What happened to those suicidal in study 329?
In May 2014, the RIAT team asked GSK what the children who became suicidal in the course of Study 329 have since been told. (Marty Keller’s “take” on this is at the bottom).
The consent form says that anyone entering the study would be treated just the way they would be in normal clinical practice.
In Study 329, the children taking imipramine were by design force titrated upwards to doses of the order of 300 mg, which is close to double the dose of imipramine given in adult trials by GSK or in normal clinical practice.
In normal clinical practice it would be usual to inform somebody who had become suicidal on an SSRI that the treatment had caused their problem.
- It is important to the person’s image of themselves, that they are aware this problem might have come from the drug rather than from themselves.
- It is important that they be told that they are likely to react in the same way to any other serotonin reuptake inhibitors – including some antihistamines, isotretinoin and some antibiotics and that they should be cautious about such treatments in the future.
- It is important the patient’s family be warned about this adverse event as some blood relatives will be more susceptible to commit suicide on an SSRI than the rest of the population might be.
Responding to our letter, GSK’s Dr James Shannon made it clear that 20 years later the company have still not informed any of the participants in Study 329.
One reason he offered was that it had only recently been agreed these drugs posed risks. [One of the features of GSK’s response to the published study appears to be a public acceptance that SSRIs do cause suicidality in at least this age group].
But the key reason for not doing so that he offered was that:
As I have mentioned in my earlier letters, it is standard in clinical trials carried out according to good clinical practice guidelines for our trial investigators and treating physicians to be responsible for patients’ medical care during and after a trial. This would include the management of any adverse experiences that arise during the trial. Being closest to patients’ medical histories, they are best placed to do this and we are confident of their commitment to provide the care patients need.
This may be the first recorded appeal to the use of the Learned Intermediary doctrine in clinical trial settings.
One lesson of the 329 story is that without access to data, the learned intermediary doctrine is supremely dangerous for patients – and for doctors.
Learned what?
The notion of a learned intermediary arose in the 1950s when the first reliably effective drugs emerged, when an ‘ethical’ pharmaceutical industry distinguished itself from a patent medicines industry by advertising to physicians only, when Congress decided to make all new drugs available on prescription only.
Doctors then were seen as a bulwark against pharmaceutical advertising, by inclination and by training more likely to resist the pressures of advertising than the rest of us.
This was a Marcus Welby world, in which the forerunners of today’s mega-corporations were still divisions within chemical corporations and were run by doctors or scientists rather than by marketing people.
Just as prescription-only status is a police function, the idea of a Learned Intermediary is a legal notion. Neither have anything to do with the practice of medicine.
The term ‘learned intermediary’ was first used in 1966 in Sterling Drug Inc v Cornish, 370 F.2d 82 (8 Circuit):
‘we are dealing with a prescription drug rather than a normal consumer item.’ In such a case the purchaser’s doctors is a learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect in some patients and is advised of the symptoms normally accompanying the side effect there is an excellent chance that injury to patient can be avoided’.
Based on the doctrine, it is held that:
- Warnings about a medication’s hazards need only go to physicians because they are the only people that know both a particular patients medical history as well as the risk profile of the drug being prescribed.
- That directing routine prescription drug information through the doctor in this way preserves the physician patient relationship from outside interference.
- That the complicated medical terminology necessary to explain the risk benefit profile of prescription drugs is difficult for ordinary patients to understand.
- It is more effective for drug companies to have to communicate with physicians only rather than directly with all potential patients. [This assume drug companies will tell physicians the truth].
329 & learned intermediaries
The doctrine is premised on the notion that the physician is an objective intermediary who will draw an independent judgment about the best course of treatment for his or her patient.
Two factors have been put forward as compromising the objectivity and independence of doctors – gifts and Direct to Consumer Advertising (DTCA).
But 329 opens up a whole new dimension.
When the learned intermediary doctrine was introduced most information about drugs came from doctors writing up their experience in case studies or running trials where they were in possession of the data and they wrote the manuscripts about what the trial had shown. There was some sales pressure but almost no marketing pressure.
- From the 1980s, companies ran trials, increasingly hiring second rate investigators to tick the protocol boxes, and latterly locating trials in third world settings where there can be no guarantee the patients exist.
- From the 1980s, an increasing proportion of the clinical literature about on patent drugs has been written within companies or by ghost-writers. That proportion is likely now over 90%.
- From the 1980s, companies have sequestered clinical trial data so there is no independent oversight of what this data shows. Not even FDA get to see all the data.
- From the 1980s, the pharmaceutical companies were on their way to being the profitable corporations on earth, managed no longer by doctors or pharmacologists but by business men with a background in marketing.
In this new world:
- Few doctors can distinguish between sales and marketing.
- Few doctors appreciate that RCTs, adopted in 1962 to contain companies, are now the major marketing tool of companies.
- Few doctors appreciate how adept companies have become at marketing diseases as a means of selling their drugs.
- Few doctors appreciate that companies make most money from marketing risks such as marginal elevations of cholesterol levels or reductions in bone density, where if the patient takes a medicine they take on risks with little likelihood of benefits.
- Few doctor appreciate that Safe and Effective in Keller et al 2001 means Safe for GSK and Effective for GSK not safe and effective for their patients.
