Safety and Risk Assessment of No-Prescription Online Semaglutide Purchases

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821882

The popularity of branded semaglutide is surging, with widespread media coverage, viral social media exposure, and celebrity endorsements.¹ Although Wegovy (Novo Nordisk) is approved for long-term weight management, Ozempic (Novo Nordisk) (only approved for type 2 diabetes) is often used off-label for this purpose. Global regulatory agencies, including the US Food and Drug Administration (FDA), European Medicines Agency, and World Health Organization (WHO), have warned about fake versions driven by patient demand, high cost, and shortages. Illegal online pharmacies, which operate without valid licenses and sell medicines like semaglutide without prescription, represent a consumer risk for ineffective and dangerous products.

In this qualitative study, we conducted risk assessment of semaglutide online sourcing (Figure and eAppendix in Supplement 1). We followed the SRQR reporting guideline.

First, we conducted structured searches on Google and Bing to catalog websites advertising semaglutide without a prescription in July 2023. Websites meeting inclusion criteria were selected for a product test buy protocol.² Two 0.25-mg per dose prefilled pens or equivalent semaglutide injection vials were ordered from each website. Upon product receipt, authors (A.R.A., and A.F.) used the International Pharmaceutical Federation’s (FIP) checklist for visual inspection to assess potential counterfeiting or falsification risks, compared with genuine Ozempic brand 1-mg semaglutide solution for injection in a prefilled pen.³ Products were then tested for quality, including sterility and microbiological contamination, according to European Pharmacopoeia and US Pharmacopeia guidelines. Quantification of active ingredients was performed using liquid chromatography–mass spectrometry (LC-MS). Test purchases and analytical testing were performed August from 2023 to March 2024.

Search engine monitoring generated 1080 hyperlinks, with 317 (29.35%) for online pharmacies. Nearly one-half (134 sites [42.27%]) belonged to illegal pharmacy operations; 763 links were websites not offering products for sale, including 615 news and informational websites and 148 telemedicine websites requiring consultation to obtain prescription before purchase.

Six online vendors classified as not recommended or rogue by LegitScript and/or National Association of Boards of Pharmacy and offering parenteral semaglutide products were included in test buys. Three websites offered prefilled 0.25-mg per dose semaglutide injection pens, and 3 sold vials of lyophilized semaglutide to be reconstituted to solution for injection (1-3 mg). All vendors referred to weight loss and obesity on their product page. Prices for the smallest dose and quantity ranged from US $113 to $360 (mean [SD], US $218.5 [$93.6]) (Table).

Test purchases were confirmed via email and WhatsApp. Of 6 products purchased, only 3 were received. Three vendors selling Ozempic injections engaged in nondelivery scams requesting extra payments (range, US $650-$1200) to purportedly clear customs, confirmed as fraudulent by customs agencies. Although genuine Ozempic scored the full 22 points on the FIP checklist, test purchased products scored 8 or 9 with clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed.

Upon quality testing, one sample had elevated presence of endotoxin (8.95 EU/mg) indicating possible contamination, although no viable microorganisms were detected. LC-MS revealed the presence of semaglutide in all samples, but with considerably lower purity levels (7%-14% vs advertised 99%). The measured semaglutide content substantially exceeded the labeled amount in each sample by 29% to 39%, meaning that users could receive up to 39% more semaglutide per injection. These risk factors indicate likely falsification that does not meet legitimate product quality standards.

This qualitative study found that semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products. Two websites evaluated were sent FDA warning letters for unlawful sale of unapproved and misbranded semaglutide.^4,5 US poison centers have reported a 1500% increase in calls related to semaglutide, highlighting the need for enhanced pharmacovigilance including for online sourcing harms.⁶ Study limitations include limited sample of products tested due to nondelivery scams. Furthermore, although tested products represent some accessible semaglutide products sold online, higher priced offerings were excluded, limiting generalizability of the findings.

Filed under: General Problems | Leave a Comment »

I remember that period very well, I had just graduated from Butler U in May 1970. I passed my first pharmacy board test and got licensed in July 1970 in KY. I now had my Pharmacist license and a job with a regional chain which – at the time – was a good income, so “we” decided to add to our family and what turned out to be our only Daughter was born in Aug 1971. I remember when gasoline increased to the awful level of the $0.40/gal range, and fuel was rationed. But $.45/gal in 1973 was like gas at $2.62/gal in 2020. Wasn’t fuel ~ $2.00/gal at the end of 2020? How much are you paying for fuel today? You could only purchase fuel on odd or even days- based on the last digit of your license plate. The speed limit on all the interstates was lowered to 55 MPH. I remember people talking about if fuel got to $1.00/gal. They were going to stop driving.

