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Direct to Consumer Advert Update

Earlier this month I posted about prescription drug TV commercials and mentioned the Strattera video game ad. You will see this commercial no more. I noticed a lot of referrals for Google searches for "Strattera TV Ad" and found this:

The Food and Drug Administration warned Eli Lilly and Co. (LLY) Thursday about a television advertisement for Strattera, a drug used to treat attention deficit hyperactivity disorder, or ADHD.

[...]

It potentially broadens the use of the drug beyond the indicated patient population, while also minimizing the serious risks associated with the drug.

You can read the complete FDA warning letter here, but I've quoted the more salient points below. In my earlier post I used the Strattera drug commercial as an example to describe what I call the "pay no attention to the man behind the curtain" segment, and how this commercial for a drug to improve concentration in those who are easily distracted ironically uses over-stimulating and flashy visualizations to distract the viewer's attention from important facts about the medication. I'm pleased to see the FDA crack down on a misleading advertisement that overuses the "pay no attention to the man behind the curtain" marketing strategy.

Among other things, the FDA said in its letter to Eli Lilly:

The overall effect of the distracting visuals and graphics, including competing messages related to efficacy, and the competing audio message, is to undermine the consumer's ability to pay attention to and comprehend the risk information, thereby minimizing these risks and misleadingly suggesting that Strattera is safer than has been demonstrated by substantial evidence or substantial clinical experience.

[...]

The ad visually presents a person in a variety of situations as seen through the screen of a videogame, including: leaving the house; walking to his car; going back to the house for his car keys; looking into a shop; looking at a wristwatch; handing in a "Quarterly Report;" and sitting down at a desktop computer. These scenes are presented with a box that displays a descriptor or attribution for each behavior (e.g., "DISORGANIZED," "DISTRACTED," "TROUBLE FINISHING THINGS") and the word "penalty" beneath it.

[...]

The TV ad fails to clearly communicate the indication for Strattera because of competing visuals, graphics, and music that are presented at the same time as the information described above relating to the indication.

[...]

During the presentation of the various situations the character is engaged in, boxes with the words "SCORE" (including a running tally of numbers), "LEVEL 1," and superimposed text are shown. The text scrolls and flashes. The text, graphics, and voice-over are also accompanied by eerie sound effects. All of this distracts from the viewer's ability to process the visual information related to the product's indication. Similarly, there are numerous competing and distracting elements, such as a large SUPER that types out the word "RESTLESS penalty," a SUPER with the words "LEVEL 1" and "SCORE" which loses points every time a symptom is displayed.

[...]

The audio communication of serious risk disclosures in the "major statement" is minimized by the distracting visuals and graphic SUPERs, which combine to interfere with the presentation of the risk information. The audio presentation of risk information is accompanied by concurrent erratic camera movement, quick scene changes, and visual changes in point-of-view. The SUPERs scroll in and out and flash, and the "SCORE" is constantly moving (gaining points). The risk information is presented very rapidly in the audio.

Well said!

:: Bryan Travis :: 06/18/2005 @ 22:58 :: [link] ::
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The Chronicles of Maya Part 1: Of Cat Pee and RU486

All Chronicles of Maya entries:

In 2002, a clinical trial began to study a synthetic steroid hormone called mifepristone in the treatment of severe psychotic depression. The results of the trial were reported this week, showing significant short-term improvement during depressive episodes. The more common name for mifepristone is RU486, or the "early option pill."

Mifepristone is NOT the "morning after pill." This is a common misconception, and one I failed to catch in an earlier version of this post. Mifepristone (early option pill) induces early abortion. Plan B (morning after pill) is a contraceptive; that is, Plan B prevents ovulation and fertilization, and failing that, may prevent implantation in the endometrium, but does not terminate established pregnancies.

This week, New Hampshire passed a law allowing pharmacists to dispense Plan B as emergency birth control, making it the seventh state to do so, joining Alaska, California, Hawaii, Maine, New Mexico, and Washington. Plan B is a high dose of the synthetic progestin hormone levonorgestrel, roughly equivalent to what's in 6 tablets from the 3rd week of Enpresse, Tri-Levlen, Triphasil, or Trivora birth control pills, except that these birth control pills also contain an estrogen (ethinyl estradiol), while Plan B only has levonorgestrel.

