This is part 3 of Laurie Oakley’s series on Pharmaceutical Rape.
We learn a social script in which a “good patient” obeys the orders of doctors as authority figures. The ideal patient is a passive patient, subordinate to the physician. We are expected to relate to doctors as experts whose judgment we should trust when being prescribed medication. Because of drug industry influence, this everyday scenario invites pharmaceutical violation. Thus a pharmaceutical rape culture exists that fosters widespread harms to individuals. In those instances where a patient ends up recognizing that something has gone wrong, he or she will often place full blame on the doctor without recognizing that entire systems of individuals are ultimately responsible for the damage, with participants in those systems remaining far removed from the consequences of their actions. Only rarely does a victim of this kind of offense see the inside of a courtroom. Lawyers who represent the giant pharmaceutical companies will then scrutinize a victim’s traits and behaviors in an attempt to prove personal factors such as poor health habits or an individual’s own underlying illness are responsible for the condition.
Between 1999 and 2004, the heavily marketed pain reliever, Vioxx (rofecoxib), caused an estimated 88,000 heart attacks and strokes, with an estimated 38,000 deaths. After the drug was withdrawn from the market in 2004, lawsuits by patients and their families against the drug manufacturer, Merck, were beginning to pile up. One of the plaintiffs was the wife of Jamie Gregg:
“Jamie Gregg, a 32-year-old construction worker from Katy, Tex., and father of three boys, had just reported for a job at Houston’s Hobby Airport when he collapsed, apparently from a heart attack.
“He was rushed to the hospital, where a medical team saved his life. But his brain had been deprived of oxygen for so long that Mr. Gregg is now in a nursing home in Lufkin, Tex., fed through a tube, unable to move more than his head or to utter more than a few syllables[…]
“Mr. Gregg, who had undergone a series of back surgeries, had been taking a high dosage of Vioxx, 50 milligrams a day, for four years to treat back pain. So the day after Mrs. Gregg heard that Vioxx was being withdrawn from the market, she walked into the offices of Goforth Lewis Sanford, a law firm in Houston. That firm, along with W. Mark Lanier, a prominent Houston plain-tiffs’ lawyer, are now preparing a lawsuit against Merck.
“‘[Vioxx] has got to be the reason,’ she said[…]
“But the plaintiffs’ lawyers face a big obstacle in convincing juries that a person’s heart attack or stroke was caused by Vioxx, because many people suffer such attacks for many reasons[…]
“Thomas B. Moore, a Los Angeles lawyer who represents pharmaceutical companies in such matters, although not Merck in this case, predicted that even the estimate by Dr. Graham of the F.D.A. that the drug caused more than 27,000 deaths and heart attacks would not help plaintiffs win cases. “‘The problem is that David Graham can’t name one of them,” Mr. Moore said. “He can’t name one of those 27,000.'”
—The New York Times. November 14, 2004
It is no remedy for pharmaceutical companies to pay out large settlements in instances where survivors are able to prove injuries were caused by medications that were prescribed with undisclosed risks. Since the problem lies in a culture that trusts in doctors who prescribe medicines to fix health problems while patients remain largely passive and dependent, one solution is to look at pharmaceutical injuries, in part, as a product of this authoritarian/passive relationship and to begin by addressing it at a personal as well as cultural level.
Social conditioning through direct to consumer advertising firmly establishes this pharmaceutical rape culture. When individuals are daily encouraged to “talk to your doctor,” the implicit message is that the starting point for good health is regular visits to a doctor who will prescribe medications to be taken regularly. Accustomed to turning to pharmaceuticals for what ails us, we have all but forgotten that all medicines are poisons which pose risks of harm, even when instances are rare.
The mother of three-year-old, Brianna Maya, was advised by a pediatrician to give her daughter the over-the-counter medicine, Children’s Motrin (Ibuprofen), for a fever and cough. The girl developed a rash but since her mother was not aware that this was a side-effect, she continued giving her daughter the medicine. As ABC News reported:
“Over the next few days, a fine rash on her body and mild redness around her eyes morphed into something insidious: a rare, painful and potentially fatal skin reaction that burned and blistered her body inside and out, blinded her in one eye and left her fighting for her life in a burn unit 1,000 miles from home.
“‘It was like something you see in a science fiction movie,’ said her mother, Alicia E. Maya Donaldson, 34, an assistant professor of social work at the University of Tennessee at Martin, as she recalled how her daughter looked at the time[…]”
“Brianna, now 13, has spent the last decade living the painful aftermath of SJS/Tens: She has undergone repeated eye surgeries and suffered recurrent eye and lung infections. Last summer, she developed seizures stemming from oxygen-deprivation during the worst of her illness. One of the ironies is that doctors have had difficulty controlling her seizures because anti-seizure drugs can trigger Stevens-Johnson syndrome. Because of vaginal scar-ring, “she will never be able to have normal sexual relations or bear children,” her mother said[…]”
Dr. Bernard Cohen, director of pediatric dermatology at Johns Hopkins Medical Institutions in Baltimore, reminds us:
“All drugs have risks, whether they’re topical, oral or intravenous, The patient takes some risk, the nurse-practitioner or physician prescribing it takes some risk. Sometimes pharmaceutical companies are at fault.” In the case of Stevens-Johnson syndrome, “this is one where everybody should take some responsibility for it.”
—ABC News, June 3, 2011
The drug manufacturer in Brianna Maya’s case was ordered to pay her family $10 million for her injuries because the label on over-the-counter Children’s Motrin had not warned of this rare but life-threatening condition. Stevens-Johnson syndrome had been a known risk, fully acknowledged by the drug company; the prescription version of Children’s Motrin had always carried a warning. Yet when the risks are this rare, safety information is brushed aside.
The cultural tendency to focus only on a drug’s benefits has been set in place by pharmaceutical companies and reinforced by the medical establishment; this denial of potential risks prevents patients from being able to make an informed choice. While many of us benefit from “safe” medications, children like Brianna (and her family) pay the horrendous consequences alone.
A pharmaceutical rape culture is a culture in which iatrogenic harms are pervasive and normalized due to societal attitudes about medicine and health care. It is a complex set of beliefs that tolerates the commercialization of healthcare and supports everyday harms in medical and mental health care settings. It is a society where harm is only acknowledged as rare, yet is accepted as necessary, and inevitable. In a pharmaceutical rape culture, doctors and patients unknowingly trust what are oftentimes pseudo-scientific facts put forth by drug makers about drug safety. Both doctors and patients end up disbelieving the reality of the adverse events they see, and instead believe alternate explanations for such events. A pharmaceutical rape culture condones widespread medical harms that are rooted in reckless practices within the industry-government-medical trade alliance because multiple societal systems are involved in producing, reproducing, and disseminating “information” about pharmaceutical products. This “information” sat-urates the public and reinforces that alliance.
Jeremy Brooking was a U.S. Marine who, after surviving a sniper attack in Iraq, was sent to Camp Lejeune, NC, to recover. It was then, he says, that the real battle began. News correspondent, Bob Segall of Indianapolis, reported in April of 2014:
“The battle Brooking is talking about is an addiction to pain killers. Military doctors prescribed him 22 different medications – many of them powerful narcotics like Oxycontin and Hydrocodone – to numb his chest pain. A VA hospital gave Brooking 43 pills a day. That’s nearly 1,300 pills a month. More than 15,000 pills a year. A 1-month supply of medication filled a plastic grocery bag.
“‘I lost three years of my life where I barely remember anything,’ he said. ‘I’d sleep 23 out of 24 hours of the day because of those pills. It destroyed our family. It really destroyed me.’”
His wife, Tia, who witnessed him turning into a different person, decided to consult with medical staff at the VA to inquire about alternative treatment options.
