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.
Policy
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.
Ethics
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.
Sources:
I did not know that painting, nor did I realize that direct-to-consumer pharmaceutical advertizing was prohibited nearly the world over. Thanks, Lauren, today I've learned something!
ReplyDeleteWill Big Pharma go the way of big tobacco? (Which is what, exactly? Big tobacco is still with us.) We've learned to see through the self-serving disinformation of the latter. What will it take to open our eyes to that of the former? And how much should "caveat emptor" apply, given the public's evident credulity?