As the “pet food recall” blossoms into yet another mushroom cloud of “incompetence” and “nobody coulda known”, I think it’s important to point out a few things that came up on “The Google” when my memory was tweaked regarding the recent history of the FDA.
Unsurprisingly – it’s another tale of cronyism and politics undermining the true work of government to keep it’s citizens safe. I have no idea if this is being investigated by anyone in an official capacity, but it sure needs it.

This time it’s the drug companies. And of course the Bush White House.
Almost makes you wonder if one of them has an antidote to melamine poisoning in the pipeline.

Follow another depressing tale of selling our country’s safety for a campaign contribution inside>>>>>>

I found this letter to president Bush from a group of 118 drug company CEO’s called the Biotechnology Industry Organization dated May 21, 2002

We, the undersigned biotechnology company CEOs, are writing to ask that you nominate, as soon as possible, an individual to become the next commissioner of the Food and Drug Administration (FDA). We commend your appointment of Lester M. Crawford Jr., D.V.M., Ph.D., to the position of deputy commissioner. The time has come to take the next step and name an FDA commissioner. We cannot stress enough the importance of filling this position.
[snip]
  A new commissioner must reverse the trend of increased review times, demonstrate to Congress the need for additional appropriations, lead on bioterrorism issues, and insist on quick action to extend the Prescription Drug User Fee Act.
The ideal candidate would possess the qualifications listed above, and perhaps current or past industry experiences as well.

OK, let’s just call these BushCo’s marching orders for the sake of argument. After all, why else would the heads of 118 different drug companies get together to describe the ideal candidate to head up the federal agency that oversees their products? (my favorite is the “current industry experience” – wink, wink) The points in the above letter bear some examination unless you’re a neocon, so here we go;
1) We need a new commissioner. It’s an important agency.
2) Lester Crawford (the veterinarian) is just the guy.
3) Review times for new drugs are increasing.
4) FDA needs a bigger budget.
5) Terra terra terra.
6) Save the PDUFA.

I’m inclined to agree with #1. It’s a job somebody qualified should fill, otherwise you might end up with a drug like Vioxx getting out there …
But #2, not so much. After his time as “acting” director, Crawford was passed over for the job while Mark McClellan ran the agency from November 2002 until March 2004. McClellan, now where have I heard that name before… Yup, he’s Scotty’s brother!!  And according to Newsweek, he has politics in his blood. It also appears he can’t hold a job. Since his temping as head of the FDA, Marky has temped as Administrator of the Center for Medicare and Medicaid Services. Now he temps at the Brookings institute and (drumroll, please) The American Enterprise Institute. Another heckuva fall upward, eh?

Sounding AT ALL familiar yet? Because it continues.
We’ll come back to the reign of Lester Crawford shortly.
But let’s take a look at that assertion about the “trend of increased review times” shall we?

This is from an excellent report from a group called the George Washington University Medical Center  Rapid Public Health Policy Response Project (Read the whole report, if you want to really understand what’s gone wrong with the FDA as an institution.):

Evidence suggests that FDA has met its primary PDUFA goal of speeding the review of new products, primarily by increasing the size of the review staff. Median review time for standard new drugs was 27 months in 1993, 14 months in 2001 and 10.5 months in 2004.
Similarly, the median review time for priority drugs-those for serious and life-threatening diseases that lack satisfactory treatments-was 21 months in 1993 and six months in 2004.

OK, so that line asserting increasing review times is just a big fat lie.  Under Clinton, drug review times were almost cut in half. Priority drugs cut the review time by more than two thirds. That wasn’t good enough, apparently. Pfizer execs were seen starving in the streets all last year.  {sigh}
On the bright side, the drug companies felt they had to lie to Bush at least a little bit. Worth noting, too, is that the report says the main goal of PDUFA was speeding up approval of new drugs so the profits could flow faster. Money well spent, I’m sure. Just like the campaign donations.
So if the PDUFA funds 42.5% of the human drug program at the FDA, and over half of the drug review budget, why is it so critical to increase the Congressionally appropriated FDA budget, as the BIO group insists??
From GWU’s Rapid Response Project:

