Episode Description

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Looking at the website for Troy Medical Center, it is a 97-bed hospital servicing a six-county area in Southern Alabama. According to this  https://www.rasmussen.edu/degrees/health-sciences/blog/types-of-hospitals/  a hospital with < 100 beds is classified as a “small hospital” This appears that this system encourages nursing staff to “just say no” when pts request an opioid dose, which there are prescriber’s orders for a particular pt.  Does this term “improves nurse practices”  means that they lowered the number of “nursing hours per pt” ?  I did a word search on this article and the word PAIN did not appear ONCE in the entire text but in the text… Reducing excess.. prolonging lengths of stay and increasing the risk of readmission  Is this another reference to the bottom line of the hospital ?

https://www.troymedicalcenter.com/about/

Significant Reduction In Inpatient Opioid Use Achieved With Careeffectstm Stewardship Service

https://menafn.com/1106430328/Significant-Reduction-In-Inpatient-Opioid-Use-Achieved-With-Careeffectstm-Stewardship-Service

(MENAFN– PR Newswire) Indicator Sciences Highlights 20% Inpatient Opioid Reduction at Troy Regional Medical Center

BIRMINGHAM, Ala.
, June 13, 2023 /PRNewswire/ –Indicator Sciences, the provider of the CareEffects Stewardship consultative analytics service, today proudly unveils the results of a successful initiative at Troy Regional Medical Center. Implementation of the service has led to a 20% reduction in inpatient opioid use within just six months, underscoring its value and effectiveness.

CareEffects reduces inpatient opioid use by 20%, improves nurse practices & elevates patient care at Troy Medical Center

Opioids pose a challenge for hospitals in that inpatient administration can cause complications and influence outpatient utilization.

Reducing excess
opioid utilization is critical to prevent opioid-related adverse drug events, complications which occur in nearly 10% of inpatient admissions in U.S. hospitals, prolonging lengths of stay and increasing the risk of readmission.

Leveraging comprehensive context-of-care risk-adjustment analytics, CareEffects Stewardship identifies individual nurses whose practice patterns lead to increased opioid utilization compared with their peers. As nurses manage roughly 80% of inpatient opioids on a PRN (as needed) basis, there is an urgent need for closer monitoring of individual nursing practices. This pioneering approach paves the way for focused stewardship education, fostering improved patient outcomes.

Rick Smith, CEO of Troy Regional Medical Center, praises the program: “As leaders of a small hospital, we have a zero-tolerance policy towards preventable complications. CareEffects Stewardship has become an integral part of our pursuit of delivering the highest quality of patient care.”

Led by Chief Clinical Officer Amy Minor, RN, a targeted nursing intervention was conducted, focusing on approximately 5% of the inpatient nursing staff. These nurses each exhibited a significant increase in opioid use per shift compared with their peers, after risk-adjusting for context-of-care.

Minor points to a success story: “One of our nurses, initially identified as an outlier, has since evolved into a practice leader. Our non-punitive approach has not just enhanced patient safety, but also nurtured a supportive and learning-centric environment for our nursing staff.”

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An example of our judicial/legal system AT IT’S BEST?

https://threadreaderapp.com/thread/1523720324855914498.html

jesús a. rodríguez

This is Joshua Smith, a client of @GeorgetownLaw‘s Civil Rights Clinic. In May 2020, while visiting family in Virginia, his legs went numb. 911 was dialed.

12 hours later, he ended up face down in a jail cell, unconscious and permanently paralyzed. Let me tell you his story.🧵

After the 911 call, an ambulance took him to the ER of a local hospital in Galax, Virginia.

Noticing that Smith had previously been on opioid medication, the doctors and nurses assumed he was looking for drugs. They gave him a shot of Benadryl. Then they called the cops on him. 

Since he couldn’t walk, a sheriff’s deputy wheeled Smith out of the ER, arrested him, and forced him into his police car. He took him to a local magistrate judge’s office, all while calling him a “junkie” who just “shot up some bad dope.” 

When they arrived at the courthouse, three other cops joined in, put Smith on a rubber welcome mat, and dragged him on the ground to the judge’s chambers. The judge noticed an old probation violation, and decided he should go to jail.

But first, he wanted Smith to stand up. 

The officers grabbed him from the floor and picked him up, only for his knees to buckle.

From his desk, the judge told Smith, “If you can stand up and talk to me like a man, you can go home.”

Smith was sobbing on the floor. He couldn’t get his legs to work. 

The judge ordered he be held in jail. The officers shackled Smith’s hands and legs, dragged him through the courthouse out into the parking lot, picked him up, swung him three times, and hurled him into the back of a police van. 

During the 40-minute ride, the officer drove erratically, hitting pot holes and taking sharp turns. Smith wasn’t secured in any way—just lying on his back on the floor of the van. Every bump sent shock waves of pain through his body.

