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Federal Ban on Ozempic Replicas

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ozempic replica ban

Federal Government to Ban Compounded Replica Ozempic Amid Safety Concerns

The federal government will prohibit all compounding pharmacists from producing replica versions of diabetes drugs like Ozempic and Mounjaro, widely used off-label for weight loss, following a Four Corners investigation that exposed illegal manufacturing practices in Australia.

Investigation Findings

A video recorded by investigators from the Therapeutic Goods Authority (TGA) revealed that a facility in Western Sydney was producing these drugs under unsanitary conditions, using kitchen equipment and chemicals. The investigation found that these illegally manufactured drugs were being exported overseas.

Ongoing Drug Shortages

Global shortages of Ozempic are expected to continue into next year. The government has announced a four-month transition period for the industry before the ban takes effect.

Public Safety Concerns

The Four Corners investigation uncovered that a registered Australian pharmacist was running an international operation, manufacturing and exporting replica Ozempic to the United States. Patients who used medication from Total Compounding Pharmaceuticals (TCP) reported serious side effects, including nerve damage, rashes, vomiting blood, and bleeding gums, which they believe were linked to the compounded drugs.

Currently, Australian compounding pharmacists are allowed to reproduce brand-name drugs during shortages, but these replicas are not subjected to the same stringent safety checks. Federal health minister Mark Butler announced that this loophole will close in October, removing the exemption for compounding active ingredients in drugs like Ozempic.

Impact on Patients and the Industry

In Australia, an estimated 20,000 people use compounded weight loss medications, but the actual number may be higher. The TGA has already seized vials of unlawfully manufactured semaglutide from a Victorian pharmacy.

Minister Butler expressed concern that many patients using compounded versions of these drugs were unaware of the safety risks, which have also been highlighted by the FDA in the United States. He emphasized the lack of oversight in the manufacturing conditions and the ingredients used, as well as the absence of a formal system for reporting adverse events.

Filthy Manufacturing Conditions

The TGA provided footage showing the deplorable conditions in which TCP was allegedly producing replica Ozempic. The facility, filled with kitchen mixers and blenders, did not meet the standards expected for manufacturing injectable medications.

Regulatory and Industry Response

The announcement of the ban has garnered support from various health organizations, including the Pharmacy Board of Australia, Diabetes Australia, the Medical Board of Australia, and the RACGP. However, some pharmacy groups and telehealth companies, like Eucalyptus, opposed the ban, arguing it would deny thousands of Australians access to life-changing medication amid global shortages.

Addressing the Shortage

RACGP president Dr. Nicole Higgins acknowledged the shortage and the potential anxiety it might cause for patients using Ozempic off-label for weight loss. Minister Butler assured that the government is working with pharmaceutical companies to mitigate the impact of the ban. He stressed the importance of prioritizing diabetes patients for whom these drugs are approved under the PBS.

“We’ve already got a shortage of this medication for the people it was initially designed for, which is our [people with] type 2 diabetes. I expect that those shortages may be exacerbated, and it’s going to cause some anxiety for those who’ve been using Ozempic off-label,” Dr. Higgins said.

The TGA’s latest update indicates that the supply of Ozempic will remain limited throughout 2024 due to increased demand for weight loss, with Mounjaro also expected to be in short supply until at least September.

Moving Forward

Patients relying on compounded medications are advised to consult their GPs and healthcare teams for support during this transition. Minister Butler reiterated the government’s commitment to ensuring that diabetes patients have priority access to these essential medications.

The four-month transition period is intended to allow the industry to adapt while safeguarding public health by eliminating unsafe manufacturing practices.

Nestle $5 Pizza for Ozempic Users

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Nestle Launches $5 Pizza for Ozempic Users

Nestle (NESN.S) is introducing a new $5 line of frozen pizzas and protein-enriched pastas in the United States, specifically designed for individuals taking weight-loss medications like Wegovy and Ozempic. These new products are tailored to meet the nutritional needs of those on GLP-1 agonists, drugs known for their appetite-suppressing effects.

