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Advisers Say FDA's Flaws Put Lives at Risk
WASHINGTON - The nation's food supply is at risk, its drugs are potentially dangerous and its citizens' lives are at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to an alarming report by agency advisers.
The report, made public on Friday, is the latest and perhaps most far-reaching in a string of outside assessments that have concluded that the F.D.A. is poorly equipped to protect the public health.
It was written by three members of the F.D.A. Science Board, an advisory panel that reports directly to the agency's commissioner, Dr. Andrew C. von Eschenbach. The three authors in turn had 30 scientific advisers.
The report concludes that over the last two decades, the agency's public health responsibilities have soared while its appropriations have barely budged. The result is that the F.D.A. is falling farther and farther behind in carrying out its responsibilities and understanding the science it needs to do its many jobs.
"F.D.A.'s inability to keep up with scientific advances means that American lives are at risk," the report stated.
Sandy Walsh of the F.D.A. said the agency "values the evaluation done by the subcommittee members and the scientific experts that were consulted" but would not comment further.
Barbara J. McNeil, a professor of health care policy at Harvard Medical School and one of the report's authors, said she was stunned at the agency's sorry state.
"This was the first time that a group of people got together and really looked at all the areas that the F.D.A. has to cover," Dr. McNeil said. "We were shocked at the scope of its responsibilities, we were shocked at how little its resources have increased, and we were surprised at the conditions those in the F.D.A. had to work under."
The report notes that the agency's computer systems are aging and prone to breakdowns, "most recently during an E. coli food contamination investigation."
"Reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with customs and other government systems," the report stated.
The agency often misses significant product arrivals because its computers are so poor that they cannot distinguish between shipments of road salt and those of table salt, the report said.
The Institute of Medicine, the nation's most prestigious scientific advisory organization, concluded last year that the agency's system for ensuring the safety of drugs needed an overhaul. Recent legislation enacted some of the institute's recommendations.
More hearings regarding the F.D.A.'s oversight of food are in the offing, including one in the Senate on Tuesday. The report concluded that the "F.D.A.'s ability to provide its basic food system inspection, enforcement and rule-making functions is severely eroded, as is its ability to respond to outbreaks in a timely manner."
Garret A. FitzGerald, a pharmacologist from the University of Pennsylvania and adviser to the authors, said the report was raising an alarm because "this is a crisis." Dr. FitzGerald pointed to a series of food and drug scares that have demonstrated how little oversight the F.D.A. provides.
He blamed a "cabal of Congressional majorities and presidential administrations that has serially stripped the agency of assets."
Copyright 2007 The New York Times Company
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16 Comments so far
Show AllBillions for illegal invasions and occupations for Big Oil, nothing to protect the environment, water, food, medicine, the infrastructure, nothing for veterans, no health insurance, no pensions, no homes, no jobs, no credit, inflation, recession, climate change, but hey, we got our Corporate Military Empire on the fast track, we just need more oil to run it.
Perhaps the larger message we, citizens should get from this report is that of taking more personal reponsibility for our choices. Most folks are too eager to give away their power to any authority figure assuming they will keep our best interests paramount. Clearly that is not so. I am not advocating no govt. involvement in protecting the health and safety of its people---only saying that we need to realize that such a task will always be questionable due to all sorts of factors as we well know.
I suspect we are being pushed by circumstances to start looking more closely at all of our consumption patterns.
The vast chasm between what we eat and who and where it is produced has created a myriad of problems and the list will only grow longer until we consciuously begin to reverse the trends. LOCAL is a good thing!
BANDIDO & STAR OF THE SEA: "Stop, you're both right!" Bandido raises critical points about the abject poverty of the priorities this abominable government and its various and sundry administrators have put into motion (to profit their own small circles of corrupt friends); whilst STAR raises the issue of personal accountability. Still, I don't think I am a citizen of dreamland to presume that a nation/society that takes in tax monies ought pay for services of at least some benefit to its citizens, while these citizens learn to take better care of their precious gift of life via the body as temple. Your points are not mutually exclusive. Thanks for making them.
"We were shocked at the scope of its responsibilities, we were shocked at how little its resources have increased, and we were surprised at the conditions those in the F.D.A. had to work under."
May I suggest you read "The Shock Doctrine" by Naomi Klein?
Like everything else, 'shock' is one of the psychological manipulations being used in effort to privatize all government entities in the name of "Free Market" captitalism.
BigPharma would love to get total control over the FDA!
The FDA is not flawed. It is operating exactly as it was designed. It is doing the very thing that Republican rule has made sure it would do, namely allow corporate America to write it's own guidelines.
This has been done through appointing persons to key government jobs who are bought-and-paid-for servants of corporations including Big Pharma, Meat Packing, Corporate Agribusiness. When they leave their government jobs where they were being paid with our tax dollars to keep us safe from inferior products at unfair prices, they go staright to work for the industry they were supposed to be regulating.
