Saturday, February 04, 2006

Rigging the Scale

Washington Post article on backlog of applications to approve generic equivalents of high cost brand name drugs:

“...As the backlog of generic applications has soared, the number of applications for new or reformulated drugs and biologics submitted by brand-name companies has remained consistently smaller than predicted. But while the Office of Generic Drugs had about 200 employees to process almost 800 new applications last year, the offices that review new drugs had more than 2,500 employees for about 150 applications in 2004.

The generics office's budget was about $26 million last year, a fraction of the more than $400 million spent to evaluate and monitor new drugs and biologics, according to FDA documents. In response to questions from Congress, the agency said the generics program would have to make cuts in 2006 to offset pay raises.

‘We have a kind of crazy situation now where the FDA's generic reviews -- which are supposed to be quicker because they're less complicated -- on average take longer than the new drug reviews,’ said Kathleen Jaeger, president of the Generic Pharmaceutical Association. ‘The flood of applications is coming in generics, but the review resources mostly go to new drugs.’ [snip]

‘The branded industry has to be delighted by this backlog,’ said Jake Hansen, vice president for government affairs for Barr Laboratories Inc., a maker of generic drugs. ‘If they can't stop competition in the courts, stopping it as applications go through the regulatory process is just as effective. For consumers, to flatline or cut funding makes absolutely no sense.’..."

Corporate welfare at its subtle best.

Thursday, February 02, 2006

Flashback to the Present

Thirty five years after drawing down American forces in Vietnam, America looks well on its way to doing the same in Iraq. Plans are in the works to reduce US troops from165,000 to100,000 by the end of 2006. BushCheney has long claimed that American policy would follow facts on the ground. And it appears that a compliant military with little understanding of Iraqi society and culture is creating the facts needed to reduce the number of ground forces, according to a recent article in the Financial Times. Just in time for the November elections. Who says BushCheney isn’t listening? The growing concern about War Without End is forcing his hand.

Of course, that does not mean an end to the war. BushCheney is dug well into Iraq. A massive bunker-like embassy combined with unrelenting aerial bombing will allow the US to continue the war in a different form without all the messy American body parts (we can largely ignore Iraqi bodies) that have undermined the support for the war created by the Republican Noise Machine back in 2003. BushCheney knows he needs to show “success” so he will make it up. Hell, lying and dissembling have worked well for him all these years, why stop now?

This sounds like Vietnam where we drew down ground forces in favor of massive bombing, substantial logisitical assistance, financial support and backstage influence to continue fighting. War by different means. What sounds even more like Vietnam to me are the Financial Times quotes from American soldiers about living in the “United States of Iraq” and their hopes for drawdown and less risky duty. The “United States of Vietnam” would pretty accurately describe my experience in that country; I never left American culture although I knew for sure that I was in a wholly different place (and did get to see that beautiful jungle, mountain and forest) . The US military created its own environment in Vietnam that was largely cut off from the country we were saving. American isolation in Iraq sounds even more complete.

But the hope for salvation, for reprieve from this tedious duty is what really captures my attention.

“...There is a sense that with the final lap of the political handover completed with December's election and, even more importantly, with the forthcoming US congressional elections in November, a substantial part of the army is on its way home - for good.
One staff major in a combat unit, who is about to head home after completing his second tour in Iraq, is pretty certain he will not have to come back. ‘By 2007, when we are up for the next rotation, we will not be here any more, at least not as extensively,’ he says....”

In 1971, American troop strength dropped by half–from about 200,000 to100,000. I came in-country in December 1970 hearing that my tour would be cut short as the US withdrew forces. The 101st Airborne Division went home in March. So did two-thirds of my unit, the 1st Cavalry Division. But The Cav left me behind in a brigade that absorbed troops too new in-country to rotate back to The World with their units. Nothing changed for us; we stayed in the field, built firebases, patrolled and took casualties. But possibilities still existed. Rumor was that my unit would pull back to the big base at Bien Hoa, which was a veritable Oz of possibilities for safety, comfort and entertainment compared to infantry patrol. It never happened; I made it to Bien Hoa as company clerk but my unit was still in the field when I left in December 1971. Even as I refused to believe that early rumor, though, I welcomed the hope. I can empathize with soldiers hoping to forgo another round of combat. Hope was my final refuge in combat.

