Dennis Miller, R.Ph. is a retired chain store pharmacist. His book, The Shocking Truth About Pharmacy: A Pharmacist Reveals All the Disturbing Secrets, can be downloaded in its entirety at Amazon for 99 cents.
On February 18, 2026, FDA Commissioner Dr. Marty Makary suggested on CNBC that most medications should be available without a prescription. The implication was clear: consumers could access pharmaceuticals directly, bypassing traditional gatekeepers like doctors and pharmacists. Dr. Makary’s argument rests on the premise that people should be trusted to make their own health decisions and that the medical system’s paternalistic approach ought to be re-examined. But is such a sweeping change in drug policy warranted or even safe?
The Roots of the Debate: Trusting Consumers
Dr. Makary’s comments raise a fundamental question about the relationship between consumers and the healthcare system. By suggesting that most medications should be sold over-the-counter (OTC), he challenges the longstanding presumption that expert intervention is necessary to protect public health.
In this CNBC interview (at 7 minutes and 46 seconds), Dr. Makary declared, “We have to trust people to make their decisions. We’ve gotta get away from this paternalistic mindset.”
In my opinion, this statement encapsulates his controversial stance: that individuals are capable of making informed choices, just as they do with other products in their daily lives.
See CNBC interview with FDA Commissioner Dr. Marty Makary (Feb 18, 2026, “Everything should be over-the-counter unless it’s unsafe or requires monitoring”)
The idea of consumer self-determination is not new. Advocates for healthcare autonomy have long argued that people should have more control over their bodies and medical decisions. However, the push to make nearly all drugs OTC is unprecedented in its scope and potential impact. It forces us to ask: are most consumers equipped to understand the complexities of pharmaceuticals, including side effects, interactions, and contraindications?
Challenging the Idea of Consumer Self-Determination
To illustrate the potential risks, consider these analogies from other professions. Should people without extensive training be trusted to fly jumbo jets? Should people be trusted to perform brain surgery on their friends, family, or neighbors? Should the layman be allowed to perform dental implants or root canals in lieu of a dentist? Should the average person on the street be trusted to run a nuclear power plant? For decades, many professions have required years of specialized education. Are we now expected to believe that such expert knowledge is not important?
These rhetorical questions highlight the central issue: expertise matters. The complexity of pharmaceuticals is often underestimated. Medications are not just consumer products; they are powerful agents that can heal, harm, or even kill. The knowledge required to prescribe drugs safely involves years of education, clinical experience, and ongoing professional development. Removing healthcare professionals from the equation could lead to misuse, dangerous interactions, and missed diagnoses. The proposal to make most medications OTC, therefore, raises concerns about public safety and the erosion of professional standards.
Makary’s Position: OTC Unless Unsafe or Requires Monitoring
Dr. Makary essentially stated during this CNBC interview that everything should be over-the-counter unless it’s unsafe or requires monitoring. This approach would radically transform the pharmaceutical landscape, making access to most drugs as simple as buying aspirin.
But the criteria of “unsafe” and “requires monitoring” are not always clear-cut. Many medications, including those for chronic conditions like diabetes or hypertension, require ongoing assessment to ensure efficacy and prevent complications. Even drugs considered relatively safe can pose risks when combined with other substances or taken in inappropriate doses.
Makary’s argument seems to hinge on the idea that consumers can educate themselves about drug safety, using resources like product labels, online information, and personal research. This belief is rooted in an optimistic view of public health literacy and personal responsibility.
However, evidence suggests that many Americans struggle to interpret medical information, understand dosage instructions, or recognize contraindications. Health literacy varies widely, and misunderstandings can have serious consequences.
A Pharmacist’s Perspective: The Value of Expertise
Pharmacists undergo rigorous training, typically spending four years in pharmacy school. Is Dr. Makary suggesting that this education is unnecessary? The knowledge pharmacists possess extends far beyond dispensing pills. They are trained to evaluate drug efficacy, prevent harmful interactions, counsel patients about side effects, and collaborate with physicians to optimize treatment. The pharmacist’s role is especially critical for vulnerable populations, such as the elderly or those with multiple chronic conditions, who are at higher risk for medication errors.
