This post is designed to be read with the Drugs and Smell post on RxISK.
The second drug in the Anosmia Table in the Drugs and Smell post is Zinc Gluconate which was traded under the name Zicam. For anyone concerned about adverse events this is one of the most important drugs in History.
Zicam was marketed by Matrixx Pharmaceuticals. The company’s shareholders became concerned about reports it could produce anosmia and parosmia and asked to “look at the books”. The Board said no. The shareholders took them to court and ultimately to the Supreme Court. The company defense was that all it had were animal studies that were not statistically significant and some anecdotal reports of a problem, but as nothing had been properly linked to treatment there was no need to tell the shareholders. The Supreme Court disagreed.
If you are going to gamble with your money, the Supremes figure you are entitled to make up your own mind what the data means but not it seems if you are someone gambling with your life or your child’s life or perhaps the life of child yet to be born or a doctor gambling with your patient’s life.
The Supreme Court decision doesn’t stand quite alone though. There is an extraordinary legal case from 1981, Oksenholt vs. Lederle Laboratories, which no one seems to have picked up on.
Dr Oksenholt was sued by a patient whom he had put on a treatment for tuberculosis, Myambutol. This had caused her to go blind. He settled the case with her for $100,000 and then sued the drug company for withholding information from him that their drug could cause someone to go blind. He won the case. He also won $50,000 damages and an unspecified amount for future loss of earnings and $5 million punitive damages. See Oksenholt.
None of the doctors who gave medication to any of the Mass Shooters of recent years or Airline Pilots who have crashed – and there have been many on antidepressants – have interrogated companies legally about the with-holding of data. There is a precedent there for them.
This is the third post in the Magna Carta series, a place-holder while we try to FOIA or otherwise find the missing Crusoe Report mentioned in the Witty Report last week. It’s the twenty-first post in the Persecution series.
Illustration: Magna Farta, 2015 created by Billiam James
Copyright © Data Based Medicine Americas Ltd.
What can we say about this.
Anyone, with a smattering of law knowledge knows it is highly unlikely to start a case unless you have a precedent. Something that has happened in a legal situation which gives you an opportunity to use this as a lever for your own particularly messy case.
I am so used to no money, no family, no home – more or less, an, invisible, shamed, vagrant – that it has to be pointed out, at this stage, that Pharmaceutical Lawyers have only one intent.
This is to further publicly defame you, more; destroy you, more; and, possibly, make you ‘suicidal’ all over again….which all began with the mis-use of their drugs – which they know can cause aggression, violence, murder and suicide.
They know this and they have always known this.
Seroxat came to the UK on the back of dodgy data, children killing themselves, adults killing themselves, adults killing their children, adults wiping out entire families, and, for this, they paid a price. Pharma, that is.
Paying money is easy when you have loads of it stuffed up your jumper.
The whiff surrounds me and has surrounded me for thirteen years when I repeatedly told my doctor that Paroxetine was seriously hurting me. She did the usual thing of monstrous amounts of criticism and bucketloads of benzos and beta-blockers.
This is not unusual.
Blood money paid for drug trials and blood money pays people off, even amounts to make your eyes water; it doesn’t matter any more.
Lick a few quid off your palm and anything is possible.
Let’s hope our folk police group continue to talk about it and let’s hope this sort of blog continues to wade in where it is not wanted.
Except, by, us…..Peat Bog Faeries…coming soon, to a festival near me……….:) Really.
The Drugs and Smell issue is fascinating over on Rxisk.
It hadn’t occurred to me, that my anorexia from Paroxetine was linked to ‘the vapours’ off the food and tea/coffee drinks and why all I actually ate/drank for nearly two years was the gulping of water………and, nibbling, variously, because I knew if I didn’t I would die.
May be this is the correct place and time to congratulate Leonie, on her law degree, superlative, considering she lost her boy….with more admiration that I can muster, here……and Irish Law is different from Scottish Law is different to English Law, but, I think the basic sentiment is similar regarding precedent.
