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FDA's Shoddy Science Puts Public Health at Risk

Lives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is under funded, a panel of advisers to the agency said at a public meeting on Monday.

Inadequate staffing, poor retention, out-of-date technology and a lack of resources mar the FDA's ability, the report by a subcommittee of the agency's Science Board said.

"FDA's inability to keep up with scientific advances means that American lives are at risk," the report said.

The panel, chaired by Gail Cassell, vice president for scientific affairs at Eli Lilly & Co., and representatives from Genentech Inc and Wyeth, among others presented their findings to FDA Commissioner Andrew Von Eschenbach and other agency officials.

Eschenbach asked the Science Board to examine the problems that have plagued the agency in recent years including recalls of drugs, contaminated food and toxic toothpaste. The agency regulates products from drugs to food and cosmetics representing about $1 trillion, or a quarter of every dollar spent in the United States, according to the report.

The U.S. Congress passed more than 100 laws expanding the FDA's authority since 1988, but has not increased the funding appropriately, the report found.

Among its recommendations, the panel suggested hiring more scientific talent, naming a chief scientific officer and reorganizing how the agency handles science issues.

The FDA is requesting $2.1 billion in its fiscal year 2008 budget, a 5.3 percent increase over the current budget.

"Without a significant increase in resources," the "recommendations will be superfluous," the report warned.

The panel's report said the agency's track record in regulating the safety of the food supply - noting a systems failure during a recent E. coli food contamination inquiry - " has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry."

Public health is at risk as "reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still hand written," the report said.

Poor retention of critical staff was faulted. The report noted the turnover rate of the science staff is twice that of other government agencies.

The agency lacks a good system of talking to scientists outside the agency, "thus limiting infusion of new knowledge and missing opportunities to leverage resources," it said.

The panel "was extremely disturbed" at the state of the agency's information technology infrastructure, calling it the "weakest but most critical link."

(Reporting by Kim Dixon; Editing by Leslie Gevirtz)

© 2007 Reuters

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Matt Tyler
post Dec 5 2007, 09:33 PM



It is interesting to note that the panel issuing this report was chaired by, Gail Cassell, vice president for scientific affairs at the drug company Elli Lilly. (Other panelists were from Genetic Engineering firms, among others.)

Is she proposing this funding increase so that the FDA and do REAL science to verify the claims of her company, or does she simply want the FDA to rubber stamp her drugs in a more timely manner? I suspect the latter.

Real reform will likely require a lot more than increased funding... Probably starting with regime change here at home.

InsideOut
post Dec 6 2007, 12:46 AM


QUOTE (Matt Tyler @ Dec 5 2007, 02:33 PM) *
Real reform will likely require a lot more than increased funding... Probably starting with regime change here at home.

Bwahahahahahahahha

I'm beginning to like the concept of regime change...

QUOTE
The panel's report said the agency's track record in regulating the safety of the food supply - noting a systems failure during a recent E. coli food contamination inquiry - " has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry."


This is disturbing. I wasn't aware the congressional mandate authorizing the FDA stipulated they were tasked with "efficiently supporting innovation in the food industry." I thought they were tasked with providing oversight and industry was responsible for supporting its own innovation. We samll "industrious" companies are busy working to protect the public with old but effective technologies (heating, dehydrating, freezing...)

I don't think the FDA's science is shody... it is these quackerists wiggling through the old school sound science of the FDA.

[quote]
Public health is at risk as "reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still hand written," the report said.[quote]

Boy... Our inventory system is still on hand written note cards but we have a 99.85% trace back in less than 2 hours for each trace drill we've conducted. It ain't sexy... it doesn't have itunes... but hey... it works. In fact, most errors or delays are caused by mishandling of information. It the inspector distributes the report by hand or by email and the supervisor is too busy to read it... it doesn't matter what format it is in.

Funding should be spent on staff. Staff the hell out of them... better yet, staff the CORPORATIONS out of them!


--------------------
House centipedes feed on spiders, bedbugs, termites, cockroaches, silverfish, ants and other household pests. They kill their prey by injecting venom through their fangs.


diana
post Dec 6 2007, 02:34 AM


QUOTE
I wasn't aware the congressional mandate authorizing the FDA stipulated they were tasked with "efficiently supporting innovation in the food industry."


Scratch a government agency, and when the shiny paint comes off, this is what you'll see. It's there for the USDA and all the other D's. And the Federal Reserve is a private bank that sells us our own money at interest. There are still good people in all the D's, but mostly their good hands are well tied. --d

InsideOut
post Dec 7 2007, 12:28 PM


QUOTE (diana @ Dec 5 2007, 07:34 PM) *
Scratch a government agency, and when the shiny paint comes off, this is what you'll see. It's there for the USDA and all the other D's. And the Federal Reserve is a private bank that sells us our own money at interest. There are still good people in all the D's, but mostly their good hands are well tied. --d



Agreed, but what about the conscientious mid-level workers who joined these agencies hoping to help? They are there... I've met and worked with them.

