Pam Bondi confirmed as attorney general in 54-46 vote

https://www.cbsnews.com/news/pam-bondi-confirmed-as-attorney-general/

Washington — The Senate on Tuesday confirmed Pam Bondi as attorney general, installing a key ally of President Trump’s to take the helm of the Justice Department.

Bondi’s nomination for attorney general was approved by the upper chamber 54 to 46, with one Democrat, Sen. John Fetterman of Pennsylvania, joining all Republicans in voting to confirm her. She will take over as the nation’s top law enforcement officer as Mr. Trump has pledged to end what he calls the weaponization of the Justice Department and threatened to target his critics.

During her confirmation hearing before the Senate Judiciary Committee earlier this month, Bondi said she would “not politicize” the department and said “justice will be administered evenhandedly throughout this country.”

“If confirmed, I will work to restore confidence and integrity to the Department of Justice and each of its components,” she said. “Under my watch, the partisanship, the weaponization, will be gone. America will have one tier of justice for all.”

In the days since Mr. Trump began his second term in office, the Senate has been working to confirm his Cabinet picks. The GOP-led upper chamber installed the top members of his national security team first and now is moving to approve the remaining nominees who will lead federal departments. 

Bondi’s nomination was first approved by the Senate Judiciary Committee in a 12-10 party-line vote before it was considered by the upper chamber.

As attorney general, Bondi will oversee a sprawling department that includes numerous law enforcement components, including the FBI and the Bureau of Alcohol, Tobacco, Firearms and Explosives. Both agencies have often been the target of attacks by Mr. Trump. The president selected another staunch defender, Kash Patel, to lead the FBI.

Bondi will also have the power to investigate the federal probes involving Mr. Trump that were overseen by former special counsel Jack Smith. Smith resigned from the role before the president returned to office, and the two cases brought against Mr. Trump were dismissed because of longstanding Justice Department policy that precludes the prosecution of a sitting president.

Now, with Mr. Trump back in the White House, his administration has been overseeing the ouster of certain Justice Department employees. Acting Attorney General James McHenry, selected by the president to temporarily lead the department, fired roughly a dozen Justice Department employees who worked for Smith because “he did not believe these officials could be trusted to faithfully implement the president’s agenda because of their significant role in prosecuting the president,” a Justice Department official said.

And department leadership directed the acting U.S. attorney in Washington, D.C., Edward Martin, to terminate prosecutors who investigated the Jan. 6, 2021, assault on the U.S. Capitol, according to a Jan. 31 memo reviewed by CBS News.

At the FBI, which is a component of the Justice Department, the acting deputy attorney general ordered the acting head of the bureau to compile a list of all current and former FBI employees who were assigned to the investigation into the Jan. 6 attack for review to “determine whether any additional personnel actions are necessary,” according to a memo reviewed by CBS News.

FBI supervisors have also received questionnaires for certain agents in their field offices that contain questions about their possible work on the Jan. 6 cases, such as whether they participated in a search, if they made any arrests or testified in court.

Bondi has previously suggested that the Justice Department prosecutors who were involved in the cases against Mr. Trump would face their own investigation and has repeated the president’s claim that there is a so-called deep state of career government employees working to undermine him.

“The Department of Justice, the prosecutors will be prosecuted, the bad ones. The investigators will be investigated because the deep state last term for President Trump, they were hiding in the shadows. But now they have a spotlight on them,” she told Fox News after he was charged in 2023.

Bondi takes the helm of the Justice Department without the federal prosecution experience that her predecessors have had. She served two terms as Florida’s attorney general, during which her office led lawsuits challenging the Affordable Care Act and former President Barack Obama’s immigration policies.

After leaving office in 2019, she worked as a lawyer and lobbyist for Ballard Partners, a Florida-based firm. During her tenure there, she represented corporations including General Motors, Amazon and Uber, and lobbied on behalf of the Qatari government, according to registration forms submitted to the federal government.

Bondi briefly left her post at Ballard Partners to serve as a member of Mr. Trump’s defense team during the first set of impeachment proceedings pursued by congressional Democrats in his first term. She defended Mr. Trump’s July 2019 call with President Volodymyr Zelenskyy of Ukraine, in which he pressured Zelenskyy to investigate former President Biden.

