The FDA Disgusts Me

You would think I would be thankful for an agency that held my health and safety as priority.  I suppose I would… if that were the case. It is not.

Contrave is going to market.

Contrave?

It’s supposed to be an anti-fat pill. This is a country of lardos. Everyone’s talking about it. Mickey D’s has become a bad word.  All of the TV news agencies have shown video of big old swaying bellies at the mall. Blah, blah, blah. Something must be done!

Anyone offhand know the desiccation rate of a corpse? We’re mostly water, right? I’d bet a 350 pound corpse would be down to 175 in a year. Okay, I’m guessing… but you catch my Drift.

Contrave is a combo of two other drugs that have been out since the mid-1980s. Bupropion has been used as an antidepressant and in smoking cessation. Naltrexone is some sort of anti-addiction drug. Put the two together and you have Contrave. There are “issues.”

In trials Contrave didn’t produce results in 5% or more of those participating. One might even wonder why, with such a low percentage of efficacy, it could claim any at all! But wait! There’s more!

It appears there’s a risk of heart attack and stroke. More than a few of the pharmacological science folks have recommended that further trials be done before Contrave goes to your doctor’s script pad. It looks like the FDA has decided to use the general public as the trial. Quoting from a News Service article:

“…out voted by 11 who said that such testing could be done by tracking 10 percent of the millions of patients likely to take the drug after it is approved for general use.”

No, man, I’m not shittin’ ya’. For reals.

And over here, we have cannabis. A drug that has gone through 10 thousand years  of human trials (documented) and has proven to be, quite possibly, the safest damned drug on the planet.

The FDA won’t touch it with a ten foot pole.

Many of the cannabis legalization detractors point out that “in this country” drugs go through the FDA approval process. Not the process of initiative and ballot. I hope the fat bastards choke on their Contrave.

Yeah. I’m pretty pissed.

Orexigen’s stock went up 111% after the announcement of the pending approval.

Update, Feb. 4th 2011: Contrave was declined, after all. I can’t help but wonder if the publicity didn’t put some pressure on the FDA to “do the right thing.” I mean, it sure looked like they were going to give it a public trial. So much for a good rant (shrug).

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1 Comment

  1. somewhatbent said,

    January 5, 2011 at 4:30 pm

    Naltrexone can make you completely, totally and FATALLY intolerant to opioids. Something that should be Med-Alerted for the rest of your life according to the prescribing information (on Naltrexone, not Contrave — haven’t read that one), Spot Forbid you end up in and Emergency Room unresponsive.

    5% response rate in a clinical trial? Any trial *I* was ever monitoring (as a clinician) that would be considered EPIC FAIL.


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