FDA WILL CLOSE LABS DESPITE CONGRESSIONAL PROTESTS

[nosmokes]

i'm sorta like congress. i wanna know how closing down the labs is gonna make me safer as a consumer? cause frankly i have my doubts. not that i don't trust my government or anything like that. oh, no. nothing like that. absolutely nothing remotely like that. not even a reasonable facsimile thereof. no ma'am.
--###--

original-PEER
***News Releases***

For Immediate Release: February 15, 2007
Contact: Carol Goldberg [phone]

FDA WILL CLOSE LABS DESPITE CONGRESSIONAL PROTESTS — Denver, Detroit, Philadelphia, SF and KC Labs on Chopping Block

Washington, DC — Shrugging off congressional objections, the U.S. Food and Drug Administration will immediately move to close more than half of its laboratories across the country, according to documents released today by Public Employees for Environmental Responsibility (PEER). The closures will be completed during the next few months, before the new Congress can act to block the shutdowns through the appropriations bill for the next fiscal year.

According to briefings of agency staff, FDA’s current network of 13 laboratories will be reduced to six as a result of closing facilities in Denver, Detroit, Philadelphia, Kansas City, San Francisco, Winchester (Massachusetts) and San Juan (Puerto Rico).

These laboratories are often the first line of defense in detecting and combating bio-terrorist attacks on our food supplies. In addition, they trace tampering with food and medicines and respond to public health threats, such as E. coli outbreaks, and support agency compliance inspections and enforcement actions.

Top FDA officials have postponed any formal notification of affected staff until after they finish briefing members of Congress. Already, congressional committee chairs, such as Sen. Ted Kennedy (D-MA) and Rep. John Dingell (D-MI) have raised concerns about FDA lab closure plans revealed last December by PEER.

In addition, FDA has informed agency staff that no money has been set aside for buy-outs of employees who lose their positions or relocation costs for specialists whose jobs have been moved to one of the six remaining labs. As a consequence, employees who lose positions may be removed from federal service or face high out-of-pocket expenses to uproot their families in pursuit of jobs opened in other locations.

“FDA has yet to explain why slashing its network of laboratories will make it more capable of protecting the American people,” stated of PEER Executive Director Jeff Ruch, noting that a previous review by the Government Accountability Office failed to confirm any fiscal savings from a similar laboratory consolidation plan a decade ago. “FDA claims it wants to move into the 21st century but seems determined to leave its own employees behind.”

Ironically, both, President Bush and Congress have been proposing more funds to increase FDA laboratory capacity in responding to bio-terrorist attacks. Due to the collapse of the FY 07 budget process, however, none of those funds were actually delivered to FDA.

FDA specialists have argued that eliminating laboratories will slow agency response time to outbreaks or attacks, as samples may have to be transported long distances. In addition, closing laboratories located near ports or large food distribution centers may reduce the agency’s ability to uncover contamination or other hazards before the effects ripple deeply through the country’s food chain.

###

Read the notes from the recent all-hands FDA employee briefing

View the email postponing FDA employee notification

Look at more information about FDA lab closure plans























complete press release including links to more info here

[rocktivity]

1. Money trumps public health sometimes.

And WHY can't Congress can't do anything about it?

:headbang:
rocknation

[pnwmom]

2. Very interesting post.

Also interesting in light of all the pro Merck people who are trying to convince us that the FDA is the one agency in government that is above partisan politics.

[TZ]

8. FDA compliance and clinical trials

There are regulations that HAVE BEEN IN PLACE FOR YEARS with regards to monitoring and approval of certain biologicals. The problem is rapidly becoming one of enforcement. They still cannot totally undercut the procedures in place such as GLP and GMP compliance (Good Laboratory and Good Manufacturing Practices) and clinical trials have set patterns of phases and testing that are still in place. They can to some extent "fasttrack" some products (which yes is done more frequently now) but even then there are certain procedures that have to be followed. I myself have been through an FDA inspection of a private firm. WHEN they are done they are quite thorough believe me. The so called "pro-Merck" poeple have never said that FDA is above partisan politics what they do say is that you cannot TOTALLY dismiss anything even with the partisan politics because of the in place regulations.And there are still plenty of upright scientists that work there. I am very very concerned about what I hear about this. I do think it will have some impact. But believe it or not besides the built in regs there still is a lot of self regulation within the industry. There are alot of companies that do understand that it is in their best interest to have strict regs and produce quality products. There are also some very bad apples who know doubt will thrive with the current system.

