Click Here For
WiredPatrol Site
"You Are a Child of the Universe, No Less than the Trees or the Stars"
  << Previous Topic | Next Topic >>RETURN TO MESSAGES INDEX  

"Sense about Science - Follow the Rhetoric"

June 17 2014 at 8:48 AM
admin 

http://davidhealy.org/sense-about-science-follow-the-rhetoric/

"Sense about Science: Follow the Rhetoric
June 5, 2014 25 Comments

Editorial Note: This is the first of four posts about the link between Sense about Science and AllTrials triggered by the post Fucked and comments afterward by Ben Goldacre, Tracey Brown and others which raised these links.

My first contact with Sense about Science was linked to the Simon Singh affair. Singh had made some relatively innocuous statements about chiropractic and been sued for libel as a result. The case became a cause celebre – there was widespread support for his position among the scientific community and widespread concern about an inappropriate deployment of British Libel Law.

I supported him. I ended up on the mailing list for Libel Reform. As both of us had been on the receiving end of efforts to shut us up on academic issues, I met him when we were both invited to a workshop on academic freedom in 2011 in Cambridge.

It made sense that Singh’s efforts to change the libel laws was linked to an organization called Sense about Science, and by association Sense about Science seemed a good thing. It didn’t seem unreasonable to me either to have Sense about Science linked to AllTrials when AllTrials took shape.

The Cowardice of a Pampered Society

Long, long before I had ever heard of Sense about Science I’d read Living Marxism and thought it a breath of fresh air. Marxism like this felt like it might even stand a chance in the marketplace.

Looking at the Sense about Science website now, I realise I know some of its trustees and even have stayed in one of their houses. The people I know are reasonable people. Others must think they are reasonable too as these trustees have ended up as Presidents of Royal Colleges for instance – very much part of the establishment as Dick Taverne the founder of Sense about Science is. I’d imagine Tracey Brown is engaging and interesting also.

Being a consultant to a pharmaceutical or tobacco company or the military is no bar to being engaging. I have several friends who have been consultants for all three and the greatest help in terms of adverse events has come from people employed within Pharma.

I’m sure Andrew Witty (AW 1) is also engaging and interesting. Guido Rasi of the European Medicines’ Agency is handsome, charming, engaging, sophisticated, dresses in great suits and had me believing him after a meeting at EMA eighteen months ago on data access that he wanted me to keep in touch.

And many of the views that Sense about Science espouse are ones that should be heard. They think the precautionary principle is over-precautionary – “Over-precautionary Tales: The precautionary principle represents the cowardice of a pampered society”. That people who smoke should be responsible for their own behaviour. That we need GM foods. That climate change has been overplayed.

The problem arises with views that aim to capture or pre-empt debate and rather than being views for debate are part of an agenda that is being implemented. Not that being part of an agenda to be implemented is wrong either, but a political program deserves more scrutiny and anyone engaging with such views deserves to know that the person opposite them is not holding incidental views. It’s good to know when you’re dealing with a believer.

Risk Management

The common focus in Sense about Science views is on risk – the risk to corporations and other interested parties such as governments of things being perceived by the public as risky rather than the risk to you and me from treatments or climate change.

Within the pharmaceutical domain, the luckiest break for the Sensible Scientists was Andrew Wakefield (AW 2). Wakefield’s paper on the risks of the MMR vaccine gave the British and other governments a wonderful example of how a scientific paper can cause a huge scare that threatens lives and corporate profits. Managing the fall-off in vaccination uptake was a significant national event.

While many people fought shy of the MMR vaccine, perhaps even Tony Blair himself, this was an event that the public – me included – could readily understand and we were quite prepared to turn on Wakefield as the perpetrator, the bogeyman, the visible manifestation of why we needed sense about science.

In the UK, the most potent weapon on the lips of the academic puppets sitting on corporate hands ever since has been that Godlee or Jefferson is another Wakefield. In the fuss about the BMJ’s article about the hazards of statins a few weeks ago, Rory Collins, one of the industry associated statin supporters, accused Fiona Godlee, the editor of BMJ, of potentially being far worse than Andrew Wakefield.