“The doctor said ‘Your husband is never going to get better. This is how he’s always going to be.’ And I said ‘What can I do?’ And he said ‘I can write you any prescription you want. Tell me what you want, and I’ll write it.’ He said ‘I’m in the business of writing prescriptions.’ I remember him saying that, and I said ‘I don’t want prescriptions. I want him to get better,” she recalls, shaking her head. “It was horrible. Sometimes […] when I got home, I thought he was going to be dead.”
Jeremy Brookings did eventually break free from his addiction to narcotics after he gave up on the VA’s pain program and found a doctor willing to try other options. But thousands of returning veterans have lost the quality of their lives, while many others have died, as a result of the prescribing practices at the VA.
Dr. Pamela Gray, a VA Medical Center doctor in Hampton, Va., from 2008 to 2010, advocated for alternatives to the routine practice of prescribing narcotics but was told to stop by VA Administrators:
“I was told by the department chair of internal medicine to think twice about not prescribing these narcotics,” the doctor said. “I was ordered to write these drugs or be fired. I was ordered, as a physician with 25 years of experience, by a non-physician to do something that was medically incorrect. That is an intolerable position.”
Gray recalled a severe shortage of qualified pain specialists within the VA yet the idea of creating pain management programs was rejected by supervisors. Treatments other than the prescribing of narcotics were not a cost effective option for the VA so doctors continued to over-prescribe.
—WTHR 13 Indiana’s News Leader. April, 2013
An attitude about patients that places primary value on what treatments or procedures can be employed for reimbursement or compensation. Reducing the patient to a commodity with value being limited to financial usefulness.
Many in our communities, from the most vulnerable children to military veterans, end up experiencing serious medical consequences and unacknowledged suffering after trusting a doctor’s advice. This is a literal type of rape that is downplayed by medical practitioners, regulators, and the entire healthcare systems that are charged with our care.Share this:
Copyright © Data Based Medicine Americas Ltd.
For treatment, drug, pharmaceutical, narcotic, Vioxx, Ibuprofen, Oxycontin etc, read Electroconvulsive therapy. Except the side effects of brain damage, memory loss are not rare but almost universal.
This is an interesting point. Rape in some sense must refer to the way things are used rather than the actual thing – or else the human race would go out of existence. There is no doubt that ECT and other treatments have been used abusively and in some instances are used abusively. When it comes to medication people should be aware that they are about to be poisoned just as they are for the most part undergoing are aware they are about to be mutilated and undergoing ECT that they are about to be shocked. Its the factors that intervene to conceal the nature of what is happening, whether this is the fault of a government, an industry, a profession or a culture that lead to abuse – not the actual effort to help using a tricky and potentailly harmful intervention provided the therapeutic alliance is entered into willingly.
How the system responds after an injury is critical. For many rapes a great part of the problem lies in the subsequent abuse entailed in bringing the problem or event to light.
Another excellent piece of writing. Thank you.
I have often wondered how some conditions get their name. What is Stevens-Johnson syndrome was named, ‘Merck Syndrome’ or some such attribute? Might the public become more aware of the dangers in which they are putting themselves? It will never happen but it seems to me that the naming of a syndrome can endorse or shame. Take the name, ‘Chronic Fatigue Syndrome’ as a shaming device. On that occasion the public were not hoodwinked but fought hard to rename it, pointing out its belittling nature.
On a different note, systemic problem requires a systemic approach. Dr Healy, are you familiar with the Clinical Human Factors Group? This group is applying the systems approach that is found in aviation. While it is not perfect – people will always try to find a way around the system – it will have the capacity to acknowledge all of the levels present in a system, including suppliers. It then becomes obvious when a near-miss situation has become critical and where those near-misses are becoming habitual. See http://chfg.org
It is worth noting that in the UK the Legal Services Commission, currently re-incarnated as the Legal Aid Agency, failed to support legal moves against Merck over Vioxx despite successful prosecutions in the US. You might wonder about the solicitude by the British state or government for a pharmaceutical company not even based in this country.
All pharmaceuticals in the UK are de facto consumed purely at risk of the patient. It is not that I go round thinking I want to sue people but I would like the idea that they were in practice liable for harm. I like the idea also – perhaps even more important – that individuals could be prosecuted for harm if they cover them up. It might help just a little.
Very Good Comments in response to our esteemed American Lady Author, LO…shall we bring in the US to expand the conversation further as this is the crux?
There was a Conflict and Mr. Francis, commented by Mr. Pies, wrote the following:
This was the Reaction to this Post:
Meanwhile on !BOM, Mr. Nardo, wrote:
“I don’t mind your peeing in my boot, but don’t tell me it’s water”…
This is lively and what happens in A merica is quite important, believe it or not…..
Plus, on the plus side, A State has a GSK Discovery:
Ta to T30.
The crux of the trial was his whereabouts at the time of the murder.
Thanks for the link to Allen Frances’ article– I just joined that discussion, and agree that what is happening in America is important and quite interesting.
I am declaring a holiday from the Madness spawned in America– I am going to envision a Pharma free zone, making withdrawals from my long term memory bank , where there is still a wealth of experience deposited by doctors and nurses who were motivated to care for and cure people who suffered from illness. Interest in this reality has been compounded daily since the beginning of Laurie’s series–. I hope to be fully rejuvenated by this long overdue vacation….
ECT can feel like rape if you are coerced into it. I don’t want to open the old ‘ECT is the most terrible thing that can ever be done to a patient’ because the debate never, ever goes anywhere. Thanks to blinkered, rigid thinking which also, as I remember, involves telling people with a different opinion that they have brain damage – only they don’t know it. Not a million miles from psychiatrists telling patients that they feel suicidally restless because its part of their illness – only they just don’t realise it. But ECT is the sole form of psychiatric treatment that you can refuse in advance now in the UK – thanks in no small measure to the efforts of David Healy and his colleagues. Were any doctor or nurse to ignore an advance directive you would have the legal right to sue. It isn’t possible to refuse drug treatment – if you lack capacity you can quite legally be held down and forcibly injected with an antipsychotic. And, thanks to community treatment orders – you can be hunted down at home and forcibly treated which seems closer to rape than anything..
The law, as I get slightly repetitive about, is a blunt instrument at the best of times. I doubt there was any overt government or political agenda preventing UK claims against Merck. The roots of the inability of the law to hold people to task are historical. They derive partly from the fact that ‘negligence’ as a cause of action is very new, in legal terms,(established in 1934 which is yesterday to the law). Negligence has never sat comfortably alongside contractual obligations which are a thousand years old and has been subject to extreme judicial caution since birth. The fear of ‘Opening the floodgates’ to legal actions always underpins that caution. Fear of imposing huge financial burden on industries, stifling commerce – protecting capitalism, in essence. It’s a social and political matter but at a far more fundamental level than some deal between government and Big Pharma.
There have been noble attempts to establish corporate manslaughter as a crime, and group actions in civil negligence since the 1970s – they’ve gone nowhere. You cannot sue or prosecute without an established legal mechanism – boring, but true. As any law student kno
The most acute similarity with sexual rape for me is that people are simply are not believed when they try and tell those who have poisoned them about the harm they’ve suffered. Not being believed prevents many victims of abuse from telling anyone. Sexual rape victims are also in the appalling position of having their characters dragged through the mud (or court). Just as our psychiatric history comes into play, every time. Laurie illuminates that beautifully.
Not that I think that 82 years is a negligible time but regarding Merck and Vioxx I don’t think we are talking merely about negligence.
It is very clear the UK Legal Aid Agency is not going to help anyone trying to launch a civil suit over a pharmaceutical product and this is not because they have been asleep since before 1934, it is because actually it does everything and anything to frustrate the interests of citizens, and it is matter of policy.