[pnwmom]

17. I don't "totally dismiss" the potential value of the HPV vaccine. Not at all.

I don't have a problem with it being released, or marketed, or passed out for free by state governments, as my state is doing.

I have a problem with it being mandated prematurely.

And, unlike many very vocal DU'ers, even top doctors at the American Pediatric Society -- while very enthusiastic about the vaccine -- are not recommending that it be MANDATED at this point in time.

And in Texas, serious questions are being raised as to why the vaccine should be mandated for HPV so soon after release -- when the same state has not yet mandated older and more proven teenage vaccines for pertussis and meningitis! Could it be because of Gov. Perry's friend who lobbies for Merck?


http://www.nytimes.com/2007/02/17/health/17vaccine.html

SNIP


Typically new vaccines, like the one for chicken pox in the mid-1990’s, have been rolled out gradually in this country, with public health officials endorsing mandatory use only after several years of experience have shown the new products to be generally safe and effective.

“Generally the mandates have been enacted over years,” said Dr. Janet R. Gilsdorf, the director of pediatric infectious diseases at the University of Michigan.

An advisory panel of the federal Centers for Disease Control and Prevention recommended last summer that girls and women ages 11 to 26 be vaccinated with Gardasil. But members of the committee say that such a recommendation is not equivalent to calling for mandatory vaccination.

SNIP

"Gardasil and another vaccine under development by the drug maker GlaxoSmithKline are aimed at the human papilloma virus, or H.P.V., which is known to be the cause of cervical cancer. Analysts see a potential $5 billion a year market for H.P.V. vaccines, and some say that Merck is intent on inoculating as many girls as possible before the introduction of Glaxo’s product, which could become available this year.

SNIP

The American Academy of Pediatrics is not advocating mandatory Gardasil vaccination, either. . . . Dr. Bocchini of the American Academy of Pediatrics also said too much of the Gardasil focus was being placed on 11- and 12-year-olds, when legislatures should be focusing on trying to obtain funding to vaccinate girls and women in the 13-to-26 age group,

[TZ]

19. and thats a very healthy debate that we should be having

I actually am kind of on the fence on mandatory administration. I see both pov and the rational debate on it is something I desire as well. There are other people who are clouding the issue. Thats why I have started posting specifics and lecturing to some point. I just want people to have some background so we can argue this sensibly. I have seen your posts and your concerns are very very valid

[pnwmom]

22. Thank you, Turtlesue.

There's been more than a little name-calling on these threads and I appreciate your taking the time to actually read my posts and not just respond in a knee-jerk way.

You might be interested in this thread that another poster has started about the FDA.

http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=233282&mesg_id=233282

[TZ]

27. not at all surprised by the source

I don't even need to read the post to know where its going. I might have to avoid it because I may feel like name calling. I like to pride myself on my rationality but sometimes the nutty stuff gets to me. That OP in particular bothers me frankly. Its people like you who are true DU members. And if you can be a little more patient I am going to see if I can get some of yours and others questiona and concerns addressed by an extremely creditable source and post it. What do think?

[pnwmom]

31. Sounds good to me. I'd appreciate it.

[TZ]

28. actually if you would do something for me here

if you saw my post about the whole blind trust or dismissal due to paranois thread about the FDA could you post something like that on the thread? I don't trust myself to keep my temper with the OP and also if it comes from you I think it actually will go over well in some quarters:-)

[emcguffie]

30. Please do something for me, although you do not know me.

Please get a copy of the book Project Daylily by Garth and Nancy Nicholson. It's self published, available on the internet.

I know there are plenty of legit, responsible, honest scientists and doctors and bureaucrats. But there are also some very nasty people that have done some very nasty things with bugs and germs and such.

There are quite a few people like me who have been chronically ill for many, many years with strange diseases that our government spends excessive energy HIDING and discouraging good research about. They tell lies about these diseases, hide the truth about them, and seem to be more interested in keeping people ill than in helping them get well. Chronic fatigue syndrome -- what a ridiculous name! -- is NOT about FATIGUE! And it IS NOT caused by STRESS! Any more than any other contagious disease is caused by STRESS!

