American Elephants


Schooling the FDA On The Meaning of the First Amendment by The Elephant's Child

_78425952_517716225I’m afraid I’m becoming something of a crank, grumbling constantly about the depredations of bureaucracy. The Food and Drug Administration has believed its powers so encompassing that it can even prohibit drug companies from making true statements about their products unless they are approved by the FDA.

A federal judge has just called this political control a violation of the First Amendment. Once the FDA has approved a new drug for FDA specified uses, physicians often repurpose them in other doses, or for other diseases, or for entirely different patient populations. A drug designed for breast cancer might prove effective against tumors in other parts of the body, or a medicine for adults may prove effective for pediatric care. About one of every five U.S. Prescriptions is for non-FDA approved uses.

In a small miracle, these off-label experiments are legal, and they drive innovation. The artificial conditions that the FDA demands for clinical trials are increasingly divorced from how medicine is practiced, and modern care advances far faster than the FDA’s regulatory molasses. Off-label use is vital for complex conditions like cancer and psychiatric disorders that require trial and error for individual patients, who can’t wait years for the FDA’s blessing.

But the FDA and Justice Department are targeting off-label prescriptions as a threat to their hegemony. Their goal is to force drug makers and physicians to seek FDA approval for every new real-world use, as if it were an entirely new drug. Until recently, drug makers were banned from making off-label claims backed by solid evidence or even from distributing peer-reviewed journal articles.

Prosecutors have also become increasingly aggressive. In 2012 GlaxoSmithKline paid $1 billion for encouraging doctors to use Paxil to treat depression in patients under 18, which research shows helps although the FDA has not endorsed this conclusion. The FDA construes some forms of off-label promotion as crimes, and people are serving jail time.

The nature of a bureaucracy is to grow, prosper, be better rewarded monetarily and extend its reach. Was there ever a bureaucracy that thought that much that they did was unnecessary, and they should probably downsize for the benefit of the taxpayers? I rest my case.

Judge Paul Engelmayer explained to the FDA that if they believed that a different use of a drug gravely undermined the drug approval process, it should have sought review of that decision, not tried to liken distributing information to an assault on their drug-approval authority, and tried to compare it to illegal speech such as blackmail or insider trading. Free speech wins one!

 



Quotation of the Day from Theodore Dalrymple by The Elephant's Child

quote-the-appeal-of-political-correctness-is-that-it-attempts-to-change-men-s-souls-by-altering-how-they-anthony-daniels-psychiatrist-222584(click to enlarge)

Theodore Dalrymple is the pen name of British psychiatrist Anthony Daniels. He was, for many years, a psychiatrist who treated the poor in a slum hospital  and a prison in England. One of his books, (essential), is Life At The Bottom: The Worldview that Makes the Underclass. (2001)  in which he suggests that long term poverty is caused, not by economics, but by a dysfunctional set of values, one that is continually  reinforced by an elite culture searching for victims. This culture persuades those at the bottom that they have no responsibility for their actions and they are not the molders of their own lives.  He writes often at City Journal, where he is an editor and a  fellow at the Manhattan Institute.



Why Is Freedom of Speech So Hard To Understand? by The Elephant's Child

Amendment I

Congress shall make no law respecting an establishment of religion or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press, or the right of the people peaceably to assemble, and
to petition
the Government for a redress of grievances.

So, naturally, Hillary Clinton, who has desperately wanted to be President ever since she failed to be co-president with Bill (because the people of the United States reminded her that she was not elected) announced as the item of first importance in her quest to be the first woman president 23 years later, that she wants to rewrite the First Amendment to get rid of that annoying bit about “freedom of speech.”

If you need extreme evidence of the failure of our schools to teach the history of our country — there you go. Were you taught why the founders came to believe that the Bill of Rights was an essential part of the Constitution that had, at first, been overlooked?  That’s a dramatic story in itself.

The clear lesson of history is that individual liberty,
the basic underpinning of American society, requires
constant defense against the encroachment of the state.¹

Far too many people simply do not understand what the First Amendment is about. They like the idea of free speech until they find out that it means that people can say unpleasant, offensive or even hateful things, and you can’t get the police or the government to force them to stop. (The faculty will probably help). But “hate speech?” Triggering? Free-Speech Zones? Have American universities become only places of indoctrination rather than citadels of free thought?

The Left today has little use for free speech. After all, they used to be plain “Democrats,” then they became “Liberals,” and when that name fell into disrepute they became “Progressives.” They are deeply concerned with the use of language to sway minds. That’s why they are so careful about “talking points.” They don’t want anyone to foul up the conversation by not using the approved words. They get very annoyed when conservatives respond with pure logic, or even facts.

You have probably noticed that Leftists don’t like to be disagreed with. It depends on the particular subject, but in general, the Left approaches problems emotionally. They are deeply troubled by inequality, overflowing with empathy, and want to take all the extra money the rich have tucked away and give it to the unfortunate.

Free speech is under threat today as never before, especially on our college campuses, where students are often too fragile to hear a speaker who might deliver words uncomfortable to tender ears. Banned speakers have been George Will, Condoleeza Rice, and Ayaan Hirsi Ali — brilliant people who have important things to say.

