Persecution: Dangerous Liaisons
This is the seventeenth in the Persecution Series. See Brand Fascism for a listing of prior posts in the sequence.
In the novel Les Liaisons Dangereux, later the movie Dangerous Liaisons, the Marquise de Merteuil engages the Vicomte de Valmont to corrupt the incorruptible Madame de Tourvel…
From 1951, a system designed for heroin and cocaine addicts – prescription-only status – was applied to all new drugs. Why? These were after all the first truly effective drugs in medicine. But the ability to do good came with a likelihood of doing harm. There was a trade off to be made between risks and benefits. The new complex trade-offs could not be put on to the label of a drug or even captured in a forty page package insert. They needed to be individual to each person.
Having seen hundreds of different treatments and people, the patient’s doctor seemed to the US Congress like the person best able to explain the use of a new drug, and knowing their patient, best placed to help them make any trades.
Doctors, almost all men, were seen as skeptical of the latest fashions, if not entirely incorruptible. Patients, mostly women, faced with exaggerated claims for benefits were seen as likely to have their heads turned by the latest claim – and what did they know about medicine anyway.
Hide the data, control the spin
In 1962, there was a sea-change in what there was to know about drugs. There was a switch from the knowledge a doctor might have born from his experience of drugs and diseases in general and of this patient in particular to a knowledge of the average effects of drugs derived from controlled trials. At first blush, this seemed even more scientific and beyond the reach of the average woman in the street.
But data are public – or were in the 1960s – in a way that experience isn’t. And using public data on breast cancer survival rates, women created the need for informed consent. Medicine was temporarily on a road to becoming democratic.
The information in controlled trials has two components. One component is the data that is collected and should always be public or else medicine is a tyranny. The second is the interpretation put on that data – the spin if you will.
Industry resisted the move to prescription only medication. But the pharmaceutical industry has an unrivaled ability to co-opt developments that it initially might not seem to favor them. In this case, controlled trials gave industry a way to displace clinical experience. Hide the Data and Control the Spin.
The result – the heads of incorruptible doctors turned at the first hint of an exaggerated claim for benefits. Adolescents faced with a rack of designer clothes would show more discretion (bottom) than the average doctor.
Hide the Data, Control the Spin, and then check on my precious, my “Learned Intermediary”.
Does my bottom look big in this?
This is how a Texas Court put it in 1974:
Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His has the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgement bottomed on a knowledge of both patient and palliative.
Bottom is a beautiful word that has all but vanished. It referred to professional judgment. Discretion. This is what you paid money for. This is what a leader like Churchill had.
Bottom is what made a Learned Intermediary. This was the person in between you and pharma whom you’d hope in your case had bottom. This is what made a Good Doctor.
Except if this person can be persuaded that any bottom that doesn’t fit into the straitjacket of a controlled trial is just too big to put on public display, then the Learned Intermediary idea makes the perfect cover for a pharmaceutical company.
Despite DTC adverts, drug companies don’t sell to the public – they sell to doctors. If the Doctor is happy with the information they convey – they claim they are relieved of a duty to warn the patient. That’s the doctor’s sacred professional duty, they say.
There is no Law or Statute that says this is the case. It just seems like common sense to many courts like the court in Texas. And if on the basis of this, you have the most clear cut drug induced suicide or whatever, but your doctor says he’s not convinced the drug causes this kind of problem and would have prescribed it to you anyway, to put it politely you don’t have a case against the company.
There is no Law of Statute that says the role of a doctor is to provide cover for a pharmaceutical company, but….
This is where controlled trials and controlling the Spin is important. If a hazard like suicide is more common on treatment than placebo in trial after trial but none of them are significant, and the company can persuade the doctor that if it’s not significant it doesn’t exist, then despite any number of convincing cases she can draw on from her own experience – she’s theirs – unless that is her Bottom is too Big for this. Or some Court decides this is a bad joke.
A midsummer’s night’s study
Between 1994 and 1998, GSK ran a trial of paroxetine v imipramine v placebo in adolescents with “depression” in North America. Study 329. SmithKline, later GlaxoSmithKline, wrote up the results to claim that the study showed Paroxetine is well tolerated and effective – even though there were a host of problems aside from just suicidality.