Read about the vets who tried to take antibiotics for gulf war illness in the years following the first gulf war -- the vets who LOST THEIR medical benefits if they filled a prescription for an antibiotic to treat their gulf war illness. Why would the government do that? Take away medical benefits from sick vets because their doctor prescribed antibiotics? Why did they want these vets to NOT take antibiotics, which could save their lives? Please don't tell me it's because too many people take too many antibiotics. It's the people who take antibiotics for COLDS, and their physicians that have prescribed them, that have caused that problem. Not seriously ill vets, or people with MS or "chronic fatigue syndrome". Why does the government refuse to change the name of CFS, no matter what Congress says, no matter what the real experts, the people who treat the disease, say? No matter how much research piles up demonstrating neurotoxins and -- what do you call it? -- destruction of STAT1 proteins, I think, and malfunctioning immune systems, and destroyed red blood cells?

Lots of researchers have found evidence for a virus causing CFIDS, but all those researchers seem to lose their funding and get shut down.

I can see you will think me too tinhatty, but why did Lyme disease show up the first time just across the sound from Plum Island?

Please, read Project Daylily. By Garth and Nancy Nicholson. And then tell me how you can guarantee, no matter how safe the actual vaccine is, that no vaccines are ever contaminated by mycoplasma? Even inadvertently?

There are very nasty people who make lots and lots of money creating biological weapons and selling them to people like Saddam. But first, they test them on real live human beings, living in this country. (Check out what happened in Huntsville, Texas.) Without their knowledge. Those people are not nice, and they do not worry about breaking the law, or about making innocent people terribly ill, even to the point of death.

[Laurab]

32. I'm one of them....and thanks for the book recommendation

CFIDS is a disease I wouldn't wish on my worst enemy....well, there are one or two people in the world I MIGHT wish it on, and I know there are others like it. I seem to remember the government taking 12 million geared toward CFS research, and giving it to other programs a few years back, and they weren't caught for quite a while.

It's also supposed to be approved for disability, but still doesn't appear on the list of diseases. When one sees how devastating the disease is to a person, their family and friends, it's unbelievable that more hasn't been done. I do think promising research is being done in other countries, but not much has changed here in the past 15 or so years that I've struggled with it.

As far as laboratory closings go - I was a longtime employee at FDA - if people honestly think industry is going to regulate themselves, I have a bridge to sell them... this pResident has wanted industry to regulate themselves for a long time, because he is owned by industry.

The labs in the office I worked in were closed years ago due to "consolidation". At that time, there weren't enough labs or investigators to do the work that needed to be done. The chemists and investigators are the "ground troops" here, who do their best to keep us safe. The idea of industry regulating itself is terrifying to me...

[Pithlet]

13. No one tried to convince anyone of that.

All they did was ask for evidence. No one was proclaiming the FDA perfect and pure. Pro-Merk. As if we're all financing our second vacation homes with Merck money merely by posting on message boards, and laughing at you and wondering why you aren't getting in on the easy money.

[pnwmom]

15. Oh really. That's news to me.

[TZ]

20. The FDA is not perfect but it does not even rubber stamp

everything that comes down the pike for approval. For every drug/vaccine that the FDA approves there are at least 4-5 more that the FDA shuts down because they are either a) unsafe or b) not effective. I know of a very large biotech firm that in the last 4 years or so has had multiple products pulled by the FDA before clinical trials were even complete. And many people were laid off because of it. Including some people I know. Thats the point we are trying to make here. You should take new products with a grain of salt. Blind faith is not rational or healthy. But neither is total distrust of any agency even if there are political problems with it. The scientific advisory groups in the FDA that do most of the work are staffed with nonpolitical scientific technical people who do know what they are talking about. Its the heads and go ahead guys who are the real problems there.

[pnwmom]

23. I agree. Neither blind faith or total distrust is healthy.

As I have said repeatedly, my children are almost fully vaccinated despite the reactions family members have had to vaccines. But I have learned the hard way to weigh each new vaccine decision on the merits -- rather than closing my eyes and hoping for the best.

[TZ]

26. thats a very good attitude to have

and I really wish more people whould share it. Thats really what I have been trying to say for awhile but sometimes I don't communicate it well I guess.:) :thumbsup:

[HCE SuiGeneris]

3. It's the same logic that applies to closing the EPA libraries,

I swear. Does everything have to be explicitly laid out. C'mon!
:sarcasm:

[TZ]

7. great minds think alike I see

love your cat and tp thing btw.

