Thursday, February 04, 2016

Free Speech and Pharmaceutical Regulation

The FDA kills more Americans every year than motor vehicle accidents do, so it was good to see its grip loosened a little recently. Because of the FDA, it takes something like 10 years and half a billion dollars to get a new drug approved.  In that ten years many people who would have been helped by the drug die.  Additionally, drugs for uncommon illnesses are not even researched, let alone approved, because not enough of them would be sold to recoup the half a billion needed to get them approved.  So the FDA is a huge millstone around the neck of new drug development and a rational government would kill it off

The reason it survives is because the *intentions* behind it are good.  It aims to make sure drugs are safe before people start to use them. But the question is how many lives does it in fact save?  Probably only a few as there is always a great uproar when a drug is found to have adverse effects.  Fear of being sued causes companies to take a drug off the market rapidly.  Vioxx was taken off the market in that way.

So we have to weigh the chance of a few deaths from adverse reactions against the large and steady stream of people who die because their doctors cannot get the best drug for their condition to them.

A better system would be to put in the place of the FDA a "Drug Safety Authority" which would have authority to advise only.  Individual doctors could then make up their own minds and take any risks that might flow from that.  But the article below is from a medical journal and the author just defends the existing system with the usual corny arguments

It should be noted that the drug in contention below has already been certified by the FDA as safe.  After that point the FDA  should surely need strong reasons for further interventions.  Such reasons would not seem to exist in the case discussed below

Recent research has not been kind to fish oil salesmen, or the value of ω-3 fatty acid supplements for the secondary prevention of cardiovascular disease.  Amarin Corporation, in particular, has been hit hard. The company’s only approved product is icosapent ethyl (Vascepa), a prescription-based derivative of fish oil. In 2012, the US Food and Drug Administration (FDA) approved the drug to treat patients with very high triglyceride levels, but the company has long wanted to promote its use in a much larger group of patients: those with lower triglyceride levels and cardiovascular disease who were already being treated with statins.

In 2013, an FDA advisory committee voted 9 to 2 against approval for this use, in part because several recent studies of other drugs with similar effects on blood lipids showed no clinical benefit when they were added to statins.  Amarin’s stock price plummeted, and investors brought suit claiming that they had been misled about the promise of the drug.

In May 2015, Amarin struck back, suing the FDA in US district court in Manhattan, arguing that the First Amendment gives the company the right to market its drug for this broader group of people despite the lack of regulatory approval and the lack of evidence of an outcomes benefit for patients. The company's argument hit at the heart of the drug regulatory system in the United States. For decades, that system has required companies that want to promote pharmaceutical products for new uses to first prove to the FDA that the drugs are safe and effective for these uses.

Amarin argued that this system is unconstitutional, and that companies should instead be allowed to market their products in any way that a judge would consider to be neither false nor misleading. Amarin relied in particular on a recent and much criticized judgment from a federal appeals court, US v Caronia.  That 2012 decision came close to declaring the FDA’s prohibition of off-label marketing unconstitutional, citing recent Supreme Court cases that have strengthened constitutional protections for commercial speech.

In August 2015, the judge in the Amarin case, relying largely on the Caronia ruling, handed the company a major victory. He ruled that the company could market Vascepa for the desired broader population, and make many of the very claims that the FDA views as misleading —claims such as “supportive but not conclusive research” shows that the drug “may reduce the risk of coronary heart disease.” As of December 2015, the FDA had not decided whether to appeal or settle the case.

The stakes are high indeed: the Amarin precedent, if it holds, has the potential to unleash a flood of misleading marketing to physicians. Under Amarin, if a company wants to market its drug off-label, it need only convince a judge, not the FDA, that its claims are not “false or misleading.” In effect, the decision replaces drug regulators with judges—whose expertise in science and medical research varies considerably —when off-label promotion is concerned. The judge in Amarin saw the problem clearly: “You're talking to somebody who has difficulty using a toaster,” he said at the hearing. “I’m the last person who should opine on this.”

