DOJ Subpoenas Doctors Over Youth Gender Care

Posted on July 10, 2025 by Pharmaciststeve

DOJ Subpoenas Doctors Over Youth Gender Care

https://www.medpagetoday.com/washington-watch/washington-watch/116458

The U.S. Department of Justice (DOJ) announced that it had sent more than 20 subpoenas to doctors and clinics “involved in performing transgender medical procedures on children.”

Though additional details on the subpoenas and their recipients were not immediately available, the department said investigations include healthcare fraud and false statements.

“Medical professionals and organizations that mutilated children in the service of a warped ideology will be held accountable by this Department of Justice,” Attorney General Pamela Bondi said in a statement.

The issue also came up in a Wednesday workshop held by the Federal Trade Commission (FTC) on “unfair or deceptive trade practices” in gender-affirming care for youth.

Speaking at the event, Chad Mizelle, chief of staff at the DOJ, noted that “there’s a basic principle of law, you cannot deceive consumers.”

“You cannot lie to them to get them to buy your products, use your services,” Mizelle said. “You cannot commit fraud. This is true in providing medical services, but also more generally. There’s no doubt in my mind, based not only on what we’ve heard here today, but just looking around with our own eyes, that the industry that is formed around providing gender-affirming care and transitioning services for children has perpetuated one of the greatest frauds on the American public.”

“One of the most important tasks of government is to prevent this fraud from continuing and to remedy the consequences of this fraud,” he added.

The subpoenas are just the latest in a string of actions taken by the Trump administration regarding gender-affirming care for youth.

In January, President Donald Trump issued an executive order entitled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.”

And in May, a 409-page report from HHS urged therapy for transgender youth rather than broader gender-affirming care, questioning standards of treatment issued by the World Professional Association for Transgender Health (WPATH). The Associated Press noted at the time that the report was likely to be used to support the federal government’s “abrupt shift in how to care for a subset of the population that has become a political lightning rod.” Medical experts sharply criticized the report as inaccurate.

Also in May, CMS announced that it had sent a letter to certain hospitals “performing pediatric sex trait modification procedures outlining urgent concerns with both the quality standards adherence and profits related to these harmful procedures.”

In June, the FBI issued a public plea on X: “As the Attorney General has made clear, we will protect our children and hold accountable those who mutilate them under the guise of gender-affirming care.” It then asked for reports of any hospitals, clinics, or practitioners performing these surgical procedures on children.

Additionally, the HHS Office for Civil Rights began an investigation into a major health system in Michigan regarding allegations that a healthcare provider there fired a medical professional for “exercising her federally protected rights of conscience” after requesting religious accommodation from certain employment practices. These included “requiring use of patient pronouns that do not align with the patient’s sex,” and “assisting in certain sex trait modification procedures.”

And earlier this month, the Wall Street Journal reported that the Trump administration was weighing whether to cut funding to hospitals that provide gender-affirming care for youth.

In a statement to MedPage Today, WPATH and its U.S. arm, USPATH, said the FTC workshop “sends a discouraging and unfortunate message – that the lives and very existence of transgender and gender-diverse youth are somehow up for debate. Let us be perfectly clear: they are not.”

“Transgender and gender diverse youth are human beings deserving of dignity, respect, and the freedom to access healthcare that can improve their lives and well-being in consultation with their parents and doctors,” the statement said. It continued that the workshop was a way for the federal government to “platform misinformation, further sow division, and weaponize patient-doctor relationships to pursue a purely political agenda.”

