If they had chosen to publish their results in acceptable scientific journals rather than the mainsteam media, they would have had a chance at getting unbiased peer review. Most of the time, a study is published in such journals, subjecting itself to peer reiew and subjection to another study which might or might show reproduction of the same results in a second study, before every hitting mainstream media. That is good science. Mainstream meida is not.
Independent lab analysis of FDA study
- Thread starter Territoo
- Start date
- th_trl_thread_readers 0
- Status
If they had chosen to publish their results in acceptable scientific journals rather than the mainsteam media, they would have had a chance at getting unbiased peer review. Most of the time, a study is published in such journals, subjecting itself to peer reiew and subjection to another study which might or might show reproduction of the same results in a second study, before every hitting mainstream media. That is good science. Mainstream meida is not.
So question: Can a pharmaceutical company do their testing and then just submit to the FDA un-peer reviewed or do they have to have a peer review their study before submitting or is the FDA considered the peer review?
I ask because I find it interesting that if the FDA is considered the peer review, how is that actually unbiased when the pharmaceutical company is paying big money to have their studies submitted? This is also leads back to when the scientists at the FDA cried foul last year, regarding their review of some drugs that were allowed on the market anyways, even though their own scientists had questions.
Kind of a weird flaw if this is the case.
EDIT: Also, aren't studies peer reviewed prior to being published?
The way I understand Lacey's post is that it refers to the FDA study. Confusing to have discussion of
FDA Study
Review of FDA Study
Sebastian's Study
all in the same thread. The reader has to decide what is being discussed and it all leads to confusion.
_____________
FDA Study
Review of FDA Study
Sebastian's Study
all in the same thread. The reader has to decide what is being discussed and it all leads to confusion.
_____________
Sun, I understand that the taxpayer is not going to bear the burden, however, my question still stands: Is there a measure of peer review before a submission hits the FDA for approval or is that burden left to the FDA? As a taxpayer, I would like to think that if someone were to submit a study to the FDA, it would save time and taxpayer money if the study was in fact peer reviewed prior to that time.
If not, then that leads me to believe that the FDA approval process is literally a free for all... which concerns me.
Last edited:
So in general, studies are peer reviewed and the FDA does not act as a peer review for studies submitted?
To answer your second question first, no, peer review comes when an article is published for all "peers" to see in a respected journal. That's why if some one says that "such and such" was reported in "so and so" medical journal, it doesn't necessarilly mean I'm going to change my medical practice. But if you quote multiple articles about the same subject, I'll pay more attention.
As far as the FDA, they'll definitely be looking at the peer reviews and also the duplication of results (one of the reasons it takes so long to get FDA approval), but ultimately they will do their own peer review. Most of the tests done by BP are not published because of concerns about loss of control over the product they are testing. If they publish the results about a partiular drug, and some other company can complete the necessary studies first, the first company loses everything they've invested in the product to date. That's why studies conducted by BP are more suspect than those conducted by a university. Their peer review is weaker and there's less opportunity for a lab to duplicate the test without financial motive, which leads to premature presentation of test results to the FDA, premature approval of a drug, and subsequent withdrawal of same drug based on a more transparent and peer reviewed analysis once a drug is released.
Furthermore, if a BP company finds a problem with a drug at the final hour, it's more likely to try to hide the results because of the time and money spent to develop that drug. This is what occurred w/ the COX-2 inhibitors Vioxx and Bextra. (FYI, these drugs are still a lot safer than aspirin!)
Last edited:
Lacey,
I'm sorry and removed the post. It just gets a little ridiculous sometimes on the forums...as far as berating goes. It didn't read that way because it was a response to another poster responding to my posting.
My apologies.
Seb
I'm sorry and removed the post. It just gets a little ridiculous sometimes on the forums...as far as berating goes. It didn't read that way because it was a response to another poster responding to my posting.
My apologies.
Seb
Territoo -
Thank you... that makes complete sense.
Sebastian -
Wonderful... I edited my post as well.
(And not to beat a dead horse, but I did respond to the third post in this thread... not to anything that was directed at you... personally, I appreciate that you have done testing... I think it's wonderful and I do believe it deserves it's own thread.)
No hard feelings... Total misunderstanding is right... I appreciate you and having nothing but good words for you.
Thank you... that makes complete sense.
Sebastian -
Wonderful... I edited my post as well.
(And not to beat a dead horse, but I did respond to the third post in this thread... not to anything that was directed at you... personally, I appreciate that you have done testing... I think it's wonderful and I do believe it deserves it's own thread.)
No hard feelings... Total misunderstanding is right... I appreciate you and having nothing but good words for you.
- Status
Similar threads
- Locked
- Locked