Having been “paid off” by Lilly after losing a family member myself, and watching the doctor go Scot free though I tried to have him upbraided/censored/whathaveyou by the medical board in my then state (to no avail), I relish the idea of an actual physician bringing suit for being “misguided” and basically lied to with regard to the risk/benefit profile of a pharmaceutical drug. Here’s hoping some pioneering doctors, tired of pushing dubious (at best) products on patients, will re-think what their -perhaps-original intent was when going into medicine and bring creative and well-thought-through lawsuits against the various BigPharms.
As we see here, there is precedent for it.
Thanks for making me laugh. (Small text after clicking on image).
I needed it.
Today I presented my RxISK report to a doctor. It showed that long-term prescription of Klonopin could well be responsible for my ongoing chronic insomnia. I told her I suffered through withdrawal without medical support ten years ago because support wasn’t available. I also showed her a Pub Med article on protracted withdrawal syndrome related to long-term benzodiazepine use. She was patronizingly sympathetic without showing a whole lot of interest in what I was saying or showing her. The appointment ended with her OFFERING ME KLONOPIN because I told her my sleep was worse after my sister passed recently.
I hope we crack the code soon because I don’t think I can take much more of this.
Oh the anti-climax it would be for me if my prescribing doctor sued GSK for withholding data on Seroxat. He is morally entitled to start and win such litigation, but the contrast to me being the one who has lived through 15 years of Seroxat-hell and can’t sue them myself, would be an even greater ‘torment’.
Like a loved Swedish ‘socially engaged’ songwriter once wrote: -“where the common man is sentenced and condemned, the Noble man slips through the cracks. And he who watches it all with his own Eyes, are told he shouldn’t Believe what he saw”. (Rather freely translated)
My prescribing doctor WAS kept in the dark about most of Seroxats possible sideeffects, no doubt about it, but he was (and still is..) on the ‘winning’ side of the Seroxat bargain.
Another song reference:
-“Now all the criminals in their coats and their ties
Are free to drink martinis and watch the sun rise
While Rubin sits like Buddha in a ten-foot cell
An innocent man in a living hell…..”
Pretty easy to interchange ‘criminals in ties’ with my doctor and GSK, and myself being Rubin “hurricane” Carter in a 10 foot cell.
Now I could never have become the ‘champion of the world’, but I sure as hell wasn’t destined to see the inside of a prisoncell either.
This is interesting..
I have long believed that GP’s hold more than the balance of power between the patient and the drug company. Doctors have the power to boycott drug companies and hold them to account, yet very few even speak out or criticize drug companies- never mind boycott them or protest. Perhaps it’s a case of toeing the line by most doctors, and also maybe most of them are afraid to speak out, particularly about drug side effects and anti-depressants because maybe they fear that they would be implicating themselves in the process? Maybe they also fear they would be sued as well? If this is the case then its understandable. Not excusable but certainly understandable. However, until doctors use that power to boycott and criticize, drug companies will continue to maim, kill and harm patients with shoddy ‘medicines’. However the act of doctors turning a blind eye to the abuse of patients by drug companies is reprehensible at this stage- too many are being harmed and something has to give…
I was put on a a heavy dose of “antipsychotic” drug by a doctor who thought I was bipolar. I wasn’t; I was having a common drug reaction. He didn’t ask if I was taking any prescription drugs. I found out later he’d been disciplined two years earlier for all of these:
Repeated Negligent Acts
General Unprofessional Conduct
Sexual Relations with a Patient [she alleges that he drugged and raped her. He admits to drugging her and to an episode of sexual intercourse.]