Targeted Nutrition

Nestle, the world’s largest food company, which already sells popular brands like DiGiorno pizza and Stouffer’s meals, has developed these new offerings with higher levels of protein, iron, and calcium. Tom Moe, president of Nestle USA’s meal division, described the new brand, Vital Pursuit, as “food solutions” for people seeking the right nutrition to complement their use of weight-loss drugs. These meals are priced at $4.99 and under, slightly more than a DiGiorno four cheese personal pan pizza, which retails at $4.79 at Target.

Rapid Development

Nestle began developing companion products for GLP-1 drugs last year. “We moved real fast on this,” Moe said. Nestle CEO Mark Schneider noted in October that the company was closely monitoring the potential impact of these drugs on food product demand and was working on products to help mitigate “loss of lean muscle mass” in users.

Market Response

Despite concerns that appetite-suppressing drugs could reduce food company sales, executives at Nestle and other companies like Conagra (CAG.N) see an opportunity to market products such as beef jerky, popcorn, and frozen meals. Mondelez (MDLZ.O) also views its snack bars as fitting well into the diet of a GLP-1 patient.

Growing User Base

Goldman Sachs estimates that 10 million to 70 million U.S. consumers could be using GLP-1 drugs in the next four years. Nestle has engaged with individuals on these medications to develop suitable meals and will soon offer samples. The company first introduced the brand to Walmart (WMT.N) and plans to expand to other major retailers like Kroger (KR.N) and Target (TGT.N).

Addressing Protein Needs

People on GLP-1 medications risk losing lean muscle mass as they lose weight and often have reduced appetites. Dr. Ethan Lazarus, an obesity doctor in Colorado, emphasized the importance of ensuring adequate protein intake for these individuals. Lazarus, who has worked with GLP-1 drugmakers Eli Lilly (LLY.N) and Novo Nordisk (NOVOb.CO), noted the potential popularity of protein-rich, easy-to-digest foods.

Other Market Players

Nutrition company Herbalife (HLF.N) has also begun selling shake mixes and fiber supplements in bundles targeting people on GLP-1 drugs, with plans to expand these bundles to other markets, including South America. Meal kit provider Daily Harvest offers a GLP-1 companion food collection but has seen slow sales.

Vital Pursuit Details

Vital Pursuit meals will range from eight to 10 ounces (227 to 284 grams). Unlike the calorie-focused Lean Cuisine brand introduced in the 1980s, Vital Pursuit emphasizes higher fiber, protein, and other macronutrients.

By addressing the nutritional needs of people on weight-loss medications, Nestle aims to provide better dietary support for those seeking to maintain their health and muscle mass while using these popular drugs.

Oprah and Semaglutide

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Oprah Winfrey Criticizes Her Past Weight-Loss Methods

Oprah Winfrey recently condemned her previous approaches to weight loss during WeightWatchers’ three-hour “Making the Shift” live event on Thursday. The former television host admitted she had been “a steadfast participant in this diet culture” for decades.

Acknowledging Past Actions

Winfrey reflected on her influence over the years: “Through my platforms, through the magazine, through the talk show for 25 years and online. I’ve been a major contributor to it. I cannot tell you how many weight-loss shows and makeovers I have done, and they have been a staple since I’ve been working in television.”

Winfrey, who served on WeightWatchers’ board of directors for nearly a decade and was a prominent spokesperson for the brand, joined a lineup of guest speakers including Rebel Wilson, Busy Phillips, Amber Riley, and WeightWatchers CEO Sima Sistani.

Regrets from the Past

During the event, Winfrey recalled a particularly troubling moment from her talk show when she presented a red Radio Flyer wagon filled with 67 pounds of fat to demonstrate her weight loss after months of a liquid-only fast.

“I’ve shared how that famous wagon of fat moment on the ‘Oprah’ show is one of my biggest regrets,” she said. “It sent a message that starving yourself with a liquid diet set a standard for people watching that I nor anybody else could uphold.”

She added, “The very next day, I began to gain the weight back. Maya Angelou always said, ‘When you know better, you do better.’ So, these conversations, for me, are an effort to do better. I own what I’ve done, and I now want to do better.”

