Johnson & Johnson sues Biden administration over Medicare drug price negotiations

This could prove to be interesting. It has been reported that the PBM industry will extract a discount/rebate/kickback of up to 75% of AWP (Average Wholesale Price) to put a pharma med on the PBM’s approved formulary – NO PRIOR AUTHORIZATION NEEDED. I suspect that the price that the FEDS are demanding will not change AWP… and the pharma has an agreement with the PBM industry that the agreed upon rebate/kickback/discount is based on AWP and not the FED’S SO CALLED negotiated price. In the end, the pharma could end up getting less $$$ per bottle than it cost the pharma to make the med.

 

 

Johnson & Johnson sues Biden administration over Medicare drug price negotiations

https://www.cnbc.com/2023/07/18/jj-sues-biden-administration-over-medicare-drug-negotiations.html

on Tuesday sued the Biden administration over Medicare’s new powers to slash drug prices, making it the third pharmaceutical company to challenge the controversial provision of the Inflation Reduction Act.  

The lawsuit filed in federal district court in New Jersey argues the Medicare negotiations violate the First and Fifth Amendments of the U.S. Constitution.

Earlier suits brought separately by drugmakers Merck and Bristol Myers Squibb, as well as by the U.S. Chamber of Commerce and PhRMA, the pharmaceutical industry’s largest lobbying group, made similar arguments.

J&J’s complaint asks a judge to block the U.S. Health and Human Services Department from compelling the drugmaker to participate in the program.

The company said its suit aims to stop the “innovation-damaging congressional overreach that threatens the United States’ primacy in developing transformative therapies and in patients’ access to those treatments.”

President Joe Biden’s Inflation Reduction Act, which passed in 2022 by a narrow party-line vote, empowered Medicare to negotiate drug prices for the first time in the program’s six-decade history. 

The provision aims to make drugs more affordable for older Americans but will likely reduce pharmaceutical industry profits. 

The Centers for Medicare and Medicaid Services will publish a list of which drugs were selected for a first cycle of negotiations on Sept. 1, with prices taking effect in 2026. The companies that make those drugs face an October deadline to sign agreements to participate in those negotiations.

J&J said its patented drug Xarelto, which treats blood clots and reduces the risk of stroke, will be subject to price negotiations in 2023 because it is among the 10 most widely reimbursed drugs for Medicare Part D patients.

J&J argues that Medicare negotiations “inflict an uncompensated physical taking” of the company’s drug and essentially force J&J to provide access to Xarelto on terms set by the government that the company “would never voluntarily” agree to.

The company claims this violates Fifth Amendment protections against the government seizing private property without just compensation.

J&J last year booked $2.47 billion in revenue from Xarelto.

J&J also argues that the new provision forces the company to agree that the federal government is negotiating fair drug prices. That compels J&J to make “false and misleading statements” in violation of the First Amendment, according to the complaint.

The company believes the provision doesn’t involve true negotiations since the government “unilaterally dictates” drug prices. 

Real negotiation involves finding a way for both parties to freely agree on terms, J&J said.

“While the Government may choose to deceptively describe the Program as involving an ‘agreement’ to ‘negotiate’ a ‘fair’ price, it cannot force manufacturers to echo its misleading messaging,” J&J said in the complaint. 

HHS said in a statement it will “vigorously defend the President’s drug price negotiation law, which is already helping to lower health care costs for seniors and people with disabilities.”

“The law is on our side,” the agency added, reiterating previous remarks made by HHS Secretary Xavier Becerra.

Walgreens: The Pharmacy America Trusts, The “corner of happy and healthy”

My, how times have changed at the “Pharmacy America Trusts” ?  Walgreen states that they are “invested in your safety and wellness”, but we are refusing to fill the controlled meds that your prescriber has deemed are medically necessary for treating your specific health issues.  This IN NO WAY IMPACTS YOUR RELATIONSHIP WITH WALGREENS and WE APOLOGIZE FOR ANY INCONVENIENCE. On Walgreens you can find any medicine you need like for example if you are having prostate problems  and you are looking for a medicine like prostadine you can go there and I’m pretty sure you will find them.