It is not merely that most judges lack the requisite training to effectively assess complex drug claims. They also lack access to the necessary data, and the tools that regulators have to evaluate and shape that data. When a company seeks approval from the FDA for a new indication for a marketed drug, it must submit extensive clinical research and trial data, as well as details about the trial design. FDA scientists can therefore reanalyze the data, detect flaws in protocols and case reports, and, when necessary, reject trial results or require more information. A recent FDA review conducted after safety concerns were raised about rosiglitazone (Avandia), for example, involved manual reviews of forms and efforts to collect additional data for hundreds of trial participants and revealed important new facts, including 8 deaths that had not previously been recorded.

The most insidious aspect of the Amarin decision, therefore, is that it undermines the structures that encourage companies to produce high-quality clinical evidence to support new uses of drugs. If the decision stands, companies with a drug approved for one use will have to produce only enough evidence to convince a judge, not the FDA, to market it for additional indications. To be effective, a company’s marketing must also influence the prescribing patterns of physicians.

Although physicians are a more sophisticated audience, they are not in a position to substitute for regulators. Relatively few have training in research methods. Those who do have such training lack access to comprehensive clinical trial data and rely heavily on the published literature, which is skewed toward positive results. In addition, there is a strong and specific association between pharmaceutical marketing and physician behavior, independent of the evidence supporting the products.

The Amarin decision—if it is neither modified nor reversed—may well put patients, and the evidence base for medical practice, at risk. Drugs that are prescribed for unproven indications can cause serious harm. For example, tiagabine (Gabitril), a medication to reduce the frequency of seizures in patients with epilepsy, can cause seizures when used off-label for other indications. Risk-benefit ratios also shift when new uses are contemplated: a drug whose adverse effects may be acceptable when used to treat patients with serious illness may cause more harm than benefit if used to treat healthier patients. Even a drug that is safe, but ineffective, can be harmful, for example if it is used instead of an effective intervention. Because health care budgets are limited, spending on ineffective treatments also squanders money that might be better spent elsewhere.

Does our constitutional commitment to free speech really require this result? Not if the traditional legal standard for commercial speech protection prevails. Commercial speech serves an “informational function” and can be regulated to ensure that the public has access to accurate information. The FDA serves exactly this end. The agency aims not to censor company speech, but to foster the development of accurate and reliable information, and channel that information into settings where it can be rigorously evaluated.

For example, companies are not prohibited from marketing outright. They may make marketing claims if they provide adequate supportive evidence to the FDA. Nor are companies prohibited from conducting research, and publishing such research —whether meeting FDA standards or not —in the medical literature. Indeed, this is encouraged, and companies can distribute reprints of studies directly to physicians, if the publications have certain indicia of reliability, such as having undergone peer review.

The FDA did not appeal the ruling in the Caronia case. The ongoing settlement negotiations in Amarin suggest that the agency may not yet wish to take its chances in the higher courts in this case. At some point, however, the FDA will have to either take the underlying issue about off-label marketing up the chain, to the Supreme Court itself, or lose a key aspect of its regulatory authority by a thousand cuts.

If and when the FDA finally takes a stand, it will need the help of experts who can help judges understand our drug regulatory system and render vivid the acute dangers of deregulation where medicines are concerned.


Sen. Cotton Introduces Bill to Rescind ‘Nonsensical’ Directive on Israel/West Bank Product Labelling

Accusing the Obama administration of a new “effort to put daylight between the United States and Israel,” Sen. Tom Cotton (R-Ark.) on Monday introduced legislation aimed at annulling what he called a “nonsensical” directive on labeling goods produced in the territories disputed between Israel and the Palestinians.

“That directive plays right into the hands of those who are driving insidious efforts to boycott Israeli goods,” he said in a statement.

“There is an effort in some quarters around the globe to delegitimize Israel,” Cotton said. “Those behind it know they are too weak politically and too wrong morally to succeed in quick and dramatic fashion. They instead seek to achieve their aims gradually with incremental steps like labeling rules.”

