America’s problem with managing chronic pain and the addiction crisis

https://www.axios.com/2023/04/21/americas-problem-chronic-pain-addiction-crisis

The Food and Drug Administration’s attempts to manage the overdose crisis by reining in on the use of narcotics are weighing on patients with chronic pain, who say the result has been harder-to-fill prescriptions and heightened withdrawal and suicide risks.

The big picture: The FDA for years grappled with criticism it helped fuel the opioid epidemic by approving products like OxyContin and a tablet 1,000 times more powerful than morphine.

• Now, patient groups are concerned the agency is proposing a large study of opioids’ long-term effectiveness in treating chronic pain without enough of their input.
• Addiction experts say its clinical trial design could be tilted toward benefiting manufacturers.
• And while the FDA has encouraged the development of alternative pain control methods, safety concerns and insurer resistance to covering them have hindered adoption.
• The result is more opioids have been approved in the last five years than non-opioid options.

Driving the news: FDA outside advisers this week slammed the agency’s proposal and, without a vote, recommended the agency reconsider pursuing the study.

• Pain care specialists criticized how the plan wouldn’t address addiction potential or improve care for the millions of Americans managing chronic pain.
• The National Council of Independent Living, a disability rights organization, also noted that these decisions are being made and discussed without patients involved.
• The nine-hour meeting on Wednesday came a week after the FDA announced it’s now requiring both instant and extended-release opioid pain medicines to carry warnings about overdose risk and potential for increased sensitivity to pain.

Details: The study’s design would have participants shifted from prescription opioids to extended-release morphine while a randomly selected group would be switched to a placebo without being told.

• There would then be an eight-week period where the placebo group would be weaned off opioids — a factor agency officials acknowledged could result in high dropout rates and challenges in recruitment.
• Diana Zuckerman, president of the National Center for Health Research, questioned the ethics behind the FDA’s proposal during public comment, saying that, “In addition to withdrawal, won’t that potentially make them even more desperate and more reliant on opioids?”
• Andrew Kolodny, medical director of the Opioid Policy Research Collaborative, asked why administering non-opioid alternatives wasn’t considered.

• “Wasn’t it the practice of switching patients from [instant release] opioids to [extended release] opioids what got us into this mess in the first place?”

Between the lines: A crackdown on opioid prescribing hasn’t stopped overdoses from rising in recent years as the epidemic becomes defined more by fentanyl-laced counterfeit pills than painkillers prescribed in clinical settings.

• But some chronic pain patients say the agency’s latest moves have made physicians more likely to deny needed pain relief out of fear of regulatory scrutiny.
• In an online public comment, Earenya Chapman wrote that “this has left patients with no alternative but to suffer in silence.”
• The policies to limit prescribing have also led to “life-altering harms” including overdose, unemployment and death, said Theo Braddy, executive director of the National Council of Independent Living.
• Some studies have found chronic patients may have an elevated suicide risk following discontinuation of opioid therapy.

The bottom line: The U.S. continues to grapple with how to slow the addiction crisis while helping millions of Americans with conditions causing chronic pain, leaving both public health issues at risk of getting worse.

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Long after heyday, soda fountain pharmacies still got fizz

https://apnews.com/article/soda-fountain-pharmacies-phosphate-drinks-85da13b45d7d0c94fb82d9d302b2584f

KENOVA, W.Va. (AP) — The jukebox plays Chubby Checker’s “The Twist” as Malli Jarrett and Nathaniel Fornash take turns at the Griffith & Feil Drug food counter preparing old-fashioned, soda-fountain phosphate drinks.

Soda fountains like this were hugely popular a century ago. Often located in pharmacies, they were a gathering spot during Prohibition when bars shut down. But over the past half century, their numbers fizzled, relegating soda fountains to the scrapbooks of U.S. history.

In West Virginia, Ric Griffith is keeping the tradition going. His 131-year-old business is a Norman Rockwell scene and time-travel tourism all wrapped into one.

“When you had a soda fountain, people would stay longer, they’d sit down and they’d share stories,” Griffith said. “It would not become the place where you grabbed lunch. It was a place where you had an experience.”

