Americans for Safe and Effective Medicines (ASEM) has been established as a national advocacy organization focused on safeguarding patients from the risks associated with illegal large-scale drug compounding, counterfeit medications, and deceptive marketing practices. The organization also aims to hold companies and individuals accountable for practices that may compromise patient safety. Its launch coincides with the release of its first national survey, which found that while 84% of consumers prefer GLP-1 medications that have received approval from the U.S. Food and Drug Administration (FDA), only 17% are aware that compounded GLP-1 products do not undergo FDA approval.

Compounded GLP-1 products continue to be widely promoted through telehealth providers, medical spas, online vendors, and other distribution channels. These marketing practices often fail to clearly distinguish FDA-approved medicines from compounded alternatives, leading many patients to mistakenly assume that all such products meet the same regulatory standards for safety, effectiveness, and quality.

Fred Mills, Chief Policy Officer at ASEM, stated that many patients are making treatment decisions without receiving complete information about the products they use. He noted that ASEM was created to address a marketplace where consumer misunderstanding has become commercially advantageous. According to Mills, pharmaceutical compounding was originally intended to address the unique needs of individual patients rather than serve as a large-scale commercial enterprise.

Survey Highlights: Consumer Expectations vs. Awareness
The organization's survey identified a substantial gap between consumer expectations and their understanding of compounded GLP-1 medications:

Report Highlights Risks Associated with Mass Compounding
In addition to the survey, ASEM released a report titled The Shortage is Over. The Risks Are Not: How Illegal Mass Compounding Is Undermining Patient Safety—And What Must Happen Next. The report argues that temporary compounding practices permitted during the GLP-1 drug shortage have expanded into a largely unregulated commercial market for compounded GLP-1 products. According to the report, these products are distributed outside many of the regulatory safeguards that apply to FDA-approved medicines.

Drawing on FDA inspection records, product recalls, warning letters, and state regulatory enforcement actions, the report concludes that patient safety is being compromised by several factors, including:

As federal regulators begin taking a closer look at the growing overlap between healthcare and consumer influence, one physician is bringing the issue into the national spotlight. Danielle Kelvas, MD has announced the upcoming release of This Is Your Brain on Marketing, a thoroughly researched and deeply personal work arguing that modern medical marketing has moved beyond persuasion and into the realm of biological influence.

Planned for release in late 2026, the book arrives at a pivotal moment, as the Federal Trade Commission and its newly established Healthcare Task Force begin addressing misleading and manipulative healthcare practices. According to Dr. Kelvas, this level of oversight has been needed for years.

“We’ve spent too long thinking of marketing as simple communication. In reality, it functions as behavioral neuroscience deployed on a massive scale,”said Danielle Kelvas, MD.

Rather than presenting a purely argumentative stance, This Is Your Brain on Marketing examines how healthcare marketing systems can shape biology, behavior, and identity. Drawing from neuroscience, behavioral psychology, and clinical experience, Dr. Kelvas explains how modern marketing strategies can influence dopamine systems, interfere with hormonal balance, and gradually alter how individuals perceive themselves and their lives.

The book follows a four-part structure — Becoming, Immersion, Rupture, and Reckoning — and applies these themes to major areas of health, including nutrition, sleep, weight management, mental wellness, and relationships. Throughout these discussions, Dr. Kelvas argues that many struggles people interpret as personal shortcomings are often biologically predictable responses to carefully engineered environments.

“What many people see as a lack of willpower is often a normal biological reaction to environments intentionally designed to shape behaviour,”said Danielle Kelvas, MD.

One especially controversial section explores how direct-to-consumer healthcare advertising has expanded the boundaries of diagnosis, turning ordinary emotional experiences into medicalized conditions while tying identity more closely to labels and treatments. Another chapter focuses on children, examining how marketing systems may affect developing brains, accelerate identity formation, and weaken long-term emotional resilience.

At its core, the book makes both a scientific and ethical case. Dr. Kelvas argues that any system capable of consistently influencing human biology and behavior should be subject to the same level of scrutiny and accountability expected of other major medical interventions.

“If a system can consistently shape biology and behavior, it deserves the same level of accountability as any other powerful medical intervention,”said Danielle Kelvas, MD.

Dr. Kelvas views the FTC Healthcare Task Force as an important institutional acknowledgment that the environments influencing patient behavior may themselves contribute to widespread health challenges — a recognition that strongly aligns with the book’s central message.

Ultimately, This Is Your Brain on Marketing is intended as a compassionate examination of modern healthcare systems and their impact on patients. After years in clinical practice watching individuals blame themselves for problems shaped by forces beyond their awareness, Dr. Kelvas hopes readers will better understand the systems influencing them — and stop seeing themselves as fundamentally flawed.

“This book helps explain why so many people feel damaged or inadequate — and why they aren’t. I’m exhausted by hearing patients dismissed as simply ‘noncompliant,’” said Danielle Kelvas, MD.