So one of the basic functions of the practice of medicine is the starting, changing, stopping a pt’s therapy. So if this pt can’t find another pharmacy to fill her controlled med Rxs… could Walgreen be considered the genesis of this pt’s medications being stopped ? They clearly state in the letter that the pharmacists at her local Walgreens had no involvement with this decision, which would imply that it was done by someone or some computer algorithm at Walgreen’s corporate HQ.  NOTHING PERSONAL !

AMERICAN MEDICAL ASSOCIATION MUST INVESTIGATE AND STOP THE RECKLESS ACTIVITIES OF GOVERNMENT “OPIOID TASK FORCES” AND IT’S CRIMINALIZATION OF MEDICINE/ PROTOCOLS

Jesse M. Ehrenfeld, MD, MPH Specialty: Anesthesiology/Clinical Informatics Conflict Of Interest Members Only AMA Affiliated Groups President, AMA, Board of Trustees Members Term: 2023-2024 Email:Jesse.Ehrenfeld@ama-assn.org

IT’S TIME THE AMERICAN MEDICAL ASSOCIATION (AMA) INVESTIGATE ACTIONS OF AUSA KENNETH POLITE’S “OPIOID TASK FORCE,” CRIMINALIZATION OF MEDICINE

 

Morris & Dickson’s Controlled Substance License Revoked

I have not seen anything that would suggest that the controlled meds allocated to this drug wholesaler – 4th largest in the country.. will be divided among the existing drug wholesalers across our country, or will what has been allocated to them JUST DISAPPEAR ?

But here is a settlement between 50 state AG’s and others that got the THREE LARGEST WHOLESALERS to agree to reduce the number of controls that they sell to ALL PHARMACIES.

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

So now the DOJ/DEA & our judicial system has got three largest drug wholesalers to sell less controls to all pharmacies and may be cutting the controls that were being sold by the 4th largest drug wholesaler. I just wonder how many of these pharmacies that are going to find themselves without access to their normal purchases of controls are long term nursing home providers?

 

Morris & Dickson’s Controlled Substance License Revoked

https://www.policymed.com/2023/07/morris-dicksons-controlled-substance-license-revoked.html

Recently, the United States Drug Enforcement Administration (DEA) announced that, barring a settlement, it will revoke Morris & Dickson’s license to sell and ship opioid medications and other controlled substances as of August 28, 2023. In the decision and order published in the Federal Register on May 30, 2023, the DEA affirmed a 2019 Administrative Law Judge’s (ALJ’s) decision to revoke DEA registrations held by Morris & Dickson, the United States’ fourth largest wholesale drug distributor.

Background

Morris & Dickson was accused of failing to accept responsibility for its prior actions, including shipping 12,000 unusually large orders of opioids to pharmacies and hospitals from 2014 to 2018. The DEA notes that Morris & Dickson received purchases from “high-volume independent pharmacies” in Louisiana that were “purchasing quantities which were not indicative of the pharmaceutical market” and some were purchasing more Oxycodone and Hydrocodone than the larger chain pharmacies – sometimes more than 10 times the amount of narcotics the average Louisiana pharmacy purchased per month. Despite the large number of unusual orders, the company only filed three suspicious order reports with the DEA during that time frame, an indication that the company did not have a suspicious order monitoring system in place. Additionally, the company failed to maintain effective controls against diversion of drugs by distributing controlled substances without performing adequate customer due diligence.

On May 4, 2018, the DEA announced an Immediate Suspension Order on Morris & Dickson, immediately suspending the DEA Certificate of Registration issued to the company as the DEA felt that “the continued registration of this company constitutes a substantial likelihood of imminent danger to public health and safety.”

Morris & Dickson appealed that decision, and an administrative hearing was held on the matter in May 2019. After that administrative hearing, that suspension was recommended to become a revocation by ALJ Charles W. Dorman in November 2019. According to the Associated Press, the 2019 ALJ decision noted that while Morris & Dickson may have made some revisions to their procedures, anything less than revocation of the license “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.” The judge went on to note that “allowing [Morris & Dickson] to keep its registration would tell distributors that it is acceptable to take a relaxed approach to DEA regulations until they are caught, at which point they only need to throw millions of dollars at the problem to make the DEA go away.”