Mr. Trump was impeached by the Democrat-led House, becoming the third U.S. president to be impeached, and acquitted by the Republican-led Senate following a trial, where Bondi was part of Mr. Trump’s team.

She also spearheaded legal efforts following the 2020 election to challenge the results in Pennsylvania and falsely asserted Mr. Trump won the battleground state. Bondi told the Senate Judiciary Committee during her confirmation hearing that she accepts the results of the election.

Mr. Trump selected Bondi for attorney general after his first pick, former Rep. Matt Gaetz of Florida, withdrew his name from consideration. Gaetz had been under investigation by the House Ethics Committee for alleged sexual misconduct and illicit drug use, and he denied any wrongdoing.

Pam Bondi is an American attorney, politician, and lobbyist, best known for her tenure as the 37th attorney general of Florida from 2011 to 2019. Before becoming an attorney general, Pam had served as a prosecutor and an assistant state attorney in Hillsborough County, Florida. A staunch Republican, she is known for her campaigns against same-sex marriage and her unsuccessful lawsuit against the Affordable Care Act. She has also been in the news for her association with Donald Trump’s political campaigns. She stirred up a controversy when she dropped the idea to join a lawsuit against Trump University, after a committee she was associated with received generous donations from the Trump Foundation. She was part of Trump’s defense team for his impeachment trial in January 2020. She also spoke at the Republican National Convention in August 2020. She has been married and divorced twice, and in spite of rumors of a third marriage in 2012, she remains single.

If you want a good background on Pam Bondi – go to the search input block on the front page of this blog and type in Bondi. Many, many articles about Bondi when she was Attorney General of Florida and pay attention to the blog post with her 30-second TV add when she ran for re-election for a second 4 yr term – which she won.

here is the link to that ad  https://www.youtube.com/watch?v=jjlT8kgDQyo

https://www.pharmaciststeve.com/there-is-no-blood-on-our-hands-its-the-pharmacists-fault/

This blog post contains several new video by Matt Grant WESH Channel 2 in Orlando while Bondi was running for re-election

https://www.pharmaciststeve.com/bondi-comes-out-against-enslavement-and-abuse-of-people/

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https://www.fourstateshomepage.com/news/more-than-100-pharmacies-in-kansas-to-temporarily-close-in-protest-of-pbm-practices/

More than 100 Sunflower State pharmacies will close shop next week—to help send a message to lawmakers.

Wolkar Drug president and pharmacist Brian Caswell says on Wednesday, February 5, roughly 100 stores in 56 Kansas counties will close—including Wolkar Drug in Baxter Springs.

Roughly 400 people from those stores will be headed to Topeka—hoping to make a change in healthcare laws.

Caswell says pharmacy benefit managers—or PBM’s—have had a big, and negative, impact on the healthcare industry.

Caswell tells us PBM’s act as the middlemen between insurance companies and pharmacies—and can cause higher deductibles and even dictate what medications are covered, based on what makes them more money.

“PBM’s have been around for, like, well over 40 years, and they’ve slowly kind of changed the industry altogether and taken over. With the success of money and power, they’ve actually created a healthcare industry that’s just unsustainable right now,” said Brian Caswell, Wolkar Drug president & pharmacist.

Caswell says many pharmacists—including him—have collected letters from customers of their pharmacies in support of changes to the law to deliver to lawmakers.

He says you can help—by contacting your state and federal lawmakers and voicing your opinion.

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The reduction or elimination of a patient’s long-term opioid pain management could potentially lead to legal issues for the prescriber, but the situation is complex and depends on various factors.

Prescribers who abruptly discontinue or substantially reduce opioid therapy for patients on long-term treatment may face legal risks:

1. Potential civil liability: Healthcare providers who improperly prescribe or discontinue opioids may be held civilly liable under a negligence theory if a patient is injured as a result[1].

2. Risk of patient harm: Sudden discontinuation or substantial dose reduction can cause distressing withdrawal symptoms, inadequate pain control, and potential negative consequences for the patient’s quality of life[2].

3. Duty of care: Prescribers have a responsibility to provide appropriate pain management and to follow established guidelines for opioid therapy discontinuation or reduction[3].