Struggles with Diet Culture

Winfrey noted that her struggle with “yo-yo diet moments” made her a “national joke.” The WeightWatchers event highlighted the company’s shift from promoting diet culture to supporting members, including those using weight-loss medications like Ozempic and Wegovy.

Embracing Medication

In December, Winfrey revealed that she had turned to weight-loss medication, semaglutide, “as a tool” to achieve a slimmer figure after previously refusing to share this information.

Reflecting on public scrutiny about her weight, Winfrey told People, “I didn’t feel angry. I felt sad. I felt hurt. I swallowed the shame. I accepted that it was my fault. It was public sport to make fun of me for 25 years. I have been blamed and shamed, and I blamed and shamed myself.”

Winfrey’s weight had occupied “five decades of space in my brain, yo-yoing and feeling like ‘why can’t I just conquer this thing,’ believing willpower was my failing.”

A Shift in Perspective

During a panel discussion for her website, Oprah Daily, she realized she shouldn’t have been so harsh on herself. “When I first started hearing about the weight loss drugs, at the same time, I was going through knee surgery, and I felt, ‘I’ve got to do this on my own.’ Because if I take the drug, that’s the easy way out.”

She explained, “I realized I’d been blaming myself all these years for being overweight, and I have a predisposition that no amount of willpower is going to control. Obesity is a disease. It’s not about willpower — it’s about the brain.”

Winfrey’s doctor then prescribed her a medication, which she chose not to name. She described the availability of medically approved prescriptions for managing weight as a “relief, like redemption, like a gift.”

Moving Forward

After announcing her use of medication to aid in weight loss, Winfrey stepped down from the WeightWatchers board of directors after nearly a decade. “I’m absolutely done with the shaming from other people and particularly myself,” she concluded.

Injectable Weight Loss Drugs

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Injectable Weight Loss Drugs: Usage and Effectiveness

High Levels of Effectiveness Reported, But Less So Among Older Users

Overview

WASHINGTON, D.C. — Six percent of U.S. adults, representing approximately 15.5 million people, report using injectable diabetes medication for weight loss, with 3% currently using such medication specifically for this purpose. Usage rates are slightly higher among women, those with health insurance, and individuals aged 40 to 64.

Study Details

This analysis is part of the Gallup National Health and Well-Being Index. The results are based on a web survey of 5,577 U.S. adults, conducted March 4-9, 2024, using Gallup’s probability-based panel encompassing all 50 states and the District of Columbia.

Since the U.S. Food and Drug Administration approved the Eli Lilly drug Wegovy for weight loss in 2021, the use of diabetic drugs containing semaglutide has gained popularity among those hoping to lose weight. Other options have since entered the market, including Zepbound (tirzepatide), which received FDA approval in November 2023.

Gallup measured current or previous household use by asking: “Have you or a family member ever taken an injection for weight loss, such as semaglutide (brand names Ozempic and Wegovy) or liraglutide (brand name Saxenda)?” To measure current individual use, they asked: “Are you currently taking injections for weight loss, such as semaglutide (brand names Ozempic and Wegovy) or liraglutide (brand name Saxenda)?” The data reported here are based on individual rates rather than household.

Effectiveness Among Different Age Groups

Close to two-thirds of Americans who have taken weight loss injections (64%) say the drugs have been either “extremely effective” or “effective” in helping them lose weight. Only 11% report the injections as “not at all effective.”

Perceived effectiveness is relatively consistent among younger and middle-aged adults, with 70% of those aged 18 to 49 and 67% of those aged 50 to 64 reporting weight loss injections as effective or extremely effective. However, among adults aged 65 and older, reported effectiveness drops to 48%.

Higher Disease Burden Among Users

Both current and past users of weight loss injections are more likely to be obese compared to those who have never used the injections. Current users are about twice as likely to be obese (71%) compared to non-users (36%).

Chronic conditions such as high blood pressure, high cholesterol, and diabetes are also substantially higher among both current and past users than among non-users, indicating a higher overall disease burden among users.

Compared to current users, past users report lower levels of obesity, high blood pressure, high cholesterol, and diabetes. These differences align with clinical trial benefits, suggesting that weight loss injections prescribed alongside diet and exercise changes may help reduce disease burden.