In hindsight, the only real winner from these price controls – was Nixon himself – because it helped him get elected to a second term.  He ended up resigning after “The Watergate scandal” at abt 16 months into his second term. Of course, Nixon’s (abbreviated) second term was plagued by a stock market crash, a surge in inflation, and the 1973 oil crisis. With this fall’s election are we looking at the possibility of history repeating itself?

Did Nixon’s price freeze influence future U.S. economic policies

Nixon’s price freeze, part of his New Economic Policy in 1971, had a significant impact on future U.S. economic policies, although not always directly. The immediate effect of the price freeze was a temporary halt in inflation, but it did not solve underlying economic issues, and inflation re-emerged once the controls were lifted[1][2][3].

The price freeze and associated measures, such as ending the dollar’s convertibility to gold, marked the end of the Bretton Woods system and led to a shift towards a system of floating exchange rates[2][3][5]. This transition had a lasting influence on international monetary policy.

Domestically, Nixon’s use of wage and price controls was a notable departure from traditional economic policy and demonstrated the government’s willingness to intervene directly in the economy during times of crisis. However, the long-term economic instability that followed, including stagflation in the 1970s, led to skepticism about the effectiveness of such controls[3][4].

While Nixon’s price freeze itself did not directly influence specific future policies, it contributed to a broader understanding of the limitations of wage and price controls and the importance of addressing structural economic issues. The experience highlighted the challenges of balancing inflation control with economic growth, influencing future economic strategies and policies in the U.S.[4][5].

Citations:
[1] https://www.counterpunch.org/2022/09/22/nixons-famous-price-freeze-did-stop-inflation/
[2] https://www.federalreservehistory.org/essays/gold-convertibility-ends
[3] https://en.wikipedia.org/wiki/Nixon_shock
[4] https://millercenter.org/president/nixon/domestic-affairs
[5] https://history.state.gov/milestones/1969-1976/nixon-shock
[6] https://time.com/archive/6876939/the-nation-nixons-freeze-and-the-mood-of-labor/
[7] https://www.pbs.org/wgbh/commandingheights/shared/minitext/ess_nixongold.html
[8] https://www.wsj.com/articles/nixon-fight-inflation-price-controls-stagflation-gas-shortages-biden-democrats-reconciliation-bill-federal-reserve-11628885071

Was President Nixon’s second price freeze more successful than the first 90-day price freeze

President Nixon’s second round of price controls, which followed the initial 90-day freeze, was not more successful than the first. The initial freeze, implemented in August 1971, was considered a short-term success because it temporarily halted inflation and was popular with the public and business leaders. However, the subsequent phases of price controls, which were intended to maintain the initial gains, did not achieve the same level of success.

The second round of controls aimed to be more flexible but faced significant challenges. Inflation returned after the controls were lifted, and the broader economic issues were not addressed. This led to economic instability and contributed to the stagflation of the 1970s, characterized by high inflation and unemployment.

While the initial price freeze was seen as a bold and effective move in the short term, the longer-term effects of the extended price controls were less favorable. Inflation eventually rose to higher levels than before the controls, reaching double digits by the mid-1970s[1][3]. Therefore, the second round of price controls did not succeed in achieving sustained economic stability or controlling inflation in the long run.

Citations:
[1] https://www.counterpunch.org/2022/09/22/nixons-famous-price-freeze-did-stop-inflation/
[2] https://www.citywatchla.com/important-reads/25549-1971-nixon-s-famous-price-freeze-did-stop-inflation
[3] https://www.aier.org/article/nixonomics-in-retrospect-devaluation-and-wage-price-controls-august-15-1971/
[4] https://newrepublic.com/article/162931/richard-nixon-changed-us-economic-policy-forever
[5] https://study.com/academy/lesson/richard-nixons-economic-policies-stagflation.html
[6] https://politics.stackexchange.com/questions/2631/what-is-nixons-wage-and-price-control
[7] https://www.investopedia.com/terms/n/nixon-shock.asp
[8] https://millercenter.org/president/nixon/domestic-affairs

Filed under: General Problems | Leave a Comment »

Medicare Advantage insurers ranked by prior auth denial overturn rates

https://www.beckerspayer.com/payer/medicare-advantage-insurers-ranked-by-prior-auth-denial-overturn-rates.html

Centene is the most likely to overturn a prior authorization denial decision when appealed, while Humana is the least likely, according to a KFF analysis.

