Why do drug ads list all those side effects? And should they?
by James Hubbard, M.D., M.P.H.
Have you ever been watching one of those ads for prescription drugs touting how wonderful the drug is … then they go into detail about side effects like may it may cause blurred vision, anal leakage, heart palpitations, blindness, maybe death? Why do they do that? You don’t see it on all drug ads, just some. Are these drug companies just more open and truthful than others?
Stay tuned for “the rest of the story.”
Unlike for herbs and supplements, Congress has given the FDA authority to regulate prescription drug ads. The FDA has divided the ads into three different categories, each with different rules.
The divisions are:
- Health seeking advertisements
These ads can’t mention specific drug names, only diseases or symptoms. Something like, “If you sneeze, cough and your eyes water, you may have allergies,” or, “If your legs wiggle all night you may have restless legs syndrome. See a doctor for diagnosis and treatment.” Obviously, the advertiser thinks it has the answer to your problems but can’t say so. However, they can mention the manufacturer’s name and give you a number to call. The FDA doesn’t consider these “prescription drug ads” and generously passes their regulation on to the Federal Trade Commission. - Reminder Advertisements
These may give the name of the drug but not what it is used for. They can’t even use hints or photos. An example would be an ad for, say, Claritin. The assumption is you know what it’s used for, but they can’t mention allergies or even show someone sneezing or a bunch of flowers. In return, the advertiser doesn’t have to list all those side effects and risks. - Product Claim Advertisements
Here’s where the FDA gets picky. If the ad mentions both the brand name and what it’s used for, they must name all those side effects listed in the drug’s prescribing information (an extensive report the FDA requires for each prescription drug). So it doesn’t matter if 10 percent or 0.01 percent of people taking antidepressant X report hearing “It’s a Small World” when they go to the bathroom, it has to be reported at the end of the ad. One alternative is the advertisers can choose to list just a sampling of side effects and provide several sources of where to get the extensive list.
So there you are. Do you think the listing helps or not? Does everyone deserve to hear all the bad along with the good or do people just kind of tune out the list except for comic relief?
What’re your thoughts?
Doctors and business owners: Send customized issues of James Hubbard’s My Family Doctor to your customers or patients. E-mail publisher-at-familydoctormag.com for details.
Tags: FDA, government, medicine safety
February 12th, 2009 at 8:48 am
That’s really interesting! You know, informed consent is drilled into us from the first day of med. school. At least, I haven’t seen, “Results not typical,” on the bottom of the screen like for those weight loss products!
Dr, Js last blog post..Nibbles: Obese moms have higher risk of birth defects, health scares don’t change weight much, and the high cost of healthy eating in Canada
February 12th, 2009 at 9:51 am
I think it’s good for the ads to list potential adverse effects. One reason is that too many doctors aren’t thorough enough about it due to time constraints in the office.
My current favorite drug ad is the one for an asthma drug. I’m paraphrasing, but it says something like, “Use of this drug is associated with a higher risk of asthma-related death in some patients.”
Here’s the office visit: “Yeah,…um…doc, I’d like that asthma drug that kills people.”
I’m not a big advocate for government intervention in the marketplace, but this “required warning” program doesn’t bother me. I guess if the warnings weren’t there, the trial lawyers would help sort it out.
-Steve
Steve Parker, M.D.s last blog post..Mediterranean Diet Reduces Risk of Mild Cognitive Impairment
February 12th, 2009 at 10:24 am
I knew there were certain regulations involved but didn’t know the specifics; that’s very interesting. I think there really should be a required warning. For some drugs, it seems as though all of the side effects are exactly the same thing as what you’re trying to prevent! I’ve seen so many ads for allergy medication that then go on to say that sneezing and rashes etc etc are all side effects. Don’t really see the point in the drug itself then…
Sagans last blog post..Interpretations of Marketing Strategies: Botox for Dogs
February 12th, 2009 at 10:33 am
Dr. J, Yeah those weight loss products are not FDA regulated.
February 12th, 2009 at 10:35 am
Dr. Parker:
It will make you think. You have the bright, happy commercial and then “may cause death.”
February 12th, 2009 at 10:35 am
Sagan:
Usually the side effects are pretty rare but need to be considered.
February 12th, 2009 at 12:26 pm
I like to know what I’m getting into, so I guess I’m more in favor of them having to declare them during ads than not - especially since it too often seems like I have to beat out potential side effects when a doctor prescribes a medicine (and even then it seems doctor’s aren’t always thorough). I wish they could give a better indication of how common the side effects are, but guess that can be hard to convey in a 30 second slot.
Plus, they do add comic relief!
cathys last blog post..Guest post time! How much sugar is too much for kids?
February 12th, 2009 at 3:54 pm
Cathy, you are right. Every medicine has a lot of side effects that are rare but real. A lot of docs only hit the highlights, maybe because they are afraid if given all the side effects, it would scare the patient (nocebo effect), maybe because they don’t have time.