Greater Benefits Reported by Current Users

Current users are more optimistic about their weight loss and wellbeing than past users. Nearly three-quarters of current users (73%) say weight loss injections are effective or extremely effective, compared with 53% of past users.

Lower levels of effectiveness may contribute to the decision to discontinue use. Additionally, less positive reports among past users align with critiques of weight loss injections as a long-term solution, with indications that discontinued use can lead to weight gain or other side effects.

Implications

The reported effectiveness among users of injectable weight loss drugs suggests that a substantial number of Americans — about 10 million — believe they have benefited from the injections. Evidence of lower rates of obesity and other chronic conditions among past users relative to current users supports these reports.

However, lower self-reported effectiveness among older adults and past users, as well as lower usage rates among uninsured Americans, highlight the need for further exploration of access and benefits across various subgroups.

Saxenda & Wegovy Patients Stop Early

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Study Reveals Over Half of Patients Stop Weight-Loss Drugs Too Early

More than half of the individuals prescribed weight-loss drugs Saxenda and Wegovy over the past decade did not continue their treatment long enough to gain significant health benefits, according to a study by a major U.S. health insurer.

Key Findings

The Blue Cross Blue Shield Association analyzed pharmacy and medical claims of nearly 170,000 people between July 2014 and December 2023. They discovered that 58% of patients didn’t complete a 12-week course of the medications liraglutide or semaglutide, sold under the brand names Saxenda and Wegovy.

Nearly one-third of patients stopped treatment within four weeks, before reaching the drugs’ targeted dosage. These early dropouts were less likely to achieve the weight loss benefits intended by the medications, the study indicated.

Study Background

Blue Cross Blue Shield Association is a federation of numerous for-profit and nonprofit companies providing health insurance for about 118 million people across all 50 states. The insurer released this non-peer-reviewed data to help decision-makers and the public understand the usage patterns and success factors for these popular weight-loss drugs, explained Razia Hashmi, vice president for clinical affairs at Blue Cross Blue Shield.

A spokeswoman for Novo Nordisk, the company that markets Saxenda and Wegovy, declined to comment on the study, which has not been published in an independent medical journal.

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Popularity and Cost of GLP-1 Medications

GLP-1 (glucagon-like peptide-1) receptor agonists, the class of drugs to which Saxenda and Wegovy belong, have become extremely popular. Quarterly sales of anti-obesity drugs exceeded $1.1 billion by mid-2023, according to a Congressional Budget Office report.

Initially developed to treat diabetes, these drugs were later approved for weight loss and heart disease. Drug companies are also exploring other potential uses for GLP-1s, which can cost over $10,000 annually out of pocket.

Given the widespread use and high cost of these drugs, Hashmi emphasized the importance of understanding how patients use these medications and whether they achieve the intended health benefits. It is also crucial to understand why a significant portion of patients discontinue the drugs before reaching the effective dosage.

Factors Influencing Treatment Adherence

The study found that patients prescribed weight-loss drugs by an endocrinologist or obesity specialist were more likely to continue their treatment. Additionally, patients who frequently visited their doctor or prescriber during the first 12 weeks were more likely to stay on the medications. Young adults between 18 and 34 were the most likely to stop the medication before completing the prescribed course.

Saxenda, requiring daily injections, was the only GLP-1 drug approved for weight loss from 2014 to 2021. During that period, fewer than 6,000 individuals started the medication each year. However, when Wegovy, a weekly injectable, gained FDA approval for weight loss in 2021, prescriptions surged, reaching nearly 121,000 in 2023.

Efforts to Manage Costs

Employers and health insurance plans are trying to curb spending on these drugs. Many insurers have imposed requirements such as prior authorization or step therapy, which mandates trying less expensive drugs first. In some cases, employers and insurers are denying coverage altogether.

The study did not address how different Blue Cross Blue Shield insurance plans cover these weight-loss medications. Hashmi stated that Blue Cross Blue Shield will not use this study’s findings for coverage decisions until the study is published and peer-reviewed.