In1965 Vermont Senator George Aiken recommended that the US declare victory in Vietnam and bring our troops home. Neither Lyndon Johnson nor Richard Nixon paid attention to that idea. BushCheney declared victory in May 2003 but missed the chance to bring the troops home. Now he is declaring victory in slow motion, hoping that fewer boots on the ground will mean fewer body bags to remind Americans of what their government is doing in a foreign country. The death and destruction will continue, adding to the moral and ethical debt we owe Iraq even as it destroy’s our credibility to pay that debt. BushCheney’s promises to the Iraqi people were as false as their promises to their countrymen.

While BushCheney distracts Americans with “Mission Accomplished, the Sequel”, war by other means goes on. Americans who care about this nation’s honor and credibility should not believe that lower troop numbers and fewer casualties mean we are doing anything different in Iraq or that we have somehow satisfied our obligation to that nation. Only the means will change.

Don’t get your hopes up.

Wednesday, February 01, 2006

L'Irak n'est pas le Vietnam

Vietnam is a constant undercurrent to the Iraq War. No one wants to repeat the THAT mistake. Vietnam is not the model anyone wants to follow. BushCheney says Iraq is different. It’s much the same say many critics. Both sides can claim some verity but, even with the differences, Iraq is enough like Vietnam to cause worry. The American Occupation and Sunni resistance is a classic insurgency against a foreign occupier. America and the world have seen this drama before with the same results: the foreign occupier departs. Sometimes they leave in a somewhat orderly manner, like the French in Algeria or Britain (usually after a certain amount of unpleasantness and bloodshed). Other times departure is hasty and a bit more dramatic. Either way, the locals win.

Iraq is a varient on a familiar theme, leavened with the political machinations of the newly emergent Shi’a majority and Kurdish nationalists. The Iraq War will not end for a while, during which a motivated opposition will attack Americans and their allies and the US military, a highly lethal force on hair-trigger alert (US troops just shot up some Canadian diplomats who, like many Iraqis were near an American convoy) will respond with massive violence. We can expect much more bloodshed and destruction as these forces play themselves out. Assuming that Americans don’t soon recognize the futility of our presence Iraq and how it works against our national interests. That is much the same as Vietnam

Unlike Vietnam where both sides drafted soldiers into service, Iraq is not a conscript war. The Iraqi insurgents are volunteers as f I ar ascan tell. Many are Iraqi nationalists, others are seeking revenge for American assaults on their homes, family and honor. Some are Jihadists, fighting a holy war in Iraq just as they did in Afghanistan with US support. American forces in Iraq are not conscripts; they started out as volunteers who willingly joined the military, although many were not aware how much of their lives they were putting at the military’s disposal. These volunteers signed up for fixed enlistments. Reserve or National Guard volunteers expected to serve their enlistments in their communities. For these soldiers, war was, at best, a vague possibility. So imagine their surprise when called to war duty. Imagine, too, their surprise, along with Regulars, when they learned that their enlistment was indefinite.

Most soldiers who served in Vietnam served a single year-long tour. Career soldiers could expect to return one or more times. (A first sergeant in my company was serving his fourth tour; he was not at all happy about it). But for most, once you left Vietnam, you were done. Not so in Iraq, where the US military not only rotates units back to combat multiple times, but it also extends enlistments so that “volunteers” cannot leave the service. The consequence is that this war’s burden of war falls heavily on a certain group of people. Even the most enthusiastic soldier may be frustrated to once again be at risk in an environment that is little different and perhaps worse from the one he left a year ago. It’s wearing. And deadly.

America has a “backdoor draft”. During Vietnam, the burden was (theoretically) spread among all draft age males, the Iraq war is the burden of a relatively few, although this time around women get to participate. I now see reports of soldiers on their second and third tours (while most Americans hardly even notice the war). As long as Americans are stationed in Iraq–right now the term is indefinite–they will be at risk. This burden falls on the few who had the misfortune to be in the military when BushCheney decided to launch a war rather than think.

I think the burden is particularly difficult for the Reserves and Guard. Regular forces–Army and Marine–know that combat is always a possibility. That’s why they exist. They train for it. But hte Guard and Reserves have traditionally been community based rather than combat. Now they are serving in a deadly combat environment with minimal training and out dated equipment. In Iraq; like Vietnam, the enemy is everywhere and everyone. This is a far cry from reinforcing levees or rebuilding after a disaster. It breeds fear, paranoia callousness and brutality in a person.