However, instead of issuing a decision and order shortly after the ALJ decision, the DEA took several years. During that time, Morris & Dickson was still able to distribute controlled substances, despite the strong words in the ALJ’s decision – and the DEA’s strong words in the final decision and order. The decision and order took “longer than typical for the agency” in part because of the COVID-19 pandemic and actions taken by the company.

Complicating matters – and frustrating some – was an Associated Press investigation that found that a top DEA official previously served as a consultant for Morris & Dickson as part of the company’s attempt to avoid revocation or other punishment. The DEA says after the individual returned to work for the DEA, they were recused from any participation in the Morris & Dickson matter.

Kaiser Permanente Whistleblower Reveals that the story was fabricated.

Kaiser Permanente  Whistleblower Reveals that the story was fabricated.

The person who published this came out on Twitter,  who claims that he has FOUR DIFFERENT TWITTER ID’s and also penned this article under an assumed name ( George Bailey).  On Twitter, his tweets seem to follow a pattern one would expect from a TROLL or a SPAMMER. So I have taken this article down…

Enforced Tapering: The Dangers of PAWS

If a person is stable on long term low-dose opioid therapy AND shows no signs of addiction, abuse or serious side effects: 1. WHY have Medical Authorities chosen to taper chronic pain patients from their mobility-restoring opioids, without supports in place? 2. WHY are chronic pain patients being advised they will experience “no long-term side effects from tapering”, yet many suffer from a life-changing condition known as Post-Acute Withdrawal Syndrome? 3. WHY have demonstrably flawed and “one-size-fits-all” Guidelines for Deprescribing Opioid Analgesics been released in Australia on 26-5-23?

VP Kamala Harris Calls To ‘Reduce Population” – heart beat away from being our President

Regular, Optimal Sleep Tied to Lower Mortality Risk

So how many chronic pain pts with under/untreated pain get a “good nights sleep”?  Another contributing factor to premature deaths of chronic pain pts with poorly treated pain ?

Regular, Optimal Sleep Tied to Lower
Mortality Risk

https://www.medscape.com/viewarticle/992942

Maintaining a regular healthy sleep schedule may help guard against premature death, new research suggests.

In a diverse group of older adults, those with regular and optimal sleep had about a 40% lower risk of dying of any cause during follow-up than peers who with irregular and insufficient sleep.

“If sleep were an eight-hour pill, it would be beneficial to take the full dose at regular times consistently,” lead researcher Joon Chung, PhD, with Harvard Medical School and Brigham and Women’s Hospital, Boston, Massachusetts, said in a news release.

The findings were presented at SLEEP 2023, the 37th annual meeting of the Associated Professional Sleep Societies.

Broad Adverse Health Effects

“Evidence is mounting that irregular sleep is associated with pretty broad adverse health outcomes, most prominently cardiometabolic disease, obesity, and cardiovascular disease,” Chung told Medscape Medical News.

In the current study, the researchers estimated the association of regular sleep of optimal sleep duration with all-cause mortality using data from 1759 adults the Multi-Ethnic Study of Atherosclerosis Sleep Study.

Sleep regularity and duration were classified using 7 days of data gathered by wrist actigraphy. Adults were categorized as “regular-optimal” sleepers (n = 1015) or “irregular-insufficient” sleepers (n = 744).

During 7 years of follow up, 176 people died. In the fully adjusted model, the regular-optimal group had a 39% lower mortality risk compared to the irregular-insufficient sleep group (hazard ratio, 0.61; 95% CI, 0.45 – 0.83). The findings were robust in sensitivity analyses.

The regular and optimal duration sleep pattern maps behaviorally to regular bed and wake times, suggesting potential health benefits of adherence to recommended sleep practices, the researchers note.

“Results suggest benefits of expanding the public conversation on getting ‘a good night’s sleep’ and broadening this goal to getting many good nights of sleep, in a row, on weekdays and weekends,” Chung said in the release.

