This post on the eight hundredth anniversary of the signing of Magna Carta is the second in a Magna Carta series, and the twentieth in the Persecution series.
Faced in 2012 with questions about the $3 Billion fine imposed on GSK – triggered by a sequence of events starting with Study 329, – is it just the cost of doing business? Andrew Witty snapped back:
“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors.
Accounts of what led to the 2022 Amendments to the Food and Drugs Act vary wildly. Some point to the new President’s first grandson being born with Tetralogy of Fallot linked to the mother’s antidepressant intake. Conspiracy theories invoked Marilyn’s Curse. They noted things like the coincidence of initials between the unknown American Woman whose baby had a Tetralogy of Fallot and Andrew Witty (See American Woman and American Woman 2). Others thought it was triggered by the increasing evidence of cognitive failure in more than one previous President linked by some to the fact both were on Statins.
Whatever the reason, Andrew Witty was recruited from GSK to rewrite the Charter between the people and Pharma. Here is a précis of his option appraisal.
The licensing of drugs is a bureaucratic procedure that has nothing to do with science. As things stand, the way FDA goes about approving drugs has enough of the appearances of science so that most doctors and patients are fooled into thinking there has been a science based decision when there hasn’t.
To an extent the public can’t imagine, the bureaucrats are just interested in getting boxes ticked and to paraphrase Tom Lehrer, “When the drugs go up who cares where they come down, that’s not my department”.
Regulation is completely incompatible with science. Science seeks uncertainty, whereas regulation seeks to abolish uncertainty.
We in GSK thought it must be crystal clear that Pharma does regulation and not science when to support a legal action against the European Medicines’ Agency Data Access policies in 2013 that proposed to let doctors and others see our clinical trial data we argued that this “data” was simply the result of a regulatory exercise and regulators ordinarily maintain the confidentiality of submissions on products they regulate.
This was the winning option in the opinion of the Courts. Some of my colleagues had doubts about our ability to win using this argument while maintaining the illusion that companies do science. The argument was a blow to the self-esteem (amour propre) of FDA and EMA who, while asleep at the wheel, like to claim they base their actions on science.
But medicine predictably noticed nothing. As Thomas More said about the Nobles of England – they’d have slept through the Sermon on the Mount. The only time they woke up was at Runnymede when there was something in it for them – (see Magna Carta).
Regulation needs to be disentangled from science. This cannot easily be done while the 1962 Amendments to the Food and Drugs Act contain an effectiveness criterion. The idea of forcing companies to show their drugs worked was a well-intentioned move but a disaster all round – a simple solution to a complex problem that has made things worse.
In the new regulations to mark the sixtieth anniversary of the 1962 regulations the word effectiveness needs to be replaced by safety.
For those who want companies to say what a drug is for, we can revert to the wording before 1962 by stating a drug should have a clear effect on a structure or function of the body.
Getting rid of the effectiveness criterion would do a lot of things. First it would make it a lot cheaper to develop new drugs. As a result, the cost of drugs would fall, more new drugs would be brought on the market and after marketing a lot of discoveries would be made. We could look forward to a new era of Wonder Drugs to rival the 1950s.
Second it would get rid of off-label marketing at a stroke.
Third it would mean that doctors and patients would have to be personally convinced a drug was actually helping them rather than depend on company claims that it was.
Fourth it there would be much less company clinical trial data and campaigns like BMJ and the Cochrane collaboration to access the data would likely wither on the vine. It would even be safe to appoint Peter Doshi and Tom Jefferson as data access Csars.
Whether a drug works or not is not critical to companies but it is critical to medicine and patients. This is a question that cannot be left to industry. As with a lot of these things women have blazed the way as in trials like the Women’s Health Initiative study of HRT. There were earlier trials run by medicine like this during the 1960s but everyone has forgotten them – it’s so long since medicine ran a serious trial.
This would be real evidence based medicine.
One of the consequences of this is that it would likely mean that a full appreciation of the risks and benefits to be obtained from a treatment would only really be clear several years after the launch of a new compound when the proper clinical trials began reporting. What doctors do while waiting for these results to come in is the key issue. Our hunch is that hope is the most powerful incentive of all for most patients and most doctors. No regulatory system will ever change that.
Quite simply these need to be dismantled. Anyone who doesn’t understand this doesn’t understand marketing – most doctors.
If prescription-only privileges are to be retained in some modified form, only those who do understand the need to abolish them should be involved in any modification.
There are a range of things that could be done such as:
Where alchemists, homeopaths, chiropractors and others, who have slavishly copied medicine, failed to make inroads, we have been able to walk in and leave with the Crown Jewels.