Excessive Use of Drugs or Alcohol
Furnishing Dangerous Drugs without Examination
Failure to Maintain Adequate Accurate Medical Records
[Also in the report is that he sold marijuana to a patient]
I lost a great deal as a consequence of entering “the system.” Most people here know that kind of story too well. I wondered why he only got probation. After reading and appreciating Magna What?, I looked at his online records again and noticed that the board had intended to revoke his license permanently, but changed their collective mind. It occurred to me to find out who signed off on that deal. Luckily, an unnamed angry person had collected a number of legal documents and new articles in a blog. This is what I found out about that authority that let an immoral, incompetent putative:
FIRST AMENDED COMPLAINT FOR DAMAGES
1. Discrimination and Harassment based on Sex and Race in Violation of Government Code section.
2. Failure to Prevent Sexual and Racial Discrimination and Harassment in violation of Government Code section.
3. Retaliation for Reporting Discrimination and Harassment based on Sex and Race in Violation of Government Code section
4. Discrimination in Violation of Right to Privacy and Marital Status
5. Retaliation for Identification as Potential Witnesses to Improper Government Activities in Violation of Labor Code and Penal Code section .
He was having sex with an underling on other underlings’ desks.
Does anyone have a chance, I wonder.
“I was put on a a heavy dose of “antipsychotic” drug by a doctor who thought I was bipolar. I wasn’t; I was having a common drug reaction.”
describe my own experience EXACTLY.
I wonder, how often is this happening and WHY?
I have just started the process of challenging my diagnosis. My first step has been to ask for a clear and thorough explanation of which symptoms I presented with that determined a bipolar diagnosis. So far, an answer to this first, relatively simple and straightforward, question seems to be proving an unachievable feat for my hospital and outpatient consultants and the local NHS Trust……. but I am being persistent – it’s an interesting process!!
My next question will be: Why wasn’t a common adverse reaction to SSRI (prescribed by GP) considered? Or, if it was, why wasn’t it considered to be the reason for my sudden insomnia, agitation, anxiety? (ie. my sudden descent into a living hell – God, it was AWFUL!)
Any advice gratefully received!
Hi Jane – I am nearly 15 years down the line of asking that very same question, not about myself but about my son.Before being prescribed Seroxat – no mental health problems whatsoever ( just anxiety over completion of college course). On Seroxat for 3 months – all hell broke loose ( details too exhaustive to include here). STILL on high doses of medications to deal with anxiety, depression, dissociation, hearing voices, seeing non-existing weird beings, self harming, attempted suicide ….. the list goes on! Will ‘they’ answer the question as to why this has happened? – no. Will they accept that, in his case, meds reduction works better than increase? – no. GP leaves local MHT/ psychiatrist to deal with the whole scenario – he will neither i ncrease nor decrease without their say so. Psychiatrist is totally baffled and has now diagnosed Borderline Personality Disorder as being ” the most likely cause of the problems”. Why can they not bear to hear any criticism of these drugs? We have watched our son go to hell and back so many times – present psychiatrist has seen him fairly regularly over the last 5 years or so. We have witnessed the devastating changes in him – present psychiatrist has only known him during the most hellish of times. Yet, our observations count for very little while his diagnosis is, supposedly, sound enough to be worked on. I have now stopped asking the question and instead quite forcefully come out with the comment ” he has been damaged by Seroxat, I don’t care what anyone tries to say otherwise. He doesn’t seem to fall into a clearcut diagnosis – why? – the simple answer is that there is no true diagnosis to be made because it is DAMAGE and as such will not give clear answers”. They don’t like my speech but they still get it at every opportunity!!!! Last December, he was seen by another psychiatrist at the psychiatric unit. His Care Co-ordinator explained our feelings about the matter. The psychiatrist immediately phoned me at home to say that he agreed that the meds were not the answer to the problems, that they were not working for him and THAT HE WANTED HIM WEANED OFF THEM ALL!! I could not believe what I was hearing! Once out of the unit, it was VERY hard work convincing his usual psychiatrist that this was the way forward. In the end, our son has had to do it alone – no guidance given on likely reactions or how to decrease safely ( in fact suggested an increase during one bad reaction!). He has done away with his ‘backup’ Diazepam,is now down to half his dose of Quetiapine and is yet to tackle the Depakote![Interesting note – the psychiatric unit psych. was on his last day there when he spoke out about the meds I know why they SAY he left – but don’t necessarily believe it!!!
