Introduction

In the 1980s, pharmaceutical companies began enacting direct-to-consumer marketing of drugs with the approval of the FDA (Food and Drug Administration) in magazines and on television.1 Today, one of the largest controversies regarding pharmaceutical research is related to companies spending more money on advertising and marketing than on research and development (R&D).2 For example, a study by AHIP (formerly America’s Health Insurance Plans), a political advocacy and trade association consisting of health insurance companies, found that seven out of ten prominent pharmaceutical companies, including Pfizer, AbbVie, GlaxoSmithKline, Bayer, Johnson & Johnson, and others spent billions more on marketing and advertising than they did on R&D in 2021.3 Many experts also support these claims, asserting that major pharmaceutical companies spend much more on “self-enriching activities” like advertising, marketing, stock buybacks, and executive compensation than they do on actually developing new medications.4,5

 

     However, other sources, including R&D World, defend pharmaceutical companies, claiming that it takes a tremendous amount of time and money ($5 billion per drug developed) to support pharmaceutical R&D, and that most major pharmaceutical companies spend more on R&D than they do on advertising and marketing.6 These conflicting reports make the spending habits of pharmaceutical companies unclear, which raises an important ethical question: “Do pharmaceutical companies have a moral obligation to society to prioritize scientific advancement and drug development over commercial growth and financial success?” Deontology is an ethical theory that holds that individuals are morally obligated to act according to duty, rules, or principles, regardless of the consequences of their actions or personal feelings. Those who subscribe to deontology would argue that pharmaceutical companies should take the moral “high road” and prioritize developing as many safe, effective, and affordable drugs as possible with the intention of helping as many people as possible, even if it means prioritizing less marketing/advertising and accepting a decline in revenue.7 Adopting an alternative framework such as corporate social responsibility could lead to a different conclusion. Corporate social responsibility is an ethical theory which states that businesses should prioritize maximizing their profits while operating within the minimal constraints of the law. Using the theory of corporate social responsibility, one might argue that pharmaceutical companies should prioritize marketing, advertising, and self-enriching activities because it could allow the companies to make more money while remaining within the constraints of the law.8

 

     In this essay, I argue that drug companies have over-commercialized medicine and healthcare by providing kickbacks to physicians and using potentially misleading direct-to-patient advertising. These acts are unethical because they violate patient autonomy by altering a patient’s ability to objectively choose which medications they take, and ultimately, how they choose to manage their health.

 

Background - How Opaque Clinical Trials were Harmful in the Past

     When a medication is in the process of being approved for widespread use, one of the critical stages in its development is conducting clinical trials to determine patient responses. Clinical trials are essential for helping researchers ascertain if a drug is safe for patients and identifying any potential side effects. Moreover, doctors rely on information from clinical trials to decide whether or not to prescribe a drug to their patients. In the past, pharmaceutical companies were not required to make their clinical findings public, and clinical trial reports were even considered commercially confidential between pharmaceutical companies and regulatory agencies.9,10 This lack of transparency created risks, enabling pharmaceutical companies to direct doctors to prescribe drugs in a manner that may pose risks to their patients. This is precisely what happened in 1999 when drug company SmithKline Beecham (now GlaxoSmithKline) developed the antidepressant Paxil. While this drug was approved for use in adults, it was not deemed safe for adolescents. Regardless, GSK promoted the drug to doctors as being safe for adolescents, even paying a consulting firm to publish an article discussing all of the positive outcomes of the clinical trials while excluding the negative ones. On top of this, GSK failed to publish studies revealing their findings that Paxil caused suicidal ideation in individuals under 25, along with other adverse side effects. Additionally, two other unpublished studies showed that Paxil “failed to show efficacy in” treating depression.10

 

     One can see how past regulations and laws have created the opportunity for pharmaceutical companies to behave unethically. However, in recent years, the US government has tightened its policies on clinical trial transparency so that all findings are required to be published, whether the study was successful or not.11,12 This alone is a big step towards making pharmaceutical research more ethical, preventing pharmaceutical companies from influencing doctors to prescribe drugs in ways that have not been tested or that have been proven in clinical trials to be explicitly dangerous. However, issues still remain today that could influence the way doctors prescribe medications in potentially unethical ways.  

 

Negative Impacts of Direct-to-Physician Lobbying and Kickbacks

     One act that could lead to unethical prescribing practices pertains to kickbacks provided by pharmaceutical companies. While it is illegal for doctors to receive payment from pharmaceutical companies for prescribing a specific medication, there is a gray area that still allows pharmaceutical companies to provide doctors with gifts, free drug samples, and even finance meals as well as travel and accommodations to conferences.13,14 A 2007 study published in the New England Journal of Medicine found that 94% of physicians surveyed had some sort of relationship with the pharmaceutical industry in terms of accepting food, drug samples, and reimbursement for travel and consulting.15 While most doctors do not believe that they (or their medical practices) are affected by these industry relationships,16 several studies indicate the presence of a positively associated relationship between physicians prescribing pharmaceuticals and the gifts they receive from pharmaceutical companies.17 In other words, the more gifts physicians receive from a drug company, the more likely they are to prescribe more of a drug from that company than a doctor who isn’t receiving gifts.18 The ethical concern regarding doctors’ prescribing practices being influenced by gifts from pharmaceutical companies is that it could lead a doctor to prescribe one medication where an alternative might be cheaper, more effective and cause fewer side effects for a patient, or where a non-drug treatment might be more effective with less risks of side effects or addiction.19