Griffith and his daughter, Heidi, are pharmacists whose pharmacy staff works in the back. Up front, the restaurant offers daily lunch and dinner specials. Customers soak in the ambience: the jukebox, neon-pink signs, black-and-white photos of local landmarks, marbled counters, retro padded stools and a metal-tiled ceiling.

And, of course, those tart-and-sweet phosphate drinks.

Griffith leaves the dispensing to soda jerks like Jarrett and Fornash (they’re not really jerks — the term describes the motion used to pull the handle of the soda water dispenser).

“It’s fun working at a place like this, watching all the customers come in, looking around, taking a step back in time and telling me about how a lot of them used to work here when they were younger,” Jarrett said.

The first U.S. patent for dispensing carbonated water through a soda fountain spigot dates to the early 1800s. Acid phosphate drinks were developed decades later as pharmacists mixed tonics for customers who sought cures for ailments. As soda fountain manufacturing and efficiency improved, so did the recipes and flavors. The drinks were given names like Green River or Black Cow.

Food menus were added, and customers ate while waiting for prescriptions to be filled.

Pharmacist-owner Michele Belcher was a soda jerk starting in middle school after her parents bought the Grants Pass Pharmacy from the original owner in 1973. Part of the challenge, she said, is updating old equipment while preserving some of the character of the original soda fountain.

“Many times people will make the effort to come back and touch base with me or leave a note that they appreciated that it was still here in our community,” Belcher said.

By the late 1950s, pharmacists were reviewing their business models to make the most of tight spaces, including replacing the soda fountain with shelves stocked with home staples. Mom-and-pop drug stores eventually couldn’t keep up with tightening government regulations or competition from mall food courts, chain pharmacies and fast-food restaurants.

Some stayed open but closed either the pharmacy or soda fountain sides. Others morphed into side businesses such as gift shops and ice cream parlors.

The past decade has been especially rough. The Highland Park Soda Fountain in Dallas, which celebrated its 100th anniversary in 2012, shut down in 2018. The Central Drug Store in Bessemer City, North Carolina, open 94 years, closed in 2021. Borroum’s Drug Store in Corinth, Mississippi, also closed its pharmacy that year after more than 150 years in business, but keeps its soda fountain going.

Now, a new generation of owners is emerging — literally out of the ashes in the case of the Phoenix Pharmacy and Fountain in Knoxville, Tennessee. It opened in 2016 in a century-old building that had seen two devastating fires.

The Phoenix “is not about resurrecting your grandfather’s neighborhood pharmacy; it is about reintroducing the attitude of it,” its website says.

Also in 2016, Rhode Island pharmacist Christina Procaccianti founded the Green Line Apothecary, a full-service pharmacy and soda fountain in two locations.

At Griffith & Feil, in West Virginia, Ric Griffith, 74, is proud of his collection of 41 presidential signatures and other memorabilia and is always ready to explain them on cue.

What he can’t share are memories of the soda fountain as a child. His father removed it in 1957. Griffith reinstalled one in 2004 after three years of painstaking prep work. “I always yearned for that myself,” he said.

After the reopening, Griffith recalled, a man sitting in a booth with his granddaughter was sharing stories of his youth. Decades before, the man said, he would arrive in the same booths after school and order a cherry Coke. Griffith listened to the conversation, “and the look on his granddaughter’s face was wonderful,” he said. “She’d never thought of her grandfather as ever having been young. He was always her grandfather.”

It solidified Griffith’s hope that people can still partake in what once was a common tradition in little towns across America: sharing meals and stories rather than choosing the easy route of a fast-food drive-thru.

“And so when we preserve history, we’re not just preserving actifacts,” Griffith said. “We’re preserving a style of living, a way of interacting. That soda fountain has blessed me in many ways.”

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This is so sad, this is about 10 miles from our home.  The pharmacy was in “downtown” Corydon.  Right off the typical town square. Corydon was also the FIRST CAPITAL of Indiana.  When I was first licensed there was a second pharmacy on the town square (Davis Pharmacy)… which closed years ago.

With the closing of Butt Drug, this very rural county of abt 40,000 and abt 500 sq miles with FOUR PHARMACIES – CVS, Walgreens, Walmart in Corydon and a Walgreen  in the unincorporated community New Salisbury geographically close to the center of the county.