Today at 1:55 PM
Dear AllTrials friend
We hoped to tell you more about the case Richmond Pharmacology is bringing against the HRA. That’s not been straightforward. Richmond has now changed their argument three times and has altogether abandoned some arguments it relied upon earlier, so getting to grips with what is at stake has been difficult and time consuming for us and for our lawyers.
At the beginning of this week it looked as though Richmond had narrowed the case down to a technical argument about the wording of HRA’s guidelines which only applied for a period of 10 days earlier this year.
Just as the issues seemed to be narrowing, Richmond then asked the Court not to allow AllTrials to be heard. We had written to Richmond and the HRA outlining our planned argument to the court and inviting their response. HRA replied to us, Richmond did not. Instead they went straight to the Judge and asked him not to hear us.
And then yesterday we saw that Richmond has asked the Court at the very last minute to rule on something huge. They want the Court to declare that no trial sponsor or person running a trial has any legal requirement to publicly register any clinical trial unless the sponsor has given a legally binding commitment to do so, or an ethics committee has asked them to do so for every trial. So now the Court is being asked to rule not on the specifics of the case but on a much broader point.
Richmond has asked the Court for a hastily arranged hearing in Manchester on Monday where they will ask to seek that declaration as part of the case. This is after they have warned the court that AllTrials’ references to international rules and protocols are irrelevant and will only add to their costs!
We need to be there on Monday to make it clear to the Court that it is being asked to rule on something that has real ramifications beyond this case. If Richmond win, this would go in the face of international laws, regulations, professional standards and the ethical rules of research. If such a declaration was made it would shatter the progress towards transparency made by AllTrials and the progress made internationally before AllTrials even started.
Today we are writing our submission to the Court to be allowed to speak on Monday. We’ll tell you more as soon as we know it. We have only been able to do this because hundreds of you have sent support, encouragement and donations. Thank you.
Sense About Science
Science and evidence in the hands of the public
Offers to put us………….
Today at 4:37 PM
Monday’s Court hearing in the judicial review against the Health Research Authority is not going ahead. We’ll let you know as soon as we hear about a rescheduled date for it. In the meantime, we have gathered together all the updates we have about the case here. Thank you for your continued support, offers to put us up in Manchester and kind words.
Good news that EL had their motion to dismiss the cymbalta withdrawal cases dismissed. The trial will be going ahead in August.
Services included Fraud Investigation 2002 – 2004
Additional Honors & Awards
I have received several awards in recognition of my achievements at GSK including an invitation to a day at Wimbledon hosted by the CEO and tickets to the British Grand Prix.
Two ‘thoughts’ from John Tucker on MIA
4 thoughts on “Antidepressant-linked Suicide Data Doctored In Seminal Study”
JohnTucker on June 30, 2015 at 1:07 pm said:
Both the analysis and Healy’s are pretty much bullshit due to the loss of randomization that occurred from treatment reassignments.
During the first 12 weeks, 9 participants from the PBO group were moved into the fluoxetine group and 2 from the cognitive therapy group were moved into the the combination therapy group because they were doing especially poorly. This leaves behind only those who are doing relatively well in the non-fluoxetine treatment groups, while adding those with especially severe depression to the drug treatment groups.
At the end of 12 weeks, only those who were regards as “responders or partial responders” to their assigned treatment were kept in the trial, while those with a poor response were removed and “treated as medically indicated”, but their data continued to be collected. What a mess!
