Drug regulators in Europe have shown that there is a golden third way between inaction and legal enforcement: creative nudging.
I completely agree with a "sunshine law" for clinical trials. As it stands, I have a DEEP mistrust in Big Pharma's relationship with the FDA. When all the COVID vacc propaganda came out, I have often been reminded of a quote from The Outlaw Josie Wales: "Don't piss down my back and tell me it's raining." We have been thoroughly lied to as physicians and patients, and I'm sick of it. It's time to hold the bureaucrats, public health officials, and ivory-tower Pharma institutions accountable.
I think that Pfizer should be forced to release results of its Teratology Covid19 jab trial C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry.”
because we have a right to know NOW about all the Birth Abnormalities that have been reported. Waiting until end of 2025 can't be justified.
Sooooo.... if these trials use public funds, why not have in the enforcement tool box the ability to claw back those funds if the trial results are not published? Money talks. That possibility would seem to be useful. Or in addition to that, release only half the funds for such trials upfront, with the rest due upon submittal. There are ways to encourage meeting the terms, and do so upfront. Transparency, no hidden weenies, etc.
Any thoughts on when we can expect a write-up of MedinCell's trial?
“While the FDA does have legal powers to enforce a 2007 trial reporting law, it has so far argued that it does not have the resources to chase up each and every of the thousands of clinical trial results that are missing from the public ClinicalTrials.gov database. “
This argument doesn’t hold up with the 5 billion dollar budget reported in this piece. Like a lot of government agencies the FDA needs to decrease the money they send out the door and start using it inside their walls to fund these types of programs. Government agencies can’t just be a bag of money to dole out without then monitoring how that money was spent and if it was worth it to the tax payers.
It always boils down to a $$ problem with the FDA when it's accused of incompetence. Gee. Why doesn't it simply ask for more money from the big pharma companies it's supposed to regulate? What could go wrong with that? [sarcasm]
Surprised you didn't mention the campaigning work of https://www.alltrials.net/ in achieving more CT transparency.
Does this include negative or damaging trial results? With the off and on research I have done over several years, I trust no big pharma drug trials. This is one reason that at age 73 I am still avoiding taking any drugs, even OTC's are on my never use list.
Evidence distortion? To me that means that most evidence is lacking, invented, manipulated or non-existent. The near perfect scenario that the FDA proudly uses to approve drugs. Why do so many drug trials use near perfect and healthy humans when the drugs they are creating are for the diseased and ill?
After the mRNA prototype gene manipulating substance approval process, including the safe and effective mantra etched in granite, I trust none of it and never will.