In his spine, an abscess was about to burst. 

During the whole 40-minute ride, Smith cried out for medical help. At some point, he recalls hitting a particularly hard bump, feeling a wave of excruciating pain, and then nothing.

He had lost all feeling in his legs. He’d later learn that the spinal abscess had ruptured. 

The officers arrived at the New River Valley Regional Jail, and then unloaded Smith, who is at this point unconscious, into a jail cell. It’s the middle of the night.

They leave him there, face down, until they bring him breakfast the next morning. 

Some time later, a jail officer returns and asks him why he hasn’t eaten his breakfast. He can’t inhale enough air to respond.

A nurse notices him, and immediately calls for help. She may be the reason he’s alive today. 

He gets taken to a hospital in Roanoke, where he goes into emergency surgery. The doctors manage to save his life, but he’d lost all feeling from the chest down. He’s now permanently paralyzed.

When he wakes up, a cop is posted in his room and he’s shackled to the hospital bed. 

A few days later, while still sedated and intubated, the cop holds an iPad in front of him and requires him to appear in his own bond hearing. The judge asks him to respond simply by blinking his eyes or nodding his head. 

Although he was released from custody, Smith feels that the system “practically ended [his] life.” He can’t sleep longer than a few hours a night and when he can, he dreams he’s trapped in a jail cell. The financial strain has left him on the brink of homelessness. 

Smith is bringing a federal lawsuit against the hospital, the medical staff, the cops, the judge and the jail for discrimination and multiple violations of his constitutional rights. You can view it here: georgetown.box.com/s/uv03ktm44w69…

I hope you’ll RT and share his story far and wide. 

More from @jesusrodriguezb

jesús a. rodríguez

@jesusrodriguezb

Jan 31

Today is my last day as senior articles editor of @GeorgetownLJ, so I thought I would share some pointers for authors in #lawtwitter submitting to the spring cycle, which opens tomorrow for us! After poring over thousands of submissions last year, here’s what has stood out to me:

1. Effective titles often caught my attention, especially when it was 1 a.m. and I was up assigning articles. Intros should tell us upfront what’s original about your piece — like in journalism, don’t bury the lede

2. Authors sometimes treat conclusions like 2–4-paragraph bows on top of the piece, but this is where the discussion and the implications of your argument need to be clearest.

Read 15 tweets

jesús a. rodríguez

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After reading this, I did a “word search” for “strength” & “potency” and came up with ZERO MATCHES. The word “quality” shows up 18 times and here is a recent post on my blog  How Reliable Are Your Generic Drugs From India?

Are they using the word “quality” to encompass  strength or potency or give the illusion that the potency and/or strength from the testing are within FDA standards ?  Am I the only one that is concerned that the FDA such quality control violations that the FDA shut down a pharma production plant  …But it made an exception for 25 medications, including the cancer drugs, because of shortages.  If you are dealing with cancer, and your only choice of a med provided by a pharma whose plant has been shut down because of quality control issues in the plant. Would you be concerned that if the cancer does “do you in” .. the medication might ?

How Reliable Are Your Generic Drugs From India?

US military is so worried about drug safety it wants to test widely used medicines

https://thebrunswicknews.com/news/world_news/us-military-is-so-worried-about-drug-safety-it-wants-to-test-widely-used-medicines/article_ce03d883-0c1e-5ffc-a6bc-b55d1baad263.html

U.S. military officials are so concerned about the quality of generic drugs that the Department of Defense is devising a program to test the safety of widely used medicines.

Defense officials are in talks with Valisure, an independent lab, to test the quality and safety of generic drugs it purchases for millions of military members and their families, according to several people familiar with the matter who asked not to be named as the details aren’t public.

The move raises questions about the Food and Drug Administration’s ability to adequately police generic medicines. With mounting drug shortages, most of which are caused by quality problems, military officials have gone so far as to call vulnerabilities in the drug supply chain a national security threat.

Aware of growing quality problems, the White House has convened a task force that’s exploring whether testing could be expanded more broadly in the US. If the Pentagon pilot is successful, it could serve as a model for Medicare or the Department of Veterans Affairs, people familiar with the matter said. But there are tensions in Washington: In conversations with the White House, the FDA has pushed back against additional quality checks, questioning the accuracy of third-party labs like Valisure.

The agency said it stands behind medicines sold in the US and Americans can be confident about their quality.

Generics 101

Drugmakers are required to test their drugs for impurities. The industry doesn’t share results with the FDA, rather companies keep files that agency inspectors comb through when they visit drug production plants once every year or two. Over the last decade, FDA inspectors have found many manipulated test results. The agency can ask a plant to shut down if it finds major problems. This can lead to or exacerbate drug shortages, which is an acute problem in the US right now.

