David R. Henderson and Charles L. Hopper recount a real horror story in the Wall Street Journal.

On April 27, the FDA rejected Arcoxia (etoricoxib), a new COX-2 inhibitor from Merck. The FDA explained that it didn’t see the need for another drug like this. Robert Meyer, director of the FDA’s Office of Drug Evaluation II, told reporters that, “simply having another drug on the market” wasn’t “sufficient reason to approve the product unless there was a unique role defined.”

The FDA is supposed to judge whether a drug is safe and efficacious and that’s all. In its literature, the FDA even agrees with this role, saying that, “Once a new drug application is filed, an FDA review team — medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts — evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use.” But the FDA slyly added a third requirement: Is Arcoxia better than what’s currently on the market?

According to the law, this isn’t part of the FDA’s approval process and for three good reasons. First, it would be difficult and expensive to show, before it’s marketed, that a new drug is better than all competing drugs. It already costs on average just shy of a billion dollars to get a new drug approved. A study by Joseph DiMasi, an economist at the Tufts Center for the Study of Drug Development in Boston, found that the cost of getting one new drug approved was $802 million in 2000 dollars ($956 million in 2007 dollars). Most new drugs cost much less, but his figure adds in each successful drug’s prorated share of failures. And this $1 billion figure was before the FDA dreamed up this new requirement.

The fact that we’re talking about drugs often causes us to forget what we know about other products whose safety and efficacy are important. We shouldn’t. Imagine that Saturn had to prove that its new car, Aura, is safe, works well, and is better than Accord and Camry before a single Aura hits the showroom floor. If the evidence is too costly for Saturn to collect, Aura will be rejected regardless of the facts. To prove superiority, what manner of tests would Saturn run? How much would this cost and how long would it take? What if five years later Saturn presented its evidence and, on some attributes Aura was better, on some it was equal, and on some it was worse than Accord and Camry? Is it a better car?

There’s no right answer. It would be better for some drivers and not as good for others. But there doesn’t need to be a right answer. This is the second reason drug companies don’t have to prove their drug is better than existing drugs. People are capable of choosing the cars that best meet their specific needs. Faced with this situation, however, the hypothetical federal agency regulating cars would probably say, as the FDA did with Arcoxia, “Why do we need Saturn’s Aura when we’ve already got Honda’s Accord and Toyota’s Camry? The Camry and Accord are fine cars.” Hasta la vista, Aura.

Complete article

I found the statement “It already costs on average just shy of a billion dollars to get a new drug approved” really horrifying. Can you imagine how many drugs must be abandoned because there is not a sufficient market for the individual item to justify development costs on that scale? Be sure not to get a rare disease, Americans.

CNN:

Authorities in northern Iraq have arrested four people in connection with the “honor killing” last month of a Kurdish teen — a startling, morbid pummeling caught on a mobile phone video camera and broadcast around the world.

The case portrays the tragedy and brutality of honor killings in the Muslim world. Honor killings take place when family members kill relatives, almost always female, because they feel the relatives’ actions have shamed the family.

In this case, Dua Khalil, a 17-year-old Kurdish girl whose religion is Yazidi, was dragged into a crowd in a headlock with police looking on and kicked, beaten and stoned to death last month.

Authorities believe she was killed for being seen with a Sunni Muslim man. She had not married him or converted, but her attackers believed she had, a top official in Nineveh province said. The Yazidis, who observe an ancient Middle Eastern religion, look down on mixing with people of another faith.

Original posting

We ought to deal with this sort of thing in Iraq as General Napier did with suttee in India. Napier told the natives:

You say that it is your custom to burn widows. Very well. We also have a custom: when men burn a woman alive, we tie a rope around their necks and we hang them. Build your funeral pyre; beside it, my carpenters will build a gallows. You may follow your custom. And then we will follow ours.

The new Coen Brothers film No Country for Old Men (2007), showing at the Cannes Film Festival, is reviewed by Todd McCarthy in Variety. We won’t get to see it until next November 21th.

