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“In what follows it should always be remembered that there is no question of illegality involved. Everything reported is strictly legal, just as Hitler’s extermination of the Jews was legal – a little point I mention merely to suggest how much weight one may attach to the notion.”
– Ferdinand Lundberg, The Rich and the Super-rich
It was not an earth-shaking decision made this past December by the Court of Appeals for the Second Circuit in New York, if one goes by the breadth of media coverage. (The Milwaukee Journal-Sentinel’s article being an honorable exception, and the source for many of the facts mentioned here.) But it was certainly a judicial moment to take note of, one of those milestones a society passes as it merrily skips down the garden path toward … what, exactly? That is the question.
And here is the story behind what is perhaps the second worst judicial decision of the still-young century, a nose behind the notorious Citizens United ruling, which begot this horror.
U.S. v. Caronia involves Big Pharma, shedding a gloomier darkness on that already stygian world. Plaintiff Alfred Caronia is or was a sales rep for the wonderfully named Orphan Medical, which makes a drug named Xyrem. Xyrem has been approved by the Food and Drug Administration (FDA) for a restricted use: namely, to treat narcoleptic patients suffering from cataplexy, once known as hysterical paralysis. The laws currently state that doctors are free to prescribe drugs for “off-label” – i.e., unproven – applications. However, drug manufacturers cannot promote off-label uses. Their marketing statements are limited to the range of uses approved by the FDA, based on the results of clinical testing. These have long been the rules of the game.
But minor matters of science, legality and ethics couldn’t stop a go-getter like Mr. Caronia. In his spiel to prescribers, he would make a series of wishfully inflated claims for Xyrem, claiming it could be of use for everything from Parkinson’s syndrome to fibromyalgia to “restless leg syndrome.” He also informed doctors that the drug was safe for patients under the age of 16, although a black box warning printed on the label bluntly states that it has not been tested for safety and efficacy on children. There was good reason to be cautious in this regard, as Xyrem is essentially a gussied-up form of GHB, the date-rape drug of choice for sexual predators.
Some of Mr. Caronia’s mendacious sales pitches to doctors were caught on tape. Unruffled by a situation that would induce remorse in a lesser man, the wayward rep went on the offensive, charging that the regulations requiring strict honesty in his presentations to physicians were a violation of his sacred First Amendment rights, which his ancestors died for at Bunker Hill. Looked at squintingly, as lawyers are wont to do, it was the corporate shill Caronia, and not the children being plied with knock-out drops, who was the real victim here.
To my mind, and I hope to others’, the correct judicial response to this plea would have been a rude chortle and a summary dismissal. But we live in earnest times, when a corporation’s right to pry the last nickel from a prostrate and overdosed public is considered by many (viz. the 47 percent of voters who opted for vampire capitalist Mitt Romney) to be the very keystone of the edifice of freedom. And so the three-judge panel sided with the plaintiff, declaring that “the government clearly prosecuted Caronia for his words – for his speech.”
Only if the liberty-loving Mr. C. had conspired deliberately to mislead physicians could he be considered criminally culpable, according to the appeals court. Merely making crap up in order to move product is a different matter. It shows initiative and enterprise, the things that made America great, or at least America. It is hustle that fuels the system, and the system must be fueled. Above and beyond the myriad statutes and regulations, this law abides, the commandment that trumps all others.
The drug companies practically wet themselves with excitement following the ruling. Law professor Tamara Piety (quoted in the Journal-Sentinel) noted that the decision, if upheld by the Supreme Court, could open the door to widespread television advertising of off-label drug use. (“So go badger your doctor for a prescription for Xyrem, the miracle panacea whose uses are limited only by our marketing director’s imagination.”) No one expected that the Roberts court, the same nine who gave us Citizens United, would have a serious problem with the appellate court’s outcome. And so, with tail between bureaucratic legs, the FDA in January decided not to appeal, whimpering that it does not believe the decision will “significantly affect” the agency’s enforcement of misbranding rules.
Also in the Journal-Sentinel, a drug manufacturer attorney explains with straight face and crossed fingers that the decision will actually benefit the public, as companies could now spread more information about their wares, allowing for more informed decision-making. Who cares whether the information is accurate? Not those who reside in lawyerland, a place of filings and billables, where it is the quantity of information that defines the quality of the process.
Not everyone is joyful, such as those who view patients as vulnerable, suffering human beings, not as faceless, pill-popping customers. In the article, psychiatrist Andrew Kolodny observes that “A large portion of Americans are already taking drugs with serious risks that outweigh the benefits…. It’s a safe bet that health outcomes will decline from medication side effects, while spending on prescription drugs will continue to rise.”
But what Dr. Kolodny forgets is that drugs are commodities, and it is the exchange of commodities in itself that creates human happiness, according to the tenets of neoliberalism – the more action the better. From this viewpoint, the harm caused by misuse, overuse and abuse of by-prescription medicaments is really an economic boon, spurring spin-off growth in such fields as emergency room care and rehab/detox clinics – not to mention the nation’s entrenched and powerful funeral home and cemetery interests.
From a historical perspective, the ruling shows that we have come full circle from the days of the snake-oil salesmen, who would have warmly welcomed Mr. Caronia into their supple-tongued fraternity. Drug marketing back then was the original infotainment, and if the salve or bolus or tincture you bought didn’t actually cure your (and/or your horse’s) lumbago, ague, catarrh or vapors, it probably didn’t do that much tangible harm. The salesman’s lilting patter brought a momentary relief from boredom and isolation, the true chronic ailments of rural and frontier life.
