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"Side effects may include ..."

I don't think pharmaceutical advertisers should be required to include medical disclaimers in their television commercials.

You know what I'm talking about—"Side effects may include nausea, bloating and diarrhea ..." "Be sure to tell your doctor if ..."Do not take this medication if ..."

Requirements to include these warnings are based on the fallacy that the advertising will sell the product. The advertising is a small piece of the sell, and the doctors and product literature, which are also part of the sell, can fill in the warnings. Why should the rest of us have to listen to that unpleasant information? After all, a campaign might be successful and still have 99%+ of viewers not in the target audience. So don't make the rest of us listen to that stuff. The video of happy patients is insufferable enough.

I'm all for protecting patients. But let's not inflate the power of the ads—which don't function in a vacuum. Let the doctor do the dirty work when only the interested patient is listening. (If he can't be trusted to do that he shouldn't be trusted to prescribe the medication. TV commercials do not exist to protect us from doctors.)

Steve Yastrow posted this on 04/03/06.

Comments

Then let's just legalize all drugs. Hell people know the side effects. Do you want people to be free or not?

MD’s toil the pharm line, it is their bread and butter. Just look through any medical journal. It is a monopoly, a system of government control.

Why beat around the bush on this one? The war on drugs is a disgrace.

What is your logic here? Government control or not? If yes, give me your logic for government control. If no, then let's let everyone be free.

Posted by Marty at April 3, 2006 10:25 PM


My point is just that it's silly to expect that advertising should be the method to protect patients. Advertising is only one piece of the puzzle, and a very ineffective one for teaching people about the dangers of drugs. Why assign advertising a responsibility that it is ill equipped to deal with?

If the argument is that "MD's toil the pharm line," than you'll need something more powerful than a TV voiceover to protect patients!

Posted by Steve Yastrow at April 3, 2006 10:28 PM


It's a good point Steve, but I don't think it's necessarily the right one.

A clearer parallel is the requirement to place the word 'simulation' in the bottom-right corner of an advert where some anonymous candy product is flying around the room - i.e. someone in the US will take the manufacturer to court if their candy doesn't exhibit flight when opened!

We all know that it is computer graphics that is making the candy fly, but unfortunately the litigious nature of the American citizen requires extra protection. Over here in the UK, the same adverts don't require such protection, and our courts would close any case brought to bear on such foolish charges.

Because the MD is not as rich as the pharma company, I'm afraid they'll continue to be the easy target until your legal system changes, which means no end to fast-talking disclaimers...

Posted by Stewart Rogers at April 4, 2006 2:46 AM


What if someone sees an add for a product, rushes off to the supermarket (where it may be cheaper but he won't get any advice like he would from a chemist or from a doctor with a prescription-only drug) and buys it... only to find he shouldn't be taking it? His impression of the product and its maker is...?!

Is this any different from ads that are required to point out that they're, "serving suggestions only" or "part of a clorie controlled diet" or "batteries not included"?

Posted by Mark JF at April 4, 2006 4:54 AM


I agree with Stewart's assessment above; and believe that advertisers are bound by some legal obligation to make mention of side effects during promotion of their products. Not too many advertisers would want to waste their creative space with such blanket warnings when they could use it to show beautiful, half-naked ladies and gentlemen getting high on their stuff.

Posted by Tom O'Leary at April 4, 2006 5:10 AM


I imagine a line that said "Taking this medication may result in serious side effects for a minority of consumers." would be better... this would inspire someone to actually ask their doctor what those effets would be....

Wouldn't it be interesting if you were required for other products to provide the same graphic warnings:

Drinking Miller beer may result in a pot belly, lethargy, liver disease, vomiting, divorce, depression, accidental death, intentional homicide, impaired judgement, memory loss, money loss, lonliness and public nudity.

Posted by James Hathaway at April 4, 2006 8:06 AM


Agree with Stewart and Tom re legal requirement and with Steve about the snarkie factor.

Amazing the business pharma rakes in - Wal$Mart pharmacists make $100k+/year - seems every 3rd magazine page is a pharma ad - USA/EU loves its drugs apparently - Baby BOOM investment opportunity - time to get CHINDIA HOOKED.

Posted by Sean at April 4, 2006 8:21 AM


I definitely think the possible side effects should be in the ads. The real question you should be asking though is why spend all of this money advertising a product to individuals when the decision-makers are the smaller audience of physicians.

