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.

(UPDATE: The Obama campaign is claiming that Anthony changed the password and froze them out of the MySpace site, starting all this. Interesting. If so, it alters the moral equation, but the fact that we’re seeing this neener-neener he said-he said play out in public is still shockingly dumb…)

(UPDATE2 – Not so fast, says Micah at techpresident:

(UPDATE 3: Dean campaign netroots pioneer and Obama activist Zephyr Teachout chimes in… check the bottom of the article, as I’m running out of update room on top.)

Okay, if you haven’t heard, here’s the story.

An Obamaphile named Joe Anthony creates an Obama MySpace fansite in 2004. Over the years, he’s done the whole social networking thing, including staying up long hours, making connections and building the Obama buzz. The site has been a roaring success – a model, even, of how to use such social networking sites for political causes.

As the Obama campaign ramped up, so did the workload. The Obama campaign forged a relationship with the guy and they seemed to have a good working connection – they’d let him know about errors that he’d correct, and so forth – and the list of connected “friends” to the Obama site ballooned to a mammoth 140,000 – particularly after MySpace started highlighting political sites.

So in March, the relationship went sour in a big way about the time Obama brings political veteran Scott Goodstein into the fray to run the online social networking (more on him in a moment). Anthony says he is getting worn out keeping up the site, which is turning into a serious committment, and emails the campaign asking to be compensated. The O campaign decides it wants hands-on control and discusses options – including bringing  Anthony on in a paid capacity. Eventually they decide to approach the guy and – this is key – ask him to make an offer to compensate him for his work to turn it all over, lock stock and barrel.

(Continued below the fold…)

Anthony admits he had no idea what would be an appropriate amount (and how could he , in a sense…. this is uncharted territory). He also admits to being sick of a campaign that he felt was now “bullying” him, and even harassing him by such things as setting up inconveniently scheduled phone meetings with him and routinely canceling at the last minute, and other such petty things that seemed all but intended to make him feel belittled and dismissed. He makes it clear that, after this treatment, he felt a right to compensation out of principle.

After considering his time since 2004, he came back with a number of about $39,000 as well as a share of any fees paid to MySpace up to that time up to a max of $10,000. (from his MySpace blog:)

(Obama staffer and facebook.com founder) Chris (Hughes) suggested a one-time fee to transfer over the profile to them and that they discussed this with Myspace and they were agreeable with any arrangement we could work out. He did not suggest how much, or what sort of a fee. He did say that he needed it by the next morning so we scheduled another meeting and I stayed up all night working on a proposal that I thought would be fair to everyone. This was a positive conversation and he seemed sincere enough.

That meeting finally happened yesterday. It was clear at that time that there was no “one-time fee”. I felt like it was a bit of a setup so that they could have a reason to take the profile without my consent.

I was accused of using this profile for commercial purposes. I was threatened that I would be responsible if the profile was deleted (they even followed up via email to be sure I knew it was my fault!) The conversation really was about them taking control of the profile. There was no counter offer, or anything to suggest that they had any intention of paying me anything at all.

At this point there was no way I would turn this community over to them and would rather keep it as an unofficial site and keep doing what I’ve been doing. I expressed this, and they said that if I did not turn the profile over to them immediately, they would delete it and all of my hard work would go to waste. They reiterated this several times, and repeated “You are the one making the decision to kill this profile”. In fact, I responded each time, that I have no plans to delete this profile, and that decision would be between them and Myspace. (I even added that he sounded like Bush telling congress/senate it was their decision not to fund the troops. How hypocritical is this!)

Finally, Chris from the campaign emailed me, indicating that Myspace needed my consent to give them access to the profile. I replied that Mypace did not have my consent to grant access to the profile to anyone.

An hour or so later, I was blocked from the profile and the content was altered to redirect traffic to the new, “Official” profile. Myspace has in fact granted access to the profile without my permission.

So, it’s a mess. The Obama campaign is apparently actively calling this guy a cybersquatter and telling folks he’s only in it for the money. For my part, I’m not entirely sure whether the number Anthony proposes was appropriate or not – but that very uncertainty suggests the need for negotiation and a considered response, rather than dropping the boom and trying to smear the guy – and make no mistake, the guy is getting trashed online by Obama supporters using words like “blackmail” and “extortion.”

