A History Of Drug Ads On Tv
It seems like only yesterday when Direct-to-Consumer Advertising (DTCA) of prescription drugs didn't exist. Now, of course, it can't be avoided. Let's take a look at the history of this practice and see if we can explain how this all came about.
Before 1980, there was no such thing as DTCA. The times just weren't right. But in 1981, a few drug companies made small forays into this unchartered territory. The reaction of the Food and Drug Administration (FDA) was to impose a moratorium on all DTCA so it could research the issue. After a few years, the moratorium was lifted, but essentially it only allowed print advertising in magazines and the like. But it took 14 more years before the FDA issued rules on how to undertake TV advertising.
Why print and not TV? The answer is in the fine print - the fine print in this case being the package insert or the full prescribing information (you know, that little folded up piece of paper that comes in drug boxes and magically opens into something the size of a towel?). More specifically, the fine print refers to the so-called brief summary.
So in the early days, it was in a nutshell: no brief summary no drug ads on TV. But some of you may recall the early days of TV DTCA during which there were a number of very bizarre TV ads that seemed to say nothing. The prototype were the original ads for Rogaine, which said "Did you know that Rogaine was minoxidil?" or "I didn't know that minoxidil was Rogaine." Unless you already new what Rogaine was, these ads were quite baffling.
This happened because the FDA Regulations stated that a product could advertise itself on TV if it only presented the brand and generic names (both are required) and more importantly there could be no representation of what the drug was for. The regulations were intended to allow drug companies to detail doctors on their products, and since they would then know what the drugs were for, reminders that just called attention to the name would be worthwhile (for the drug companies).
Now we understand the premise behind those seemingly absurd ads. As reminder ads, they were perfectly legal, but they caused a whole lot of confusion, particularly among regular people who might not have known what those drugs were for. All they could do was to sit and scratch their heads. You still occasionally see these ads such as the ones with people surfing through corn fields saying nothing more than ask your doctor about, let's say, Allegra (fexofenadine).
We're coming into the home stretch here, the modern era of DTCA on TV. In 1995, the FDA relented and devised a scheme that they felt everyone could live with. The key phrase in the Regulations that they took advantage of was that ads require a brief summary "unless there are adequate means of disseminating the full prescribing information." So FDA crafted a set of rules that would be considered "adequate means." The ads would have to have four components: a toll-free number for people to call to obtain the PI, a reference to see a magazine where they were concurrently running a print ad (so the person could read the accompanying brief summary), a Web site where the PI could be found and lastly, instructions to ask your doctor or pharmacist for more complete information - got that? Well, the drug companies sure did, and the rest, as they say, is history.
Is TV DTCA here forever? Not necessarily. The FDA has been charged with studying the impacts of DTCA and if they or others were to prove significant negative outcomes, it wouldn't take FDA very long to say: "Remember that stuff about ‘adequate means?' well we just decided that the four criteria aren't enough, and you must now include the entire brief summary." Of course, they could just as easily say the same thing without any data, but even the FDA likes to practice safe regulating! And lastly, Congress could always write new laws precluding TV ads for prescription drugs. Stay tuned.
Ed Zimney, M.D.
Dr Z's blog can be found at http://blog.healthtalk.com/zimney/
For more information, articles and programs on Diseases, Health, Medicine and making the right choices please visit http://healthtalk.com/
Would You Like Tea With Your Crohn's?
I have always been a tea drinker, which is saying something now that I live in the land of the ubiquitous coffee stand, Seattle.
My mother and my grandmother were big tea drinkers and introduced me to tea when I was 5. We had just discovered that I had asthma and allergies. Back then, caffeine was welcome as it was considered helpful to my asthma, keeping my lungs open and stimulating my nervous system.
Four years ago, I visited Ireland and though I'd already been diagnosed with Crohn's, I had no trouble at all with the fat-laden Irish breakfasts (which include a plate full of fried bacon, blood sausage, fried tomato and an egg, which I always skipped, plus fresh oat bread with butter and preserves). And, of course, no Irish breakfast would be complete without a large steel pot of strong Bewley's tea. If you had the nerve to ask for decaffeinated tea, the waitress would look at you as if you'd just asked for a chunk of cheese from the moon. I don't know if it was the water or the freezing March weather, but Irish tea was gloriously refreshing and delicious, yet I was never able to duplicate it once I got home to Washington. And caffeine in tea, or even in coffee soy ice cream, has been a trigger for Crohn's attacks ever since I returned. Even green tea, which isn't heavily caffeinated, gives me cramps.