While there is something to be said for a Learned Intermediary in medical extremis, when a person’s judgment may be compromised, there is much less to be said for having a third party make a judgment call that requires you to accept risks they would not personally accept, for benefits that are unlikely.
Cause and effect
When the Learned Intermediary doctrine was introduced, doctors were trained in how to determine cause and effect in terms of the adverse effects of a medicine.
The way doctors assessed such events through to the SSRIs and Suicide was in line with what the Federal Judicial Reference Manual outlines to this day. Broadly speaking if exposure to a drug produces a problem (challenge) and the problem clears up on stopping the drug or reducing the dose (de challenge) and reappears on re exposure to the drug (re challenge) this is definitive evidence that the drug can at least cause the problem in some of those who are exposed to it.
However under company marketing pressure most doctors have been persuaded that such evidence is anecdotal. That the only evidence of cause and effect that counts is the evidence that comes from controlled trials. For 25 years doctors across medicine have been systematically educated to override the evidence of their own eyes.
- As a result major problems that came to light quickly in the 1960s may now take 10 or 20 years to be accepted by the field as caused by treatment.
- As a result drug induced death is now a leading cause of death.
- As a result, even in the face of Black Box Warnings a majority of doctors may still believe there is no evidence that these drugs can cause this problem.
This extraordinary situation has arisen because in their defense of Prozac 25 years earlier, Lilly deployed selected data from sequestered RCTs and a sophisticated understanding of doctors, to counter compelling clinical evidence that Prozac could cause suicide.
This is caught in this quote from Leigh Thompson, who was coordinating Lilly’s efforts in 1991, contrasting the fate of Prozac with that of the 1980s Oraflex (Opren):
Today at PSC was Medical’s finest hour. Dave Thompson and Gene Stap told me that it suddenly gave them a glimpse of how far medical has come and the vision that they knew (about global databases, super handling of ADE, proactive excellent relations with FDA, complex analyses and presentations made simple, DEN, GPT etc) but had never really had burned into their brains the elegance and mastery of the complexity!
So many of us were not here for the Oraflex , Moxam, etc crises, that it is very hard to measure the progress over the last few months on so very very many fronts.
When you battle the media and politicians, the only thing that counts is the first word. The rebuttals are always on the last page and forgotten. You have to get out front and enlist your allies. The rapid flights to Boston to visit Teicher, the trips to FDA, the consultants coming in, the huge complex database, having so many large trials, the ability to quickly perform elegant analyses, DENs mastery of ADEs, have all come together in a significant effort.
I’ll try to give a global overview of our past (Oraflex and Moxam especially) and our present and our future (with Mobius, Scientology etc after us) tomorrow at DEN. Please pass on my congratulations and profound thanks to your spouses/friends for tolerating your extra work/pressure and to those colleagues whom I have left off the list of addressees in my rush to get out this note.
I’d like to have some buttons or mementos of other kinds made with a logo along the lines of: “I saved Prozac.” Suggestions please for design, memento and words. (Exh 10 in Deposition of J Potvin in Fentress Vs Eli Lilly).
From a company risk management point of view, an aggressive management of adverse events that might jeopardize the sales of a Flagship Brand and in so doing sink the company is a No Brainer. The trouble is it plays straight into a medical blind-spot – Marty Keller and Stan Kutcher and the rest of us would prefer not to think that something we have done might have injured our patient.
Control and consent
Since prescription only status was copper-fastened in place, and since the emergence of the Learned Intermediary doctrine, legal cases in the 1950s tackling the use of radical mastectomy and other drastic treatments for breast cancer and the use ECT within mental health gave rise to a Doctrine of Informed Consent.
Informed Consent is incompatible with notions of a Learned Intermediary whose role includes deciding whether to withhold information from a patient based on his judgement about what is in that patient’s interests.
When the Learned Intermediary doctrine arose it was not unreasonable to think that while patent medicine makers found no difficulty in creating an advertising industry in order to communicate with the general population, there were legitimate grounds to think it might be a problem to convey complex information about an entirely new class of compound that contained ingredients that for the first time ever could save lives and restore function but could also kill.
A case could be made for engaging doctors in communicating that information.
But with the development of the internet, the extension of education, and 75 years of familiarity with modern medicines, the pharmaceutical industry appears to have little problem communicating with the population at large.
And so, there no longer appears to be a good reason to exempt drug manufacturers any more than other manufacturers from a duty to warn – and a duty to make public the data behind their claims.
Instead of helping patients, the Learned Intermediary doctrine now helps companies. It allows companies to keep their data under wraps. It shifts liability from a careless manufacturer onto an intermediary who is responsible for distributing a defective product to a vulnerable citizen.
He (your doctor) is coached by companies in the arts of persuasion to play on his patient’s (your) anxieties so that they (you) take medications they (you) would never take if left to themselves. He was once skeptical of the benefits of drugs and a bulwark against unwarranted treatment, but many of his patients (you) are now more skeptical than him even though they (you) don’t quite know (you’d never guess) the extent to which his recommendations to take a treatment are based on sand.
The fact of prescription only arrangements allows companies to sell to doctors only. In a world where medical education does not cover how companies market medicines, we have produced a generation of doctors more susceptible to marketing that the most designer label addicted adolescent.
Marty Keller & summary judgement
Pharmaceutical companies make medicines. Because doctors use medicines and are trained in medicine, they might appear to be equipped to assist their patients in making decisions about those medicines.
