Drug Advertising: “Side Effects May Include” MIA – Why?

March 3rd, 2011. By Hunter West

You know all those drug ads on TV, where new drugs for everything from erectile dysfunction to depression, to cholesterol are touted complete with a shopping list of side effects against a backdrop of shiny, happy people dancing in slow motion in the green grass of a city park, or cavorting across an idyllic beachfront? Case in point, Cialis ad at left.

All that damning voiceover information on side effects and adverse reactions can get lost in the visuals (which is probably the plan), but at least the requisite information is there. 

Why did that not happen with Tylenol, and the potential for acetaminophen toxicity? 

Why did that not happen with denture adhesive, and the potential for zinc poisoning? 

Most realize that most drugs have side effects. Fewer realize that all drugs have side effects at all. And the more intense the drug, the longer the list of adverse reactions. When a new drug designed to treat, say, the propensity to have to get up to pee several times in the night for aging Americans comes on the market, manufacturers know that in order to advertise the drug where their constituents are—parked on their sofas, watching television—they have to abide by advertising regulations and include the side effects. 

You may not recall every adverse reaction rattled off in such TV commercials. You may not remember even one. But you are left with the sense that this is serious stuff, and if you’re at all interested in the benefits such drugs provide, you’ll damn well talk to your prescribing physician about them. 

So why didn’t the manufacturers of denture cream containing zinc, include the risk for zinc poisoning in the TV ads? 

Simple. They didn’t have to. 

It may not be the case now, but at one time manufacturers of denture cream didn’t have to include zinc levels on product labeling. Yes, they had to include the fact that zinc was in the product. But not how much. Nor were they required to mention that denture cream used excessively could lead to neuropathy caused by too much zinc in tandem with diminished levels of copper. 

All they were required to say is that when used as directed, denture cream is safe. Of course it is—when used as directed. 

Sadly, too many people used denture cream like toothpaste. No, even more excessively than toothpaste. While a series of small droplets of cream will do a decent job of holding perfectly fitting dentures in place—it often does not do the job if dentures are ill fitting. Using as directed is no reassurance for a lack of self-confidence. 

So you lather up, not knowing that you could be hooking yourself up to a walker long before your due. 

Then there’s acetaminophen toxicity from Tylenol. Did you know about that? I didn’t know about it until I researched it. Acetaminophen toxicity can be a serious health hazard. And yet how many of us have popped Tylenols like candy, in an attempt to eradicate a persistent headache, or tooth pain? Are we careful to avoid other products that might also contain acetaminophen? Are we careful to avoid alcohol as well? Sure, that glass of wine could help dull the pain, but you could be affecting your health in the process. 

Where’s that information in the Tylenol ads? 

Reality TV is all the rage right now. Okay, how about a reality TV commercial for denture adhesive containing zinc? 

[TV ad] 

Here is the part that says, “…When used as directed.” The perfect-world snapshot. 

Now, here’s Marge. She got her dentures ten years ago. They’re discolored and she’d like to get new ones, but her husband died and her benefits died with him. She can’t afford a new pair, so her old ones will have to do—even though they don’t fit so well, either. Now, what Marge doesn’t know is that the mouth changes shape over time. Dentures do not, so they will eventually be ill fitting and will have to be replaced. 

But Marge doesn’t know that. And even if she did, she can’t afford new dentures. But she can afford to buy much more denture cream than she would otherwise use “as directed’ for properly-fitting dentures. Instead of droplets, she lines each edge with a thick strip of cream. That gets ’em in there good. They don’t move now…

But what Marge also doesn’t know is that a healthy body requires balanced levels of copper and zinc. Marge doesn’t know that there is zinc in her denture cream, and that it is the zinc that helps to make her dentures stick. But that’s okay. Zinc is a mineral, right? Minerals are good for the body, right? 

What Marge doesn’t know is that too much zinc will deplete copper levels in the body. The copper can’t compete with the zinc. And when you have too much zinc in the body, it can lead to all sorts of problems from which you may never recover, dear Marge. 

So Marge changed her game plan. She’s using denture cream as directed. She’s just not going out quite as often, not wearing her dentures quite as often. And she’s taking the money she’s saving on denture cream, and putting it aside for new dentures… 

Ad educated consumer is the best consumer, they say. But then an educated consumer will buy less denture cream… 

Product manufacturers will do what they have to, to comply. Sometimes less, but certainly no more. Precious few will advertise the negative aspects of their product just because it is the right thing to do, instead of being forced to by regulatory authority. In the same vein, why would a medical device manufacturer actually bother with expensive clinical trials that will result in a delayed introduction to market of a new product that is substantially similar to an existing one? The FDA provides a fast track. So hey, we’ll take it. 

Just imagine the pain and suffering that would have been avoided if denture cream containing zinc were advertised with the same degree of caution as other drugs? 

Just imagine if the potential for acetaminophen toxicity from Tylenol were advertised in similar fashion? 

But then, that wouldn’t be good business, would it?

Tags: Acetaminophen, Adverse Events, denture cream, Durg Marketing, Fixodent, Side Effects, tylenol

This was posted on Thursday, March 3rd, 2011 at 5:46 pm and is filed under Drugs/Medical, Emerging Issues . Feel free to respond, or trackback. Read our comments policy.