The investigators on this study became “authors” on the article – some of the biggest names in the field. But their authorship was notional. The article was in fact written by a ghost writer.
Neither the notional authors nor the ghost writer had access to the raw data from the study. All that anyone had access to was data that had been tabulated by the pharmaceutical company and coded in ways that concealed the issues. For instance any of the children who became suicidal were coded as having emotional lability.
The article was published in 2001 in the Journal of the American Association of Adolescent and Child Psychiatry – the journal with the highest impact factor in the field.
Sales boomed even though the drug hadn’t been approved – well what self respecting Learned Intermediary wouldn’t follow what an article by the brightest and the best in the field and published in such a good journal.
But in fact privately years before, the company had already accepted this Study showed the drug didn’t work.
The play within a play
Midsummer’s Night’s Dream famously contains a play within a play.
When New York State became aware that in 1998 SmithKline had decided the data showed paroxetine didn’t work, they instituted a fraud action against GSK which the company resolved by agreeing among other things to post the “data” from Study 329 and other studies on the company website.
They published material that had not previously been in the public domain (Clinical Study Reports) but did not publish the data from the trial. To this day the trial data remains unpublished and unavailable.
Along with colleagues I have had an opportunity to access the Study 329 data. This has led to an article currently under review. Our Spin, if you like, is paroxetine doesn’t work and isn’t safe.
But you don’t have to believe us, the data will be published with the revised article – “when” and wherever it is published. You can make up your own mind – which is how it should be in a democracy.
What this scenario reveals is that once controlled trials were made mandatory for new drugs, the combination of prescription only arrangements and lack of access to the data sets up a situation where it is impossible for a doctor to function as a Learned Intermediary.
They will be faced with the apparent data published in peer-reviewed journals authored by the most distinguished academics. Even when the study is stuffed full of a problem the doctor is seeing daily in his clinic, the article will claim these side effects simply do not happen – and few doctors have either the Balls or the Bottom to argue.
Enter bottom stage left
The Midsummer’s Night’s Dream becomes surreal before Shakespeare wakes everyone up.
In Study 329 a host of children became suicidal on Paxil. Were any of them told the drug was likely to have caused this?
GSK have made it clear that 20 years later they have still not informed any of these that there was even a possibility their treatment caused the problem, when it is probable that it did so in all instances.
Why not? Well they say it’s the role of the patients’ doctor, who in GSK’s opinion knows the patient best, to inform them of this possibility if the doctor thinks it’s in the best interests of the patient to know this. They, GSK, feel they would be intruding on the sanctity of an all but intimate relationship if they were to do so.
This is the first ever recorded appeal to the Learned Intermediary “doctrine” to cover this situation.
What kind of Bottom would these doctor “Authors” have to have if they are to do the right thing by these children – given that in their article they committed themselves to saying the drug was safe, and denying it caused suicide – an article that laid the basis for a successful fraud suit against GSK in 2004, and a $3 Billion fine from the Department of Justice in 2012 – an article that they have been asked to retract but have refused to do so?
What kind of Bottom would it take for them – the supposed Authors – to ask to see the Data?
What kind of Bottom would it take for Doctors generally to say “This is to make an Ass of me”.
Now wake up
This is not a fancy story about trials in ancient Athens that makes a slightly scary but ultimately pleasing entertainment before retiring to bed.
This is every drug trial for every drug in every area of medicine, right now.
Meanwhile we have ended up with Doctors without Bottoms. A Doctor without Bottom is like salt without its bite – good for nothing.
Shrugging and saying the course of True Science never did run smooth in the expectation that things will sort themselves out when the curtain falls is not sensible.
There are three things that can be done:
- If my participation in clinical trials, ones in which I have a treatment induced adverse event, can be used to deny that such events happen, then by participating I put my family, friends, and community in a state of legal jeopardy through articles that end up in say the New England Journal of Medicine, in which case there is only one sensible course of action….
- Open a petition to have the New England Journal of Medicine forced to change its name to the New England National Enquirer (NE-NE).
- You might think if the law on Learned Intermediaries is as the Texas Court thought it was, then the Law’s an Ass. But in fact there is no law about this. Lawyers need to push this point home.