This was true in the 1960s when doctors’ clinical experience (not RCTs) meant they knew more about taking risks with chemicals than their patients did.
Medicines are chemicals that come with information. The chemicals are unavoidably risky. The information component of a medicine and the culture about using chemicals in medicine was commensurate with those risks in the 1960s but the information and the culture have both been degraded and now systematically conceal risks.
Worse again this information is portrayed as objective and scientific. It has become the primary determinant of prescribing, over-riding the natural caution of both doctors and patients.
The problem that sales techniques such as gifts pose in compromising the doctor patient relationship is minor compared with this.
If doctors are now truly to function as Learned Intermediaries, it would be by informing their patients and the Courts that the bulk of the academic literature, especially that in the most distinguished journals, cannot be believed.
Sitting in the midst of a Maelstrom in 2004 when New York State were suing GSK for Fraud, faced with demands to “modify” Study 329, on June 13 Marty Keller emailed some of his co-authors to get a united position about what they would say to GSK about the modification:
that [it must be] 100% clear in this paper that there is no way to read it and think that 329 is being criticized and that it was not written with complete integrity and accuracy given the data we had and should have had….. We also want it to be crystal clear that any new data or analyses, case report forms, narratives etc. you have worked with since 329 was published, was not made available to the 329 investigator’s by SK, otherwise we could look foolish, naïve, incompetent or “biased” (the most likely accusation that will be made) to present things in a way that was favorable to SK, disregarding our responsibility to the proper scientific method, to the public, children and their families.
So as MK & GSK see it, while the Learned Intermediary Doctrine rules, he and his colleagues have a responsibility to their patients. Someone needs to do the right thing by the Paxil 12.
Explaining the nature, effects and possible adverse effects of medications seems to be, fundamentally, attached to the principle of informed consent. At present, it appears that a person harmed by a drug has no legal recourse by way of showing a lack of informed consent. For example, if what was proposed was a surgical procedure and informed consent was not obtained but the procedure was done and caused damage, there may well be a cause of action for medical battery. This is the intentional violation of a patient’s right to direct their own medical treatments. Doctors must obtain a patient’s informed consent when rendering non-emergency treatment. If medical treatment is performed without the patient’s consent or against their will, the patient may have a claim for medical battery, even if the doctor did not intend to cause any harm. In a medical battery claim, however, there is generally no need to prove injury or negligence but in all battery cases, it is necessary to prove that the medical personnel engaged in unauthorized touching, contact or handling of the victim.
This does not seem to be applicable to the uninformed consumption of a medication, so what recourse for damages does the patient have? The main point of dispute in most medical battery claims is whether the patient agreed to the treatment or whether they refused it but, in order to make an informed decision, one must have honest and clear data on which to base that decision.
Dr Healy: “While there is something to be said for a Learned Intermediary in medical extremis, when a person’s judgment may be compromised, there is much less to be said for having a third party make a judgment call that requires you to accept risks they would not personally accept, for benefits that are unlikely.”
I would suggest that the uninformed patient is the typical patient. Where is the protection against harm?
An excellent post …… which should be made MANDATORY reading for all GPs and medical students – if only, somehow, this could be done! What a magnitude of human suffering could be prevented!
This post NAILS IT.
I like Bernard Carroll’s tone when he says:
“It may have seemed like a win-win arrangement but some of these listed authors I am sure wish they had never consented to be so trusting.”
While it’s tempting to castigate Keller and the other so-called authors of Study 329, I think it’s critically important they not be scapegoated. The case being made by the RIAT Study 329 is that science is done this way in all of medicine and that fact should be the take home message.
All of this has been like watching a picture develop and I get overwhelmed thinking about so many other pharmaceuticals that have been in use for decades yet need to be subject to major reanalysis. Ove mentioned something on your last post that I also think is particularly urgent:
“Is Keller aware of that ALL doctors (99,8%) use data from RCT’s to say: “that is an anecdote because RCT’s did not show that”?”
How many people have had the experience of telling doctor after doctor what they have experienced on a drug only to be told, “no it’s not the drug because, science.” In a world where Science Trumps Everything, the source of much patient suffering has been made literally invisible to doctors (and therefore to all of society) as science has fallen into the hands of these profit-driven corporations.
Dr. Healy, I hope your comrades are listening to you because most of us, as survivors, have been made painfully aware that we are too low in the medical caste system for our words to be counted. That you listen to the likes of us is truly revolutionary and gives us dignity when others treat our input as valueless.
I am grateful to any doctor or professional who recognizes their moral obligation to pick up this torch because ironically, while they are the ones the system has conditioned to NOT LISTEN TO PATIENTS, they possess the social capital necessary to shed light on the extent to which Western medicine is hemorrhaging.
There’s a heap of injustice and abuse of power here. I just want to explain one small corner of it for readers who are not familiar with older anti-depressants like imipramine (Tofranil). The kids in this study were randomly put on Paxil, Tofranil or placebo. Studies had already confirmed what many docs knew from practice: Tofranil was NOT effective for relieving teen depression.
I was briefly on Tofranil in my early 20’s, back in the Jurassic era, and also took Elavil. Both are older antidepressants called tricyclics with a different mode of action than SSRIs like Paxil. They actually are more helpful for severe depression than SSRIs, but come with side effects many patients find hard to handle–especially sedation. Tofranil made me so “dopey” I refused to take it after the first week. I took Elavil for longer. It did help, but I wondered if part of the benefit was to make me too foggy to feel anything as strong as actual despair.
