4 ms·
Not really, this study was required by the FDA to be performed by Pfizer. That's how drug safety studies are always conducted in the US, by the drug maker under
by zymhan 10y ago
Not really, this study was required by the FDA to be performed by Pfizer. That's how drug safety studies are always conducted in the US, by the drug maker under the supervision and guidance of the FDA.
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534...
"Q: Does FDA test drugs?
A: No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians, statisticians, chemists, pharmacologists, and other scientist."
http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm279676.htm http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm...
- amelius 10y agoThis of course is a very bad situation.
- zymhan 10y agoWell it could certainly be more ideal, but how you could achieve a better situation would require rearchitecting a significant chunk of the US healthcare system. I'm personally in favor of publicly funding drug research and open sourcing the results, but fat chance that'll happen anytime soon.
- truth_sentinell 10y agoThe FDA is a joke then. So any greedy business man can fake the data or some of the data and just send it to the FDA for approval?
- zymhan 10y agoNo, the FDA is staffed by myriad professionals in biotech and drug testing and any number of relevant fields. They pour over the methodology, the results, and ensure that the study was conducted accurately and appropriately. We have these regulatory agencies for a reason. The FDA is in fact far stricter about drug testing and approval than the EU is.
- dhimes 10y agoNo they actually have to enlist the help of physicians at hospitals and/or academic centers(for drugs) who would put a lot at risk if they faked the data. They also have to have external auditors.
- truth_sentinell 10y agoThen how is "The FDA doesn't test the data sent by the corps" true then? I don't understand.
- zymhan 10y agoYou should check out http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534..., it gives a good overview of how this works.
- truth_sentinell 10y agoThanks. I just checked, but it's still not clear. As far as I can understand, the drug application, along with results, tests, etc (which is conducted by the company) is reviewed by the staff at the FDA, which is not the same as doing the same tests and getting the same results, am I right?
- zymhan 10y agoSo, it would be extremely time consuming and cumbersome and expensive for the FDA to replicate the procedures of the manufacturer's study just to confirm the result. You're right that the FDA isn't replicating the study. But the premise of the system is that this replication isn't necessary, assuming that the process for exploring a new drug and testing its' safety and efficacy is well defined and considered.
- truth_sentinell 10y agoWell, that's my point. If they aren't replicating the study, then that's wrong. It's like only validating input on the client and not server-side. It would be much more difficult for a company to fake both FDA results and their own. And public health is what's at stake here, so there should never be enough tests.