However, the reality this is also that even if you get a successful civil suit in the USA, and substantial fines against a pharmaceutical manufacturer by the FDA, the risk is bourne by the shareholders not by the executive – I don’t think you even hear about people losing their bonusses let alone their jobs (nor do they ever end up in jail which is what in many cases ought to happen). JK Galbraith wrote strikingly about this problem in 1999:
“The fraud also conceals a major change in the role of money in the modern economy. Money, we once agreed, gave the owner, the capitalist, the controlling power in the enterprise. So it still does in small businesses. But in all large firms the decisive power now lies with a bureaucracy that controls, but does not own, the requisite capital. This bureaucracy is what the business schools teach their students to navigate, and it is where their graduates go. But bureaucratic motivation and power are outside the central subject of economics. We have corporate management, but we do not study its internal dynamics or explain why certain behaviors are rewarded with money and power. These omissions are another manifestation of fraud. Perhaps it is not entirely innocent. It evades the often unpleasant facts of bureaucratic structure, internal competition, personal advancement, and much else…”
“A more comprehensive fraud dominates scholarly economic and political thought. That is the presumption of a market economy separate from the state. … But few economists take note of the cooptation by private enterprise of what are commonly deemed to be functions of the state. This is hidden by the everyday reference to the public and private sectors, one of our clearest examples of innocent fraud.”
It’s completely true that the Legal Aid Board/Agency is government funded – and therefore has been subject to severe cutbacks since the 1990s. It has no money to allocate. Consequently it reflects the political agenda of our poisonous government: restrict access to legal remedies to the very few people who can afford the risk of enormous legal bills. Legal Aid was a great democratic tool – which no longer exists except (at the moment) for children and people charged with a criminal offence.
The destruction of state aid for people wanting to bring a case meant shifting the financial risks onto the insurance companies. Which, as discussed in a previous post, are possibly the most venal, grasping, ruthless and inhuman bunch of corporations known to humankind.
Access to the law is a fundamental human right – which has been systematically eroded because, as your great JK Galbraith quote suggests, holding corporations to account is inconvenient to a market economy aka capitalism
Sally, isn’t it interesting that the most common reporting of pharmaceutical harm is to the systems that are doling it out? (Talk to your doctor…sheesh!) Kind of like going to the police for clarity about an “officer involved shooting,” when you know they’re in the business of covering up.
Even though politicians can be part of the problem, it might make sense to bombard our elected officials with our reports and stories.
Logical arguments have a place, but they don’t have the power of our stories. There are MANY victims/survivors, all with a story. Perhaps we should band together and make some NOISE.
How many people know that brain damage/ECT actually still exists so they can write up “no ECT” on an “advance directive”?? Invariably they get very sick, are driven iatrogenically insane by psychiatric drugs, told they are “treatment resistant”, told ECT is “safe and effective”, and, in a now suicidal state or tormented by akathisia and panic, are willing to “do anything” to make it “stop”. Uninformed, bc the consent forms fail to state ” you could lose years of your memory, become cognitively damaged, lose skill sets, become apathetic from frontal lobe damage, become suicidal bc of these injuries….”. There is NO informed consent.
Most drug damage, except long term neuroleptic, can be reversed. Brain damage from ECT is permanent, the gift that keeps giving.
ECT is a rape of the mind and soul. It creates trauma and destroys hope. Some people given low dose unilateral, limited numbers may survive and feel it “helped”. This does not make up for those who are destroyed. Vioxx “helped” some people. Should it still be on the market?
Truth is a shifting concept – one person’s truth is another person’s lie. I’d never be arrogant enough about anything to maintain my view was the One True one. Too blinkered for me. But I wonder why you are so very angry? More about your personal experience of ECT would be a helpful way of understanding your fundamentalist attitudes and the frankly silly statement that ‘Most drug damage except neuroleptics can be reversed’.
1. You concede that neuroleptics can cause brain damage, and that the harms cannot be reversed. Leaving aside the fact that many other classes of drug (statins?) can cause irreversible damage to the body – what difference is there then between the damage you talk about in relation to ECT and that caused by the psychotropics? One brought about by shock, one by medication. Why is ECT worse?
2. I could, unkindly, turn your argument that everyone who’s had ECT is brain damaged (even though they don’t know it) back on you. If you have suffered cognitive damage and your frontal lobes are knackered – why should anyone take any notice of what you say?
3. I reiterate: the legal right to say ‘I refuse consent to ECT now and at any point in the future’ is a small but crucial step in giving us, patients, a say in what happens (or doesn’t). Unfortunately we have no right to refuse drug treatment. To maintain we are all too addled and ill to REFUSE consent to ECT makes no sense. See point 2.
Yes, I am obviously angry. I lost 15 years of my life, my 31 year teaching career, my personality, my wit, my almost photographic memory, my ability to think, read, to form new memories.
All I retained was enough cognition to know how injured I was, how destroyed I was, something that has traumatized me and my children. Weddings, birthdays, graduations, books, movies, special events, holidays, funerals, all simply gone, like wiping off a chalkboard.
My nighmare began with paradoxical drug reactions, escalated to poly drugging,scary “doctors” pissed off I was not “responding” and with nothing to offer but shock. I had no advocate, was in no shape to give consent- in large part since the “booklet” I was handed stated specifically:
MYTH: ECT causes permanent memory loss. And “ECT is safe and effective”. Both are lies. Does giving consent base on lies seem reasonable? Zero warning, as I said, about the REAL risks of ECT. How many decades have victims been trying to speak against electrical lobotomy while people like Fink derided their complaints and Sackeim, holding the half million in research grants conspicuously avoided doing studies until 2006, when he found gee, ECT seriously impacted memory and cognition, decades after all the denials.
Do psych drug inserts list the following possible side effects: psychosis, mania, suicidal thoughts, anxiety, akathisia, homicidal thoughts, abnormal thoughts, worsening depression, tardive dyskinesia, dystonia?? Is that informed?
There has been a concerted effort to hide the scientific data, to ignore the studies, to refuse testing. The ridiculous blaming of ECT damage on “benzo” use or anesthetics is appalling, like telling the rape victim she wasn’t raped or is perhaps confused about the rape.
And, it is fabulous for you to joke about my “knackered” frontal lobes and say “why should anyone listen to me”? Do you laugh at cripples and mock the blind, poke fun at the people with tardive dyskinesia and long term neuroleptic damage, suggesting they should have no voice or “why should anyone listen to them”?
Well, maybe no one should listen to Mary Maddock or Ted Chabasinski or Linda Andre or Deirdre Oliver or Leonard Roy Frank, or Sue Carke-Wittenberg, or Wendy Funk or the heart breaking testimonies of 1000’s of others damaged by ECT? Let’s assume they are liars, mental cases, and people with no intellect remaining, ignoring the fact they persevere in spite of. And what is their motivation? Fame? Money? Career security?? No, they want to protect people from the injuries they sustained. They are compassionate and know the difference between right and wrong. They have a moral sensibility.
But then why listen to patients who claim damage from neuroleptics? Surely they are too knackered to express anything worthwhile about their “damages”. Why pay attention to their testimonies, their anger, their benzo outrage? Why accept their claims instead of blaming their decline or injuries on the statin or aspirin or energy drink they drank too many of? Or, just blame it on their “mental illness”??
Like the shrinks who tried to blame TD on “schizophrenia”? That is like blaming benzos and anesthetics for aeCT injuries when the patients, in tears, keep stating :” I have had multiple anesthetics and eaten
Years of benzos, but had ZERO of these problems before ECT.”