However, it’s important to note that:

1. CDC guidelines: The Centers for Disease Control and Prevention (CDC) has published guidelines for responsible opioid prescribing, which may support a prescriber’s decision to reduce or discontinue opioid therapy in certain circumstances[3].

2. Tapering recommendations: Opioid use should not be decreased sharply or discontinued abruptly, but should be gradually reduced through a process known as tapering[2].

3. Informed consent: Prescribers should obtain informed consent from patients, which includes discussing potential risks and benefits of treatment, as well as alternative options[3].

Regarding civil rights or ADA violations:

1. ADA considerations: If the patient’s chronic pain condition qualifies as a disability under the Americans with Disabilities Act (ADA), they may have grounds for a claim if they can demonstrate that the prescriber’s actions resulted in discrimination or failure to provide reasonable accommodations.

2. Civil rights: It’s less clear whether this situation would constitute a civil rights violation, as opioid prescribing decisions are generally considered medical judgments rather than civil rights issues.

To minimize legal risks, prescribers should:

1. Follow established guidelines for opioid prescribing and tapering.
2. Document their decision-making process and rationale for changing opioid therapy.
3. Provide alternative pain management strategies and support for patients during tapering.
4. Ensure clear communication with patients about changes in their pain management plan.

While there is potential for legal action, the outcome would depend on the specific circumstances of the case, including the prescriber’s adherence to medical standards and guidelines, the patient’s medical history, and the impact on the patient’s health and well-being.

Citations:
[1] https://www.ue.org/risk-management/health-and-well-being/avoid-liability-for-prescription-opioid-abuse-by-student-athletes/
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC6857102/
[3] https://www.ncbi.nlm.nih.gov/books/NBK572085/
[4] https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes
[5] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2703950
[6] https://dhhs.ne.gov/DOP%20document%20library/Pain%20Management%20Pain%20Guidance.pdf
[7] https://www.azdhs.gov/documents/prevention/womens-childrens-health/injury-prevention/opioid-prevention/appendix-b-state-by-state-summary.pdf
[8] https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

Based on the search results provided, there is limited direct evidence of clinical studies supporting the validity of the Morphine Milligram Equivalent (MME) system’s conclusions. However, some relevant information can be extracted:

1. A study identified 232,913 opioid prescriptions for 49,060 unique patients from 2008-2019, which was used to validate an MME conversion framework[1]. This framework achieved high performance (F-measure of 0.97) in converting opioid prescriptions to MME values[1].

2. The MME system is used as a tool for monitoring opioid prescribing patterns and can help healthcare systems assess the variation of MME values compared to CDC guidelines published in 2016[1].

3. MME values are considered useful for associating prescribing patterns with patient outcomes and as an indicator of overdose potential[1].

However, it’s important to note that:

1. The search results do not provide specific clinical studies validating the conclusions drawn from the MME system.

2. The concept of validity in clinical studies is generally related to a measure’s ability to record or quantify what it purports to measure[4]. The search results do not provide information on clinical studies specifically testing the validity of MME-based conclusions.

3. Clinical validation typically involves demonstrating that a tool acceptably identifies, measures, or predicts clinical, biological, physical, or functional states in a defined context of use[5]. The search results do not provide evidence of such validation for the MME system.

In conclusion, while there is evidence of the MME system being used and validated for conversion accuracy, the search results do not provide specific clinical studies supporting the validity of conclusions drawn from the MME system. Further research focusing on clinical outcomes and the predictive value of MME-based assessments would be necessary to establish stronger evidence for its validity in clinical practice.

Citations:
[1] https://pmc.ncbi.nlm.nih.gov/articles/PMC9477978/
[2] https://arxiv.org/html/2501.16688v1
[3] https://pmc.ncbi.nlm.nih.gov/articles/PMC8270512/
[4] https://mmshub.cms.gov/measure-lifecycle/measure-testing/evaluation-criteria/scientific-acceptability/validity
[5] https://www.nature.com/articles/s41746-020-0260-4
[6] https://mmshub.cms.gov/2024/2024-10/mms-information-session-research-reality-translating-reliability-and-validity-findings
[7] https://health.ec.europa.eu/document/download/9f9dbfe4-078b-4959-9a07-df9167258772_en?filename=hta_clinical-studies-validity_guidance_en.pdf
[8] https://www.ewsolutions.com/managed-metadata-environment-mme-complete-walkthrough/

Based on the search results provided, there is no evidence that the Morphine Milligram Equivalent (MME) system incorporates pharmacogenomics DNA tests in its calculations of opioid therapeutic equivalence[1][2][3].