Using clinical trials and ghostwritten articles – the appearances of medicine – we have infected the body of medicine with an AIDs-like virus turning medicine’s defenses against itself. The insertion of these sophisticated adverts into the medical literature has triggered a Clinical Auto-Immune Deficiency (CID) reaction that leads most doctors and scientists to turn as viciously as they would turn on a quack on anyone who questions the results of these ghostwritten articles and trials that have no data and sometimes no patients. It’s been amazing to watch.
Physicians have had decades to find a way to get this cuckoo’s egg out of the nest of science. They could have based clinical practice only on investigations whose data is publicly available. They could have used the Human Rights of their patients as a lever – it is not for instance possible for any doctor to prescribe any branded medicine with informed consent as things stand at present.
But they haven’t done anything like this. The branches of medicine linked to the prescribing of branded products are finished as a profession. They have no brand value.
The market has now developed so that nurses, pharmacists, clinical psychologists and others can take over the role of prescribing drugs and are far less expensive than doctors.
If medicine has any value and we believe in market forces, abolishing it might lead to a solution. If people and governments come to think they need a set of experts who have brand value when it comes to good quality information on drugs, a new profession will be called into being.
Other physicians practicing in areas of medicine where branded products have little penetration could be allowed to continue.
One issue for others to consider is whether areas of medicine that are heavy users of medical devices are as badly affected as mainstream medicine.
A further option might be a promotion of patient co-operatives. Groups like ACOR.org are making a significant difference to healthcare. They might find it far easier to work with nurse and pharmacist prescribers than with doctors.
One of the few things that might have influenced my behavior as CEO of GSK would have been a boycott. Record fines and even jail time are not deterrents. Almost everyone views these as a cost of doing business already. A jailed CEO might even boost share value.
We in GSK know that boycotts can hurt. In the crisis over making ARVs available to South Africa for AIDs the threat of a boycott was the only time our Board substantially altered its position.
The boycott would be aimed at getting companies to hand over Adverse Event data. Groups like AllTrials – which we did a lot to nurture – are campaigning for efficacy data. It’s been interesting to watch them punch themselves out on this issue which is tied to disease indications that don’t exist, and center on meaningless surrogate markers, and are produced for bureaucratic purposes only. These data are frankly close to worthless and are not what we have been trying to hide anyway.
What we have been hiding has always been the adverse event data.
In 1962, in the frantic panic triggered by thalidomide all the wrong options were picked – the effectiveness criterion, prescription-only arrangements, and controlled trials. They all looked good at the time but companies are a bit like the dinosaurs in Jurassic Park, we are always going to find a way around the controls.
There was only one proposed change we really didn’t like and made sure we killed off – this was a proposed revision to the patent arrangements. Having US style product patents has been the key to the Pharma companies becoming Magna Pharma – the most profitable corporations on earth.
Companies need to be rewarded but the current product patents reward us beyond the dreams of avarice for delivering treatments that increasingly shorten life and increase disability.
There are other ways to cut this cake such as process patents, that would make blockbusters less valuable. Process patents would put a premium on diversifying the portfolio of compounds we hold rather than have us dependent on a small number of blockbusters.
At a stroke this would begin to turn us away from making everyone chronically diseased for life in order to make huge amounts of money out of them and away from just looking for drugs that millions will consume even though they don’t need them and turn us toward drugs that everyone will recognize are worth paying a lot of money for.
The last decade has seen a huge fuss about access to Clinical Trial Data since we in GSK kicked open this door by posting the results of our trials on depressed children on the company website. We have been able to keep the lid on this and have fall back options such as the AllTrials proposals that if adopted will probably leave academics worse off vis-à-vis transparency than they are now.
We have taken some risks to win the argument so far by claiming that patients’ data is confidential – when pretty well everyone who volunteers for a company trial expects that independent experts will get to view the data at some point and would be horrified to find this is not the case. So far this has been a winning argument.
But the startling thing that everyone has missed so far and shows no signs of spotting is that there are thousands or hundreds of thousands of drug trials that remain completely unregistered, where there are no issues of clinical confidentiality. These are studies undertaken in healthy volunteers – normals. There is a compelling cases for ensuring these data are made fully available.
These contain the data we really want to hide – the adverse event data.
Companies will likely need an amnesty for some of the abuses of people that will come to light if the new regulations make these studies available to view.
This is a key step.
We have taken astonishing steps to prevent decent reporting, or to denigrate reporting when it happens, and to manage the perception of risk rather than risks themselves. If the Nazis had access to our bag of tricks, there would be real and widespread doubt that the Holocaust ever happened.