I guess, slow and delayed as I am, I look at the books, articles, written by Dr. Breggin, (whose frontal lobes are fine) who ruefully admits he once “administered” ECT and clearly outlines the science and elucidates it is brain damaging and should be banned. His website lists 125 articles outlining the reality of ECT as trauma and brain injury.
He is a clinician, he was the initial voice in the wilderness warning about psych drug injuries. But he is “wrong”? Multiple Neurologists like John Friedberg speak to the horrific injuries it inflicts
. Robert Whitaker has indicated he is baffled by Healy’s stance on ECT; his perspective is that ECT is not a safe or effective “treatment”. He isn’t a “clinician” but that does not mean that he was “wrong” about the dangers of psychiatric drugs, does it? But he, brilliant, Pulitzer prize nominated medical researcher somehow is “wrong” about the research involving ECT? Why is that? Not because he is a victim who is angry or a person who is frontal lobe knackered. Researchers like Colin Ross, Richard Bentall, and John Read, Mangoang and Lucey, have no “knackered frontal lobes” and they clearly point out the devastation ECT wreaks upon its victims. Read and Bentall’s statement is that the “use of ECT cannot be scientifically justified”. Lucey and Mangoang suggest patients be told they will possibly require “rehabilitation” like brain damaged car crash victims. Robertson and Pryor point out the extent of the damages and the stupidity of using simplistic tests to suggest things aren’t so bad- crude tests of overlearned memory…
To say “I refuse ECT now and in the future” seems useful. I, however, did not know it existed till it was recommended to me in hospital, presented completely untruthfully. Why would I think a hospital would be doing something dangerous? Why would the expert doctor lie and fail to inform? As Rebecca Beddoe (drugged and manic) said in her book- the doctor said I “needed it”, so I went with that…but her experience would be unusual? No.
Chemical lobotomies are horrific, enforced drugging is criminal, and so is ECT.
After the bioethicist for my region reviewed my complaint and my “case”
, he went to the “psychiatric leadership” ( well known for its love of debilitating drug cocktails and enforced injections and restraints) and recommended they adopt his prepared mandatory checklist of REAL risks ( not just nausea, headache, confusion- the signs of head concussion), rewrite their “booklet” to remove misinformation and lies, that they change consent processes, increase documentation,enforce pre-cognitive and post cognitive testing that required more than “what is your name” “what day is it”, “where are you”, “connect 1-8 and a-h in alternate lines”, include information which helps nurses differentiate “better” from euphoria and organic brain syndrome. He said these changes were “necessary to protect patients” in his estimation. What happened? The shock docs and nurses were hostile, and smirkingly laughed him out of the room, stating their pathetic protocols “met the Canadian ‘guidelines'” and “nobody could “make” them change anything. Concerned about their $ and jobs, they told him to f*** off.
Drug -addled or not, the majority of victims WOULD refuse CONSENT IF they were told the truth about the risks and outcomes and fleeting “benefit” ( not evident beyond 4 weeks of treatment with 90% relapse in 6 months?)
Marilyn Rice, seriously injured 40 years ago said she wasn’t opposed to ECT, she was opposed to the lying about ECT.
Sub-concussive multiple hits to the head and multiple grand mal seizures seem “reasonable” and less than barbaric?
Thalidomide was withdrawn, Vioxx was withdrawn, but ECT, with its documented history of damaging many more people is fine? Why is brain injury, clearly identified by research scientists, doctors, neurologists fine as a “treatment”?
I think David Healy has done phenomenal work in bringing to light the dangers of psychiatric drugs.
Restoring study 329 was so important. Now I suggest restoring and re-interpreting the supposedly favourable studies on ECT, studies that multiple researchers call “flawed” and inaccurate and biased.
I found three people who were documented to be content with the outcomes of their real lobotomies. Is that enough to suggest it should still be an “option”?
I do not encourage the use of statins, I believe that SSRIs and neuroleptics and benzos are toxic to the brain, restraints are inhumane, and no one should be injected or drugged against their will. No one should injure living human beings with drugs or shock. I barely survived the drugs, I know I can’t survive what shock has done to me.
I did not say everyone has the same degree of brain injury or state those who were happy with it were just too brain damaged to know the difference. I suggest they had low dose ECT, ultra brief pulse, widely spaced, low number ECT so they survived and their brains rebounded.
But then again, some NFL players avoided CTE despite multiple concussions.Why? Thicker skulls? More time to recover between injuries, better genetics? Luck?
Is it worth the risk? Several athletes with multi million dollar contracts and full scholarships have recently “quit” the sport at ages 24, 27, and 30, stating now that they are informed about concussions and CTE, they will not accept the risks.
Over 50% of patients interviewed for a NICE report stated they had not been truly informed of the risks. Patient surveys found the number to be even higher. So that is working well, isn’t it?
First no one here has questioned the idea that someone who was given ECT and claims to have been damaged – hasn’t in fact been damaged in some way. There is a distinction to be drawn between believing the person about changes that have happened in them and buying into their view about what has caused those changes. All physical treatments harm, this is their nature. The harms we are talking about here it seems to be when they are used indiscriminately and after the event when someone who has been harmed is discredited and ridiculed. On that score both drug treatments and ECT have been used abusively. The attitude of doctors through to the 1980s across the board in medicine was one that, with exceptions, close to completely dissed the patient as a possible partner in treatment.
But the proponents of ECT did a great deal to put their house in order. Some of them like Max Fink played key roles in creating the idea of informed consent for all of us across medicine and not just for ECT. This is likely in part because they didn’t have an industry sitting on their backs.
There are no or close to no unpublished trials in ECT – whereas a very large proportion of trials of psychotropic or other drugs remain unpublished. There are no ghost-written studies in ECT, whereas close to 100% of the trials on on-patent medicines are ghostwritten. There are no sequestered data on ECT, whereas there is complete sequestration of trial data on pharmaceuticals – at least in industry trials.
So in principle there can never be informed consent for a pharmaceutical. Some doctors will do the best they can, others won’t. ECT comes closer to surgery. In most clinical settings there is a formal consent procedure. Granted the doctors may minimize the risks but for any patient or their relative googling ECT immediately draws up a horror list of problems that mean that many people have to be rather brave to undertake the risks. This is in complete contrast to the culture surrounding pills where googling will often result in industry material extolling the virtues of their pill.
In the event of damage, it is relatively easy in the UK and US to take an action against a doctor for negligence. Its much more difficult to do so for a medication. But these actions are invariably lost. In contrast when some of us have engaged in legal actions against much greater odds – against companies, there have been wins.
Having had a look at what happens in both drug and ECT actions, part of the problem has been the experts in ECT cases. Rather than tailor their opinion to the situation of the person taking the case, they have tended in the actions I’ve seen to use someone’s case as a pulpit from which to launch an attack against ECT. And while juries often find it hard to accept a person has been injured they will do so, but if asked to support a ban on a treatment they are unlikely ever to do so – not for ECT, not for drugs.
The other aspect to it is the evidence put forward by anti-ECT experts has never been compelling. This is partly because they have been trying to nail ECT rather than prove the person they have been called on to represent has in fact been injured in the way claimed. In the face of repeated failures to win cases they haven’t changed strategy in the way for instance some of us involved in pharmaceutical cases had to when it became clear that following a Christmas Tree Lightbulb approach to causation – even though scientifically the correct thing to do – wasn’t going to work legally. Linked to this latter point, if the scientific case against ECT was so strong, how come it hasn’t worked legally even though those making the case are not up against an industry – indeed will often have a large chunk of the pharmaceutical industry, the APA and Royal College of Psychiatrists on their side?