The Tofranil Kids in Study 329 were put on a dose the investigators knew was much higher than the average adult patient would get. They must have been completely miserable. They also were exposed to other risks such as cardiac arrhythmias, and I believe several left the study early due to “cardiac problems.” This was an unreasonable risk to take, even with healthy young people.
The only possible reason to do this was to artificially make Paxil look as good as possible. In that way it was both an abuse of the young people in the study, and an abuse of millions of other patients who were sold an inflated belief in Paxil as a “wonder drug.”
Brilliant points being made here…
Fully agree on the point about informed consent in regards to the violation to the body and mind from not being warned of side effects… Seroxat is the poster-child for it. Thalidomide is the only thing comparable Seroxat in terms of public outcry and controversy, however with the SSRI’s this is a class problem, and of course the RIAT study on Paroxetine opens cans of worms way beyond one drug. I’m so glad that Healy, Doshi, Nardo, and the others, had the tenacity, and courage, to open those cans of worms…
Furthermore, it’s utterly horrifying to read about how these kids were treated in the study itself, then to know how it was marketed (mostly off label) to hundreds of thousands of youngsters, and well … we know the rest… utterly shameful..
However, as was pointed out- we must not scapegoat the authors, that’s what GSK would want. Yes there has to be accountability of course and they played a part, as did drug reps, marketing departments, the regulators and psychiatrists on the pay roll, but in my opinion it”s GSK who should hold the most accountability here..
They are the Godfather and Kingpin behind the scam itself…
This is the question we all ask ourselves on a daily basis.
Having experienced the experience from a top law firm who advertise ‘have a claim of medical negligence, then we will talk for you’ and having it dismissed because a GP, legal budgerigar, could not find fault with the ‘service’ I was given and actually said that she could not see how my doctors could have done anything differently (squawk)…it was all copy and paste…a report, it was not.
I won an award from the British Overseas Development Agency, for report writing for my textile company, of £2,000. Not to me, you understand, for my company.
I know how to write reports.
All this wonderful back ground that David has given us, which has taken him, and, his, colleagues, years in the making, might give grounds for a Serious Legal Challenge to a Pharmaceutical Company, but, it doesn’t stop our doctors and psychiatrists pulling fast ones, which, they, know, they are doing….we are not represented by anyone against their duplicitous work…and we either need a Class Action Against the Doctor, living near you, or, we need a healthy dose of realism from Government Agencies, who, as, far, as, I, can, read, it, have no place in this provision.
The work David and Team have done, which, is on our behalf, really should eventually lead to a whirlpool of patient complaints about Doctors.
If anyone can think how to resolve this particular issue, I would love to hear it……
http://1boringoldman.com/index.php/2015/09/21/60048/
• If there is evidence that a person is biased in some manner that would affect the reliability of her claims, then an Argument from Authority based on that person is likely to be fallacious. Even if the claim is actually true, the fact that the expert is biased weakens the argument. This is because there would be reason to believe that the expert might not be making the claim because he has carefully considered it using his expertise. Rather, there would be reason to believe that the claim is being made because of the expert’s bias or prejudice.
• If a person makes a claim about some subject outside of his area(s) of expertise, then the person is not an expert in that context. Hence, the claim in question is not backed by the required degree of expertise and is not reliable. It is very important to remember that because of the vast scope of human knowledge and skill it is simply not possible for one person to be an expert on everything. Hence, experts will only be true experts in respect to certain subject areas. In most other areas they will have little or no expertise.
The Data was Not Spoken from where we sit with our doctors
… As with most scientific papers, Keller and colleagues convey an impression that “the data have spoken.” This authoritative stance is possible only in the absence of access to the data. When the data become accessible to others, it becomes clear that scientific authorship is provisional rather than authoritative.
A cad em micks
Someone needs to do the right thing by the Paxil 12….well said…but, its not just 12, is it?
Today, that is…..
Thanks for Background….increasingly hypnotic
http://study329.org/study-329/
What about the adults who became suicidal trying to get off this drug .. what were they told….adults in their forties like myself who had never been suicidal or depressed before.
Well in trying to get answers i was told i had an underlying depression …that was news to me so when i immediately replied that is not right I was referred to a psychiatrist. Being totally ignorant as to my plight i asked Dr Simon Bainbridge on secondment from the UK if he was aware of any issues or problems with people getting off paroxetine. He replied, “If there were problems then people would be suing the drug companies,” At the time i interpreted that as a ‘no there are no problems.’
I was then over the next few years of suffering an emotional and psychological hell – protracted ssri withdrawal, to come to the conclusion, after a little of my own research, that Bainbridge was a man who clearly had his initials round the wrong way !
Question: Am i the only one to be uninformed of an enduring horror story scripted by a doctor and arrogantly dismissed like this.
Answer: What do you think?
no, many doctors bury their head in the sand, deny, or simply patronize their patients.. some don’t, but many do.
So my wife had to attend a funeral on Friday – one that brought chills to her soul. It was the younger brother of a friend since school, a friend who had supported her though her darkest times on antidepressants.