Thanks
February 13th, 2009 at 12:34 pm
I appreciate the added detail….Unfortunately in our world there are individuals looking for any opportunity to make a buck vial legal means. So it appears that the extra precaution is almost necessary to protect one from these situations.
Mark Salinass last blog post..Suspend Your Reality
February 13th, 2009 at 4:26 pm
How true, Mark.
February 15th, 2009 at 4:11 pm
DTC Advertising
Not long ago, usually on television, one viewing will often at times see an advertisement for some type of medication- usually it is a drug involved with the treatment in a large market disease state. Such commercials are sponsored by large pharmaceutical corporations for particular networks on television. This is called direct to consumer advertising, and both doctors and citizens largely prefer that they do not exist.
Since 1997, when the FDA relaxed regulations regarding this form of DTC advertising for the pharmaceutical industry, the popularity of the creation of such commercials has greatly increased. The pharmaceutical industry has spent around 5 billion annually on this media source. The industry ranks number two on their spending of media campaigns- next to automobiles, I believe. Normally, the creation of such a commercial becomes visible to the consumer within a year of the drug’s approval, which raises safety concerns typically associated or possible with newer medications, as history has shown.
The purpose of DTC ads are not to educate and inform the viewers, in my opinion, as others have claimed. Any advertising of any type shares the same objective- which is to increase sales and grow their market for a particular product and, in this case, for a particular perceived medical condition or disease state that may or may not exist, as a television is not by definition a health care provider for the viewer.
The intent of DTC advertising is to generate an emotional response from the viewer, such as fear or concern, believing upon research that the viewer will then question as to whether they need to seek treatment soon for what may be an unconfirmed medical condition or disease suggested with such DTC advertisements. Furthermore, the FDA has admitted that they are ignorant as far as the content of such DTC ads before they are presented to the public, in relation to their accuracy and clarity, as well as possibly their effect on the health care system, as the FDA allows the DTC advertising to continue, yet now it is becoming more restricted, I understand.
DTC advertising is also a catalyst for and similar to disease mongering.
Disease mongering is the creation of what some believe should be medical flaws, and illustrated by the creators through exaggeration and embellishments through such media sources as an avenue for what appears to be propaganda often, as is often seen with DTC advertising. The content of the advertisements appear to be medically absent, yet realistically they are in fact corporate creations of these questionable human ailments that do not or may not require treatment, possibly, and may be attempts by the makers of certain drugs to develop or embellish a particular medical condition to acquire additional profit.
One of my favorite DTC advertisements is the new concept for the use of an anti-depressant for a social disorder. Social disorders appear to be another phrase for what are known as introverts- a term created by Dr. Carl Yung. And it is a personality trait, not a medical disease, many believe. There are other questionable medical conditions claimed in the contents of DTC commercials, as the creators of these commercials again wish to grow the market for a particular, and possibly fictional, disease state. Then there is also baldness treatments advertised, as another example by the advertisers who attempt to create a need for treatment.
Lifestyle medications are not treatment options for illnesses, and should not be portrayed as such in certain direct to consumer advertisements. Then there are the Viagra commercials with the happy man who is fully energetic on the advertisement for this drug is not your typical man who has erectile dysfunction. So DTC advertisements are intentionally deceiving to grow the markets for the benefits of the makers of the drugs advertised.
Also, DTC ads discuss only one treatment option normally, so it seems, when likely there are several treatment options that exist for authentic medical disorders. The options for treatment should be left to the discretion of the health care provider, as they are the ones who assess your health, not your television or another media source. That’s why most of the world does not allow DTC advertising, with the exception of our country and New Zealand.
Finally, DTC advertising and its ability to influence viewers to make their own assessment instead of a medical professional remains largely unregulated, yet apparently effective for the creators of direct to consumer advertising. People are prone to believe what they see and hear, regardless of whether or not it is actually true. Many, after viewing a DTC ad, seek out a doctor visit and request whatever product that was advertised, which makes things cumbersome if not awkward for the health care provider chosen by the viewer of a DTC ad for such a visit. So the doctor and patient relationship is altered in a negative way, because most DTC ads require a prescription. Also, in some situations, the sponsor will speak and acquire a dormant/inactive actor, perhaps, or a former athletic celebrity, to fuel their intent.
Medical information and claims of suggested health ailments should come from those in the medical field instead of the corporate world utilizing media outlets such as television. Perhaps this will save some over-prescribing of expensive medications that progressively has been occurring recently, which will benefit everyone in the long term. And the Health Care System can regain control of their purpose, which should be far from financial prosperity. This elimination of DTC advertising would only be a start to achieve control in the U.S. Health Care System as it exists today.
“Ignorance is not innocence but sin.” — Robert Browning
Dan Abshear
Author’s note: What has been written was based on information and belief
Published on http://www.brainblogger.com
February 23rd, 2009 at 12:02 am
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