To be continued…
Share this:Illustration: The Doctor’s Nightmare (from Fildes), 2012 © Billiam James
I was placed on Paxil. Then, for lack of insurance, could no longer afford. This was 2004. This, and other Psychoactive drugs put me in a “failure to thrive” mode. Could not eat, sleep, bathe. My Cats were given for adoption. I made 3 trips to E.R., only one ending up in an overnight hospitalization. My Psych Doc of over 30 years, who had given me diagnosis of Major Depression, Severe and Recurrent, would not see me as I wasn’t insured. Not even a courtesy visit to say why. Finally ended up in Public Psych Hospital, where I stayed about 3 weeks, till stabilized on still more drugs. Fast forward to 2010, when I was finally told that based on my multiple SSRI, SNRI, Tricyclic sensitivities over the years, and they were legend, I was re-diagnosed as Bipolor-Depressed. Had my 1st full blown Mania in 11/14. I had been a Psych RN, cruel irony. I am now on Lamotrigine. A trial of lowest dose, Cymbalta had left me in a condition of SIADH-essentially low Sodium levels. Found in older women, now just being linked to Antidepressant use in older (I am now 64y/o) women. I am left with no alternatives when depressed, but Lamotrigine seems to be helping with both. However, I am still at the mercy of not knowing long term effects. Was at NIH, in Bethesda, Maryland when earliest Clinical trials with Ketamine were being conducted. This demanded another controlled withdrawal from all Psychoactive medications. I learned that Paxil, at that time was awful to come off of. I had been there 3 months, when with BP’s at over 200 systolic, and well over 100 diastolic, Tachycardia, unable to eat, sleep, or otherwise function, I told the Doctor I needed to withdraw from the study. He was not happy. Tried to get me to reconsider. I refused. Later, before discharge, Psych RN’s there confided they were glad I had withdrawn, as they were increasingly alarmed. I was discharged on Cymbalta. Recognized when about 5 weeks later was Hypomanic. This was approximately 2011. A long trek indeed.
Finally found this online, in a dictionary (Collins) marked British — is #15 the sort of “bottom” you’re referring to? It’s a new one on me — not in the American dictionaries at all.
It’s sad how many good puns can run aground on this rock. I was thirty before I had the foggiest idea that John Lennon’s “a Spaniard in the works” was some sort of pun (had never heard of a spanner, it’s a WRENCH, people!)
So, is medicine a bottomless pit these days? Sure seems that way.
1. the lowest, deepest, or farthest removed part of a thing: the bottom of a hill.
2. the least important or successful position: the bottom of a class.
3. the ground underneath a sea, lake, or river
4. (Nautical Terms) touch bottom to run aground
5. the inner depths of a person’s true feelings (esp in the phrase from the bottom of one’s heart)
6. the underneath part of a thing
7. (Nautical Terms) nautical the parts of a vessel’s hull that are under water
8. (Literary & Literary Critical Terms) (in literary or commercial contexts) a boat or ship
9. (Commerce) (in literary or commercial contexts) a boat or ship
10. (Billiards & Snooker) billiards snooker a strike in the centre of the cue ball
11. (Physical Geography) a dry valley or hollow
12. (Physical Geography) (often plural) US and Canadian the low land bordering a river
13. (Mining & Quarrying) the lowest level worked in a mine
14. (esp of horses) staying power; stamina
15. importance, seriousness, or influence: his views all have weight and bottom.
16. (Anatomy) the buttocks
(Whatever you think of his political views (#15), you can’t deny Winston Churchill had a substantial bottom (#16))
The “learned intermediary” doctrine is a shameful, anachronistic relic of a mid-Twentieth Century American TV model of medicine that has not existed for many a year. It is premised on the notion that modern consumers of medicines are simply too stupid to make wise and informed decisions for themselves. Oh, forget that. They CAN make a decision to ASK FOR a drug, or to take a drug. BUT, they are too naive to decide when NOT to take the drug. Judges and lawyers should be ashamed that this anomaly, and the miscarriage of justice that it frequently spawns, has allowed to exist this long. Our firm is fighting hard to eliminate it. … And we will!