A scorching blast of tense genre filmmaking shot through with rich veins of melancholy, down-home philosophy and dark, dark humor, “No Country for Old Men” reps a superior match of source material and filmmaking talent. Cormac McCarthy’s bracing and brilliant novel is gold for the Coen brothers, who have handled it respectfully but not slavishly, using its built-in cinematic values while cutting for brevity and infusing it with their own touch. Result is one of the their very best films, a bloody classic of its type destined for acclaim and potentially robust B.O. returns upon release later in the year.

Reduced to its barest bones, the story, set in 1980, is a familiar one of a busted drug deal and the violent wages of one man’s misguided attempt to make off with ill-gotten gains. But writing in marvelous Texas vernacular that injected surpassing terseness with gasping velocity, McCarthy created an indelible portrait of a quickly changing American West whose new surge of violence makes the land’s 19th century legacy pale in comparison.

For their part, Joel and Ethan Coen, with both credited equally for writing and directing, are back on top of their game.

IMDb

Algis Valiunas, in the Claremont Review of Books, proposes taking another close look at the descriptions of Islam in those old-time travel books condemned by Edward Said for falsely creating a myth of an alien Islamic world.

In 1978, Edward Said, the late Palestinian-American professor of English at Columbia University, published Orientalism, a study that condemns virtually all Western literature and scholarship on Islamic matters as an instrument of imperialism. The Orient, he maintains, is the Orientalists’ invention. There is in fact no Islamic civilization that circumscribes the thoughts and feelings of individual Muslims. Rather there are numberless individuals who happen to be Muslims, and who are every bit as singular in their experiences as their counterparts in Christendom, so that to spout sonorous generalities about Islamic types is an unforgivable imaginative and moral failure. In describing this Islamic Orient that doesn’t exist in the first place, Western writers always get it wrong. Although Said discreetly avoids describing in any detail what a true representation would be, one gathers from scattered remarks that his Muslims are universally tolerant, peace-loving, moderate in their religious devotion, and passionate in their pursuit of political freedom-essentially indistinguishable from their Western brethren in everything but the experience of Western oppression. …

Someone who reads only Edward Said—and he is a sainted authority among leftist academics today—may come away convinced that his argument is true. But to read in the travel literature he disparages is to see how wrong he is. The travelers’ tales do not originate in malevolent prejudice or issue in gross distortion; rather they are drawn from carefully observed reality. A great variety of writers see many different things; but more importantly, they see some of the same things over and over again, not because of the Orientalists’ engrained turn of mind, but because those things are striking and significant and true. The travel literature overwhelmingly shows Islam recoiling from the Western touch, perhaps in part out of legitimate fear that it might be transformed into an alien shape with all the West’s deformities, and to a great degree out of blind hatred inculcated over centuries of prejudice and ignorance. In any case, the Orientalists’ writings testify to the deep roots of the modern Islamist fighting creed, in which Islamic purity must be preserved from Western, liberal, modernizing pollution.

Said writes with what he supposes is withering irony of the Orientalists’ configuring Islam as the Other; but one cannot read these works without concluding that Islam, especially in its militant form, is the Other, not as the West’s fantasy nemesis but in its own deeply graven traditions and chosen historical course. That does not mean accommodations cannot be reached by men of good will and moderate heart. Of the travelers, Chateaubriand is really alone in the depth of his loathing for Islam. Among the others, even those who are justly horrified by the barbarities they witness, a moderate and sensible spirit prevails, while some of the 20th-century travelers feel as much at home in Arabia or Afghanistan as in England. Such decent and thoughtful souls as Tocqueville, Twain, Lawrence, and even the querulous Naipaul, show how the breach between cultures might begin to be healed. But they and their fellow writers also show that the clash of civilizations is real, that certain aspects of it may be irreducible, and that the conflict will not be over any time soon.

Hat tip to Karen L. Myers.

Barcepundit reports a pretty spectacular election promise made by Tania Derveaux, a protest candidate for the Belgian senate running on behalf of the NEE (I think that translates as: “No!” -JDZ) Party. She is pledging to deliver 40,000 oral sexual services, either in person, or in the computer game Second Life.