The FDA said in 2019 that 62% of drug shortages were caused by quality issues. Sometimes even the threat of a shortage can force the US to accept drugs from low-quality suppliers that, under other conditions, would have been cut off. Drug shortages are currently at a five-year high in the US and climbing.

The idea for the Pentagon’s drug testing program was motivated by weaknesses in the pharmaceutical supply chain exposed by the Covid crisis. A recent Congressional mandate also required military officials to further investigate the threat of America’s increasing reliance on overseas manufacturers.

“They’re taking that risk very seriously,” said Valisure Chief Executive Officer David Light, who declined to comment specifically on the department’s plans to partner with his company.

The Defense Department didn’t comment on a detailed list of questions sent by Bloomberg News.

The Kaiser Model

The Pentagon’s proposed program follows a similar one quietly launched by Kaiser Permanente, details of which have never been reported. Kaiser, which serves 12.7 million Americans, started working with Valisure on additional drug quality checks more than two years ago, said Sean Buhler, Kaiser’s vice president of pharmacy strategic sourcing and procurement.

If Valisure detects quality issues, Kaiser turns to other manufacturers. That data also provides an early warning system for shortages: If a drug’s quality is so bad that it could trigger a recall, the health system starts preparing.

Kaiser has pursued the testing program with Valisure as “an additional assurance for our members’ safety and care beyond the current testing that the FDA is mandating,” Buhler said.

Through its testing for Kaiser, Valisure flagged that the ingredients from one supplier contained higher levels of lead when compared with another option — though both suppliers’ lead levels fell within the FDA’s standards. This finding allowed Kaiser to avoid the drug with more lead.

University of Kentucky started a program in 2019 to test drugs purchased through the college’s network of hospitals and clinics. More than 10% of drugs have been flagged with potential problems, said Robert Lodder, a pharmaceutical sciences professor who co-leads the testing effort.

These programs aim to unearth issues that are invisible to the average person. Patients may not know if they’re repeatedly taking small amounts of a chemical that can cause cancer, as has been the case with some heart and diabetes drugs.

Filling the Gap

Valisure is known for finding dangerous chemicals in drugs and personal-care products. It hopes to become the go-to source for ingredient verification for many products on store shelves.

The FDA has repeatedly pushed back against testing programs including Valisure’s, saying third-party labs don’t use the same protocols as drug manufacturers. The agency has also warned unnecessary testing and inaccurate results could exacerbate drug shortages. The FDA does a limited amount of drug testing itself.

“Protecting patients is the highest priority of the FDA,” Jeremy Kahn, an agency spokesman, said in an email. “The FDA continues to work to build a safe, secure and agile drug supply chain so that American patients have the medications they need – medications that have been carefully reviewed by the FDA for safety, effectiveness and quality.”

In response to the FDA’s suggestion that third-party labs don’t follow the same protocols as drug companies, Valisure’s Light said the company’s tests are faster and less expensive and still accurately spot problems.

A Shredding in Ahmedabad

FDA inspection documents, mainly from visits to factories in India over the past year and a half, have outlined a rash of violations. Some of the more alarming findings concern Accord Healthcare, a subsidiary of India-based Intas Pharmaceuticals Ltd.

Intas makes more than 100 generic drugs approved in the US, including copycats of the cholesterol-lowering pill Lipitor and erectile-dysfunction drug Cialis, according to an FDA database.

Last November, agency inspectors visited an Intas facility in Ahmedabad, India. Workers appeared to have recently destroyed sensitive quality-control documents, according to an account of the visit written by FDA inspectors. After shredding documents before inspectors arrived, Intas workers stuffed remnants into trash bags and tossed them into a truck, throwing acid on a bag that hadn’t made it onto the truck.

Following the inspection, Intas shut down operations at the plant. The FDA required extra testing on some cancer drugs — a slow but necessary process that resulted in shortages of critical chemotherapies like cisplatin, methotrexate and carboplatin. Last week, the FDA banned the Intas factory from sending drugs to the US. But it made an exception for 25 medications, including the cancer drugs, because of shortages. Intas didn’t respond to a request for comment.

The FDA is similarly allowing Sun Pharmaceutical Industries Ltd. to send another widely used cancer drug to the US despite it being made in a factory in India that was so rife with safety violations it was banned in December from selling an undisclosed number of other treatments in the US.

Both Sun and Intas are required to get extra quality tests on the drugs they’re sending to the US from banned factories.

A Sun spokesperson said the company is “taking all necessary steps to resolve the outstanding issues as fast as possible.”

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States Must Stop Criminalizing Medicine, AMA Delegates Say

“This is unacceptable…and it’s time for us to push back”

https://www.medpagetoday.com/meetingcoverage/ama/104948

CHICAGO — The criminalization of medicine is taking its toll on physicians — and not just those who perform abortions, members of the American Medical Association (AMA) House of Delegates     said here Saturday during the AMA annual meeting.

