In the Super Bowl 2025, Hims & Hers ran a commercial titled ”Sick of the System” that aimed to address the U.S.obesity crisis and promote their weight loss care services. The minute-long commercial,which aired during the third quarter,featured rapid-paced images including people stepping on a scale,newspaper clippings,and a bowl of colorful cereal to highlight the seriousness of the issue [2[2[2[2].
the ad was designed to be thought-provoking and to challenge the outdated norms of healthcare, emphasizing Hims & Hers’ mission to make weight loss care more accessible, affordable, and trusted by doctors [1[1[1[1]. Forbes reported that the commercial was intended to showcase Hims & Hers as a solution to the obesity crisis [3[3[3[3].
Though, critics have pointed out that the ad lacked critically important information typically required for FDA-approved medications, such as listing possible side effects and contraindications. This oversight is notably notable given that Hims & Hers offers compounded versions of drugs that are not FDA-approved, which could pose risks to consumers [1[1[1[1].associated-compounded-glp-1-receptor-agonists”>read more. GLP-1 receptor agonists are a class of drugs used to manage type 2 diabetes and promote weight loss. They include brand-name drugs like Victoza,Ozempic,and Wegovy. Compounded versions of these drugs may not have the same labeling and packaging as FDA-approved versions,which can lead to dosing errors.As a notable example, a compounded version might be labeled in milligrams (mg) rather of micrograms (mcg), leading to a patient taking a much higher dose than intended. This can result in serious health consequences. The FDA has issued alerts about these dosing errors and the importance of proper labeling for compounded medications.
Childhood Obesity: New Guidelines Urge Early and Aggressive Treatment
Table of Contents
childhood obesity is a growing concern, and new guidelines emphasize the importance of treating it early and aggressively. But is this approach safe? Let’s delve into the details.
The Urgency of Early Intervention
Recent guidelines stress that addressing childhood obesity promptly can prevent severe health complications later in life.Obesity in children can lead to a host of issues,including type 2 diabetes,heart disease,and even mental health problems. Early intervention can help children establish healthier habits and reduce the risk of these complications.
The Role of Semaglutide
One of the medications gaining attention is semaglutide, a compounded drug used to manage weight. However, there have been concerns about the safety of compounded medications.In July 2024, the FDA issued an alert regarding dosing errors with compounded weight-loss drugs, leading to hospitalizations. Additionally, there have been reports of compounding pharmacies using different versions of the active ingredients, causing adverse events.
Compounded Medications: A Risky Path?
Compounded medications have a history of causing tragedies. In 2012,an outbreak of fungal meningitis linked to unsanitary conditions at a compounding pharmacy resulted in 64 deaths and nearly 800 infections. These incidents highlight the risks associated with compounded medications and the need for stringent regulation.
Hims & hers: A Different Approach
Hims & Hers has taken a different approach by using compounded semaglutide exclusively from FDA-regulated bulk outsourcing facilities. According to Dr. Craig Primack, a medical expert at Hims & Hers, this ensures the safety and efficacy of the medication. This approach aims to balance the need for effective weight management with the safety concerns surrounding compounded medications.
Balancing Safety and Effectiveness
While the new guidelines urge aggressive treatment of childhood obesity, it’s crucial to balance this with safety.Using FDA-regulated facilities for compounded medications is one way to mitigate risks. However,it’s essential to stay informed about the latest developments and consult healthcare professionals for personalized advice.
Summary of Key Points
Here’s a summary of the key points discussed:
| Aspect | Detail |
|—————————–|————————————————————————-|
| Guidelines | emphasize early and aggressive treatment of childhood obesity |
| Safety Concerns | Risks associated with compounded medications, including dosing errors and adverse events |
| Past Incidents | 2012 fungal meningitis outbreak linked to unsanitary conditions |
| Hims & Hers Approach | Uses compounded semaglutide from FDA-regulated facilities |
| Expert Opinion | Dr. craig Primack emphasizes the importance of safety and regulation |
Conclusion
Addressing childhood obesity early and aggressively is crucial, but it must be done safely.Using compounded medications from FDA-regulated facilities is a step in the right direction. Stay informed and consult healthcare professionals to ensure the best outcomes for children struggling with obesity.
For more information on childhood obesity guidelines and the latest developments, visit Livescience.
Senators Draw FDA’s Attention to Misleading Drug Commercial Set to Run during Super Bowl
In a move that could reshape the pharmaceutical landscape, Senators Richard Durbin (D-IL) and Roger Marshall (R-KS) have taken a stand against what they perceive as a regulatory loophole in the marketing of compounded medications.Their focus? A controversial Super Bowl commercial by hims & Hers, which promotes compounded versions of popular drugs like Ozempic and Wegovy.
