Tuesday, May 5, 2015
Advertising & The Physician-Patient Relationship: Part III
Part III: Policy & Ethics
I have described the tobacco companies of the mid-twentieth century and modern pharmaceutical companies as almost predatory in their tactics. I should take a moment to clarify my attitude toward Big Pharma as a whole.
In class, we have discussed at some length the harm that can result from extensive distrust of allopathic medicine by groups such as anti-vaxxers. I think these anxieties are depicted poignantly in Alexander Beydeman’s “Homeopathy watching the horrors of Allopathy” (1857). Supernatural forces on the right represent Homeopathy, while doctors at work embody Allopathy on the left. Notice the gold bars behind the doctors as they pour medicine from an oversized bottle and amputate a patient’s lower leg. This is an image with which many people holding suspicions about direct-to-consumer pharmaceutical advertising would likely identify.
By no means am I promoting a paranoid attitude toward pharmaceutical advertising. I don’t think this is an “us vs. them” issue or that Big Pharma’s end game is to profit at the expense of public health. I do think main goal of these companies is to profit, but not explicitly at the expense of public health.
That being said, I think it is important to evaluate such advertising with a critical eye.
The Federal Food, Drug, and Cosmetic Act grants the Food & Drug Administration (FDA) authority to oversee advertising of prescription (but not over-the-counter) pharmaceuticals. FDA is not at all involved in the process of creating ads and does not prohibit the advertising of any drug, including drugs with serious risks and the potential to become addictive. There are certain requirements for drug ads that make efficacy claims. These ads must demonstrate one or more FDA-approved uses for the drug, the generic name of the drug, and the risks of using the drug. There are also certain requirements for the way the ad content is presented visually. For example, risk information must be presented in a similar way as the potential benefits of the drug (similar font size and style).
However, drug companies are not required to submit ads for approval before launching them, which means they are freely accessible to the public even if they are in violation of the law. Violations may include excluding or understating risks associated with the medication, suggesting that the drug is appropriate for a condition it has not been approved to treat, and misrepresenting data from studies. I suspect the latter violation is the most difficult to correct because only a very small population of people are qualified to detect it, including researchers and physicians who are intimately familiar with the drug and the research characterizing it.
FDA states that the typical action in response to an illegal ad is sending a warning letter to the company explaining the violation and requesting that the ad be withdrawn. If the company does not comply, legal action may be taken. The most extreme outcome is seizing the drug from the company and filing criminal charges.
Meanwhile, New Zealand is the only other country in the world that allows direct-to-consumer advertising of prescription drugs.
A study published in 2013 found that over 50% of the most-emphasized pharmaceutical claims were “potentially misleading” and that 10% were false altogether (although this includes only 2% of ads for prescription medications). Reporter Chris Lo writes that this “level of doublespeak might be par for the course in the advertising sector, but from a clinical standpoint it's truly worrying.”
It seems clear that direct-to-consumer pharmaceutical advertising significantly impacts the relationship between doctors and patients. A potential benefit could be that patients are encouraged to be more active participants in their care by asking questions and becoming informed, and therefore empowered, regarding treatment options. As of May 2011, however, medications that used public advertising were prescribed at nine times the rate of medications that didn’t employ public advertising.
According to the World Health Organization, there exists "an inherent conflict of interest between the legitimate business goals of [drug] manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way".
I have concluded that there is legitimate cause for concern about modern pharmaceutical advertising. Unacceptable ads from both the past (tobacco, psychotropic medications) and present involving rampant misrepresentation of prescription drugs demonstrate the need to re-evaluate the way pharmaceutical advertising in the U.S is supervised.