He broke up with his girlfriend a while back, and his mild OCD symptoms got worse. He went to see a psychiatrist and was prescribed antidepressants. He was sectioned some weeks later. He injured himself escaping, and tried on his own to stop the medication that he said was making him worse. They found him eventually. Some weeks later when he was calmer and compliant, he was released into the custody of his parents. Last week, he wrestled the car keys from his dad, and proceeded to drive the car into a wall at high speed. Now he is dead.
We watched this all unfold from a distance over the past year or so completely unable to affect the outcome.There was nothing we could do other than for Claire to pass on some of what we had learned to his sister. As the situation progressed, the things that took place raised all sorts of red flags that made us believe that he was in this trap for life, or at least for as long as he could hold on to life. Sadly, he couldn’t hold on for long.
For Claire it was hard. She saw someone that was going through what she went through, but because of an extremely unlikely turn of events, she made it and they didn’t. This has to stop.
Lets hope the Restoring of Study 329 is the start of something because this really has to stop.
I think this is a very important point, Neil, has brought up. A tragic tale, Neil.
What do we do under these circumstances?
I have a new friend, bright, breezy, and very clever; an Open University tutor.
She has immense personal problems with an errant husband, a policeman who was siphoning off monies in their joint account. They are separated and share the children and she escapes to the Caravan Park, with one, two or three children in tow.
We recently socialised and she mentioned she had been given Sertraline. Hmmmm
She volunteered these words “my doctor is lovely and supportive and has become a real help to me. She said that my body was so ravaged from lack of Serotonin over the years, from stress, that these pills would normalise my Serotonin and go a long way to help with my stress levels.”
I said, actually, that is not scientifically proven.
As she launched into drinking a second bottle of wine, and became somewhat animated, I really was at a loss…I didn’t feel that I should push the point as I became aware that she might develop hostile feelings towards me…..
Just don’t suddenly stop taking them, I said.
No worries, she said. Everyone knows you have to taper and my doctor told me I am on the lowest dose, one 100 mg. and one 50 mg. daily.
I worry for her and feel that all I can do, if I become a true friend, is just to watch how it goes…but, I am completely aware that this isn’t enough, on my part…..
There is little you can do. I was barely able to affect the outcome for the mother of my children, never mind someone outside of my immediate circle.
But it’s like watching a car crash in slow motion. You can see this persons life being destroyed, and you know what would likely turn that situation around yet there is nothing you can do and no one you can tell that would believe you.
I expect I am going to have to get used to that feeling more and more as the years go by.
The evolution of the Learned Intermediary doctrine is indeed a problem today. How many lawsuits have failed because the plaintiff was caused irreparable loss (e.g. death of a loved one from drug-induced suicide), but the doctor admitted that s/he had been warned, but did not see any need to pass along that warning, or did not really comprehend or believe it. Since the doctor was warned, because of Learned Intermediary a legal action for failure to warn could not succeed, even though the patient and his/her family had no clue.
Yes this post should be mandatory reading and not just for doctors, because the main point that sticks with me is that drug companies should be like car companies: if the brakes are faulty, tell the people who own the cars. Make a public announcement.
Of course, that would tend to undermine marketing messages. From the consumer perspective, all the more reason to demand it.
Dr. Healy,
VW stocks plummeted +25% yesterday and the company will pay BILLIONS of Euros for cheating emissions for diesel engines. Yet, all is quiet on the Pharma Front.
Yes, interesting isn’t it; goods count for more than human lives of course – we must not forget that! When I heard that story on the news, it struck me how similar it was to the Study 329 outcome but oh so different in the reaction to the news. Anyone heard mention of GSK or Study 329 in any news programmes in the UK since the publication? – I certainly haven’t. Let’s bombard Parliament with letters now and see if we can wake them up to our news. Letters I suggest, not e-mails, – if enough of us write, then at least the delivery postman might begin to wonder what is going on even if our messages fall on deaf ears! Seriously though, alone I am one, and maybe the only one that will have sent a letter to my actual MP, but I am sure that between us all we would cover a good few individuals in the House. Jeremy Corbyn ( whatever our feelings regarding that post) has started a trend of asking questions from the public in PMQ time so he may be the very chap to turn to with our plight. Actually, the Labour party has recently appointed a minister for mental health (not sure if that is actual title but roughly so) – she, yes SHE , had an article in the Sunday Express last Sunday which I have kept so she will get a letter too. Am also writing to a Welsh Lord as well as to my son’s MP who was, until May’s election, a local GP – so he certainly needs a copy, especially as, at present, he seems to like the sound of his own voice by all accounts; maybe he’ll be glad of a new topic to share with Dave C( who actually has more than enough on his own plate at the moment it seems!).
The reality of all this, surely, is – we are the ones who have suffered either personally or by watching a loved one suffer; the experts have done their work and dedicated hours and hours of their time to it – isn’t it now in our hands to do all that we can to further their work? Without our “evidence” their hard work could go to waste – it would simply be another report without a human face to it – and that should not be allowed to happen. As David has reminded us, this goes way beyond the Seroxat issue – it is a light for the majority of us who are popping pills in the dark,without a clue of what is really in them nor of what harm we may be causing to ourselves and, in the process, creating a great wealth in all the wrong places. I shall be waiting to hear a newsflash in the near future regarding a bottleneck at Downing Street as Royal Mail vans queue up to deliver sack after sack of mail addressed to both Houses of Parliament!!! Any cartoonists among us? – bet you could create a good one there!