None of this is to say that anyone figuring they have been damaged by ECT hasn’t been harmed. It is difficult to spend months or years in the mental health system and not be damaged. Pinpointing exactly where the damage arises and working out how to minimize it is critically important. There are many things need changing not least of which is the fact that when problems are caused by treatments the mental health system delivers but the system doesn’t recognize this, the system can turn punitive and nasty when people question it.
This attitude has to change. If this doesn’t change, then the odds of each and every treatment being used abusively rise significantly. Its this attitude that means that even though there are many more safeguards in place for ECT than for drug treatment, it is still the case that ECT is being used abusively in some settings.
Calling for treatments to be banned doesn’t seem the way forward. To be consistent those calling for ECT to be banned should call for all physical treatments to be banned. The world however isn’t going to buy into this. Such a call is viewed as a nice but pious and romantic aspiration. The Thalidomiders outlined in a post last week on RxISK – The Devil Doesn’t Have All the Best Tunes – aren’t calling for all drugs to be banned. They would never have achieved all they have if they had made such a call.
The other aspect to such a call is that it diverts attention away from the people doing the raping. It is never an ECT machine or a drug that rapes – its a person.
Confused by the “distinction” between “believing the person about changes that happened to them” and “buying into their view about what has caused those changes”?? Is that like saying ” I believe you were damaged, but question your view that ECT caused the injury”? Is that like saying “I do not believe your narrative, your logical description of what led to this horrifying change”? My opinion is that you were harmed by anesthetics or benzos or you have somataform disorder or you put too much value on memory or condition?
Am I wrong or did Fink not suggest people claiming ECT damage had a “somataform disorder” and some liked to get together and “complain” about ECT. Is that disrespecting the victims?
As far as the lawsuits, how many were settled out of court or settled with an enforced publication ban?
Why would the APA and Royal College of psychiatrists back patients when they condone, recommend, and green light this “treatment” as safe and effective?
Confused by “the Thalidomiders aren’t asking for all drugs to be banned”- this has been to their advantage, but anti -ECTers should logically call for a ban on all physical procedures?? Why would they- did anti-lobotomists need to focus on other physical treatments being banned?? No, just the one brain injuring people, like electrical lobotomy injures people.
I agree the situation regarding psych drugs is horrifying, from ghost writing to hiding data, falsifying data, corrupting legal trials with back door payouts. It affects so many more people- 10 in one 250,000 people region having ECT to possibly 25,000 being “treated”, many abusively, coercively, carelessly, and with little true consent, since you say ” there can NEVER be informed consent for a pharmaceutical”.
I agree that damages occur bc of the person doing the raping and the doctor being careless, incompetent, abusive…
Why would it be difficult to simply eliminate brain disabling bilaterals, to include the REAL risks on mandatory checklists, and to limit ECT to 6 sessions as they have done in some countries (Australia? I think?) Why is there such opposition to informing the patients of the actual risks?
Given all the evolving information about repetitive head trauma and CTE, should ECT be viewed in a different light, the ECT Mad Fink said produced similar effects as “craniocerebral trauma”? Is repetitive craniocerebral trauma via ECT, with the increasingly promoted “maintenance ECT” a good idea?
Thank-you for your post and for your willingness to address this issue, even though, once again, it is off topic. I really hold this tiny hope in my heart that you will revisit the evidence and as a renowned scientific researcher, see the merit in the conclusions of the researchers, neurologists, doctors, and journalists who have delved into ECT and its negative effects.
Yes, my ECT was “administered by a completely incompetent, negligent, and abusive doctor who viewed me as a dead car battery to be zapped until he got some response, angrily determined he would not “fail” in his mission. He has injured many people but his actions are deemed “acceptable” if crazy suicidal people are his targets.
When i say the person has to be believed but not necessarily their idea of what’s causing their problem, this has several aspects. First if I complain about a problem to a doctor or whoever – it may be to do with my memory and i figure its caused by Drug A but I am also on Drug B and C, the doctor may agree there is a problem but figure its linked to Drug C. Our reporting of things that happen is usually much more likely to be right than our explanations – if this weren’t the case there would be no need for science. This by the way cuts both ways. Doctors or engineers or whoever can be wrong too.
When it comes to memory problems on ECT, some of the difficulties are that the classic memory problems people typically mention are undoubtedly happening them but there is much more evidence linking these problems to benzodiazepines and antipsychotics than there is to convulsions.
This doesn’t mean that there aren’t memory problems linked to ECT but those complaining would get a lot further if they didn’t keep mentioning problems that are also caused by the drugs.
Secondly in the case of drug induced problems, the cases that make breakthroughs are often very clear cut – the patient is a healthy volunteer and becomes suicidal. To get somewhere ECT cases need to focus on negligence but the experts involved in cases have often not been very smart.
I’m not aware of hidden settlements or enforced bans. ECT is an embarrassment for the Royal College of Psychiatrists and for APA – neither organization puts on ECT symposia or gets behind the treatment whatever about any brochures they may have felt obliged to issue.
Having said all this, there is a worry that managed care and changes in the delivery of US healthcare may be leading to increased use of ECT with the risk of increased rates of misuse but here again the true target of any legal action will the healthcare delivery apparatus or doctors who resort to ECT when they shouldn’t.
I think part of why few people are going to go along with what you are saying is a resorting to statements like ECT Mad Fink when the man has perhaps done more than anyone to put informed consent on the map and is the only person that I am aware of that has produced evidence of memory problems specific to ECT. He has also had the temerity to out argue or outwit experts who have taken the opposite side in court cases but this has often been easier than it might have been because they are calling for the abolition of a treatment that can save lives.
By using words like this are you perpetrating the same kind of abuse you accuse him of? Comments like and earlier ones linked to other posts openly disparage people who don’t agree that ECT should be banned – no one has been saying it cannot cause problems. The stridency of calls like this in other forums can get intimidating and close to abusive in its own right. Unlike drug treatments where people are free to come out and say that treatments have helped them (perhaps paid by industry to do so) without being abused indeed they can get abusive in their dismissals of those who have been injured, very few people who have benefited from ECT feel free to come out and say it helped because of the abuse that results – they can only be saying things like this because they are brain damaged.
Truth, what you describe sounds painfully familiar and, for what it’s worth, I want to acknowledge your suffering. Even though ECT is not the focus here, it sounds like the medical culture has been similar when it comes to ECT (be passive/doctor knows best).
And it’s hard to watch the system “get away with it.” Treatments that wrecked my health and life (long-term, ongoing) are still being used, and while I can’t help but focus on the harm being done by this kind of prescribing, there are plenty of people who seem to be living just fine on their medications (at least for now). The injustice isn’t that the treatment is used and seems to work well for others, but that many of us are wrecked without warning, and then the truth about the source of our suffering is denied. We are effectively silenced.
A year or so ago I saw an article on MIA where the doctor suggested the best way to deal with discontinuation syndromes from SSRI’s and/or anti-psychotics might be to prescribe a benzodiazepine. I was truly, truly horrified by that. Perhaps this mirrors the strong emotions you feel when Dr. Healy does not completely abandon ECT.
I find, in the end, I must make room for the experiences of others. Our truths may differ but all are equally important.
Thank- you for your comments. They resonate with me. I am sorry that the “treatments” you were administered have wrecked your life and are “long- term and ongoing”. Yes, as you say, some people seem to be doing just fine. I think the “at least for now” part is important, however.
Yes, it is hard to see them “get away with it.”
Agree that “many of us are wrecked without warning and then the truth about the source of our suffering is denied. We are effectively silenced.” True for ECT and drug harms, both. I was disregarded and disrespected and told my “cocktail” was not the cause of suicidal thoughts. Then the agitation, akathisia, and suicidality justified ECT, an ” indication” supported in the “accepted” literature and embraced by the doctors, who have ignored or never looked at the studies showing patients having ECT are more likely to kill themselves.