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Judge Orders CVS’ Omnicare Unit to Pay $949 Million Over Invalid Prescriptions

Posted on July 9, 2025 by Pharmaciststeve

Judge Orders CVS’ Omnicare Unit to Pay $949 Million Over Invalid Prescriptions

https://gvwire.com/2025/07/08/judge-orders-cvs-omnicare-unit-to-pay-949-million-over-invalid-prescriptions/

  • The pharmacy giant was accused of filing more than 3.3 million false claims for reimbursement by the U.S. government.
  • The fraudulent claims surfaced as a result of a whistleblower lawsuit filed by a former Omnicare pharmacist.
  • Omnicare improperly billed Medicare, Medicaid, and Tricare for prescriptions for tens of thousands of patients in assisted-living and other long-term care facilities

NEW YORK — A federal judge ordered CVS Health’s Omnicare unit to pay $948.8 million in penalties and damages, in a whistleblower lawsuit claiming it fraudulently billed the U.S. government for invalid drug prescriptions.

In a Monday evening order, U.S. District Judge Colleen McMahon in Manhattan imposed a $542-million penalty for filing 3,342,032 false claims between 2010 and 2018.

McMahon also awarded $406.8 million of damages, representing three times the $135.6 million that a jury awarded on April 29.

The tripling was required under the federal False Claims Act, which lets whistleblowers sue on behalf of the federal government and share in recoveries.

CVS plans to appeal the judgment. The Woonsocket, Rhode Island-based drugstore chain and pharmacy benefits manager bought Omnicare in 2015. Omnicare has asked McMahon to throw out the case or grant a new trial.

“This lawsuit centered on a highly technical prescription dispensing recordkeeping issue that was allowed by law in many states,” CVS said in a statement on Tuesday. “There was no claim in this case that any patient paid for a medication they shouldn’t have or that any patient was harmed.”

The lawsuit was filed in 2015 by Uri Bassan, a former Omnicare pharmacist in Albuquerque, New Mexico, and joined by the federal government in 2019.

Lawsuits Alleged Improper Billing

They said Omnicare improperly billed Medicare, Medicaid, and Tricare, which serves military personnel, for prescriptions for tens of thousands of patients in assisted-living facilities, group homes for people with special needs, and other long-term care facilities.

Omnicare allegedly assigned new prescription numbers without necessary paperwork and pharmacist approvals, after the original prescriptions expired or ran out of refills.

McMahon rejected CVS’ argument that a $948.8-million award violated the U.S. Constitution’s prohibition against excessive fines under the Eighth Amendment.

“This was a very big fraud on the government, one that lasted over almost a decade, and one that Omnicare was aware of but avoided taking steps to correct,” the judge wrote.

McMahon found CVS jointly liable with Omnicare for $164.8 million of the penalties, after jurors found it failed to stop Omnicare from submitting 30% of the false claims after buying that company. CVS itself did not submit any claims.

The case is U.S. ex rel Bassan v. Omnicare Inc, U.S. District Court, Southern District of New York, No. 15-04179.

 

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Google – Gemini AI – is out after your data on your Android cell phone

Posted on July 9, 2025 by Pharmaciststeve

The message below is going around the web and apparently Google has decided to let their AI program Gemini to have access to all the data on a Android cell phone, unless you do specific things to stop it from doing this. Remember your data is part of the next “gold rush” and worth a lot money to Goggle and whoever Google sells your data to

 

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Switch to Dry-Powder Inhaler Worsened COPD, Asthma Patient Outcomes

Posted on July 8, 2025 by Pharmaciststeve

Switch to Dry-Powder Inhaler Worsened COPD, Asthma Patient Outcomes

Veterans Affairs formulary change acted as a “natural experiment” for the study

https://www.medpagetoday.com/pulmonology/smokingcopd/116412

Key Takeaways

  • Switching from a metered-dose to a dry-powder inhaler after a formulary change increased emergency department visits and hospitalizations in people with COPD or asthma.
  • The absolute changes in risk were small.
  • The findings suggested potential harm from the switch, with the medication, the device, and other factors potentially contributing.

Shifting from a metered-dose inhaler to a dry-powder inhaler for chronic obstructive pulmonary disease (COPD) and asthma in one healthcare system formulary led to increased healthcare utilization, a study showed, suggesting potential harm.