Elsewhere in the world, where AW is not a household name, the accusation is one of being an anti-vaccinationist or being someone who pays heed to the TV actress Jenny McCarthy.

Many of the people I know who seem to have been approached to be a Trustee of Sense about Science would have readily signed up to an organization offering to bring sense to bear on scientific issues like this. I might have signed up myself if approached and unaware of its background.

Ben Goldacre began life taking on health fads and health scares like MMR (AW 2) for which he got a GSK sponsored prize (AW 1).

Fighting Fire with Fire

But something else has happened over the last decade since Sense about Science has been set up.

Doctors in general like a quiet life. Not unreasonably, they assume that what the regulators and their professional bodies say on issues are likely to be right. Doctors are also horribly vulnerable to complaints from patients or colleagues should they speak out about something. In addition for the last two decades, many of them are likely aware that they increasingly face a world where if they speak up about some treatment related problem – to do with Vioxx, Avandia, or SSRIs – they will be subject to vituperative rhetoric and be branded as being in league with the forces of darkness – in a way that would never have happened twenty years ago.

The rhetoric gets at doctors where it hurts. It’s been designed by people who understand doctors better than they understand themselves, and know just what to say to make them feel uncomfortable.

Some of the Sense about Science trustees that I know who have been subject to death threats from people unhappy with their scientific views could be forgiven for thinking its maybe no bad thing to fight fire with a little bit of fire.

Before coming to AllTrials, two housekeeping points. Another important and increasing criticism is that critics are anti-capitalist. We’ll tackle this in a third SaS post.

Yet another defence has been that raising questions linked to Sense about Science is just a smear tactic. This will be tackled in a fourth SaS post.

The AllTrials Coalition

AllTrials is a coalition between the BMJ, PLoS, the Cochrane Collaboration, Sense about Science, the Centre for Evidence Based Medicine (Carl Heneghan), the Dartmouth Institute for Health Policy and Clinical Practice, the James Lind Library (Iain Chalmers) and Ben Goldacre.

It called for the registration of all trials and their results to be shared as open data. It probably took off so well because this ask was simple and vague. Even GSK could sign up.

In embryo this looked like a great thing. The idea that getting only the appearances of greater access might be harmful is too subtle a point for most people. And we don’t like to think that good intentions can be hazardous.

From outside it’s hard to know what might be going on in the AllTrials bedroom. The BMJ, and PLoS can be expected to go along with proposals that ask for the registration of trials and it’s hard to argue against greater access to the data from trials. Their editors, Fiona Godlee and Virginia Barbour, working within constraints have taken their journals to places no man would ever dare.

I know nothing about Dartmouth or the CEBM.

Cochrane is a mixed bag – Peter Gotzsche, Tom Jefferson and Peter Doshi have done more to drive this debate forward than anyone else.

The Sense about Science website is a masterpiece of non-direction but their track record suggests a clear focus even if all their trustees don’t realise it. GSK, one of the major signatories to AllTrials, have an even more focussed agenda.

When the Music Stops

Iain Chalmers and Ben Goldacre are the two who are hardest to read. It came as a huge surprise to many to see Iain co-author an editorial with Patrick Vaillance a senior figure within GSK, accepting the view that patient level data was out of bounds.

Ben has eloquently told Pharma on many occasions that people will simply not accept the sequestration of data. But what is data?

For AllTrials and EMA it now looks like Clinical Study Reports (CSRs) are data. This is likely not what most people understand by data. It’s certainly not my understanding.

CSRs are a company’s first edited report on what the underlying data looks like – the point at which they begin to mislead themselves. If companies know these and only these are going to be made public they will very rapidly become tools designed to mislead the rest of us. These are the documents that even when the company didn’t think they might become public have already coded suicidal events as episodes of emotional lability. Without access to the data its impossible to know what is reliable and what isn’t.

The data are contained in what are called Clinical Record Forms (CRFs).

After a study is finished, a company will ghostwrite an article like the infamous Keller et al article in Study 329. For every page of this article there will be roughly 100 pages to the CSR from which it is drawn – or 500 pages if the company is being fully transparent. Behind this lie the CRFs. For every published page in a standard article there are between 5000 – 10,000 pages of CRFs. This is as close to the data – the patients – as we are ever likely to get. In some cases the real data never exist.