Posted by Buz Dale at April 4, 2006 8:28 AM



Steve -
Your assumption is inaccurate as in "advertising is a small piece of the sell", since DTC advertising was approved by the FDA, the number of patients asking for a "branded" drug at physicians offices has increased significantly, as in I want Lipitor, not some generic. Pharma sales reps don't have nearly the pull or face time that they had 10 years ago. Large pharma spends millions on DTC advertising because it yields significant returns and fends off the eventual migration to generics after the product goes off patent. You over estimate the role of the physician/patient relationship and underestimate the impact of advertising.

The other issue as to why the disclaimers should remain as part of the ad is that it creates patient awareness about the serious medical nature of the product, patients need to be more engaged and involved in their own healthcare. The realization that a drug has potential serious side effects is a necessary nuisance and holds pharma and the patient accountable. The majority of patients don't bother to read the miniscule package insert, and physicians don't always communicate the risk of side effects.

I respectfully disagree.

Posted by Sheryl Kravitz at April 4, 2006 9:12 AM


Hmm.. and In Holland, you're not allowed to market medicines direct to consumers. And that's good I think.

Doctors and pharmacists should be the right folks telling patients what medicine to take, not just someone's uncle..

So you see, as far as the disclaimers go, putting an end to mass-tort litigation in the US is just part the answer. The next time someone you know just suggests that you take a new headache pill, you can ask "But aren't there side-effects? I remember seeing something on TV"..

Posted by Arun Sadhashivan at April 4, 2006 9:55 AM


Mmmm,

Strange discussion... I live in Belgium and there are some differences between the US situation and the Belgian situation.

Advertising medication is done but mostly for non-prescription medication, and ALWAYS with the mention that it is medication and that advice of a doctor or pharmacist is advised.

I guess that it's an ethical discussion. Doctors prescribe the medication. Pharmacists can offer a generic replacement, or the patient can ask for one. I think that, just like with cigarettes, warnings should ALWAYS be CLEARLY seen/heared/... The pharma industry must be responsible for informing people in the most correct way even if that involves transmitting details that some people don"t like.

Steve, I guess it's up to this: EVERY commercial is annoying me! and maybe a lot of others to. But I/we/you don't have the power to change that. So yes, when it comes to health and other subjects that can directly or indirectly harm people ( to any level ) warnings should be given.

Posted by Raymond Hermans at April 4, 2006 10:16 AM


I am on a new drug to deal with an old heart rhythm problem. It's potent, and 7% of "users" get a certain side effect. I'm one of the "7%," and as of last Sunday on yet another drug to deal with the side effect. Drug interactions are an extraordinary cause of harm. I surely don't read all that fine print--I simply by this comment want to call attention to the gravity of the issue. Thousands unnecessarily die as a result. I'd add that many, far too many, docs are sloppy about these interactive effects. This last is exacerbated when someone is seeing several specialists simultaneously--as is typically the case by age 65 or so. (As usual, the Web helps enormously if you are persistent.)

While on this particular high horse, I'd also point out that more thousands die because of the continuing absence of electronic, portable medical records. There is a large-scale, federally led initiative pushing on this--but it should have occured 10 years ago. It's damned hard work, and rather expensive, but we'd almost automatically save more lives with electronic rescords than the next three (10?) "blockbuster" drugs.

Posted by tom peters at April 4, 2006 5:05 PM


Tom's case as an example, and the potential problems from drug interactions/side effects, etc., highlight the absurdity of depending on television advertising to convey important warnings. Despite the fact that patients are asking for ads they see on TV, television advertising is a very blunt and ineffective way to convey complex messages. We are deluding ourselves if we think it works. Besides the famous Cialis 4 hour erection warning, how many of us have really absorbed the pharmaceutical warnings we've heard on TV?

Businesses waste gazillions of dollars every year overestimating the power of their advertising. Let's not make that same miscalculation with health care warnings.

Posted by Steve Yastrow at April 4, 2006 7:57 PM


Steve,

You make it so hard for me to agree with you. If you have seen even a single report/article on DTC (Direct-to-Consumer) pharmaceutical advertising, it is especially effective. Moreso than the typical mass market ads. Why? We all want to take a pill to fix our medical condition whatever it may be. Also, perhaps, the golf junkets and payola that doctors get from Big Pharma that convince them to give in to their patients with the symptoms du hour.

So you're seriously off abour "overestimating the power of their advertising." It is outrageously effective.

You are absolutely correct that issuing those disclaimers are useless. But HELLO!?, that's not selling the product, it's CYA for lawsuits.

So I take it back, as usual, I disagree with all of your argument.

Posted by Paul Davidson at April 5, 2006 12:28 AM


du hour = du jour

Posted by Paul Davidson at April 5, 2006 12:29 AM


Wow! Good discussion. In Oman, this is what should be written in cigarette packs - "Health Warning: Smoking is a main cause of lung cancer, lung diseases and of heart and arteries diseases." It has nothing to do with advertising. It is all about legal obligation as mentioned by Tom O'Leary before.

