"He who controls the narrative, controls the debate."
So why insist that the FDA certify the a priori declarations and analysis plan entered into ClinicalTrials.gov prior to beginning the study?
That one is easy. The FDA is the only agency that can. Usually, the a priori Protocol and Statistical Analysis Plan have been filed with the FDA Registration and the IRB report, so the certification os no hardship. But why insist? Far and away, the commonest bit of deceit in these reports is "outcome switching" – selecting an outcome after the fact that gives the statistical results that are most favorable to the drug. The only way to prevent that kind of sleight of hand is to have a bona fide certified listing from before the study begins. Only the FDA has the power to get that.
So why insist that the FDA certify the entries into the ClinicalTrials.gov RESULTS database at the time of submission to the FDA?
First, the FDA is the only agency that has direct access to that information. At the time of submission, the Sponsor has those RESULTS and can easily put them into the ClinicalTrials.gov RESULTS database to be checked during the FDA Approval process. If they’re not right, the FDA can insist that they be made right before proceeding. Again, this is a necessary check to prevent the ubiquitous "outcome switching."
Any other reason to insert the FDA into this process?
Absolutely! The FDA is a governmental agency tasked specifically to insure that our pharmacopoeia is safe and populated with drugs displaying at least some degree of efficacy. There is beyond ample evidence that the current version of that process hasn’t worked. The FDA has done a fairly decent job of approval/disapproval, but has turned a blind eye to the gross distortion of many trial results in journal publications – distortions that they alone have the data and power to correct. Is that part of their charge? Absolutely! It’s false advertising in plain sight. They’re not charged with riding herd on what journals publish, but they are definitely tasked with surveillance for false advertisement, and academic journal articles have become a [if not the] major vehicle for pharmaceutical advertisement.
Why petition Congress?
The suggested change would make fundamental changes in the system. ClinicalTrials.gov would become the official interface betweem the FDA and the public rather than something that is either optional or treated as optional. The FDA would become accountable for both the timing and content of the information available to the public about our pharmaceuticals. Such a change would mean that the FDA would itself need oversight and authority. In our system, such things come from Congress, not the Agencies themselves. Likewise, it would make willful ignoring the mandate to comply a potentially criminal offense.
Currently, the FDA is an unwitting part of the problem. Maybe they have to keep the actual data from clinical trials private as things stand now. But currently, they are keeping the results private as well, and that’s unacceptable. It has had disastrous consequences well known by all. If the FDA is to be the eyes and ears for the public and the medical profession, they need to tell us what they see and hear – need to be accountable for what they tell us. If they find that Paxil® Study 329 is a failed study [which they did] and it is published as positive by treating non-protocol variables as if they are Primary Outcome Variables [which it was], we shouldn’t have to wait fourteen years for confirmation [which we did]. We need to know that shortly after they know it – by law – rather than allowing the pharmaceutical industry to "control that narrative"…
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