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Danger of Safety Deafness to Pharma DTC Ads

Pharma ads are a relatively “new” phenomenon. In the late 1990s, the FDA allowed pharma companies to advertise directly to consumers (DTC). These DTC campaigns were reviled by physicians who believe that the ads would create pressure on them from the patients and disrupt that physician patient relationship.

Pharma companies do not have “free speech” because they operate under “commercial speech”. They are therefore dictated by the Food and Drug Administration (FDA) on what they are allowed to say and they are required to provide the information about the safety of the drug as part of “fair-balance”.

This is why you will see the disclaimers built into the ad, as the narrator smoothly go from talking about how the drug works and to ask your doctor about the drug to the standard —

“…WonderDrug is not for everyone. Women who are pregnant or nursing should not take WonderDrug. Your doctor may do routine liver testing when you are on WonderDrug. Do not take WonderDrug if you are also taking IncrediblePill. Patients who experience big toe palpitations should stop WonderDrug immediately and call their doctor….”

From an industry perspective, one of the arguments *for* DTC is that diseases and conditions become educational opportunities.

For example, depression is a stigmatized condition — then Pfizers happy little marshmallow cartoon (or pill? or cloud? I don’t know what that Zoloft character was meant to be) showed up on screen and it was a way to encourage consumers to talk to their doctors about conditions they may otherwise not discuss. For erectile dysfunction, it used to be an uncomfortable topic, but it is one of the side effects of diabetes and patients care about sexual function (compliance on meds) — so you have ads that break the ice of conversation that patients need to have so that doctors can work with them on adhering with medication regimen for best outcomes.

So there are definitely positives as a result of DTC.

On the other hand, when a DTC for restless leg syndrome came out, I didn’t like that campaign very much. I felt this was such a specialized population of patients, that having a DTC campaign may cause patients to start diagnosing themselves, erroneously, based on seconds of soundbite.

In the past when pharma companies have been sued for not disclosing safety risks and full side effect profile, their DTC ads have usually been part of the lawsuit where the charges would be that patients have not been properly informed of the full risks of the drug and that the time spent on effectiveness tips the fair balance to make the drug appear “safer than it should appear”.

Image by http://www.sxc.hu/profile/StillSearcOne of the concerns I have is that over time, patients may begin to ignore those safety statements. This can be a real danger.

It’s not unlike how many of us have grown “blind” to online ads. We go to the website and our eyes are hit by ads all over the place, but we’ve trained ourselves to selectively ignore them. Ad-blindness is a real phenomenon and internet marketers talk about this and how to bypass or overcome them.

In pharma DTC, we may become so used to those safety disclaimers that we may become selectively deaf to those statements. Many of those statements are also repetitive and similar — such that we may begin to downplay the real risks that “need for liver monitoring” may pose.

Here’s an example from real life:

We’ve all seen various statin drug commercials — these are widely used blockbuster drugs. There are always safety statements about muscle weakness — sign of serious adverse event that can result in death.

One of my relatives was on a statin drug and he watches a lot of TV, he no doubt has seen ads for these statin drug commercials including the one he was taking. One afternoon when he visited and we were sitting at a picnic table he casually mentioned that he had trouble walking very far because he seems to have very low energy.

I knew he must be on a statin drug but he’s been on several drugs for several years: this person is a chronic smoker who still wouldn’t give up smoking or horrible fat-laden diet after multiple surgeries including a quadruple bypass (I am not kidding! Quadruple bypass! One of the most serious heart surgeries you can get). He’s always complaining of aches and pains — but still:

I asked him if he had switched meds recently and sure enough, he had been taken off an old statin in favor of “a newer” statin. I told him that he needed to call his doctor immediately and make sure that his “weakness” isn’t due to a serious adverse event like rhabdomyolysis, which can cause fatalities because of kidney over-burden.

He called his doctor and was taken off that statin to another statin and his “weakness” improved dramatically.

In other words, patients who are watching these commercials may grow deaf to these statements that sound very clinical but they don’t know what this looks like in real life. We aren’t thinking “oh I’m feeling this way because the drug is causing my muscle fibers to massively break down” — we think “I’m feeling really weak.”

Updated: June 30, 2013 — 8:03 am

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