Given the very high number of non-responders moved from the placebo arm to the fluoxetine group, nothing meaningful can be said about either group. The comparison betwen the first 12 weeks of the combination therapy group and the first 12 weeks of the cognitive therapy only group is somewhat better due to fewer subjects crossing over. In this comparison we find essentially identical suicidal behavior rates between drug treated and non-drug treated persons.
Rigorous statistical analysis requires thinking about the issues and not just blindly applying formulas. Neither Healy nor the original authors appear to have done the former.
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o Steve McCrea (MIA Author) on June 30, 2015 at 5:28 pm said:
Not sure what else could be done with the data after the hash the investigators made of it. I think the big news here is that the investigative team appeared to be both incompetent in terms of understanding and adhering to the study protocols as well as intentionally deceptive in their findings, and we must assume significantly biased regarding the results. It illustrates that many studies that purport to have some important finding are deeply flawed and that the researchers are often either “on the take” or bring personal or professional biases to the table. It seems like we may need researchers from other fields to take over for psychiatric researchers, because the bulk of them appear to be either incompetent or corrupt or both!
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JohnTucker on June 30, 2015 at 7:55 pm said:
I agree its generally a mess, but am not sure that the attempt to torture this data to make it confess a negative outcome is any less blameworthy than the attempt to torture it into confessing a positive outcome.
What I think is important is to look at and evaluate data with an open mind to see what it is telling us, or even to see if it is telling us anything at all. There are too many people out there who simply see it as a polemic tool to twist in whatever way is necessary to argue their pre-existing positions.
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anothervoice on June 30, 2015 at 11:37 pm said:
I am afraid I disagree with your relativist notion that making this kind of data confess a positive outcome is morally the same as making it confess a negative one.
Many people taking these medications are not left to make their own choices in the matter. All medication is a risky business, and to produce false positive results opens many people to a forced drugging of and in itself risky.
In contrast, to “make it confess a negative outcome” leaves the medical ethic to do no harm intact. Obviously this ancient medical precept was directed at the physician’s tendency to do something (for cash) no matter what and to thereby harm the patient for his own gain.
Every drug is risky and causes harm. This is not a theoretical argument. Manipulating evidence to create positive outcomes will bring harm to others.
Just giving and giving……..this tricky time…
Today at 12:55 PM
Dear AllTrials friend
We have just received the judge’s orders in respect of Richmond Pharmacology v Health Research Authority. As some of you know, Richmond Pharmacology wrote directly to the judge to try to stop us being heard. So we are very pleased to tell you that the judge has ruled that Sense About Science can intervene to represent AllTrials.
We are relieved too, because the Judge has also decided to allow Richmond to take forward a broad argument it introduced at the last minute, asking the Court to declare that no trial sponsor or person running a trial has any legal requirement to publicly register any clinical trial unless the sponsor has given a legally binding commitment to do so, or an ethics committee has asked them to do so for every trial. That makes the issues at trial potentially very serious indeed.
We now have to write a submission for the Court by 10 am on Monday 6th July. It’s not much time. We and our legal team of Robert Dougans and Jonathan Price are working flat out on it. James is coordinating volunteers and drafting in other staff help, assisted by your great offers and donations, to keep the rest of the AllTrials activity on track during this tricky time. You may have seen that while all this has been going on, the number of organizations committing to AllTrials across the USA is growing every day! And we have more announcements to come. Your marvellous support means a great deal.
Join the AllTrials campaign here http://www.alltrials.net/get-involved/ and donate to the campaign here https://www.justgiving.com/alltrials
……………………….in the last remaining seconds “where are our diseases coming from…………………..
Mark S. “get the nutter out of my patch”
Another half an hour might have seen some interesting developments….well, done, David.