The Loophole in Fair Balance
The FDA’s doctrine of fair balance mandates that drug advertisements must include information about risks and side effects alongside benefits. Though, compounding pharmacies, which create customized medications, frequently enough fall outside this regulation. This has raised concerns among lawmakers and healthcare experts alike.
Dr. Craig Primack, the senior vice president of weight loss at Hims & Hers, explained that the company’s compounded medications undergo rigorous testing for bacterial and viral contamination, impurities, and drug concentration accuracy. These tests are accessible via the company’s app. However, Primack noted that because Hims & Hers is not a drug manufacturer, it is not subject to the FDA’s fair balance doctrine. This means that the commercial can highlight the benefits without detailing potential risks.
Senators’ Concerns and Proposed Legislation
Durbin and Marshall have written a letter to the FDA expressing their concern that the lack of fair balance in compounded medication advertisements could mislead consumers. They argue that this loophole needs to be closed to ensure consumer safety.
“To the extent this falls within a regulatory loophole for the FDA’s authorities, we plan to soon introduceisan legislation to close this gap,” Durbin and Marshall wrote.
The Appeal of Compounded Medications
Companies like Hims & Hers are allowed to offer compounded versions of drugs like Ozempic and Wegovy because the brand-name drugs are in shortage and have been for years.For consumers, the appeal is clear: the company offers brand-name Ozempic for $1,799 a month, while their compounded semaglutide starts at just $165 a month.
However, Dr. Nirav Shah, a clinical assistant professor at Stanford University, emphasized that compounding was never meant to provide a cheaper, mass-market version of FDA-approved medications. “We need compounding,” Shah said, “but the rules were designed [the way they were] because no one ever thought we would have wide-scale usage of these medications.”
The Super Bowl Commercial and Its Implications
The Hims & Hers Super Bowl commercial signals a potential shift in this status quo.If Durbin and Marshall’s bill moves forward, it could considerably alter how compounded medications are marketed and sold.
Key Points Summary
| Aspect | Details |
|——————————|————————————————————————-|
| Fair Balance Doctrine | Requires advertisements to include risks and side effects alongside benefits. |
| Senators’ Action | Durbin and Marshall wrote a letter to the FDA and plan to introduceisan legislation. |
| Compounded Medications | Offered due to shortages of brand-name drugs like Ozempic and Wegovy. |
| Cost Comparison | Brand-name ozempic: $1,799 a month; Compounded semaglutide: $165 a month. |
| Regulatory Concerns | Compounding pharmacies ofen fall outside the FDA’s fair balance regulation. |
Conclusion
The upcoming Super Bowl commercial by Hims & Hers has sparked a debate that could have far-reaching implications for the pharmaceutical industry. As lawmakers and healthcare experts weigh in, consumers must stay informed about the potential risks and benefits of compounded medications. The future of this regulatory landscape remains uncertain, but one thing is clear: the conversation is just beginning.
For more information on the FDA’s guidelines and the ongoing debate, visit the FDA’s website and keep an eye on developments from Senators Durbin and Marshall.
The Art of Journalistic Writing: A Comprehensive Guide
Journalistic writing is a unique craft that distinguishes itself from othre forms of writing through several essential characteristics. These characteristics ensure that the information presented is accurate, objective, and engaging. Let’s delve into the key features and tips that make journalistic writing stand out.
Key Features of Journalistic Writing
- Accuracy and Objectivity: These are of utmost importance. Journalists go to great lengths to gather reliable information, verify sources, and present a balanced outlook. This ensures that the news is fair and unbiased, providing readers with a clear understanding of the events.
- Inverted Pyramid Structure: Journalistic writing is most often written in a format called the Inverted Pyramid. This structure arranges the information in descending order of importance, or newsworthiness. The most crucial details are placed at the beginning, followed by less important information.
- Short, Simple Words: Journalistic writing uses short, simple words that most people will understand. This makes the content accessible to a broader audience, ensuring that the message is clear and easy to comprehend.
- Short Sentences and Paragraphs: The use of short sentences and paragraphs helps to break up the text, making it more readable. This format also allows for better flow and easier navigation through the article.
Tips for Effective Journalistic Writing
- Use Short, Simple Words: ”Use short, simple words that most will understand” [2[2[2[2].
- Use Short Sentences and Paragraphs: “Use short sentences and short paragraphs” [2[2[2[2].
- Summarize the story in the Lede: The lede, or introduction to the story, should be a single sentence of 35 to 45 words that summarizes the main points of the story. This helps to grab the reader’s attention and provides a fast overview of the article [1[1[1[1].
