The Devil’s Disclaimer

Editorial Note: The marketing of pharmaceuticals avails of something given to no other area of marketing – the product is made available on prescription-only.  In this post Johanna Ryan, from RxISK’s Community Advisory Board, spells out the risks this gives rise to. This is a theme that has come up often and one we will return to. 

Direct to Consumers? 

If you live in the USA, I don’t have to tell you about Direct-to-Consumer Advertising of prescription drugs. You’ve seen the TV spots all the time, introducing some disease that sounds awfully serious but whose symptoms are broad enough that you start wondering if you should “Ask Your Doctor.”

Then you hear about the wonder drug that is helping sufferers Get Their Lives Back. Happy couples stroll hand-in-hand through meadows or romp with their adorable children … while a polite voiceover tells you about vague but ominous side effects, from strokes and cancer to “certain fungal infections.” (And of course, those alarming “erections lasting more than four hours” which have become a staple of TV comedy thanks to DTC ads for Viagra and Cialis.)

Many of us suspect the drug’s advantages are being oversold and its risks artfully downplayed. But we also assume there must be at least one thing restraining all that hype: If patients run to the doctor asking for the drug, and suffer harm as a result, won’t that rosy TV ad be playing for a jury somewhere soon? Surely they can sue the drug company!

Cynthia DiBartolo

Actually, no, they can’t. An earlier column on this blog told the story of Cynthia DiBartolo, who developed head and neck cancer after treating her psoriasis with Humira, a widely advertised biologic drug made by AbbVie Corp.  If you don’t live in the USA, you may be amazed by this sample ad for Humira aimed at women with psoriasis.

Ms. DiBartolo faces an uphill fight for justice because of something called the “Learned Intermediary Doctrine,” which holds that AbbVie’s only responsibility is to inform the doctor of all the relevant risks – not the patient. No matter how aggressively a drugmaker advertises, they can still leave the doctor holding the bag for their failure to warn the patient. In recent years the Texas Supreme Court upheld this doctrine even in the case of a woman who watched a drug-company video at the clinic where she got her first IV infusion of the drug (Centocor, Inc. v. Hamilton, 55 Tex. Sup. J. 774). And in Illinois, a man whose doctor sent him to a patient-education class taught by a drug-company nurse was not allowed to sue the company for its failure to warn him of the risk of blindness (Hernandez v. Schering Corp., 958 N.E.2d 447).

Given the odds consumers face, perhaps these ads ought to come with their own set of warnings. Here’s my proposal for a “Devil’s Disclaimer” to run with American DTC advertising[1]:

  THE DEVIL’S DISCLAIMER FOR DIRECT-TO-CONSUMER ADVERTISEMENTS IN U.S.A.

If you should experience any adverse effects from this medication, please note the following legal disclaimer:

Don’t Come Crying To Us. Legally Speaking, It’s Not Our Problem.

It’s true, we have used this ad to approach you about your personal medical problems while you were innocently leafing through a movie-star magazine or surfing the Net. We seem quite warm and friendly. And we have supplied you with a long list of possible side effects and contraindications, via the small print or the mellifluous voice-over.  (Not that you know what a contraindication is, you poor sucker.)

However, we do not and never will have a Relationship with you. So, it’s been nice getting to know you  – but no commitments, baby.

It’s not just us saying that either. The courts of just about every state in the nation are backing us up on this. So don’t go muttering about your father the police chief or your sister the lawyer. They can’t help.

Specifically, if you want to get all technical, we have no FIDUCIARY relationship with you. That’s the kind of relationship where we’d be expected to look out for your welfare, with the same degree of care that a reasonable person would devote to their own affairs. That’s up to your doctor.

All we’re obliged to do is give your doctor all the appropriate warnings, and let him sort it out for you. He’s the one that’s supposed to care, according to the courts. (Yeah, that guy – the one you just picked off the insurance company list. You can’t remember his name, and he can’t remember yours. But we’ve been snuggling up to him since he was in med school.) He’s in charge of digesting all that information, and thinking hard about how it applies to little ol’ you.  And he’s the one we think you should sue if things go wrong. Let us know how that goes for you, okay?  LOL.

