Wednesday, April 16, 2008

Restless leg-up syndrome

Do you suffer from hypochondria? Of course you do, and Big Pharma is here to help.

Whether your favourite CEO suffers from Leg-up Syndrome or your favourite jazz musician has a bad case of Deeply Vain Trombonesis, Big Pharma is here to help.

And Justin Rohrlich, at Minyanville, shows us how.
Big Pharma’s latest innovations aren’t new drugs, they’re new syndromes and disorders.... the pharmaceutical industry currently spends more on advertising than they do on research and development.

pharmaceutical companies are “fostering the creation of a condition and aligning it with a product.” Like Restless Legs Syndrome (RLS). GlaxoSmithKline’s (GSK) Requip was a drug used to treat Parkinson’s disease – and the infinitesimal number of people who suffered from RLS, an extremely rare condition discovered in 1945 by Swedish doctor Karl Ekbom.

Consumers hear a roll call of symptoms and become convinced they’ve got them, whatever they are. That’s why, these days, RLS “affects” nearly 12 million people in the United States alone.

Does feeling sleepy mean you’re ill? According to Cephalon (CEPH) it does. It’s helping people combat Excessive Sleepiness (ES) with a drug called Provigil, prescribed to “improve wakefulness.” Seriously.

[And then there's] Intermittent Explosive Disorder, sometimes called Road Rage Syndrome, characterized by recurring outbursts of extreme anger and violence. Luckily, Dr. Daniel Deutschmann, a psychiatrist and clinical professor at Case Western Reserve University, found success medicating IED patients with existing anti-epileptic drugs....

[And] Oppositional Defiance Disorder (ODD) [, sometimes called Rebellious Youth]. ODD is described as an ongoing pattern of disobedient, hostile and defiant behavior by children toward authority figures. Joe Biederman, M.D., a leading pediatric psychopharmacologist at Massachusetts General Hospital and Harvard Medical School, recommends “atypical antipsychotics,” like Risperdal, Clozaril, Abilify and Seroquel.

Steven Woloshin and Lisa M. Schwartz of the Dartmouth Medical School had this to say: “Helping sick people get treatment is a good thing. Convincing healthy people that they are sick is not. Sick people stand to benefit from treatment, but healthy people may only get hurt: they get labeled “sick,” may become anxious about their condition, and, if they are treated, may experience side effects that overwhelm any potential benefit.”


Guambat received this Legal Alert of date 24 April from a large-ish law firm:

Welcome to the April edition of Pharma Insights. In this edition, we consider tips and tricks for sponsors of prescription medicines when designing educational campaigns for the general public, bearing in mind Medicines Australia's Code of Conduct.

Educator or promoter - Are you at risk of an identity crisis?

The US and New Zealand are currently the only industrialised countries that allow Direct to Consumer advertising ("DTC"). As most of you will be aware, DTC advertising of prescription-only products is prohibited in Australia. The prohibition is achieved via the Therapeutic Goods Act 1989 ("TG Act") and Medicines Australia's ("MA") Code of Conduct.

Critically however, there is a distinction between "promotion" and "education" as the latter is permitted by the Code provided it meets certain requirements, for example, the need for educational material to be "current, accurate and balanced". Issues also exist in relation to "ask your doctor" advertising which fall outside of the scope of this article.

It is obviously within a company’s best interests to rigorously pursue its marketing interests within the scope of the "educational material" allowance under the Code. The business advantages of active marketing must however be balanced against compliance with the Code and general legal risk. Code compliance is important because breaches can have significant ramifications: fines of up to $200 000 apply for severe breaches, and the reputational risk is also significant.

Etc., etc.


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