Does FDA Not Test Anything in order to Approve It?

This addresses the third question, which was about the recall of any drugs that had been misrepresented by company-sponsored research. Paroxetine has not been recalled, but calls for the retraction from the scientific record of its maker's clinical trials with adolescent subjects have yet to cease. The FDA warns of serious side effects including suicide that would not have occurred without the drug, but apparently doesn't believe that's enough of a reason to recall it. Just a note about the FDA and the premise of the question: The FDA does not limit approvals to drugs that are universally helpful and harmless, and they do not necessarily recall drugs that have killed people. They do require warnings of adverse events when those are known, and highlight the most important ones by drawing a black box around them. They have yet to recall Serzone (nefazodone), which caused so many liver failures, transplants, and deaths that it can no longer be sold in Europe. Here, the manufacturer withdrew it voluntarily after the death of a 15-year-old girl followed 20 other deaths and dozens of liver failures, but the FDA doesn't object to the availability of generics; doctors can prescribe it and pharmacies can still sell it.GSK (formerly Glaxo Smith Kline) was found to have mis-reported results from their Phase III trials of the safety and effectiveness of paroxetine for adolescents. Paroxetine is a selective serotonin re-uptake inhibitor (SSRI) sold as Paxil in the US and Seroxat in the UK (and many other names around the world). The FDA relied on the reports and the drug was approved for the expanded market of adults and adolescents. Also, there was a heavy contribution of GSK-funded ghostwriters on the original study, which listed high-profile academic psychiatrists as its authors.Reports of unexpected suicides among adolescents on the drug began to surface. In 2002, the British series "Panorama" presented an investigative report called "The Secrets of Seroxat" that had a large impact on the British public. BBC received nearly 1400 emails and published all of them. The episode is currently viewable on youtube.

In 2004, New York State Attorney General Eliot Spitzer sued GSK for withholding negative information about the drug's effect on children. The company promised to post clinical trial data on their web site and paid $2.5M to the state. Last year the British Medical Journal published a multi-author study that presented a re-analysis of the trial data, and new findings about the drug's safety and effectiveness, in a purportedly unbiased manner. In sum: not especially effective, and more likely to induce suicidality than placebo or the comparison drug, an older, non-SSRI antidepressant. From the study:The efficacy of paroxetine and imipramine was not statistically or >clinically significantly different from placebo for any prespecified >primary or secondary efficacy outcome. Suicidal adolescent test subjects on paroxetine in GSK's write-ups were described as emotionally labile, if their adverse events were even mentioned. This was explicitly stated in an email among several dozen that were leaked Emotional lability can mean nothing more than rapidly changing moods, none of which are depression or despair, and isn't interchangeable or closely linked with "suicidality" in mental health parlance. In the current Diagnostic and Statistical Manual, these related terms are offered as equivalent to emotional lability:prone to mood fluctuations, emotions that are easily aroused and >intense, unstable emotional experiences and frequent mood changes, and >incapacitation by extremity of emotionsThe authors of the BMJ article built a web site, Study329.org, that describes the process of obtaining access to the raw data, along with information about the original study, the original investigators, and press coverage of the BMJ article. The anonymized patient-level raw data they needed were not posted to the company's web site, and gaining access to the data and copying it over to the authors' computers, given the difficulties imposed by GSK, were among the largest challenges of the project

I watched something a bit back and was thinking about one of the claims this morning as I listened to SGU on the way to work. I unfortunately can't recall the source anymore, but am fairly confident that it was either Food, Inc., Sweet Remedy, or perhaps this vaccine class with a nearby chiropractor.

In any case, the claim was that the Food and Drug Administration (FDA) does not actually conduct any of its own tests in order to approve foods or drugs as safe for public consumption/treatment.

The implication is that the companies seeking approval can "doctor" the data and test methods however they want in order to pass the FDA approval process, and I'm blanking on what the specific was at this point -- it might have been MSG, aspartame or a particular vaccine... I can't recall.

My questions are:

Is it the case that the FDA does no actual testing itself, only reviews of other studies?

If so, is it left up to the company to conduct it's own studies, and are these studies verified by independent and/or trusted testing agencies?

If the above are true, have there been cases of substance/drugs being recalled because falsified data, improper test methods, and/or suppression of potential negative effects allowed a drug to pass the FDA approval process when they were actually unsafe?

·OTHER ANSWER:

I watched something a bit back and was thinking about one of the claims this morning as I listened to SGU on the way to work. I unfortunately can't recall the source anymore, but am fairly confident that it was either Food, Inc., Sweet Remedy, or perhaps this vaccine class with a nearby chiropractor.

In any case, the claim was that the Food and Drug Administration (FDA) does not actually conduct any of its own tests in order to approve foods or drugs as safe for public consumption/treatment.

The implication is that the companies seeking approval can "doctor" the data and test methods however they want in order to pass the FDA approval process, and I'm blanking on what the specific was at this point -- it might have been MSG, aspartame or a particular vaccine... I can't recall.

My questions are:

Is it the case that the FDA does no actual testing itself, only reviews of other studies?

If so, is it left up to the company to conduct it's own studies, and are these studies verified by independent and/or trusted testing agencies?

If the above are true, have there been cases of substance/drugs being recalled because falsified data, improper test methods, and/or suppression of potential negative effects allowed a drug to pass the FDA approval process when they were actually unsafe?