For instance companies supported the development of an FDA MedWatcher App in 2013. This was widely applauded as we knew it would be. But it was in fact a way for companies to reduce the expense of maintaining a pharmacovigilance department, reduce their legal liabilities, and transform adverse events into anecdotes all in one go. Companies you see have a duty to follow up and decide if their drug caused the problem – FDA don’t have this duty.
But what was astonishing about all this was that pretty well everyone completely bought the idea that when it comes to working out whether a drug has caused a problem, a bureaucrat in FDA who is there because they don’t like meeting patients, has never treated the condition you have and never used the drug you are on, would be better placed than a good team of doctor, pharmacist and informed patient perhaps in touch with other good teams, to work out what’s going on.
If we’re good enough to get people to buy this, perhaps next April 1 we should see if we can persuade people the earth is flat.
Unless an independent patient organization gets involved in assembling real-time data and both doctors and patients combine to put risk mitigation programs in place, the other changes are less likely to work.
The bottom line is the average drug has at least 100 effects. Using clinical trials we have been hugely successful in hypnotizing doctors and patients to focus on one effect and to miss the other 99. This blind spot is the major driver of Pharmageddon (See Marilyn’s Curse).
If the climate change encroaching on healthcare is to be rolled back, we need someone to spit on some clay on the ground, make a paste, and rub it into the eyes of doctors or anyone who ends up prescribing.
Following the Supreme Court decision in the Matrixx case (note to self – check I am not confusing this with the movie), which said that while doctors and patients have no rights to access company adverse event data, shareholders have, one option is through Government to give everyone a shareholder stake or stakeholding in companies.
There was a doctor on my panel who had a different point of view. Dr Crusoe. She produced a minority report which I will forward under separate cover.Share this:
Copyright © Data Based Medicine Americas Ltd.
quote that particluarly interests me “”Rewarding doctors for reporting adverse events
Penalizing doctors if they do not report them at a certain rate per year.”””
Even just the rewarding doctors for reporting adverse events.WOULD BE A MAJOR IMPROVEMENT!! And the second, is a great idea “Penalizing doctors if they do not report them at a certain rate per year””
My newborn died due to Zoloft HLHS. I am a pathologist..I know every drug has side effects. I was told that using zoloft during pregnanacy WAS SAFE…….. (I learnt to my horror later, that no side effects during pregnancy are listed, as it was NEVER TESTED for use in pregnancy)……….. THAT IS EVIL!
Even in my inconsolable grief, I reported it wherever I could…1996…
. The doctor who delivered my baby, was told, I told him, that zoloft caused it. My baby and I were sent 450km via RFDS, to Western Australias Childrens Hospital, they did the scans.. The doctors there were told by myself, it was Zoloft. I was on no other medication, and have other healthy children………… as a mother, I knew, and I only took the stuff for 8-10 weeks (not realising I was pregnant).. I would never have taken in at all, except for the “no side effects to baby””, I am a very wary person…. even if there was 1% chance of my falling pregnant, had I been told “this drug has never been tested on pregnant women, and no test done on foetal health”” that would have been the truth. NOT THE LIE I WAS GIVEN.
Worse than this, after 19 years, I open the death certificate and the space that says “any possible contributing factors”,,, where it should say Zoloft use in first trimester IS BLANK.
I contact TGA Australia, they have no record of my orginal report.
If they didnt get my orginal report, where was the doctors report,. the doctor who delivered Steven? Next time I see him I will ask if he made one. I truly believe he would have done (he didnt prescribe the zoloft).
Since then I have read all sorts of stuff on-ine from gps… ah I have prescribed balah blah blah for 25 years, only had two adverse reactions… Now did they report those adverse reactions. NO. Why not? Are they sure they had all their patients who had adverse reactions, report it to them? I doubt it. And if they try reporting it through TGA, if they can work out how to do it, will their report also somehow end up filed in the bin?
I am too upset by the story on Rxisk to speak.
I have tears streaming down my face because even reading it half way through I didn’t expect her to die.
I am not going to shed any crocodile tears over A. Witty and Seroxat; he, the drug, isn’t worth it.
It was my little girl who shed the tears when her mother disappeared twice.
Does any one realise the hurt when adults continually talk about closure. It’s not the parents who ever get closure.
It’s those on the outside looking in who would like closure…….