If we recognized where they are going astray and look back to the letter of the law... and the intent... we will find guidelines are there. Food, Drug, and Cosmetics Act of 1938 and the Food Act of 1906 are pretty sound regulations stipulating "oversight" of the industry. What the mid level employees need is a congressional push to trim the flab and get back to departmental roots.


--------------------
House centipedes feed on spiders, bedbugs, termites, cockroaches, silverfish, ants and other household pests. They kill their prey by injecting venom through their fangs.


bachflower
post Dec 10 2007, 12:42 PM


I agree with the comment that this is a pitch for more money.
They may try to get it from taxpayers or they may seek a "public-private partnership." That's what we have with prisons and is why we lead developing countries in prison population. Does the science establishment (government-university-corporate) deserve more funding and more power?

The FDA needs lots of funding from somewhere to implement their new agenda, called the Critical Path Initiative, under which nutrition is redefined as pharma crops and treatments are proposed based on statistics. Biomarker treatments have already killed people.

The FDA has deceived the public since the beginning. See Byron Richards book and articles. His latest is at this link (copy and paste into browser):
http://www.wellnessresources.com/newsroom/...camp=news120707

diana
post Dec 10 2007, 08:43 PM


QUOTE (InsideOut @ Dec 7 2007, 12:28 PM) *
Agreed, but what about the conscientious mid-level workers who joined these agencies hoping to help? They are there... I've met and worked with them.

If we recognized where they are going astray and look back to the letter of the law... and the intent... we will find guidelines are there. Food, Drug, and Cosmetics Act of 1938 and the Food Act of 1906 are pretty sound regulations stipulating "oversight" of the industry. What the mid level employees need is a congressional push to [...] get back to departmental roots.


It'll take a groundswell we don't currently have, and clarity I'm gonna ask you to provide, to change this. But it sure seems possible. The conscientious mid-level and lower-level workers are there, of course, as I've met them in various institutions, myself. But they have no power, no pull, no say -- and usually no support.

Start us a campaign, man! You have the lingo and the knowledge we need. I'm happy to write and call and e-mail my representatives, but I need to know what to say to get the point across. --diana (with pen poised and ready to begin ... but actual writing may be delayed by the inches of ice about to fall from the sky and down the power lines sad.gif)

InsideOut
post Dec 10 2007, 10:24 PM


QUOTE (diana @ Dec 10 2007, 01:43 PM) *
It'll take a groundswell we don't currently have, and clarity I'm gonna ask you to provide, to change this. But it sure seems possible. The conscientious mid-level and lower-level workers are there, of course, as I've met them in various institutions, myself. But they have no power, no pull, no say -- and usually no support.

Start us a campaign, man! You have the lingo and the knowledge we need. I'm happy to write and call and e-mail my representatives, but I need to know what to say to get the point across. --diana (with pen poised and ready to begin ... but actual writing may be delayed by the inches of ice about to fall from the sky and down the power lines sad.gif)



Yikes!!!

Not me. I'm (one of) the guy(s) behind the who-ever.


--------------------
House centipedes feed on spiders, bedbugs, termites, cockroaches, silverfish, ants and other household pests. They kill their prey by injecting venom through their fangs.


diana
post Dec 11 2007, 09:28 PM


QUOTE (InsideOut @ Dec 10 2007, 10:24 PM) *
Yikes!!!

Not me. I'm (one of) the guy(s) behind the who-ever.


You don't hafta sign yer name! Just give us the lingo, the text, and we (or I?) will do so. You get to be the brains behind the campaign, without ever divulging identity. Me, I'm old and out there. --d

InsideOut
post Dec 12 2007, 01:58 PM


QUOTE (diana @ Dec 11 2007, 02:28 PM) *
You don't hafta sign yer name! Just give us the lingo, the text, and we (or I?) will do so. You get to be the brains behind the campaign, without ever divulging identity. Me, I'm old and out there. --d


Do you mean specifically related to FDA reform?

I'm totally mixed on this. There should be a single agency rather that five plus agencies supervising food. Since it represent 25% of the GDP it should likely have a Federal Department with an executive secretary like Ag and Defense. Other wise, the food biz guys says "put food in Homeland Security and Drugs and Cosmetic in DHS." The slow food crunchy guy says, "Food and Drugs belong together because they are coupled in our total wellbeing."

So... yep. Pull the FDA out of DHS and make it a stand alone agency with equal voice on the cabinet with the Ag department... pull FSIS and food related issue from the AMS into the new FDA.

So it would need to be a grass roots push in several states to get congress to urge the exec. branch to creat a ne department.

Your thoughts?


--------------------
House centipedes feed on spiders, bedbugs, termites, cockroaches, silverfish, ants and other household pests. They kill their prey by injecting venom through their fangs.


diana
post Dec 12 2007, 02:01 PM


Sounds like the beginnings of a plan. I'm in (later, as I have to go to work, now). --d