“A doctor who can’t get in trouble for malpractice because no patient has been harmed can end up in federal prison for 20-plus years because they prescribed off-guidelines,” said Stuart Gitlow, MD, MPH, MBA, of New York City, a delegate for the American Society of Addiction Medicine (ASAM). “This is unacceptable. It’s been unacceptable for more than 2 decades now. And it’s time for us to push back.”

Gitlow was speaking at an AMA reference committee meeting in favor of a resolution introduced by ASAM that called for the AMA to “study the rapidly changing environment in which the practice of medicine has been criminalized” and how that is affecting medical practice. The resolution also sought a report back to the delegates by the AMA June 2024 annual meeting. ASAM’s resolution was discussed in conjunction with a similar resolution from the New York delegation.

Gitlow noted that the Controlled Substances Act “requires that physicians who prescribe controlled substances do so by issuing the prescription for a legitimate medical purpose,” but the Justice Department sees it differently from physicians. The department “has said on multiple indictments, that if somebody departs from guidelines, such as by prescribing a medication off-label, for instance, that they are then not acting in the usual course of professional practice, and therefore, they are subject to indictment,” he said. “As a result, we have past presidents of three different state addiction societies, and multiple pain medicine societies, who are either under indictment, have been raided, or are in prison.”

Monalisa Tailor, MD, of Louisville, Kentucky, speaking for the Kentucky delegation in support of the resolution, said that when gender-affirming care came up for discussion in the Kentucky legislature this year, “there were many terrible things said about the practice of medicine and physicians in my state. This is also applied to our abortion providers and our ob/gyns … We’re going to continue to see state legislatures propose these types of laws that suggest that the practice of medicine should be criminalized — for us just taking care of our patients.”

Criminalization also increases the likelihood of violence towards physicians “because it gives people the idea that we are doing something wrong,” said Sean Figy, MD, of Omaha, Nebraska, who spoke on behalf of the Young Physicians Section and the Plastic Surgery Caucus. “And therefore, for some reason, it makes people think they can threaten us and threaten death for our families … So I do think it’s really important to help us figure out how we can make it better.”

Delegates also discussed a report by the AMA Council on Ethical and Judicial Affairs (CEJA) on ethical principles for physicians involved in practices owned by private equity firms. The report recommended that physicians who contract with these companies make sure that the contract “minimizes conflict of interest” in the way doctors are paid and doesn’t encourage undue restrictions on patient care, and that it also “does not compromise physicians’ own financial well-being or ability to provide high-quality care.”

In addition, the contract should “allow the physician to appropriately exercise professional judgment” and “enable physicians to participate in, if not outright control, decisions about practice staffing,” the report said.

Several people spoke up in favor of the report. “As we know, there is a national trend to more and more practices being taken over by private equity, with the consequent pressure on the physicians to do things not in the best interest of the patients,” said Tim Fagan, MD, alternative delegate from Arizona speaking on behalf of the PacWest delegation. “So the PacWest speaks strongly in support of this report.”

But others complained the report didn’t go far enough. “[The report] did discuss the requirement for physicians to maintain fiduciary responsibility, but does not discuss whether or not it is ethical for a corporation to take large profits out of healthcare,” said former AMA president Barbara McAneny, MD, of Albuquerque, New Mexico, a delegate from the American Society of Clinical Oncology (ASCO) who was speaking for herself.

“Private equity companies are composed of wealthy people seeking to increase their wealth; they expect to exit their investment with returns of five to 10 times the investment. And that level of profit is not going to be generated by efficiencies of delivering care or by avoiding unnecessary care,” said McAneny. “That money will come from somewhere — and the only options are that that money comes from patients, physicians, and the taxpayers who support governmental programs.” She urged the committee to “send this report back to CEJA and ask them to give us guidance on one of the more pressing issues of our time, which is whether or not private equity should be playing any role in profiteering in healthcare.”

“This is a pretty toothless report,” said Brett Coldiron, MD, an Ohio delegate from Cincinnati who spoke for the Great Lakes delegation in favor of sending the report back to CEJA. “Private equity has devastated dermatology and anesthesiology, and it’s coming your way.” When private equity-owned practices go broke, “they seize their accounts receivable and [the doctors] still have a non-compete,” he added. “So it’s a terrible situation and we need a better recommendation to work with.”

The committee will consider the delegates’ comments and then issue a report with its own recommendations, which the entire House of Delegates will vote on during its general session starting on Monday.

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ECONOMY OF SCALE: The Wall Street Journal reports that “the combined company will have significantly heightened bargaining power in negotiating with hospitals and doctors,” a factor the companies hope “will boost profits and possibly even drive down medical costs to patients.”