And what if we don’t tell him everything? What if we’re manipulating what he sees in his doctor journals and his continuing-ed seminars, just like we do with that celebrity magazine you were skimming? Oh, don’t worry. The FDA will make sure we do the right thing. (We know, because nowadays we pay the bulk of their salaries. Betcha didn’t know that.) And if the FDA doesn’t catch us, then we’ll definitely pay some kind of fine in nine or ten years. That’ll keep us in line for sure! ROFL.

So don’t come around whining that we promised you this, we promised you that. To quote that old country song, Here’s A Quarter, Call Someone Who Cares.

Or as we like to say: Ask Your Doctor.

LMAO,

<<Insert name of drug company>>


[1] Here is the actual disclaimer posted on one of AbbVie’s websites:

“The content on this site has been created solely for U.S. residents. It is intended for informational purposes only and should not be used to replace a discussion with a health care professional. All decisions regarding patient care must be handled by a health care professional, and be made based on the unique needs of each patient.”


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You and your meds. Give the real story. Get the real story.

Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. This disclaimer gives me the creeps but does very well iterated how devilish the whole system is designed and how people get helplessly trapped after gettiin into the hell of SSRI withdrawal or other adverse drug effects.

    It exactly describes the merry-go-round I went into after issueing complaints at several watchdog-offices here in the Netherlands, namely LARBE, CBG and IGZ.

    After my complaits at Seroxat-manufacturerer GlaxoSmitthKline was heartlessly dismissed my them and my files closed, the next stepts was reporting at the perviously mentions offices, who all refused to answer my questions, refused to offer me help in forcing GSK to react and offer compensation, and indeed, in the end always came with the “talk to your doctor” mantra!

    I still am busy coming to terms with the undescribable damage Seroxat did to me (and many others) and the total lack of understanding and cooperation of all offices who appear to be nothing more than teethless toy dogs of those Big Pharma mafia-companies.

    It really make me feel that our Western civilization is one big farce and even in countries like the Netherlands, Sweden and England, corruption fares well and criminal companies have more power than the governments. Or the gonverments are formed by politicians who opt for a job at those same companies after their political career… Who knows?

    Dr. Healy is one of those who stands up and I would like to follow his example, unfortunately I am no doctor or lawyer… But thumbs up for him!

  2. Let us talk about being a professional patient.

    I am a professional.

    I am also very patient.

    Let us play the devil’s advocate.
    Why do I feel like I have been through a kangaroo court?

    My medical records are two inches thick. I am 62.

    My medical records, since 1964, are in my possession.

    They sum up my complete medical history since the age of 13.

    Things that went wrong for me during my journey through the National Health System.

    A tonsillectomy which went terribly wrong and at home I disgorged a huge ball of blood and I had to be re-admitted.

    A cervical cancer scare which went terribly wrong and after lazar treatment a huge ball of blood fell out of me and I had to be re-admitted.

    An ectopic pregnancy where my fallopian tube was removed and I nearly died before I was admitted to hospital.

    A huge parotoid gland was removed from deep in the jaw and I just about escaped a total collapse of my face due to a genius surgeon with a twelve hour operation.

    A bunion operation collapsed and the screw fell out of my foot and I had a piece of bone taken from my hip in a very clever and successful operation.

    Following delivery of my baby I had acute piles.
    The operation went wrong and I haemorrhaged at home and returned to the hospital.

    And, during all these difficulties, I was a professional patient and I was looked after by professional medical people who were always polite and respectful and kind.

    Fast forward to 1988 and for some reason I was given Imipramine.
    Things took a nasty turn when I became ‘emotionally labile’ and I met an up to date psychiatric professional who told me to stop taking it. I was ‘vaguely suicidal’. I didn’t know why, but, he, clearly did.
    “weepiness, impaired concentration, anorexia, disturbed sleep with intermittent wakening *terrified all the time*.
    No, Imipramine, for her, this drug is well known for causing intolerable symptoms, in some patients.”

    Fast forward to 2000 and for some reason I was given Seroxat.
    Things took a nasty turn when, for some reason, a doctor in a surgery started to screech and scream at me when I visited her over 40 times, in six weeks, complaining of side-effects from Seroxat. Very similar side effects to Imipramine.

    I did not screech and scream back. I was a professional patient.