Harrison county being the 4th oldest county in the state and its southern border being the Ohio River has quite the history being founded over 200 yrs ago https://en.wikipedia.org/wiki/Harrison_County%2C_Indiana

ironically enough, I got this email today from the National Community Pharmacist Assoc, whose membership is almost exclusively independent pharmacists and I have been a member for FORTY YEARS.  Calling attention to the all the “pharmacy deserts” that the PBM industry is creating from the “financially strangling” independent pharmacies by reimbursing independent pharmacies less than the cost of purchasing the medication from their wholesaler.

50 states sign up for Walmart’s opioid settlement framework -3.1 billion

The above agreement with Walgreen, CVS, Walmart and them paying abt 13 billion settlement, from being sued by the 50 states Attorney Generals, Native American Reservations, and others.  While admitting no wrong doing,  it has been rumored that all three agreed to REDUCE the number of opioid and/or controlled substances they dispensed.  I have seen some feed back from some chronic pain pts that Walgreens is sending a 26 questionnaire to some prescribers to help Walgreen understand and apparently meeting  Walgreen’s medical justifications that they will fill a particular prescriber’s controlled med Rxs. 

Here is the SMOKING GUN to prove civil rights violations – could support a class action lawsuit – but the community needs to stand up

here is a second article about the three major drug wholesalers that covers abt 80% of the Rx medications to pharmacies and they also was sued and ended up with nearly a 600 page agreement with them also agreeing to REDUCE the opioids and/or control meds sold to pharmacies.  The chronic pain community seems to being “painted into a corner” and/or corralled into some area with only one way in and out and that is being controlled/managed by entities that are determining what and how much medically necessary medications each needs based on some- one size fits all – formula or statistic.  

ironically enough, I got this email today from the National Community Pharmacist Assoc, whose membership is almost exclusively independent pharmacists and I have been a member for FORTY YEARS.  Calling attention to the all the “pharmacy deserts” that the PBM industry is creating from the “financially strangling” independent pharmacies by reimbursing independent pharmacies less than the cost of purchasing the medication from their wholesaler.

NCPA April 21, 2023

The letter that Butt Drugs sent out to their patients stated that >50% of prescriptions “went out the door”  with the pharmacy getting paid less than the cost of the medications from their wholesaler. It can’t go unnoticed that Butt Drugs Rx files were sold to CVS in Corydon, which just happens to own one of the top three PBM’s  – Caremark ( Prescription Benefit Managers) as well as Aetna Insurance and Silver Scripts Medicare Part D  and the top 5 PBM’s control the price pharmacies are paid and the CVS in Corydon has the closest pharmacy to Butt Drugs.

there are more videos on www.youtube.com

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FDA Panelists Slam Agency’s Proposed Opioid Trial Design

https://www.medpagetoday.com/painmanagement/opioids/104117

Advisors said outcomes from an enriched enrollment study would not be broadly generalizable

FDA advisors recommended that the agency reconsider its planned postmarketing trial design to evaluate the long-term efficacy and tolerability of opioids in chronic pain patients.

Without holding a vote on Wednesday, the Anesthetic and Analgesic Drug Products Advisory Committeeopens in a new tab or window shared concerns about using an enriched enrollment randomized withdrawal (EERW) design as a required phase IV study for certain opioids currently available on the market.

“I don’t think this really tells us anything about the most clinically meaningful question for this population, whether opioids are a better treatment than non-opioid analgesics or other approaches to treatment,” said committee chair Brian T. Bateman, MD, MSc, of Stanford University School of Medicine in Palo Alto, California. “I think that’s really where the agency’s attention should be focused.”

The 12-month trial, for chronic non-cancer pain patients who had initial tolerability to an extended-release (ER)/long-acting (LA) opioid, would include an open-label portion followed by a tapering period and a placebo period for the control group.

“It’s just an awful lot of work for a possibly very predictable answer,” said Mary Ellen McCann, MD, MPH, of Harvard Medical School in Boston. “It’s called enriched enrollment. I almost think it’s enhanced enrollment. It’s designed to give a positive result before the study’s even begun.”

Maura S. McAuliffe, CRNA, PhD, of East Carolina University in Greenville, North Carolina, noted that she’s “come away with the impression that, for me, to use an old-fashioned term, it lacks face validity. The outcomes to me are very predictable. If you give somebody … 42 weeks of opioid therapy at relatively high doses, or potentially up to 240 mg a day, yeah, I think that they will have relief of their pain.”