The young lady’s campaign promise is clearly intended as a response to what her party believes are exaggerated promises of new jobs by other Belgian parties, so I would not necessarily count on receiving that promised service from Tania (live or on-line) if I were you.

She will probably get Bill Clinton’s endorsement though.

AP:

Deep-sea explorers said Friday they have mined what could be the richest shipwreck treasure in history: 17 tons of colonial-era silver and gold coins estimated to be worth $500 million.

A jet chartered by Tampa-based Odyssey Marine Exploration landed in the United States recently with hundreds of plastic containers brimming with coins raised from the ocean floor, Odyssey co-chairman Greg Stemm said. The more than 500,000 pieces are expected to fetch an average of $1,000 each from collectors and investors.

“For this colonial era, I think (the find) is unprecedented,” said rare coin expert Nick Bruyer, who examined a batch of coins from the wreck. “I don’t know of anything equal or comparable to it.”

Citing security concerns, the company declined to release any details about the ship or the wreck site Friday. Stemm said a formal announcement will come later, but court records indicate the coins might come from a 400-year-old ship found off England.

Because the shipwreck was found in a lane where many colonial-era vessels went down, there is still some uncertainty about its nationality, size and age, Stemm said, although evidence points to a specific known shipwreck. The site is beyond the territorial waters or legal jurisdiction of any country, he said. …

He wouldn’t say if the loot was taken from the same wreck site near the English Channel that Odyssey recently petitioned a federal court for permission to salvage.

In seeking exclusive rights to that site, an Odyssey attorney told a federal judge last fall that the company likely had found the remains of a 17th-century merchant vessel that sank with valuable cargo aboard, about 40 miles off the southwestern tip of England. A judge signed an order granting those rights last month.

In keeping with the secretive nature of the project dubbed “Black Swan,” Odyssey also isn’t talking yet about the types, denominations and country of origin of the coins.

Bruyer said he observed a wide range of varieties and dates of likely uncirculated currency in much better condition than artifacts yielded by most shipwrecks of a similar age.

The Black Swan coins – mostly silver pieces – likely will fetch several hundred dollars to several thousand dollars each, with some possibly commanding much more, he said.

Complete story

AP 1:14 video

Corporate site

John Bolton delighted Richard at EU Referendum with his combative performance in an interview conducted by snidely superior BBC “presenter” John Humphrys.

BBC radio 18:48 interview

Senators from both parties, including Edward Kennedy of Massachusetts and John Kyl of Arizona, are sponsoring a comprehensive immigration bill which would potentially legalize the status of an estimated 12 million illegal aliens and would fundamentally change immigration policy.

AP:

The proposed agreement would allow illegal immigrants to come forward and obtain a “Z visa” and – after paying fees and a $5,000 fine – ultimately get on track for permanent residency, which could take between eight and 13 years. Heads of households would have to return to their home countries first.

They could come forward right away to claim a probationary card that would let them live and work legally in the U.S., but could not begin the path to permanent residency or citizenship until border security improvements and the high-tech worker identification program were completed.

A new crop of low-skilled guest workers would have to return home after stints of two years. They could renew their visas twice, but would be required to leave for a year in between each time. If they wanted to stay in the U.S. permanently, they would have to apply under the point system for a limited pool of green cards. …

In perhaps the most hotly debated change, the proposed plan would shift from an immigration system primarily weighted toward family ties toward one with preferences for people with advanced degrees and sophisticated skills. Republicans have long sought such revisions, which they say are needed to end “chain migration” that harms the economy.

Family connections alone would no longer be enough to qualify for a green card – except for spouses and minor children of U.S. citizens. Strict new limits would apply to U.S. citizens seeking to bring foreign-born parents into the country.

The anti-immigration element of the right is howling with rage.

Senator Jim DeMint (R-SC) complains:

This rewards people who broke the law with permanent legal status, and puts them ahead of millions of law-abiding immigrants waiting to come to America. I don’t care how you try to spin it, this is amnesty.”