He further told Medscape Medical News that “getting adequate, regular sleep seems to be something that is good for all. I don’t know of anyone who wouldn’t benefit.”

Fariha Abassi-Feinberg, MD, spokesperson for the AASM and sleep specialist with the Millennium Physician Group, Fort Myers, Florida, agrees.

“We know our bodies have an internal clock, known as the circadian rhythm, which regulates various biological processes, including sleep-wake cycles. Sticking to a consistent sleep schedule allows your body to align its natural rhythm with the external day-night cycle. This synchronization promotes better sleep quality and therefore better health,” said Abassi-Feinberg, who wasn’t involved in the study.

“The AASM recommends adults try to aim for at least 7 hours of sleep and I often tell my patients that keeping a regular routine is best for your sleep and health,” she told Medscape Medical News.

Funding for the study was provided by the American Academy of Sleep Medicine Foundation and the National Institutes of Health. Chung and Abassi-Feinberg report no relevant financial relationships.

Mexican authorities raid pharmacies in inquiry into fentanyl-tainted pills

Mexican authorities raid pharmacies in inquiry into fentanyl-tainted pills

https://www.latimes.com/world-nation/story/2023-07-07/mexican-authorities-raid-pharmacies-in-inquiry-into-fentanyl-tainted-pills

A man walks past a storefront advertising prescription drugs
Pharmacies in Cabo San Lucas, Mexico, are selling counterfeit prescription pills laced with illicit substances and passing them off as legitimate pharmaceuticals.

Authorities in Mexico raided several Los Cabos drugstores last month and arrested four people as part of an ongoing investigation into pharmacies selling counterfeit pills laced with fentanyl and methamphetamine.

The flurry of law enforcement action in the peninsular municipality comes on the heels of a Los Angeles Times investigation that found pharmacies from Tulum to Tijuana were passing off powerful drugs, including fentanyl and methamphetamine, as weaker medications commonly sought out by tourists. Of the 55 opioid painkillers and ADHD medications The Times tested over a four-month period, slightly more than half proved to be counterfeit.

Alejandro Torres Pineda, a delegate of the attorney general’s office in Baja California Sur, said Mexico’s investigation was sparked by local media coverage of the issue — coverage that was based on and extensively credited The Times’ reporting.

In total, authorities confiscated nearly 25,000 pills in the raids. None of them tested positive for fentanyl or methamphetamine, according to Pineda, but came back as other controlled substances that the pharmacies did not have authorization to sell.

“We’re continuing the investigations,” he said in a phone interview last week.

The raids are important, Pineda said, “because the sale of controlled medicines is inhibited, the health of citizens is protected and the type of medicines sold in pharmacies is controlled.”

Ahead of the raids, federal police went to different pharmacies around Los Cabos and interviewed people — including one from North America — as they left the businesses. One person told police that she was buying medicine for back pain. When authorities tested the pills, they found that her purchase also ran afoul of regulations.

A judge then granted law enforcement authorities permission to search the pharmacies in Cabo San Lucas and San José del Cabo. Two were raided June 3 and three others were raided June 20. Authorities found diazepam and clonazepam, anti-anxiety medications usually known in the U.S. by the brand names Valium and Klonopin.

The raids by law enforcement — including federal police, the attorney general’s office and the Mexican navy — netted a cache of money and boxes of pills. Images released by Mexico’s attorney general showed clusters of gun-toting, camouflage-clad police wearing balaclavas standing in front of blurred-out drugstores.

Of the people arrested, Pineda said, three were pharmacy employees and the fourth was an owner of one of the businesses. There’s nothing yet that points to cartel involvement, he added.

The municipal director of public safety in Los Cabos, Jesús Antonio Gómez Rodríguez, framed the recent operation as a positive step.

“In terms of security, the work coordinated by three levels of government is yielding good results, with the aim of guaranteeing the safety of locals and visitors,” Gómez said. “It’s protecting the health of our young people who can fall into the clutches of drugs, as well as the numerous groups of visitors who come to our municipality to enjoy its natural beauties and tourist services.”