Here and here are EMA’s proposals about how CSRs will be redacted, and here is Ben’s acceptance of this redaction and apparent buying the line that CSRs contain commercially confidential information.

At the moment with the music stopped Iain and Ben look like they are in bed with Tracy, Guido and Andrew. Are they in bed just to stay in the game, still hoping to make the right call at the right time?

The time is now."



    
This message has been edited by peagee on Jun 17, 2014 9:03 AM


 
 Respond to this message   
AuthorReply
admin

"Sense about Science: First Admit no Harm"

June 17 2014, 8:52 AM 

http://davidhealy.org/sense-about-science-first-admit-no-harm/

"Sense about Science: First Admit no Harm
June 9, 2014 9 Comments

Editorial Note: This is a second post exploring Sense about Science. The first post Follow the Rhetoric is here.

Anyone interested in Pharma will know about its ability to Astroturf – to create patient organizations whose role is to promote an illness or subvert an existing one. Creating awareness of conditions sells drugs.
On a Higher Astral Plane

Less well known is what happens at a higher Astral level. You can’t sell a product that gets a bad reputation or is removed from the market. The marketing mission at this meta-level is to risk manage by influencing the debate on Risk.

You do this by setting up think tanks, hiring ex-regulators, academics and others, capturing the regulatory system, and working with a body with a name like Sense about Science.

The regulators advise you on how to get an indication for a drug even though it doesn’t work for that. The academics advise on how to do trials that use a problem your drug causes to hide a problem your drug causes. The lawyers advise on the trials or studies that need doing in order for you to be able to defend the product in academic and legal settings.

All are involved years, perhaps a decade, before any sign of a legal action or public fuss. You are able to brief them on the likely legal actions or publicity you could face because the right hand already knows what problems your drug causes, even though the left hand never concedes anything – even after the drug has been removed from the market. It would be irresponsible to your shareholders not to have defences like this in place.
Sinister Operations

But the key thing is to have groups help change the wider climate of debate – their efforts will make you seem mainstream. These are not the right hand (dextrous) experts you engage to take the known problems and hide them but the left hand (sinister) experts that take it as read you have been acting in good faith and don’t want to see you irrationally victimized.

Your, and accordingly their, mission is to transform poisons into fertilizers or even into vaccines. To transform inevitably risky chemicals into something where the greatest risks lie in non-use.

The climate changing operations of Pharma and its Sinisters have been so successful that two hundred years after Pinel’s famous medical dictum:

“The art of medicine lies in treating when possible but it is an even greater art to know when not to treat”,

medicine has been turned inside out and the essence of medical wisdom has become:

“The art of medicine lies in getting people on as many drugs as possible even though most of these will not help them; non-treatment is not acceptable in this day and age”.

And the Hippocratic Oath has become:

“First Admit no Harm”.
Clinical Trials – the Perfect Marketing Tool

In this scenario, RCTs, which initially seemed like a problem to industry, incorporated into the regulatory apparatus by Louis Lasagna, became a godsend (See The Tragedy of Lou Lasagna).

There should have been no excuse for not smelling a rat in the 1960s when industry began to use controlled trials to market their drugs.

The same applies to Evidence Based Medicine. Industry rapidly became one of the strongest proponents of EBM, and adherence to the guidelines it spawned. Most of the continuing medical education doctors have had on EBM has come from industry – with a particular focus on the hierarchies of evidence that put controlled trials on the top.

EBM can’t be blamed for trials that use surrogate outcomes, and are of inadequate duration, or for the fact that regulators will license products on the basis of two positive RCTs even if there are 10 or more negative studies, and the fact that pretty well all the publications that stem from these two positive studies are ghost-written. And Cochrane researchers have been among those who have established that companies can pull up to 50 publications out of just one trial.