Nation Review Online is editorializing against it.

As bad as the status quo on immigration policy is, it is preferable to this bill. Recent improvements in border security have apparently reduced the number of illegal crossings, and well-publicized raids on workplaces can be expected to have a chilling effect on employers who are in violation of immigration laws. But we suspect that this increased enforcement was largely designed to win passage for amnesty and a guest-worker program, and will end once this goal is achieved. We urge senators to cast protest votes against this bill, and House members to do their best to defeat.

And Michelle Malkin is on the warpath.

——————————–

The ravings against “amnesty” are, I’m afraid, ladies and gentlemen, just plain nuts.

Conservatives imagining that the federal government is going to conduct house-to-house searches all over the country to round up and deport every single illegal alien are just as goofy as liberals yearning for house-to-house searches to find and confiscate every firearm in the land.

This sort of thing is just not on.

The kind of draconian measures required to eliminate private gun ownershio, or to deport every illegal alien, are fundamentally inimical to our Constitution, laws, and culture. Those federal agents would run into armed resistance before long in either enforcement project.

What kind of country would we be if we kicked in doors in order to deport poor people who have for the most part come here to do the humble and unpleasant jobs that you can’t find a native-born American to do?

Back before WWII, where I grew up in Pennsylvania, high school kids living in the small towns used to work for the farmers during the harvest to earn pocket money. Does anybody really think that today’s American kids are going to go out and dig potatoes?

America is a nation of immigrants. We have a lot of illegal immigrants today, not because those immigrants are bad people, but because our immigration system and laws have been drastically at odds with economic reality. Americans need, and want, low-priced labor not otherwise available, but Americans (not uncharacteristically) lacked the realism and political will to modify our laws in order to make legal immigration of laborers possible.

I think reforming the system to make it much easier for technically skilled, highly educated people to come here to work is extremely desirable, but we need more unskilled labor than we produce at home, too.

I’m in favor of legalizing illegal aliens, and I don’t have a problem with making them learn to taken an oath in English, and pass a simple test on American civics. On the other hand, the idea of the federal government charging poor laborers $5000 to become citizens is downright nasty, and making those people jump through pointless hoops (like returning to their country of origin) as a mere ritualized procedure is just a sop to the nativist yahoos (Sorry, Victor & Michelle!), which ought to be eliminated.

In general, laws need to reflect reality. When our immigration laws, like our current drug laws or Prohibition in the old days, conflict with the heart’s desires of Americans, those laws will always be found to be less than universally enforceable. Laws which can be only randomly and selectively enforced make a mockery of the rule of law and always lead to widespread law-breaking and to the corruption of law enforcement.

Hillary Clinton’s campaign site is asking readers to help pick her campaign song, suggesting as possibilities:

City of Blinding Lights – U2

Suddenly I See – KT Tunstall

I’m a Believer – Smash Mouth

Get Ready – The Temptations

Ready to Run – Dixie Chicks

Rock This Country! – Shania Twain

Beautiful Day – U2

Right Here, Right Now – Jesus Jones

I’ll Take You There – The Staple Singers

Skippy offers a few alternatives here.

The Wall Street Journal’s Washington Wire blog reports:

Washington Wire came up with several suggestions this afternoon for songs that could be used as Clinton’s campaign song. Sadly, we weren’t allowed to print them, as the editors deemed them “inappropriate” and it was “unseemly” of us to suggest them.

There are some more suggestions in this Shakesville posting’s comments.

My own suggestion would be the song performed on this 2:28 video.

In a move calculated to forestall further inquiries into his thefts and destruction of Clinton Administration National Security documents from the National Archives, Sandy Berger has offered to accept voluntary disbarment.

He hasn’t been practicing law recently, it’s true. But it seems unlikely that he would be so willing to relinquish that valuable professional status without serious concern over what might come out under his own cross examination at a bar hearing.

Washington Times

Samuel R. Berger, the Clinton White House national security adviser who was caught taking highly classified documents from the National Archives, has agreed to forfeit his license to practice law.