The MME system primarily relies on fixed conversion factors for different opioids to calculate their equivalent potency in relation to morphine[1][2]. These conversion factors are standardized and do not appear to take into account individual genetic variations that might affect opioid metabolism or efficacy.

The MME calculation typically uses a simple formula:

Strength per Unit × (Number of Units / Days Supply) × MME conversion factor = MME/Day[1][7]

This formula is based on the drug strength, quantity, days supplied, and a predetermined conversion factor for each opioid. It does not include any variables that would account for individual genetic differences[1][2][3].

While pharmacogenomics is an important field in personalized medicine, particularly for pain management, the current MME system as described in these search results does not incorporate genetic testing data into its calculations of opioid equivalence.

Citations:
[1] https://legislature.vermont.gov/Documents/2018/WorkGroups/Senate%20Finance/Bills/H.386/H.386~Nolan%20Langweil~MME%20Informational%20Documents~4-13-2018.pdf
[2] https://www.cms.gov/files/document/methodology-comparison.pdf
[3] https://www.fda.gov/media/150436/download
[4] https://apps.health.ny.gov/pub/ctrldocs/bne/nyosammeformulation.pdf
[5] https://pmc.ncbi.nlm.nih.gov/articles/PMC8270512/
[6] https://www.ohiopmp.gov/med_calculator
[7] https://medicaid.utah.gov/Documents/files/Opioid-Morphine-EQ-Conversion-Factors.pdf
[8] https://www.hhs.gov/guidance/document/opioid-oral-morphine-milligram-equivalent-mme-conversion-factors-0

—
Answer from Perplexity: pplx.ai/share

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Walgreen’s stock price has dropped ~ 80% over the last 5 yrs. The DOJ has been “going after” these large chains for BELIEFS that they were filling controlled Rxs for pts without a valid medical need.  As I remember this all started around 2011 – just after the Decade of Pain Law expired and not renewed.  Rite Aid is in bankruptcy with ~ 1,250 stores down from ~ 5,000 stores in 2008. CVS has stated that they are going to close 200-300 stores/yr going forward. In 2016 they peaked with > 9,600 and currently have ~ 9,150.

If one looks back to 2011 and going forward, how many times has the DOJ/DEA/State AG’s sued pharmas, wholesalers, and chain stores.  Each time, extracting multi-billion settlements for alleged violation of the CSA. It is claimed that 46% of the counties in our country has at least one area that is consider a pharmacy desert. Between 2010 & 2021, 26,145 pharmacies have closed their doors. That is SEVEN PHARMACIES A DAY CLOSING FOR 12 YEARS.

Walgreens suspends dividend, breaking 90-plus year streak of shareholder payouts

https://apnews.com/article/walgreens-suspends-dividend-stock-plunge-c1d2d0c151864821ddf04dec954039e7

Walgreens shares sank Friday, a day after the drugstore chain said it was suspending its dividend, breaking a streak of quarterly shareholder payouts that stretches back more than 90 years.

The drugstore chain said late Thursday that it made the decision in an effort to strengthen its balance sheet and improve free cash flow as company leaders try to turn around the struggling business.

Walgreens has been dealing with thin prescription reimbursement, rising costs, persistent theft and inflation-sensitive shoppers who are looking for bargains elsewhere. The company is in the early stages of a plan to close 1,200 of its roughly 8,500 U.S. locations.

The company said in a brief statement Thursday that its cash needs over the next several years for things like litigation and debt refinancing were big parts of the decision to suspend the dividend.

Earlier this month, the U.S. Justice Department filed a lawsuit in federal court accusing the drugstore chain of filling millions of prescriptions without a legitimate purpose, including some for dangerous amounts of opioids.

In September, the company said it would pay $106 million to settle separate litigation over false payment claims.

Walgreens started last year by cutting the quarterly dividend nearly in half. The company slashed the payout to 25 cents from 48 cents after spending about $1.7 billion on cash dividends in fiscal 2023.