Like combat veterans before them these Regular, National Guard and Reserve soldiers will bring the war home with them when they return. They will be very different from the men and women who left to serve. Most will get on with their lives even as their experience and memories stay with them. Some will never be at peace, either on constant alert for the fatal attack or wrestling with the moral dilemmas of killing. Those few veterans will bear these heavy costs. The rest of us can ignore them, much as we have ignored the war, explaining its death and destruction in national security generalities and rationalizations.

Vietnam’s burden wasn’t widespread but it was more so than now. About 2.5 million Americans served in Vietnam. That’s less than three percent of a population that was around 200 million. Although more were at risk of military service then due to the draft, many eligible males (Dick Cheney, George W. Bush, Bill Clinton, my brother) avoided conscription, so relatively few saw service and even fewer, maybe 250,000 actually saw combat. The burden of this war is even less. At best Iraq war veterans are only 1.5 percent of our population. Knowing that soldiers do, in fact, serve multiple tours, the burden is even more concentrated on a small number of Americans.

In the end, America must be able to say that we asked for this sacrifice honestly in the best interest of our nation and, as far as I am concerned, the world. Three years on it is obvious to me, as it was when BushCheney rushed to war, that Iraq is not in anyone’s best interest–except, perhaps, Shi’a fundamentalists, oil companies and large contractors.

Iraq is not Vietnam. But it is close enough to know that whatever result the United States achieves in Iraq will be forever tainted by the unnecessary sacrifice of so few.

[Note: Title with homage to Rene’ Magritte].

Tuesday, January 31, 2006

Games Nations Play

Fubar at Needlenose has today's best piece on BushCheney's dilemma in Palestine after the Hamas electoral victory:

"...When it comes to diplomacy in the Middle East, the other side is playing chess while the Bush administration plays checkers."

A Tale of Two Mines

Seventy Canadian miners were rescued 24 hours after a fire broke out in their mine. They waited out the fire in sealed emergency rooms with at least 36 hours of oxygen and other supplies. In the US during January 2006, 14 died in mine accidents, primarily from the toxic fumes. Unlike their colleagues to the north, American miners had no refuge to wait out the time rescuers needed to reach them.

Now federal mine regulators are reviewing new emergency and safety rules, incuding requirements for refuge rooms that would extend survival times. BushCheney could have implemented this requirement six years ago but abandoned the effort. The reason:

"...The idea of special caches was formally abandoned by MSHA in September 2001. The agency's explanation: 'MSHA is withdrawing this entry from the agenda in the light of resource constraints and changing safety and health regulatory priorities.'..."

Bogus reasoning wrapped in weasel words, indeed, but it worked. Safety regulations were postponed. Fourteen more casualties in the Right Wing-Corporate assault on American government.

Words For Our Time

"Now U.S. officials say they just aren't sure who they killed that day."

CBS News report on vidoetape message by Ayman Al-Zarahri, the target of airstrike that killed 18 people, including women and children.

Monday, January 30, 2006

Broken Deal, Bad Deal, New Deal

In all the discussion of the Alito nomination, I have seen little mention of the fact that BushCheney reneged on the agreement regarding filllibusters of judicial nominees made with the Gang of 14. Part of the deal was that the president would consult with senators on nominees. BushCheney famously failed to consult. Harry Reid early on recommened someone not from the federal bench, noting that Harriet Miers was a good choice on that criterion. But when the Wingers howled, BushCheney gave them a fighting activist, Bork Lite. And it worked. No consultation there. Not with senators, anyway. Next time around Democratic senators must demand to meet and discuss nominations. In doing so, senators could guarantee an end to the nomination circus with its Kabuki theater performances that mean nothing.

Now that Alito is in for life, I'll have to make the best of him. Alito is itelligent and experienced. His friends and many associates call him likable and reasonable. Perhaps he will evolve into a justice I admire. All I can do is hope. I doubt if he will ever be a Warren or a Marshall(Oh, wouldn't that be perfect!)but perhaps he may become a Potter Stewart or even David Souter. Alito could do much worse. I hope he will have the judgment and brillance of predecessors such as (either) Marshall, Holmes, Cardozo, Black, Douglas, Powell and the justice he replaces, Sandra Day O'Connor.

Along with Chief Justice John Roberts, Alito is the second Baby Boomer on the Court. Seventeen years after the first Boomer (Dan Quayle) ran for national office, my generation has its first presence on the Supreme Court. I hope they do not acquiesce to the dismantling of Constitutional government by an arrogant out-of-control executive. I surely don't want that to be our legacy to future generations.