Prior to sharing their overall reservations about the agency’s proposal, the committee discussed the practicality of the EERW design, and highlighted several specific concerns, including the shorter tapering schedule and the use of pain scores as a secondary endpoint. Several advisors said a focus on patient functionality would be more clinically meaningful than self-reported pain scores. They also recommended the tapering period be increased to a minimum of 14 days.

“One of the main concerns about this proposed design is a bit of an underestimation of the potential risks that would be there,” said Mark C. Bicket, MD, PhD, of the University of Michigan in Ann Arbor. “While the internal validity would be strong, it would have the potential for some difficulty of interpretation, as well as not necessarily providing information that would be as clinically relevant when there is a large opportunity for that, so I would be certainly in favor of thinking about some of these other designs.”

The committee also pointed out that it is unlikely that the study design would allow the researchers to maintain a sufficient number of study participants, which could affect the interpretation of outcomes.

While the advisors felt the length of the study (38 to 52 weeks) would be acceptable to evaluate long-term efficacy, they did express concerns about safety and the potential for confounding during such a long trial period. They also said they were doubtful that enough participants would be willing to remain in the placebo arm for the proposed length of the study.

While FDA staff acknowledged several challenges, they also emphasized that the EERW study design would likely be the best available option, considering the difficulties of conducting a placebo-controlled trial for chronic pain over a long time period.

During the public comments portion of the meeting, several stakeholders voiced their disapproval of the EERW design and the failure of the Opioid Postmarketing Requirements Consortium and FDA to successfully study the long-term efficacy and safety of opioids in the 10 years since the original postmarketing requirement was issued in 2013opens in a new tab or window.

“The EERW is not double-blind. It’s not even single-blind. Patients who take a drug with a strong psychoactive effect for weeks and months then switch to a placebo are likely to know it,” said Andrew Kolodny, MD, co-director of the Opioid Policy Research Collaborative at the Heller School for Social Policy and Management at Brandeis University in Waltham, Massachusetts. “For obvious reasons the results from EERW are not generalizable because only patients who tolerate opioids and find them helpful are randomized.”

Caleb Alexander, MD, MS, of the Johns Hopkins Bloomberg School of Public Health in Baltimore, added, “I suppose the question is why more than 20 years into this epidemic, the FDA would risk squandering this valuable moment by examining the persistence of efficacy among a highly select subpopulation, rather than requiring sponsors to demonstrate whether ER/LA opioids work in the first place.”

While the FDA typically follows the advice of its advisory committees, it isn’t required to do so.

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MINORITY REPORT: THE DOJ-DEA PRE-CRIME, DATA ANALYTICS, PARALLEL CONSTRUCTION: Prt-1

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Cigna’s PBM unit launches new pricing plan amid scrutiny over rebates

https://www.reuters.com/business/healthcare-pharmaceuticals/cignas-pbm-unit-launches-new-pricing-plan-amid-scrutiny-over-rebates-2023-04-13/

April 13 (Reuters) – Cigna Group’s (CI.N) pharmacy benefit management (PBM) unit said on Thursday it will launch a new pricing plan that will include exact information on rebates, as pharmacy middlemen come under scrutiny by U.S. lawmakers for their opaque drug pricing practices.

The new plans from Cigna come amid close examination from regulators including the U.S. Federal Trade Commission which is conducting a study to see if rebates sought by pharmacy middlemen reduced competition, ultimately leading to higher drug prices.

The PBM unit, Express Scripts, will also introduce a new co-pay plan for consumers which will cap out-of-pocket costs between $5 and $45, depending on whether the drug is generic or branded.

PBMs negotiate drug prices with manufacturers, health plans and pharmacies.

Last month, Ohio filed a lawsuit alleging PBM units of Cigna Group, Humana Inc (HUM.N) and others use their market power to push drug companies to increase prices, some of which goes to PBMs in the form of fees.

Express Scripts said under the new pricing plan its clients will “receive 100% of drug rebates” that are paid to it by drug manufacturers. The pricing and co-pay plans will be launched this summer.