Chief Financial Officer Manmohan Mahajan told analysts earlier this month that Walgreens still was evaluating “the appropriateness and size of our dividend as part of our capital allocation policy.”

The suspension was “prudent and somewhat overdue,” Leerink Partners analyst Michael Cherny said Thursday in a research note. He added that the divided had “become out of whack” in terms of its yield and the cash it required.

There were only two dividend suspensions last year in the S&P 500, including one from the chipmaker Intel. There generally are only a few each year.

A dividend suspension “is sending a signal to the whole world that I have a problem, and it’s cash flow and it’s not short term,” said Howard Silverblatt, senior index analyst at S&P Dow Jones Indices.

But he added that markets frequently see a dividend suspension as a positive sign initially because the company recognizes it has a problem and is taking a step to correct it.

Gabelli Funds portfolio manager Jeff Jonas said last fall that another dividend cut was likely for Walgreens.

“The balance sheet is slowly improving, but that still needs to improve further,” he said.

The company says it has paid cash dividends every quarter since 1933, a streak stretching more than 90 years or nearly 370 straight quarters.

Shares of Walgreens Boots Alliance Inc., based in Deerfield, Illinois, tumbled more than 15% to $9.66 after markets opened Friday. Broader indexes were up slightly.

The drop wiped out a brief rally the shares had after Walgreens reported better than expected earnings earlier this month. The stock has now shed more than half its value since last spring, and company shares have been on a steady decline for a decade.

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abdominoplasty –commonly known as a “tummy tuck

bunionectomy — surgically reduce a bony bump that forms at the base of the big toe

all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication

Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo (SUGAR TABS/CAPS)

The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA

According to this article, a New Class of Non-Opioid Pain Medicines – Journavx’s maker Vertex Pharmaceuticals was granted Fast Track approval.

In CONCLUSION, the med Journavx is better that placebo (sugar) doses, but pts were given Ibuprofen – no strength mentioned – for break-thru ACUTE PAIN!

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain

First Drug Approved in New Class of Non-Opioid Pain Medicines; Agency Continues to Take Steps to Support New Approaches for Pain Management

Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.  

Journavx is the first drug to be approved in this new class of pain management medicines.

Pain is a common medical problem and relief of pain is an important therapeutic goal. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery. Acute pain is often treated with analgesics that may or may not contain opioids.

The FDA has long supported development of non-opioid pain treatment. As part of the FDA Overdose Prevention Framework, the agency has issued draft guidance aimed at encouraging development of non-opioid analgesics for acute pain and awarded cooperative grants to support the development and dissemination of clinical practice guidelines for the management of acute pain conditions.  

“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo.

The safety profile of Journavx is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy, with supportive safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions.

The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx.

The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA.  

The FDA granted approval of Journavx to Vertex Pharmaceuticals Incorporated.

###

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I have read – or someone told me – that the DEA/DOJ when they RAID a practitioner’s office.  They ask the practitioner how did they know that the pt was suffering/dealing with chronic pain. They ask for the “tests” to prove that the pt was dealing with pain, but we all know that there are no test to document that the pt has pain. Apparently the DEA works under the belief that anyone getting opioid Rxs filled routinely, are just “drug seekers”  Here is one of my recent blog post where some practitioners are attempting to create a new disease that would allow all pts taking opioids regularly could being labeled with this new “medical disorder” Prescription Opioid Use Disorder (POUD) The introduction to a NEW MEDICAL DISEASE associated with opioid uses. “We” now have pharmacogenomics that will determine – via DNA test – that a pt is a fast/ultra faster metabolism and will have a biological reason to have high and/or frequent doses. It is common knowledge that the MME system is “JUNK SCIENCE”. How many and how long is the DOJ/DEA going to be able to continue to ignore the growing number of tests, that confirms that a pt is dealing with chronic pain?

Novel Biomarkers Predict Pain Sensitivity

https://www.medpagetoday.com/neurology/painmanagement/113965

Cortical activity signature may tell who will develop chronic pain

A novel biomarker signature that assessed cortical activity predicted individual pain sensitivity, the PREDICT validation study showed.

The signature consisted of two measures: sensorimotor peak alpha frequency (PAF) and corticomotor excitability (CME). In the training set, it correctly classified study participants with high or low pain sensitivity with an area under the curve (AUC) of 1.00.