Patients who were switched from budesonide-formoterol metered-dose inhaler (Symbicort) to fluticasone-salmeterol dry-powder inhaler (Wixela Inhub) had 5% more all-cause emergency department visits and more hospitalizations as well — increases of 8% overall, 10% respiratory-related, and 24% pneumonia-related — as compared with pre-change rates in a within-person, self-controlled case series.

The absolute differences in hospitalizations in a matched observational cohort of those who switched and those who didn’t were 0.49 percentage points more for switchers overall, 0.41 percentage points more for respiratory causes, and 0.12 percentage points more for pneumonia over 180 days.

These findings suggested “potential harm and the need to reevaluate this policy change,” researchers led by Alexander Rabin, MD, of the Veterans Affairs Ann Arbor Healthcare System in Michigan, reported in JAMA Internal Medicine

Dry-powder inhalers eliminate the hydrofluorocarbon propellants used in metered-dose inhalers, which could reduce healthcare-related greenhouse gas emissions

However, dry-powder inhalers put different demands on patients “Metered-dose inhalers deliver medication to the lungs independent of inspiratory effort but require patients to coordinate actuation with inhalation, whereas dry-powder inhalers rely on rapid, deep inhalation to minimize oropharyngeal deposition, which may be difficult for patients with diminished lung function,” the researchers explained.

Using the “natural experiment” of the Veterans Health Administration’s formulary change in July 2021, the investigators followed outcomes for all 260,268 patients on combination inhaler therapy for treatment of COPD and asthma both before and after the formulary change.

The primary analysis was a self-controlled case series of the 260,268 patients already on budesonide-formoterol before the formulary change who were switched to fluticasone-salmeterol. Their median age was 71 years, 91% were male, and 69% had COPD, while 32% had asthma.

Findings were “robust” across sensitivity and subgroup analyses, the team reported.

Of these patients who switched inhalers and experienced the adverse outcomes of interest, the findings showed that during treatment with fluticasone-salmeterol dry-powder inhaler therapy there were:

  • 10% fewer albuterol fills (incidence rate ratio [IRR] 0.90, 95% CI 0.90-0.91)
  • 2% more prednisone fills (IRR 1.02, 95% CI 1.01-1.03)
  • 5% more all-cause emergency department visits (IRR 1.05, 95% CI 1.04-1.06)
  • 8% more all-cause hospitalizations (IRR 1.08, 95% CI 1.06-1.09)
  • 10% increased respiratory-related hospitalizations (IRR 1.10, 95% CI 1.07-1.14)
  • 24% more pneumonia-specific hospitalizations (IRR 1.24, 95% CI 1.17-1.31)

To eliminate the risk of temporal confounding with a self-controlled analysis and to be able to generate absolute risk differences, the researchers also completed a cohort study with 167,331 patients who switched to fluticasone-salmeterol dry-powder inhaler therapy matched with 91,226 patients who continued receiving other inhaler therapy.

No difference was seen in 90- or 180-day mortality nor in albuterol or prednisone fills between groups.

Limitations of the study included inability to directly measure inhaler use, the largely older male population, and the focus on relatively short-term outcomes.

“A key question raised by our study is whether the increased incidence of adverse outcomes among patients who switched to the dry-powder fluticasone-salmeterol inhaler was associated with the medication, the device, or other factors. The answer likely involves all three factors,” the investigators suggested.

In terms of the medication, industry-sponsored head-to-head comparisons of the two inhaler combinations have shown similar clinical efficacy, but “other studies indicate that fluticasone is associated with a higher pneumonia risk than budesonide, likely due to its more sustained systemic and local immunosuppressive effects,” Rabin and colleagues wrote.

A relative unfamiliarity with dry-powder inhalers might have decreased tolerance, worsening disease control, while “older patients with COPD may also have struggled to generate sufficient inspiratory force for effective dry-powder drug delivery,” the group added. Forced device switching can decrease medication adherence too, with errors in inhalation technique worsening clinical outcomes.

