RxISK STORIES: If you’re going to look after patients, Man up

Pharmalot has just posted a piece – ‘Controversial FDA official, Tom Laughren, retires.’

This is a must read for anyone with anything to do with mental health – both the post and the comments afterwards where some have posted that they still believe the Black Box warnings on antidepressants arose because of pressure from the Church of Scientology rather than in response to the data.

Despite my billing as a must-read, the Pharmalot post will likely seem boring to many. But the comments won’t – they seethe with anger. This is one of those cases in which if you weren’t there its hard to appreciate the depth of feeling this man generated in many as he – and a few others including Paul Leber and Bob Temple – appeared to stand in the way of natural justice and patient safety. The most comprehensive cover is on the AHRP website where Vera Sharav dubs Laughren a double-agent.

He seemed a quiet man. He was grey. He behaved like a functionary. But he was the focus of one of  the most dramatic moments I have ever witnessed. This was at the FDA hearings about antidepressants and suicide in children, some 8 years ago now. Because of FDA procedures, the public get a chance to offer views. There were 73 three-minute slots. At this hearing a range of doctors and other men usually with affiliations to pharma spoke against the Black Box warnings and it was down to a series of mothers to plead for warnings.

Many of the pleas were aimed straight at the bureaucrats – Laughren and Temple. The moment is at the center of Pharmageddon, where I compared what happened then and happens over and over to the Greek Myth in which Demeter implores Zeus to restore her child to life. It is appropriate perhaps in that unlike the other Gods, who were dashing and colorful, Zeus often seems to have the character of the bureaucrat who ran Olympus rather an all-powerful Jehovah.

Demeter’s stories  

Demeter was the Greek goddess of the Earth and of fertility whose daughter, Cora, was forcibly abducted and carried off to the underworld by Hades. Demeter protested to Zeus, who professed himself helpless, until Demeter threatened Earth with permanent Winter. Zeus intervened and restored Cora to her mother as Persephone. Because Persephone had eaten some pomegranate seeds while in the underworld, however, she must return to Hades each year, the several months of Winter each year.

Winter’s Tale

Mary Ellen Winter confronted Laughren and the FDA about her 23-year-old daughter, Beth:

“Beth was looking forward to a career in communication and was experiencing some anxiety and having trouble sleeping when she consulted our family physician. He prescribed Paxil and said she would start feeling better in two weeks. Seven days later Beth took her own life.

We, like most of you in this room, grew up with confidence in the strides made in medicine and accepted with faith antibiotics and vaccinations prescribed. We believed the FDA would always act to protect our family’s well being. When my daughter went to our family GP last year, we trusted that our doctor was well educated and informed. We were wrong. We now know that pharmaceutical sales are a high stake business, driven to increase shareholder wealth. The consolidation of pharmaceutical companies like GlaxoSmithKline has resulted in increased sophistication in the quest to market and distribute pharmaceutical products. Priority has moved from health to profit. Not all doctors are equipped to understand the marketing targets they have become. The FDA has allowed our daughter to be the victim of a highly commercial enterprise that selectively releases clinical data to maximize sales efforts and seeks only to gain corporate profits…

As residents of the State of New York, we thank our Attorney General, Elliot Spitzer, for addressing issues that the FDA has been unwilling to address…”

[This action on the part of Ruth Firestein within Spitzer’s department in many ways triggered the Access to Data issues that have since engulfed GSK and gave rise to the recent EMA hearings and a debate within RxISK and its supporters about what to do with the data that arises from people reporting to RxISK].

Thy Neighbour’s Child

But Demeter came right into the room in the last but one slot when Mathy Downing singled out Tom Laughren:

“On January 10, 2004 our beautiful little girl, Candace, died by hanging four days after ingesting 100 mg of Zoloft. She was 12 years old. The autopsy report indicated that Zoloft was present in her system. We had no warning that this would happen. This was not a child who had ever been depressed or had suicidal ideation. She was a happy little girl and a friend to everyone. She had been prescribed Zoloft for generalized anxiety disorder, by a qualified child psychiatrist, which manifested in school anxiety… . She had the full support of a loving, caring, functional family and a nurturing school environment.