In the test set, the signature had an AUC of 0.88 (95% CI 0.78-0.99), reported David Seminowicz, PhD, of the University of Western Ontario in London, Canada, and co-authors in JAMA Neurology

Results were reproduced across a range of parameters. The PAF and CME biomarkers showed good to excellent test-retest reliability.

“The combination of biomarker accuracy, reproducibility, reliability, and pain model validity suggests high potential for clinical translation, particularly in predicting the transition from acute to chronic pain,” Seminowicz and colleagues wrote.

PAF is the dominant sensorimotor cortical oscillation in the 8-12 Hz (alpha) range. CME is the efficacy of relaying signals from the primary motor cortex to peripheral muscles. Previous work showed that slower PAF before pain onset and reduced CME during prolonged pain were associated with more pain, while faster PAF and increased CME were associated with less pain.

“Given that individuals who experience higher pain in the early stages of a prolonged pain episode (e.g., postsurgery) are more likely to develop chronic pain in the future, slow PAF before an anticipated prolonged pain episode and/or CME depression during the acute stages of pain could be predictors for the transition to chronic pain,” the researchers noted.

Identifying objective biomarkers to track pain severity has been dubbed “the holy grail” of pain neuroscience, observed Prasad Shirvalkar, MD, PhD, of the University of California San Francisco, and Christopher Rozell, PhD, of the Georgia Institute of Technology in Atlanta, in an accompanying editorial

“While pain is among the most fundamental, ubiquitous, and adaptive experiences that can befall an organism, there is still a murky understanding of how pain is generated in the nervous system,” they noted. The consensus on mechanisms underlying chronic pain — pain that persists for more than 3 months, which affects 21% of U.S. adults — is even less clear.

The PAF and CME signature “will likely have broad applicability across many medical fields,” Shirvalkar and Rozell said. “If successfully translated into clinical practice, biomarkers that predict a transition to chronic pain would have a tremendous impact for the treatment of millions of individuals.”

Advances in pain biomarkers also need to incorporate advances in global neuroethics guidance and address ethical concerns about pain treatment, the editorialists pointed out. “We must take care to ensure that quantitative measures do not supplant lived experience reports, introduce distrust in the physician-patient relationship, set unrealistic patient expectations, or exacerbate existing inequalities in pain treatment across this vulnerable population,” they wrote.

The PREDICT validation study included 150 people (100 in the training set, and 50 in the test set) who were given an injection of nerve growth factor into the right masseter muscle on day 0 and day 2 to induce prolonged jaw pain that lasted up to 4 weeks.

Participants were healthy adults recruited in Australia with a mean age of 25. They had no history of chronic pain or a neurological or psychiatric condition, and 84 participants (56%) were men.

The research aimed to determine whether individuals could be accurately classified as having high or low pain sensitivity based on baseline PAF and CME readings. The researchers used electroencephalography to assess PAF and transcranial magnetic stimulation with resulting evoked potentials to assess CME on day 0, day 2, and day 5.

The primary outcomes were jaw pain on chewing and yawning. Pain sensitivity was assessed twice daily from day 1 through day 30 through self-reported pain scores.

Seminowicz and colleagues used five machine learning models on the training set. Of these, the winning classifier was logistic regression. Including sex and pain catastrophizing as covariates did not improve model performance.

The study assessed healthy participants using an experimental pain model; results may not apply to other people or other circumstances, the researchers acknowledged.

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NCPA warns CMS that many independent pharmacies won’t carry MDPN drugs

https://ncpa.org/newsroom/news-releases/2025/01/27/ncpa-cms-third-independent-pharmacies-wont-carry-drugs-negotiated

The National Community Pharmacists Association today submitted comments to the Centers for Medicare & Medicaid Services with a stern warning that more than 90 percent of independent pharmacies may decide, or have already decided, to not stock drugs in the Medicare Drug Price Negotiation Program because they will cause massive financial losses and potentially put them out of business.

“Pharmacies will have to float thousands of dollars every month waiting for refunds from the manufacturers. That will cause a massive cash flow problem in an environment where thousands of pharmacies have already closed,” said NCPA CEO B. Douglas Hoey.