The January 23 U.S. Customs and Border Protection (CBP) directive reminds traders that goods produced by Israeli companies located in the West Bank or Gaza Strip may not be labeled “made in Israel.” Any that are will be “subject to an enforcement action.”

The State Department says it is merely a “reissuance” of 20 year-old guidance and does not constitute a change of policy.

But its appearance, just days after European Union (E.U.) ministers agreed that products made or grown in the disputed territories and destined for European markets no longer be labeled “made in Israel,” raised some eyebrows.

“This has been reported widely in the Israeli media this evening as a new policy and as some kind of rebuke to Israeli settlement policy,” a reporter pointed out to State Department spokesman Mark Toner at Thursday’s daily briefing.

Toner disputed that, saying the “guidance was simply a restatement of previous requirements.”

He said it was his understanding the guidance was reissued because of “allegations of mislabeling,” received from “around nine or ten” complainants.

“Many countries around the world do this kind of labeling. It in no way represents a boycott or anything like that,” Toner said. He recalled that the State Department said the same thing last month about the E.U. labeling move – that it did not constitute a boycott.

However Toner himself said last November, when the E.U. first approved the changes, that labeling products from settlements “could be perceived as a step on the way to a boycott.”

The U.S. directive does differ from the E.U. one in an important respect: In the U.S., a product from an Israeli settlement in the West Bank must be labeled “West Bank,” whereas in the E.U. the same item must now be labeled “West Bank (Israeli settlement)” or similar.

Cotton said the 20 year-old guidance now reissued by the CBP had rarely been enforced in the past.

“While some say the directive merely ‎restates an old labeling rule originally drafted 20 years ago with no intention to stigmatize Israel, the truth is the rule was lightly if ever enforced and serves little purpose today,” he said.

“Its vigorous enforcement now – coming after a concerted lobbying campaign on the part of groups looking to weaken Israel – will have the undeniable effect of isolating our closest friend in the Middle East and giving other nations an excuse to unfairly treat Israel in trade relations,” Cotton said.

“That is why I’m introducing a bill today to rescind the administration’s nonsensical rule and halt this latest effort to put daylight between the United States and Israel.”


Harry Potter is a conservative

Harry Potter is the most successful book of all time next to Pilgrim’s Progress and the Sear’s Catalogue.

And so, naturally, there is a certain cult, known in his world as Deatheaters, and in our world as Political Correctness, that seeks repulsively to claim that success as their own.A recent article in i09 reports that Anthony Gierzynski, a political scientist at the University of Vermont, found that Harry Potter fans are more open to diversity and are more politically tolerant than nonfans.

The fans are also less likely to support the use of deadly force or torture, more politically active, and more likely to have had a negative view of the Bush administration.From this the conclusion is put forth (in a leap of logic that would make the cow jumping over the moon blush with shame) that Harry Potter draws children toward the political Left.

What an utter load of rubbish.

I have inspected neither Gierzynski’s data nor his methods, but I know blast-ended skrewt dung when I smell it.

Asking on a questionnaire whether one is open to diversity is like asking whether one likes raindrops on roses and whiskers on kittens. And the caricature of conservatives as cretins who applaud deadly force and torture, intolerance and cruelty, is as much of a world make-believe as Voldemort himself.

Finding that no one in real life believes what bigoted leftists pretend conservatives believe does not mean most people lean left: it means leftists are bigots.

It is no surprise that more leftists buy books, including fairytale books, for their children, and pass along their political viewpoints as well. Leftists already live in Cloudcuckooland, which is next door to fairyland.

I suggest that some enterprising political scientist perform a similar study for any book-reading of any kind, not just books about schoolboy wizards, or, indeed, any idle pastime whatsoever. Leftism is found more among idle folk whose mental immune system is weak: among teens, among university professors, and among everyone else who does not work for a living. (And the People’s Republic of Vermont is as thick with the leftism-carrying vectors as a fever swamp with mosquito and tse-tse fly.)

As part of their ongoing attempt to politicize private life, and spread their cult, leftists since the 1930s at least have attempted to import their messages into movies, popular songs, television, everywhere. It is a particular badge of courage to them if they can get a conservative father to buy a book containing propaganda for his child unknowingly.

