FDA Shortchanged?

In the middle of this Lebanon-Israeli shitstorm, a wee story broke on NPR that barely got any attention.

David Graham is at it again blowing whistles about the FDA's borderline malfeasance when it comes to approving drugs and keeping them on the market despite data that points to these drugs being unsafe. Yes, this time it is Aventis who pushed through an antibiotic called Ketek. They got approval the old fashioned way, they said they would put a warning about potential liver failure.

This has become sort of commonplace lately. A drug is pushed through the FDA process, where the safety data may not be 100% kosher, but with a little label negotiation and a promise of a safety study, the drug is approved and gets launched into the world market. Then, a few years later, the study is complete and lo and behold, it isn't as safe (or is less safe) than first imagined.

One of the biggest causes of this is the combination of lack of funding and understaffing at the FDA to actually follow the Safety issues while the drug is in development (ie. before it is approved).

So what does it say about the state of affairs when the Head of the Health and Human Services is practicing tax evasion? Shouldn't the people who have to grovel and beg Congress for funding have clean tax records?

$1.2 million in writeoffs could probably fund 1 or 2 or even 3 (on government salaries) more people that could be dedicated to following up on Safety issues BEFORE a drug is even submitted for approval.

$1.2 million could fund 1-3 more auditors, to ensure the company is doing what it is supposed to.

$1.2 million could fund lots of things that are currently viewed as weaknesses in arguably the most important government agency we've got.

I think it's time to find a new Secretary.

What's Missing?

From this NYTpuff piece on Sen. Lindsay Graham?

Just the fact that before his righteous fight for upholding the rights of the Gitmo detainees, and his attempt to legislate the Hamdan decision, he tried to subvert said decision.

Nina Tottenberg hearts Lindsay Graham

It is the only explanation as to why Senator Graham was the only Senator chosen for every soundbite in this story about the Haynes hearings.

Which is odd given the sort-of cloud over Sen. Graham's legal ethics.

Economic good news?

The headlines are all sunny about the projected $100 billion decline in the Deficit. Swallowing Bush's line that it is due to the tax cuts, and regurgitating it to their open-beaked readers. Luckily, DeLong allows the more discerning open beaked readers (such as myself) a more tasty morsel.

In this feast of economic mealworms and such(ok stop with the bird metaphors), he gives us plenty of reasons to give this news the old gutteral distrust reaction that is typical of almost any statement about our economy by the Bush admin. Amongst the various highlights, DeLong gives us this:

In July 2003 the fiscal 2003 deficit was estimated at $459 billion; the actual outcome was $378 billion. In February 2004 the fiscal 2004 deficit was estimated at $521 billion--more than $100 billion higher than the Congressional Budget Office's contemporaneous estimate, and $108 billion higher than the actual fiscal 2004 deficit of $413 billion. In January 2005 the adminnistration's forecast for the fiscal 2005 deficit was $427 billion--the deficit came in at $318 billion. And in each case the Bush administration trumpeted the "progress" on the deficit made relative to the benchmark set by its own highballed previous forecasts.

Which makes me wonder. Since we have Congress in the mood of legalizing things that aren't. Maybe it is time they switched gears, and expanded a law that is currently on the books for Corporations to regulate the Government's own Financial reporting. Seems to me false reporting of the Government's financial state is indeed illegal if Sarbanes-Oxley were to apply to the Government.

After all, the idea behind Sarbanes-Oxley was more transparent financial disclosure. Besides the fact that our Government is run for/by corporations, these numbers that are falsely inflated do affect financial markets, including all things that are backed by the "full faith and credit of the United States Government."

So if this full faith is undermined by constant lying and unreliable financial statements by the people who matter. Aren't lots of people loosing money because of it? Aren't lots of other people getting played by this game? Sort of like the Enron days, when Ken Lay would tell the employees that everything was great, and that they should invest in the stock, knowing full well that the opposite were true.

Syd Barret Dies

Pink Floyd co-founder Syd Barrett dies, and the AP can't get basic facts straight before going to press.

Same article:

Barrett co-founded Pink Floyd in 1965 with David Gilmour, Nick Mason and Rick Wright, and wrote many of the band’s early songs.

So the AP later gets it right, again same article:

However, Barrett suffered from mental instability, exacerbated by his use of LSD. His behavior grew increasingly erratic, and he left the group in 1968 — five years before the release of Pink Floyd’s most popular album, “Dark Side of the Moon.” He was replaced by David Gilmour.