A. Witty will never get closure because A. Witty is suffering from exposure….of the beautifully crafted kind…..
Oh God Annie, I read that too but didn’t realize that Hannah had died. I just re-read it and I cannot believe that the doctors could have been so stupid. Her poor mom – what a terribly tragic story. So many victims. Our children deserved so much better…
Leonie, yes the adverse reactions go on in Ireland as you know too well – I spoke to Eleanor, secretary to Independent Deputy in Leinster House, Finian McGrath this morning, I had challenged Finian McGrath several times through email and in person outside Leinster House last Monday on the cover up of pharma crime in Ireland – he whisked away as did Richard Boyd Barrett – Eleanor of Finian McGrath’s office said to me that Finian McGrath has raised the issue of Prozac several times in the Dáil, and asked me if I knew of a Mrs Duffy whose son died at the age of 23…Eleanor stated that Mrs Duffy had refused to sign the Death Certificate to agree that her son had died of pneumonia – seemingly her son had had an adverse reaction to a vaccine as a young child and never recovered – he was left in a crippling state since up to the age of 23 years and then got pneumonia and died – I had never heard of this case – Eleanor went on to state about Prozac being raised several times in the Dáil by Deputy Finian McGrath- I asked her then why is Stephanie Lynch being fobbed off by the HSE and Coroner’s Court on the issue of prozac that was prescribed to her 14 year old son Jake – Eleanor who works with Finian McGrath stated she never heard of the case (yet she stated that Finian McGrath is well tuned into the damages of Prozac) – I told Eleanor that Jake’s death at 14 from Prozac is well documented in Irish papers – she went on to state “well you know that Independent Newspapers are sponsored and controlled by Pharma” – she then mentioned about a dreadful killing in Bray that she believed was because of Pharma drugs – she said it went to her heart – I then mentioned that it was Leonie’s son – Shane – who had suffered such drug side effects – and I mentioned your blog – Eleanor stated that she did not know you had a blog – and I told her to look it up because she will see of all of the tragedies – Eleanor stated that Finian McGrath works so hard for such side effects of other drugs and she mentioned that Novartis needs to take account (her words) she mentioned of course cover ups in Eli Lilly also…when I mentioned Dr David Healy’s expert witness views, and his blog comments on such events – Eleanor had to go…another one, perhaps, Leonie you need to follow up on…
‘The boycott would be aimed at getting companies to hand over Adverse Event data. Groups like AllTrials – which we did a lot to nurture – are campaigning for efficacy data. It’s been interesting to watch them punch themselves out on this issue which is tied to disease indications that don’t exist, and center on meaningless surrogate markers, and are produced for bureaucratic purposes only. These data are frankly close to worthless and are not what we have been trying to hide anyway.
What we have been hiding has always been the adverse event data.’
Wonder if BG still thinks Witty is a good guy.
This shows Witty for what he is a cold blooded shark. Anything he looks like he’s giving or comprising on is purely for the benefit of GSK. He doesn’t care about anyone who has been damaged by the data they’ve hidden and never will.
For things to change it can’t come from Pharma because they cannot be trusted. There has to be new laws, strict laws that are regulated by a pharma free independent body.
One thing I do agree with Witty on is that fines are not a deterrent but I don’t agree about a jailed CEO not beng a deterrent though. I think if some of the big shots in Pharma started getting sent to prison it certainly wouldn’t do any harm !
The only way to change the rotten game is to remove the sociopaths at the top. It’s the same in pharma as it is in all the corrupt systems: governments, psychiatry, regulators, finance, banking, war-mongering military industrial complex, big business etc.
These are spheres where power and money are insatiable. They commit evil deeds in order to acquire more power and money, and this is also why the sociopaths (those without compassion for other human beings or the world itself) thrive in these worlds like viruses. The rotten systems attract the sociopaths because the sociopaths are attracted to the rot and then the sociopaths keep the systems rotten…
Get rid of the sociopaths and you’ll eventually clear up the rot…
Also this needs to be posted as far and wide as possible. People need to see this.
Dear Andrew: Your proposals makes my head spin. Some of them sound like a genuine shakeup of the system, while others sound like the corporate spin at which you excel. Worse yet, it gets hard to tell the two apart! A few questions, if you don’t mind:
1. “Regulation” in reality refers to people – the various political appointees, mainly doctors and lawyers, at the head of FDA and EMA. When you talk about empty-headed box-tickers, you’re talking about them and their subordinates. “Medicine” in reality refers to people – from the heads of specialty societies and the top-ranked medical school professors who shape opinion, down to the doctors who carry these opinions into their clinics. When you talk about Medicine being asleep at the switch, you’re talking about them.
