By: D. H. Williams @ 12:09 AM - EST
Pharmaceutical and FDA insiders have confided to Daily Newscaster that the FDA’s clinical review and approval procedure, “does not work.” In candid interviews conducted over the last couple of weeks concerned employees within the FDA and big pharmaceutical cite three major problems all of which have become institutionalized since 9/11.
The first admission FDA sources make, “We do not have good science.”
FDA management cites salary caps placed upon them by Congress are too low to attract and maintain the top scientific talent necessary to conduct competent critical path trials of the multitude of new compounds being submitted. Pharmaceutical company executives confirm the FDA’s lack of scientific understanding, telling us that scientist hired by the FDA cannot comprehend most of the scientific papers presented for drug approvals.
Driven by a lack of knowledge and fear of being wrong the FDA will not allow pharmaceutical companies to explain to physicians’ a drugs side effect prevalence. As a result potential but highly unlikely side effects are added to the warnings associated with any drug approved, causing the public to have a poor understanding of a drugs side effects and the likelihood of occurrence.
One pharmaceutical executive told us, “So for a single medication you may have a warning of nausea and sudden death what that does not tell you is that 30% will experience nausea with .01% at risk of death.”
The second revelation made, “We have no standardized methodology for comparing the final results of our scientific studies.”
There is a real question within the ranks of the FDA on what standards should be adopted for the scientific studies formalized review process. One source says, “For example what are the measures if we have A equals B then approved, if not then we proceed to C. We lack a structured process for making decisions so decisions are being made by a review team … nothing on paper exist that says, this is how we make decisions “
Not having a standardized written review process for decision making means if a new compound is being approved or existing compound needs a safety language update the FDA has no procedure for that.
As a result the risk information now exceeds the amount of time spent on benefit analysis, thus decreasing the relevant understanding of a drug’s effectiveness and decreasing the public’s faith in drugs that are useful while being taken under a doctor’s administration.
The third admission is, “Every aspect of the drug approval process is stymied by a ‘cover your ass’ mentality within the Food and Drug Administration culture.”
A concerned FDA source said, “There has been a stark difference in the level of conservativeness [in the FDA] since 9/11.”
All of the industry and government insiders who spoke to us mentioned that there is an attitude of relying on big brother for everything including that all drugs should be 100% safe all the time and guaranteed by the government.
“Since the attacks on 9/11 the public looks to the government to keep them safe from everything.” , Says an FDA manager.
Our FDA sources also expressed alarm that consumer laws allowing direct public advertising has had a negative effect on the entire drug process and culture of the FDA.
Overall the FDA is concerned about the decrease in the number of innovative medical products being submitted for approval in a time of unprecedented advances in the biomedical sciences.
I am convinced the confidential sources interviewed for this article have a genuine concern for the public health and are troubled about the rising challenges and unpredictability of medical product development.
Clearly the Food and Drug Administration is defunct federal agency that simple does not possess the skills to carry out its regulatory mandates. These confessions only prove further that big centralized government creating massive bureaucracies to oversee virtually every aspect of American life is a complete failure and massive overhauls are required.
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9 comments ↓
“Since the attacks on 9/11 the public looks to the government to keep them safe from everything.” , Says an FDA manager.
You’ve got to be kidding.
I wouldn’t trust the government to keep me safe from ANYTHING.
No kidding, Maxx. You’d think 9/11 would’ve well illustrated the fact that govt does not exist to protect its people and that Katrina would’ve drive that point home.
The FDA is a joke! Has been for years….just look at how aspartame has come onto the market & stayed there. Please sign the petition to ban aspartame from the food supply. http://www.thepetitionsite.com/petition/555759748
Anyone interested in Chance’s comment about the approval process of aspartame check out this article:
Dark history of aspartame
Everything I’ve read about the FDA shows that it’s being run by the drug companies themselves. All the science and statistics in studies are questionable since the drug companies pay for the studies and even pay for the review of the studies. So for the drug companies to complain about the FDA doesn’t make sense unless you understand one thing: these companies are manipulating the FDA so that the drug companies cannot be legally liable for drugs that don’t work and drugs that kill people. If Bush hadn’t put his incompetent, corrupt cronies in charge of so many government agencies, maybe we would have gotten some protection. But until all these bastards are thrown out or prosecuted, no one is safe.
“Since the attacks on 9/11 the public looks to the government to keep them safe from everything.”
Umm…I think that was the whole point.
A little known fact is that the FDA does no testing of new drugs or supplements coming onto the market. They rely entirely on the company that invented it to do all the testing and provide the results that it ‘is safe’. There have been many examples of falsified testing results submitted to the FDA over the years. Cigarettes for example. Canola, Mercury, Vioxx…
The excuse is that the FDA does not have enough people to test everything. SO they test nothing.
Mercola.com has the scoop on this from a few years ago.
That ought to outrage anyone!!! The watchdogs are dead at the wheel.
Another tidbit on the FDA is that they years ago, made it against their rules to have any Fluoride in any water that they served to employees.
Why does the public not know these facts? Look to the media, the gov and corporate interests (Big Money).
http://netctr.com
Closer to the Truth
I know of one drug company which threatened scientists with a lawsuit if they did not stop gathering information about a drug already in use, having been approved. This follow-up is just the sort of thing which can reveal serious harm (and can show that prior testing was inadequate). With stricter FDA enforcement, such scientific after-studies might be made immune to lawsuits by the pharma companies, and it might become a more routine part of the approval process. Approval would be subject to follow-up. I guess the reason that cannot happen now is because of the powerful lobby. The letter I read to the scientist was shocking to him (not to me though) and just-short-of-death-threat-tone nasty.
So….the industry wants to be deregulated? That’s really, really frightening given the deaths, dubious results, hideous side effects and escalating costs already attributable Big Pharmacy.
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