It might sound appealing to say, “We have to trust people to make their decisions.” However, in my opinion, the average consumer does not know how deceptive and corrupt the pharmaceutical industry is. Pharmacists have firsthand experience with the marketing tactics used by drug manufacturers. This often includes exaggerating benefits and downplaying risks. Without expert oversight, consumers may be swayed by advertising, misinformation, or online “health influencers” with no scientific credentials. This raises the question: is the public truly prepared to navigate a marketplace full of complex and oftentimes misleading information?
Risks and Unintended Consequences
A dramatic shift toward OTC medications could create new risks. Without proper guidance, people might misuse drugs, delay seeking medical care, or fail to recognize serious side effects. The risk is especially high for complex conditions, rare diseases, or medications with narrow therapeutic windows. Additionally, increased accessibility might worsen issues like antibiotic resistance, as individuals could self-prescribe antibiotics and contribute to the development of drug-resistant bacteria.
Another concern is the potential for socioeconomic disparities. Health literacy is not uniform across the population, and those with fewer resources or less education may be at greater risk for medication errors. The absence of professional guidance could exacerbate existing inequities, leaving vulnerable groups without the support they need to manage their health effectively. The healthcare system must consider these challenges before implementing sweeping changes.
The Role of Regulation and Oversight
Regulatory agencies like the FDA exist to protect consumers from unsafe products and ensure that medications meet rigorous standards for safety and efficacy. Prescription requirements are a key part of this framework, serving as a safeguard against misuse and harm. Dr. Makary’s proposal would require a fundamental rethinking of how drugs are regulated and monitored in the United States. It is not enough to simply declare that most medications should be OTC; policymakers must develop robust strategies for education, surveillance, and intervention when things go wrong.
Pharma’s Twenty Questionable Assumptions About Pills and the Human Body
The pharmaceutical industry wields immense influence over medical practice and public perception of health. Its assumptions—often presented as established facts—profoundly shape drug development, regulatory policy, and patient care. Yet, many of these foundational beliefs warrant rigorous scrutiny.
Here is a brief discussion of twenty highly questionable assumptions propagated by the pharmaceutical industry regarding the human body and pharmaceuticals. In my opinion, the layman is not capable of understanding pharmaceuticals without knowledge of these false assumptions.
Assumption 1: Side Effects Are Extremely Rare
Drug advertisements and industry communications frequently downplay the prevalence of adverse effects, suggesting that side effects are rare exceptions. However, post-market surveillance and independent studies reveal that side effects are often underreported, especially for new drugs. Many adverse reactions emerge only after widespread use, and the true incidence of harm often remains concealed due to reporting biases and short clinical trial durations. This assumption fosters a false sense of safety around pharmaceuticals, leading to complacency among prescribers and patients alike.
Assumption 2: Surrogate Endpoints Reliably Predict Real Outcomes
Clinical trials often rely on surrogate endpoints—biomarkers or intermediate outcomes, such as cholesterol levels or blood pressure—rather than measuring actual health benefits like reduced mortality or improved quality of life. The industry assumes these proxies are reliable, yet history is replete with examples where drugs improved surrogate markers but failed to enhance, or even worsened, real-world outcomes. This disconnect can result in the approval and widespread use of drugs that do not meaningfully benefit patients.
Assumption 3: The Skin Is an Effective Drug Barrier
It is commonly assumed that the skin is an impermeable barrier, minimizing concerns about topical or environmental drug exposures. In reality, the skin’s permeability varies based on factors such as age, hydration, and the presence of solvents or enhancers. Transdermal drug delivery systems exploit this very permeability, and accidental exposures can lead to systemic effects. Overlooking this complexity can result in unanticipated risks, especially for vulnerable populations.
Assumption 4: No One Knows What Causes Cancer
The industry often frames cancer as a mysterious, unpredictable disease, emphasizing genetic mutations or “bad luck.” While cancer is indeed multifactorial, this narrative sidesteps substantial evidence implicating environmental toxins, lifestyle factors, and occupational exposures—some of which are related to pharmaceutical products themselves. This selective uncertainty serves to deflect attention from preventable causes and the industry’s own responsibilities.
