The Horror Of Asking For Data

Sent to you by Rio via Google Reader: The Horror Of Asking For Data
via In the Pipeline on 7/9/10

A reader in the UK sent along this item from the BBC, and those of us
in the drug industry will enjoy it very much. An EU regulation is
forcing health food and supplement companies to. . .wait for
it. . .actually provide evidence that their advertising claims are true.

For those of us living in Orrin Hatch's world here in the US, this will
certainly be a change of pace. US readers know how it works - listen to
the ads, with the first two sentences delivered as a low-decibel
mutter: "Sold as a nutritional supplement only. Not intended to treat,
cure, or modify any disease. But the hell with that! It'll grow hair,
regenerate your liver, detoxify your colon, improve your memory, and
boost your immune system! You'll lose weight, have more energy, sleep
better, and you'll have to fight off the attentions of the opposite sex
with whatever weapons come to hand! And it's all-natural! Call now for
a free thirty-day supply!"

No, the EU isn't letting this stuff pass. Want to claim that your
cranberry drink reduces the risk of urinary tract infection? Show us
your clinical data - and no, not from someone else's study. From yours,
with your product. Glucosamine for arthritis? Got some data to back
that up? Green tea for cholesterol, or as an antioxidant? Show them
some numbers, or go home. The marketers aren't too happy:

Ioannis Misopoulos, director general of the International Probiotics
Association (IPA), is openly hostile.

"It can take three years to get these kinds of human studies together
but in the meantime the claims are going to be wiped away," he
said. "The regulation is killing this industry and the job losses are
already being felt."

Cry me a procreating river, dude. Or come over here to where you can't
get near the market without going through the clinic first - and for a
lot longer than three years, I might add. And where every claim you
make for your product is hammered out with the regulatory authorities,
and if they catch you stretching out past them you can get fined out
the wazoo. So they won't even let you keep running the ads while you go
fetch some evidence, eh? Well, it gets worse:

Not surprisingly, the process has left many manufacturers here in the
UK angry. Some say EFSA is demanding the same kind of clinical evidence
which prescription medicines would require.

"EFSA is rejecting most of the proposed food supplement claims," says
Jenny Baillie of the York-based health foods company Power
Health, "even established claims like cranberry for urinary tract
health, which will mean that there will be no information on packs for
the consumer to assess what the product is supposed to do."

She believes the regulation may even drive consumers into buying from
less reputable sources.

To which I am tempted to reply: Mundus vult decipi, ergo decipiatur.
Except in the EU.

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