Yes, shamefully, I initially Dr. Shipko’s benzo solution for withdrawal seemed reasonable by virtue of his anecdotes and I did not find myself enraged as I am whenever I read one more story about people destroyed by ECT.
It sounds awful, but I would prefer to suffer from fatigue, gastro problems, aching bones and muscles, weakness, rashes, vomiting, and any other physical manifestation of drug injury rather than being intellectually destroyed, amnesiac, unable to read, made new memories, be myself, lacking my sense of self and identity. Stories like Monica’s or Melissa Bond’s on benzo hell point to hope of recovery, even after two years of being bed- ridden in Monica’s case. That hope does not exist for those whose very self and history has been obliterated. If I had my “usual brain” I could and would fight and claw my way back to some normalcy. ECT obliterated any chance of returning to my old life-zero, permanent brain injury, severe.
Your articles are beautifully written. I struggle to understand them, however, and I won’t recall their content by tomorrow. Anything that has the potential to do that to a person should not be “offered” as any kind of option or “treatment”.
Once again, thank you for your comments; they were kind and thoughtful.
Truth, I would say the harm I have had to live with post-benzo is not as severe as what you describe. My memory was not wiped, just blotted. But sometimes I’m alarmed at what I don’t remember. I struggle more with new memories than old. Most things I learn aren’t retained unless I use the information daily. It’s interesting that I can retain a sense of what I’ve learned, but few details. So I have to do a lot of looking up and relearning of things in order to compensate. Maybe it’s from brain damage, maybe from ongoing insomnia, or a combination of both. Hard to tell because no doctor will look into it.
I ask the same questions of the same people, often in the same day, because I forgot we’d already had that conversation. Many assume I just don’t listen. But I do have memory of those conversations once reminded. It often takes me a day or two, or even a week, to process something someone says. This makes me a total dunce in social situations. People whom I would like to have take my story into account don’t even remember that I have a story. Whatever I say this is, just doesn’t happen says my culture.
I am constantly fatigued, especially mentally. I have constant pain. Yet, I am better able to bike/walk rather than work all the hours it takes to pay for car, insurance, gas, repairs, and this is one of the things I can still enjoy. People observe this and say, “see, you’re fine!” I’m categorized a granola-loving hippy in their minds, trying to save the earth–not because this is reality–it’s just a convenient slot to put me in. (That, and mentally defective).
After 10+ years of trying to heal (on top of attempting to keep up with all the demands of life, working, raising kids, etc.), and having not really healed, and having all of my life affected, the “healing is possible” rhetoric really grates in my ears, too. And I’m not supposed to share that I didn’t heal. That would be doing a disservice to those just starting out on their journey. This is not what I wanted my life to be about, but as I put it into the much larger context of world events, I am slowly making sense of it.
If there’s something really true about rape, it’s that everyone’s story is different, and there are many different circumstances that end up being rape. And here I’m just talking sexual rape. It’s the unwanted nature of what happened, the lack of consent, that makes it rape. Survivors support one another regardless of differences in circumstances or extent of damage, because rape is always inherently damaging. I think there are parallels for us in this as well.
I’m sure that I speak on behalf of all who have read your comments here when I say that I am truly sorry to hear of your suffering and your understandable anger regarding your situation. I am sure that you are putting into words the thoughts of so many other sufferers who, for whatever reason, are unable to voice their thoughts as eloquently.
To me, you are all suffering – regardless of the cause of your suffering, you need to stick together in the name of ‘psychiatric damage’ rather than splitting into different ’cause groups’.
From your teaching days, you will know that being split into so many unions was the downfall of a ‘teachers’ united front’ on many occasions. Rarely did the Headteachers Union, Schoolmasters Union, Union of Female teachers, Further Education Union, Higher Education Union, National Union of Teachers and (here in Wales) National Union of Welsh Teachers agree on the way ahead which resulted in a disjointed approach which allowed Government to walk all over us in many instances. I would hate to see the same happen to the push towards greater transparency in mental health.
Pain is difficult to quantify, each person knows the depth of their personal suffering which cannot be compared with the suffering of any other individual but some solace can be taken from a feeling of ‘group suffering’. As the saying goes – United you stand (for divided you’ll fall) and, to me, that is your way forward. I should also add ‘I hear your pain’ for I am not a sufferer in the way that you are, I have merely watched a loved one suffer which, actually, brings with it its own brand of pain and anger.
“Pharmaceutical rape culture is a culture in which iatrogenic harms are pervasive and normalized due to societal attitudes about medicine and health care. It is a complex set of beliefs that tolerates the commercialization of healthcare and supports everyday harms in medical and mental health care settings. It is a society where harm is only acknowledged as rare, yet is accepted as necessary, and inevitable. In a pharmaceutical rape culture, doctors and patients unknowingly trust what are oftentimes pseudo-scientific facts put forth by drug makers about drug safety. Both doctors and patients end up disbelieving the reality of the adverse events they see, and instead believe alternate explanations for such events “.
It doesn’t help either that newspapers, magazines, medical journals and even the TV refrain from exposing iatrogenic drug problems simply because pharmaceutical companies would then withdraw the large financial benefit of their ad revenue. Pilot Andreas Lubitz had been given an antidepressant only days before the deliberate disaster, yet every online newspaper I read thought nothing of playing the personality card to create the impression it was all about his instability rather than an instability in him created by those drugs. The disaster will go down in history only ever having stigmatised people with depression rather than having exposed drug side effects. I feel raped by the media more than I do by the drug that ruined my life.
It is that mentality that puts faith and trust in the medical professionals that hoodwinked people to believe they have your best interest in mind. We have addictions, virulent viruses and resistant bacteria because of this thought process. It boils down to here,”take this pill and go away because, I am too busy to really give a shit”. Remember, they work for you, do your research, educate yourself, there are good mechanics and bad in every field. Be cautious with your trust!
I have shared this on Twitter but when I shared it to some Irish Politicians my twitter page went off – as it does when I post anything on medical/pharma harm and Government cover up. In Ireland Rape has always been covered up by The System and so is Pharma/MedicalRape in Hospitals and in The Doctor’s Surgery. This week I came across another cover up on another tragic story of rape in the SouthEast of Ireland http://www.breakingnews.ie/ireland/whistleblower-claims-hse-did-not-apologise-to-victim-of-savage-rapes-at-foster-home-717280.html
and just as in Pharma Rape the System when finally exposed still deny they knew anything – this is another horrific case coming out of Ireland which only was publicly exposed when UK authorities raised concerns.
Pharmageddon is at a frightening stage in Ireland – where HSE Bounty Hunters for Pharma literally go to your door and with chemical weapons and Garda Taizering one’s health is forced down for the Pharma Lab tecnicians who are on standby at A & E. Just like in The Magdalene Laundries and Clergy Rapes – a whole Irish Society comes together to cover up Pharma & Medical Rapes. It is indeed criminal – everyone knows yet no one admits the crime or gives help or support – the patient is lost in a World of her own – I thank Laura & Dr David Healy for their posts,
In keeping with this same theme, I like the term “Prescription Drug Whores” to describe doctors that take large sums of money to promote drugs that are dangerous and without adequate testing. My doctor made $170,775 from drug companies between 2009 and 2013. He promoted Klonopin as a good long term therapy for those that had anxiety problems. When I complained of memory loss and cognitive decline due to 18 years on the drug, he became angry and insisted that I had ECT. Electroshock therapy for someone because someone complains of memory loss.
Yep, “prescription drug whore”!
18 years on a drug, clonazepam, that is only supposed to be used for 3-4 weeks.