In order to collect and spend user fees, PDUFA requires the FDA to dedicate a certain level of appropriated federal dollars to the drug review process. Most of that pays for salaries, since more than 80 percent of the FDA’s total budget supports the agency’s workforce. To meet its commitment to timely drug reviews, the FDA has shifted staff away from other activities, especially research, training and field inspections, and kept staff positions, including those of medical officers and statisticians, vacant when they become open. The result has been a rather dramatic redistribution of personnel within the agency.  (bolding mine)

Oh, I see. Still not fast enough. I mean, if you can’t get Botox approved the same day you think it up, then the terrorists win. Of course, shifting personnel away from their normal duties like FOOD INSPECTIONS just might have a consequence down the road somewhere, but hey, have you seen the stock price??

From the same report:
 

Four former FDA Commissioners, [who] spoke at a February 2007 policy workshop at The George Washington University. Frank Young, MD, PhD, commissioner from 1984 to 1989, said early proposals for user fee legislation reflected “a moment of desperation. No one really wanted to go this route.”  At the workshop, Young asked his colleagues, “Given a choice of having PDUFA or an appropriation of equal amount, which would you take?” The other commissioners spoke with a single voice. “Appropriations,” said David A. Kessler, MD, JD, whose tenure from 1990 to 1997 coincided with the enactment of the first PDUFA law. “No question.”
  Institute of Medicine report, which stated, “Congressional appropriations from general tax revenue are a mechanism by which the public can directly, fairly and effectivelyinvest in the FDA’s postmarket drug safety activities.”
  Consumer groups, which issued statements as part of a public meeting held Feb. 16, 2007 to gather stakeholder views on PDUFA IV recommendations. The Consumers Union, the National Research Center for Women and Families and the Center for Medical Consumers all expressed a preference for full FDA funding through federal appropriations.
  Twenty-two experts in drug safety and regulatory issues, who signed an open letter to Congress calling for full FDA funding through appropriations and a reauthorization of PDUFA only long enough to reform the current system. Signatories included three former editors-in-chief of the New England Journal of Medicine, four members of the IOM drug safety committee, and six former senior HHS and FDA officials.

OK, so the drug company CEO’s just love the PDUFA, all the former FDA heads, the Institute of Medicine, all the consumer groups (aka “the people”) and the career professionals hate it.
Hmmm. Sounding a little more familiar?
We’ve got a situation where a federal agency is in turmoil and has to deal with emerging crises with diminished personnel, poor leadership, and agency focus on business interests, not the public good.
Does that remind anyone else of FEMA?

Well, another common thread with the Bush Crime Family is, well, criminal behavior, so how about that Les Crawford guy the CEO’s like so much?

From Vitabeat:

Food and Drug Administration (FDA) Commissioner, Dr. Lester Crawford, has resigned, after repeated claims that he allowed his agency to “play politics” with drug approvals, and oversaw some very high profile drug safety recalls. The White House quickly named Andrew von Eschenbach, the director of the National Cancer Institute, as acting FDA commissioner.

Oh, well, playing politics with the public health, and even though Vioxx et al slipped through, where’s the crime in that?
From Wikipedia:

On October 17, 2006, [Crawford] pleaded guilty “to conflict of interest and false reporting of information about stocks he owned in food, beverage and medical device companies he was in charge of regulating.”

Well, whattaya know.
Another Bush mole put in to serve the patrons and he can’t keep his fuckin’ mitts out of the till.
Jesus jumped up Christ. And this guy was given two shots at running the FDA. Does Bush know anyone who isn’t a crook?
I’m sure after that embarassment the new guy will reflect lessons learned, right?