“Implementation strategies likely play a role in lessening the impact associated with inhaler formulary changes: how transitions are implemented may be as important as the choice of drug or device,” the researchers concluded. “Structured inhaler education and clear patient and health care professional communication during formulary changes are essential to minimize interruptions in care. Regular reassessment of inhalation technique and peak flow monitoring may also improve dry-powder drug delivery among patients who switch to this device class.”

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Let’s get to the CHASE – why your Rx COST SO DAMN MUCH!

Posted on July 8, 2025 by Pharmaciststeve

I have always contended that the average Rx price went up in direct proportion of the percentage of the Rx market that the PBM’s controlled
Look at the chart below, as the percentage of generics increased, which should have showed the average Rx price would have been lower, but the percentage of the Rx market place that the PBM controlled. The average Rx price went up.

How Insurance/PBM industry use PAs to pad their bottom line

 

 

 

 

 

 

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Clinical Trial Sheds Light on Daily CBD Use and Liver Enzymes

Posted on July 7, 2025 by Pharmaciststeve

Clinical Trial Sheds Light on Daily CBD Use and Liver Enzymes

https://www.medpagetoday.com/gastroenterology/generalhepatology/116386

Key Takeaways

  • Daily CBD use at typical consumer doses led to significant liver enzyme elevations in healthy adults.
  • About 6% of CBD users had liver enzymes over three times the normal upper limit.
  • CBD use is common in the U.S. and should be part of routine medical screening in certain patients.

Some trial participants had peak levels ten times higher than normal upper limit

Daily use of cannabidiol (CBD) at doses commonly reported by consumers was associated with potentially dangerous increases in liver enzymes, a randomized clinical trial found.

Among 201 healthy adult participants followed for 28 days, eight (5.6%) of those randomized to CBD had liver enzyme levels greater than three times the upper limit of normal (ULN) compared with none in the placebo group, said a team of FDA scientists led by Jeffry Florian, PhD, of the FDA’s Center for Drug Evaluation and Research in Silver Spring, Maryland.

Five individuals (3.3%) experienced peak aminotransferase levels greater than five times the ULN, and two (1.3%) had aminotransferase levels greater than 10 times the ULN, with the highest more than 18 times higher. These seven participants met criteria for drug-induced liver injury, Florian’s team reported online in JAMA Internal Medicine

Eosinophilia was also observed in seven of the eight individuals with elevated liver enzymes. However, no participants experienced jaundice or clinical symptoms related to impaired liver function, and liver enzymes normalized within 1 to 2 weeks of discontinuing CBD, the researchers said.

“This clinical trial is part of the FDA efforts to understand the safety of CBD products and inform discussions about safeguards and oversight to manage and minimize risks with CBD products. These findings may have important implications for consumers who may otherwise be unaware of potential safety risks,” Florian and colleagues wrote.

“Given the growing popularity of unregulated CBD-containing products in the market and the ability of CBD to cause liver enzyme level elevations, inclusion of CBD use as part of routine medical screening could be considered, particularly in patients with existing liver conditions or those taking medications metabolized by the liver,” they added. “For patients presenting with elevated liver enzymes, CBD use could be considered in the differential diagnosis.”

In an accompanying editorial, Nathan Stall, MD, PhD, of the University of Toronto, and Kenneth Covinsky, MD, MPH, of the University of California San Francisco, noted that data from the 2022 National Survey on Drug Use and Health indicated that more than 20% of U.S. adults reported using CBD in the past year. “Given the high use and increasing access to CBD without a prescription, the study by Florian et al raises several important concerns,” they wrote.

The results “underscore that clinicians should be aware of CBD-associated hepatoxic effects and screen patients with elevated liver enzyme levels for CBD use. Finally, regulators should balance the free market proliferation of CBD with the need for increased public awareness and clinical vigilance,” Stall and Covinsky said.

The randomized, double-blinded, placebo-controlled trial was conducted from January to August 2024 using per protocol analysis. It included healthy adults recruited from a clinical pharmacology unit. Participants were randomized to CBD 5 mg/kg/d (2.5 mg/kg/d twice daily), or placebo for 28 days. Laboratory assessments were done weekly. The primary endpoint was the percentage of participants with an alanine aminotransferase or aspartate aminotransferase level elevation greater than three times the ULN during the study.