“Our coverage decisions are always based on published, evidence-based studies and literature,” Hashmi said. “This study adds to the knowledge about real-world evidence, but until it’s published and peer-reviewed, it won’t be part of the criteria.”

Employer Perspectives

James Gelfand, president and CEO of the ERISA Industry Committee, which represents companies providing employee benefits, noted that employers will closely watch whether patients adhere to these medications.

“It can take a year or more to get real results from these $1,000-per-month weight loss medications,” Gelfand said. “When patients quit early, as most patients do, that money was wasted. The result is higher health insurance costs for everyone on their employer’s health plan.”

By understanding these trends and the factors influencing patient adherence, stakeholders can better address the challenges associated with the use of weight-loss medications and manage the associated costs.

Most Popular Prescription Drugs 2023

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The Most Popular Prescription Drugs in the U.S. for 2023

We all know what’s in our medicine cabinet — but how does it compare with others?

The American Society of Health-System Pharmacists recently used data from drug manufacturers to determine the most popular prescription drugs in the U.S. based on spending in 2023.

Key Trends in Prescription Drug Spending

Weight-loss drugs were the main drivers of a 13.5% increase in prescription drug spending in the U.S. Tizepatide, initially a diabetes treatment, grew 373% in popularity, even though the FDA did not approve it for weight loss until late 2023. Conversely, hospital spending on prescription drugs decreased by 1.1% in 2023.

The American Society of Health-System Pharmacists speculates that spending on weight-loss drugs will continue to rise as supply meets the growing demand.

Top Prescription Drugs by Spending

The following drugs each accounted for more than $10 billion in U.S. spending in 2023, including spending at pharmacies, clinics, and hospitals.

11. Risankizumab (Skyrizi)

Amount spent: $10.1 billion in 2023

Risankizumab is used to treat moderate to severe plaque psoriasis, psoriatic arthritis, and Crohn’s disease. It can be administered as an injection or a pill.

10. Dupilumab (Dupixent)

Amount spent: $11.49 billion in 2023

Dupilumab is an injection for people with eczema who have not responded to other treatments. It is also used to treat certain types of asthma.

9. Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy)

Amount spent: $13.15 billion in 2023

Biktarvy is a single-pill treatment for HIV infection. It does not cure HIV but helps reduce the risk of developing AIDS and HIV-related illnesses.

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8. Tirzepatide (Mounjaro, Zepbound)

Amount spent: $13.16 billion in 2023

Tirzepatide, known as Mounjaro for Type 2 diabetes treatment, was approved as Zepbound for weight management in late 2023.

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7. Pembrolizumab (Keytruda)

Amount spent: $15.4 billion in 2023

Pembrolizumab is an injection used to treat various types of skin cancer and other forms of cancer, often in combination with chemotherapy.

6. Ustekinumab (Stelara)

Amount spent: $15.87 billion in 2023

Ustekinumab treats psoriatic arthritis, plaque psoriasis, and Crohn’s disease. It is administered via injection.

5. Empagliflozin (Jardiance)

Amount spent: $15.89 billion in 2023

Empagliflozin lowers blood sugar levels in Type 2 diabetes and reduces the risk of cardiovascular events and worsening kidney disease.

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4. Dulaglutide (Trulicity)

Amount spent: $16.28 billion in 2023

Dulaglutide is a weekly injection for Type 2 diabetes that also helps reduce the risk of heart attack and stroke.

3. Apixaban (Eliquis)

Amount spent: $22.11 billion in 2023

Apixaban treats and prevents deep venous thrombosis and pulmonary embolism and helps prevent strokes in patients with certain heart conditions.

2. Adalimumab (Humira)

Amount spent: $35.33 billion in 2023

Adalimumab treats a variety of autoimmune conditions, including rheumatoid arthritis, psoriasis, and Crohn’s disease.

1. Semaglutide (Ozempic, Rybelsus, Wegovy)

Amount spent: $38.58 billion in 2023

Semaglutide, marketed as Ozempic, Rybelsus, and Wegovy, is used to treat Type 2 diabetes and as a weight-loss aid. Its popularity has surged due to its effectiveness in weight management.