[HCE SuiGeneris]

9. Ah. Thanks.

Did you happen to see Issa (Rep. Darrell Issa (R) San Diego) during the hearings (global warming) conducted by Waxman? Biggest ***hole ever! He exhibited no concern for the scientists -- only disdain for any and all postulations put forward by them. His caustic manner and vitriol was so calculated to intimidate, that it made my stomach turn to watch his maneuverings and know they were orchestrated by big business and the corrupt regime currently in office. Ackkk- I'm getting wound up again!

I guess my point is. This maladministration has no concern for the welfare of the majority. It is an Oligarchy that continues to concentrate its wealth into ever tightening circles.

[TZ]

21. yeah Issa is a total asshole

I agree. This admin has definitely been on the attack on facts and critical thinking and the scientific method. There philosophy is if we say it it must be SO! Everyday I see how much damage these guys have done and it really alarms me. You can even see that its so poisoning the well that its leading to a certain amount of distrust that is not entirely healthy either. We need to get these monsters out of power asap.:(

[TZ]

4. this is as bad as the closing of the EPA libraries

They seriously think NO regulation is good regulation. And to do this now when we had that Salmonella outbreak too?

[youngdem]

5. This is what happens when Industry runs its own regulatory agency

They stock it with insiders, defund it, then dismantle it.

American food safety used to be the envy of the world. Now, it is ILLEGAL to test your own cattle for Mad Cow disease without governmental permission because they fear the result of positive results.

This is the same FDA that just approved a fucking laser hair brush to treat baldness!

The FDA has become an industry promotion organism.

Corporate whores feeding at the trough.

[TZ]

6. and unfortunately the true corporate whores that have been

put in charge at the FDA and other places are really making it difficult for the good scientists that still work in FDA and other places. I can't imagine how horrible it must be for them to be stuck there. Missed that laser hair brush thing geez. When does AEI get designated as the next "EPA"?!!!

[Ilsa]

10. Well, we can point this out next time FOX Noise Network

reminds us to be afraid of everything, including terrorism in our food supply. Bush* and Company have no real interest in protecting regular folks.

[nam78_two]

11. K&R-the EPA, the FDA and the USDA have been in a race tothe bottom since 2000.nt

[caligirl]

12. someone send some spinach to the WH please. Are they that out of touch.

[Pithlet]

14. This is bad news.

Expect even more incidents like the Peter Pan salmonella outbreak.

[undergroundpanther]

16. They want people to die.

Bush is a fucking NAZI and it is time to quit being COY about it. This is because the fucking eugenicist assholes rich pig-boys are bullying and bribing congress to roll over like spaniels for their own agenda, which is to cull the"unfit"(as they define it which is NEVER their own kind of empty soulless degenerates.).They doublespeak everything,because they know if they said what they were doing to us OUTRIGHT the rage of the people knowing the danger would mean the elitist fuck-wads would be hunted like vermin their gated palaces busted down,and their bodies would be be dragged through the streets of DC like Mussolini or they'd hide like worms blowing their brains out in Cheney's hidey hole rather than face the people's wrath who's lives they harmed. God dammit I hate the psychopath elitist fuckers,sitting on top of us like stones.. I HATE them all. Elitists are the true cultural parasites.

[Cobalt Violet]

24. I agree; they want people to die.

And they don't want people to be able to sue businesses that harm them. It's as simple as that.

[mhatrw]

18. And what about the few that remain open in BushCo's America?

See: http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=222x14467

[Laurab]

34. "Under Bush, the FDA has in fact become Big Pharma's chief enabler...

when it comes to getting away with murder".

He just likes death and murder, that's all there is to it....

[MetaTrope]

25. "first line of defense in detecting and combating bio-terrorist attacks..."

Remember how the Bush administration shut down the intelligence operation tracking Al Qaeda financing during their first few months in office?

[rman]

29. What's good for the general population is not necessarily good for business,

and vice versa.

[blues90]

33. I suppose they can add this to the list of terrorist attack stats

You are now more likely to die from food poisoning than in a terrorist attack .

I guess now since we get food from all over the globe this will work real well . Also another loss of more jobs .

I only hope if I happen to pick the poison food item that it is quick and not some long lingering death .

Just cut back everything but make certain the airplanes are safe as if this is the only way we are at risk .

[eppur_se_muova]

35. Hmmm...where are the ones that stayed open? Are they all in red states?

I can't help but notice SAN FRANCISCO (Feinstein, Boxer & Pelosi), DETROIT (Conyers), WINCHESTER, MA (Kennedy? or Kerry). It's like they're cutting the throats of hostages.