Limitations included that the study enrolled healthy participants between 18-55 years of age who were not taking other medications and who had no comorbidities that could have increased their susceptibility to hepatic enzyme level elevations, so impacts on populations outside these conditions were not captured. In addition, the study’s short duration could not determine potential longer-term health effects. Because dosing was discontinued when elevated liver enzymes were observed, it is not known whether they would have resolved on their own or escalated further.

Finally, the researchers noted, the CBD dosing in the study was within the range of reported consumer use, but it was on the higher end and administered twice daily. “While many consumers report taking unregulated CBD more than once daily, most consume it less frequently. In addition, given the reports of inaccurate labeling of some over-the-counter CBD products, it is possible that individuals self-dosing CBD are consuming different doses than expected,” they said.

 

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The DOJ/DEA AGENDA doesn’t seem to align with the FACTS & TRUTH

Posted on July 7, 2025 by Pharmaciststeve

The Decade of Pain Law expired in 2009-2010 and the political majority of  Congress had FLIPPED and it was not renewed.

Between 1985 and 2025 our population has increased 43%. Between 2010 & 2025 the MME/capita reduced 54 %

The number of opioid Rxs filled peaked 2010-2012.

Between 2010 & 2023 number of filled opioid Rxs dropped 69%

The graphic directly below is from ~ 2014.

 

 

 

 

 

If you look at the last graphic on this page, notice that OD/poisoning was flat to lower from 2012 on Rx opioids, but OD/poisoning from synthetic opioids (illegal Fentanyl, etc) went from abt 5,000 to 70,000 by 2021. while at abt the same time frame filled Rx opioids dropped 64%. 

Maybe someone should asked the DOJ/DEA how they come to the conclusion that Rx opioids is behind all the increased OD/poisoning over abt 14 yr period, when the number of filled Rx opioids dropped down by nearly 2/3 in the same/similar time frame.  Maybe the DOJ/DEA’s agenda is based on outdated facts and just working on their fabricated opinions.

 

 

 

 

 

 

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IMAGINE THIS: Louisiana filed several lawsuits accusing pharmaceutical giant CVS of abusing customer information

Posted on July 2, 2025 by Pharmaciststeve

Louisiana files lawsuits alleging pharmaceutical giant CVS deceived customers in text messages

https://apnews.com/article/louisiana-cvs-lawsuit-text-message-liz-murrill-landry-38cfcac6ff3bed3ce6358ca7bab34214

NEW ORLEANS (AP) — Louisiana filed several lawsuits accusing pharmaceutical giant CVS of abusing customer information and using its dominant market position to drive up drug costs and unfairly undermine independent pharmacies, the state’s attorney general said Tuesday.

Attorney General Liz Murrill began investigating CVS after the company sent out mass text messages to thousands of residents on June 11 to lobby against legislation that took aim at its business structure. The texts warned that medication costs could go up and all CVS pharmacies in the state would close.

The lawsuits, which were filed Monday in central Louisiana’s St. Landry Parish, seek “injunctive relief, civil penalties and restitution,” Murrill said.

CVS “abused customers’ sensitive information to push a political message,” Republican Gov. Jeff Landry said Tuesday at a press conference.

He noted CVS had lobbied his wife over text via the same messaging chain normally used to notify her about picking up a prescription drug or other healthcare-related matters.

One lawsuit argues that the text message lobbying constituted “unfair or deceptive acts” in violation of state trade law. Two Louisiana-based law firms have filed a separate class action lawsuit against CVS over the text messages.

CVS has denied any wrongdoing.

“Our communication with CVS customers, patients and members of the community was consistent with the law,” CVS said in an emailed statement. “We believe it was important for people to know about a potential disruption to where they get their medicine.”

Two other lawsuits allege that CVS artificially inflates prices for consumers and independent pharmacies.