Assumption 5: Depression Is Caused by Chemical Imbalance
Pharmaceutical marketing has popularized the “chemical imbalance” theory of depression, positing that low serotonin or other neurotransmitter deficiencies are the root cause. This simplistic model lacks robust scientific backing, as depression’s etiology is complex, involving genetics, environment, and psychosocial factors. By promoting this reductionist view, the industry justifies widespread antidepressant prescribing while neglecting holistic and psychosocial interventions.
Assumption 6: The FDA Ensures Drug Safety
There is a widespread belief that regulatory agencies like the FDA act as infallible gatekeepers, ensuring only safe and effective drugs reach the market. In reality, the FDA relies heavily on industry-sponsored data, and its expedited approval pathways often compromise the thoroughness of safety evaluations. Post-marketing surveillance is inconsistent, and conflicts of interest can undermine the agency’s objectivity. Blind faith in regulatory oversight is therefore unwarranted.
Assumption 7: Animal Carcinogenicity Studies Are Irrelevant to Humans
Pharmaceutical companies often dismiss worrisome findings from animal carcinogenicity studies, arguing that results do not translate to human risk. While interspecies differences exist, many carcinogens were first identified in animals before being recognized as human hazards. Disregarding animal data can delay recognition of genuine risks and compromise public safety.
Assumption 8: All Patients Respond Similarly to Drugs
Drug development and marketing often presume homogeneity in patient responses, suggesting that a drug’s efficacy and safety profile are universally applicable. In truth, genetic variability, age, sex, comorbidities, and concomitant medications significantly influence individual reactions. This assumption leads to one-size-fits-all prescribing and overlooks the need for personalized medicine.
Assumption 9: Drug Interactions Are Negligible
The complexity of polypharmacy is frequently underestimated, with the industry downplaying the risks of drug-drug interactions. In reality, interactions are a major cause of adverse events, hospitalizations, and therapeutic failures. The assumption of negligible interactions ignores the realities of multi-morbid, aging populations who often take multiple medications concurrently.
Assumption 10: Placebo Effects Are Insignificant
Some pharmaceutical communications suggest that placebo effects are minor or irrelevant compared to drug effects. However, placebo responses can be substantial, especially in conditions like pain, depression, and anxiety. Minimizing the placebo effect’s significance can inflate perceived drug efficacy and obscure the importance of patient expectations and therapeutic context.
Assumption 11: Chronic Diseases Are Best Managed with Lifelong Medication
The industry promotes lifelong medication as the gold standard for chronic disease management, often neglecting the potential of lifestyle interventions, reversible causes, or disease remission. This approach can lead to overtreatment, medication dependency, and an underappreciation of non-pharmacological therapies.
Assumption 12: Newer Drugs Are Always Better
A pervasive industry narrative holds that innovation invariably produces superior therapeutics. Yet, many new drugs offer marginal or no advantage over existing treatments, and some are less safe. This assumption drives up healthcare costs and diverts attention from established, effective therapies.
Assumption 13: High Drug Prices Reflect Research Costs
The justification for exorbitant drug prices is often rooted in claims about the high cost of research and development. However, analyses reveal that pricing is more closely tied to market exclusivity, competition, and profit maximization than to actual R&D expenses. This assumption perpetuates unaffordable healthcare and undermines access to essential medicines.
Assumption 14: Over-the-Counter Drugs Are Inherently Safe
There is a widespread belief that OTC medications are essentially risk-free. In reality, many OTC drugs carry significant risks, especially when misused or combined with other substances. This complacency can result in preventable harm, particularly in vulnerable groups such as children and the elderly.
Assumption 15: Drug Withdrawal Symptoms Are Rare
The industry frequently understates the prevalence and severity of withdrawal symptoms associated with many medications, including antidepressants, benzodiazepines, and opioids. In practice, withdrawal can be common and debilitating, often mistaken for relapse or new illness. This assumption hampers informed consent and patient autonomy.