From Public Citizen:

If confirmed by the U.S. Senate to be the next commissioner of the Food and Drug Administration (FDA), Dr. Andrew von Eschenbach will become yet another Bush appointee whose main reason for being selected is that he is a family friend, someone who has been warmly embraced by the regulated industries – especially the pharmaceutical industry – and someone who has been and will continue to be loyal to the White House agenda. Von Eschenbach continues to exhibit extraordinarily bad judgment, a lack of being in touch with reality and insensitivity to the hopes and fears of other cancer patients and their friends and families, as evidenced by his oft-stated “plan” to eliminate the suffering and death from cancer by 2015. Eradicating cancer within 10 years is not realisitic, and by making this statement, von Eschenbach is cruelly raising people’s hopes. 
He is a very poor choice to head this critical agency, and his nomination must be defeated. Otherwise, the FDA will be further weakened and the public health further damaged by someone who is so unqualified. (bolding mine)

Well, turns out Andy is a crony. What a shock. And according to this piece, delusional.
Now, I haven’t turned over any rocks regarding von Eschenbach, but it’s likely because I haven’t tried. Let’s just review here and see if we can’t find a pattern.

1) Congress enacts PDUFA. Drug companies are financing safety reviews of their products, and review times go down dramatically. “Nobody could have imagined” that that might mean a reduction in the quality of these reviews, and that public health, the central function of this agency, would be seriously compromised.
2) Enter Bush, owing big favors to Big Pharma.
3) Big pharma whines about nonexistent bottleneck. Vioxx recall hasn’t happened yet, so in spite of the reduction in review times over the preceding 8 years, they want their place at the neocon trough, and push for faster testing.
4) Bush, in an effort to do his masters’ bidding, puts corrupt toad in the driver’s seat, replaces him with a crony toad, then reinstates toad #1 when toad #2 gets an even bigger federal dept to screw up.
5) Both toads oversee escalating shift of manpower and resources from oversight of food safety to drug approval, and show zero committment to the agency by treating it as an ATM (in Crawford’s case) and a resume item (McClellan).
6) Vioxx and other recalls, and the idiotic Plan B pill morality play, both direct results of Republican and Bush policies, use up remaining resources of slavedriven FDA, which has now become Rubber Stamp Drug Approval Central.
7) Weird stuff starts getting into the US human food supply, foodstuffs from spinach to peanut butter are “tainted” more often than I can ever remember, and the first response of the FDA is “Don’t worry”.

Just Like FEMA
Just Like the Department of Justice
Just like the GSA, and the Forest Service, and NASA, and the FCC, and the Department of Education, and the National Weather service…
Just like Iraq.
Nothing is untouchable. Nothing is nonpolitical. Nothing is sacred, and nothing is safe.
Every organ of government has been simultaneously treated as a trough for the connected and a tool of the vaunted Permanent Republican Majority. The damage to each of them won’t even be fully known until they each break down, one by one.
As did FEMA, as did the DoJ, so did the FDA.
This is NOT “incompetence”. It is negligence.
It is the direct result of misusing another government agency charged with protecting the public good for narrow political ends.
And “nobody could have known” is bullshit, too. If the FDA were headed and run as an organization dedicated to public health, and not a political payback machine, the chances are far higher that:
a) somebody might have been assigned to check up on China’s food additives more often than their DVD piracy, and
b) somebody might have noticed the sick animals sooner, and
c) A full statement and action plan would have happened much sooner.

This is Republican governance.
This is what they mean when they promise to cut your taxes.
Can we please, please, PLEASE impeach this cancer?
Now it is on the verge of literally killing us in our homes.

( – promoted by odum)

In order to keep the pressure to represent their constituents on our state lawmakers, there will be a rally of sorts Wednesday at the State House in Montpelier. I say “of sorts”, because from what I can tell from this article in the Rutland Herald, it’s more of a group lobbying effort.

Sorry for the short post, but I have little info, less time, and wanted to get this out to the progressive community ASAP.
If anybody wants to carpool, my email is in my profile.
Let’s let our elected representatives know how we feel.

( – promoted by odum)

Crossposted at Daily Kos

For the second day in a row, the corporate media is running with the new revelations
around the Bush administration’s data mining adventures.

Arlen Specter, so aptly named for his tendency to vanish when the lights go on, is puffing
harder than ever over this issue, and our own Pat Leahy, ranking Democrat, is nearly
apoplectic with rage.

Bush just limboed below the magic 30% approval number.
BEFORE this story hit.