George, the step-father in HBO's Six Feet Under, has been suffering from "depressive psychosis" in the fifth season of the show. George received several treatments of electroconvulsive therapy (ECT), aka electroshock. Mifepristone may offer a safer treatment alternative than ECT.

As a pharmacy student, all this got me thinking. Mifepristone is an anti-progestin; that is, it counteracts progesterone, the hormone that causes the uterus to build up the endometrium to support implantation of a fertilized egg. In other words, in the first week after conception, RU486 prevents a fertilized egg from implanting into the uterus. After the egg implants (about a week after conception) until day 49 of pregnancy, it will cause the endometrium to slough, removing the embryo along with it. If a woman isn't pregnant at the end of the menstrual cycle, progesterone levels drop, causing the endometrium to slough off in what is more commonly known as a "period" or "menstruation." If a fertilized egg is present, it secretes hormones that maintain progesterone levels until the egg can safely implant into the uterus (about a week after conception). Mifepristone blocks the action of progesterone, making it seem to the uterus as if progesterone levels have dropped, thus signaling the end of the menstrual cycle, in effect, "forcing" menstruation to occur.

So mifepristone is a synthetic hormone, of sorts. And it shows promise for the treatment of severe depression.

Hmmm... this reminds me of my wife's cat, Maya, who was prescribed Ovaban, (megestrol acetate, a progestin), for treatment of urinating on furniture. Apparently, many cases of inappropriate urination in cats are due to depressive or anxiety disorders. But unlike mifepristone, which is an anti-progestin, Ovaban works in the opposite direction as a progestin. Ovaban is usually prescribed to female dogs to keep them from going into heat, but it's also indicated in cats who refuse to use the litterbox.

I was puzzled when my wife came home with a bottle of Ovaban... after all, what effect would a progestin have on where my wife's spayed cat decided to pee? Megestrol also has nasty side effects in cats like changing coat color, diabetes, and liver problems. I was so bewildered that we called the vet and asked him to prescribe something else.

The vet laughed at us and gave us amitriptyline, a sedating anti-depressant. I'm used to people laughing about it, because friends at school couldn't wait to hear me tell each new cat-pee-story throughout the spring semester - they positively thrived on my exasperated story-telling. The amitriptyline didn't work, so we went back to the Ovaban, but that didn't work either. In fact, the cat starting pooping on the bed when we gave her Ovaban... four times in all before she stopped.

Two other drugs we haven't tried are Valium and Buspar, but frankly, we've abandoned hope for Maya. The most effective of these drugs is 75% effective at stopping inappropriate urination during treatment, but only 50% effective after therapy ends.

Maya was born on July 17, 2003, so she's about 2 years old and has always had sporadic problems going outside the litterbox, but now she's habitual and seems to favor furniture over the litter box. After the fourth time peeing on a sofa, we locked her in the spare bedroom and put a mattress cover on the bed. When we try a new drug or cat litter, we wash and bleach the sheets with an extra rinse cycle and replace the mattress cover in hopes of preventing Maya from smelling her urine outside the litterbox. Nothing has worked. Things we've tried:

  • Trimming the hair around her butt because she's a long-hair
  • Isolating her in a bedroom from the other cat
  • Daily litter box cleaning
  • Test for urinary tract infection and crystalluria
  • Fastidious cleaning of soiled spots
  • Two drugs: Ovaban and amitriptyline
  • Replacing the litter box
  • Three different kinds of litter, including Dr. Elsey's Cat Attract, which boasts "100% Litter Box Use Or Your Money Back. I Guarentee It! - Dr. Bruce Elsey")... Dr. Elsey, you owe us $18
  • Placing food and water bowls on the bed where she urinates, because cats don't like their food near where they use the bathroom

She doesn't have claws, so she can't be an outside cat. We don't want to take her to the shelter because that's a death sentence for an adult cat with a behavior disorder. Maya's a cute cat, but still, everyone wants a house-broken kitten, not a 2 1/2 year old adult cat who won't use the litter box. We figure our best bet is to find one of those families who don't seem to be bothered by the smell of cat urine because they have 70 cats in the house coating everything in a "lacquer of yellow urine," sneak her in late at night, and hope the family won't notice an extra cat.