I have come to believe myself a partner in my healthcare, and the proactive word “Client” rather than the submissive term “Patient” In this day and age, it is after all a “Business Relationship.” Managed Care has taken care of that! Also, Physicians give you more respect if you make your designation clear, and not up for negotiation. I do quite a bit of Research now, especially regarding drugs that a Physician prescribes. I can not count on them to know everything about every drug out there, and few demonstrate interest in Supplements as they should. Also about Procedures before they take place, not after. Gone are the days when your Primary Physician, who knew all about you was the leader in your health care. Now their are Hospitalists managing your care, and one rarely sees the same one twice. One needs to take a Proactive approach to their own health care.
Regarding Andy Vickey’s comment, yes, “a patient can ask for the drug, but are too naive NOT to take the drug” begs the question, since when does a patient dictate to a physician, hopefully a Psychiatrist, not an internist, or other Physcian/General Practioner, who should NOT be prescribing Antidepressants of any sort, or Benzodiazepines, as are not qualified? Either the Psychiatrist/other prescriber, is woefully uninformed, or allowing patient(s) to dictate care. But to suggest patient NOT take a drug he/she has asked for, is not what I would expect. Other parts of his post are appreciated, and taken as Andy’s intent. Particularly, his comment regarding his”firm’s intent to work hard. Yet he does not specifically state which firm he is with. Still, I am gratified that his firm is taking a stand. Perhaps it is I that is uninformed, as may have missed Mr./Dr. Vickery’s in the past.
Bravo Mr. Vickery! Just one thing to add:
GSK has a special kind of nerve to say that the patients’ right to **know their own diagnosis** is subject to their doctors’ discretion as to what they ought to know for their own good. In most of the world, that’s regarded as an antiquated, patronizing and even dangerous doctrine which belonged on the scrap heap a long, long time ago. Even when the patient’s a child, or considered incompetent for some reason, the parent or guardian has a right to know. And these “Paxil kids” grew up a long time ago.
Not knowing puts them at risk for taking SSRI’s again, which they should clearly be warned not to do. Not knowing also increases their risk for suicide, and that of their children as well. Nothing makes the act come so naturally to mind, as having that bleak precedent in your own life or your family’s. GSK saddled them with an inaccurate and potentially damaging life story which they should get the chance to rewrite.
A lot of patients feel that they have been left in a bottomless pit quite apt then that they were left there by a bottomless shit.
Thank goodness you guys make me laugh, don’t want another day sinking into the custard…my doctors did not tell me one joke…it might have cheered me up…po- faced and humourless. Is Andrew Witty a laugh a minute person around his dinner table…I wonder how he does entertain his dinner guests…………?
I am still tittering about Snoopy in Furs……
Let’s call today Fun Friday..
Have you heard the one about when Clare and Gisela met David?
IAI – Docs in the Doc
http://iai.tv/video/docs-in-the-dock?utm_source=Institute+of+Art+and+Ideas&utm_campaign=5998b1fef5-IAI+Weekly+Newsletter+22%2F01%2F15&utm_medium=email&utm_term=0_33593fe9fa-5998b1fef5-47027401
Loved the Sunflowers – in the vase…
She said “the patient has to take some responsibility for taking the pill as they are the ones swallowing it”……..that takes the ‘proverbial’ biscuit.
This video is posted at an extraordinarily good time – its all about Bottom
DH
What was missing in that debate was the patient! Shame they weren’t there. Annie point’s out one of them as saying “patients have to take some responsibility”,That’s very easy and convenient for a qualified Dr to say who’s studied medicine for over 7 years but very hard for someone with no knowledge at all let alone someone who is drugged up to the eyeballs in a daze of confusion not knowing what the hell is going on.
I wrestle with my outrage, disgust and heart wrenching grief for the behavior and attitudes of GSK, AACAP journal editor Mina Dulcan, Dr.Keller– ALL connected with the scandal of study 329 exhibit *depraved indifference for human life*. – No prosecution –forget retractions and apologies, is another scourge.
As I continue my crusade- speaking out and trying to educate former colleagues, I am grateful for the mood altering experiences I have with my grandchildren– and the prospect of impacting the sensibilities of a generation (mine) of *bad doctors* who have sequestered themselves behind a wall of silence– and like a predatory pack have no conscience for the loss of life that sustains their survival.