The strong feeling I got from my surfing yesterday, is that this transgression crossed a line with the American people, and I am inclined to agree.
So doesn’t this transform Senator Russ Feingold’s censure resolution from ‘fringe politics’ to a no-brainer?

And why is nobody talking about it?
More after the jump 

Like many progressives, I dutifully wrote and called both VT Senators urging support for
the Feingold censure resolution. One (the democrat!) ignored my letter, Senator Jeffords
office responded with a personal letter saying he was concerned and would wait for the
“investigation” into the matter to be completed.

No doubt he knows this, as we all do, but the investigation was just decapitated yesterday. 
So now what?

Senator Jeffords, you just lost the escape hatch.
There is no reason left for any Democratic or Independent Senator NOT to cosponsor Feingold’s
resolution.
Likewise, Republican Senators can be forced to state their support for unchecked executive power by opposing this resolution.
I wrote both senators again this morning, highlighting this specific point, and I urge you to do the same.
http://leahy.senate.gov
http://jeffords.senate.gov

Maybe this is the subject for another diary, but here’s some thoughts about the ramifications of this odious program;

What happens if somebody outside the father/protector/decider/bigbrother government gets ahold of this information? Do you think the NSA is keeping these records in a hack-
proof vault somehere? (I would remind you that the other hallmark of BushCo is its
systemic incompetence).
Read this story and sleep comfortably (not!!)  This guy was looking for UFOs. The next guy might be looking for your identity, or when you’re not at home, or when you’re home alone.
Or, how about this one?  Saying “hi, babe” over the phone is a coded terror message. See you in Guantanamo. That is, if they take our hoods off.

Finally, some cozy thoughts. I will preface this last by saying that I do not believe for one second that this program is “limited” to analyzing calling patterns. BushCo has unfailingly lied about every aspect of this program, and is illegally blocking investigation of its own illegality.
Fool me three times, I’m a fool.

The venomous wingnuts who still run to Bush’s defense like to claim that if you have nothing to hide, you have nothing to fear. 
Think about what you have to hide, for a moment. 
Have you ever dialed a phone sex number? Bought a little pot over the phone? Confided to a drinking buddy about how you don’t remember driving home last night? Discussed a loved one’s illegal activity over the phone? Cheated on your spouse and confessed to your best friend on the phone? Called in sick to work, then didn’t go to the doctor? Called in a prescription you’d rather everybody didn’t know about?  How about those calls to your doctor discussing your medical situation? Then have you ever discussed that awful family secret (you know the one) with your trusted confidant? Come to think of it, can you vouch that no one you have spoken to via telephone since 2001 has anything to hide? 
Because that makes you a target. 
Everything you have said over the telephone for the last five years is known to the government. When some bored adolescent hacks into the database and publishes it on the web, you gonna have some ‘splainin’ to do. Or maybe sooner.

You know what to do. Censure is a moderate first step. Let’s at least get that far with this.

http://jeffords.senate.gov

http://leahy.senate.gov

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Cross-posted at www.DailyKos.com

I’ve been reading, both with bemusement and a little frustration, several recent articles urging restraint or denouncing the proposed censure and potential impeachment of George W. Bush.  And to this Vermonter, it looks like a microcosm of the troubles of the Democratic party.  Simply, if you oppose bringing impeachment or censure into the national discussion, no matter the reason, then don’t complain about the Appeasement Democrats. You are one.

Because making this an election issue is the right thing to do.

Way more on the flip

Before I go any further, a little background;  I’m no politico, I never had a job where even finding Washington DC on a map was necessary, never ran for office, and until 2004, had never donated money to a political campaign.  But I gave my time going door to door for Robert Drinan in the seventies, was present (at the tender age of 5) when the National Guard rolled through the streets of Chicago, and have never missed a voting day since my eighteenth birthday. I was also scared shitless of Bush before he stole the Oval Office. So I’m what you might call aware, but certainly no expert. 