“Science” in reality refers to – who? When you say that “science” is at home with uncertainty and actively seeks it out, you make me want to get rid of Regulation and cast my lot with Science. But who is Science, exactly? Where does Science live, and who signs his or her paycheck?
2. How would “getting rid of the effectiveness criterion” get rid of off-label marketing? Granted, you’d have no government seal of effectiveness for any use – but then you’d have no government prohibition on claiming “effectiveness” for any use you could dream up, either. Your friends at Sprout Pharma could market flibanserin as “Pink Viagra” to improve women’s sex lives, and also as an antidepressant – the sexy antidepressant! (Kind of like you did with Wellbutrin! Only now it would be legal.)
3. That Independent Patient Safety Group sounds really cool. But it’s gotta be at least 100 times bigger than any group we’ve come up with at the grassroots. Who’s going to fund it? Or would you like to have several competing ones, most of them funded behind the scenes by you guys?
If we succeed in pulling together a publicly funded and genuinely independent group, I know you’ll be there. Calling them a bunch of Bone-Headed Box-Ticking Regulators, who are standing in the way of genuine, life-saving Innovation, which only the private sector can provide, yadda yadda yadda. Maybe I’d best hold out until I hear from Dr. Crusoe. Later, Johanna
That’s the trouble with ‘working towards a solution with Pharma’.
All the top dogs are master spin doctors that’s why they are paid so much.
Spin or truth … you can’t tell but I would bet that any move they make towards transparency will be on their terms for their own agenda.
It’s all smoke and mirrors and no glass to see through. If pharmaceutical companies have any hand in transparency in medicine, we will be no further forward. They will still hide anything that will affect their profits.
It will be like opening the curtains and revealing a filthy window you can barely see through.
More words fail me at this juncture………….’breathless’ being one of them….
Oh, god, Tucker…………Mad in America…….Magna Carta
JohnTucker on June 15, 2015 at 10:48 pm said:
“Doctors make a living out of the work done by the rest of the population – swallowing pills. These doctors are highly unlikely to confront Andrew Witty or any of the big beasts of the pharmacockracy – unless some of them do so as shareholders”
I’m not sure I follow. In my last 10 encounters with the healthcare system:
1. I received a generic cough suppressant for a particularly nasty flu-associate cough.
2. My PSA was checked. Had it been sufficiently high, it would have been followed up with a biopsy.
3. I was recommended physical therapy for a frozen shoulder
4. I underwent colonoscopy as part of routine colon cancer screening
5. My eyes were checked as part of glaucoma screening. Had the test come back positive, I likely would have been prescribed a generic drug such as a carbonic anhydrase inhibitor
6. I had a pre-cancerous area removed from the skin of my left cheek
I can’t actually remember the last time I was prescribed a drug that wasn’t manufactured by an Indian generics company and sold to me for pennies a pill. Overall, in the U.S., which has unregulated drug prices, pharmaceuticals are 9% of national healthcare expenditures.
So its fine to have a beef with the pharmaceutical industry. But its extraordinary hyperbole to describe the healthcare system as “Doctors make a living by watching patients take pills” or to suggest that clinical trial participants are “serfs”. Unlike serfs, no one is conscripted to participate in a trial against their will, and multiple studies have shown that most participate in hopes of personal benefit.
A few good points here, but hard to find among the breathless hyperbole.
“In hopes of personal benefit”? Oh, yeah. Like the hope of getting meds you otherwise couldn’t afford. Or seeing a doctor, for that matter. The vast majority of American research subjects are NOT patients frustrated with their conventional treatment, who decide to take a chance on an unproven new treatment for their own good and that of Science. They’re people who are thrilled at the chance to get any treatment at all.
It’s so well known, nobody even blushes anymore. Take this article from the Natl Psoriasis Fdn, on How Clinical Trials Make Treatment Affordable:
“Without insurance, the retail value of a year’s worth of Stelara injections would cost between $30,000 and $70,000. (Editor’s note: Many, but not all, without insurance qualify for assistance that significantly reduces the cost of biologics.) When Franklin spent five years on the drug during its phase II and phase III clinical trials in the latter half of the last decade, the medication – which dramatically improved his psoriasis – cost him nothing out of pocket. In fact, Franklin even made a little money: Most clinical trials pay a small stipend to compensate participants for their time and travel expenses, generally $20 to $50 per visit. Franklin used the cash to buy himself new golf clubs.
“Accessing affordable treatment is one reason many participate in clinical trials. Not only do patients have the opportunity to try the latest and greatest new medications at no charge, Franklin said, they also get regular free exams by the doctors and nurses administering the study. For some patients, this may be the only consistent doctor’s care they receive.
