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Saturday, October 22, 2005

They Seldom Limp and Quack This Early

Sometimes The Economist comes up with some hilarious stuff.  Unfortunately, this howler is subscription-only, but perhaps a few quotes will convey the idea.

Lexington

Et tu, Brute?

Oct 20th 2005
From The Economist print edition

The waning of the imperial presidency

[...] Mr Bush has turned himself into the most powerful president since Richard Nixon, whose “Imperial Presidency” was anatomised by Arthur Schlesinger in 1973. Mr Bush and his consuls came into office determined to restore the prerogatives of the chief executive (Dick Cheney and Donald Rumsfeld were particularly zealous, having served in Gerald Ford's post-Nixon, tethered presidency). Even before September 11th 2001, they took every opportunity to concentrate power in the executive branch, but after the terrorist attacks Mr Bush's advisers seized on the crisis to restore the imperial presidency to its full purple—so much so that Chuck Hagel, a Republican senator, complained that they treated Congress as a mere “appendage”. [...]

As Andrew Rudalevige points out in “The New Imperial Presidency”, all presidents have tried to erode the post-Watergate constraints on them; Mr Bush didn't so much erode them as blow them out of existence.

Now, however, Mr Bush is beset by woes on all fronts. Five separate polls this month have put his job approval-rating below 40%. And the emperor's Praetorian Guard is terrified that Patrick Fitzgerald, a special prosecutor, may indict leading members of the administration.

All second-term presidents become lame ducks (though they seldom limp and quack this early). [...]
Despite the humorous turns of phrase, the article is a serious one.  They point out that, in response to a series of political missteps, Congress and the Supreme Court are acting to reign in the Executive Branch.  Not only that, but religious conservatives and fiscal conservatives are breaking ranks as well.  And, FINALLY, the American press is loosing faith in the President:
But the most vigorous opposition will come less from Congress (where the Republican majority is still tied to the president) than from the fourth estate. There is a noticeable mood of shame in the Washington press corps: shame that it failed to ask tough questions about weapons of mass destruction; shame that it was not quick enough to dig into the murky world of lobbying; shame that it was used to smear critics of the Iraq war. That shame is congealing into a desire for revenge. The press will be asking a lot more hard questions—and this time it will find eager sources among disillusioned conservatives.
The Economist doesn't adequately address one interesting question, though: Exactly what happened to turn the press against the President?  Is it true that the press has turned against Bush because of their own shame?  Perhaps that would explain the about-face of a few reporters.  But with the exception of Fox News (HT: For Real Things I Know), it seems that most media outlets are rushing to criticize the Administration; it is not just a few reporters.  A more comprehensive explanation is needed.

The shame was just the beginning.  This was highlighted when bloggers called attention to the Downing Street Memo.  The mainstream media did their best to ignore it, as the White House still had control of the media's agenda.  Then Cindy Sheehan's campaign captivated the media, causing the White House to loose control over the media.  Sheehan's campaign also made it acceptable to at least mention criticism of Bush, even if that criticism was not wholeheartedly endorsed.  It was this sequence of events that set the stage for the transformation of the media, from Bush's lapdog, to Bush's gadfly.

With the stage set, there came an avalanche of bad news: investigations and indictments, hurricanes, mismanagement of just about everything, the quagmirization of Iraq, deficit spending, environmental stupidity, propaganda revealed, and a bunch of other stuff, perhaps culminating with the Commission of Inquiry on Crimes of the Bush Administration.  With the media free to set their own agenda, and the prohibition against criticism of Bush lifted, it was not possible for the White House to manage the reporting on these events.  Thus, it was not merely the shame of reporters who had failed to question the War, that led to the media turning against the President.  If that had been the only factor, the Presidency would have its Imperial splendor still intact.

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Tuesday, October 18, 2005

Evidence-Based Legislation, Part I

Recently, the US FDA has been criticized extensively for failing to adhere to scientific principles.  However, one fact has gone unnoticed:  For all its failings, the FDA is the most scientifically-based part of our government, and the rest of the government could learn a lot from how they do things.  In this essay, I examine the differences between the approval process for new drugs, and the process for crafting new laws.  I demonstrate that the FDA uses the scientific method, to great advantage, whereas Congress uses a cumbersome, unscientific, and unnecessarily dangerous process to develop new legislation.  When I get around to it, I will post a Part II, describing a proposal for a new way to draft laws: evidence-based legislation.

When the FDA receives a new drug application (NDA), they start out with the assumption that they do not know whether the drug is safe or effective.  The burden of proof is on the pharmaceutical company to prove that the drug does work, and that it has an acceptable safety profile.  The FDA will accept only certain kinds of evidence.  Evidence that does not meet quality standards is not accepted and cannot be used.  The FDA receives information about safety and effectiveness, then has a panel of experts review the information.  Only if a majority of experts recommend that the drug be approved, does the drug proceed forward in the approval process.

When the drug is marketed, only some statements can be made to promote the use of the drug.  Statements that can be disproved are prohibited.  Statements that are not in full accordance with FDA guidelines cannot be used.  For example, a pharmaceutical company cannot promote a drug for a purpose other than that for which it has been approved by the FDA.  

Once the drug is approved, the manufacturer is supposed to monitor the outcome of patients treated with the drug.  If there is an indication of a possible problem, the drug is reviewed again.  Continued approval of the drug is contingent upon the outcome of surveillance studies.  It is true that the system does not always work correctly, but at least the basic framework is sound.  For example, the drug Mellaril was taken off the market a few years ago, when new evidence emerged that it had the potential to cause fatal irregularity of heartbeat.  That action was taken about 40 years after the drug was put on the market.  It took a long time, but the system eventually did work.  

To summarize: In the process of drug approval, the starting assumption is an assumption of ignorance: we do not know if the drug is safe or effective.  Evidence is presented to support the hypotheses that it is safe, and effective.  The drug is put on the market, but ongoing surveillance is required.  If the surveillance detects a possible problem, the drug comes under greater scrutiny.  If a problem is found, the drug is withdrawn.

Contrast this to the process of making legislation:  In the making of legislation, the starting assumption is that the legislators know a priori  what is right and what is wrong.  For example, murder is wrong.  It would follow, logically, that legislation that prohibits murder would be the right thing to do.  When legislation is proposed, legislators, lobbyists, and others can make any claims they want about the bill under consideration.  The claims do not have to meet be testable; indeed, they do not have to meet any quality standards at all.  Claims can be made that are outright lies, and there is no penalty.  The assumption is that the deliberative nature of the legislative process will expose any flaws in the legislation.  But the deliberative process follows only a loose outline.  There is no requirement that testable hypotheses be advanced, then subject to rigorous, structured scrutiny.  It is not necessary to define ahead of time what outcomes can be expected from the legislation; nor is there any surveillance after the legislation is passed.  

Clearly, the drug approval process is superior to the legislative process.  We jump all over the FDA if they screw up, yet we let Congress jump all over us with bad legislation, without giving it a second thought.  Most laws have the potential to affect every citizen, whereas even a blockbuster drug has the potential to affect only a small proportion of the citizenry.  Bad legislation can be extremely hazardous to our health.  Why do we let Congress get away with lower standards for themselves, than the standards they set for the FDA?  

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