 

Direct-to-Patient Advertising and why it is Potentially Harmful

     Another aspect of medical commercialization that could have ethically questionable implications is direct-to-consumer advertising by pharmaceutical companies. In the 1980s, the FDA approved direct-to-consumer commercials on TV for advertising drugs so long as they accurately represented the benefits and risks of taking the medication. Just last year, the FDA tightened restrictions on these ads; now, on-TV advertisements must be “presented in language and terminology that is consumer friendly and readily understandable,” audio information must be “… understandable… in terms of volume, articulation, and pacing,” there must not be “visual elements that might interfere with a consumer’s understanding of the content,” and “text information must be presented in a way that is easy to read.”20 While these regulatory measures may seem helpful in ensuring that patients get accurate and easy-to-understand information about a given drug, they are also extremely vague and are not monitored or enforced by the FDA. Other regulatory agencies, like the Federal Trade Commission (FTC), broadly monitor advertising practices in an attempt to ensure that consumers get the most accurate information possible. While the FTC has sued over various medical-related ads ranging from false claims about arthritis treatment using stem cells to fake health insurance ads, it has no jurisdiction in the direct-to-consumer drug advertising scene. Instead, these policies are expected to be self-enforced by drug companies as well as patients and doctors who catch policy violations on-screen. According to an article by American physician and New York Times reporter Elisabeth Rosenthal, the department of the FDA that monitors complaints about drug commercials only has nine full-time employees and, from 2019 to 2024, has received only 32 letters lodging complaints against drug ads.21

 

     In addition, even if the FDA did attempt to enforce its new loosely interpretable rules for drug commercials, it would likely see very little success when one considers past precedents and the current regulatory forces in this field. In 2019, the Trump administration attempted to pressure pharmaceutical companies into including drug pricing information in their commercials, and in response, drugmakers filed and won a lawsuit, claiming that the new rule violated their First Amendment rights.22 Evidently, pharmaceutical companies are largely allowed to advertise their drugs with little to no regulations about what they say or how they say it. While this is not to say that drug companies explicitly lie in their drug commercials or violate FDA protocol in an attempt to misinform patients, it certainly creates the opportunity for potentially misleading advertisements for medications. Moreover, many experts and physicians are concerned that using direct-to-patient advertising could create the perception in the minds of many consumers that they need to be taking a drug when they actually don’t, which could contribute to over-prescribing or increasing medicalization.19

 

     In addition, drug advertising could result in the promotion of less effective medications that are more expensive to patients. In fact, a 2023 study found that the less effective a drug actually was, the more money drug manufacturers spent on direct-to-patient advertising compared to physician education about that medication. The article claims that “… further research is needed to understand the implications of these findings.”23 I think these results may suggest that pharmaceutical companies put a special emphasis on direct-to-consumer advertising as a way to market less effective drugs for two reasons: 1: the general public is not as educated about medications as physicians are, and 2: the lack of specific regulatory guidelines and enforcing agencies for drug ads makes it easier for drug manufacturers to spread potentially misleading information about their medications. While this is somewhat based on speculation, I am not alone in believing that direct-to-consumer TV drug ads are problematic. Indeed, as early as 2015, the American Medical Association endorsed a ban on such TV ads due to “concerns (among physicians) that a growing proliferation of ads is driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives.”24

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Conclusion: Impact on Autonomy

     Overall, I believe that the commercialization of medicine by pharmaceutical companies in the form of giving gifts to doctors and direct-to-patient advertising on television violates the first pillar of medical ethics: autonomy. The British Medical Association describes autonomy as “the right of adults with capacity to make informed decisions about their own medical care”.25 I believe that patient autonomy in making informed medical decisions could be impacted by pharmaceutical companies. For the general public, a patient’s two most readily available sources of information about a medication are their doctors, who may be unintentionally influenced by gifts from pharmaceutical companies, and TV ads that have little to no regulations, creating the opportunity to perpetuate misleading or confusing information about medications. Therefore, pharmaceutical companies have the power to alter most of (if not all) of the information that a patient learns about a medication. I am not saying that pharmaceutical companies will use this power for evil or to simply make a profit, but there is also a large opportunity for pharmaceutical companies to sell ineffective, unnecessarily expensive, and even potentially dangerous medications to consumers with little to no consequences for the corporations. This finally leads us to answering the question: if a patient’s access to information about the medications they are using is skewed, how can they make autonomous, informed decisions about their medical care? The answer: they can’t.