You received a reply to your comment Ove………..14
15 thoughts on “Antidepressant-linked Suicide Data Doctored In Seminal Study”
JohnTucker on July 5, 2015 at 6:37 am said:
I don’t think it’s in any way “utopian” to say that we should look at the data with an open mind and not twist it to make it support our pre-existing beliefs. Nor do I in any way understand your accusation that by opposing misrepresenting the facts I am attempting to “prevent the truth”. Are you arguing that such misrepresentation makes the truth more apparent? Sounds prety Orwellian to me.
The best and most widely cited evidence tying antidepressants to increased suicide rates comes from an FDA meta analysis of data from manufacturer clinical trials. That data forms the basis of the current warning on the FDA label for all antidepressants, while the small and underpowered study criticized in the Healhy paper barely shows up on the radar as part of the evidence base. Attacking it does not really accomplish anything but allow the authors to publish a paper with a highly provocative title in a minor journal, hoping that it will nonetheless be picked up by blogs such as this one. It really doesn’t add to the scientific discussion in any way, but I guess they accomplished their goal.
16 thoughts on “Antidepressant-linked Suicide Data Doctored In Seminal Study”
Olga Runciman, Cand. Psych. B.Sc (MIA Author) on July 7, 2015 at 12:14 am said:
A lie is a lie and here this lie proved to be a highly lucrative one by implying these drugs are not only safe but helpful and then quoted worldwide as one of THE most reliable pieces of research.
I agree with Boring Old Man “Among the bizarre misrepresentations in Clinical Trials of psychiatric drugs during the Age of the Decepticons, this one may take the grand prize,”
Shameful piece of damaging ‘research’
……it’s why I don’t have a suntan……..
Today at 5:55 PM
Hi AllTrials friends
Yesterday we sent our submission to the court in the judicial review brought against the HRA by Richmond Pharmacology.
We have spent the last few weeks ploughing through the hundreds of pages of documents. Richmond is currently asking the judge to rule that there is no overriding legal requirement to publicly register any trial. That’s not correct. Since 2011 all trials except for adult phase 1 have been publicly registered through the EU Clinical Trials Register. And by next year this legal requirement will extend to all clinical trials unless exempted according to some very tight criteria. Richmond is effectively asking the judge to set the clock back 10 years and wipe out the careful progress that has been made in relation to trials registration at national and EU level. We have set out in detail the legal frameworks related to this, and put forward legal arguments as to why HRA has a duty to monitor compliance with both legal requirements and sound practice for running a trial. However, Richmond has changed its case three times and may yet change it again.
The hearing will be in open court in Manchester on Thursday 16th July. We will be there. It would be lovely to see any of you who’d like to come along too; we could do with some help capturing what is discussed in Court. We are unlikely to know the result on the 16th, we hope the Judge will make his decision by the end of July but it could be October.We and our barrister Jonathan Price and solicitor Robert Dougans knew that we faced a demanding timetable and it meant that two of us here at Sense About Science have been almost completely absorbed by reading and writing legal arguments (it’s why I don’t have a suntan, when most of London does!).
We have managed to keep the rest of the AllTrials campaign going only in the face of that because many of you have given us help and topped up our fundraising appeal. Thank you! In a couple of weeks I will be able to show you just how significant that is. We are about to break a story about a new group coming on board for all trials registered and all results reported, in a way that should change part of the international scene, for good. We are also reaching the critical mass to be able to launch a US campaign. I can see from the comments on the Just Giving site how determined you are that the challenge of the Richmond/HRA case is not going to stop this. And if you have been thinking about giving something, however small, could I urge you to do it now?
Let us know if you can join us in court on 16th.
Síle and James
Tucker keeps Tuckering……
I have just joined up as the tenth member to an honourable list of supporters….