Uh no. As the journalistic source of integrity filled facts Wikipedia notes:

Pink Floyd evolved from an earlier band, formed in 1964, which was at various times called Sigma 6, The Meggadeaths, The Screaming Abdabs, and The Abdabs. When this band split up, some members — guitarists Bob Klose and Roger Waters, drummer Nick Mason, and wind instrument player Rick Wright — formed a new band called Tea Set, and were joined shortly thereafter by guitarist Syd Barrett, who became the band's primary vocalist as well.[6] When Tea Set found themselves on the same bill as another band with the same name, Barrett came up with an alternative name on the spur of the moment, choosing The Pink Floyd Sound (after two blues musicians, Pink Anderson and Floyd Council).[7] For a time after this they oscillated between 'Tea Set' and 'The Pink Floyd Sound', with the latter name eventually winning out. The word Sound was dropped fairly quickly, but the definite article was still used occasionally for several years afterward, up to about the time of the More soundtrack. In the early days, the band covered rhythm and blues staples such as "Louie, Louie", but gained notoriety for psychedelic interpretations, with extended improvised sections and 'spaced out' solos.

Thanks AP. Syd Barret deserves more than this!

Inskeeping With the Times

This morning Steve Inskeep of NPR's Morning Edition talked to Sen. Patrick Leahy about this wee problem of the administration being found guilty of holding folks against domestic AND international laws by the SCOTUS. You see the SCOTUS let the White House know that there is this little thing called Habeas Corpus that is sort of a basic Human Right. Anyway let's take a look at some of the choice quotes starting with this one:

INSKEEP: The Supreme Court has said that Congress can legalize some form of criminal proceedings for these suspected terrorists. On the one hand you could legalize what the Bush administration is already doing, these military commissions or tribunals. Maybe on the other extreme you could do more of a regular trial like a military court martial where the defendant has many more rights.

(as usual emphasis mine)

First off, the SCOTUS did not say that Congress can legalize anything. They said what the Bush administration did was illegal. Sort like Inskeep admits in his next breath where he says Congress could legalize what the Bush admin has been doing (illegally). I remember this broohaha in the 90's about some President lying in court about a blowjob and how this was sort of illegal and yet, Congress wasn't expected to legalize the practice of perjury.

Of course the other choice quote there is that he finds it "extreme" to offer up court martial trials to folks who are innocent until proven otherwise (except if you get caught up in this Kafkaesque nightmare).

Anyway, let's continue, Inskeep then keeps on keeping on:

INSKEEP: You're against allowing what's already been done, are your Republican colleagues on board with you.

LEAHY: I think some are... What's been done so far is the incompetance. We haven't had a single trial. We haven't had a single conviction. We're getting criticized around the world. We've had people committing suicide down there. We have had... embrasingly to us a number of times totally innocent people being held in prison.

INSKEEP: So Senator, do you want to go to the other extreme then and give them something under the Uniform Code of Military Justice. A regular court martial, where they get a defense lawyer, where they can present a solid defense, where they can confront the accuser. And other rights?

Again, why is this extreme? You just heard from the Senator (and certainly as a top journalist covering these matters daily) that there have been innocent people held without this "extreme" right of Habeas Corpus! Faster than you can say Ted Nugent, Inskeep mouths off some more:

INSKEEP: So you would want a courtroom setting where you would want a fuller hearing of the evidence...
Senator as I understand it, the Supreme Court ruling was wrong because it violated the Geneva Conventions, and the reason it did that, was because it permited the use of evidence that was obtained under coercion. Would you change that?

LEAHY: Yes, I would and we should reinstate that.

INSKEEP: ... I can hear someone saying, these are some of the worse people on earth, and Senator Leahy and other Democrats want them to have lawyers and access to the ACLU and all kinds of rights...

Obviously, Inskeep doesn't understand what "rights" are and how they should apply to all human beings regardless of color, gender, or being suspected of something. It is sort of what Rule of Law means. Letting the Law sort things out. Simply accusing someone of doing something should never be enough to remove their rights.

Luckily, Sen. Leahy puts Inskeep in his place for me.

LEAHY: Well what you're doing is reading the White House talking points in saying that. My response to that is this. You guys have done such a great job. You have had a Republican controlled Supreme Court tell you that you have been breaking the law. And what have you got to show for it? Not one single conviction.