At Last! Major Pharmaceutical Company Rapped Over the Knuckles Because of Overblown Claims

This week we were given a rare insight into the way in which the big drug companies attempt to tug at our heartstrings in order to get us to open our wallets. It came from perhaps the most unexpected source namely the Food and Drug Administration (FDA). It sent a letter to Shire Pharmaceuticals questioning the way in which its new ADD/ADHD product Intuniv is being marketed. Shire is desperately trying to get anxious parents to sign up to this product as it tries to recover revenue lost due to the generic version of Aderrall reaching the market in mid April of this year. In the process they made some pretty amazing claims for Intuniv and the message was clear, if you really have the best interest of your child at heart you should ‘switch’ to it!
Somehow the FDA was not impressed with the overblown rhetoric contained in the marketing material for this product (including the Waiting Room Brochure, Brochure Holder, and Parents’ Guide). It lists its problems with these materials under the devastating heading: “Overstatement of efficacy”! Let’s look at some of the claims and taglines that the FDA had a problem with:
• “Does your child’s ADD/ADHD treatment get to what matters?
Reveal the kid within: A difference the whole family can see”
• “The symptoms of ADD/ADHD (attention-deficit/hyperactivity disorder) can hide who your child really is and disrupt family life. If you can separate the kid from the symptoms, you and your family may see more of the great kid inside. That’s where INTUNIV comes in. Revealing a difference the whole family can see”
The promotional materials also include the exhortation to “Imagine the moments ahead” as a tagline throughout its marketing material.
The company claims, furthermore, that Intuniv can be effective in helping parents to deal with:
• “Bedtime blowups”
• “Toothbrushing tantrums”
• “Homework hassles”
• “Dinnertime defiance”
• “Sibling struggles”
• “Excessive energy”
• “Mall meltdowns”
Instead of these ghastly scenarios it offers:
• “Manageable mornings”
• “Assignments accomplished”
• “Drama-free dinnertime”
In response to all of this overblown hype the FDA’s letter states: The overall impression conveyed by the above claims and presentations is that treatment with Intuniv will improve individual behavioral problems in children with ADD/ADHD that “the whole family can see.” FDA is not aware of substantial evidence or substantial clinical experience to support this implication.
Getting a letter like this, especially from an organization which, to put it mildly, does not have a sterling record of holding big pharmaceutical companies to account, must have been devastating for Shire Pharmaceuticals as they attempt to replace their revenue base. We should, however, not shed too many tears for them. These overblown claims simply show once again what I’ve been saying all along namely that big multinational drug oligarchies are simply chasing after the bottom line. On one level we cannot blame them; the desire to maximize revenue is ingrained in most companies. On another level, however, their complicity in the drugging of a significant proportion of an entire generation is deeply troubling.
The example of Intuniv shows the almost desperate lengths to which some of these companies will go to secure positive ADD/ADHD diagnoses so that people can take up their preferred ‘solution’ to it. The FDA highlights parts of the marketing material that actively encourages parents to look for ADD/ADHD symptoms before encouraging them to ask for their specific product as a ‘remedy’: “Tell your child’s doctor about temper outbursts, fidgeting, and irritability You may not think of these as symptoms of ADD/ADHD”  This is followed by a graphic of children playing a board game together nicely as their parents smile at them, in conjunction with the claims, “Ask the doctor if once-a-day INTUNIV could make a difference for your child” and “Parents and teachers reported that INTUNIV improved symptoms”
This case should not surprise us. We’ve had the same kind of overblown claims for years and years and for a variety of different products. In most cases the FDA looked the other way. It is only now (perhaps due to the greater public awareness of the dangers of ADD/ADHD medication) that they feel forced to comment on particularly egregious examples of false advertising. My advice is, as it has always been, to avoid ADD/ADHD medication at all costs. They are dangerous, addictive and have horrible side effects. So why do people use them? Simply because the drug companies tell them that they are so effective and that they are the only things that can turn the lives of their children around. This is, however, exactly what we would expect them to say even if it is not exactly true. The rare times when companies are ‘caught out’ playing this game should alert us to the fact that there is probably much more of this going on, undetected and unremarked upon. Let the buyer beware and preferably keep away as far as possible! The ‘Three Steps’ will teach you to do just this!
For the full text of the FDA’s letter to Shire Pharmaceuticals see:
http://pharmalive.com/News/index.cfm?articleid=715054&categoryid=30
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