Have you taken your pill yet, honey!

A Pharmacy Europe (Add laugh track here.) article reports approval appears near for a new psychiatric drug. This article then claims the new drug a safe and effective treatment for people suffering from schizophrenia and bipolar disorder.

1. Where have we heard this kind of thing before?
2. For both schizophrenia and bipolar disorder? How convenient.

The Food and Drug Administration (FDA) said that Saphris, from health care firm Schering-Plough, appears to be as safe as other drugs in the class, known as atypical antipsychotics. The regulator, however, has not yet reached a final decision on the drug.

We have a wee problem here, ladies and gentlemen, as safe as other drugs that have proven very unsafe is not safe. People labeled mentally ill are dying 25 years earlier than the rest of the population, and atypical antipsychotic drugs have a great deal to do with why this is so.

According to the article, a panel of ‘independent experts’ (Add laugh track here.) in the field of psychiatry will vote on whether the Federal Food and Drug Administration should approve the drug. The agency, although not bound to do so, usually follows the advice of such panels.

Schering-Plough held four studies into the effects of Saphris on schizophrenia patients. Two of the studies produced positive results, according to the FDA. It also studied the drug in two trials of bipolar patients, both of which showed positive results.

In 2 out of 4 studies–That’s 50%, isn’t it? Interesting. Notice, if you will, who is doing the research, and consider, if you will, 50/50. Them ain’t good odds! Also, note that they want to approve the drug for use on ‘bipolar patients’, and thus circumvent complaints of ‘off label’ prescribing.

The drug’s most common side effects emerged as sleepiness, restlessness, dizziness and weight gain.

Okay. So a patient will be nodding off all the time, perhaps in a zombified state. That sounds wonderful, doesn’t it? For restlessness, google ‘akathasia’. Oh, and you might google ‘acute akathasia’ and ‘tardive akathasia’ while you’re at it. This dizziness? That can’t be good. Excessive weight gain comes with a number of the newer atypical antipsychotic drugs. A slew of health conditions, all life shortening, are associated with excessive weight gain. I think we’ve heard much about a number of health complications associated with this drug. Now how is this drug safe?

And just in case you were wondering, folks, here’s the clincher…

If approved, Saphris would enter the market occupied by already established products such as AstraZeneca’s Seroquel and Eli Lilly’s Zyprexa, both of which are already approved for schizophrenia and bipolar disorder.

Speaking of which, didn’t the FDA approve the powerful antipsychotic drug Abilify for use in cases of depression awhile back. Turn on the television now, and ‘if nothing else works’, etc., you have Abilify. With these advertisements, Bristol-Myers profits have gone through the ceiling. Of course, when it comes to profits and corporate interests, we cannot stop there…

Well, here’s another one, folks! Soon to be appearing at a pharmacy near you: Saphris.

“I don’t think we’re in Marlboro Country anymore, Toto.” (Camera pans a graveyard.)

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