And it follows that “hospitals and doctors will be willing to offer more enticing price concessions in order to treat more patients.“

It was announced on our local news a few nights ago that Humana was canceling  Humana gives up 1,600 downtown Louisville parking spaces

I wouldn’t put any money on doctors treating more pts, it is more likely that the mid-level practitioners to physician ratios will increase.  I have read that reimbursement for services provided by mid-levels reimbursed by insurance companies is 85% of what would be paid if a physician provided the same service.  Typically, mid-levels pay scale is not up to 85% of that of a physician. 

UNITED HEALTHCARE: Announces $6 Billion Merger With Humana

https://californiahealthline.org/morning-breakout/united-healthcare-announces-6-billion-merger-with-humana-endstoryhed/

United HealthCare Corp., the Minnesota-based managed care giant, yesterday announced that it is merging with “rival” Humana Inc. of Kentucky in a $6 billion deal that will create “one of the nation’s most powerful players in the managed care industry.” The AP/Minneapolis Star Tribune reports that the two companies are among the nation’s “ten largest health care corporations.” United’s headquarters will stay in Minnetonka, MN, and William McGuire, will keep his CEO and chair titles. The AP/Star Tribune reports that the merged entity will “the nation’s largest publicly held health plan company” (Howatt/Feyder, 5/29). The long-term effects of Humana’s sale to United will not be felt in Kentucky for “four to seven months,” said Humana spokesperson Tom Noland. The Lexington Herald-Leader reports that “[w]hile United HealthCare has pledged to keep ‘a significant work force’ in Louisville, job cuts are likely.” Humana is Kentucky’s sixth-largest corporate employer and has played a key role in the state’s health care reforms, the Herald-Leader reports. Humana CEO Greg Wolfe told Kentucky’s insurance commissioner that his company would participate in the state’s individual market beginning this summer (Fernandez/Sharp/Butters, 5/29).

10 Million Strong
      The Wall Street Journal reports that “the combined company will have significantly heightened bargaining power in negotiating with hospitals and doctors,” a factor the companies hope “will boost profits and possibly even drive down medical costs to patients.” The new company will cover 10.4 million people nationwide, bringing in annual revenues of $27 billion, according to the Journal. “If you have a million members instead of 500,000, people will listen to you a lot more attentively,” said Kenneth Abramowitz, an analyst with Sanford Bernstein & Co. And it follows that “hospitals and doctors will be willing to offer more enticing price concessions in order to treat more patients.” The Journal reports that “United is hoping to achieve cost savings of 3% to 5% of its $4.8 billion in annual operating expenses, or nearly $200 million,” and to save another $200 million in total medical care costs through renegotiated contracts, according to United officials. The Journal notes that the companies make a good couple because they are both “regarded as industry leaders in efforts to promote quality-of-care among the doctors who participate in their health care plans” (Burton/Lipin, 5/29).

Terms Of Engagement
      Under yesterday’s agreement, the New York Times reports that United will “exchange one of its shares for two shares of Humana and assume $850 million of Humana’s debt.” On the New York Stock Exchange yesterday, United shares fell $1.625 to $62.50 and Humana’s rose $3.625 to $29.875. The Times reports that based on United shares’ Wednesday closing price of $64.125, the “stock swap” is valued at $5.5 billion (Freudenheim, 5/29).

From The Mountains, To The Oceans
      Humana will strengthen United’s “presence in several key states, especially Illinois, Wisconsin, Texas, Florida and Ohio,” according to the Star Tribune (5/29). The Chicago Tribune reports that the deal will “change the competitive health care landscape in Illinois,” as United is currently the state’s second largest HMO and Humana is the third largest. “The combination will knock Blue Cross and Blue Shield of Illinois … out of first place,” and in a first, the state’s “HMO markets will be dominated by a publicly traded, for-profit company based elsewhere,” the Tribune reports (Buck/Graham, 5/29). The Dallas Morning News reports that the two companies serve over 1.5 million Texas members and that the “merger caps a hectic year of repositioning among the ten largest [HMOs] serving North Texas” (Ornstein, 5/29). In Ohio, the merger “will result in Greater Cincinnati’s largest HMO changing hands twice in less than a year,” the Cincinnati Enquirer reports. The deal “will affect about 380,000 Tristate residents covered by United, Humana or ChoiceCare — the once-independent HMO that Humana acquired last year” (Bonfield, 5/29). The merger will affect 1.4 million Humana members in Florida and about 900,000 of United’s in the Sunshine State. Gary Frazier of Bear Stearns & Co. said the deal would create the nation’s third largest health plan in terms of enrollment, second only to Kaiser Permanente and Blue Cross and Blue Shield

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Once again a BENCH TRIAL, don’t know if Walgreens asked for a trial by jury and it was denied by the judge who mandated a BENCH TRIAL. So that the judge is judge and jury. This whole agreement is both interesting and a contradiction. Walgreens “agreed” to pay $500 million – while admitting no wrongdoing – for claims that Walgreens failed to stop ILLEGAL PILL SALES.  Mark Pifko, attorney for the state, seems to conflate pharma Rx opioids and illegal street opioids and likewise, what is the real reason for the estimated 500,000 drug overdose deaths?

https://www.newsmax.com/newsfront/drugs-chamber/2023/06/09/id/1123052/

Walgreens Boots Alliance has agreed to pay $500 million to New Mexico to settle claims that its pharmacies helped fuel opioid addiction in the state by failing to stop illegal pill sales, lawyers for the state announced Friday.