“I’m constantly under the care of a physician,” Franklin said. “There’s a real added benefit with having regular contact with a dermatologist.”
Hooray for Franklin — the guy with severe psoriasis who finally gets to see a dermatologist! By becoming a guinea pig. You go, Frank.
Hi – would this John Tucker, who reports his positive experiences of medication so fully, be one Formerly98? I came across him first when he posted (the first) comment on my 2013 post for Rxisk about my experience of withdrawing from olanzapine – and the consequences. Basically saying that it had nothing to do with having taken olanzapine for 12 years. I didn’t think much of it – apart from thinking it was an odd name to use. Then I came across him again – about a year later when I wanted to quickly check the meaning of a ‘surrogate endpoint’ in a trial – for a book I’m writing. All sounded a bit odd – so went onto the Wikipedia talk page for the first time in my life. There was Formerly 98. Checked his editor’s profile – former Pharma employee, no problem with that, but his mission, to remove anti-Pharma bias seemed to extend to removing all adverse effects data (Sometimes whole pages/articles)…from all Wikipedia articles about all drugs and the industry. Seemed more like a whitewash job than editing to me.
Now he’s changed his Wikipedia editor user name again to – wait for it –
Renamed user 51g7z61hz5af2azs6k6
You can’t see his old editor profile, Formerly98, because it’s been removed. Nor can you see the new one, which sounds like a Safari suggested password, because – Wikipedia will tell you it doesn’t exist. Nor does it. An entity called “xeno’ is lurking around on the talk pages where Formerly98 used to be active. Xeno doesn’t seem to exist either.
All very fishy to me: one person, or….? Probably wouldn’t matter too much, except that the vast majority of people look at Wikipedia first for information about a drug. And I don’t like being taken for a ride.
I would say that a lot of participants in medical trials are doing it because they can make a decent amount of money tax free. One of my sons was setting of travelling last year. I was horrified when he told me he had signed up for a trial. He had been for the interview he got £30 in ‘expenses’ just for that. He told me it was easy money. He would get £700 tax free for being there for a couple of days. He said it was great, like a hotel.
Needless to say we perseuded him not to.
What I’m saying is that at 23 yrs old desperate for extra funds he didn’t start looking at small print or considering any possible dangers. He just listened to them telling him it was easy money getting paid to sit around and watch films. My son said to me “that’s the equivalent to what I bring home for 3 weeks wages at my job.”
While I agree there are a lot of people with medical conditions who are hoping it will help them there are also a lot of people who are desperate for money and a nice tax free lump sum is a big draw to them. You’re not going to find a middle aged well paid exec in that clinic it’s going to be students and people on low incomes.
Another Russian Roulette situation is playing out at this very moment.
If you do nothing else today, you must listen to this…….
What would you do if you had 4 ½ hours to make your mind up?
A jumble of data, he said…serious clinical trial failings…dangerous and killing patients…he said
This is File on Four discussing treating stroke victims with Alteplas which has become ‘controversial’.
You may wonder why a stroke pill ‘debate’ is happening and why a stroke pill is relevant to you.
If you follow the ‘discussions’ this is almost an identical scenario to Seroxat and the like.
Damned if you do and damned if you don’t?
The conclusion is being sought by the MHRA shortly…..as, Seroxat had a long protracted investigation by the MHRA, I think we should all be watching the result of this particular use of Alteplas with considerable interest………..
Who should pay heed to ye olde Scottish proverb:
If the mud sticks to your boots, you shouldn’t be in it
GSKs fall-guy from ‘Chinagate’ has just been released…
“Weeks later investigators targeted ChinaWhys, but the drugmaker has kept Humphrey and Yu at arm’s length. GSK says the charges against Yu and Humphrey may not be related to GSK, and Chinese state media have never explicitly made the link”.
Let’s hope GSK can’t buy him off, and he dishes the dirt on what happened out there, preferably by writing a book on Reilly and co.
There seem to be many occasions when A. Witty could have stepped in, instead of stepping out……
O’Reilly, oh, really, where is the sex tape now?
Sitting in Witty’s bottom drawer…
We used to think extreme cruelty were only words used in Animal Charities requests for donations, and, Alltrials, request donations….
Now their feet are resting on British soil, and, probably hospitals beckon to look after them properly, there are many options for this couple….
There are far too many ‘self-help’ books on the market which only continue to drive up sales of psychotropic drugs like Seroxat as the readers realise they are not being ‘self-helped’ at all….and, maybe, become a little anxious……..
We weren’t in the friendly, delightful confines of a prison cell in China, but, we might as well have been when our doctors provided us with their con su lar assistance.
