Archive for 2016
January 26, 2016
RICHARD EPSTEIN: THE OTHER DRUG WAR:
Earlier this month, the Food and Drug Administration rejected the application of Biomarin Pharmaceutical to market its drug KyndrisaTM (drisapersen) for use in the treatment of Duchenne muscular dystrophy. The FDA, as is often the case when it rejects a drug application, listed all sorts of technical reasons why the data presented was not sufficient to establish by respectable scientific means that the drug in question was safe and effective in its intended use. Without question, much evidence from the clinical trials revealed serious complications from the drug’s use, including blood-platelet shortages that were potentially fatal, kidney damage, and severe injection-site reactions. But the no-treatment alternative could prove far worse.
Duchenne is a rare but fatal genetic disorder that attacks only young boys, roughly 1 in 3,500 to 5,000. Typically, it first manifests itself between two and five years of age. With time, it relentlessly weakens the skeletal muscles that control movement in the arms, legs, and trunk. Most of its victims are wheelchair-bound between the ages of seven and 13. By 20, many have died.
The source of the problem is the absence from the cell of the key chemical dystrophin, which is needed to control muscular movement. The proposed treatment is known as “exon-skipping,” which allows the body to produce the needed quantities of dystrophin. At present no drugs are on the market to fix the genetic defect. But other drugs are also under investigation. If the door is closed for drisapersen, it remains ajar for an unnamed drug produced by Sarepta Therapeutics, which will be reviewed by the FDA shortly. But, based on early rumblings from the FDA, it is likely that this drug too will be kept from the marketplace.
As might be expected, the decision by the FDA has left parent groups and their physicians tied up in knots. You can get a sense of their frustration by looking at the desperate petition of a mother whose son has the disease. Tonya Carlone wrote a public letter to the FDA pleading for the drug to be allowed on the market: “This medication has allowed my son, Gavin, to be able to ride a 2 wheel bike, to play on a soccer team, to run and play with his healthy 10 year old peers. Dr. Craig McDonald of UC Davis Medical Center and a Duchenne expert of over 30 years, has stated that he has never seen a boy with Duchenne at the age of 10 have as much function as Gavin.”
All irrelevant, says the FDA. But it’s critical to understand why parents like Ms. Carlone and physicians like Dr. McDonald are right and why the FDA is dead wrong. The FDA thinks the problem lies in the merits of a particular drug when it really lies in its deeply flawed approval process.
It’s not at all clear that the FDA has saved more lives than it has cost.
QUESTION ASKED: Why can’t Donald Trump handle Megyn Kelly?
IN THE MAIL: Spitfire!: The Experiences of a Battle of Britain Fighter Pilot.
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TAXPROF ROUNDUP: The IRS Scandal, Day 992.
DE BLASIO’S NEW YORK:
Perhaps the City Council should be thinking about making it easier for New Yorkers to start a business before it makes it easier for them to do their business on the street.
Silliness aside, there are real risks involved with the kind of policy change the Council is considering, especially in a year when many cities around the country have seen a spike in violent crime rates. If enacted, the measures would amount to a partial rollback of “broken windows” policy, which is the idea that police departments should aggressively enforce “quality-of-life offenses,” like public urination, on the grounds that public disorder foments more serious criminal activity. There is, however, evidence that these policies have worked over the past quarter-century.
The New York Times editorial board supports the measures because they could “ease the burden of overpolicing in communities of color.” Maybe—but police reformers shouldn’t get ahead of themselves. Broken windows policies made America’s cities much more livable, and probably had a substantial impact on crime rates. If crime rates aren’t falling—or at least stable—the demand for “overpolicing” could come back with a vengeance.
Let the blue zones experiment on themselves.
VLADIMIR PUTIN’S SECRET BILLIONS:
Vladimir Putin has a vast personal fortune and may be one of the richest men in the world, according to a number of former Kremlin insiders.
From their exiles around the world, they spoke to the BBC for a Panorama investigation into the alleged corruption of the most powerful man in the world. Here’s what we learned.