The settlement, the largest obtained by New Mexico against a single company over opioids, came after a non-jury trial last year in the state’s lawsuit against the company. The judge overseeing that trial had not yet ruled on the state’s claims.

“We are confident that this record settlement positions New Mexico to turn the tide on this deadly epidemic,” Mark Pifko, a lawyer for the state, said in a statement.

Walgreens did not admit wrongdoing under the settlement. A spokesperson for the company declined to comment.

More than half a million people died from drug overdoses in the United States from 1999 to 2020, with opioids playing an outsized role. Overdose deaths have risen further since then, according to data from the U.S. Centers for Disease Control and Prevention

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The 3 largest drug wholesalers – all of whom are publicly traded companies – got to pay a fine to settle similar violations and continue in business but apparently, this 180-year-old family-owned business was shut down by the DEA because it was unique in its willingness to challenge those accusations in the DEA’s administrative court.

The question that has to be asked, is what is going to happen to the controlled meds that had been allocated to this wholesaler?  Will the estimated 600-800 million dollars of controls allocated to this wholesaler, just “disappear ” and be a reduction in the various pharma production quotas?

After a years-long delay, DEA revokes license of drug distributor over opioid crisis failures

https://abcnews.go.com/US/wireStory/after-yearslong-delay-dea-revokes-license-wholesale-drug-99626816

The U.S. Drug Enforcement Administration stripped one of the nation’s largest drug distributors of its license to sell highly addictive painkillers Friday after determining it failed to flag thousands of suspicious orders at the height of the opioid crisis.

The action against Morris & Dickson Co. that threatens to put it out of business came two days after an Associated Press investigation found the DEA allowed the company to keep shipping drugs for nearly four years after a judge recommended the harshest penalty for its “cavalier disregard” of rules aimed at preventing opioid abuse.

The DEA acknowledged the time it took to issue its final decision was “longer than typical for the agency” but blamed Morris & Dickson in part for holding up the process by seeking delays due to the COVID-19 pandemic and its lengthy pursuit of a settlement that the agency said it had considered. The order becomes effective in 90 days, allowing more time to negotiate a settlement.

DEA Administrator Anne Milgram said in the 68-page order that Morris & Dickson failed to accept full responsibility for its past actions, which included shipping 12,000 unusually large orders of opioids to pharmacies and hospitals between 2014 and 2018. During this time, the company filed just three suspicious order reports with the DEA.

Milgram specifically cited testimony of then-president Paul Dickson Sr. in 2019 that the company’s compliance program was “dang good” and he didn’t think a “single person has gotten hurt by (their) drugs.”

“Those statements from the president of a family-owned and operated company so strongly miss the point of the requirements of a DEA registrant,” she wrote. “Its acceptance of responsibility did not prove that it or its principals understand the full extent of their wrongdoing … and the potential harm it caused.”

Shreveport, Louisiana-based Morris & Dickson traces its roots to 1840, when its namesake founder arrived from Wales and placed an ad in a local newspaper selling medicines. It has since become the nation’s fourth-largest wholesale drug distributor, with $4 billion a year in revenue and nearly 600 employees serving pharmacies and hospitals in 29 states.

In a statement, the company said it has invested millions of dollars over the past few years to revamp its compliance systems and appeared to hold out hope for a settlement.

“Morris & Dickson is grateful to the DEA administrator for delaying the effective date of the order to allow time to settle these old issues,” it said. “We remain confident we can achieve an outcome that safeguards the supply chain for all of our healthcare partners and the communities they serve. … Business will continue as usual and orders will continue to go out on time.”

Morris & Dickson’s much larger competitors, a trio of pharmaceutical distributors known as the Big Three, have already agreed to pay the federal government more than $1 billion in fines and penalties to settle similar violations. Cardinal Health, AmerisourceBergen and McKesson also agreed to pay $21 billion over 18 years to resolve claims as part of a nationwide settlement.

While Morris & Dickson wasn’t the only drug distributor who the DEA accused of fueling the opioid crisis, it was unique in its willingness to challenge those accusations in the DEA’s administrative court.

In a scathing recommendation in 2019, Administrative Law Judge Charles W. Dorman said Morris & Dickson’s argument that it has changed its ways was too little, too late.

