What the FDA isn't telling: Patient deaths in drug tests

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(Mod edit- All cap title)

[edit on 27-9-2005 by asala]

Trade Secret = Number of patient deaths caused by "treatment".

Commercially protected information = FDA role in keeping trade secrets secret



[edit on 9/27/05 by eeper69]

Thanks for posting But for a better response could you tell us a little bit more in your own words or your thoughts on the topic,

Thanks Asala..

I did:

Trade Secret = Number of patient deaths caused by "treatment".

Commercially protected information = FDA role in keeping trade secrets secret

Some reasons drug companies don't release negative study findings:

1. They don't want competition realising their potential errors, and thus improving on the product before they get chance themselves.

2. In the clinical trial phases prior to submission/approval, it's hard to actually discern much of the time whether adverse events are actually caused by the drug or not; it doesn't make sense to scare the public if there's no proven link.

3. If efficacy is in question, the drug would not be approved anyway, and thus would never reach the public.

The trouble with anti-depressants and suicide is simple:

There's just no way to tell whether a particular patient's depression would or would not have included suicidal ideology to begin with. This particular research group is already much higher risk for suicide. In addition, clinical trials invariably end up with deaths amongst their numbered patients; the difficulty once again is assessing causality.

This is less to do with an FDA conspiracy than it is to do with fair business practices...if the FDA were allowed to release every bit of clinical data, you'd find panic-mongering going through the roof and that would feasibly result in even more deaths as people would be too afraid to take the drugs that often save their lives, and this would in turn cripple an industry which does, regardless of the "conspiracy" factor, end up saving more lives than it harms.

Bear in mind:

If you see "headache" listed as a possible side-effect, this does not mean you're going to get a headache. Same with palpitations, rash and/or death.

That's just not how side-effect reporting works

There are many products that make it by the FDA if they're pockets are lined with the right amount of money. Examples?:

- Aspartame (aka Nutrasweet)
- Flouride
- Celebrex, Vioxx, Bextra
- Fluvirin....vaccine for serratia bacteria that was approved by the FDA even though it was laced with high levels of bacteria that made some people sick and killed others.
- Ephedra
- MSG

etc. etc. etc........

Originally posted by XanaX
There are many products that make it by the FDA if they're pockets are lined with the right amount of money. Examples?:

Sorry, what's your point here?

Drugs have side effects.

Some of them are indeed deadly. Are you expecting a drug to have absolutely no risk factors at all?

Perhaps more to the point though, it's often only in the post-approval studies that we actually find dangerous trends involving certain side-effects; iow, once the drug is out in the general population.

Vioxx etc, Redux/Pondimin (phen-fen)...that's what happened.

Originally posted by Tinkleflower

Sorry, what's your point here?

I think his point is that if the FDA cared about consumers rather than their pockets, a lot of things would not be on the market.

Then not to mention a lot of "illegal" things would be "on" the market.

Perhaps more to the point though, it's often only in the post-approval studies that we actually find dangerous trends involving certain side-effects; iow, once the drug is out in the general population.

Post-approval studies? So these drugs are approved before they make sure they are safe? This makes sense to you? Dangerous trends are found AFTER they are approved? Shouldn't these trends be found BEFORE the drugs make it into the general population? That would make sense to me.

Merck representative: "Oh, we're sorry Mrs. Johnson, we didn't know that your husband's high blood pressure medication would make his heart explode. That's just one of those pesky post-approval side efects that we weren't aware of. We're sorry."

[edit on 30-9-2005 by _Uforia_]