Techpresident.com has the focal piece on it, and their assessment seems reasoned and reasonable:

Indeed, it appears the Obama internet team was shocked by the size of Anthony’s proposal and argued to themselves that it was proof that he was just in it for the money, even though campaigns like theirs regularly give tens of thousands of dollars to highpriced media consultants who would give their eye-teeth to deliver 160,000 rabid activists to a campaign. Instead to them, Anthony’s bid was all the more reason to get control of the site. Obama’s staffers are now spreading the word that Anthony wanted a big payday, including a huge percentage of any ad buys on MySpace. I have a copy of Anthony’s email proposal, however, and it contradicts that claim.

Of course, no one really knows how to value the creation of a popular political website with tens of thousands of members. Big sites like Flickr.com and Weblogs.com have earned their owners somewhere between $20 and $40 per member. Care2, the massive progressive email list vendor, charges about $1 per email address that they generate for a campaign. But it would be silly to suggest that Anthony generated 160,000 MySpace friends for Obama on his own–if he wasn’t plugging a very charismatic candidate like Obama he’d never have grown such a large site.

Whatever the case, at this point it appears the Obama people simply decided that they would get control of the myspace.com/barackobama url by going around Anthony and getting MySpace to lock down his access to it.

Which is where we’re at.

Now look, where I can’t help but have sympathy with the Obama campaign when I read how the stink developed – and I have no idea what financial offer they were expecting (although $39,000-$49,000 clearly was more than they were bargaining on), I find their handling of the relationship with Anthony (short of any new revelations that alter the picture) both morally appalling and mind-numbingly stupid.

Let’s start with the “stupid” part, eh? Why do I say it’s stupid? Because of posts like this that are filling up the internetz today (from Anthony’s blog again):

This was just WRONG, the man lost my vote.

Posted by Guze on Wednesday, May 02, 2007 at 9:52 AM
[Reply to this]

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This is about as rotten as it gets. The story of your plight just hit Slashdot, so every tech-minded person in America should know about the “MyTheft” shortly.

Posted by Jason on Wednesday, May 02, 2007 at 10:04 AM
[Reply to this]

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This is really disappointing; it’s unfair and un-American on so many different levels that it’s hard to quantify.

Things like this will definitely have an impact on deciding my primary voting and where my support goes; whether that be as a campaigner or a contributor.

Ultimately I’m left wondering if this will blossum into a defining moment for the Obama campiagn- the day Obama broke the ‘Netroots’ back.

Keep up the good work; and sorry about the crappy treatment from Barak Obama.

Posted by Skip on Wednesday, May 02, 2007 at 10:08 AM
[Reply to this]

Why, oh why did supposedly net-saavy staffers like Goodstein and Hughes not think this would happen? And it’s only getting worse. The fundamental misunderstanding of the nature of the internet – both in how netroots activists should be treated (and the potentially national consequences of treating them poorly) and the impossibility of controlling web hubbub with traditional spin – makes the mind boggle. Obama’s net campaign is often compared with Dean’s – but this incident shows how far behind the Dean perspective Obama’s people really are. Early on, the Dean crowd realized there was no controlling a lot of that independent, spontaneous energy circulating among the netroots, so they wisely went with that and tried to harness, support, and by supporting steer (to an extent) that energy – but with the understanding that they could only steer it to a very limited degree. This attempt at old school command-and-control of a key – possibly even critical netroots blossom shows that Obama’s net folks do not understand the medium and its participants the way the Dean crowd did – meaning this could be only the first big screw up of its kind.

But, barring any changes to what looks like a fairly consistent picture – this was clearly a pretty crappy way to handle Anthony, and trashing him after the fact just seems sleazy. The truth is it’s not too hard for me to imagine that Anthony may have been feeling bullied by Goodstein because… well… Scott can be that way.

Scott Goodstein has a history in Vermont. Back in the late 90’s, he helped out as a fundraising consultant for the Vermont Democratic House Campaign, and when I was brought on board, he was hired to work on the first “David W. Curtis leadership Awards.” I always liked the guy, even though he rubbed a lot of people the wrong way, precisely because he was hardcore. He put the hard, hard sell on people to ante up and contribute. The guy was relentless.

He popped back up in the area running Jan Backus’ unsuccessful primary campaign against Ed Flanagan for the privilege of getting trounced by Senator Jeffords in 2000. It was here that he really started annoying the crap out of people – even folks who were his friends. He was playing the role of pushy, aggressive politico-guy to an almost caricatured degree, including by having his lieutenant persistently and inappropriately calling me at home at all hours to try to strong arm me into giving his candidate unfair and unethical special access to the Party’s database which I guarded like it was my child. As mad as I would get, I was a paid hack at the time, and I suppose it came with the territory. If Anthony – who is simply an idealistic, and probably naive volunteer – got a piece of that… er… interpersonal styling, it’s not a wonder he got mad.

