Author Topic: Choice For Men?  (Read 6809 times)

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Offline Scheavo

  • Posts: 5444
Re: Choice For Men?
« Reply #35 on: May 31, 2012, 02:41:32 PM »
Seems inept to me to take the manufactures word on it. Isn't the point of the FDA to check these claims?
The problem is that for the FDA to truly do that, they'd have to redo the studies the drug companies themselves performed and see if everything matches what's being claimed. But that would require way more manpower than we have at this time and would cost a lot lot more money.

I don't think they'd have to completely redo the studies. Hell, you could even have the last stage public. Make it obvious that the drug in question is new, that it's somewhat experimental, and that some side effects and reactions could have gone unnoticed so far. However, after thinking about the issue a little, I think I have a more solid complaint, which may not directly relate to the FDA, but is certainly the way in which our medical industry is set up. And it relates with this last point:

For most things, especially newer drugs, people need prescriptions. I know the FDA is somewhat in control regarding what needs a prescriptions, what can be OTC, etc, and I'm not really going to address that issue. But what about the doctors prescribing the drugs to patients? I know I've heard of more than one study detailing the corruption between doctors and pharmaceutical companies. Proper regulations of the system would mean doctors act as more of a safeguard.

I've also seen a recent strew of such events. There's been a LOT of drugs recently that have had huge settlements made. The FDA came about because of this reason, not to simply fine and bitch-slap the companies post facto, but to prevent such events from occurring in the first place. I know this isn't going to always be possible, especially for long-term effects.
While you've got a point to an extent, there's a problem that payouts (in form of settlements or jury-imposed damages) don't always translate into companies doing bad things. For instance, lots of women got money for breast implants causing diseases for them when it's been shown that the diseases don't occur in any greater frequency than in the general population.
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That also said, is there a threshold requirement before a company is held liable? There are certainly some things which would be unreasonable to expect being caught. And I think it theoretically make me want to retract everything.

I guess I left it out of it, but this was also something I meant by the above. I think you point to a real problem in the way our legal system is set up, and the way in which it awards people damages.


Offline slycordinator

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  • Gender: Male
Re: Choice For Men?
« Reply #36 on: June 01, 2012, 12:25:21 AM »
I don't think they'd have to completely redo the studies. Hell, you could even have the last stage public. Make it obvious that the drug in question is new, that it's somewhat experimental, and that some side effects and reactions could have gone unnoticed so far.
The last stage, though, is post-marketing. The drug is, assuming it passes the previous stages, it is approved for use for a certain disease and allowed to market it as a safe treatment for the disease. And the previous stages are all 100% based on the data the drug companies produced. Essentially, if we don't trust the claims, it makes sense to not trust the data used for it either.

For most things, especially newer drugs, people need prescriptions. I know the FDA is somewhat in control regarding what needs a prescriptions, what can be OTC, etc, and I'm not really going to address that issue. But what about the doctors prescribing the drugs to patients? I know I've heard of more than one study detailing the corruption between doctors and pharmaceutical companies. Proper regulations of the system would mean doctors act as more of a safeguard.
These days, they consider even a drug rep giving a doctor a cheap, ball-point pen to be illegal, although the reps can still give them expensive catered food as part of a presentation and that's not considered illegal.

Offline Scheavo

  • Posts: 5444
Re: Choice For Men?
« Reply #37 on: June 01, 2012, 11:24:07 AM »
I don't think they'd have to completely redo the studies. Hell, you could even have the last stage public. Make it obvious that the drug in question is new, that it's somewhat experimental, and that some side effects and reactions could have gone unnoticed so far.
The last stage, though, is post-marketing. The drug is, assuming it passes the previous stages, it is approved for use for a certain disease and allowed to market it as a safe treatment for the disease. And the previous stages are all 100% based on the data the drug companies produced. Essentially, if we don't trust the claims, it makes sense to not trust the data used for it either.

It's a way of testing those claims, and also getting a larger audience, without implying the kind of safety which w do now. I don't really see how your first remark makes any sense, considering I'm talking about redoing that process. Yes, that's how it's done, so what? Why not how it should be done?

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For most things, especially newer drugs, people need prescriptions. I know the FDA is somewhat in control regarding what needs a prescriptions, what can be OTC, etc, and I'm not really going to address that issue. But what about the doctors prescribing the drugs to patients? I know I've heard of more than one study detailing the corruption between doctors and pharmaceutical companies. Proper regulations of the system would mean doctors act as more of a safeguard.
These days, they consider even a drug rep giving a doctor a cheap, ball-point pen to be illegal, although the reps can still give them expensive catered food as part of a presentation and that's not considered illegal.

I never said the reps, I said the pharmaceutical companies.

http://www.nybooks.com/articles/archives/2009/jan/15/drug-companies-doctorsa-story-of-corruption/?pagination=false

http://www.levaquinadversesideeffect.com/2012/05/26/fraud-cover-ups-and-corroption-welcome-to-the-drug-industry/

http://www.dailyfinance.com/2009/09/02/pfizer-settles-off-label-uses-promotion-and-kickback-charges-for/

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What exactly has Pfizer done that has officials basking in their success? Well, once again it has been charged with promoting off-label uses for its drugs and for "certain payments to healthcare professionals." In other words, representatives of the company were promoting the drugs for conditions that they haven't been approved for and giving doctors kickbacks to encourage them to prescribe the meds.

It's technically illegal for lobbyists to bribe members of congress - yet we all fucking know how corrupt that system is. There's always a loop-hole, like you even mention. Where there's a lot of money to be made, there's going to be corruption - and the current American health care system is a huuuuge money maker. It's what. 17% of our economy?




Offline slycordinator

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  • Gender: Male
Re: Choice For Men?
« Reply #38 on: June 02, 2012, 12:18:08 AM »
It's a way of testing those claims, and also getting a larger audience, without implying the kind of safety which w do now. I don't really see how your first remark makes any sense, considering I'm talking about redoing that process. Yes, that's how it's done, so what? Why not how it should be done?
1) With regard to the "remark that makes no sense", you were suggesting that the FDA shouldn't just take the drug company's word for it that the claims are legitimate. I suggested that if you don't accept their claims then you shouldn't really be willing to accept their data to begin with, both in the sense that that "taking their word for it" should include everything they provide and in the sense that the data is the basis for the claims. Also, remember that the data itself is usually what is fudged to make the things the drug company wants, so I'm suggesting that if we have to fix something somewhere, it's gonna be there...
2) And on the "redoing the process" claim, I thought you said that redoing the collection of data was un-needed.

Quote from: Scheavo link=topic=32492.msg1303498#msg1303498 I never said the reps, I said the pharmaceutical companies.[/quote
My bad. You're right; the off-label controversy is ridiculous and I misunderstood you.