  More to the point, I have been a New Englander all my life, and a Vermonter for the last sixteen years. Our small population and grassroots style helps keep it simple.  Helps me see the forest through the trees, while so many better heads than mine are lost in the multitude of details. Details that obscure the larger truth. Wonks tell me it’s a matter of political calculus. I never took calculus, but I got a chainsaw. So let me get it started…

The rationales I’ve seen for opposing impeachment/censure discussions are as follows:
  1) It will never happen with the Republican Congress.
  2) It will put Cheney/Condi/Freddy Kreuger  in the #1 spot.
  3) It will be compared to the Clinton impeachment
  4) It will mobilize the Troglodyte base
  5) Bush is a lame duck, so it’s moot.
  6) It will backfire on the Democrats in `08
  7) It’s a distraction. Win the `06 election first.

These are excellent Republican talking points, folks.  And like all Republican talking points, they are easily cut down, even with my little chainsaw. 

  To all of these, I offer one simple response: It’s the right thing to do for America. 

  I knew this for sure when my Repub nemesis from college came up for a ski trip. I tried to avoid politics, but he must’ve seen my “Impeach” car window signs. He amazed me by agreeing, “`cuz it’s the right thing for America.”  If the Democratic Party still cannot embrace the idea of stopping this administration’s assault on its people, and force the issue with all the ferocity of the anti-Clinton Republicans, because it is the right thing for America, it truly has no courage, no message, no hope of victory in this or future “elections”.
  So let’s cut some wood.

  Reason #1 above would be far more accurate if it said “it will never happen with a Republican Congress that is not held accountable for their dereliction of duty over the last five years.”  Then I would agree. There is a solid repub majority in both houses of Congress, and the media has spun all accountability away from their total lack of oversight of a blatantly criminal administration.
And this line of argument essentially says “don’t rock the boat.”
  How’s that approach working for us so far?  An opposition party is supposed to oppose.  Does that mean offering amendments to appropriations bills that get whitewashed in Republican committees? Making bold statements in their fundraising emails to me, then running from Feingold’s and Conyers’ resolutions?  No. Never did. Really doesn’t in the GOP golden age of homicidal politics. Opposing this conspiracy means spitting in the face of the traitors. It means calling them out. It’s the right thing to do. Playing by the rules of public decorum and observing parliamentary good manners went out the window when the sitting vice president told  Senator Leahy to go fuck himself. And was lauded on Faux News for his forthrightness.
I can’t recall any (D) national officeholder even calling Bush a liar, much less a criminal.
But. He. Is.  Make impeachment/censure an election issue.
ALL democratic candidates should issue a joint statement declaring their support for robust and timely investigations of the myriad mischief of the last five years. Focus on the discussion, not horseracing it with polls and pundits. It’s a strong stand, and it’s the right thing to do.

  #2 is the most obvious straw man of all. Cheney is way more guilty on all counts than Bushie. And the conspiracies behind covering up the NSA business and Iraq weapons intel hits just about everybody else. Hastert would sit impotent in office until removed with the rest of the cabal at the newly scrutinized ballot box.
  I must admit I was stunned and disappointed to hear this bogus argument being proferred by Bernie Sanders in response to my letter to him urging investigation and impeachment. But Bernie is Bernie, and for now I will reluctantly cut him some slack during this campaign. But not much. Vermont is perfectly situated to be ground zero for State Based Impeachment.

  #3 is put forth as a negative, but is in my view a positive. Dig this: The impeachment of two presidents in a row would be a wake up call to Americans that something has gone terribly wrong in our government, in a way that affects them. This can only serve to increase citizen involvement in politics. That has never been a bad thing for the Left. Never. Witness GOP voter suppression, swift boat, and myriad other ways the peddlers of the failed ideology of the Right have tried to pare down public involvement and awareness. 
  Furthermore, Clinton was never a media darling. From Hillarycare to Filegate, every manufactured “scandal” was given weight by the manure-spreaders on TV and in Congress, whereas every violation of law under this beast has been tempered with “supposed” or “some say”.  The media hasn’t given any of this fair play, but swearing witnesses has a way of cutting through spin. I welcome the comparison. Hell, I DEMAND the comparison, and so should every American who thinks a) Clinton got shafted by the GOP’s abuse of impeachment power, and/or b) Bushco deserves to be tried for these crimes. 
  In short, BRING IT ON, because it’s the right thing to do.