CVS serves as a pharmacy benefit manager — essentially an intermediary that buys medication from manufacturers and distributes drugs to pharmacies.

CVS and the mail-order pharmacy Express Scripts dominate the market by processing about eight out of every 10 prescription drug claims, according to the Federal Trade Commission, which warned in a 2024 report that this allows for “inflating drug costs and squeezing Main Street pharmacies.”

Because CVS also owns a vast network of retail pharmacies — including 119 in Louisiana — it sets the terms for how prescription drugs are sold to customers there.

The proposed law that sparked the text messages from CVS had sought to ban pharmacy benefit managers like CVS from owning drug stores. The law failed to pass, but Landry has stated he will seek to revive it.

In the state’s litigation, Murrill alleges that CVS business structure and practices allow the company to “manipulate prices, restrict competition and channel profits internally.”

One lawsuit accuses CVS of “systematically under-reimbursing independent Louisiana pharmacies to the point of economic hardship, while routing patients to CVS-owned facilities.” The lawsuit alleges that CVS imposes “unethical, unscrupulous, and exorbitantly high fees on independent pharmacies.”

CVS said that it should not have to pay higher rates for “less efficient pharmacies” and that this would lead to “higher costs for consumers.”

“Importantly, CVS Pharmacy remains the lowest cost pharmacy and a critical partner in lowering prescription drug costs for Louisianans,” the company said.

Another lawsuit argues that CVS uses its market control to exclude lower-cost drugs for “high-rebate, high-price brand drugs” and other practices that “distort the drug market” and “drive up costs for the state’s public health programs and its citizens.”

CVS said that its business structure allows for “better access, affordability, and advocacy for those we serve.” The company said that removing CVS pharmacies from Louisiana would increase costs to the state by more than $4.6 million.

Landry said he would seek new legislation targeting CVS if existing laws were insufficient to win in court.

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Microsoft’s new AI can be 4x more accurate and 20% cheaper than human doctors — Mustafa Suleyman calls it “a genuine step toward medical super intelligence”

Posted on July 1, 2025 by Pharmaciststeve

Satya Nadella’s vision to deliver real-life change using AI might have just manifested through the company’s latest AI health system.

https://www.windowscentral.com/software-apps/microsoft-new-ai-4x-more-accurate-20-percent-cheaper-than-human-doctors

With the rapid emergence and prevalence of generative AI, job security remains a top concern for most professionals, aside from security and privacy. As the technology becomes more advanced, it’s becoming more apparent that it could take over some jobs.

Salesforce CEO Marc Benioff recently revealed that the company is using AI to automate up to 50% of its work. As you might already know, the executive indicated that the company was “seriously debating” hiring software engineers in 2025, citing “incredible productivity gains” from agentic AIs.

As it now seems, medicine could be on AI‘s chopping block. This is after Microsoft recently claimed that its new powerful AI-powered tool can diagnose diseases up to four times more accurately than a human doctor (via WIRED).

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Association Between Concurrent Prescription Opioid and Benzodiazepine Use and Risk of Opioid-Related Overdose

Posted on June 29, 2025 by Pharmaciststeve

This article is fairly wordy. There is a hyperlink below where you can pull it up and read it.  However, the chart below is pretty telling

Key Points

Question  How does the risk of overdose change with the number of days with concurrent opioid and benzodiazepine use?

Findings  In this cohort study of US Medicare data, the overdose risk associated with concurrent benzodiazepine use changed over time. Concurrent benzodiazepine use was associated with a 5-fold increase in the risk of opioid-related overdose during the initial 90 days and an increase of 1.87 times on days 91 to 180.

Meaning  Policy interventions should focus on preventing concurrent opioid and benzodiazepine use in the first place instead of reducing the length of concurrent use. Patients using both medications should be closely monitored, particularly during the first days of concurrent use.

Association Between Concurrent Prescription Opioid and Benzodiazepine Use and Risk of Opioid-Related Overdose

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2685628

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