    I was very used to things going wrong and taking a nasty turn.
    Even, a terrible telephone call when I was 20 weeks pregnant, with a hysterical woman who warned me I had a 1 in 64 chance of having a down’s baby, although, scary, did not make me hysterical. If the baby was a down’s baby, I fully intended to keep it.
    I was nervous, everyone wants a healthy baby. She was a stunningly perfect baby.

    My experiences with both Imipramine and Seroxat measure one quarter of one inch in my two inches of surgical brilliance, but, with, unfortunate accidents and how I was repaired and looked after. I had no reason to complain, I was grateful.

    During the course of the Seroxat scenario, I met not one helpful and caring doctor. I found myself in front of no less than 20, twenty, I repeat, 20, medical personnel in the space of just eight weeks. What a stir, I seemed to cause.
    All discussing me like an inanimate object. They all got a page in my medical records; all banging off their theories about my Seroxat scenario. But, it wasn’t Seroxat they were talking about. It was me under the spotlight.

    Seroxat was never repaired and has been the only time in my entire medical history, when things took a nasty turn and I was left to bleed to death.

    Interesting isn’t it. When the going get’s tough, the tough get going…………..

    Tied to the spinning wheel where the magician throws the knives, just missing the jugular and the audience gasp at the cleverness of it all.

    If I had wanted assisted euthanasia, I would have asked for it.

    Klaas, the doctor nor the lawyer took Seroxat, we took it and we are quite capable of dancing with the devil and creating some sort of victory……it’s just a matter of perseverance.
    You are far from alone in trying to get a handle on it and very well done for complaining. You may think you are not making a difference, but you are. We are nice people, innocent people, that is the devilish tragedy.
    Slange Var.

  3. A law that exists to protect the pharmaceutical companies and their profits but dismisses the damage done to many is surely a bad law. Haven’t bad laws been broken and replaced before?

  4. The problem is: who makes the laws?
    Laws are created by politicians who often have a double agenda. Here in the Netherlands, many politicians get a well-paid job at a bank, oil company or pharmaceutical company after their policiar career. In onther countries this will probably be the same.

    And that is the difference between a politician and a statesman, most politicians are in it because of their career, a statesman really wants to make a difference for his people.
    We would need statesmen who are not afraid of the power and money of these so-called pharmaceutical companies who are not better than murder-for-profit mobs. And have the guts to dismantle them and put the biggest criminals in jail for a long time, if possible under a forced regime of their own “wonder drugs”.

    My hope is that the awareness is rising now and more and more people begin to see the light about medicine and SSRI AD’s in particular.
    Annie, indeed we can make a difference. Itonly feels each time as a slam in the face when you put a lot of effort in issuing a complaint, add articles and user experiences, only to get 1 lines back which do not address one of your points.
    But when more and more people speak out, things will change on day.
    I keep healing and believeing!

  5. I’ve lost much respect for the medical system because of priority marketing of pharmaceuticals over actual concern for the patient. I’m one who has experienced negative side effects of prescription meds, including SSRIs. Quite frankly, I’d take my chances with a tribal Shaman or believe in elves before I ever go back to the medical system I encountered again. People are more than a label; or at least they should be, but don’t tell American psychiatrists that because psychiatric labels are forever. They say love is supposed to be for life. Psychiatry isn’t a discipline based on love in my experience; it is based on selling pharmaceuticals and telling people who they are based on limited or no knowledge of the actual person. I am and always have been ultra sensitive to medications and vulnerable to negative side effects. I don’t like being mistreated. I don’t like being lied to or having my civil liberties violated. I haven’t seen any doctor in many years now because of my experiences. Whatever is left of me, is just too precious to me, even in it’s dilapidated physical state, to expose to the wrecking ball of modern medicine.

  6. It is not right that we fear going to a doctor because of what we might be given having experienced such profundities as life-threatening experiences.

    I have held back because I have been so intimidated by such awful people who don’t seem to realise that it is healthcare they are subjecting us to, not a reason for them to protect their own backsides.

    When I approached the top legal conglomerate in Glasgow with an obvious piece of dirty work by a doctor I was greeted with enthusiasm and the lady lawyer said wow, you have some case here.

    And what stopped it in its tracks? My medical records had to be sent to a recommended general practitioner, for her opinion, as to my allegations, of serious misconduct from a gp who allowed me to nearly die from Seroxat withdrawal over the course of eight weeks.

