“Warnings of serious side effects in drug advertising can actually improve consumers’ opinions and increase sales, rather than frightening them away, new research finds.” That was the opening statement in a recent PharmaTimes article (“Serious side-effects warnings can increase drug sales: study“).

All you have to do — which a LOT of people NEVER do — to discover that this statement is rubbish — i.e., a non-sequitur conclusion based on a faulty interpretation of the data — is to read the original research paper or even just the abstract, which you can find here in case you actually care to read it. Here, let me force you to read at least the relevant section of the abstract:

In one experiment, for example, smokers saw an ad for a brand of cigarettes: One version of the ad included a warning that smoking causes lung cancer, heart disease, and emphysema, while another version did not include the warning.
Predictably, participants who had the opportunity to purchase the cigarettes soon after seeing the ad bought less if the ad they saw included the warning. 

In contrast, participants who were given the opportunity to purchase the cigarettes a few days later bought more if the ad included the warning. The same outcome emerged when the researchers ran a similar experiment with ads for artificial sweeteners. 

According to Carmon and his colleagues, the warnings backfired because the psychological distance created by the delay between exposure to the ad and the decision to buy made the side effects seem abstract—participants came to see the warning as an indication of the firm’s honesty and trustworthiness. 

In fact, participants evaluated drugs for erectile dysfunction and hair loss that had potentially serious side effects more favorably, and as more trustworthy, when they were told the products weren’t on the shelves yet.

I added emphasis to the last bit, which talks about actual Rx products — although I am not sure there is an Rx product for hair loss (OTC, yes).

Why this is NOT RELEVANT to direct-to-consumer (DTC) advertising of Rx drugs here in the U.S. is this: drug companies CANNOT advertise products BEFORE they have been approved by the FDA for marketing and are “on the shelf” ready to go.  Well, yes, it’s possible to advertise a drug after approval and BEFORE launch, but I have never seen that. DTC is designed to lift sales, especially when there is competition.

The other issue is whether or not the study authors are correct in assuming that warnings in ads give consumers “warm and fuzzy” feelings of trust for the firm. Perhaps the authors meant “brand” instead of “firm” because most of the time we don’t know what company is behind a brand unless the names are the same. And most of the time, the firm is not even mentioned in the ad. This is even more true in the pharma sector, which does everything in its power to distance the firm from the brand in the mind of the consumer.

Does the drug industry devote almost 50% of TV DTC ads to reciting the litany of side effect warnings because it believes — like the authors of this study — that it increases consumer trust in the brand? Despite the industry’s purported mastery of psychology (see “Physicians Under Pharma’s Influence: Are Physicians Powerless Pawns of Pharma Psychology?“), it fails to appreciate the “psychological distance” theorem of the study authors.

I know this because over one-third of FDA notice of violation letters involved the “Omission or Minimization of Risk information” (see here and here) and even when sales reps are “staying on label” in discussions with physicians, they almost never mention serious adverse events as required by law (see here).

Nevertheless, I recall one TV DTC ad that MAY have used side effect information to bolster trust in the brand. It was that two-and-one-half-minute Celebrex TV ad that Pfizer ran after the Vioxx debacle(see Celebrex Ad: Let’s Dive Deeper).

The mention of “death” due to side effects two times in these ads was striking. Was that side effect mentioned to imbue trust in the brand, which was available “on the shelf” at the time? It’s hard to tell, because the main message was that Celebrex is like other NSAIDs: “All NSAIDs,” said the ad’s voiceover, “including Celebrex, also increase the chance of serious skin reactions or stomach and intestine bleeding and ulcers, which…may cause death.” In other words, “you can’t avoid the possibility of having this side effect if you take another similar product, so why not take Celebrex, which has been on the market for X years?”

OK, I think I made my case that this study about the positive effect on sales of side effect warnings in ads is bunk, especially when applied to Rx drugs. In MHO, PharmaTimes misled its readers from the get-go with that opening statement.