In any event, the issue is metastasizing across the internet. It may soon behoove the big O himself to step in and calm some ruffled feathers, as well as rein in some of his more aggressive operatives, lest his operation start to lose wavering onlookers to the Edwards campaign, which has become their netroots rival…

UPDATE 3 continued… Zephyr Teachout from a comment at techpresident:

Check the link and scroll down for her comment. There’s more to it, and it’s an interesting read.

UPDATE 4: Why, god, why is Rospas still out there trashing this guy (go here and scroll down to the second comment)??? Don’t they realize how bad that looks? How it feeds the poor beset upon, David-v-Goliath narrative that is blossoming. Or even apart from that, how utterly classless and tacky it looks. They screwed up by letting this get out, now it’s time to cut losses by rising above it and taking the high road. By continuing the “let’s call this guy an extortionist every chance we get” approach, they drag it out in an unseemly manner, when Obama is the only one with anything to lose, at this point. Bizarre and mindless – and these guys are supposed to be political pros?

It gets easier to understand Dem campaign screw-ups, doesn’t it?

The L.A. Times is reporting that Senator Leahy, in anticipation of a possible Gonzales resignation and continued stonewalling in regards to the testimony of White House officials, is saying that his committee (judiciary) will not hold confirmation hearings for any potential future nominees unless Karl Rove and other White House aides testify about the firing of U.S. attorneys to clarify whether “the White House has interfered with prosecution.”

Of course, whether it be because of that special channel of communication he has with the Almighty, the years of coke and alcohol abuse, or just sheer stupidity/brain damage, Bush more than likely will dig in and keep Gonzales on. But as Elizabeth Holzmann reports, it very might well be in Bush’s own personal interest to not let Speedy Gonzales go:

All this is reminiscent of the Watergate scandal. In 1973, as the coverup was unraveling, the Senate imposed a condition on the confirmation of President Nixon’s nominee for attorney general, Elliot Richardson. Richardson’s predecessor had resigned because of Watergate troubles. Concerned that the Justice Department would not get at the truth, the Senate insisted that Richardson would name a special prosecutor to investigate Watergate. Richardson duly appointed Archibald Cox.

The rest is history. Cox’s aggressive investigations led to the prosecution of top administration officials and the naming of Nixon as an unindicted co-conspirator in the coverup. When Cox sought White House tapes of Nixon’s conversations with his staff, the president had him fired, unleashing a firestorm of protests. Americans demanded that a previously reluctant Congress start impeachment proceedings against Nixon. Congress complied; the House Judiciary Committee, of which I was a member, voted for impeachment, and Nixon resigned.

Aspects of this history could easily repeat themselves. The Senate could demand, as it did in 1973, that a new attorney general appoint a special prosecutor, and this could again have dire consequences for the White House.

A new special prosecutor would have many questions to investigate.

With a new Bush/GOP related atrocity coming to light nearly every day, who knows where this one may go? Regardless, its reassuring to know that Bush isn’t going to have it easy either way on this particular matter.

Now that Bush has stamped his Veto across the Iraq spending bill the question is: how do Democrats continue to drive the point home that America wants an end to Bush’s war?

Do we vote no money for the troops and give the Republicans Ammo they’ve been dreaming of?

Or do we fold, give Bush his bill with no timelines, and remain committed to this endless and wasteful Republican debacle?

Jack Murtha of Pennsylvania has got a plan that seems pretty damn good to me.

According to the AP story, Democrats weigh post-veto Iraq options,:

Rep. John Murtha, D-Pa., who chairs the House panel that oversees military funding, said he wants a bill that would fund the war for just two or three months. Before that second bill would expire in summer, Democrats would try again to pass legislation calling for an end to combat.

It sounds like a good idea to me…it does two things:

• It Shows Democrats DO support the troops
• It Shows Democrats WILL NOT roll-over and play dead for Bush

Still, I’ve yet to read any substantive discussion of the merits of the idea (It’s very similar to something the DLC put out, so that alone may make it very unpopular here on GMD).  Does anyone have any thoughts?

Some readers know that I have two sons, and I’m insanely proud of both of them. John is in graduate school at Yale Drama School and Adam is a student at the University of Montana. This post happens to be about Adam, who is more politically active than John.