[Ip-health] Citizens United for BigPharma on drug promotion?
Riaz K Tayob
riaz.tayob at gmail.com
Mon Feb 18 06:35:52 PST 2013
Weekend Edition February 15-17, 2013
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The Caronia Decision and a Culture of Mercantile Nihilism
by HUGH IGLARSH
"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
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 hiiglarsh at hotmail.com
<mailto:hiiglarsh at hotmail.com>. /
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