Next year, Express Scripts will begin including information on drug prices and out-of-pocket costs as part of its prescriptions for consumers.

Express Scripts, UnitedHealth Group Inc’s (UNH.N) Optum unit and CVS Health Corp’s (CVS.N) CVS Caremark are among the biggest PBMs in the United States.

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If the TX judge’s ruling ends up prevailing on this one medication where:

He conducted his own assessment of the drug’s safety, contrary to courts’ historical deference to the FDA’s scientific determinations — and in this case, a drug for which all available data since its approval in 2000 demonstrate its safety and effectiveness.

Then any one medication or category of medications could be taken off the market from the “research/opinion of a judge – most likely a a person with only a doctor of jurisprudence  degree.” and could basically NEGATE 10+ yrs of clinical trials that it takes to get the FDA approval to bring a new medication to the market.  Since most/all R&D involving clinical trials to get a med approved by the FDA to bring to market.

The Mifepristone Battle: The Supreme Court Steps In

https://www.medpagetoday.com/opinion/the-health-docket/104061

FDA’s regulatory authority hangs in the balance

On Friday, Supreme Court Justice Samuel Alito put on hold rulings by a federal district court judge in Texas and by the Fifth Circuit Court of Appeals that would have severely restricted access to mifepristone (Mifeprex), an abortion medication used as part of a two-pill regimen to terminate pregnancies through the first 10 weeks of gestation. Alito’s orderopens in a new tab or window is intended to pause the current legal chaos and maintain the medication’s status quo while the Supreme Court has time to review the rulings from the lower courts. His order lasts until Wednesday night, and he has instructed the litigants to file their brief by noon on Tuesday.

So, how did we get here and what can we expect going forward?

On April 7, Matthew Kacsmaryk, a federal judge in Texas, suspended the FDA’s approval of mifepristone in a preliminary rulingopens in a new tab or window. Kacsmaryk stayed his order for 7 days.

Less than an hour after Kacsmaryk’s decision, a federal judge in Washington State issued a contradictory rulingopens in a new tab or window. Judge Thomas Rice ordered the FDA to do nothing to restrict access to mifepristone in 17 states and the District of Columbia, jurisdictions that filed a lawsuit against the agency over its risk evaluation and mitigation strategy (REMS) program for the medication.

In essence, a judge in Texas directed the FDA to remove mifepristone from the market and a judge in Washington directed the FDA not to impose further restrictions on that drug — requiring the FDA to march north and south at the same time.

That’s untenable. Given the accelerated pathway of the Texas case to the Supreme Court, we will focus our attention on that ruling.

The Texas Ruling

In November 2022, the Alliance Defending Freedomopens in a new tab or window (ADF), a conservative Christian legal advocacy group that works to expand Christian practices, challenged the FDA’s approval of mifepristone on safety grounds on behalf of its clients, the Alliance for Hippocratic Medicine coalition and other anti-abortion physicians.

Last week, Kacsmaryk issued a ruling in which he said that the FDA failed to consider safety concerns “based on plainly unsound reasoning and studies that did not support its conclusionsopens in a new tab or window.”  He conducted his own assessment of the drug’s safety, contrary to courts’ historical deference to the FDA’s scientific determinations — and in this case, a drug for which all available data since its approval in 2000 demonstrate its safety and effectiveness.

When taken as part of the two-pill regimen, mifepristone successfully terminates the pregnancy over 99%opens in a new tab or window of the time and has an extremely low risk of major complications (0.4%opens in a new tab or window) and mortality (0.0001%opens in a new tab or window). Ironically, the Trump-appointed judge with a history of opposing abortion and of judicial activism, claimed that “significant political pressure” caused the FDA to forego a rigorous safety check to advance the agency’s “political objective” of increased access to medication abortion.

Medical associations expressed concern that Kacsmaryk’s ruling “introduces the extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisionsopens in a new tab or window.” Hundreds of executives from the pharmaceutical and biotech industries stated the “decision ignores decades of scientific evidence and legal precedentopens in a new tab or window.” Professional organizations and pharmaceutical companies strongly condemned the Texas ruling, stating that it undermines FDA authority, reduces access to a safe drug, and could impactopens in a new tab or window all FDA approved products.