Sergei Kolesnikov told the programme he worked for the Kremlin to collect money from the super-rich, which they believed was to be spent on healthcare, but which was ultimately used “to help build a $1 billion palace for Putin on the Black Sea coast”.
The BBC said it had seen documents from one of the offshore companies that diverted millions of dollars to the palace, which was constructed during Putin’s first term as president.
It said that, according to Kolesnikov, the owner of the company, Lirus Investment Holding, was Putin himself.
It’s good to be the Czar.
THEODORE DALRYMPLE: The Preposterous Nonsense Known as Homoeopathy.
ROGER KIMBALL: Inside The Media’s Myth-Making Machine. “The worst thing about Barack Obama’s legacy is not any particular policy or program. You might think, as I do, that Obamacare is a disaster, that his foreign policy has been criminally inept, and on and on. But when Obama stood before his adoring fans in 2008 and promised that he was on the threshold of ‘fundamentally transforming the United States of America’ he didn’t just mean he was going to advance a certain legislative agenda. He meant that he was going to upend the way the United States had been ruled since 1787. The Founders of America bequeathed us a Constitution designed to limit executive power and provide important protections to citizens against the coercive power of the state. Obama has assaulted those protections at every turn, ignoring Congress and governing partly by executive fiat, partly by the alphabet soup of regulatory preemption, i.e., through the instrumentality of unelected bureaucrats who have enormous power over you but are almost wholly unaccountable.”
BOB MCMANUS: Why Bloomberg might try his luck in a White House run. “In a very real sense Bloomberg is Trump’s lace-curtain cousin — more dignified, with a credible resume and vastly more wealthy, to be sure, but he’s also an ego-driven usurper with more money than he could ever spend and no accountability to a grassroots political infrastructure. There’s seductive freedom in all that, even as the lack of such an anchor could be downright dangerous in the unlikely event that Bloomberg were to catch some real traction.”
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PUNCH BACK TWICE AS HARD: Student Unjustly Suspended by University of Tulsa Announces Lawsuit.
In 2014, Barnett’s then-fiancé—who was not a TU student—criticized two TU professors and a student in Facebook posts tagging Barnett or written directly to Barnett’s page. Susan Barrett, one of the professors mentioned in the posts, filed a complaint against Barnett, claiming he should be held responsible for his fiancé’s posts.
In September 2014, TU Senior Vice Provost Winona Tanaka notified Barnett of the complaint and imposed eight harsh interim measures against him, including removal from three classes and a theater production he was involved in, as well as a ban on communicating with certain faculty members. Less than a month later, Tanaka found Barnett guilty of harassment without providing him the hearing he was entitled to under TU’s policies. She also found him guilty of retaliation for discussing the complaint with his fiancé, who had provided Tanaka with a sworn affidavit stating that he, not Barnett, wrote the posts. Barnett was informed that, as punishment, he would be suspended until at least January 2016, and that he was forbidden from receiving a degree in his major from TU.
Tulsa is affiliated with the Presbyterian Church (USA). Its President is Steadman Upham.
RUSH LIMBAUGH ANNOUNCES POSSIBLE LAUNCH OF OPERATION CHAOS 2: The main difference is instead of helping Hillary as in the original, this time the purpose will be to boost Bernie Sanders.
UH OH: Clinton losing support among N.H. Dems, Sanders ahead by 16.
Meanwhile, the National Enquirer identifies another problem for Hillary — losses in New Hampshire, gains everywhere else:
ELIANA JOHNSON: Why Ted Cruz Thinks He Can Win A General Election.
Since his election to the Senate in 2012, Cruz has argued that center-right candidates such as John McCain in 2008 and Mitt Romney in 2012 demoralized conservatives and kept them away from the polls; run a right-winger who can energize them, he promises, and the resulting outpouring of enthusiasm will carry Republicans to victory. Cruz and his team have talked endlessly about the power of these missing conservative voters, and their theory remains the subject of considerable skepticism in the political class. And yet, Cruz heads the most data-driven campaign in the GOP race, employing cutting-edge technology to profile, target, and turn out supporters. Statistical awareness permeates the culture of the operation from the candidate to his most junior aides. And Cruz’s top advisers, speaking strictly on background, say the Texas senator’s controversial claims about the untapped conservative masses — along with many other calculations and assumptions the campaign is making about the upcoming election — are far from conjecture.