So I've become a connoisseur of decaffeinated teas of every kind imaginable, and thankfully, have people like Heather Von Vorous, of the IBS Newsletter, to thank for recipes like the one below, which gives me delicious options when I'm seeking a warm morning brew to start my day. You can add decaffeinated English or Irish breakfast tea to the brew below for even richer flavor.
Cinnamon Chai
This is a safe (dairy-free, caffeine-free) version of the chai tea served at Starbucks and other espresso stands. It's exotically spiced and smooth, creamy and dreamy. Cloves, fennel and cinnamon are all digestive aids, so this tea is downright beneficial for IBS.
Cinnamon Chai Recipe
Makes 1 Serving (easily doubled or tripled)
Chai Mix:
1 tablespoon whole cloves
1 tablespoon whole fennel seeds
1-tablespoon whole cardamom seeds (not in pods)
4 small cinnamon sticks, broken into small pieces
Add:
1-cup vanilla soy or rice milk
1 teaspoon honey
Stir together all chai mix ingredients. Add 1-tablespoon chai mix to soymilk and bring to a boil. Remove from heat and steep for 3 minutes. Strain and stir in honey. Store extra chai mix in an airtight container.
DeAnn Rosetti
DeAnn's blog can be found at http://blog.healthtalk.com/crohns/
For more information on living with Crohn's Disease please visit http://healthtalk.com/crohnsdisease/
The Physical Therapy And Pain Connection
Exercise is a four letter word, isn't it? I know some forms of exercise are. Let's see, there's leap, jump, lift, flex, hike and the most friendly of all, walk. Okay, so it isn't my favorite thing to do. I'm not nor have I ever been the athletic type. I'm not lazy. I'm just more cerebral.
As a nurse, my experiences with physical therapy were with those therapists who came onto the unit to walk about with the patients who had a fractured hip, or they applied the motion machines to those who had total knee replacements or generally helped those who were recovering get back on their feet.
After struggling with pain in my sitter, my neck (accompanied by excruciating headaches) and a few other places, I still was unable to get an adequate diagnosis. I looked for and found one of the best rheumatologists in the country, Dr. Rodney Bluestone. He had treated my oldest sister who had psoriatic arthritis and she got better. So I figured he must know what he was doing. His practice was in Beverly Hills, which was three hours from where we lived at the time. The trip was gruesome, with the sit, the ride and the damnable L.A. traffic. But he was well worth it. His approach was a practical one of function. I had to keep moving even if we didn't have a name for this thing that had come to destroy my life. The local internist I had been seeing belonged to the old school of joint protection. That was the philosophy which said, "If it hurts, let it rest."
I began to suspect if I let it rest any longer, my husband would come home one day and find me a tangled mass of protoplasm! At the time, my arms and legs were intertwined, unable to even make it into the bathroom. I was tired of lying down, loathed the constant pain and felt completely ostracized from society. By the time I saw Dr. Bluestone, I was on my last nerve, dissolved into tears just talking about myself. It's important to note that this doctor is British, and he has a totally different idea about moving the joints. Thankfully, those same ideas are now mainstream thinking, but at that time they were not. He even had his own physical therapist in the office. After my second or third trip down to see him, he called her in to evaluate me. I was totally discouraged. I hate to admit my ignorance, but I didn't see what that had to do with me. I was sick. I needed more medication. I needed a firm diagnosis. I needed someone to relieve me of this burden. I did not need to be told to move. I must confess to you that I can be very stubborn and just didn't get this whole PT bit, at all. I couldn't imagine how it pertained to me. I thought he was just passing me off to get rid of me. I know. How stupid can you get?
The first thing the PT did was to explain to me that if I didn't move, my body was going to become even more misshapen and useless. I'm sure that wasn't her word "useless," but that was the general idea. I was having a great deal of neck pain from the long drive down and felt as if my whole body was twisted from my head down to my always painful behind. She directed me over to a full-length mirror and had me look at myself. I was wearing a slip, and it was all too evident that my shoulders were not the same height. Funny, I had never noticed that before. One shoulder was at least two inches higher than the other. Right there before my eyes, I was becoming that tangled mass of protoplasm. It was indeed happening. That was my day of conversion. That was the day I began to embrace physical therapy, faithfully following all of my PT's recommendations for daily stretches and moderate exercise. I went on and connected with a local physical therapist, and he followed Dr. Bluestone's protocol.
Over the last 20 years, I have relapsed many times, become lazy and let the whole movement thing slide, only to be brought back abruptly by the pain and suffering that ignoring my body brings. True, it's overused but the old adage is painfully true, "If you don't use it, you lose it."
Sue Falkner Wood
Sue's blog can be found at http://blog.healthtalk.com/chronicpain/
For more information, articles and programs about living with chronic pain please visit http://healthtalk.com/