Pamela Geller is a courageous woman who is trying to expose the reality of radical Islam. She helped to plan a Prophet Muhammad cartoon contest that was attacked by two gunmen in Garland, Texas over the weekend. Organizers knew they’d be targeted, but refused to back down.The contest was designed to show the importance of freedom of speech and the savagery of the Islamic State. A policeman was shot, and the two shooters were killed by the police.

Pamela Geller has been threatened with an anonymous message boasting of “71 trained soldiers in 15 different states, ready at our word to attack.”  That’s serious. Judicial Watch has identified an ISIS training camp just 8 miles south of the border in Mexico. Homeland Security denied any such camp, though Mexican authorities authenticated it to Judicial Watch.

What is particularly disgusting is the American media, who attacked Pamela Geller for staging a contest that would offend Muslims, rather than attacking the shooters who claimed to represent ISIS.

That the American media should be so lacking in understanding of the importance of free speech is astonishing, for they are extremely conscious of the freedom of the press, another part of the First Amendment, and depend on it for their livelihoods. But conformity with Leftist talking points trumps liberty every time.

And certainly they are aware of the Charlie Hebdo murders, and the beginning of the cartoon controversy in 2005 as the Danish newspaper published a series of cartoons on September 30, some depicting the Prophet Mohammad as a terrorist with a bomb. If you missed that whole thing, or didn’t understand what the fuss was all about, The Telegraph has published a complete timeline from the beginning at Jyllands-Posten down to today and the shooting at Garland, Texas.

Here’s where it gets really interesting. “The belief that Islam prohibits drawing Prophet Mohammed pervades public debate over what causes “cartoon” violence.

At the root of Muslim protestations is the false belief that Islam prohibits the depiction of Prophet Mohammed. There is no prohibition on creating images of Prophet Mohammed in the Qur’an. Up until the 14th century; such depictions were common in the non-Arab Muslim world. On my website, www.tarekfatah.com, I have posted many depictions of Prophet Mohammed, drawn mostly by Muslim artists. Even if it were true that such depictions were prohibited, the prohibition would not be applicable to non-Muslims.

That article was published in The Toronto Sun, not in the “mainstream” American press. Do read the whole piece from the Middle East Forum. The key sentence: “On the contrary, many Muslims rejected Geller’s right to freedom of expression, admitting that even as Americans they believe there should be limits to free speech enshrined in the U.S. Constitution.”

“Here is the hard truth; that the world contains many cultures inured to tyranny from time out of mind. There are peoples who may long for freedom, but have no practical idea how it can be got and maintained; or if they know, no energy for the task.” ²

¹ Walter Wriston: Risk and Other Four Letter Words
² David Warren
three-man-imprisoned-nearly-40-years-thanks-teenagers-lie


George Will, Who Was Disinvited, Spoke at the Disinvitation Dinner by The Elephant's Child

The William F. Buckley Program at Yale University, sponsored a “Disinvitation Dinner,” in honor of those who our American universities had invited to speak, and then disinvited because some of our precious students had been frightened by the possibility they might hear some words spoken which disagreed with their own. Excellent idea. The dinner, not the disinvitation. Students are enrolled in our colleges and universities because they don’t know much of anything, a fact of which they need be reminded.

George Will gives an excellent speech that is very funny about the very serious matter of freedom of speech, which is under threat today as never before. Make time for this when you can. You will enjoy every minute.



Free Speech Has Been Expelled From Our Universities. Students Must Be Shielded from Uncomfortable Ideas. by The Elephant's Child

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The cries of pain from our coddled college students grows ever more shrill. It would be helpful if the media stopped paying attention. It is not newsworthy. It is largely about a misunderstood First Amendment to the Constitution with which they are seriously, deeply, unfamiliar. Clearly, they have not the slightest understanding of freedom of speech, human nature, nor real life. No wonder they don’t seem to know anything.

The problem is that they are easily offended, and not just that, but they somehow have the idea that they have a right not to be offended. And even beyond that, there is an expectation that they shouldn’t encounter opinions that conflict with their own. And these are supposed to be institutions of higher learning? Jack Kelly wrote at Real Clear Politics:

The Center for Campus Involvement at the University of Michigan recently cancelled a screening of “American Sniper” the Clint Eastwood film about Navy SEAL Chris Kyle. It was cancelled after sophomore Lamees Mekkaoui gathered “roughly 200” signatures (out of a student body of 42,700) on a petition alleging that the film “promotes anti-Muslim rhetoric and sympathizes with a mass killer.”

The Center for Campus Involvement said in a statement “We deeply regret causing harm to members of our community, and appreciate the thoughtful feedback provided to us by students.”

In a recent essay for the Weekly Standard, historian Gordon S, Wood wrote about his own history professor and mentor Bernard Bailyn and the state of history in our colleges and universities. Bailyn got off on the wrong foot from the outset with his “Peopling of British North America Project.” Didn’t he know, his critics carped, that there were people, indigenous people already here before the English came?”