In a written statement issued by Larry Breuer, Mr. Berger’s attorney, the former national security adviser said he pleaded guilty in the Justice Department investigation, accepted the penalties sought by the department and recognized that his law license would be affected.

“I have decided to voluntarily relinquish my license,” he said. “While I derived great satisfaction from years of practicing law, I have not done so for 15 years and do not envision returning to the profession. I am very sorry for what I did, and I deeply apologize.”

In giving up his license, Mr. Berger avoids being cross-examined by the Board on Bar Counsel, where he risked further disclosure of specific details of his theft. The agreement is expected to be formalized today.

Mr. Berger, national security adviser from 1997 to 2001, was convicted of removing documents from the Archives in 2005 while preparing to testify before the September 11 commission.

Fined $50,000, sentenced to 100 hours of community service and barred from access to classified material for three years, he also was ordered to undergo a polygraph test if asked — although the Justice Department has declined to administer the test despite urging by Rep. Thomas M. Davis III of Virginia, ranking Republican on the House Committee on Oversight and Governmental Reform.

Failure of school authorities to impose discipline on unruly minority students due to political correctness has led to a legal award of damages to a white female teacher subjected to verbal obscenities in Charleston.

Real Clear Politics:

In a new twist in American race relations, a federal court has ruled that a white teacher in a predominantly African-American school was subjected to a racially hostile workplace.

The case concerned Elizabeth Kandrac, who was routinely verbally abused by black students at Brentwood Middle School in North Charleston. Their slurs make shock jock Don Imus look like a church deacon.

Nevertheless, despite frequent complaints, school officials did nothing to intervene on Kandrac’s behalf, arguing that the racially charged profanity was simply part of the students’ culture. If Kandrac couldn’t handle cursing, school officials told her, she was in the wrong school.

Kandrac finally filed a complaint with the Equal Employment Opportunity Commission (EEOC) and subsequently brought a lawsuit against the Charleston County School District, the school’s principal and an associate superintendent. Last fall, jurors found that the school was a racially hostile environment to teach in and that the school district retaliated against Kandrac for complaining about it.

The defendants sought a new trial, but U.S. District Judge David C. Norton recently affirmed the verdict. However, he did not support the jury’s findings of $307,500 in damages for lost income and emotional distress.

Although Kandrac clearly suffered — she was suspended from her job shortly after a story about her EEOC complaint appeared in the local newspaper, and her contract was not renewed — her case didn’t meet evidentiary requirements for damages. The judge said a new trial would have to determine damages, but the school district and Kandrac settled for $200,000.

Complete article

Daily Express:

School chiefs are today under fire for banning pupils from wearing crosses in class while allowing the jewel­lery of other faiths.

Christian groups and politicians condemned the education bosses and accused them of ­“double standards”.

The officials have told headteachers to ban jewellery except in “exceptional circumstances” when schools need to be “sensitive” towards other faiths. The “exceptions” include lockets worn by Muslims and Hindu bracelets.

But even Muslim leaders have join­ed the condemnation, arguing that all religious groups, including Christian­s, should be treated the same.

The guidance, issued to headteachers in Croydon, south London, has echoes of the row last year over Nadia Ewedia, the British Airways employee who eventually won her long battle to wear a cross at work.

“Where rights are in competition, some rights win out. So we have a situation where gay rights trump Christian rights and in some areas, Muslim rights seem paramount.”

Tory education spokesman David Willetts said: “People who issue these guidelines don’t understand how much resentment they generate by their clumsy attempts to respect every religion except Christianity.” …

A document issued by the Muslim Council this year said taweez amulets have religious significance for those who wear them and should not be considered as jewellery. It said schools should allow the symbols, which contain verses from the Koran, to be worn discreetly

The Croydon school guidance says the religious items that can be worn are: Rakhi, a cotton bracelet worn by Hindus; kara, a metal bracelet put on the arms of Sikh children when they are young and is impossible to remove; and taweez, religious lockets worn by some Muslim pupils on a string around the neck, arm or stomach.

Complete article