In its comments, NCPA cited a recent national survey of independent pharmacists that found a jaw-dropping 93.2 percent of respondents have already decided to not stock the drugs in the program, or they are considering not stocking them.

“That will be devastating to the program,” said Hoey. “Patients who need these prescriptions will be unable to get them, because their pharmacies cannot participate in the program. It’s great the government removed big insurance’s PBMs from the negotiations and the result was lower prices for these prescription medications. That’s an important outcome for patients and taxpayers. But if almost no pharmacies can stock the drugs because they will sustain huge financial losses, the program will collapse before it even starts.”

According to the survey:

• 60.4 percent of independent pharmacists are considering not stocking one or more of the first 10 drugs listed in the Medicare Drug Price Negotiation Program.
• 32.8 percent of independent pharmacists have already decided not to stock one or more of the drugs listed in the Medicare Drug Price Negotiation Program.
• 96.5 percent of independent pharmacists said PBM and plan reimbursement for Medicare Part D threatened the viability of their business.
• 40.8 percent of independent pharmacists said they were paid below what they pay to buy the drug, approximated by the National Average Drug Acquisition Cost (NADAC), on more than 40 percent of the prescriptions they filled for Medicare Part D patients.
• 29.2 percent of independent pharmacists said they were paid below NADAC on 50 percent or more of the prescriptions they filled for Medicare Part D patients.
• 80.3 percent of independent pharmacists said the financial health of their business declined in 2024.
• 48.6 percent of independent pharmacists said the financial health of their business declined significantly in 2024.
• 30.3 percent of independent pharmacists said they are considering closing their business in Calendar Year 2025.

If CMS and the new administration want to save the program, and if they want to prevent the disappearance of many more pharmacies, they will make a number of changes, said NCPA.

Among the changes the organization proposed, CMS should bar PBMs from requiring pharmacies to participate in the program in order to serve Medicare Part D patients, and it must also give pharmacies the ability to cancel PBM contracts without cause. NCPA made many additional recommendations, which can be viewed here.

Click here to view the entire NCPA survey.

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Online advertising of compounded GLP-1 receptor agonists often doesn’t meet federal advertising rules

Online advertising of compounded GLP-1 receptor agonists often doesn’t meet federal advertising rules

Researchers investigated whether online sellers of compounded formulations of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) — popular diabetes control and weight loss agents — adhere to federal advertising rules. The law requires that marketing for all prescription medications, even compounded products not approved by FDA, be “truthful, non-misleading, and accurate.” To gauge the level of compliance among vendors of GLP-1 RAs, which are frequently sourced online, study authors identified 98 unique websites offering any form of semaglutide, tirzepatide, or liraglutide between July and September 2024. Most of them — 79 out of 98 — sold compounded versions and all but two provided prescriptions for compounded GLP-1 RAs. Further analysis revealed that websites were not always forthcoming with pertinent information and at times were downright misleading. Nearly one-half failed to report adverse effects, warnings and precautions, and contraindications. More than 36% stated or suggested that compounded GLP-1 RAs were approved by FDA, and about 40% featured an efficacy claim not included in the FDA-approved label on branded versions. Some did not even disclose that the drugs were compounded. “The FDA could require websites to explicitly disclose and define compounding, including lack of FDA approval; institute unique naming conventions for compounded medications; and be given greater authority to act against misleading compounded medication advertising,” the investigators offer as regulatory strategies for meeting truthful advertising standards.

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FTC sues, chides CVS and Cigna as part of PBM probe

https://ncpa.org/newsroom/qam/2025/01/23/ftc-sues-chides-cvs-and-cigna-part-pbm-probe

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With this law, the actual who/what is guilty is what asset is confiscated. How does a house/boat/stack of money defend themself? With the majority of the currency forfeited is < $500, the cost of trying to retrieve the asset by proving it is not ill gotten gain, what is the cost of hiring an attorney to go to trial? Since many of the assets are confiscated by an attorney from the DOJ, prosecutor or district attorney, so when the “guilty party” goes to court, it is up against the attorney who first decided that the asset was ill gotten gain. Bureaucrats that seize and confiscate – especially currency – they are allowed to put it in their coffers to spend as they wish for some “toy” they want for their department.

what is the total dollars that bureaucrats- at all levels federal/state/county/city – have confiscated money from companies and individuals that were never convicted of any crime using our civil assets forfeiture law?