Drugstores in Mexico have long been known for selling a wide range of medications over the counter, including many that would require a prescription in the U.S. Until recently, drug market experts had generally believed that pills sold in stores — unlike those sold on the street — were at least what the store owners said they were.

But in February, The Times published an investigation after testing pills from pharmacies in three cities, including San José del Cabo and Cabo San Lucas. In each city, some of the pills sold over the counter as either oxycodone or Adderall tested positive for fentanyl or methamphetamine. Around the same time, a UCLA research team recorded similar findings.

Over the next few weeks, reporters identified at least half a dozen people who overdosed or died after taking pills they’d purchased at pharmacies in Mexico. Grieving families had been alerting U.S. government officials as early as 2018. It was not until March, however, that the U.S. State Department explicitly warned the public about the danger.

On June 14, The Times published a broader investigation, documenting the problem across the country, from Mexico’s southeastern tip in the Yucatán Peninsula to its border with California. Of the 55 pills reporters tested, 28 were counterfeit.

According to El Sudcaliforniano, a regional news site in Mexico, last year Baja California Sur health officials inspected 628 pharmacies, including 175 in Los Cabos. During those visits, inspectors checked licenses and documentation and found everything to be in order. But they later told the outlet it was not up to state officials to do the laboratory testing to confirm the chemical makeup of the drugs.

Health officials also told the news site in February that they found no records of people dying due to adulterated medicine — though there has been a lack of the kind of postmortem toxicology testing in Mexico that would be needed to make that determination.

After similar inspections in the spring, the Cabo Sun reported that state health officials visited more than 100 pharmacies in Baja California Sur. In Los Cabos alone, the news site said, officials shut down nine pharmacies for distributing controlled substances.

When The Times first contacted the attorney general’s office in February, a federal prosecutor there — who has since asked to not be named due to safety concerns — said it was the first time she’d heard of fentanyl-tainted pills appearing in pharmacies. She called it “a new modus operandi that we haven’t detected before” and said that officials were “concerned.”

To better understand the problem, she said, authorities would “need to find where in the process they’re faking the pills” and determine “if pharmacies are involved in criminal activity or they don’t know if they are selling medications with fentanyl.”

In June, the prosecutor told reporters in an email that federal health officials were interested in The Times’ investigation and hoped to file a complaint with her office for potential prosecution. The Times did not provide Mexican authorities with information about the pharmacies reporters visited.

After prosecutors and police opened an investigation, a judge granted them permission to search several pharmacies.

But for Mary Harrell — whose son overdosed and died after he bought a fentanyl-tainted pill at a pharmacy in Cabo San Lucas in 2019 — the enforcement actions came as little consolation. The Camarillo woman said she wished authorities in Mexico had taken action sooner.

“It’s not going to stop,” she said. “If it were a real cleanup you’d have the president going after it — but you don’t.”

Imagine if this was your medication from a mail order pharmacy

Yes, it has been this hot in the deep south.

Roberta Wright, who lives in a suburb of Houston, Tx., decided to try something we’ve always wondered about, can you bake bread in your mailbox during the summer months?

Well, according to the photos here that have gone viral, the answer appears to be yes.

Wright’s friend Howard Ceasar posted the photos on Facebook and he says that the bread baked for 45 minutes in the mailbox. 

Now, we all know how hot it can get in a mailbox during the summer, but to see a full loaf of bread baked in it is really eye-opening.

I don’t know how it tasted, but now I am intrigued and I too want to try baking a loaf of bread in my mailbox.

Disclaimer, if you try this, you may want to leave a note taped to your mailbox so that the mail delivery person is shocked when he or she opens your box to drop off the mail.

Imagine if you get your prescriptions from a mail order pharmacy and they were left in your mailbox during the summer months. Required storage for Rx meds typically tops out in the mid-80F.

Rule of thumb, is that any medications stored outside of the required temp range for >24 hrs is considered compromised and their quality/potency is questionable.

Of course, this picture is loaf of bread being baked after 45 minutes and notice that this mailbox is somewhat insulated by two layers of bricks surrounding the metal mail box.  This demonstration has nothing to do with a package of meds being in various USPS vehicles in transport