I honestly wouldn’t give Tucker the time of day. When I want to raise my blood pressure I take a look at his recent ramblings – he moved smartly over on to MIA once people on this blog, and the Rxisk stories got wind and started to challenge him. Hopefully, MIA will do the same eventually. I got a friend, a biochemist with medicines experience, to take a look at his latest words of wisdom on oncology and statins – unpick the apparently technical/expert use of language, which acts as a handy smokescreen, and there is nothing underneath. It is just risible to suggest that a cure for metastatic cancer is imminent. I doubt he has the first idea about any of it. He is silent about his qualifications. Who he is really, and why he stalks blogs like these is anybody’s guess. For me he is just a damn pain in the arse and I suspect if he was roundly ignored – completely – he would disappear.
Moving on from tracking tucker, who, by the way, is now talking about children and their behaviour, elsewhere; a timely conversation with someone who might have rather a lot to talk about…………..
The Sunday Times and the inside story on the Fraud Prevention Consultancy…
The sharks circle the sharks…………..pfizerKline….materially accretive….it was said….must look that one up……..:)
More on Chinagate here
Professor Healy says that people should ‘keep a hawk eye’ on medications.
Nice publicity for Rxisk.org and ‘drastic’ behaviour
Praying that Jakes Ammendment goes through. This will mean that suicides induced by medication is legally recognised
and recorded as such. This will be the legacy that Jake has left for others. Rest in Peace Jake.
The new Seroxat PIL, June 3, 2015 with adjustments up to 50 mg. and akathisia, which may be detrimental………….
I remember the Sunset Yellow – which may cause allergic reactions – very well and this is a must read for aspiring swallowers………….and those of us whose leaflet in 1999 was so simple……
Today at 1:25 AM
Dear friend of AllTrials
Tomorrow is the court hearing in the judicial review between Richmond Pharmacology and the Health Research Authority, in Manchester at 10:30am. I know we’ll see some of you there tomorrow. We hope to be able to tweet in the breaks in proceedings so please follow #AllTrials and @senseaboutsci for updates. We’ll update you all with news from the day as soon as possible after the hearing is over. Here’s our statement ahead of the hearing:
Richmond contends that the ethical approval body for trials, the HRA, acted illegally in asking trial sponsors to declare that previous or ongoing trials in the UK had been registered; that by doing this HRA wrongly implied there was a legal requirement and so overstepped its duties as laid down in statute. HRA responds that it did not say that and did not intend that impression, and that its role in monitoring trial registration springs from its responsibility as the ethical approval body not from law. We intervened to set out the legal and moral case for trial registration and reporting. The judged permitted us to make written legal arguments. Richmond changed its case four times from narrow to broad to narrow etc. It contends that HRA accepted some of its earlier points. HRA argues that those points were mostly pointless.
We intervened because Richmond, whether intentionally or not, said it would be asking the court to decide a major point of principle about clinical trial registration. We, and our lawyers who alerted us immediately, saw a serious risk that the public’s expectations of transparency, the hard won progress of two decades and new advances in patient safety would be unwittingly sacrificed in a squabble between a company and the regulator. Our aim was to put to the court and to HRA the broader demand for transparency and monitoring of trials, and to challenge Richmond’s and HRA’s accounts of the basis for the registration and reporting. This is a matter that is far too significant to be negotiated as part of parties’ settlement of a court case. We sought to get the arguments between the parties to narrow, about their conduct to one another, and not to threaten trial registration or create loop holes through which more trials could flow, or the new European regulations be nullified.
On the eve of the case it looks to us hopeful that this may happen, but we have been surprised by argument switches all along and so we cannot make any assumptions.
Today at 5:38 PM
Here is a quick note about yesterday’s hearing. Judgment is expected next week.
The judge grasped the importance of trial registration and when he took into account our and the HRA’s evidence on legal and ethical obligations to register trials he found that Richmond was left with an extraordinarily narrow argument. It seems the case will come down to some words in a Q&A on HRA’s website that wasn’t amended at the same time as the sponsors’ declaration was. And then whether the ambiguity was significant.