When and if they get their strength back maybe we will see something ‘radical’ and/or ‘truthful’…
Peter Humphrey has said he is not ready to talk about GSK yet.
Meanwhile the Brothers Grim (m) aka GSK are creating another fairytale. They are going to stop Grandma from killing her grandchildren. Don’t worry Granny it won’t hurt it’s only a little prick and it’s better than being the big bad wolf of the family ..
Dear friends…..hey, Walter…….
I am writing to tell you that this morning our director has instructed lawyers to apply to the Administrative Court to intervene in the judicial review brought by Richmond Pharmacology against the Health Research Authority in respect of clinical trial registration.
This has been a difficult decision for us. Sense About Science is a very small charity, and we intervene with a small but real risk of financial devastation. However, our Board of Trustees and the AllTrials steering group agree that this is our duty. Your letters of support, offers of help and kind donations have played a significant role in our decision to take on this struggle for clinical trials transparency.
The next step is to write to both the HRA and Richmond Pharmacology, and detail our planned intervention to the court. Síle Lane and Ben Goldacre are working hard to produce a summary of the issues, which I look forward to sharing with you as soon as possible next week.
What happens then remains to be seen, but I will keep you updated every step of the way.
Thank you for your support.
Sense About Science
Science and evidence in the hands of the public
This is all hardly a secret and this is a few words I had with a lawyer which you may or may not find interesting………..
Let’s just say that this particular lawyer is history……sort of……
UK Seroxat Litigation Update – June 2015
30 Jun 2011
Reply, Reply all or Forward | More
30 Jun 2011
Dear Ms Bevan
I cannot do more than I have. I cannot call the meeting. Therefore I can only chase those who can.
For the avoidance of doubt, I have advised you and all of the Claimants that this case does not have reasonable prospects of success and I reported this to the LSC. On the basis of my advice most of the Claimants discontinued and the LSC decided to discharge the funding and a small group of Claimants have appealed. It is clear therefore that neither I nor Counsel expect to continue representing the Claimants nor indeed can we.
The appellants have been advised that if they intend to continue with the case (whether successful on the appeal or not) they will need a new legal team. Indeed the submission of the appellants to the LSC was that we were prevented from continuing. They are right as leaving aside our position on the case and why it cannot be won in its present form as articulated at length to you and the other Claimants last year, we could not now continue when so many people have discontinued their claims on our advice.
I want the appeal finished as soon as possible. I have done all that I can to preserve the appellants’ position but at some point the Court will tire of waiting for the Claimants to progress their claims. You are clearly upset and have misunderstood my legal and moral position so I will not seek to respond to the last few paragraphs. Suffice to say it is not in my interests to delay the appeal.
—– Original Message —–
From: annie bevan
To: Mark Harvey
Sent: Thu Jun 30 20:07:30 2011
Subject: Re: Seroxat Litigation
Dear Mr. Harvey
Thanks for your quick reply.
What is going on here?
It is getting ridiculous that all this money from legal aid is hanging on one meeting between three people that should have been set up six months ago.
We are your clients, we should not have to push for this meeting.
Dont’t put the onus on us, we wait for an outcome from you having started this litigation.
If you really don’t want to do it any more, just tell us, and we can then move on and start to seriously get our case off the ground.
You are holding me back. I could start a civil case, and could have eight years ago, if you had not started something you couldn’t finish.
This isn’t some sort of game, people are suffering here and if you really don’t want to do it anymore just say so and I will then get on and do it myself.
— On Thu, 30/6/11, Mark Harvey wrote:
From: Mark Harvey
Subject: Re: Seroxat Litigation
To: firstname.lastname@example.org, Debra.Allen@legalservices.gsi.gov.uk, HealeyD@of.ac.uk
Date: Thursday, 30 June, 2011, 19:09
Dear Ms Bevan
I share your frustration. The setting up of this meeting is not in my gift but solely that of the Legal Services Commission who I have been chasing frequently. Two weeks ago I was told I would have dates provided so that I could canvass our generic expert witnesses for their availability. They have not arrived and I continue to chase.
Any pressure you or any other appellants can bring to bear on the LSC would be appreciated.
It is correct that your Public Funding and the costs protection it provides remain in place limited to dealing with your appeal.