Medicare Advantage insurers denied 7.4% of prior authorization requests in 2022, up from 5.8% in 2021. Among those denials, 9.9% were appealed. Among those appeals, 83.2% of denals were overturned. 

CVS Health denied the highest percentage of prior authorization requests in 2021 and 2022, denying 13% and 12% of prior authorization requests, respectively. Humana had the highest number of prior authorization requests per member in 2022, at 2.9. 

Payers ranked by prior authorization request denial overturn rates in 2022:

1. Centene: 95.3%
2. Aetna: 90.8%
3. Anthem BCBS: 89.2%
4. UnitedHealthcare: 86.1%
5. Cigna: 85.3%
6. BCBS: 80.3%
7. Anthem: 75.1%
8. Kaiser: 69.5%
9. Humana: 68.4%

Filed under: General Problems | Leave a Comment »

In 2022 the SCOTUS told the EPA & ATF that they did not have the statutory authority to create new interpretations of the laws they were in charge of enforcing.  The SCOTUS did not tell the DEA that they did not have the authority to create new interpretations of the Control Substance Act in 2022. However, this year the SCOTUS overturned the Chevron Doctrine. Which basically make it universally ILLEGAl for any federal agency to make new interpretations of laws that they were in charge of enforcing.

While the article below may seem like an apple vs oranges comparison. Maybe the ATF initially chose to ignore the SCOTUS and decided after the overturning of the Chevron Doctrine, that they better get their act together.  The DEA has created SO MANY new interpretations of the Control Substance Act over the years, could the community be just ONE LAWSUIT AWAY from having the DEA rescind all of those now illegal interpretations of the CSA?

ATF To Return Bump Stocks After 5 Years!

https://bearingarms.com/tomknighton/2024/08/13/atf-returns-bump-stock-after-five-years-n1225905

Filed under: General Problems | Leave a Comment »

Filed under: General Problems | 1 Comment »

Is this a good example of why our judicial system should not be in charge of dealing with people and addictions? The recommendation to this person is that he should get off his medication and use ABSTINENCE to maintain his sobriety. Does this suggest that those within/around our judicial system consider addictions a CHOICE?

Filed under: General Problems | Leave a Comment »

Medicare Advantage woes pose growing threat to hospitals: S&P

https://www.beckershospitalreview.com/finance/medicare-advantage-woes-pose-growing-threat-to-hospitals.html

As Medicare Advantage continues to grow and health insurers prioritize their margins in the segment, hospitals are the most vulnerable healthcare provider to rising administrative and financial MA burdens, according to a new report from S&P Global.

The Aug. 15 report shared with Becker’s highlights the major growth Medicare Advantage has seen over the last several years, with 32.8 million people, or 54% of the eligible Medicare population, now enrolled in an MA plan.

“This growth poses challenges to healthcare service providers’ credit quality, given growing risks to reimbursement from MA plans relative to traditional Medicare, as well as the payment risk and higher complexity around prior authorization requirements,” S&P’s analysts wrote. “We also see future risks to providers if at some point CMS addresses the MA program’s higher-than-expected spending.”

As MA enrollment has grown, so too have the financial headwinds facing major carriers — government scrutiny is rising, CMS regulations and payments are tightening, and the cost of care is rising.

In response, Aetna, Humana and Centene are among the insurers that have said they will exit some markets in 2025 — and potentially reduce benefit offerings — to accommodate the changing reimbursement environment and rising costs. Notably, UnitedHealthcare and Elevance Health have said they are prepared to weather the changing landscape and priced their 2025 MA plans to reflect that.

“However, if already elevated utilization rates remain high for an extended period we would expect payors to further squeeze payments to providers,” S&P’s analysts wrote. “Overall, we expect these challenges coupled with further expansion of MA as a percentage of total Medicare beneficiaries will continue to pressure margins on the Medicare portion of the provider payor mix.”

“Thus, we expect insurers to prioritize margin over membership, and we expect large insurers will use their scale and market clout to limit provider rate increases over what will prove to be a challenging contract negotiation season.”

In 2023, Becker’s began reporting on hospitals and health systems nationwide that dropped some or all of their Medicare Advantage contracts in response to administrative and financial challenges. In 2024, at least 17 systems have ended an MA contract with an insurer.

