sharply even as fatal overdoses increased, new data shows

Prescription opioid shipments declined sharply even as fatal overdoses increased, new data shows

https://apnews.com/article/opioids-distribution-prescription-data-us-overdose-crisis-8bb8d2138fb51289b0189e4af250da12

The number of prescription opioid pills shipped in the U.S. in the second half of the 2010s decreased sharply even as a nationwide overdose crisis continued to deepen, according to data released Tuesday.

The decline in painkiller prescriptions — finally dropping below the quantities sold in the mid-2000s when the overdose epidemic accelerated — happened after state and federal governments tightened prescribing guidelines and state, local and Native American tribal governments sued the industry over the toll of the addictive drugs.

“We are still at an epidemic proportion of pills,” Peter Mougey, a lawyer representing governments that are suing drugmakers, distribution companies and pharmacies, said in an online news conference to release the data Tuesday.

The distribution data is being released by lawyers after a judge ordered the U.S. Drug Enforcement Administration to share it with the plaintiffs. The governments assert that the companies should have done more to stop the flow of opioids when they saw that more than necessary were flowing to pharmacies and patients.

The lawyers obtained the updated data from the DEA’s Automation of Reports and Consolidated Orders System, or ARCOS, as part of their lawsuits. It showed that in 2019, 8.8 billion dosage units — pills, patches, lollipops — were shipped for 12 common opioids. That’s just over half as many doses as the peak of shipments in 2010, when nearly 16 billion doses were moved.

Lawyers also noted that the strongest doses of pills from before are no longer on the market.

But Mougey pointed out that as prescription drug shipments decreased, illicit opioids — particularly heroin and illegally produced versions of fentanyl — increased. And the number of deadly overdoses continued to climb.

The first public release of data four years ago was more dramatic, showing how the prescribing and shipping of powerful prescription opioid painkillers increased through the late 2000s and early 2010s. During that time, prescription drugs were the opioids linked to the most deaths in the U.S.

The data showed how doctors were prescribing more powerful pills, even as the deaths added up. And it showed just how pervasive the drugs were: Each year, drug companies were shipping enough pills for everyone living in some counties — mostly in Appalachia — to have more than a 100-day supply.

The newly released data is the first deep look at what happened with prescription drug shipments later in the 2010s. But the story of the overdose crisis from that time forward is well documented and dire.

By the early 2010s, policymakers and doctors were restricting access to prescription opioids. People who had become addicted looked for other sources and found them in illicit pills, which are often counterfeit, and other street drugs. Heroin deaths increased dramatically, and so did those from illicit and potent synthetic opioids such as fentanyl, which are often added to other drugs by dealers.

The fentanyl-driven crisis is more deadly than any other drug tragedy the nation has ever seen. In 2010, opioids were linked to just over 21,000 deaths in the U.S. In 2022, the opioid-related death toll was more than 82,000.

Cleveland-based U.S. District Judge Dan Polster, who is overseeing evidence in all the lawsuits in federal courts, previously required that the data from 2006 through 2014 be shared. The Washington Post and HD Media, a company that owns newspapers in West Virginia, went to court to seek the information, which was released publicly beginning in 2019.

The lawsuits are now in a very different place. Some have gone to trial, with mixed results. But most of the key companies have reached settlement agreements that will total more than $50 billion if they’re all finalized. That includes up to $6 billion from members of the Sackler family, who own OxyContin maker Purdue Pharma. That settlement is on hold while the U.S. Supreme Court reviews it.

Just last week, the Kroger Co., a supermarket chain that operates in 35 states, agreed to pay up to $1.4 billion in settlements.

Most of the settlement funds are required to be used to combat the opioid epidemic.

In his July ruling ordering that more recent data be shared, Polster remarked that making the earlier tranche public “was both wise and monumental” because it helped lead to the settlements. “It is fair to say none of this would have been possible without production of the ARCOS data,” Polster wrote.

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Two Senators: it remains unclear what future role — if any — prescription opioids should play in pain treatment

Markey and Manchin urge FDA to stop its study of opioids for chronic pain

https://www.statnews.com/2023/09/22/opioids-chronic-pain-study-markey-manchin-fda/

Two Democratic senators are warning the Food and Drug Administration not to proceed with a controversial trial meant to measure opioids’ effectiveness as a chronic pain treatment.