The difference is money. It is financially advantageous to the global economy and for that matter, the car industry, if the world rejects diesel cars. Just like it was financially advantageous for the world to reject gas guzzling petrol cars about 10 – 15 years ago, just like it was financially advantageous when we changed from leaded fuel about 15 years before that…. and just like it will be in ten or 15 years time when we change from small petrol cars to whatever…. electric or hydrogen maybe. Then some time after that there will be a scandal about fuel cells or batteries and we will all change again.
In the long run, even VW share holders who stick it out will probably still be winners, as all the so called green diesel cars that people bought because of government tax incentives and scrappage allowances given for their old petrol cars, are now replaced with little turbo charged petrols that are much cheaper to manufacture but won’t be any cheaper to buy. Someone’s got to build them, and that creates growth.
The only time you will ever here that Surely big pharma is just the same… the only time you will find out if a drug is dangerous, is if they have something more profitable to replace it in the pipeline. The scandal then drives everyone to the new product.
I think it will blow over as probably most other car manufacturers are doing the same thing.
Once a VW lover, always a VW lover.
Three Billion $ in fines blew over for GlaxoSmithKline.
When most people swallow their Seroxat, unless they are up to speed, reading the finance pages is the last thing they do.
Volkswagen is nothing compared to this: politicians, public bodies and even the mainstream media do not want to grapple with the systematic deceit that they have perpetuated which have wrecked and destroyed countless lives, of which the Paxil story is only the tiniest tip eof the iceberg (grievous and terrible though its consequences are). For them the new Pandora’s Box would be lifting lid on all the harms that have been inflicted on ordinary citizens (even on themselves and their own families). Will anybody ever be called on to answer for this? Instead, it would not surprise me if some new honour was not soon bestowed on Sir Andrew Witty to re-assure everyone that GSK lies at heart of the social and political order, and can do no wrong. Can a CH or an Earldom be far off?
In the United States, at the moment, a Centers for Disease Control scientist, William W Thompson, is appealing to Congress to be allowed to give evidence that he and the other authors of a 2004 paper suppressed data involving two sub-groups to give the MMR vaccine a clean bill of health over autism – one was a subgroup of population (African Americans) and one was a diagnostic subgroup (isolated autism) [1]. This has be going on for over a year: the politicians are not anxious to hear it, the mainstream media (soaked in pharmaceutical advertising) are not anxious to report it (or if the do they pour ill-informed scorn), and the agencies were captured a long time ago.
What we do not see so far with pharmaceutical industry – even where fraud and professional intimidation are by common consent exposed – are any consequences to the perpetrators. For the shareholders a fine is only a commercial risk. Suing a manufacturer is also only a theoretical possibility in the United Kingdom as things stand (and vaccine manufacturers are immunised from prosecution in the United States). When is anyone going to be sacked, or shame-facedly resign? When is anyone going to be prosecuted for state sanctioned grievous bodily harm, or mass-killing?
[1] Kevin Barry, Vaccine Whistleblower, Exposing Autism Research Fraud at the CDC, Foreword Robert F KennedyJr, JD,LLM, Preface Dr Boyd Haley. Skyhorse 2015
http://study329.org/in-the-news/
Plus, Medical Health Journalist, Jerome Burne and his views….
Jerome Burne @JeromeJB
Regulation lite allows dangerous drugs. #AllTrials not enough. #jeremycorbin could rescue ‘evidence based medicine’. http://healthinsightuk.org/2015/09/21/dose-of-jeremy-corbyn-needed-to-make-medicines-safe/ …
http://healthinsightuk.org/2015/09/21/dose-of-jeremy-corbyn-needed-to-make-medicines-safe/
http://jeromeburne.com/
Very precise recounting of the well trodden path that has led squarely to this horrific “Aha!” moment. It is clear that Jerome Burne is on target regarding the leaks in our “American” system of prestigious academics and regulatory agencies that are letting this scandalous BS (Paxil Study 329) pass through to greener pastures.
I can’t argue against Burne’s trepidation over yet another made-in-America tool. This is the tool that will craft a vehicle to provide a smooth ride over the carnage of this latest episode of plundering by the monster. A covert maneuver in the guise of legislation called “The 21st Century Cures Act”, would, according to Burne’s reporting , “… severely weaken the FDA’s already ineffective regulatory scheme for medical devices.” So, obviously America is not to be counted on in the realm od prioritizing the protection of patients, when there is money to be made by getting drugs and medical devices on the market even sooner than the fast track we already have. Now America will surpass this fiasco, creating disaster making history by approaching the speed of light…and so on. He laments the effects this will have on patient safety in the UK, which is a purely rational concern. Burne instructs his fellow citizens to hang their hopes on the political leadership of a man not yet elected–, Jeremy Corbin.
This candidate, according to Burne promotes a re-nationalization campaign, and would naturally apply much needed legislative muscle to separate the industry that makes and sells medical treatments from the process of testing them for safety and efficacy. A publicly run program to test new treatments? One that is not *yet* owned and staffed by the monster?
Interesting to note in the comments that follow the article, a proposition made for deterring the monster’s penchant for criminal behavior. Criminal prosecution directly addresses the problem, but seems farthest from the minds of those writing out their outrage over the RIAT team article published recently by the BMJ.