Since 2000, civil asset forfeiture has resulted in at least $68.8 billion being confiscated by federal, state, and local governments in the United States. This figure includes assets seized from individuals and companies without requiring a criminal conviction, but it is likely an undercount due to incomplete data from many states[4].

In 2014 alone, federal forfeitures amounted to over $5 billion, surpassing the $3.5 billion stolen by burglars that year[7]. In recent years, annual forfeitures have remained substantial. For example, in 2021, the U.S. Marshals Service handled over 17,000 assets through forfeiture[5], and California reported $33.8 million in state-level forfeitures plus $11.8 million in federal equitable sharing funds[2].

While exact totals across all levels of government are challenging to calculate due to inconsistent reporting and varying laws, civil forfeiture remains a significant source of revenue for law enforcement agencies nationwide[8].

Citations:
[1] https://www.justice.gov/afp/file/5-yr_forfeiture_trends.pdf/dl
[2] https://oag.ca.gov/system/files/media/2021-af.pdf
[3] https://www.leg.state.nv.us/Session/77th2013/Exhibits/Senate/JUD/SJUD305I.pdf
[4] https://ij.org/press-release/new-report-finds-civil-forfeiture-rakes-in-billions-each-year-does-not-fight-crime-2/
[5] https://www.usmarshals.gov/what-we-do/asset-forfeiture/fact-sheet
[6] https://www.govinfo.gov/content/pkg/CHRG-106shrg66959/html/CHRG-106shrg66959.htm
[7] https://en.wikipedia.org/wiki/Civil_forfeiture_in_the_United_States
[8] https://ij.org/report/policing-for-profit-3/pfp3content/forfeiture-is-lucrative-for-governments-nationwide/
[9] https://www.aclu-il.org/sites/default/files/field_documents/asset_forfeiture_in_illinois.pdf

A significant portion of civil asset forfeiture proceeds come from individuals who were never found guilty of any crime. While exact figures are difficult to determine due to inconsistent reporting across jurisdictions, several key statistics highlight this issue:

1. In South Carolina, 19% of people targeted for civil forfeiture over a three-year period were never arrested, and nearly 800 people were charged with a crime but not convicted[1].

2. In Philadelphia, only about 1 in 4 respondents in a study was found or pleaded guilty to wrongdoing, yet 69% saw their property forfeited permanently[4].

3. Nationwide, since 2000, states and the federal government have forfeited at least $68.8 billion through civil asset forfeiture[2]. While this total includes seizures from both convicted criminals and innocent individuals, a substantial portion likely comes from people never found guilty.

4. The median value of forfeitures is relatively low in many states. For instance, in Michigan, half of all civil forfeitures of currency were worth less than $423, and in Pennsylvania, the median value was $369[3]. These low values suggest that many seizures target ordinary citizens rather than major criminals.

5. In 2014, federal asset forfeiture accounted for over $5 billion, surpassing the $3.5 billion stolen by burglars that year[7]. This comparison illustrates the scale of civil forfeiture and suggests that a significant portion may come from non-criminal seizures.

While it’s impossible to provide an exact dollar amount, these statistics indicate that billions of dollars have likely been confiscated from individuals never found guilty of a crime through civil asset forfeiture.

Citations:
[1] https://eji.org/news/south-carolina-civil-forfeiture-disproportionately-targets-black-men/
[2] https://ij.org/press-release/new-report-finds-civil-forfeiture-rakes-in-billions-each-year-does-not-fight-crime-2/
[3] https://www.propublica.org/article/police-say-seizing-property-without-trial-helps-keep-crime-down-a-new-study-shows-theyre-wrong
[4] https://ij.org/report/frustrating-corrupt-unfair/
[5] https://standtogether.org/newsroom/constitutionally-limited-government/civil-asset-forfeiture-statistics-abuse-stand-together-trust
[6] https://www.templeton.org/news/how-policing-for-profit-disproportionately-affects-poor-and-minority-groups
[7] https://en.wikipedia.org/wiki/Civil_forfeiture_in_the_United_States
[8] https://walberg.house.gov/media/in-the-news/epoch-times-civil-forfeiture-how-government-makes-billions-taking-americans

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