Anything less than the most severe punishment, the judge said, “would communicate to DEA registrants that despite their transgressions, no matter how egregious, they will get a mere slap on the wrist and a second chance so long as they acknowledge their sins and vow to sin no more.”

But as the ensuing years passed, neither the Biden-nominated Milgram nor her two predecessors took any enforcement action. Past DEA officials told the AP such decisions usually take no more than two years.

As the pills kept flowing, Morris & Dickson attempted to stave off punishment, appealing directly to Milgram to order a reopening of the proceedings, arguing it would introduce new evidence showing it had implemented an “ideal” compliance program with the help of a consultant who is now second-in-command at the DEA, Louis Milione. The DEA said that Milione has recused himself from all agency business related to Morris & Dickson.

Milione retired from the DEA in 2017 after a 21-year career that included two years leading the division that controls the sale of highly addictive narcotics. Like dozens of colleagues in the DEA’s powerful-but-little-known Office of Diversion Control, he went to work as a consultant for some of the same companies he had been tasked with regulating.

Milione was hired by Morris & Dickson in 2018 as part of a $3 million contract and later testified that the company “spared no expense” to overhaul its compliance systems, cancel suspicious orders and send daily emails to the DEA spelling out its actions.

A footnote of the DEA’s order Friday said that since Milione returned to the DEA as principal deputy administrator in 2021, he has not had any contact with Milgram or other agency staff about the Morris & Dickson case due to his prior involvement with the company.

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By the time you read this, hopefully, I will have my NEW PARTIAL LEFT KNEE.  Unlike too many people, I did not wait until all three points that the knee rests on deteriorated to bone on bone and I only had one of three of those points is bone on bone.

They tell me that the surgeon is going to resurface/reshape that one point and insert what looks like a piece of plastic that is supposed to have a life expectancy of 30 yrs..

The procedure is supposed to be dramatically less barbaric than a total knee replacement,  with less pain, a shorter recoup period of 3-4 months as opposed to 6 to 12 months with a total knee.

I don’t have to have a 3-day stay in a  hospital stay nor a week+ stay in a PT REHAB.

Going to have PT at home for a couple of weeks and then go to out pt rehab, which is about 2 miles from our home.

Not sure how many days I will be on the “sidelines”

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What could go wrong with taking Andrew Kolodny’s advice on the fabricated opioid crisis?  Just look at the J&J trial in OK, with J&J being charged with being a public nuisance, because they were the raw opioid powder wholesaler to the rest of the pharma industry that made FDA-approved opioid medications. Reported, Kolondy was hired as the Federal expert and was paid some $500,000 – $600,000 for his involvement in the trial.  Initially, J&J was found guilty but was later overturned.  Apparently, in the end, the only ones that came out ahead financially from the trial were J&J attorneys and Andrew Kolodny.

https://www.acsh.org/news/2023/03/20/andrew-kolodny-straight-face-wants-control-tranq-scheduling-it-16941

In response to Tranq – a horrifying “new” drug sweeping the nation – Kolodny, America’s “drug expert,” proposes a solution. And gets it all wrong.

Some people just can’t admit when they’re wrong. 

A number of times in the past I have questioned whether Andrew Kolodny, a psychiatrist and the president of the execrable Physicians for Responsible Opioid Prescribing (PROP), is qualified to be the media’s go-to expert whenever drugs – especially opioids – are in a news article where a quote is needed. 

When MedPage Today needed a quote about xylazine (aka Tranq, not an opioid), the horrific drug that I wrote about last October, unsurprisingly they went to Kolodny. [Emphasis mine]

Andrew Kolodny, MD, an expert in opioid policy and addiction medicine at Brandeis University in Massachusetts, said xylazine is probably widely diverted because it’s unscheduled.

“If it were scheduled, distributors would have to have a suspicious order monitoring system. It’s a DEA [requirement] that would tell you, for example, your Philadelphia region, or a particular veterinary practice you’re distributing to, are outliers and you can’t continue to fill that order. You have to report them,” he explained.

“For sure, you would not see xylazine all over the place if it was scheduled,” Kolodny added.

Kristina Fiore in MedPage Today, “Will Xylazine Become a Controlled Substance?“

These are mind-boggling responses, but they are consistent with Kolodny’s stubbornly false narrative on opioids – that today’s surge in opioid overdose deaths is a result of the overprescription of painkilling drugs. Going a step further, PROP members believe that a further reduction will save lives, a statement that is not only preposterous but also demonstrably false, something that is made clear in Aubry and Carr’s 2022 article in Frontiers in Pain Research.

Based on the results presented in this paper and the current trends in opioid deaths, the policies of cutting [prescription opioid sales] to prevent deaths and hospital admissions… are unfounded and ineffective.”

