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Report: FDA Ignores Safety Regs, Risks Lives
From last year's outbreak of salmonella-tainted tomatoes, to an internal analysis (PDF) warning the agency can't adequately regulate new medical devices or protect the safety of the nation's food supply, all the bad publicity the Food and Drug Administration has earned in the last two years revealed an agency plagued by lack of funding and incompetence.
A report released Wednesday by Project on Government Oversight, a Washington-based watchdog group, adds another item to the list of bad ink for the FDA, this one a product of downright negligence.
POGO alleges the Food and Drug Administration deliberately disregarded regulations governing non-clinical tests of medical devices such as defibrillators, pacemakers and stents.
According to the report, officials at the Center for Devices and Radiological Health decided not to subject certain devices to the rigorous testing outlined by the Good Laboratory Practice regulation, which ensures the accuracy and integrity of safety data submitted to the FDA. Why? It isn't quite clear. GLP testing can be costly and lengthy. According to the whistle-blowers (PDF) who contacted POGO, employees were pressured to overlook any false data submitted by device manufacturers who didn't subject their products to GLP oversight.
An excerpt from one letter sent to POGO by an anonymous FDA staffer:
There is mandatory indoctrination of employees to overlook fraud and omissions in applications. Also incentives (bonuses, outstanding appraisals, and public recognition) reinforce this behavior.
And another:
Irresponsible management, supervisors, and team leaders have put corporate interests above public safety and undermine the health and lives of American citizens. The world does not know about the government’s ineptitude in the review of medical and radiological devices.
FDA Device Approval
tagged as:- result
The FDA has been run by corporate interests for a long time. My wife was injured by a catheter that's been the subject of numerous adverse event reports. The doc was using it "off-label" -- and he was being paid by the company to promote the product:
http://adventuresincardiology.com/
FDA dropped the ball [again]
The FDA - like most other "regulatory" agencies - tend to treat those regulated as clients. If a company has lots of money invested in a product they often overlook problems and stall to protect the company profits. Why else is there a revolving door between large "regulated" companies and high ranking bureaucrats. Regulation is for the rest of us. In today's socialism, the wealthy get big government as a partner and the rest of us have to obey the rules.
May God's will be done on earth and let it begin - and end - with myself. If it happens any other way it's not God's will.
The FDA needs a complete overhaul
They have many problems, such as their approval of aspartame.
http://www.organicconsumers.org/toxic/aspartame090105.cfm is a read that really opened my eyes.
I'm afraid to even think about other things. The drug commercials on the air - "approved" drugs. It seems like the possible side effects stated are worse than the condition they're supposed to help.
k.b.
Drug Advertising is Wrong
I have begun cutting off the commercials on my elderly mother's TV. I wish I could delete them entirely. Naive people like the elderly believe what they see.
I read last year that one drug that has since been pulled off the market was being sold to 12million people here in the US, where it was being heavily advertised on TV even up to the point of being pulled due to drug trials being manipulated. However, in Canada less than 1/.4 as many people were being prescribed the drug, because Canada does not allow drug advertising.
It's about time we demand the FDA pull all drug commercials.
I can remember a childhood where doctors prescribed drugs only when they believed we would benefit from them, now they get bombarded with salesmen pushing drugs on them in the office, and we get bombarded on the TV & in magazines. I think they've proven the dangers. It's time to stop.
Preaching to the Choir!
This seems like all I ever BLOG about, since I lost my Apt. and had to go back on Deadly Dangerous Pain Pills - while being harrassed by everyone from the FBI to Street Gangs; but here goes again!
You don't have to tell ANY Medical Marijuana Patient; especially not one who - for over 30 years - had successfully concealed his 'not-abuse', so that he would be free enough from Pain and Depression to be able to function well enough to rack-up 5 1/2 years of Restaurant Management Experience; that the FDA is in the Pocket of the Big PharmaCos' Lobbyists!
You don't have to tell ME that omissions and fraud run rampant, whenever Corporate Profit Margins or a Federal Agencies funding for their War on Marijuana programs is threatened by THE TRUTH!
PARITY NOW, FOR OUR STRUGGLING BROTHERS AND SISTERS OUTSIDE OF THIS COUNTRY!
AND THROW IN SOME TRUTH & RECONCILIATION FOR US 'WORKING WOUNDED' WHO USED POT TO AVOID GOING ON THE SSD THAT WE'VE (I'VE) BEEN ACCUSED OF LYING TO GET MYSELF PUT ON, SO THAT I CAN "PARTY, PARTY, PARTY FOR FREE," TOO!!!
IT'S OUR, DARE I SAY IT, "MORAL OBLIGATION" TO THEM AND EACH OTHER.
If you don't agree; then I hope you get diagnosed with an MS-like Neuropathy TOO!
A 'next reincarnation' as one of Caligulas Sex/Torture Slaves would also be apropriate.
Jim (Mad as HELL, and not gonna take it anymore!) RinX
Please read this full story
Please read this full story on Risperdal: http://www.newsinferno.com/archives/4890#more-4890
Hydroxycut Recall
The FDA initiated a Hydroxycut recall, after some Hydroxycut products were linked to liver damage and at least one death. This may seem a bad news for those looking forward to drop weight with a magic pill--- Hydroxycut recall has begun. Hydroxycut is a nutritional supplement manufactured and marketed by Iovate Health Sciences Inc., designed to help consumers lose weight. Its efficacy is considered questionable. Hydroxycut has one harmful ingredient, which is hepatoxic that damages the liver; short term loans cannot cover the medical bills for the liver damage. Hydroxycut is the top selling product in this class and market, with roughly a million units sold per year. Nevertheless, the company might turn to a short term loans to deal with the Hydroxycut recall.
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