- verify Sources: Accuracy and objectivity are paramount. Journalists must verify their sources to ensure the information is reliable and balanced [3[3[3[3].
the Importance of Structure
The Inverted Pyramid structure is a basic aspect of journalistic writing. It ensures that the most critically important information is presented first, allowing readers to quickly grasp the main points. This structure also makes it easier for editors to cut the story from the bottom if necessary, ensuring that the most crucial details are always included.| Key feature | Description |
|—————————-|—————————————————————————–|
| Accuracy and Objectivity | Ensures the news is fair and unbiased, providing readers with a clear understanding. |
| Inverted Pyramid structure | arranges information in descending order of importance. |
| Short, Simple Words | Makes the content accessible to a broader audience. |
| Short Sentences and Paragraphs | Breaks up the text, making it more readable. |
Conclusion
Journalistic writing is a craft that requires precision, accuracy, and a commitment to objectivity. By following the key features and tips outlined above, journalists can ensure that their writing is engaging, informative, and fair. The use of the Inverted Pyramid structure, short sentences and paragraphs, and simple words are all essential elements that contribute to the effectiveness of journalistic writing.
For more insights into the art of journalistic writing, visit the Writing Centre at UAGC and explore the comprehensive guide on journalistic writing from Contra [3[3[3[3].
This article is for informational purposes only and is not meant to offer medical advice.
| Fair Balance Doctrine | Requires advertisements to include risks and side effects alongside benefits. |
| Senators’ Action | Durbin and Marshall wrote a letter to the FDA and plan to introduce a legislation. |
| Compounded Medications | Offered due to shortages of brand-name drugs like Ozempic and Wegovy. |
| Cost Comparison | Brand-name ozempic: $1,799 a month; Compounded semaglutide: $165 a month. |
| regulatory Concerns | Compounding pharmacies often fall outside the FDA’s fair balance regulation. |
Conclusion
The upcoming Super bowl commercial by Hims & Hers has sparked a debate that could have far-reaching implications for the pharmaceutical industry. As lawmakers and healthcare experts weigh in, consumers must stay informed about the potential risks and benefits of compounded medications. The future of this regulatory landscape remains uncertain, but one thing is clear: the conversation is just beginning.
For more information on the FDA’s guidelines and the ongoing debate,visit the FDA’s website and keep an eye on developments from Senators durbin and Marshall.
The Art of journalistic Writing: A Comprehensive Guide
Journalistic writing is a unique craft that distinguishes itself from other forms of writing through several essential characteristics. These characteristics ensure that the information presented is accurate, objective, and engaging.Let’s delve into the key features and tips that make journalistic writing stand out.
Key Features of Journalistic Writing
- Accuracy and Objectivity: These are of utmost importance. Journalists go to great lengths to gather reliable information, verify sources, and present a balanced outlook. This ensures that the news is fair and unbiased,providing readers wiht a clear understanding of the events.
- Inverted Pyramid Structure: Journalistic writing is most often written in a format called the Inverted Pyramid. This structure arranges the information in descending order of importance, or newsworthiness.The most crucial details are placed at the beginning, followed by less important information.
- Short, Simple Words: Journalistic writing uses short, simple words that most people will understand. this makes the content accessible to a broader audience,ensuring that the message is clear and easy to comprehend.
- short Sentences and Paragraphs: The use of short sentences and paragraphs helps to break up the text, making it more readable. This format also allows for better flow and easier navigation through the article.
Tips for Effective Journalistic Writing
- Use Short, Simple Words: “Use short, simple words that most will understand” [2[2].
- Use Short Sentences and Paragraphs: “Use short sentences and short paragraphs” [2[2].
- Summarize the Story in the Lede: The lede, or introduction to the story, should be a single sentence of 35 to 45 words that summarizes the main points of the story. This helps to grab the reader’s attention and provides a fast overview of the article [1[1].
- Verify Sources: Accuracy and objectivity are paramount. Journalists must verify their sources to ensure the information is reliable and balanced [3[3].
The Importance of Structure
The Inverted Pyramid structure is a basic aspect of journalistic writing. It ensures that the most critically important information is presented first, allowing readers to quickly grasp the main points. This structure also makes it easier for editors to cut the story from the bottom if necessary, ensuring that the most crucial details are always included.
Conclusion
Journalistic writing is a craft that requires precision, accuracy, and a commitment to objectivity.By following the key features and tips outlined above, journalists can ensure that their writing is engaging, informative, and fair. The use of the Inverted Pyramid structure, short sentences and paragraphs, and simple words are all essential elements that contribute to the effectiveness of journalistic writing.
For more insights into the art of journalistic writing, visit the Writing Center at UAGC and explore the comprehensive guide on journalistic writing from Contra [3[3].