It's not our government any more, except in the sense that we pay for it. The government belongs to corporate America. It remains to be seen if or how we will ever get it back.
I agree with Nietzsche. Big Agriculture is a threat to our health and does rewrite legislation to limit regulation and consumer protection. Its got government totally in its back pocket. I recently have decided to give up dairy (I gave up beef a long time ago) given how bad the milk/dairy lobby is and just how toxic this stuff actually is to our bodies...it came as a shock to me. The website www.notmilk.com is a good resource to start with and I encourge CD readers to really explore this industry and to get the word out how we can all be more healthy. I think this country is in a huge crisis with obesity and now our over burdened health care system. There is a reason and its what we are eating and the industry behind the production of food. We would all need a lot less medications if we knew how to eat better and really understood where our food comes from and the lobbies and dirty money behind it.
If privatize we must, why not privatize the FDA and EPA providing we get a large number of bids on contracts?
heck no! do not privatize our public agencies: elect somebody who believes in making them work.
Privatize them by incorporating We the People so they'll work for us, not for other corporations.
"Heckofajob" FDA.
Is anybody else really surprised that another critical gov agency has gone AWOL.
When we tolerate a chimp-in-charge who can't even spell his own name, let alone talk, this is what happens.
Over a year ago, before all of the current recalls and hype, the Center for Science in the Public Interest evaluated the performance of the FDA and found it wanting. See:
http://www.cspinet.org/new/200606271.html
At that time, the criticism was ignored.
The USDA has also bent over backwards to accommodate corporate giants such as Monsanto and factory farms. You may want to look at:
http://organicconsumers.org
Generally speaking, the EPA, USDA, and FDA which are funded by the taxpayers are interested only in promoting the health and well-being of corporations. The idea of protecting the citizens that pay for their existence is foreign to them.
Expectations can be pretty low when the main qualifications for many gov't positions are: membership in the Federalist Society and graduation from a 'Televangelist University'.
RUTH K -- When you write that "interested only in promoting the health and well-being of corporations.", it occurs to me of another interest:
Consider that the main interst of Big Pharma and HMOs is as making health wars to prop up and accelerate the people's disease and mental anguish & frustration - 'We've got a pill for that too' - making much more PROFIT.
But coupled together, consider how insidiously unhealthy it is for the people to be both:
_ (1.) _ left bereft of reimbursable 'preventative health care' and
_ (2.) _ lacking basic food health inspections, environmental purity, functional medical treatments, control over importation of toxic toys, …
Thus the greater the illness exposure, coupled with poor medical solutions, the more the PROFIT for so many 'sick corpo-Fascists'
Namaste … … … … … … … … … … … … … … … … … Mahatma Gandhi … … … … … … … … … …
« We must be the change we wish to see in the world »
« There is enough to meet everybody's need, but there is not enough to meet everybody's greed »
Oh! Yes indeed, this is what you get when you villianize public service and disempower public process to serve as a check and balance on private interest. As Ambrose Bierce said -- politics is an art of "public service for private gain" -- and haven't the Reagans and the Bushes and the current breed of Democrats -- along with their cadres of money and power sniffing supporters proved this to be the case?
I am so pleased and agree with the diverse and deep thought that has gone into all your comments. I, for one, want to do something about the exploitations of corporate control. I don't feel quite so superior as I used to by my personal boycotting of bidnesses. It seems to me that with all of our combined intelligence and imagination we might find a way to get their attention with some proverbial brick upside the head.
Thanks to all of you and what you contribute.
You said it gramblogger65,
This is a smart bunch at CD. I've been amazed at this since I got here. Where are the attacking neocons and their "support the troops" distilled simplicity? My guess is that either they can't handle the truth, or that with rising electric bills (courtesy utility company mergers and rate hikes) they can no longer afford to plug in their surplus 386 IBM power guzzlers. Remember that only one percent of the population are wealthy neocons; the rest are the trailer trash you see on the program "Cops" every night. People who turn to plastic food and fox news for comfort. People who think having your door kicked in and your body zapped by dogs and blue bolts every week is normal! People who speak like GWB and who are just as clueless about the damage they do voting for the corporate multinational candidates. Do they call that freedom?
I know their plight is hopeless, but where is their outrage?
They are probably still wondering why gas is so high. Are we out? (no.)
Is it because of the terrorists? (Yes; the domestic CEO oil company terrorists.)
Are we winning the war against (pick one: drugs/poverty/illiteracy/terrorists/pollution/cancer/Gov spending/communism? (no.)
Will things get better after the next election with new blood? (no: we are now voting in a computer casino. The pitt boss may change, but you're still going to lose because the house rules stay the same and the machine software is rigged.)
See bradblog.com
My solution?
We should all put CommonDreams.org bumperstickers on out cars. We should all become avid disciples of these sites as a substitute for the mindless mainstream britney news. We should use our ability to boycott collectively and grow "victory gardens" like our fathers did in WWII.
Mine's getting pretty tasty now, and I'm a lot healthier and happier.
Cheers