Her death not only affected us but rocked our community… When Candace died her school was closed for the day of her memorial service, a service that had to be held in the school gym in order to seat the thousand or so people who attended. How ironic, Dr. Laughren, that your family attended Candace’s memorial service. Our daughters had been in class together since kindergarten. How devastating to us that your daughter will graduate from the school that they both attended for the past eight years and that Candace will never have the opportunity to do so.

Candace’s death was entirely avoidable, had we been given appropriate warnings and implications of the possible effects of Zoloft. It should have been our choice to make and not yours. We are not comforted by the insensitive comments of a corrupt and uncaring FDA or pharmaceutical benefactors such as Pfizer who sit in their ivory towers, passing judgments on the lives and deaths of so many innocent children. The blood of these children is on your hands. To continue to blame the victim rather than the drug is wrong. To make such blatant statements that depressed children run the risk of becoming suicidal does not fit the profile of our little girl[1].”

Laughren’s Defence

I cannot remember seeing anything ever about or by Tom Laughren where I have thought you know the man’s right on that – except the bits where he has been dragged screaming to a table and been forced to agree. But in the Pharmalot obituary on his career there for the first time was something where I jumped and said “Yes, he’s right on that”.

In another setting, faced with a barrage of criticism of FDA, “Tom Laughren, director of the FDA’s division of psychiatry products, told the panel that the agency could do little to fix the problem and, instead, pointed the finger at medical specialty societies, which he insisted must do a better job educating doctors about side effects”.

He’s right. Doctors are failing patients far more than FDA. (See Professional SuicideModel DoctorsWe need to talk about DoctorsScaremongers of the world uniteSo Long and Thanks for all the Fish). Doctors have become infantilized for whatever reason and turn to a parental figure, a Zeus, to rescue them. If you take on the responsibility of looking after people the very least you can do is Man up – or better again Mother up.

Crusoe

The next two Crusoe posts will deal with these issues. It seems right to mark the end of one year and the start of the next by stepping back from the realm of real human drama and place these in their mythic context. Taking the issues out of the domain of data, science and real clinical histories into the realm of myth seems to confuse some readers – the hope is rather to engage with a wider readership and get artists or story-tellers or poets to engage with RxISK and its issues – as Bill James has done with his cartoons and images. We are dealing here with lives and in particular the fact that we each have one life only.  The two Crusoe posts will attempt to capture the spirit of RxISK.

 

[1] Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Monday Sept 13th 2004, p 435.

[2] Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Monday Sept 13th 2004, p 332.


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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. Christine MacVicar says:

    There very little written about the situation the the UK in these stories. At least in the US Jonson& Johnson have been brought to court in several states re Risperidal. This is drug, according to Mad in America, showed a high level of suicide or attempted suicide in trials, yet patients who present with this are ignored.
    What can we do to get the UK government to take action for fraudulent safety studies as they have in the US?

  2. Ping pong was a good game, back and forth, fast and furious. Pharma telling prescribers, in all their leaflets, that the drugs are safe and a couple of weeks will suffice to stop has only led to bewildered, confused, angry, upset mums and dads losing a child through complete idiocy.
    How can a child of 12 be given Zoloft. My heart breaks.

    Maybe, I was child, at 51, when Seroxat was ceased. There you are telling these stiff, know it alls, that your drug is killing you, and all they do is sit there with pen in hand, watching you and trying to fathom what it is you are trying to tell them.
    You tell them, again and again, this drug is killing me, and a wooden voice with no emotion whatsoever, says, I think I will double your dose as it appears you are a bit excitable, a bit over the top, a bit too alive, a bit in my face, so away you go and I will get on with crucifying the next individual that comes to see me.
    The power of death is given to prescribers who seem, at the moment, to be the most ignorant in all of our society.
    Nothing has changed, at all.
    If I was presented to my surgery, now 61, ten years later, with the same scenario, then I would expect exactly the same reaction that I got then.
    Things have not moved on. Just bigger and bigger penalties, which curiously, governments allow. Fines for billions do not seem to enter the heads of anybody, that just maybe something criminal and somewhat circumspect is going on.