Aubry and Carr, Front. Pain Res., 04 August 2022
Sec. Pain Research Methods, https://doi.org/10.3389/fpain.2022.884674

Suffice it to say that any knowledgeable, rational person would know by now that the strict restrictions placed on legal (and safer) (1) drugs have resulted in a supply of illegal and far more dangerous drugs taking their place. This is not only not surprising but also predictable.

Dr. Jeffrey Singer, a Senior Fellow at the Cato Institute, a practicing surgeon, and ACSH advisor has written about the “Iron Law of Prohibition,” a term coined in the late 20th century: “As law enforcement becomes more intense, the potency of prohibited substances increases.”

Singer recently wrote in The Iron Law of Prohibition: Introducing “Tranq”:

The iron law of prohibition cannot be repealed. Drug cartels will keep generating new and more potent drugs, alone or in combination with existing ones, as long as policymakers refuse to end drug prohibition.

What is scheduling?

According to the DEA, the agency in charge of classifying drugs:

Drugs, substances, and certain chemicals used to make drugs are classified into five (5) distinct categories or schedules depending upon the drug’s acceptable medical use and the drug’s abuse or dependency potential. 

Since xylazine is a veterinary product that is relatively new on the human scene it is not a scheduled drug, meaning it can be bought or sold legally requiring only a veterinarian’s prescription. Kolodny proposes that scheduling xylazine would solve the emerging problem:

“For sure, you would not see xylazine all over the place if it was scheduled”

In what universe might this be true? Staying in ours, for now, it is trivial to demonstrate that his solution is nonsensical. There are plenty of historical data to prove this.

Scheduling does not reduce drug overdose deaths

1. Fentanyl

Pharmaceutical fentanyl, an essential medication, is a Schedule II drug – the most restrictive legal class of drugs. Yet that did not stop the US from being flooded with the illegal variety, which has been responsible for the majority of drug overdose deaths since the mid-2010s.

Fentanyl overdose deaths by year, 1999-2020. Source:  Statista

2, 3. Cocaine and methamphetamine

Both cocaine and methamphetamine have legitimate (but limited) medical uses in humans and are also Schedule II. But this hasn’t stopped the importation of many tons of illegal versions of both drugs, as demonstrated by the growing numbers of deaths:

Source: NIDA

4. Heroin

Heroin is a Schedule I drug (no legal use) and the pattern of increasing deaths over the past decade is similar, but with a wrinkle…

Source: NIDA

As was the case with illicit fentanyl, cocaine, and methamphentamine, there was also a spike in heroin deaths beginning in 2010, largely driven by the reformulation of OxyContin. But in this case, there is a drop-off beginning around 2017 when fentanyl began to take its market share, a trend that continues at the current time. 

5. Prescription opioids

Source: NIDA

The death rate from prescription opioids did not soar like the four drugs above; the number of overdose deaths has remained constant over the last decade (red hatched line). Why? These drugs are safer and more difficult to come by than whatever is on the street. It is not a coincidence that we are seeing the most deaths from the most dangerous drugs or that the most dangerous drugs have been more widely-used since the crackdown on prescription painkillers began. The Iron Law is alive and well.

During the time when opioid prescriptions were cut by 60%, overdose deaths from illegal fentanyl, cocaine, and methamphetamine all surged. What is really going on? I can come up with only one rational explanation: In the past decade the misuse of illegal drugs of all kinds, not legal prescription pills, has increased and this is what is responsible for our ever-growing annual death toll. Scheduled or not, the deadliest drugs have been doing the killing.

Summary

• These data make it clear that the misguided or delusional anti-opioid crowd has been fighting the wrong battle all along and this has done plenty of damage with little or no benefit. One can only imagine how much better it would have been had the CDC not meddled in drug policy and PROP never formed.
• The result of this misguided war has been far more death and destruction, not less. And, of course, needless suffering from pain.
• America’s real problem is not opioid addiction, it is an addiction, in this case to more dangerous illegal drugs, which took hold when safer drugs were restricted. But alcohol is always (conveniently) left out of the discussion.
• Whether or not the DEA slaps a label on the legal form of a drug will do nothing to prevent illicit versions of that drug from doing their damage. In all likelihood, it does more damage.

Back to Tranq

Let’s take one more look at Kolodny’s “solution” and appreciate how ridiculous it really is. 

“For sure, you would not see xylazine all over the place if it was scheduled”

Does anyone really believe that this is correct? I sure don’t.

But I do believe this:

We are now fighting a losing battle against heroin, fentanyl, and Tranq. Something worse will be next. Why not admit “defeat” and loosen up on oxycodone? Anyone with a working brain will be able to predict the result. Overdoses and death will drop and probably by a lot.

NOTES:

(1) Prescription opioids are far safer than drugs that can be bought on the street, both because the drug’s identity and dose are known in legally prescribed medicines but not in counterfeit versions. 

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