Consumers International (CI), which claims to be the only independent global campaigning voice for consumers, yesterday accused Takeda Pharmaceuticals — marketer of the sleep aid Rozerem — of “taking advantage of poor US regulation and advertising sleeping pills to children, despite health warnings about pediatric use.” To honor that achievement, CI awarded Takeda a 2007 International Bad Product Award (see press release).

In fact, Takeda was the overall winner!

What earned Takeda this distinguished award was a “reminder” back-to-school ad it ran over a year ago in September, 2006. I first blogged about this in March, 2007, when FDA finally got around to issuing Takeda a warning letter (see “Back to School for Takeda, Rozerem, and Abe Lincoln!“).

Why did it take so long for the FDA to issue a warning, well after the school bus door closed? Good question, points out CI in its award notice:

“This particular ad,” says CI, “was released at the beginning of the school year and used images of children,chalk boards, school books and a schools bus. The accompanying voiceover stated: ‘Rozerem would like to remind you that it’s back to school season. Ask your doctor today if Rozerem is right for you.’

Under the tagline ‘Back to School’

“It doesn’t take a PhD in marketing to see that this is an effort to persuade parents to seek out the sleeping drug for their children — to help them get through the stress of term starting.

The advertisement ran without noting the very serious side effects that this drug can have, including increased thoughts of suicide in already depressed patients. Takeda pharmaceuticals also failed to mention the precautions on its packaging about children using this drug. According to the product labelling:

PRECAUTIONS (relating to pediatric use)
Use in Adolescents and Children
ROZEREM has been associated with an effect on reproductive hormones
in adults….It is not known what effect chronic or even chronic intermittent use of ROZEREM may have on the reproductive axis in developing humans.

Pediatric Use
Safety and effectiveness of ROZEREM in pediatric patients have not been
established. Further study is needed prior to determining that this product may be used safely in pre-pubescent and pubescent patients.

“That such a potentially harmful drug should be geared towards young children is outrageous.

“Almost as outrageous was the token action taken by the Food and Drugs Agency (FDA) — the body that regulates pharma company behaviour in the US:

“It took six months for the FDA to tell Takeda to remove the ad — long after the relevance of a ‘back to school’ promotion had gone. Takeda is a US$10 billion dollar pharmaceutical company. It spent $118 million on advertising ROZEREM last year, yet the FDA issued no fine and no penalty. Just a slap on the wrist.

“This case,” says CI, “demonstrates the lengths to which some drug companies will go to increase sales of their products, how direct to consumer advertising can promote irrational drug use, and how weak regulation can foster irresponsible corporate behaviour. This company is our overall award winner for irresponsible behaviour for 2007.”

This, of course, is not the only award Rozerem has won this year. Just recently, I announced that Rozerem received the Bronze POE Award for “Most Innovative DTC Campaign” (see “Awards: POE vs. MM&M. I Pick Winners!“).

That marketers and consumers can have such divergent views of Rx brand behavior and award-worthiness is a testament to the Rubber Chicken Crowd (see “Awards. What Are They Good For?“). Speaking of which, I will be attending the MM&M Awards in NYC this Thursday. Maybe Takeda/Rozerem will also win one of those!