Television viewers in the United States watch an average of nine drug advertisements per day, or about 16 hours per year, far in excess of the time spent with their physician. That is because pharmaceutical companies spend huge amounts of money on direct to consumer advertising. In 2022 pharmaceutical companies spent 6.88 billion U.S. dollars on direct to consumer advertising! Pharmaceutical companies claim that these ads educate patients about treatment options they might not know about and foster conversations with their physicians. Pharmaceutical companies, however, are in the business of making money and these ads do a great deal to increase their revenue or they would not spend billions of dollars on them. This post will examine the claim that the ads are helpful to patients and doctors and will document the substantial harm that these ads do to both the health system and to individuals.
Almost all other countries besides the United States ban direct to consumer advertising of prescription medicines. The only other country that allows them is New Zealand.
History of Direct to Consumer Advertising
In the 1960’s congress granted the FDA the authority to regulate prescription drug labeling and advertising. The FDA was to ensure that prescription drug ads were: not false or misleading; presented a fair balance of drug risks and benefits; included facts that are material to a drug’s advertised use; included a brief summary that notes every risk described in the drug’s labeling. Because of these requirements, almost all drug advertising was directly to physicians.
In the late 90’s, the FDA changed the required risk information by stating that only major risks must be disclosed in ads and that they must provide resources that consumers can be directed to for full risk information. Because of this change, direct to consumer advertising has exploded since the late 90’s.
Compliance with FDA Requirements
Pharmaceutical companies are not required to submit ads to the FDA before they are used. They are required to submit ads to the FDA for review after they are in use, but the FDA lacks resources to review these ads in a timely manner. Many times the ad has already stopped running by the time the FDA gets around to reviewing it. A 2018 study published in the Journal of General Internal Medicine evaluated all broadcast direct to consumer pharmaceutical ads for 6 months for compliance with FDA regulations. The study found that only 26% of the ads were fully compliant with FDA regulations.
Online Direct to Consumer Advertising
Pharmaceutical companies have markedly increased online advertising through social media including FaceBook, Twitter (now X), YouTube and blog posts. This advertising reaches consumers in English speaking countries who ban direct to consumer prescription drug advertising. The FDA can only review a small portion of these. Here is a link to an article from an international policy journal about online direct to consumer ads by pharmaceutical companies: The Tip of the Iceberg of Misleading Online Advertising.
What the FDA does not require in direct to consumer advertising
Here is a list of important things that pharmaceutical companies are not required by the FDA to include in direct to consumer advertising.
- Cost – Many of the medicines advertised are very expensive, especially cancer drugs. Pharmaceutical companies are not required to tell you anything about cost in their ads
- If there is a generic version of the drug (a drug with the same active ingredient that might be cheaper) -Many times there is a generic version of the brand name drug that will do exactly the same thing as the drug advertised
- If there is a similar drug with fewer or different risks that can treat the condition – There may also be a similar drug with fewer risks that could treat the condition advertised. The pharmaceutical companies are not required to tell you that in their ads
- If changes in your behavior could help your condition (such as diet and exercise) – Eighty percent of chronic disease could be treated with life style changes. Ads are not required to tell you that
- How many people have the condition the drug treats – The percentage of people who have the condition the drug treats may be very small. They don’t have to tell you that either
- How the drug works (its “mechanism of action”)
- How quickly the drug works
- How many people who take the drug will be helped by it – It could be that only a small percentage of people who take the advertised drug will improve. Ads are not required to tell you that.
Evidence that direct to consumer drug advertising is helpful
There is evidence that direct to consumer drug advertising is beneficial for patients and their doctors. Here are the claims that have at least some evidence. This list come from a paper in the journal Pharmacy and Therapeutics: Direct-to-Consumer Pharmaceutical Advertising – Therapeutic or Toxic? The paper also summarizes the evidence for each of these claims
- Informs, educates, and empowers patients.
- Encourages patients to contact a clinician.
- Strengthens a patient’s relationship with a clinician
- Encourages patient compliance.
- Reduces underdiagnosis and undertreatment of conditions.
I don’t find the evidence for any of these particularly convincing. None of the papers cited in the article disclose whether any of the authors have financial relationships with pharmaceutical companies.
Evidence that direct to consumer drug advertising is harmful
Despite pharmaceutical companies touting the educational benefits of direct to consumer advertising, remember that the main purpose of these ads is to sell a product, not to educate consumers. Here is a list of well documented harms of direct to consumer drug advertising:
- Present incomplete or biased information – Most ads either leave out risk of the disease the advertised drug treats or use vague terms (like millions) Ads for drugs for which lifestyle modification is a viable alternative did not mention lifestyle changes. Over half of ads presented the advertised drug as a scientific breakthrough. See this paper from the Annals of Family Medicine: Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising
- Spur people to ask for medications they don’t need - A study published in the Journal of the American Medical Association found that “Fewer than one-third of the most common drugs featured in direct-to-consumer television advertising were rated as having high therapeutic value, defined as providing at least moderate improvement in clinical outcomes compared with existing therapies” (Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021)
- Promote medications before long-term safety is known. In the case of Vioxx, a new pain relief drug, it was pulled from the market due to an unexpected rise in heart attacks and strokes — but not before millions of people saw the ad and began taking it. (Merck to pay $950 million for illegal marketing of Vioxx)
- Create conflicts between patients asking for a drug and doctors who don’t recommend it – An article in Consumer reports reported that 78% of doctors report that patients at least occasionally ask them for medicines they saw in drug ads. 54% of those doctors said they often decline these requests (Consumer Reports Survey: Patients and Doctors Disagree on Some Essential Issues)
- Drive up healthcare costs without adding health benefits – New drugs are much more expensive than generic drugs that may do the same job. Also, unfortunately doctors are much more likely to prescribe the medicines that patient’s ask for rather than an alternative less expensive and/or more effective treatment. This is the biggest societal harm of direct to consumer prescription drug advertising. See this paper: Effects of Patient Medication Requests on Physician Prescribing Behavior.
Bottom Line
The FDA simply does not have the resources to adequately regulate pharmaceutical company direct to consumer advertising. Even if they did, it is unlikely that the FDA could even partially mitigate the well documented harms of the tremendous spending by pharmaceutical companies on these ads. I agree with my friend and mentor Dr. Kurt Stange that the only viable recourse is to ban direct to consumer drug advertising as almost every other country in the world has done. Here is his editorial in the Annals of Family Medicine: Time to Ban Direct-to-Consumer Prescription Drug Marketing.