PS: Dear Tom - we are eagerly looking forward to be there with you at your Muscat event on April 23, 2006. Wish you smashing success in advance.

Posted by VK Narayanan at April 5, 2006 9:40 AM


Steve - the extra page in mags of disclaimer - land shark attorney bait?

Posted by Sean at April 5, 2006 11:20 AM


I used to feel that the warnings on TV ads were a waste of good air time, as well as the ads themselves. I have since changed my mind. After my doctor prescribed Zetia for cholesterol (no, I did not request it based on a commercial), I started experiencing a side effect which the ad mentioned ("in some rare cases ...."). Seeing the ad after experiencing the side effect (and I stopped taking the medication) may have saved my life.

Posted by Ron Ingber at April 6, 2006 11:36 AM


Steve I think you grossly underestimate the sophistication of television advertising. It is hardly a "blunt" tool. Following Paul's reasoning, why do you think it has grown to a ubiquitous part of the commerical collage if it isn't effective in shifting behavior? Personally, I'm torn: I think Big Pharma can be as pernicious as Big Tobacco someday, but I am simultaneously highly averse to regulation as a front line defense. SO I guess I say, keep the warnings, and let's see some for profit intermediaries spring up who actually read the encyclopedic fine print, and educate consumers pre litigation (ala Vioxx)

Posted by Michael at April 6, 2006 12:26 PM


This is a great discussion. We don't all have to agree, we just have to think!

I do think TV ads have raised awareness of medicines, but I still think that we shouldn't depend on those ads to convey complex messages about the dangers of those same medications. Ron's case of learning about the side effects of his medication on TV highlights the problem - there should be much more effective safeguards in place, because my guess is that most people with that side effect would not have noticed it from the ad.

To Michael: I don't assume that TV advertising is effective in shifting behavior just because "it has grown to a ubiquitous part of the commercial collage." Yes, it often shifts behavior, but a lot of TV advertising is more an example of bad decision making than it is of good marketing. And, again, it is better at conveying broad messages than highly specific, technical data like drug side effects.

This isn't a question of whether big pharma needs to be policed, of whether they can be trusted, or whether docs are in their pockets. It's a question of depending on the wrong tool to do an important job.

Posted by Steve Yastrow at April 6, 2006 1:49 PM


Great discussion! I am torn-I see the value in having the warnings mentioned in the ads so that people in Ron's case catch a problem before it kills them. But in reality, shouldn't the doctor be explaning these said side effects to you when he prescribes the pills? And what about the pharmacist? This topic hits close to home for me-my next door neighbor growing up died in his kitchen on Christmas morning from a side effect caused by medication given to him to treat a tooth infection. He was 45 and possibly the nicest man I have ever met. Doctors need to be more aware of what they are prescribing, as well as the patients medical and family history, and patients need to be more aware of what medicines they are taking. Simply mentioning this "might" happen to you on TV and thinking the point is going to get across is just stupid. Big Pharma doesnt exactly do it because they care about the patient, they do it to cover their asses because of how often they are sued. Dont say we didnt warn you! The fact is the doctor, the pharmacist, and the patient need to take prescribed medications more seriously so that people like my neighbor will stop dying due to the combined ignorance and oversight of all parties involved.

On a lighter note, I dont exactly like hearing these warnings on TV because some of them are just plain disgusting-i.e., frequent bowel movements and an inability to control them....ew, thanks for the mental image. And Valtrex....lady, glad to see you have your life back but I really dont want to hear about your herpes outbreak. Some side effects associated with these meds makes me wonder why people would even want to take them in the first place. It almost makes me wonder if mentioning the side effects is actually detrimental to the sale of the drug...No matter how overweight I was, if there was a possibility-however slight-that I would not be able to control my bowels...I'm all set with that pill, thank you.

Posted by Rachel at April 7, 2006 11:18 AM


It is important to let people know the pros and cons of procedures if you are advertising to them. Leaving the explaining to doctors is irresponsible. If patients hear only about the benefits of a drug, they will go to physicians in droves to get it without regard to its applicability to their situation. I believe in informing patients, but inform them fully.

Posted by Chithra Durgam at April 10, 2006 1:08 PM


While direct to consumer advertising has its place in the pantheon of marketing tools available to pharmaceutical companies, that place should be in the pantheon parking lot. The application of the slick two dimensional view that consumer advertising makes its milieu serves the practice of medicine as poorly as the videos of high tech weaponry shown on news programs. It depicts consequence yet fails to address consequences.

Posted by J T Smith at April 10, 2006 5:10 PM



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