Possibly the two most important words in pharmaceutical/doctor speak:
Robert Whitaker (MIA Author) on February 3, 2016 at 11:22 am said:
Thank you all for this feedback. Chris Page, our operations manager, has really worked hard to create this fundraiser , and so it’s nice to hear from BDPTransformation that it looks well done. It is true, of course, that many of our readers are poor. But of course we deeply appreciate every donation, and a lot of $5 donations add up. I should also note that we have a number of people, who I am sure struggle to make ends meet, who have donated $25, $50 and so forth, which, even beyond the monetary help, is extraordinarily emotionally rewarding for us. it makes us feel that we are doing something that is meaningful to many people.
And yes, in terms of money, this is a David v. Goliath fight. Think of it this way: in the U.S. spending on psychiatric drugs is more than $100 million a day. We are trying to raise 1/400th of that amount to fund our entire operations for a year. And every amount that is donated, whatever it might be, helps us stay alive, and I think, if we can launch all the initiatives we are talking about, we can markedly increase the impact of the MIA community.
So, just wanted to drop in here, and say thank you.
Adam Jacobs @statsguyuk
My comment on the #alltrials fundraising page is now deleted. Remind me how this honest transparency thing works? pic.twitter.com/5x8YT3efgv
*Remind me how this honest transparency thing works*
As a regular participant and MIA author, I’d say this grassroots movement is “spiritually uplifting”.
The expansion of the social justice theme is a *talking truth to power* public response that was very much a central theme in the creation of Robert Whitaker’s *webzine*, madinamerica.com
There is a relevant discussion going on at:
It is amazing how the dynamics on these internet forums have changed over the past 4 years– there is no doubting the impact of David Healy’s voice and the sharing of credible information that has been exploding recently.
We may have some disagreements and differences in approach, but the evidence of efficacy of the on-line social justice movement is something to celebrate — the message is becoming clear and consistent.
Thank you, Laurie for pushing the envelope and reminding us that language is powerful. What we say and how we say it has resounding impact. Re-defining terms or sharpening the meanings to open minds and hearts is a crucial first step to the induction of major *social* change.
Bravo! David– you must be a literary genius, a frustrated writer sublimating his passion through the practice of a lost art. You have certainly removed all doubt that even a psychiatrist has the potential for expressing the full and glorious spectrum of humanity. I just wish you weren’t the only one !
There is hope.
Breaking NEWS– what is happening in America?
Interesting! Unexpected but so deserving of our attention. Hope all UK GPs take note of this! Couldn’t it be argued that issuing repeat prescriptions, without physically interacting with your patient, for years on end should fall into the same category of ‘negligence’ as the lack of care illustrated here?
I was thinking along the same lines. This is almost earth shattering when you consider its ramifications as a legal precedence.
The shift from ‘negligence’ to ‘criminal” is directly related to the deaths of these three young people. Assault and battery is also a crime. When would negligence cross the line to criminal in cases you mention?
Under the social justice banner of pharmaceutical rape, there are many crimes that should be prosecuted.
Trouble at mill…pill
03 February 2016
Jon N Jureidini
David Healy, Mickey Nardo, Melissa Raven, Elia Abi Jaoude, Catalin Tufanaru, Joanna Le Noury
Critical & Ethical Mental Health research group
55 King William Rd, North Adelaide, 5006, Australia
Click to like:
Re: Restoring Study 329: Response to Keller and selected colleagues
The response by Keller and selected colleagues  to our Restoring Study 329 article alleges three overarching faults: bias and lack of blind ratings in relation to harms; lack of detailed methodology; and failure to consider the available methodological knowledge regarding paediatric depression from twenty-four years ago. Regarding the second issue, there is in fact a detailed explanation of all the methods in our paper and its RIAT Audit Record (appendix 1). We tackle the first and third issues below.
While there was uncertainty twenty-four years ago about the appropriate rating scale to use in pediatric depression trials, there were serious methodological problems in the conduct and reporting of Study 329 that have nothing to do with that uncertainty. Instead, in their reporting of efficacy in Study 329, and their defence of it, Keller and colleagues have asked that the field suspend many widely held tenets about clinical trial analysis, by asking us to do the following:
• accept that the a priori protocol is not binding, and that changes can be made to the outcome variables while the study is ongoing, without amending the protocol with the IRB or documenting the rationale for the change
• ignore the requirement to correct the threshold of significance for the analysis of multiple variables
• ignore the requirement that when there are more than two groups, preliminary omnibus statistical analysis needs to be done prior to making any pairwise comparisons between groups – an integral part of the ANOVA analysis declared in the Study 329 protocol
• allow the parametric analysis of rank-order, ordinal rating scales [CGI, HAM-D and K-SADS-L Depressed Mood Items] rather than the expected non-parametric methods specifically derived for this kind of data
• allow 19 outcome measures to be added to the original eight at various times up to and after the breaking of the blind, purportedly according to an analytical plan ‘developed prior to opening of the blind’ (In spite of multiple requests, neither GSK nor Keller and colleagues have ever produced this analytic plan, suggesting that either it does not exist, or that it contains information unsympathetic to their claims.)
• accept the dismissal of protocol-specified secondary outcomes and the introduction of rogue variables on the grounds that ‘the Hamilton Depression Rating Scale (our primary outcome measure) had significant limitations in assessing mood disturbance in younger patients’, when none of the protocol-specified secondary outcome measures that they discarded were based on the HAM-D, and two of the rogue measures that they introduced were HAM-D measures
• accept the clinically dubious improvements in four of these rogue variables as evidence of efficacy. (Although these measures achieved statistical significance in the pre-defined eighth (final) week of the acute phase of the study, they did not do so in the weekly assessments over the previous seven weeks, a pattern unseen in any known antidepressant; we are working on another manuscript analysing Keller et al’s rogue variables.)
There was no ambiguity about the appropriateness of these methodological manoeuvres when Study 329 was conducted and reported. However, although some of these problems were obvious when the paper was first published, others were not apparent until we had access to the raw clinical data. This lack of transparency erodes confidence that RCTs will be conducted, analysed and reported free from covert manipulation.
Furthermore, Keller and colleagues also failed to report on the continuation phase of Study 329, even though that was a protocol-specified outcome. A report of this phase is almost ready for submission by us.
With regard to harms, Keller and colleagues are simply incorrect in many of their claims about our purported bias and lack of blind ratings.
First, our paper makes it clear that both coders in the re-analysis were blind to randomisation status.
Second, there was no ‘re-scoring’. This odd choice of words raises doubts that Keller et al have much expertise in analysing harms. We used a dictionary that adhered much more closely to the verbatim terms used by the face-to-face interviewers. The fact that Keller and colleagues say that we have labelled emotional lability as suicidality makes us wonder if they have seen the individual patient level data; it was the SKBs coders who came up with the term ‘emotional lability’, not the face-to-face interviewers, whose verbatim terms were of suicidal thoughts and behaviour. Simply using the verbatim terms that the named authors or their colleagues had used when faced with these adolescents reveals a striking rate of suicidal events. To argue that our return to these verbatim terms was arbitrary is bizarre.
Third, we made it clear there is unavoidable uncertainty in coding, and we invited others to download the data we have made available and juggle it to see if they can improve on our categorisation of the data. In our correspondence with BMJ, we made it clear that there are items that GSK could argue are more appropriately coded differently. We would be receptive to a rationale for alternate coding of certain items that is cogently argued rather than simply asserted, but our hunch is that a disinterested observer reviewing the coding as presented by GSK across all 1500 adverse effects in this study (or 2000+ if we include the continuation phase) would conclude that our efforts are a better representation of the data.
Fourth, reading our paper makes it clear why we reviewed the clinical records of 93 subjects; these were the subjects who dropped out or became suicidal. Our claims about underreporting of adverse events stand independently of that non-random sub-sample.