When a leftist critic calls a book “subversive.” he means it as a compliment. He means that the work undermines the expectations of art form but also that it undermines the current social order, because, to the Left, even art forms, even children’s books, can carry the plague vector of their worldview.

For better or worse, reality is conservative. Because of this, drama in any form tends to be conservative: readers still enjoy reading love stories and heroic adventures. Hence a book like Harry Potter, which is based on archetypes as old as cave paintings — wise men with long gray beards, evil serpents, trusted comrades, the unloved orphan (who, like Hercules or Moses, is chosen by fate to slay monsters or evil lords and save his people) — is innately conservative.

And so, ironically, the faithful leftist reading of Professor Gierzynski’s dimwitted paper, fooled by the pseudo-scientific smell the paper emits, will find the tables turned. It will be the conservatives who cackle when the unwitting leftist buys these magical books for his child. These books teach the most solid and conservative of messages imaginable.

And, no, I do not mean that they teach that intolerance is good and torture is even better. I mean these books show clear and edifying examples of core conservative values in action. Let us list a few:

The families in Potter consist of mothers and fathers, not various partners of various genders engaged in various acts of free love. Ron’s family is a shining example of a loving family, with a father who works and a mother who is willing to face mad witches if need be for her large and well-loved brood. Harry Potter himself is saved by his mother’s love and protected from the evil spells of her murderer.

The government in Harry Potter’s world, as in ours, in inept, corrupt, and regarded as an obstacle rather than the source of salvation. Each boy relies on his own wit and courage and friendships to save himself and to save the world.

The press in Harry Potter’s world, as in ours, is inept, corrupt, and a source of outrageous falsehoods. The main reporter-witch can assume the form of a mosquito.

The moral universe in Harry’s world rejects any form of relativism. There are no shades of gray here, or examples of a thing being right for one group and wrong for another. The ends do not justify the means here either: knowing that Voldemort is also an orphan raised in poverty does not automatically make him one of the oppressed and therefore excused in anything he does, as it would in the left-wing world.

Dumbledore is gay! And the one example in the book of Dumbledore’s love is an evil man who manipulated him. Aside from that, as best the text can show, Dumbledore lives chastely.

Do I even need to say anything about the alleged occultism in Potter? We Christians invented the medieval romance from which the modern novel takes its form, and modern fantasies slavishly copy, including this one. Romance is as Roman as Rome. If you think Sir Orfeo or Orlando Furioso or Le Morte D’Arthur is occult, go find the nearest exorcist: you’re possessed by the imp of stupid.

They keep score in Quidditch. I just thought I would throw that in.

There is no cult of victimology here. Anyone who gets ahead, even the Chosen One, is because he works hard. The Twins open a joke shop when they graduate; they do not go on the dole.

“The last enemy that shall be destroyed is death.” Harry conquers death by submitting to it at Voldemort’s hand, and destroys the Dark Lord by being reborn. He sees the Dark Lord’s soul as the shriveled and pathetic thing it is, not glorious.

Salvation requires sacrifice.

Rules are made to be broken.

A word on this last point. One might think that we conservatives, who are law-and-order types, would object to a book in which the hero defies a government order and trains in secret with his fellow students against a day of war. However, conservatism, if it is anything, is the belief in limited government. We like rebels when the authority oversteps it role and turns corrupt, as it does in Harry Potter, with the various fussy bureaucrats, traitors, and cowards occupying the Ministry of Magic.

Leftism by its nature is totalitarian, since it extends its reach to every element and aspect of life. For leftists, life is politics and politics is life. For them, everything is a political issue, from the weather in the Arctic to the size of your bank account to the volume of your toilet tank to the chemicals in a hairspray bottle to the pronouns you use when the antecedent is unknown to whether a Catholic can refuse to bake a wedding cake for a ceremony that desecrates a sacrament.