    It makes you want to become a Hobbit, where the struggles are in a sane world and they are important and brave and they have not been held back from living, by seismic stupidity that as soon as the patient walks in the door, they are doomed and their saviour is their killer, and no matter how much protestation takes place, the patient has not a chance.
    What a complete and utter waste of our time.
    Hobbitland, here I come. Can’t wait to arrive…want normalcy and real quests……excitement and bravery, so much to enjoy once the shadow of death has gone………………………………from little boxes……………………………….
    Before I entered the sick world of medication, I read The Worst Journey in the World by Apsi Cherry-Garrard, led by Scott; travels in the Antartic.
    This was a horror story, but the bravery of these men, who did what they did to survive, left me awe inspired.
    It has been to my eternal regret that I have been manipulated, to the point of death, when real and courageous people did what I was trying to do, in my small way, by having a thirst for adventure.
    Some adventure…………

  3. I always feel like crying when this subject is brought up.
    When I read the story of Traci Johnson…
    l
    I did a post at my first blog about children who took their lives due to drug-induced suicide ideation and I have these names fro Peter Breggin’s site:

    Go to CYMBALTA (DULOXETINE) SUICIDE BY HANGING, TRACI JOHNSON, 19
    Go to ZOLOFT/LUSTRAL (SERTRALINE) SUICIDE-HANGING, CANDACE DOWNING, 12
    Go to ZOLOFT/LUSTRAL (SERTRALINE) SUICIDE-HANGING, WOODY MATTERS, 37
    Go to PROZAC/SARAFEM (FLUOXETINE) SUICIDE BY SHOOTING, KEVIN RIDER, 15
    **Kara Jaye-Anne Otter was 12… Paxil/Seroxat -child suicide (2)***

    In Brazil and in many countries we don’t have any data.
    Not a single psychiatrist, I’m sure that by now they have lost patients because of their prescriptions, had the integrity of raising his/her voice.

    It’s appalling.
    I don’t have a way to search. I have access to a psychiatrist that is a researcher for Columbia University.

    I met one of his patients who told me she was “taking the drug of the research”.

    I pretended it was a good thing and she showed me the packet with the drugs with a number and not a single name.

    This woman was taking part in a clinical trial without knowing!

    I went there another time and a mother was waiting for her daughter who was taking ECT. She had tried all the drugs available but she was still depressed.

    That was the fourth section and her mother said that she would not let them do another one.

    It’s like that all over the world.

  4. GlaxoSmithKline agreed to plead guilty to criminal charges of illegally marketing drugs and withholding safety data from U.S. regulators, and to pay $3 billion to the government in what the Justice Department called the largest health-care fraud settlement in U.S. history. The government said Glaxo spent six years—1998 to 2003—unlawfully promoting Paxil for patients under 18 when the drug wasn’t approved by the FDA for non-adults. It said Glaxo helped prepare an article published in a medical journal in 2001 that falsely reported Paxil had proven effective at treating depression in children in a clinical trial, when the trial showed no such thing. According to the government, “Glaxo sales representatives sometimes referred to Wellbutrin as ‘the happy, horny, skinny pill’ as a way to remind doctors of the unapproved uses.”
    One of the main charges was that GSK had ignored safety risks. The criminal charges appear to be restricted to fraud but, when safety issues are included, should there not be additional criminal charges – wrongful death at the very least? Strange that this aspect of the case was not considered. What was the Justice department thinking constituted safety risks? These could, logically, only be effects harmful to patients.
    Change could come about through legal action against physicians who continue to prescribe drugs that have been shown, if only through such court cases, as being potentially life-threatening. If, as a practicing physician, one becomes aware of the recent litigation against Eli-Lilly for the development of metabolic syndrome in patients on Zyprexa, and continues to prescribe it without very careful monitoring of blood sugar, weight gain, raised cholesterol and triglycerides, is this not wanton disregard for human life as defined in the Criminal Code? The commission of a prohibited act by the accused – for example, causing bodily harm, must first be proven. In the case of drug induced suicide, there are obvious difficulties in obtaining what the law considers as constituting proof. Some offences, however, are based on negligence and judged “objectively” so that the person’s conduct is itself proof of the necessary “criminal” fault. Some examples, as defined in the law, include showing “wanton and reckless disregard” for the lives or safety of others. If a physician is aware of the dangers of Zyprexa yet continues to prescribe it, one could argue that there exists a certain lack of regard for the life of his/her patient. I would love to hear the defence argument.