It was to liberate us from the mercenary chaos of snake oildom that the progressive Pure Food and Drug Act came into being in back in 1906, creating the FDA regulatory apparatus, which now seems to be fading into legal twilight after a century-long run. Born about the same time was the so-called “ethical” drug industry, the corporatized and ostensibly truth- and science-based successor to the medicine wagons. These enterprises were granted sole access to the pharmaceutical marketplace in return for a noble promise to do real research, to act more or less professionally, and not to peddle amusingly advertised flimflam.
Business being business, plenty of hooey has since been made and sold, but at least the ideal of honesty had been introduced to a lucrative and politically potent industry, and the public enjoyed at least a modicum of protection. The fundamental contradiction of regulation in a capitalist state, where the state attempts to play the roles of both referee and cheerleader to industry, is painfully evident in the FDA’s history. Still, a system was in place, with genuine and citable standards, protocols, expectations.
A good thing, because nothing is as deadly as an “ethical” drug. As Colonel Eli Lilly, founder of the eponymous drug firm, said back in 1876, “Any drug without toxic effects is not a drug at all.” The old snake oil was generally a fairly benign product of nature, dissolved in a soothing base of purest moonshine. The new synthetic drugs that supplanted them derived from coal tars, mustard gas, pregnant mare piss and other similarly unpalatable stocks. “Ethical” drugs are said to kill perhaps 100,000 American per year, unlike “unethical” snake oil, which may have left many unhealed, but very few dead. As Colonel Lilly observed, prescription meds are occasionally beneficial poisons which, in a rational society, would be prescribed and consumed with a cautiousness bordering on paranoia.
Post-Caronia, we have the worst of both worlds: snake-oil rules in a Thalidomide, Fen-Phen, Premarin game.
The court ruling raises questions that go beyond the medical and into the heart of our political situation, as a business-based civilization. What does it mean exactly to say that a corporation, which is to say a notarized piece of paper in a lawyer’s office in Delaware or Luxembourg, possesses freedom of speech? Did the Founding Fathers really intend the First Amendment as a way to protect the right of salesmen to fabricate their way to higher commissions, and of CEOs to collect even more obscene quarterly bonuses, by whatever means necessary?
Free speech is the foundation of democracy, allowing all those oppressed by power to articulate their grievances and so exist as citizens, not kowtowing subjects. Right now, in the age of fracking, Citizens United, the Koch brothers, “ag-gag” laws and Astroturf politics, power is corporate and financial in essence, and corporate might is the hand that pulls the strings of state. And so it follows that at this moment, the true purpose and highest use of our First Amendment birthright is to fight the encroachment of corporate dominance and its ongoing corruption of government, not to enable its abuses. The depth and totality of money’s dominion, and the abjectness of any opposition, is illustrated by the Caronia decision, which would hardly have been imaginable not all that long ago. The court here declares that its job is not to protect citizens from corporate malfeasance, but rather to protect from legal interference the corporation’s presumed right to lie and chisel.
How could the jurists who condoned such lawlessness have made such a determination, one so indifferent to social context and consequence, so divorced from humanity, integrity, common sense? What ethics did they absorb over the course of their training and career? U.S. v. Caronia is a textbook product of our morally emptied time. The underlying logic has the trendy smell of postmodernism, a suggestion that science, business, laws, society are in the end arbitrary signifiers, mere words subject to the whims of textuality, floating at an ironic distance from any real-world anchorage. One wonders what were the names of these three justices – Derrida, Foucault, de Man?
No, they were just Larry, Curly and Moe, stooges of a soulless system, black-robed lords of misrule, working to reduce crime by declaring even the most flagrant abuses legal. But of course this judicial leniency applies only to the one percent, to the masters of commerce and the bringers of its many blessings, including the duplicitous hawking of dangerous drugs. It is the strong and powerful who must be treated with kid gloves, lest they take those blessings away.
But this is comedy of a dark and sad sort. The Caronia decision reflects and reinforces a culture of mercantile nihilism, in which ethics and values have been inverted and monetized to the point of suicidal absurdity. It is the public that has been quietly date-raped here, inveigled and violated by a legal apparatus that passes judgments in our name, while in thrall to predatory private interests. How can one feel anything but contempt for a judiciary that openly sides with the wolves against the sheep, and that interprets our most essential guarantee of freedom as a shield for hucksters?
Caronia is a reminder of just how powerful the undertow of history is right now, pulling us back toward a Gilded Age indifference, or rather “freedom to choose,” as it’s called by the wealthy beneficiaries of bad government. It is a working out of the dire logic of Citizens United, in which the sociopathic legal ciphers known as corporations are treated as rights-bearing citizens – a process that turns flesh-and-blood citizens into ciphers and powerless victims.
The decision reveals an injustice system whose function is to provide legal cover for the excesses of the corporate elite. Caronia is a wake-up moment, announcing that the institutions and the philosophy that sustains it are broken, maybe beyond repair, and must be replaced now, while we’re still standing, by new social forms imbued with sane and humane values. The process begins with the realization, born of one too many official lie and betrayal, that the status quo is not merely dysfunctional and corrupt, it is crazy and dangerous. U.S. v. Caronia is that moment for me.
Hugh Iglarsh is a writer, editor, critic, satirist and citizen based in Chicago, who writes on American politics, healthcare, culture and other symptoms of decline. He can be reached at email@example.com.