In other words, leftists applaud revolution only when it is directed to the overthrow of whatever stands in the way of their socialist utopia. No leftist of which I am aware has ever expressed sympathy and solidarity for Lech Walesa, for the Hungarian Uprising of 1956, for the protesters of Tiananmen Square, for the protest novels of Solzhenitsyn. They applaud Malcolm X and Saul Alinsky. Leftism is statism; whenever the state is growing, leftists frown on rebels. It is only small and healthy states they want rebels to overthrow.

The first thing I ever heard about Harry Potter, back before I had read it, and the thing that most strongly recommended it to me, was that liberals thought it was a bad example to give kids because the young hero defied authority.

Had I known that the book also offered up rather clear examples of Christ-like self sacrifice, self-reliance, and moral clarity, not to mention a pro-family hence antipress and antiauthoritarian message, I would have rushed out even quicker to buy it.

So, adding this all up, I would say these books are about as left-wing as a portrait of George Washington crossing the Delaware meeting Saint Peter walking on the water coming the other way, with Merlin the Magician in the background talking to Aslan the Great Lion.

This book is the opposite of subversive. To subvert means to overturn from below, and make noble things seem base. This story uplifts from above, and uses the dark material of witch and warlocks to fashion a tale of light. Harry Potter overturns expectations of the low, crude,  selfish, and replaces them with the good, noble, self-sacrificing. If I may coin a term, the story of Harry Potter is superversive.


Neo-puritans strive to find offence — anywhere

Janet Albrechtsen writes from Australia:

With January 2016 ticked off the calendar, it’s worth reflecting how the past month has provided a window into the mindset of a burgeoning class of sanctimonious neo-puritans.

A few weeks back, West Indies cricketer Chris Gayle was just about run out of the country after an interview with a female sports presenter where he said: “Hopefully, we can win this game and have a drink after. Don’t blush baby.” Social media went nuts. The media, talkback, feminists went equally manic that Gayle would dare to flirt on camera.

The cricketer apologised the very next day. But that made no difference to the remonstrating neo-puritans. The batting legend was ­labelled a sexist and a creep, his club fined him $10,000, Cricket Australia boss James Sutherland said Gayle’s on-camera flirting was “completely out of line and inappropriate”. “It’s very, very public,” Sutherland said.

A few weeks later, NRL player Mitchell Pearce was caught on a smartphone video behaving like a drunken buffoon at a private party. But privacy made no difference to the censorious neo-puritans. Public lapse in judgment? Private indiscretion? The boundaries keep moving. There but for the grace of God go I has become there but for the grace of an iPhone go all of us. Pearce clumsily tried to kiss a woman who quickly rebuffed him. So he stopped. The half-back then simulated a dopey, jokey sex act on a dog. He urinated on a couch. Dumb and dumber.

But in the minds of the neo-­puritans, there is no room for boofheads anymore. Pearce is a villain. End of story. And villains must be publicly shamed. So there’s endless talk of fines and penalties, contracts cancelled, ­careers over, rehab and counselling. Pearce has left the country. I am deeply uncomfortable to find myself on roughly the same side of the argument as Peter FitzSimons.

But here’s where the Red Bandanna and I part ways. The progressive set that FitzSimons surely calls home is to blame for the rise of the holier than thou neo-puritanism that has tried to destroy Pearce. Australia’s self-appointed moral guardians are having a ­heyday doing what they do so often: dividing the world into victims and villains. But can it really be that simple? There is something truly disturbing about the refusal by these self-appointed moralisers to make room for a few boofheads, be they drunk or flirtatious.

To be sure, no one should celebrate stupidity. Pearce behaved badly. He has to account for that. But the obsession to label every misdemeanour or error of judgment as a sure sign of bad character points to a deeper malaise infecting our society. This false ­dichotomy of victims and villains is creating a sterile, puritanical world where even minor mistakes of judgment are pathologised as serious moral misdeeds.