In a letter shared with STAT, Sens. Ed Markey (D-Mass.) and Joe Manchin (D-W.Va.) warned FDA Commissioner Robert Califf against using the method in the agency’s ongoing work to evaluate whether opioids, despite their widespread use, are effective at treating chronic pain. 

The FDA’s plan to use the research method, known as an enriched enrollment randomized withdrawal (EERW) trial, has drawn scrutiny as the agency has attempted to move forward — and as the country continues to reckon with its ongoing drug overdose crisis. 

“The potential harm of EERW studies is avoidable,” the senators wrote in their letter to Califf, which was delivered this week. “Other studies have already evaluated prolonged opioid use without biasing the outcome or exposing patients to risk.”

The senators, however, haven’t proposed an alternative study design, and it remains unclear what future role — if any — they believe prescription opioids should play in pain treatment. And while the FDA has acknowledged there is no ideal option for reevaluating the painkillers’ effectiveness, it says such studies are necessary given the ongoing opioid epidemic and lack of clarity regarding prescription opioids’ safety. 

The letter follows a contentious FDA panel discussion in April, at which the agency’s scientific advisers didn’t pull punches when criticizing the proposed study method. 

One panelist said the trial design “lacks face validity.” Another said it would represent “an awful lot of work for a very predictable answer.” Outside experts piled on during the public comment portion of the hearing, too — largely on the grounds that it will not yield useful data and that it is biased in favor of preserving access to opioids as a chronic pain treatment.

“These arguments suggest a curious and persistent attachment on the part of the FDA to a statistical design that’s completely at odds with the agency’s professed commitment to a fresh new approach,” Caleb Alexander, a professor of epidemiology at Johns Hopkins University, said then.

The study, as proposed, would require trial participants to switch from whichever prescription opioid they’re currently taking to a form of extended-release morphine. A random selection of participants would then be switched to a placebo group and undergo an eight-week taper off of opioids altogether.

Markey, Manchin, and outside experts have contended that as designed, the study would bias the trial in favor of opioids’ efficacy and, by extension, favor drug companies.

Doing so, they argue, would only double down on mistakes the FDA made decades ago when first evaluating the safety and effectiveness of certain prescription opioids, leading to a slew of overprescription and “pill mills” that helped fuel the first phase of the drug crisis. 

“Regrettably, the FDA approved these drugs before it adequately understood their profound impact, helping to facilitate this crisis,” Markey and Manchin wrote in their letter. “This history demands ongoing and careful review of opioid safety.” 

The senators noted that an external review commissioned by the FDA explicitly warned that the agency should “revisit” the use of EERW trials. 

While prescription opioid overprescribing is widely acknowledged to have driven countless addictions and overdoses in the early 2000s, prescription opioids currently account for a much smaller share of drug deaths. Over a quarter-million Americans died of prescription opioid overdoses between 1999 and 2021, according to the Centers for Disease Control and Prevention. 

Still, of the roughly 80,000 opioid overdose deaths reported in 2021, according to the CDC, just 21% were caused by prescription opioids. Synthetic opioids like fentanyl, instead, accounted for a vast majority of opioid deaths. 

While prescription opioid overdoses have held steady in recent years, chronic pain patients and prominent doctors specializing in pain treatment have warned that sharply curtailing prescription access could do more harm than good — potentially some causing stable pain patients to suffer needlessly, and others to switch to far more dangerous opioids, like illegally manufactured pills or fentanyl, once their prescription supply is cut off. 

Nonetheless, Markey and Manchin have held firm in their stance that the FDA should not only avoid using EERW clinical trials in the future, but also reevaluate past opioid approvals that relied on data derived from EERW studies. 

“Based on the risk associated with EERW studies and the availability of other study models, we ask the FDA not to permit the use of EERW to determine the long-term efficacy and tolerability of opioids in chronic pain patients,” the senators wrote. “We also urge you to reject EERW study designs for any future new drug applications for opioids and reconsider past opioid approval decisions using EERW.” 

RIP… Maggie Morgan


Maggie Moore made this video 09/20/2023 and on 09/21/2023 she DIED!  She lived in Washington state and could not find a prescriber to treat her pain… So did she die because of denial of care? Will anyone be held responsible for this otherwise avoidable/premature death?  – Don’t bet the farm on it!!