Well, Cruz is a smart guy, but who knows? Mitt Romney’s a smart guy too, and his strategy didn’t work out.
EVERGREEN HEADLINE: The Washington Post Runs a Front Page Hit Job on Marco Rubio.
THE SERVER IS THE SMOKING GUN: “One doesn’t spill classified material into an unclassified system accidentally or through mere negligence. What these new revelations show—if they are true—is conduct that was conscious, intentional, and felonious as all get-out.”
NOW THAT’S THE SPIRIT: Georgia legislator: Adopt due process protections or forget about your budget.
A Georgia legislator responsible for appropriating state funds to colleges and universities is threatening to halt budget discussions with his state’s schools unless they adopt basic due process protections for accused students.
State Rep. Earl Ehrhart, chairman of the Appropriations subcommittee on Higher Education, told college presidents in no uncertain terms to adopt such protections.
“You think you’ve got an issue with federal bureaucrats threatening your federal funds?” Ehrhart said at the close of a hearing on due process. “This committee controls your funds, Mr. President, and I want to see a clear statement from all of you — beyond what the [Board of] Regents is requiring — before I’m even going to have a conversation with you about your budgets, presidents.”
Ehrhart said he wouldn’t even talk to college presidents until they adopt “simple, basic due process protections.”
“If you don’t protect the students of this state with due process, don’t come looking for money,” Ehrhart added.
This is the clearest declaration by any legislator in the country regarding the protection of due process rights for students accused of misconduct on college campuses. The hearing on Monday focused on two cases at Georgia Tech, one involving accusations of racism and the other involving an accusation of sexual misconduct.
In the racism charge, a student accused members of a fraternity of hurling racial insults at her. Jonathan Hawkins, the fraternity’s attorney, testified that Georgia Tech investigators ignored evidence that showed the incident could not have occured, including surveillance video showing the accuser walking past he fraternity without incident, and witnesses who were there that day and saw nothing. Given the lack of evidence, and because Georgia Tech couldn’t identify any individuals responsible, they punished the entire fraternity.
The mother of the student accused of sexual misconduct also spoke. She told a story of her son helping a drunk woman home when she had lost her key. The accused student let the woman wait at his apartment until her roommate returned home to let her in, so that the woman wouldn’t be alone outside in the cold. Sometime later, another young woman accused the student of holding the alleged victim against her will, despite text messages from the drunk woman thanking the accused student for his help.
The text messages were not allowed as evidence in the hearing. Even the alleged victim didn’t even believe she was the victim of anything. Yet on the word of a third party, the accused student was suspended.
This is outrageous, and the legislative response is well warranted. More like this in other states, please.
HOW DONALD TRUMP IS EXPOSING MEDIA’S DIVERSITY PROBLEM:
Trump’s rise has exposed a gap between the views many Americans hold, and those that are commonly aired in the media. Williams says, “[Trump] is forcing America to realize that there is a large group of Americans who are skeptical of the media, of policy experts, who believe that blunt criticism and simple policies (oftentimes targeted towards marginalizing less powerful groups) would be better for America. And for the moment, those people love Trump for legitimizing their views.”
Setting aside the portentous virtue-signalling that runs throughout the article, it’s sort of amusing for the Atlantic to discover the quantum of an aura of a penumbra of how media bias angers so many readers — a decade after jettisoning Mark Steyn’s monthly column for the Faustian bargain of leftwing blogger Andrew Sullivan and his blog’s Web traffic, only to see Sullivan morph into the World’s Most Legendary Uterus Detective and immediately become, as Jonathan Last described the publication in September of 2008, “a laughingstock.” Their ill-conceived dalliance with Scientology in early 2013 didn’t help matters.