Over xmas *school break* I introduced my grand children to another of my own survival tactics- music, dance, film. Ironic , I think ,that my 8 year old grandson was drawn to a song by the band “Queen” that was number one in 1980, because this song, “Another One bites the Dust” is described as “dancing a line between gun fights and failed relationships”– to me, it speaks to the truth of the myriad ways psychiatry and Pharma have targeted and destroyed children. When my grandson began to sing and then perform it, I was at first gratified that he was internalizing the essence of my favorite *rock star– the ultimate show man, Freddie Mercury*– but as regular reader of Dr. Healy’s posts and comments here, I began to see 8 year old Cae’s performance as a symbol of what his generation is facing for what my generation has not *put right* .
I am sharing the video, which is posted on You Tube, here– dedicated to the aforementioned criminals involved with Paxil Study 329– and ALL who believe this *scandal* will just go away—
http://youtu.be/tXd92scpmXc
Cheers!
Sinead
in the spirit of Annie’s *Fun Friday* 🙂
“It’s all about Bottom”–DH
-” Bottom”?– this term is bound to conjure up more evidence of the medical practice- cultural divide between the US and the UK– as Johanna points out, the reference to leadership/judgment is not in American dictionaries– and though I have no data on the likelihood of misunderstandings, I can offer an apt anecdote to support this point.
Some 34 years ago, I worked briefly, as a temporary replacement/ RN in the private office of a doctor who owned and operated the first for profit hospital in the area where I grew up. One afternoon, while waiting for the doctor to arrive to see patients I had been appeasing and placating for over an hour, I slipped into the back office and passed the time with the office secretary, and office manager– both women, older than me– and the only employees who could maintain employment and civil relations with this particular doctor. They were *experts* whose advice and counsel was entertaining, but not information I wanted, since I couldn’t wait for my temporary assignment to end. The secretary was fuming in a half hearted manner , having just received another call from a patient whose message she had placed on *doctor’s* desk the day before. *Doctor* routinely ignored her meticulous efforts to communicate requests from patients.
“What do I have to do to get *doctor* to read my messages?”, pleaded the overly dramatic secretary–
The office manager replied,
“Tape them to *Sinead’s Bottom*.”
And there you have it–
😉
The Picture that Healy paints is not a very pretty one. Doctors who are but a one way instrument of the pharmaceutical companies. The doctor gets told what to say and what to prescribe, not by experience or knowledge, but from keen sales representatives from Pharma.
It takes alot to bite the hand that feeds you, so the doctor hesitates or just refuses to alert Pharma when he suspects an adverse event.
The more videos I Watch and the more blogs I read the more dumbfunded I get.
How can so many GP’s, Psychiatrists, Medical Scientists or other Health care workers go along with a system that is fundamentally flawed?
All the ties to Big Pharma are in plain sight, but still they press on as if their “science” is conducted ethically or morally correct!
To lie and deceive is the standard.
Thanks for posting that link Annie. I really enjoyed watching it. I thought it was a very good debate.
I have to say I think DH is good at interviews and debates.
I love his common sense attitude and how he gets the truth across in such a calm, dignified and humorous way that everyone can understand.
He doesn’t blind with science and gobbledygook.
He’s got bottom.
Adverse reactions are in fact recognised by my GPs’ but they never get reported or added to my notes, which I feel should be done automatically. There is a gap within the system which I feel should be filled in the administrative side of medical practice:) It is quite awkward to complete a RXisk form and take it along to the Doctor – who has actually acknowledged an adverse effect – it is just there is nowhere for him to record it – or is there? Confused:)
You would hope that all doctors were meticulous about record-keeping and more, importantly, reading thoroughly every scrap on information that came their way.
I don’t know if I was an isolated case, in this respect, but, nothing was read when vital letters arrived concerning me, from, hospitals, and certainly never discussed with me.
The RXisk report will be filed in medical records, awkward, or, not, and there it will sit.
In an ideal world each surgery should have a RXisk Data Sharing Facility…ie each doctor have a RXisk Report flagged up to other doctors in the practice when it arrives.
Perhaps, use it as a Yellow Card Reporting system to the MHRA?
If you always see the same doctor, and, your RXisk Report is filed away, the chances are it might gather dust….
I think one of the most important parts of a modern surgery should be the sharing of vital information, as, one, doctor, could be behaving badly and this behaviour should definitely be flagged up…it is very dangerous that one doctor can be accountable to no-one…..
