I balance on the edge of my seat watching the young skiing phenom effortlessly perform aerial tricks. As she awaits the Olympic judges’ scores, the video stream cuts away. Sandwiched between commercials from Toyota, Hello Fresh, and Stitch Fix are enthusiastic testimonials from paid actors touting the healthful effects of two new medications, guselkumab and ozanimod. My eyes struggle to read the fine print, and my ears strain to process the speedily read side effects for these medications that treat auto-inflammatory conditions.
For Americans, such direct-to-consumer advertising (DTCA) of prescription medications is commonplace. It wasn’t until an Australian friend noted that such advertisements are banned in his home country that the practice struck me as odd, too. The U.S. is one of only two countries that allow DTCA. The other, New Zealand, is considering banning the practice. Although not usually shy of being in singular company, the U.S. should be wary of this singular distinction.
In 2020, national health expenditures reached their highest level yet, $4.1 trillion, up 9.7% from 2019. Of this, 14% was spent on pharmaceuticals. The Affordable Care Act pivotally expanded access to health insurance, but several cost-control measures like the independent payment advisory board, the excise tax on “Cadillac” health plans, and alternative payment mechanisms have either been subsequently repealed by Congress or failed to yield significant savings. Prices for half of Medicare Part B and Part D drugs rose faster than inflation in 2020, and Medicare Part D spending on “ultra-expensive” drugs (those with an average annual cost in excess of annual U.S. per capita GDP) increased an astronomical 1170% between 2012 and 2018. With 55% of Americans taking at least four prescription medications, Americans are understandably worried; they reported prescription drug costs as their second most important voting issue prior to the 2020 elections. As a young physician prescribing new medications to multiple patients each week, I struggle daily with the financial toxicity to which I may be inadvertently exposing my patients.
The now-stalled Build Back Better Act aimed to address the issue of rising prescription drug costs. The Congressional Budget Office estimated that its stipulated provisions to allow Medicare to negotiate prices for a few high-cost medications, to require rebates for drugs for which annual price increases exceed inflation, to cap out-of-pocket spending for Medicare Part D enrollees above the catastrophic coverage threshold, among other measures, would lower the federal deficit by $297 billion over 10 years.
Notably, however, further regulation of DTCA was not considered. This is a gross oversight for several reasons.
The FDA is tasked with monitoring drug advertisements to ensure their accuracy. After the discovery in the early 1960s of the teratogenic effects of thalidomide use among pregnant women for morning sickness, the FDA enacted strict requirements for reporting side effects, contraindications, and effectiveness of medications in ads. In 1997, however, the FDA relaxed these requirements. This was a result of advocacy organizations’ emphasizing the potentially educational nature of drugs ads for patients, a Congressional push by Republicans toward deregulation, and the drug lobby insisting that succinctly summarizing all drug-related information in adverts was too challenging. This enabled pharmaceutical companies to include only major risks and most common side effects alongside information on where viewers could obtain more complete information. Drug manufacturers pounced.
Since 1997, spending on DTCA of drugs has skyrocketed from $1.3 billion for 79,000 ads in 1997 to $6 billion for 4.6 million ads in 2016. The Nielsen ratings service estimates that 80 drug ads appear every hour of every day on TV. Spending on DTCA pays. Harvard/MIT researchers concluded that $1 spent on DTCA boosts drug sales by $4.20.
Despite arguments that DTCA empowers patients with information that may then inform conversations with physicians, there is no data to substantiate this. Health care is rife with information asymmetries and, in the U.S., is focused on profit maximization. Given the limited information now included in drug ads and the push to maximize sales, drug companies have an incentive to positively portray their products and to leave it up to physicians to discuss appropriateness of therapy and risk/benefit profile with patients. The dastardly marketing strategy of Purdue Pharma’s OxyContin is illustrative. Within the context of a 30-minute primary care visit, I have found that correcting misinformation around the efficacy of new medications for pain or providing anticipatory guidance around side effects for a newly initiated anti-depressant can exceed the allotted appointment time.
These ads also distort perceptions around brand name drugs’ efficacy compared with less expensive generic medications and perpetuate the myth that newer medications are significantly more effective than older medications. The proliferation of ads means the FDA’s Office of Prescription Drug Promotion (OPDP) cannot verify the truthfulness of all ad content.
Indeed, 65% of FDA-surveyed physicians thought that DTCA confused patients about the risks and benefits of a drug. Physicians can feel pressured to prescribe advertised medications, and the resultant bump in sales suggests they do relent to patients’ requests. This adds to growing out-of-pocket costs and threatens to worsen the scourge of polypharmacy, particularly given how uncommon de-prescribing practices are and despite evidence to suggest de-prescribing can be done with little harm. I’ve encountered many elderly patients on statins for primary prevention or who are on several diabetes medications who are unlikely to derive cardiovascular benefit given their limited life expectancy but who are reluctant to discontinue these medications.
Finally, the de-regulated nature of DTCA, the increasing use of dubious surrogate endpoints in clinical trials, the rise in expedited FDA review, and the growing politicization of the FDA approval process send the wrong signals to pharmaceutical companies. Rather than promote development of innovative drugs with clinically meaningful benefits, the current regulatory infrastructure enables companies to shepherd drugs through clinical trials with questionable clinical benefit compared with standard of care, price these drugs exorbitantly, and use DTCA to maximize sales and profits. Patients stand to suffer rather than benefit from DTCA.
What is to be done? First, the most straightforward solution would be to ban DTCA. Calling DTCA “anticompetitive,” the American Medical Association supports such a ban. Such bans are not unprecedented. DTCA drug ads were banned from 1983-1985 after then FDA commissioner Arthur Hayes was appalled by adverts for a diuretic that included unfounded claims of its positive sexual side effects. Alternatively, given the increasing use of accelerated FDA approval and the growing need for post-marketing surveillance, another option would be to prevent DTCA for newly approved drugs until such phase IV studies are completed. The Institute of Medicine is in favor of a similar moratorium. Second, greater resources need to be invested toward non-drug company-funded academic detailing to empower clinicians to better understand the indications, efficacy, and side effects of new medications so that they can better counsel patients. Finally, more funding needs to be allocated to the FDA’s OPDP to be able to verify the claims made in DTCA ads. DTCA serves no clear purpose in the betterment of health and wellness. It’s time to rein in this profligate practice and to exclude drug company misinformation from the shared decision-making between us and our patients.
What are your thoughts on DTCA? Share your thoughts in the comment section.
Dr. Anand Habib is a third-year internal medicine resident at University of California, San Francisco. Originally from Houston, Dr. Habib completed his undergraduate work with honors at Stanford, worked as a Global Health Fellow at a clinic in Haiti's central plateau, finished a masters degree with distinction in Medical Anthropology at Oxford University as a Rhodes Scholar, and earned a medical degree from Harvard Medical School. He has previously studied the use of therapies for hematologic malignancies and oncologists' feelings of prognostic uncertainty in advanced lung cancer and is currently pursuing interests at the nexus of ethics, health policy, and distributive justice. He is a 2021–2022 Doximity Op-Med Fellow.
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