The U.S. and the U.K. are separated in a myriad of ways, but our citizens are united in their predicament, share the exact same risks of harm and a worsening fate… if this monster remains on the loose. Why, then, aren’t there signs of efforts to create a strong alliance toward a common goal that benefits all of us, such as has been demonstrated by the RIAT team? Nationalism or nationalisation rather misses the point of the findings of this global group of like minded scientists, doesn’t it?
I think it is very difficult for anyone who holds a position that allows them to directly and immediately communicate current events to the public, to sit with and ponder the implications of the loaded history behind Paxil Study 329. This is the kind of news that could incite panic because it rips the very fabric of our security blankets. Brings too much, too close to home. We accepted that medicine/health care is a for-profit business. No longer patients, we are consumers, and as such a market. But this is, after all, a business that depends on the services of a special group, qualified by a special professional license. Won’t they always prioritize their actions around serving the best interests and protecting their patients from harmful medical practices –and a [hard to imagine] band of cold, calculating thugs that will label our casualties, “collateral damage” in the free market?
To my recollection, it has been the group self identified as “psychiatric survivors” that has given testimony to the unfathomable — doctors exploiting vulnerable, suffering people for profit. Far short of calling them victims of crimes against humanity, the same sort of journalists who are detracting their readers from the full ramifications of the scandalous evidence brought to light by this recently published article by the BMJ, were not so long ago, minimizing all of the early warning signs shared in the personal stories of psychiatric survivors.
So, another suggested resolution to *it*, or rather, that which cannot be named, is a means for preventing *it* from continuing to do massive harm with impunity. Round about and off in the future, and totally discounting the odds against starting up a brand new, untainted, pristine agency to police the monster, this at least follows a very descriptive narrative of *it*.
“CURES” 21 is being sold as heaven descended to earth for the families and suffers of orphan diseases. Why wait? get what you deserve to get and get it right now. how dare regulations get in your way! If I ere not so grounded I might go a bit tinfoil and suggest there was a depopulation of the unfit genes behind this line of huckstering.
Meanwhile a different narrative is being followed, and you and I both read it. But it isn’t making page one above the fold where all the hype is displayed. And I have been advocating one of the other bills balled up and packaged with this this this….!
Comes now, and again my paranoia kicks up, a new anti-regulatory administration and insiders from the Church of the Bottom Line to set in the government agencies’ control centers, snooze a while, and then go back to industry to collect their good doggie rewards. Or perhaps the continuing acceptance of paying them while “off the job while on the job payroll” will grow so that by the time they retire from malfeasance they can actually retire and not need to return to industry for more unjust comp.
Indeed this might be the way the world ends. no bang (just a few in the inner cities at most) and no wimper just citizens dropping like flies after a DDT truckspray. Dropping from lack of care and if that doesnt work, dropping from “care.”
At which time I will still put great blame on the Anti-psychiatry movement for their overexageratioins that turn these serious medical issues into just another “conspiracy rant.” Figuratively speaking I will have a hard time deciding where to expend my ammo…Big Mad-in-America and Big-Snake-Oil or Big Pharma, Advice and or ammo donations gladly accepted.
The reminders….
http://www.gsk.com/en-gb/research/sharing-our-research/clinical-study-register/
Go to the Clinical Study Register……..we did..
http://www.gsk-clinicalstudyregister.com/
I like the way this commenter speaks up…in America..
1. bpdtransformation, B.A. on September 24, 2015 at 2:03 pm said:
Being interested in Britain’s system of mental health provision, I took a look at some of the links.
In this – http://www.bbc.com/news/health-29228148 – it says, “An estimated three quarters of people with a mental illness receive no treatment”.
To the article’s credit, it spoke about the value of psychological therapies for “mental illness” and “symptoms”. It could indeed make a big difference if more psychotherapy were provided quickly to distressed people.
On the other hand, this article could imply that “three quarters of people without mental illness” are not receiving medications. Since the net effect of medication use is usually negative, 75% of people not getting treated could be seen as an encouraging statistic, with less damage being done in the long term.
Then I looked at the NICE Guidelines. Unfortunately, some of the ones about mental illness stink. Here are some highlights from:
“Schizophrenia” – https://www.nice.org.uk/guidance/QS80/chapter/introduction
“In both hospital and community settings, antipsychotic drugs are the primary treatment for psychosis and schizophrenia. There is well established evidence for their efficacy in both treating acute psychotic episodes and preventing relapse over time in conjunction with psychological interventions.”
Therefore, the primary guidelines given by the British government about treatment of psychosis are bald lies to the public…. There is not well established evidence for any of the assertions above about neuroleptics…. nor should “symptom control” or even “relapse prevention” be the primary focus of any serious long-term effort to help a psychotic person.
So I am not sure why Kinderman suggests that NICE is commissioning interventions for which there is a “good evidence base.” Rather, it sounds like NICE has been infected by the drug companies and psychiatrists.
To be fair, I did look at some of the other NICE guidelines, and some of the information about conditions like personality disorders and depression is less distorted and more supportive in its representations.
But, the tinge of the disease model and distortions about efficacy of medications is still bleeding all over England’s national guidelines.
Hopefully Britain can learn from what sounds like a more humane, open, realistic attitude prevailing in Norway.
well, there is, but not in the big “fix it (and maintain dose) and forget about it” way that is normal with all endeavors, medical or otherwise.