:: Bryan Travis :: 06/17/2005 @ 12:09 :: [link] ::
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Brilliant Marketing, Bad Information: Direct to Consumer Drug TV Commercials

I've been paying careful attention to TV prescription drug commercials. First year UK pharmacy students work in a pharmacy during the month of May, and in my own pharmacy, I noticed several customers asking what we thought about a drug they had seen in a commercial.

It's a shocking trend. Direct-to-consumer (DTC) advertising by the pharmaceutical industry for prescription medications increased 5000% from 1990-2003. The average drug company spends 6 times more on advertising than R&D for new drugs. For me, it's the perfect argument for why unchecked capitalism is a bad thing. The pharmaceutical industry has determined the return on investment from advertising is much greater than it is for new drug research. You simply cannot argue such behavior is in the best interest of humanity and not the stockholders. In fact, hats off to the boards of directors in the pharmaceutical industry, because it is their fiduciary responsibility to ensure their companies operate in the best interests of the stockholders, and they have succeeded in that regard, if not to the detriment of the health of society.

My favorite DTC drug commercial is the video game style Strattera advert for Adult Attention Deficient Disorder (Adult ADD). It's like Doom without the BFG. Shown from the point of view of a male corporate employee who has trouble finishing tasks, focusing, and pleasing his boss, the man's "score" drops with his every act. In all probability, the poor guy could probably resolve his problems with one or more behavior modification strategies: take a vacation; stop working so much overtime; instead of watching Conan, turn of the tube and go to bed before Leno.

But in the American society, there's a pill for every ill, and for this corporate flunky, the pill is Strattera. His score immediately begins increasing, but in small increments.

My favorite part of the commercial comes next, what I refer to as the "pay no attention to the man behind the curtain" segment (apologies to the Wizard of Oz). Advertisements for prescription medications must include the most common and serious side effects and adverse reactions. When listing these adverse reactions, which can be worse for some people than the condition the drug treats, the narrator switches to fast talk mode. The visual component of the commercial becomes more engaging and captivating. The intention is clear: mesmerize the viewer with the vivid imagery so they pay less attention to the side effects.

In the Strattera ad, the corporate flunky is transformed into a career ladder-ascending all star. His score increases in exponential leaps and bounds. Everyone is smiling at him, applauding his every action. Meanwhile, the fast talking narrator is warning you about the potential for serious liver damage, that you shouldn't take Strattera if you have narrow-angle glaucoma, and to tell your doctor if you have high blood pressure, or any heart or blood vessel disease. The most common side effects include headache, constipation, dry mouth, urinary retention, problems sleeping, and sexual disturbances.

I'm sorry, but with a 17-27% incidence of headache, 4-21% risk of dry mouth, and 16% incidence of insomnia, not to mention 7% incident of erectile disturbance and 6% incidence of decreased libido, I'd be more willing to try non-drug therapies first, like going on vacation, working less overtime, and getting more sleep. I'd want to be convinced I had ADD before risking headache, dry mouth, and insomnia, any of which could further worsen, not improve, my ability to concentrate. But if you got caught up in that flashy imagery instead of carefully considering the side effects, you might have missed all that.

The next time you see a drug commercial on TV, pay attention to the "pay no attention to the man behind the curtain" segment. Note the visual hijinks to distract your attention from the side effects. It's a tried and true formula, and all recent drug commercials use it, with one exception:

Exception: the new Nexium commercial promoting its use for ulcer prevention in long-term NSAID use for arthritis and heart attack prevention. In the Nexium commercial, a couple in their 60s (Jenny and Jimmy) sit on a couch and talk to someone off camera, charming us with their playful banter. They list the three major side effects matter-of-factly: she says "headaches, diarrhea," and he jumps in with the third "and abdominal pain." No funny business. On the one hand, Nexium is fortunate to have one of the least problematic adverse reaction profiles on the market, so there's hardly reason to employ the "pay no attention to the man behind the curtain" routine, but still, I respect AstraZeneca's fresh approach.

:: Bryan Travis :: 06/03/2005 @ 22:51 :: [link] ::
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