College students and many historians have become obsessed with inequality and white privilege in American society. And this obsession has seriously affected the writing of American history. The inequalities of race and gender now permeate much of academic history-writing, so much so that the general reading public that wants to learn about the whole of our nation’s past has had to turn to history books written by nonacademics who have no Ph.D.s and are not involved in the incestuous conversations of the academic scholars.

But a new generation of historians is no longer interested in how the United States came to be. That kind of narrative history of the nation, they say, is not only inherently triumphalist but has a teleological bias built into it. Those who write narrative histories necessarily have to choose and assign significance to events in terms of a known outcome, and that, the moral critics believe, is bound to glorify the nation. So instead of writing full-scale narrative histories, the new generation of historians has devoted itself to isolating and recovering stories of the dispossessed: the women kept in dependence; the American Indians shorn of their lands; the black slaves brought in chains from Africa. Consequently, much of their history is fragmentary and essentially anachronistic—condemning the past for not being more like the present. It has no real interest in the pastness of the past.

Back at the University of Michigan, the screening was back on a day later. Michigan coach Jim Harbaugh said he would show “American Sniper” to the football team.”Proud of Kris Kyle and proud to be an American,” Mr. Harbaugh tweeted. “if that offends anybody, then so be it.”

Denying free speech is “a horrible betrayal of everything universities are supposed to be about” wrote Walter Russell Mead, a professor at Bard College. But the worst thing about “PC stupidity and mandatory cocooning on campus is…the catastrophic dumbing down of a younger generation that is becoming too fragile to exist in the current world.”

If you expect to get through life without being offended, you’re going to have a hard time of it. Colleges are offering “safe spaces” to students who are traumatized by “microaggressions.” Smith College President Kathleen McCartney apologized for causing students to be “hurt” and “made to feel unsafe” because she didn’t object when a fellow panel member uttered the “N word” during a discussion about teaching “The Adventures of Huckleberry Finn.” Free speech advocate Wendy Kaminer, wrote “It’s amazing to me [students] can’t distinguish between racist speech and speech about racist speech.”

Back at Michigan, the CCI scheduled an alternative film for those who objected to “American Sniper,” a children’s movie about a stuffed bear. When “American Sniper” was screened, the 150-seat room was filled to near capacity. Most applauded as the credits rolled. Only seven students chose to watch “Paddington Bear.”

It is interesting, if appalling, to pay a little attention to the whining students to see just what subjects or what speakers draw the outrage and offense of students, and just who those students seem to be.The Media will not touch that question.They remain unidentified.

ADDENDUM: Christina Hoff Summers of the American Enterprise Institute, also blogs as the “Factual Feminist.” An outstanding scholar, she took on a misleading ad campaign by Verizon which portrays girls as victims of sexism in math and science. Actually, girls are thriving in math and science, and it has nothing to do with sexism. But the precious little girls at Georgetown were “invited to a “Safe Space” if they feel triggered or upset by today’s events. Hate speech will not be appreciated in this space.” Can’t have their ideas questioned. They are victims, and proud of it.



Sensitivity Training 101: Andrew Klavan on the Culture by The Elephant's Child
September 11, 2012, 9:07 pm
Filed under: Islam, Middle East, Terrorism | Tags: , ,


The Heavy Hand of the State Censors A Blogger by The Elephant's Child

Steven Cooksey 51, of Stanley N.C. had diabetes. He was hospitalized in 2009 after his blood sugar spiked. At the time, Cooksey, who works for a medical equipment company weighed more than 240 pounds.  He was, he admitted, in bad physical shape, ate poorly and didn’t exercise.  In the hospital, he was diagnosed with Type 1 diabetes, and was told by a doctor that he would probably be insulin-dependent for the rest of his life.

So he began reading and studying about diabetes and how it is affected by diet and exercise. He discovered that there were many different opinions. He decided on a high-fat, low-carbohydrate diet similar to what stone age men ate with ordinary unprocessed foods like meat, eggs, vegetables and butter. He ate nuts and fruits sparingly. Within a month of reducing his carbohydrate intake, his blood sugar normalized. Cooksey is now down to 163 pounds.

He was passionate about his life-altering change. Cooksey started a website to chronicle his personal transformation. Later that year, he added a “Diabetes Support” life-coaching service, where he charged a modest fee for the same knowledge, opinions and advice he had been giving to his friends for free. He never described himself as a doctor, dietician, or nutritionist, but only offered his own success.

In December, he started answering reader questions in a Dear Abby-style column. A month later he received a notice from the state asking him to stop “providing advice to readers, friends and family in private emails and conversations, and offering a paid life-coaching service.”

The state’s interest seemed to come from a nutritional seminar for diabetics. A director of  diabetic services at a local hospital was the guest and she said diabetics should eat a diet rich in whole-grain carbohydrates and low in fat. During the question and answer session, Cooksey disagreed. Someone filed a complaint saying he was acting as an unlicensed dietician.

The state ordered him to take down the part of his website where he offered his life-coaching services. Um, there’s that little thing about free speech.




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