The Path to the Supreme Court

The Department of Justice (DOJ) immediately appealed Kacsmaryk’s order to the conservative Fifth Circuit Court of Appeals, arguing against the judge’s “misguided assessment of the drug’s safetyopens in a new tab or window.” On April 12, the three-judge panel of the Fifth Circuit issued a rulingopens in a new tab or window that overturnedopens in a new tab or window Kacsmaryk’s order suspending FDA’s mifepristone approval, explaining that the plaintiffs failed to file the lawsuit within the 6-year statute of limitations. However, the Fifth Circuit ruling upheld Kacsmaryk’s order to suspend FDA’s actions that expanded access to mifepristone from 2016 onwards, including extending eligibility for mifepristone from 7 to 10 weeks’ gestation, allowing retail pharmacies to dispenseopens in a new tab or window mifepristone, eliminating the in-person dispensing requirement (allowing it to be delivered by mail), and permitting non-physicians to prescribe or administer it.

Two days later, on Friday, April 14, the DOJ and Danco Laboratoriesopens in a new tab or window, which manufactures brand name mifepristone, both asked the Supreme Court to halt the injunction. Danco said it faces an “untenable lingo” of competing court orders and “regulatory chaos.” Meanwhile, ADF announced it would not appeal the Fifth Circuit ruling maintaining FDA’s approval of mifepristone, but would vigorously defend the decision to block post-2016 expanded access to the drug.

Alito’s temporary administrative stay on the Texas ruling avoids a nightmare scenario where pregnant individuals would have immediately lost access to a highly safe and effective medication. If the Supreme Court extends the administrative stay, and ultimately rules in favor of the FDA, the entire Texas decision would never take effect. That would be a win for reproductive health, for science, and the Biden administration.

The Supreme Court set all of this in motion in overturning Roe v. Wade in the Dobbs decisionopens in a new tab or window. The high court is no friend to reproductive choice and has demonstrated a willingness to strike downopens in a new tab or window federal regulatory action. Yet, even for a highly conservative Supreme Court, this case may be a bridge too far. The easiest path for the court is not to review the case on the merits at all. It could sidestep an analysis of the FDA’s regulatory authority by overturning the Texas decision based on plaintiffs’ lack of standing — the concept that a plaintiff must show that the challenged conduct caused them actual injury. And after all, the plaintiffs are not directly harmed by expanded access to mifepristone. Even if the court does analyze the FDA’s regulatory authority, the justices should recognize the profound effect that overturning the agency’s decisions would have on public health going forward. Furthermore, the justices understand the impact that upholding the Texas and Fifth Circuit’s decisions could have on all FDA approved products, and likely don’t want to open the floodgates of litigation against FDA decisions.

Even a 6-3 conservative super-majority should, in theory, ultimately side with science and the FDA. Yet, the ultimate outcome is far from certain.

Effects on Access to Mifepristone and Other Drugs

Upholding and enforcing the Fifth Circuit’s preliminary ruling would result in devastating consequences for many people of reproductive age. Medication abortions now account for more than halfopens in a new tab or window of all abortions in the U.S. Restricting mifepristone use beyond 7 weeks’ gestation would curtail access to essential reproductive health services for many pregnant people, many of whom do not know they are pregnant so early on. Reinstating unnecessary requirements, such as in-person office visits, would severely restrict access. Some would resort to dangerous self-managed abortions. Others would not be able to access the recommended treatment for miscarriages, which occurs in a third of all pregnanciesopens in a new tab or window. Overall, the Texas and Fifth Circuit rulings jeopardize the health, and even life, of pregnant persons. The highest risks will be disproportionately borne by low-income individuals and those living in rural areas, especially racial minorities, in states that virtually ban abortions.

Beyond reproductive health, the decision sets a dangerous precedent for future lawsuits that may contest approvals or regulatory decisions. In a new context where the FDA’s reputation for evidence-based drug approvals is no longer respected and courts no longer defer to its scientific determinations, numerous medications and vaccines could be at risk. States could try to pick and choose which FDA-approved products to permit, regardless of decades of robust evidence regarding their safety and efficacy.

Does the public trust FDA’s career scientists to determine the safety and efficacy of vaccines and drugs, or do they trust judges to do so? To ask the question is to answer it.

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