Truth, Lies, and Prescription Pills: The Ethical Dilemma of Pharmaceutical Advertising

Proponents of DCTA claim that DCTAs allow patients to take their medical wellbeing into their own hands, educates them on new treatments and reduces stigma; meanwhile opponents say that DCTA often presents incomplete or biased information, causes people to ask for unneeded medication, promotes medication before safety and creates more healthcare costs without benefits.

But the general public are not the only ones being impacted by DCTAs; doctors are also being impacted by them as well. Nowadays, it is not uncommon for clinicians to discuss pharmaceuticals that a patient has seen on a DCTA, but opponents of DCTA say that DCTA negatively affects primary care. Emeritus professor of family medicine and community health John Frey says DCT ads, which are only usually beneficial for very specific patient health conditions, tend to “create a distraction in the examination room” and result in “unnecessary prescribing,” “vague patient symptoms,” and even have a “negative effect on the clinician-family relationship. [8]” One cross sectional survey of 78 physicians found that while DCTA inspired patients to be more confident in conversations with their physicians about their treatment, the relationship between physician and patient was threatened when doctors declined a request for a DCTA medication[6].

On the contrary, other research has found that while a majority of patient-prescriber relationships were unchanged, others reported an improved relationship as a result of DCTAs compared to a minority that reported a worsened relationship[9]. Furthermore, research suggests that DCTAs even significantly impact prescribing decisions and patient care outcomes. In a meta-analysis of 38 surveys on the impact of DCTA, most surveys found that only a small percentage of patients (3.5% of clinical encounters in a Colorado health network and 7% in a survey of 683 U.S. clinic patient physician pairs[9]) actually requested a DCTA-prompted drug. In the first survey, physicians fulfilled most patient requests for the drug, but rated 50% of those DCTA drugs as “impossible” or “unlikely” to be prescribed for another patient with similar conditions to the ones making the requests. Compared to only the 12% “impossible” or “unlikely” rate for non DCTA drugs, could DCTA be encouraging inappropriate prescribing? A study done via randomized trial in which rates of prescription for an experimental patient presenting with either major depression (where medication is usually indicated) and adjustment disorder (where medication is usually not indicated) for an appropriate general drug and DCTA drug were collected with a control of no drug request. In the study, for major depression, requesting a brand specific drug resulted in significantly more prescription rates than no request at all and lower prescription rates than requests for general medication. Meanwhile, for adjustment disorder, DCTA drug requests resulted in the highest inappropriate prescription rate. This study shows that DCTA helps decrease underprescription of a drug beneficial to a patient by appropriately diagnosing and prescribing for medical conditions that clinically indicate the drug, but also simultaneously increases overuse issues in increasing rates of prescription of a drug for a condition which it was not indicated for[9].

Yet, the issue of physician bias extends far beyond DCT advertising itself. Even after DCTAs were legalised in the US, the foremost landscape of pharmaceutical marketing has always been directly at physicians themselves. And currently, almost 90% of pharmaceutical advertising cost is spent on advertising to physicians and other prescribers[10]. Marketing to prescribers comes in many forms: unsolicited promotional mailings of brochures, advertising in medical journals, detailing or face-to-face promotional activities, and even sending prescribers and physicians free samples of a drug. Payments or bonuses from pharmaceutical companies to physicians actually make up the most common form of physician-industry relationship, and over half of physicians in the U.S. receive annual industry payments from the pharmaceutical field[11]. Studies show that these payments result in increased use of brand name drugs, increased prescription of medication produced by the paying pharmaceutical company and increased medical and drug costs[10]. The positive effects of physician-industry relationships are undeniable, and supporters say these interactions keep doctors educated on advances in medication and medical technology, and it is undeniable that industry funding has resulted in numerous lifesaving advances in product development and production that physicians help test in clinical trials. However, there is concern that industry-physician payments compromise the independent clinical decision making of physicians and negatively affect patient care. Policy must seek to address inappropriate payments and interactions that endanger the integrity of the healthcare system and threatens its commitment to patient care.

All other factors aside, a drug's performance on clinical trials is the strongest empirical evidence of its effectiveness and what the FDA uses to determine whether a drug is approved or not. Even then, clinical trials for a drug are carried out by the same company that manufactures the drug, which raises ethical concerns for the reliability of the results. Recently, multiple studies showing that clinical trials financed by a pharmaceutical company perform much more favorably than independent trials has raised concern over the financing of drug trials by their manufacturer [12]. While the FDA requires raw data from these trials to be submitted, the FDA does not have the funds to replicate these trials and verify the data. As the FDA allows pharmaceutical companies to create the protocol for their clinical trials, such as selection criteria for participants, and hire scientists to perform the trial, managing executives have many strategies to allow for a more favorable presentation of their drug. According to Dr. David Michaels, professor of public health and longest serving Assistant Secretary of OSHA in U.S. history, manufacturers use strategies such as publishing only a favorable part of a trial while burying the rest, test drugs against treatments that are ineffective or don’t work, or test drugs against too high or too low a dose of a comparison test to make the drug seem more appealing[13]. Studies similarly show that when advertising their drugs to physicians and the general public alike, pharmaceutical companies tended to manipulate information from the clinical trials to highly favor their products through only reporting on positive trials or select trials where the product outperformed competitors[14]. And once the drug passes FDA approval, it is released to the general public. But how then can we know if a drug is safe and beneficial if clinical trials and results often coincide with financial incentives? Sure, pharmaceutical companies have incentive to avoid being found liable for any mass tort litigation that may arise as a result from marketing an adverse drug, but is it ethical to allow companies to release an adverse drug in the first place? Should the only check against pharmaceutical companies come at the cost of the health of thousands of Americans?

With more medications being produced, requested and prescribed more than ever but less clear impacts on patient health, is supplying health products through such financially incentivized actors beneficial for patient health and society? And it's not just prescription drugs —from over the counter health supplements to microbiome gut health products that make outlandish claims— American health and food culture today is inundated with products and advertising that may contain information a little less than scientifically rigorous. Modern policy must find a way to navigate the ethical dilemma surrounding pharmaceutical marketing and balance the commercial interests of the industry with the health and well-being of the public, while consumers everyday must carefully decide which products will help us or harm us.