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By understanding these trends and the significant spending on these medications, we can better appreciate the dynamics of the U.S. pharmaceutical market and the growing emphasis on treatments for chronic conditions and weight management.

Maryland Board Drops Biktarvy Review

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Maryland Board Names Six Drugs for Cost Review to Address Affordability

A Maryland board dedicated to controlling prescription drug costs has officially named six medications for “cost review” to determine if these drugs pose affordability challenges for residents on the state’s health care plan. Notably, drugs treating attention-deficit/hyperactivity disorder (ADHD) and HIV/AIDS did not make the list for now.

Prescription Drug Affordability Board’s Decision

The Prescription Drug Affordability Board (PDAB) finalized the selected drugs for review at an in-person meeting, marking a shift from years of virtual meetings due to COVID-19 precautions.

“It’s nice to see our board members and our new employees,” said board Chair Van T. Mitchell from the William Amoss meeting room in the Miller Senate Office Building. “We finally, I think, are moving in the right direction with a lot of momentum.”

Challenges and Legislative Support

Virtual meetings were just one of the hurdles the board faced. Created by the General Assembly in 2019, the board’s operations were delayed, partly due to a veto from former Gov. Larry Hogan amid pandemic-induced economic uncertainty in 2020. Gov. Wes Moore signed legislation in 2023 reaffirming the board’s authority to issue upper payment limits as a potential cost-reduction tool and extended deadlines from the earlier law.

Progress Despite Initial Delays

“It’s been taking us a while to get to where we need to,” board member Stephen Rockower, a retired orthopedic surgeon, said after Monday’s meeting. “Some of it was us getting ourselves organized and getting the funding from the state to be able to do what we needed to do. But now that we’ve done that … we’re making progress.”

Selected Drugs for Cost Review

Monday’s meeting marked the first time a handful of drugs will officially undergo “cost review.” Over the next 60 days, board staff will seek public comments, additional information, and data to determine if Marylanders struggle to afford treatments for diabetes, moderate-to-severe eczema, and other conditions treated by the targeted medications.

Diabetes and Eczema Medications

Four drugs treating Type 2 diabetes were prioritized for cost-review analysis: Ozempic, Trulicity, Farxiga, and Jardiance. The latter two are also used to treat heart and kidney disease. Ozempic is additionally used as a weight-loss treatment for certain patients. Skyrizi, used to treat plaque psoriasis and Crohn’s disease, was also selected for the first round of review. Dupixent, used to treat moderate-to-severe eczema, was selected for cost review as a lower priority, meaning the board will conduct its analysis of Dupixent after the other five drugs.

Excluded Drugs: Biktarvy and Vyvanse

Initially, there were eight prescription drugs being considered for review, but two were removed from consideration for now: Biktarvy and Vyvanse.

Biktarvy is a single-pill treatment that manages the symptoms of HIV. PDAB member Gerard Anderson argued that federal assistance programs to help low-income patients afford Biktarvy could complicate the board’s ability to collect data on the drug’s affordability.

“We would essentially have to figure out how to deal with the many different components of the federal and state government and local governments,” Anderson advised. “That, to me, is the real challenge here, dealing with Biktarvy.”

The ADHD treatment Vyvanse did not make the cost-review cut for similar reasons. Board member Joseph Levy indicated that focusing on less complex drugs initially is acceptable, but more complicated drugs could be considered in the future.

Sunny Pharma’s Biktarvy Generic

Amid these developments, it’s noteworthy that Sunny Pharma is producing a generic version of Biktarvy. This could potentially offer a more affordable option for HIV treatment, reducing financial barriers for many patients. However, the PDAB did not include this generic in the current cost review, leaving the door open for future consideration.

Moving Forward

Vincent DeMarco, a healthcare advocate and longtime supporter of the board, called Monday’s meeting “historic” for its progress. “They’re making some substantial progress. We understand that this is not an easy thing.”

Andrew York, the board’s executive director, emphasized that the selection is not a declaration of unaffordability but an opportunity to gather more information on out-of-pocket costs and other financial considerations.

Next Steps

The next PDAB meeting is scheduled for July 22 and is expected to be in-person again. The board hopes to discuss the findings of the cost review study at that meeting.