Head of Litigation
Hugh James Solicitors
Cardiff, Wales, UK
Direct Fax:+44 (0)29 2066 0585
Office:+44 (0)29 2022 4871
—– Original Message —–
From: annie bevan >
To: Mark Harvey; Debra.Allen@legalservices.gsi.gov.uk >; HealeyD@of.ac.uk >
Sent: Thu Jun 30 18:59:56 2011
Subject: Seroxat Litigation
Dear Mr. Harvey
I am still waiting to hear when the meeting is going to take place between the two professional psychiatrists, who you employed as your expert witnesses in the Seroxat Litigation, and Professor David Healy, as promised.
I understand from your most recent correspondence to me that I still have legal aid up to the result of this meeting. and then, I would assume that following a succesful outcome from this meeting, legal aid will be forthcoming, during and following, a successful court hearing with Glaxosmithkline.
I appointed you as my lawyer in this case. You have been my lawyer in this case for seven years now and your lack of communication is beginning to cause me some concern.
You have, for reasons only beknown to yourself, cast a serious doubt over the litigation, even before critical information readily provided for by Professor D. Healy, has become available.
If I employ a lawyer for seven years, I expect him to see it through to a final conclusion, especially when legal aid has never been denied.
After all these seven years or so, it strikes me as a bit disingenuous of you to let a huge number of us down, over 400 clients, I think, without having the integrity, foresight or will to see it through.
Perhaps you would like to give me an explanation as to why you saw fit to tell over 400 clients that you decided not to continue when crucial evidence was waiting for you from Professor D. Healy and which is still waiting for you from Professor Healy.
I thought my sons lawyers were slow but compared to this lot they were race horses !! 7 years is a long time to take to make the decision not to take a case. It’s disgusting.
The first time I have seen this and it blew me away. It was like stepping back into the week after my son was arrested. I was hearing his exact words about how empty he was, no fear , no emotions or feelings. Just an empty shell were my son used to be. How does Pharma keep getting away with it ???
That video makes me cry every time I see it cant believe a pharmaceutical company can only utter the words “Violent behaviour is an unfortunate phenomenon” I think its far more than just “unfortunate” for the people involved. I would be more inclined to use the words HORRIFIC! and TERRIFYING!
What’s wrong with these people? who work’s in these pharmaceutical companies? does nothing concern them?
I “guess I got just a tad” cross, as my former, Canadian, pilot, said……
I have so much stuff on my computer; emails from Doctors, non-emails from Doctors.
I just hope “Tosh-iba” doesn’t blow up in my face.
Like it did with these people in TG4 and the thousands of others in this extremely dire situation through no fault of their own.
These nice people did not kill their children; their doctors did and there is no excuse, now, for this appalling ignorance.
We would prefer pharma did not get away with it or the doctors.
We are all in it together, as David Cameron, famously said…..
I think it is a shame that intelligent people and doctors have to spend so much time and effort monitoring companies because of this strange culture of deception. Clearly these companies have lost the plot. What happened to honesty and the notion of conscience and open mindedness?
If co-operation and scientific excellence was the goal then perhaps more resources and thought could be spent understanding mental illness and encouraging creative and innovating solutions to this scourge.
I fervently wish we could move on from this impoverished scenario.
I often wonder, quite fanatically, what happens to the information we report to the FDA, especially myself, when we report our adverse reactions to the FDA as I did. I felt like a guinea pig for the US Government when I had to report the horror that I endured while taking Klonopin for over 10 yrs when the guidelines specifies – 2-4 weeks (as I sadly found out too late.) When I reported to the FDA that I almost died from cold turkey withdrawals that my mental healthcare workers said was ‘just fine’ to do, what happens to that data. I feel like I entered my experience like they say to do and then it disappeared into the Twighlight Zone because nothing has been done to curb prescribing. In fact, benzodiazepines are the number one selling drug-addiction in America right now. And no one seems to notice. And being a ‘just barely’ psychiatric drug survivor, I know that these toxic drugs have got to be affecting babies in the womb. If they have effected me in such a negative way for over 35 yrs, there is no way in hell, that they are safe for babies as their delicate brains are forming. And if we ever think Big Pharma will take responsibility for this when they still deny mass killings by teens taking SSRI’s, then the joke is still on us. And I was one of them. I was ready to kill while in the throws of multi psychiatric drug withdrawal induced-mental psychosis. And I am no youngster. I am 58 yrs old. If I didn’t understand what was happening to me, how on earth do we expect our children, teens, and young adults to understand. I am truly lucky that I was able to survive my years on psychiatric drugs and that I didn’t find that gun I searched for every single day while enduring their horrific withdrawals.
“The licensing of drugs is a bureaucratic procedure that has nothing to do with science. As things stand, the way FDA goes about approving drugs has enough of the appearances of science so that most doctors and patients are fooled into thinking there has been a science based decision when there hasn’t.”