Witness the weird explosion of academic literature and campus chatter about so-called micro-assaults, micro-aggressions, micro-insults, micro-invalidations and so on and so forth. So you’ve picked up a copy of Hustler magazine and looked at a naked woman? That makes you a perpetrator of “micro-insults” — and a villain. Prefer to be colourblind to race so you don’t define people by their colour? That makes you a perpetrator of micro-invalidations — and a villain. You’d think that the very mention of “micro” points to how trifling this all is. Not in the eyes of the neo-naggers, who can find wrongdoing anywhere they look.

And it’s not hard to trace how we ended up in this realm of the utterly ridiculous. The misguided taxonomy between villains and victims was given a fillip once feelings entered the realm of human rights laws. Once an offending word here or an insulting word there attracted the heavy hand of the law, victimhood became a booming business. And given that victimhood works as a political philosophy only if there are villains, it’s not surprising then that Western modernity is stretching at the seams with newfangled classes of victims and villains.

You’re a Catholic archbishop from Tasmania who produces a pamphlet that defends the trad­itional definition of marriage that has not only existed for millennia but remains the law of the land? Most would think this is a complete non-story within a healthy democracy where freedom of speech and religion are basic rights. Wrong. Under the hectoring neo-puritanism, the law allows anyone offended by that pamphlet to claim victimhood status and, hey presto, the archbishop and his church are cast as villains by a human rights bureaucracy only too willing to play along.

We seem to have reached the point where every transgression from the norm now demands either a victim or villain label. There’s no room for plain difference or straight stupidity any more. And the victim/villain ­dichotomy has reached into ­absurd places when Gayle and Pearce were cast as villains even where there were no victims.

Neither Gayle nor Pearce broke any law. The police were not called. There was no harm done, as John Stuart Mill would have concluded.

The 19th century English philosopher best explained the no harm principle when he said “That the only purpose for which power can be rightfully exercised over any member of a civilised community, against his will, is to prevent harm to others.”

Mill was addressing the importance of individual liberty in the face of state control. These days, the preachy neo-puritans imagine they are the state, imposing their judgments, wrecking reputations and careers because they have identified a villain even where there is no victim. No harm no longer matters to the neo-puritans. The principles that helped drive liberty have been upended.

Last week, the honchos who hand out Australia Day awards tried to further cement the victims and villains narrative into our national psyche when they picked David Morrison as Australian of the Year.

Morrison, a military man, is not regarded as an extraordinary soldier. So why did he get the gong? He gave one famous speech about victims of discrimination (a speech written by his then speechwriter, Cate McGregor, who transitioned from a man to a woman a few years ago).

You might have thought that upon receiving the award, Morrison would defend this great nation, maybe explaining the importance of being committed to Western values such as individual liberty and so on. Wrong again. Morrison’s Australia Day speech was replete with dark talk of victims and villains.

Not surprisingly, those who have fallen for this false dichotomy have bequeathed hero status on Morrison.

Those of us who see through the victim and villain ­baloney see a man of mediocre achievement given an award he didn’t deserve. And his paean to progressive causes is a reminder of how far we have fallen as a proud nation.

The lionisation of Morrison and the concomitant destruction of Pearce suggest it’s high time we did more to keep in check the rapacious colonisation of our communities by the neo-puritans. After all, the freedom to be a boofhead is the other side of the liberty coin.



Political correctness is most pervasive in universities and colleges but I rarely report the  incidents concerned here as I have a separate blog for educational matters.

American "liberals" often deny being Leftists and say that they are very different from the Communist rulers of  other countries.  The only real difference, however, is how much power they have.  In America, their power is limited by democracy.  To see what they WOULD be like with more power, look at where they ARE already  very powerful: in America's educational system -- particularly in the universities and colleges.  They show there the same respect for free-speech and political diversity that Stalin did:  None.  So look to the colleges to see  what the whole country would be like if "liberals" had their way.  It would be a dictatorship.

For more postings from me, see TONGUE-TIED, GREENIE WATCH,   EDUCATION WATCH INTERNATIONAL, FOOD & HEALTH SKEPTIC, AUSTRALIAN POLITICS and  DISSECTING LEFTISM.   My Home Pages are here or   here or   here.  Email me (John Ray) here


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