It is already dangerous that important information received from other parties, in any medical situation, may not be Flagged Up.
It surely should be a legal requirement for doctors to Flag Up…not use outdated human error filing systems which can be the difference between life and death for the unwitting patient…..
The point of RXisk is data sharing and no patient should be embarrassed, apologetic or humbled in to daring to, perhaps, bring in a more qualified account of adverse events than any doctor is aware of…..or, even, aware of……
No one should have to resort to telephoning The Samaritans when doctors have nearly killed them…..it is a much better idea to fill in a RXisk Report.
Middle of the night – August 2002
Samaritan
“Are you suicidal?”
I have never been suicidal…
Shirty Samaritan
“But, you just said you were suicidal”
I don’t know why I was suicidal.
Vexed Samaritan
“I can’t help you if you don’t know why you were suicidal”
I have just told you I have never been suicidal.
Exasperated Samaritan
“Samaritans are here to help suicidal people, if you don’t know why you were suicidal it is impossible for us to help”
Just forget I called, ok, just forget it……..
Thank you, Samaritan…really, really helpful……….I guess waking up a Samaritan wasn’t my best idea………..
Waking up a doctor, with a RXisk Report seems a better exposé.
It is a funny thing but my GP acknowledged a side effect caused by a drug I was on and set about weaning me off it to great effect. The funny thing is I don’t think it was ever recorded and now I know for sure my side effect was definitely caused by the drug because the symptoms have disappeared! But – a big but – who will ever remember UNLESS I mention it again to the GP? It hasn’t been placed in my notes – this is a loophole that could have consequences If I don’t remember to mention it to A Doctor when the drug I took is ever tried to be prescribed for me again:) Yes I suppose a Rxisk report should be given to the Doctor – will it ever be looked at again I wonder?:) Rxisk reports should be automatically completed by Doctors instead of just the nod of the head which Is what you are inclined to get at present:) Rxisk is attempting to fill the loophole system but it should really become compulsory for Doctors to record side effects in a prominent place::)
Totally agree. However, somewhere along the line I missed how one files a Rxisk Report is filed, and then obtained to give to my Healthcare Providers. If anyone could enlighten me, I would certainly appreciate. I have very pronounced effects to certain medications, such as recent high dose Steroids over prolonged period of time, resulted in Mania due to my Bipolar Diagnosis. There are others, too, I should never be placed on. Docs do not pay much heed, indeed seem to resent my proactive approach. My Psych doc excluded, as he seems to be impressed with my knowledge, and research ability, and follow through. But please tell me where to go, and how to obtain one of these reports. Thank you
Donna
Thanks for asking. A key point behind Rxisk is RxISK reports. You go into report a problem on a drug and work through the questions, coding what has happened to you as you go and taking the algorithm that generates a score to tell you and your doctor how likely it is that the drug contributed to the problem. When you get to the end you have an option to generate a RxISK report – this is a 3 page letter to take to your doctor outlining the problem and its timeline relative to treatment.
The hope is s/he will work with you on this and will either agree about the link or disagree – you can send her/him a link to your report and they can add their point of view. If two people both think the drug is linked to the problem this is very strong evidence it is. If s/he disagrees, s/he might be able to give you and us some useful novel angels. But ultimately the fact that this report exists at all hopefully means s/he will engage with you more – compared with simply verbalizing the problem there is less chance hopefully of being blown away – or powered over. If a record like this exists and you are injured in part because you weren’t listened to,…..
David
May be a slip of the keyboard, but, novel angels is first-class!
This is tricky for me as to what I do with a ‘historical’ Rxisk Report.
It won’t be going to my doctor, as she is deceased.
The Clinical Director, of a nearly hospital, was quite jocular about my deceitful gp being deceased as if that was the end of the matter…..as far as I am concerned this is not the end of the matter….Jimmy Savile remains dead.
The CD was guilty of covering the back of his incompetent associate who made too many mistakes to be credible.
It might go elsewhere.
My Rxisk Report, when I log in is visible as a summary and I was wondering what happens to it now and do I receive a report from a Rxisk doctor?
Thank you from a near miss novel angel…………….and I apologise if I have failed in some way with the reporting system.