With regard to suicidal ideation and attempts, Keller et al. refer to a reanalysis by Bridge and colleagues, which found that there was no significant difference in suicidality between paroxetine and placebo. But Bridge et al. relied on Keller et al.’s misleading 2001 report.
With regard to bias, our point was that the best protection against bias is rigorous adherence to predetermined protocols and making data freely available. We, like everyone, are subject to the unwitting influence of our bias. The question is whether the Keller et al publication of 2001 manifests unconscious bias or deliberate misrepresentation.
The original and restored studies, the study data, reviews and responses are all available at Study329.org, offering a broad range of options when it comes to consideration of authorship, research misconduct and the newly described species, ‘research parasite’.
1 Keller MB, Birmaher B, Carlson GA, Clarke GN, Emslie GJ, Koplewicz H, Kutcher S, Ryan N, Sack WH, Strober M. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. Response from the authors of the original Study 329. BMJ 2015;351:h4320
2 Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ. 2015 Sep 16;351:h4320.
3 Keller MB, Ryan ND, Strober M, et al. Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry 2001;40:762-72.
4 Longo DL, Drazen JM. Data sharing. N Engl J Med. 2016;374:276-7.
Competing interests: As noted in our RIAT paper
The Ke(i)ller instinct?
“…everyone, are subject to the unwitting influence of our bias. The question is whether the Keller et al publication of 2001 manifests unconscious bias or deliberate misrepresentation.”
pasted from annie’s comment above. THIS would be the factor that implicates criminal as opposed to negligent behavior. But how does one support a case for “deliberate misrepresentation”?
This manipulated study has far reaching detrimental, potentially fatal implications. The fact that Keller et al have yet to respond to these implications is, imo, a strong indication of their intention to support their goal to increase the prescribing of Paxil for adolescent “depression”—
The prudent, reasonable expectation IF, in fact, the flaws in this study were just the careless errors of overzealous promoters of this drug, would be retraction of the article and apology, replete with stronger warnings about the safety of this drug. In the absence of this reasonable response, it can be inferred that Keller’s, (et al’s) intention was purely marketing,or rather, financial gain, with no regard for the risks and dangers imposed on the adolescents who would be prescribed this drug by doctor’s who trusted the authors of study329.
This case illustrates what David commented on above:
>>This is an interesting point. Rape in some sense must refer to the way things are used rather than the actual thing –<<
A flawed study is a mishap UNLESS it was designed to market a drug; UNLESS the flaws were a deliberate means for concealing the evidence that this drug was unsafe.
I would prosecute this case as felony medical assault and battery; attempted second degree murder- depraved heart or, depraved indifference for human life.
Katie – sounds good to me; maybe you’d like to read ‘This present Madness’ ( see RxISK present post for details) as that certainly takes us into this absolute mess that we are all aware of but feel unable to conquer. If you do read it, I’m sure that you will feel, as I did, that you could add a couple of chapters at the end – your case scenario would fit quite nicely in there!
No more buttons for specific replies. This regards Dr. Healy’s response to my questions. Obviously, I mistyped a comment, leaving out a word and making a typo. The comment should read “(the) ECT (that) MAX Fink…” Not “ECT MAD Fink…”. Reading it as typed makes no sense. And, I am wrong, Max did not disparage those who “complained” about ECT?
It does appear that the ECT “experts” aren’t too smart in their approaches and have dropped the ball, except for, in Peggy Salters case, going after HOW ECT was negligently applied every day for 2 weeks and continued as deterioration was recorded.
And Fink is the “only one to provide evidence of memory problems connected to ECT?” What about Sackeim’s study? What about the Janis studies? Am I mistaken?
And drug naive people have reported the same problems with ECT.
I do not say people that are happy with their ECT experience are obviously “brain damaged”. I have suggested they seem to have received fewer, unilateral at lower doses, well spaced so less invasive?
I’d have to go back to my archives to fish out the Janis papers which is not something that’s going to happen at the moment. Part of the problem is studies like this and for instance the Hartelius study supposedly showing brain damage in animals when looked at closely rarely show any such thing – I have attached Barney Carroll’s critique of Peter Breggins analysis of Hartelius to comments here before – which is well worth reading.
As regards the Sackeim material – low dose unilateral ECT seems to me to have been an unfortunate side track that helped no-one. Anyone I’ve met who has been doing well after ECT had bilateral and not low dose treatment.
None of this is to say there aren’t harms and I have witnessed abuses that have appalled me but I’ve seen the same with drug treatments and therapy can be pretty abusive in the wrong hands also/
None of this is to say there aren’t biological harms but nailing these down requires co-operation between those who have the problems and those working on the treatment. Its much less likely to happen between those researching the treatment and a group who want the treatment abolished. But beyond that the fact that little research is happening can also stem from the fact that it is difficult to nail some of these issues down. If the damage were very obvious that would be one thing but in this case all kinds of other damaging things have to be controlled for which makes it difficult even for those who figure there is a problem but need to nail it down in a way that will withstand scrutiny.
YOU ALWAYS REAP WHAT YOU SOW;THERE IS NO SHORTCUT
There has to be an attitude of openness,willingness to discover something new.No research or theory adequately covers reality.No one can.
Each of us is responsible for personal health.Others make suggestions but no one except ourselves can eat the foods of value to us.
The health we enjoy or the amount of sickness we must endure therefore is largely of our own making.When one sincerely wants health and is willing to work patiently towards it,the rewards are usually for coming.We must not clog the pipes of the human body.Raw vegetables and raw fruits called nature they are necessary if you are going to enjoy the higher health.Only basic goodness gives life to technique permanent success
The various disease and disabilities associated with lack of exercise the hypo-kinetic disease are described ,are the consequences of lack of exercise in terms as of reduced health quality of life,incresing disability and premature ageing.The advantage of regular and adequate physical activities are alluded to and include:
Musculoskeletal efficiency and fitness
The maintance of satisfactory metabilic fuction
Including normal blood fats, blood sucar, blood pressure
psychological benefits, including improved self- image and stamina
greater self-confidence and ability to deal with stress and greater immunity
Medicine is the study of disease, where nutrition is the study of health.
Within Irish society, there is a strong expectation that women should take responsibility for health care tasks.We all know prevention is better than cure.Awareness can save our life.
The iatrogenic effect is preventable harm resulting from medical treatment or advice to patients.In the Unite States, an estimated 225,000 deaths per year have iatrogenic causes, with only heart disease and cancer causing more deaths.
Some iatrogenic effects are clearly defined and easily recognized, such as a complication following a surgical procedure.Less obvious ones require significant investigation to identify, such as complex drug interactions.
Causes of iatrogenesis include negative effects of drugs,chance,medical error, negligence, in relation to medical procedures or treatments, and the adverse effects or interactions of medications.
Illich (1926-2 December 2002)argued that the medicalization in recent decades of so many of life’s vicissitudes -birth and death, for example -frequently caused more harm than good and rendered many people in effect lifelong patients.He marshalled a body of statistics to show what he considered the shocking extent of post-operative side -effects and drug-induced illness in advanced industrial society.
Originating from physician
The author is Dr.Barbara Startfield of Johns Hopkins School Of Hygiene and Public and she describes how the US health care system may contribute to poor health
Deaths per year:
7,000 -medication errors in hospitals
20,000 other errors in hospitals
80,000 infections in hospital106,000 non-error, negative effects of drugs
There total to 225,000 deaths per year from iatrogenic causes!(http://articles .mercola.com/sites/archive /2000/07/30/doctors-death -part-one aspx)
Medical Nemesis (1974) Illich introduced the notion of iatrogenic which has been established a century earlier by British nurse Florence Nightingale.