We are so pleased we decided to intervene in the case. The court could find for Richmond on this very narrow point but it ended up exactly where we thought it should be: a principled discussion in which the judge seemed to grasp the issues well, the removal of Richmond’s broad claims that no registration was legally required and that the HRA was acting unlawfully, and alighting on a narrow matter for decision that will not impact on how trials are run or on the EU rules coming into force next year. Of course we would have liked the case refused altogether instead of it wasting public funds, which will be a lot if HRA has to pay Richmond’s costs.
Based on what was said in court, we are hopeful too that the court will find that the HRA has been going about its proper business promoting clinical trial registration. We are pleased that the judge ignored Richmond’s attempts to discredit AllTrials, and in fact that these appeared to backfire.
We will share the transcript of yesterday’s hearing as soon as we have it. I think you’ll enjoy reading it!
When the judge at the hearing yesterday heard that the HRA does not impose any sanctions on trial sponsors who don’t register their trials properly he said, “well, they should.”
Our legal team was amazing – solicitor Robert Dougans and barrister Jonathan Price – before during and after. If any of you read L Phillips’ recent speech asking where are the lawyers who are motivated above all by the pursuit of justice, well we know them.
(Tracey Brown is especially grateful for their patience with her unceasing flow of notes and questions)
Also yesterday, the pharmaceutical industry body EMIG said that Richmond’s actions do not represent the views of the rest of industry. Mark Edwards, the CEO, said that the case could have a disastrous effect on the industry. Read EMIGs letter here. It contradicts Richmond’s claim to the court that its concerns are representative. Some of you have told us that but EMIG said it publicly, which matters.
Thank you so much to those who came to court yesterday and sent messages of support. As well as the judgment, look out for some other big news stories from AllTrials next week: we can’t wait to tell you what your support has helped to achieve.
Director of Campaigns
Sense About Science
Science and evidence in the hands of the public
Neither Glaxo nor the D of H has admitted that the vaccine can cause narcolepsy.
Glaxo is *actively* researching the *observed* association between Pandemrix, narcolepsy and *other risk* factors………….
The vaccine causing narcolepsy also has an added bonus for big pharma. Xyrem the only drug specific to Narcolepsy is a ridiculously expensive drug that is cheap to make but patented by Jazz and they charge a fortune for it. The patients in the UK can’t have it as it’s too expensive but it doesn’t matter to Jazz because the American market is so lucrative. So UK patients get fobbed off with being prescribed off label drugs which include antidepressants used for the sleep paralysis and cataplexy.
So once again win win for Pharma. They make a fortune from the vaccine. Disable some of the patients by giving them a severe, debilitating, poorly misunderstood and incurable neurological condition. A condition which will require them to take a cocktail of drugs for life.
News today. Rapid withdrawal and misprescribing of a benzodiazepine leads to £1.35m settlement for Luke Montagu.
Hit and Won………..
My Scottish lawyer, reviewing my medical records, passing them to a ‘legol gp’ informed me that there was no evidence that ssris and benzodiazepines played any part in my mental elf situation……with the constructed theme of character assassination believed by all……
When this popped into my ‘following’ box, yesterday, I wondered if things might have been different if my case had been Lorded up……….
It also struck me that Lord Montagu might not have been the recipient of ‘his advisor’ telling him not to “come here looking for sympathy” and to stop “wallowing in the mess > I had< made of my life”……….
We have all been where Luke walked………….up to our necks in ssris and benzos……well done to Luke Skywalker……..
Luke Montagu has clearly suffered from this horrific benzo withdrawal (and is still suffering). The refusals of people he knows, to believe how the drugging has affected him, is a theme which is common to all of us on here, I believe.
Dr Mark Collins has been in the news previously, in 2003 (http://www.highbeam.com/doc/1G1-98106064.html). Maybe when he should have been taking care of Luke, he had his hands full.
I’m hoping Luke’s award draws a cold wind through the psychiatric establishment. This surely sets a precedent – you want to push these drugs, this is the risk you take…
Yours in hope,
Hit and Run…………