Assumption 16: Long-Term Safety Is Well Understood at Approval
Drug approval is often based on relatively short-term studies, yet the industry presents new medications as if their long-term safety profile is well established. Post-marketing surveillance may identify unforeseen risks, but these are often recognized only after widespread exposure. This assumption exposes patients to avoidable harm.
Assumption 17: Clinical Trial Populations Represent Real-World Patients
Clinical trials typically enroll selected populations—excluding the elderly, children, pregnant women, or those with comorbidities—yet results are generalized to all patients. This assumption disregards the diversity and complexity of real-world populations, leading to unanticipated adverse effects and variable efficacy.
Assumption 18: Drug-Induced Nutrient Depletion Is Uncommon
The potential for pharmaceuticals to deplete essential nutrients is often ignored or minimized. In reality, drugs such as proton pump inhibitors, statins, and metformin can significantly impact nutrient status. This oversight can contribute to adverse health outcomes and complicate disease management.
Assumption 19: Polypharmacy Is Not Problematic
The risks associated with taking multiple concurrent medications—polypharmacy—are frequently downplayed. Polypharmacy dramatically increases the likelihood of adverse drug events, interactions, and decreased adherence, particularly in elderly populations. This assumption perpetuates unsafe prescribing practices.
Assumption 20: Adverse Event Reporting Is Comprehensive
Pharma often asserts that adverse event reporting systems are robust and comprehensive. In truth, underreporting is rampant, with only a fraction of adverse events ever documented. This leads to an incomplete understanding of drug safety and delays corrective action.
Are You Aware of These Facts About Pharmaceuticals?
- Many drugs have serious side effects that aren’t apparent until after widespread use.
- Drug interactions can be dangerous and are often overlooked by non-professionals.
- Critics say that pharmaceutical companies often prioritize profit over patient safety.
- Not all generic drugs are identical in effectiveness or safety to brand-name versions.
- Some medications require monitoring of organ function, like liver or kidneys.
- Dosage errors can result in life-threatening complications.
- Some drugs are contraindicated for certain populations, like pregnant women or children.
- Adverse reactions may not be immediately obvious, and delayed effects can be fatal.
- Drug recalls occur due to unforeseen safety issues, sometimes years after approval.
- Marketing strategies can mislead consumers about effectiveness and safety.
- Pharmaceuticals can be addictive and lead to dependency if misused.
- Many drugs have narrow therapeutic windows, requiring precise dosing.
- Over-the-counter status doesn’t guarantee safety for all users.
- Some drugs mask symptoms without treating underlying causes, risking further harm.
- Patients may not recognize signs of allergic reactions or toxicity.
- Insurance coverage and pharmacy benefit managers influence drug access and pricing.
- Long-term effects of new drugs are often unknown at the time of approval.
- Counterfeit and substandard pharmaceuticals are a global problem.
- Industry-sponsored research may be biased or incomplete.
Conclusion
The pharmaceutical industry’s questionable assumptions about the human body and pharmaceuticals have far-reaching implications for patient safety, public health, and medical practice. By critically examining these beliefs, the urgent need for greater transparency, independent research, and regulatory reform should be apparent.
The suggestion to make most pharmaceuticals available over-the-counter, trusting consumers to make their own decisions, disregards the complexity of medicine and the necessity for professional oversight. There are significant risks and gaps in knowledge that could adversely affect public health. The expertise gained from years of education and clinical experience cannot be casually dismissed in favor of unchecked consumer autonomy.
The complexity of pharmaceuticals, the variability of health literacy, and the potential for harm demand careful consideration and nuanced policy solutions. As policymakers weigh the evidence and chart a path forward, they must remember that the stakes are high—and that the health and safety of millions of Americans hang in the balance.
Dennis Miller, R.Ph. is a retired chain store pharmacist. His book, The Shocking Truth About Pharmacy: A Pharmacist Reveals All the Disturbing Secrets, can be downloaded in its entirety at Amazon for 99 cents.