A side note: For the first time in 35 years, no Arizonan will sit on the Supreme Court.

Sunday, January 29, 2006

Half Measure

The Washington Post reports that climate change scientists are discussing the “tipping point” beyond which change will become irrevocable. Studies of polar ice core samples show that the earth has in the past experienced climate change far greater than any recorded in history. The changes and rate of change in gobal temperatures may well be the precursors of dramatic change, according to scientists. In response, many European nations are reducing carbon dioxide emissions. Other nations pledged reductions but have had difficulty achieving those reductions.

Meanwhile, the United States won’t even commit to reducing emissions.

“...The Bush administration espouses a different approach. [Chief science advisor John] Marburger said that though everyone agrees carbon dioxide emissions should decline, the United States prefers to promote cleaner technology rather than impose mandatory greenhouse gas limits. ‘The U.S. is the world leader in doing something on climate change because of its actions on changing technology,’ he said....”

But what do we want that cleaner technology to do, Mr. Marburger? I would think the point is to reduce carbon dioxide emissions. Do you not have some expectation that the technology would create a measurable difference in the overall level of carbon dioxide in the atmosphere? Better technology is only as good as the result it produces. The administration is not asking for any result, only a specific action, which may or may not be as effective as promise.

In performance measurement (of which I am a long-time practitioner) cleaner technology is an Input, something you bring to the specific plan or process that you to create actions or Outputs (what you get as result of the money and effort you invested). In this case the Output is reduced emissions, which according to current models is what causes higher global temperatures. Reducing the temperatures is the Outcome, the result that we want. We can measure the impact of our actions in various indicators of global climate to determining if what we are doing works..

Cleaner technology, is a far cry from being an effective solution for climate change. At least not as long as it constitutes the entire policy. Cleaner technology will be important to reducing greenhouse gases and other constituents of global warming but it is only a partial measure. In the end, we want to see the emissions reduced. For that the world needs specific goals, limits, measurement and reporting. It’s the only way we will know.

A Possibility

Robert Byrd of West Virginia has announced his support of Samuel Alito’s nomination to the Supreme Court. When I first heard this news, I wondered how the author of Saving America, the senator who spoke so eloquently against BushCheney’s illegal war could support a judge who’s view of the Constitution is so slanted toward executive power at the expense of Congress and the Judiciary. In his statement, Senator Byrd spoke of his understanding of the Senate’s Constitutional responsibilities.

“...Exactly what did the Framers mean when they gave the Senate the power to ‘Consent’ to the confirmation of a judicial nominee?
Historically, a majority of the Framers anticipated that the Senate’s confirmation or rejection of a judicial nominee would be based on the fitness of the nominee; not on partisan politics or extraneous matters.
Based on these assumptions, the Framers presumably did not expect the Senate to spend its allotted time on a nominee staging partisan warfare instead of examining his or her qualifications.
Yet, the Framers probably also would never have expected that a Senator of a nominee’s own Party would refuse to ask the candidate meaningful questions. They certainly did not intend for Senators of the nominee’s own Party to sit silently in quiet adulation, refusing to seek the truth while smiling indulgently, thus accomplishing nothing.
The Framers expected the Senate to be a serious check on the power of the President. They clearly thought that the Senate’s confirmation process ought to be fair, impartial, thorough, and exhibit appropriate respect for solemn duty and the dignity of both the process and the nominee....”

The senator then outlines his concerns about Alito and the assurances, in the Judiciary Committee hearings and private meetings with Byrd, Alito gave that assured Byrd that the nominee would no be a blank check for expanded executive power. Byrd concludes:

"...In the end, the heavy duty bourne by members of the Senate to evaluate and reject or approve the President’s nominees for the high court should come down to each Senator’s personal judgment of the man or woman before us, augmented, of course by such judicial records and writings as may exist. I know not exactly what kind of Justice Samuel Alito may actually be - - no one does. But my considered judgment from his record, from his answers to my questions, and from his obvious intelligence and sincerity, leads me to believe him to be an honorable man, who loves his country, loves his Constitution, and will give of his best. Can we really ask for more?"

Byrd’s statement gives me some hope that Alito will not be the conservative activist on the Supreme Court that he has been throughout his career. Perhaps the Republic will survive Alito’s tenure. But I would like to see further exploration of these important issues; I want to see Alito’s assurances stated explicitly and explained. So I guess I can ask more. I ask the US Senate to fully debate this nomination, however long it takes.