  5. From Maie Liiv – Cross-posted from RxISK.org

    “The blood of these children is on your hands. To continue to blame the victim rather than the drug is wrong.”

    This was the introduction to Dr. David Healy’s Facebook post this morning. The words were familiar. They belong to Mathy Downing whose 12-year-old daughter Candace died by hanging four days after being put on Zoloft for ‘school anxiety.’ I met Mathy and several other bereaved parents at a conference in the States 18 months ago.

    Tonight I think of that evening at Julie Wood’s home when we first met, shared our stories of pharmaceutical malfeasance, created the Coalition for Physician and Surgeon Oversight; and made plans for a candlelight walk through downtown Toronto and a vigil in memory of the children who will never again be coming home for Christmas.

    For me there was a childhood memory of a ‘Lucia’ parade in Sweden — held on the 13th of December, the longest night of the year. The procession is led by a young woman in a long white robe tied with a red sash. She wears a crown of lingonberry leaves and seven lighted candles. She is accompanied by children also dressed in white, tinsel in their hair, holding candles and singing, ushering in the Christmas season and dispelling the darkness. The origins of the tradition are not in Sweden, but in Sicily and no one knows how they came to Scandinavia.

    I remember watching the Lucia procession in the university town of Uppsala as a three-year-old sitting on my father’s shoulders. He died on the 25th of December that year. A doctor made a mistake.

    Tomorrow night as we walk by candlelight through the streets of Toronto, the Scriptwriter in the Sky, the Creator, the Great Spirit, that which many of us call God; will smile on us. We will hold vigil in front of the headquarters of the College of Physicians and Surgeons of Ontario and remember those taken from us by those who once took an oath to do no harm. We will call out names and the Great Spirit will weep with us.

  6. i honestly can not believe prescriptions for these highly poisonous drugs are being handed out like sugar pills still, after all the proof, all the publicity and the public humiliation of the drug companies, proven to have acted illegally promoting drugs that actually make illnesses worse and risk these dreadful terminal effects. particularly in young people and children who are even more vulnerable to pressure and enforced medication than distressed adults.
    am i the only one who sees this latest mass murder in the US as having all the marks of an SSRI overdose or rapid withdrawal? each time i hear about one of these dreadful events my first thought is, what medications was that person on? did they have a sudden increase or decrease just prior to the event? if president Obama wants to end these events at least half the issue is getting control back over the over prescription of these foul drugs. telling the entire population about the very real risks attached to casual or inconsistent use of the medications in promoting extreme states of mental distress and self harm would be a good way to start to gain that control.

  7. I, too, am sickened to think that the twenty year old Connecticut shooter might have been on an antidepressant as so many others have been. Am also wondering about the shooter in Clackamas, Oregon – in this story, a telltale mention was made of his family and friends being shocked…the behavior was inexplicable to them, based on his personalityas seems the case in Connecticut – the boy was withdrawn, perhaps having Aspergers Syndrome, but no mention of a violent personality at all. There was a case like this last year in the Los Angeles Times – a young mother drowned her two beloved little girls. She was on an antidepressant and was feeling very terrible – the story said she’d been trying to get help in vain.

    • this is a conversation that needs to be aired in the wider public, it seems to me an obvious first place to look for any ‘motivation’ if any were seriously being sought other than vilifying the poor individuals being caught up in this tragic pattern of events. i have for many years had a gut reaction to these events since they started happening, ‘what meds was this person on at the time? how much increase or decrease had they been subject to just prior to the events? why are no journalists doing anything to look into this?’
      i went so far as trying to leave a message for Obama outlining the importance of this line of enquiry, no doubt there is no chance that this will actually get through to the white house offices. and if it did, could he really stand up to the big pharma?

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