Filed under: General Problems | 2 Comments »

Heat spells trouble for mail-order medications

https://www.beckershospitalreview.com/pharmacy/heat-spells-trouble-for-mail-order-medications.html

Mail-order pharmacies run well-coordinated supply chain operations to ensure medications are safely delivered to patients’ doorsteps, but extreme temperatures are complicating the process, The New York Times reported Aug. 13.

Pharmacists and physicians told the Times that high temperatures inside delivery trucks could cause certain medications such as insulin or epinephrine injectors to overheat, degrade and become less effective.

Delivery drivers have reported temperatures as high as 150 degrees Farenheit inside their trucks, which far exceeds national drug handling standards of 68 to 77 degrees. A 2023 study published in the Journal of the American Pharmacists Association also found that simulated medication shipments spent 68.3% of transit time outside acceptable temperature ranges across all shipment methods, carriers and seasons. In addition, FDA regulations do not apply to medications being transported to patients, leaving oversight to state authorities. 

The Times interviewed more than a dozen patients who said they believed their medications were damaged by heat and humidity in transit. In some cases, patients reported serious health issues after taking the drugs, according to the report. 

Mail-order pharmacies said they use special precautions to protect the integrity of temperature-sensitive drugs, including weather-resistant packaging. Bryan Rabakon, senior vice president of supply chain and engineering for OptumRx, told the Times it monitors the duration of shipments and automatically sends a new package if transit times exceed a certain threshold. The company discontinued use of temperature-sensitive tags due to a high rate of false positives, he said. Cigna, which owns Express Scripts, did not respond to the Times’ request for comment. 

Read the full article here.

Filed under: General Problems | 1 Comment »

Collectively we are in the process of 10,000+ pharmacies have or will be closing.  Many of the major mail-order pharmacies are owned by the same major insurance/pbm companies, and they will be pushing and creating financial incentives for people to use them currently, they are pushing back on state pharmacy boards that are trying to create requirements that mail order prescriptions be properly shipped and protecting against ambient temperatures that can/may harm medications in shipment.  If/when all these pharmacies close their doors, one can just imagine all the long lines and wait times for pts to get their medications, as well as how far the pt is going to travel to get their Rxs filled.  Back in the day, most people patronized a particular pharmacy, the pharmacy was within 2 miles of their home or where they worked.

Study Shows Mail-Order Prescriptions May Be Often Exposed to Unsafe Temperatures

FTC Deepens Inquiry into Prescription Drug Middlemen

Cash crunch pushes independents to the brink, data shows PBMs the cause

Walgreens will close a significant number of US stores, shutting down many unprofitable locations

Rite Aid Bankruptcy Explained: Three Reasons Why Pharmacy Giant Failed

Filed under: General Problems | 1 Comment »

Where VP picks stand on pharmaceutical costs

https://www.beckershospitalreview.com/pharmacy/where-vp-picks-stand-on-pharmaceutical-costs.html

JD Vance and Tim Walz, the Republican and Democratic candidates for vice president, respectively, have both voiced support for aspects of the Inflation Reduction Act, a landmark law that aims to lower prescription drug prices. 

Here are each candidate’s records on rising pharmaceutical costs, which are projected to increase 3.81% by summer 2025, according to Vizient. 

JD Vance

In a 2022 interview with AARP, the Ohio senator expressed support for giving Medicare the authority to negotiate prescription drug prices. That same year, President Joe Biden signed the Inflation Reduction Act, which grants CMS negotiation powers for a selective number of drugs with no generic or biosimilar competition. 

However, Mr. Vance has criticized the act’s allocation of at least $370 billion over a decade for incentives in wind, solar and other clean energy sources.

“It’s dumb, does nothing for the environment, and will make us all poorer,” he said in a 2022 post on X. 

Mr. Vance has also been vocal on addressing the opioid crisis. In 2016, he founded a charity to address the epidemic, though it shuttered within two years. 

Tim Walz

Two years before the Inflation Reduction Act passed — which he supported — the Minnesota governor signed the Minnesota Prescription Drug Price Transparency Act. The law requires drugmakers to report and provide reasons for significant price increases of prescription drugs to the state health department. 

In June, the state published its first list of 364 drugs from 76 manufacturers that are subject to this law.

Mr. Walz has also advocated for affordable insulin. In 2020, he signed the Alec Smith Insulin Affordability Act, which ensures eligible individuals in urgent need of the hormone can go to their pharmacy once in a 12-month period and receive a one-time, 30-day supply for a $35 copay. 

Since then, the nation’s largest insulin manufacturers have significantly lowered their prices to about $35 for a month’s supply.

Filed under: General Problems | Leave a Comment »