I will lay odds that fully half those who would benefit from no meds but some talk do not have what these drugs were first saught to help, that is SERIOUS MENTAL ILLNESS. which is different than mental distress, even mental illness. SMI starts with the brain. Mental illness can start in the mind and slowly settles into the brain (epigenetic resets, just like with the SSRI survivors)
The worried well (I Will use the term) should not be allowed access to these powerful drugs. Their providors should be forewarned and the practice should halt under duress of massive suits. As for the SMI, the less that 5% (oh how less than the 25-40 + on these drugs! should be the sole recipients. And as we are now moving beyond “behavior” and connecting to genetic Expression perhaps we will be able to feed the right med from early on. That is too new to evaluate yet.
Furthermore, the vocal worried well, the overly aggrivated survivors of wrongful drugging (most not even by specialists like psychiatrists but any old prescribing g.p. and how I wince when I read of an SSRI patient having issues with his doc and THEN for the first time being referred to a psydoc!!!) should re-evaluate their relation to the BigAltMed that is full of even less regulated un tested SNAKE OIL to the tune of billion$$$. They should forsake the antiscience position of certain parties are Mad and want to bring down the whole Establishment. from Szasz forward there is a thread that lays all guilt on society alone. It certainly bears a fair share. But just as there is good in established order in the world, there is some truth and goodness in the practice of medicine. Some won’t see it because of how MAD they are. don’t be liike them.
The Worlds Best Kept Secret….Study 2.31…………….for mystery guest, and, why this matters…
http://www.alltrials.net/find-out-more/why-this-matters/
Sense About Science @senseaboutsci
Thanks @SLSingh! He’s auctioning his M-209 cipher machine (that hides secrets) to help fund #AllTrials! Please share http://bit.ly/1g4ZUTr
16h
ben goldacre ✔ @bengoldacre
blimey, @SLSingh auctioning off ww2 mechanical cipher machine to fund #alltrials and @GoodThinkingSoc http://goodthinkingsociety.org/cipher-machine-to-be-auctioned-to-raise-funds-for-good-thinking-all-trials/ … Thanks!
My guess is these kids were treated for *unmasked bipolar disorder* .
The same fate may well have befallen some of the kids who dropped out of the study due to *adverse reactions*, re-classified as disqualified due to new diagnosis of bipolar disorder.
This may sound a bit off the wall to many reading here, but the casual dismissal of adverse reactions- even suicidality following SSRI prescribing to kids, is classic “it’s the disease, not the drug” rationalizing, that boosted the “kiddie” market for mood stabilizers and atypical antipsychotic drugs.
A similar marketing strategy is the well known ADHD misdiagnosed as bipolar–. Kids diagnosed ADHD , who were adversely reacting to stimulants were also subjected to “it’s the disease, not the drug” rationalizing prescriptions for mood stabilizers and/or atypical antipsychotics. Again, the disease, was bipolar disorder.
I don’t think the apathetic attitudes noted particularly by those who authored and sponsored study 329, can be fully appreciated without a refresher course on the wider agenda that fueled pathologizing child and adolescent temperament differences and the reification of childhood bipolar disorder.
I also wonder how much outrage can be generated over study 329 without debunking the sham that is the cornerstone of child adolescent psychiatry in America.
all this is the downside of putting psychiatric patients outside of real medicine to begin with. we took freudian talkers, made the almost medically competent and set them loose wiith a prescription pad. We continue to diagnose by the esternal signs and some timeline and sstatistic note, how long, how often and how severe. Nore of which looks uunder the hood. Lets look at presenting with yellow eyes, called jaundice. It would be actionable malpractice if a doctor insisted on treating from just that observation. Luck guy has some bio-testing he can rely pretty well on. Not so lucky yet the psydoc.
The worried well should get a few relaxers…booze works and is safe in the short term just as are the psy druugs. they should get talk therapy. bartenders are often quite good at this, perhaps they could be put in some schooling and given clinics to pour and dispense advice.
Those who truly have serious problems need real doctors. They are called neurologists. some of them might want to sub specialize in brain disorders of the most serious sort for which we don’t yet know the causes as we do for even Alz to the degree we can save those folks from “its all in your mind” b.s. (which is what the anti psych fringe who deny mental illness as a reality have to hold up. ” its all in your mind” and 1. “its your fault” or 2. “society did it to you!”)
No end to the rubbish printed in psychiatric peer reviewed journals. Not only were SSRI’s recommended as first line therapy despite increased suicidality, industry backed psychiatrists claimed they had “no serious adverse or life threatening effects”. How is that SSRI’s have shown in many small studies to be associated with hyponatremia 30% of the time, across all ages in otherwise healthy patients? Why is that no-one has bothered counting the case reports of severe hyponatremia since 1999? When there were 811 case reports between 1966 and 1999?
Perhaps if there was a black box warning about this, my 19 year old daughter wouldn’t have suffered permanent brain damage when her sodium level dropped to 124 and then autocorrected to 135, 12 hours later. Maybe then the psychiatrists would have known to seek medical consultation instead of sending her home to develop ODS 5 days later. According to Harvard Publishing, hyponatemia isn’t a serious adverse event. Is that why my daughter ended up in PAU instead of ICU when she developed hyponatremic delirium and cerebral oedema on Escitalopram?