    Klaas, slapped in the face each time is tricky.
    The legal gp said she had never, ever, remotely, heard of anyone suffering any ill effects from Seroxat.
    She said my doctor had clearly spelt out huge problems in my life and that, basically, the doctor has the upper hand in all judgements.
    Va Va Voom See red, I did.

    I had waited five months for this to land. This legal gp had not even met me?
    It was snuffed out before it even began……

    Since when does a doctor have a legal right over anyone?

    It is barbaric and indeed laws need to be changed.

    The huge network of surgeries all over our country are not doing us any favours and if one more person says to me, I think you should take a statin, at your age, I swear, I could almost sock them one……or, realistically, have you not bothered to read my medical records??????????

    Seroxat, anyone?
    Isn’t it time that the Seroxat Scandal was exposed?

  7. Annie, Klaas, so much suffering, so much awareness, so little action, someone must be responsible -legally. This surely cannot continue. See Mad in America -Maria Bradshaw – Challenging The Status Quo and response from Mary. At least the Irish government has been well informed but to date zilch. However it has been a whole different story with illegal drugs. Much has been achieved. Politics and Profits before People in the legal drug market!

  8. I didn’t recognize the Rx name used here. I took “Paxil” and tried other SSRIs, too. All of them produced negative, intolerable side effects including self-injury, extreme aggressive feelings, or extreme apathy. Zoloft caused such agitation very early into treatment that I was lucky I stopped it, as I am certain it would have lead to a very bad end for me or someone else. Paxil alienated all empathy towards humanity while I was on it, so I stopped it also. Prozac triggered self-injury via cutting my legs with a box cutter (something I had never done before or since) just to see if I could feel anything at all I suppose. These side effects are real. There is no need to scratch one’s head and wonder what happened if crimes are committed, or suicides accomplished while one is taking drugs that can produce side effects like these that too often fall on deaf ears when reported. Doctors need to be held accountable. Media needs to start reporting the truth about side effects and withdrawal so that health care consumers and the public at large is better educated. Thank you! to all who advocate for greater awareness of these issues and do care about greater Rx safety. Truly.

  9. My father flew a Wellington bomber, in the second world war, at the age of 19 and was shot down over Germany. I have his mangled silver cigarette case, which saved his life.
    My brother worked, in radar, in Saudia Arabia and died in a horrific road accident. He was 25.
    My father’s career spanned four decades and he was an International Ambassador for the world’s largest aviation company, working on Concorde.
    I have already mentioned my former partner landing his two-bit plane on cockle beaches.

    So, if dad had been around when his daughter was so insulted because a ‘doctor’ actually went to the lengths of insulting his wife, she was so desperate to find a reason for her patient’s inexplicable behaviour, off Seroxat, and was rooting around and left no stone unturned in her quest and ridiculed her patient to the point of death, I know, that this quiet, unassuming, highly intelligent man would have pushed his way into Witty’s office and given him a bloody nose.

    He would also have probably sold his house to pay the legal costs of suing a drug company who gave his daughter, a drug, called Seroxat.

    He had already lost one child in a ‘senseless tragedy’.

    My father would have protected me from ‘cowards’, who do everything in their power to ‘blame’ the patient rather than the ‘medication’.

    It would be interesting to see how he might have featured in my book ‘Where is Andrew’.
    Andrew does not appear in the book.
    He is the elephant in the room.
    The gorilla passing through who no one sees.
    The poltergeist leaving the chill.

    The plot line is easy; the twist in the tale comes………… at the end.

    Who is the devil incarnate……

  10. http://uk.news.yahoo.com/millions-more-offered-statins-001343339.html#l79ygM1
    NICE are at it again.

    A rare side effect from statins is liver failure is the little sentence hidden amongst the hyperbole.

    A rare side effect from anti-depressants is suicide is the little sentence hidden amongst the hyperbole.

    Yesterday, the world’s most famous actress’s sister, died of an overdose of prescription drugs and the celebrities keep coming and the little people keep coming = Julia Roberts, why did your sister die?

    Reading between the lines, the woman was angry, very angry, raging, in fact.
    This is what anti=depressants do, when you muck about with Serotonin systems which are delicate and don’t need tampering.

    1 suicide is an accident = thousands of suicides are a statistic.

    Oh, Julia, why did they give your sister anti-depressants because she was larger than you…….another one bites the dust…………………..

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