Annie
There are lots of sites that give information about Drugs, like Drugs.com. RxISK is about challenging the power of a system that declares itself to be working for us – and revealing that its not – and in the process helping doctors get back to where they wanted to be when they entered medical school – but most importantly changing a culture so that we and our families and our wider communities are less at risk from a system that feeds on us.
A nice phrase to catch what happens to lots of us visiting doctors is we are powered out – its about reversing this. This is what RxISK is about.
There is your historic report but also when you or anyone goes on some new drug now and has a new problem we are hoping you will generate a report, take it to a doctor and help us all pick out the doctors who listen from those who don’t – and give feed us back accounts of the interaction with doctors as Sara Bostock did in Fear of Falling and Laurie Oakley did recently
David
Sorry but I have a bee in my bonnet about this – what happens to the Rxisk report when it is handed to the Doctor please? I noticed my GP seems to record things on his computer more than having paper files – so – will s/he record about the Rxisk report onto my file or do I have to ask for him/her to do it? Every Doctor has their own individual way of doing things which is why I think it should be compulsory for all Doctors to record side effects in a place where they can be viewed quickly, otherwise you are relying on the patient to mention previous side effects to their Doctors because any previous concerns have disappeared into the ether.
The key thing with a rxisk report is does your doctor do something. Fifty years ago when a mother mentioned her baby – child didn’t seem right the system often brushed her off – we doctors know best. Now all books on these issues stress listen to a mother if she thinks something is wrong even if you can see nothing.
At the moment the system brushes off people when they try to say things don’t seem right. We figure in 20 years time the books will all say – listen to someone if they try to tell you things aren’t quite right.
In the meantime, if your doctor doesn’t listen to you, you might need to change doctor. Having a RxISK report that you’ve at least tried to give him puts him into a Russian roulette position – he is gambling on things not going wrong rather than doing the sensible thing and working with you
JLN
Yes Dr Healy -Thank you – I see entirely what you are saying The Rxisk report does place you as a patient in a much stronger position . I am fortunate that My GPs are listening and work with me. I need to check with them next time I see them to find out if my records have been updated with the side effects I have experienced:)
Dear Dr. Healy,
Over 70% of paroxetine studies registered at ClinicalTrials.gov (completion date before January 1st, 2011) remain unpublished.(1)
After reading this and other posts in your blog, I also became curious about GSK unpublished studies, here is some preliminary data:
ClinicalTrials.gov – advanced search terms (search date: May 2, 2015): Closed Studies, GlaxoSmithKline.
Number of study registries (n) = 3426
Filter: ‘Completion Date’ (*) before January 2014.
Number of study registries (n) = 2889
(*) ‘Primary Completion Date’ if ‘Completion Date’ is not available.
—
PubMed expert search query – GSK study records:
– Records not found (i.e., unpublished – require confirmation in other databases – ) = 2111 / 2889
Records found (i.e., published) = 778 / 2889
Number of articles = 944 per 778 ClinicalTrials.gov study registries (more than 1 paper per published study registry)
Other search queries are necessary for a more precise estimate of unpublished studies (e.g., Embase, Google Scholar, EBSCO, others). In addition, more records can be identified in different registries (e.g., EudraCT, Chi-CTR, others) and platforms (i.e., WHO ICTRP).
About (I will quote a paragraph from your post):
“The information in controlled trials has two components. One component is the data that is collected and should always be public or else medicine is a tyranny. The second is the interpretation put on that data – the spin if you will.”
Comments:
– I think that these two information components can be also applied to the understanding of other types of studies (e.g., cohort studies, analysis of registry databases, cross-sectional studies, others).
– About open data: I agree (“…should always be public or else medicine is a tyranny.”)
http://chaoticpharmacology.com/2015/03/16/question-should-scientists-share-their-data-a-yes-b-no-via-epmonthly-figshare/
– “The second is the interpretation put on that data – the spin if you will.”
Re: I think that numbers should speak for themselves (example above with the GSK ClinicalTrials.gov data).
Sincerely,
Jorge
References
1. Re: Putting GlaxoSmithKline to the test over paroxetine (Dec 11, 2014)
http://www.bmj.com/content/347/bmj.f6754/rr/816737