  #4 is another positive. By all means, trot that troglodyte base right out for everyone to see. They now represent less than one third of America, and are growing more shrill with every self-inflicted embarrassment of the GOP. This, in my view, is the best way to tie the GOP to Bushco. Put Dobson, Robertson, Mehlman, and DeLay on TV 24/7 defending King George in their usual way, by smearing an ever-growing number of Americans. Hell, throw McCain and Frist on, too. Pandering to their base is NOT going to result in a groundswell of support for their criminality. That bandwagon swerved to avoid Terry Shiavo, broke down during Katrina, and got totaled by Dubai Ports World.

  #5; King George is a lame duck. More like a duck with mutated bird flu. Somebody show me how he’s been stopped.  They’re fixin to go after Iran, fer cryin’ out loud. Those fuckers are nothing if not tireless. Political hacks are STILL driving career experts out of federal agencies from the CIA to NASA to the Forest Service. Halliburton is STILL getting no-bid contracts and is immune from investigation. New Orleans is STILL waiting for help. Bushco is STILL raising the debt limit (think this was the last time? puh-leeze). Oh, and we’re STILL in Iraq with no exit plan. Basically, he’s STILL running amok in our country and the world, and must be stopped. It’s the right thing for America.

  #6; “It will backfire”. Yeah. Like the BS impeachment of Clinton backfired. Or the pending impeachment of Nixon backfired. Poor GOP. After that `98 fishing expedition (not to mention petulantly shutting down the government), how they paid for it at the polls. Sure taught them restraint, huh?…It was an early abuse of power that, unchecked, has since become SOP in the GOP. Or how about the Democrats back in `74. Too bad they stood up to Nixon. Voters punished them by electing one of only two Democratic presidents in the last thirty years. Mainly `cuz he kept it simple.  Yup.  It’s surely political suicide to take a strong stand.  Never works. Except every time it’s done.

  And finally, my favorite; “it’s a distraction”.
  Without a discussion of censure and/or impeachment, none of the crimes of the GOP will enter the national discussion surrounding the `06 elections. We will once again allow the GOP to frame the issues and maximize their smear potential. The Republican Party is the default choice of millions of Americans because it successfully lies to them.  And the entire GOP power structure is involved in a conspiracy to hide vital  truth from the American people. Pretending that it is not is to be complicit.

  If Americans never hear the charges and the evidence, will they have any reason to doubt their electronic paperless votes have been counted correctly? Will they believe that torture is policy if they never see the evidence of its ongoing and widespread use? Will they believe 9/11 could have been prevented if there is no investigation into why the warning signs were ignored? Will they be skeptical of claims about Iran and Syria without investigation into intelligence manipulation, past and present? Will they have reason to wonder if it’s their phone or email being watched, if nobody checks on the watchers? Will the further amassing and abuse of power stop at some point all on its own? Will we ever be anything but a cowed minority if we play the same strategy that has lost us three very important elections in a row?

  Distraction? No.  It’s the focusing lens of the comeback of law and sanity.
  Unrealistic? Not if you shift stategies from DLC-inspired Repub-lite to true opposition. 

  None of the naysayers I’ve been reading can base their positions on anything other than political tea leaf reading, and recent history shows that Democrats suck at tea leaf reading. Leave the supernatural crap to the other side. We all know impeachment is the Constitutional option, the right thing to do. Hell, most of us feel it’s necessary to save our country from dictatorship, but we dither. And fret. About even bringing it up. It’s not exactly inspiring.

  Triangulation and politesse are DEAD. It didn’t work with King George III or the Confederacy and it will not work against the neofascists.  They made great strides powerwise by shouting and screaming about every little thing, even many made-up things. They have been so successful at it they’ve managed to sweep all three branches of government and dominate national discourse with an agenda that actually hurts the vast majority of those who back it.

  We can take back power by taking it to the opposition. Adopt their tactics, but not their philosophy. We have the truth and the law (what’s left of it) on our side. Imagine what we can do. We can do what’s right.

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