But in a wonderful symbol of how Cochrane lost its moral (yes moral) compass, a 2009 Cochrane review by Cipriani and colleagues endorsed Zoloft as likely to be the most effective antidepressant when in fact it has debatable if any effectiveness. The Cochrane review was based on the published literature – when everyone except the most naïve must have known at that point that the published literature they were dealing with was likely to be close to entirely ghost-written and they didn’t know how many negative trials there might be. A year previously Erick Turner had published a widely cited article showing just how bad Zoloft really was.

Cochrane though is not one thing. In 2009, another set of Cochrane reviewers, Tom Jefferson and later Jefferson and Doshi, began publicly questioning whether the evidence would support the use of Tamiflu if the evidence were fully available. Their questioning culminated this year when Jefferson, Doshi and colleagues pretty well said flat out that it is not possible to do a Cochrane review on any treatment for which the data is not fully available.

Cochrane without Data is like a Fish with a Bicycle

The wonder is that it has taken the field so long to nudge toward the importance of data

Fourteen years earlier I lost a job on this very point. I gave a lecture in the U of Toronto which is widely cited as a lecture in which I claimed that antidepressants cause suicide when in fact the claim was:

“I believe that antidepressants cause suicide. Most people in this room likely don’t believe it. The problem we both have is that I have seen data that you haven’t. If you cannot see the data, this is just not science. And in a world where the data is not available conflict of interest becomes a big issue.”

Long before that I had written the Antidepressant Era (1995) which endorsed a recently published initiative from Iain Chalmers (1992), the founder of the Cochrane Collaboration, to have systematic reviews which he I imagine, and I certainly, at the time would have thought meant a review based on access to all the data.

But Iain and others veered off in a different direction. Iain was keen on trial registration, so that the field at least knew how many trials there had been and what remained out there unpublished.

This might make sense if RCTs are absolutely sacramental – the only form of evidence worth having. They aren’t. They are the gold standard way to hide adverse events – see A Black Box Warning for Clinical Trials.

Clinical trials are like men – they find it difficult to do more than one thing at a time. Ask them to focus on efficacy and they lose track of safety.

If Cochrane was an enterprise associated with bringing adverse events to light, and standing up for patients, it might be one thing to go along with proposals born from success at delivering the goods. But it’s not. Aside from Tamiflu, at the moment Cochrane is better known for declaring the statins to be side effect free. Against this background, where patients in the real world are concerned, making the registration of trials a key goal is primarily a box ticking exercise. Something for clinical trial collectors.

Bad Medicine

This is where Bad Pharma comes in. By putting a premium on RCTs – everything would be okay if the RCTs were just done properly – its message is everything GSK and other companies could have wanted See Not So Bad Pharma.

How could a book that catalogues industry failings and is called Bad Pharma be a win-win for Pharma?

There is nothing unprecedented about a book cataloging Pharma sins working wonderfully for Pharma. Some of the guiding spirits behind Sense about Science were once linked to a periodical called Living Marxism (see Follow the Rhetoric), which despite the title often delivered a message supporting corporate interests. It may have achieved its purposes because of its title.

It wouldn’t be any more breath-taking for good Pharma marketers to write a book called Bad Pharma. But the standard way to do these things is to support someone else who does it. This is a hazard for all of us. When Pharmacia wanted to market reboxetine – a non-SSRI – they were happy to have me on a platform to lay ouf the hazards of SSRIs.

A message that says RCTs are all that count works for Pharma because at the end of the day the only people in town able to play the RCT game are Pharma. Sure there were errors in how Pharma did trials, some of them egregious, but that was in the past. Sure there was a lack of transparency but hey we’re about to solve the perception of that one right now, further eroding medical discretion in the process.

What is Data?

In the course of the debate about access to clinical trial data triggered by Peter Gotzsche and the European Ombudsman, AllTrials emerged and called for trials to be registered and for data to be made available. Data however wasn’t defined and it seems to have morphed from data into Clinical Study Reports (CSRs).

CSRs aren’t data. CSRs are drawn from Clinical Record Forms (CRFs). CRFs are almost the data. But AllTrials is not calling for these because of clinical confidentiality issues.

CSRs that have been redacted are even further from the data. CSRs that have been redacted and are read through a periscope – the GSMA-ESK model – are further away again. A periscope that the GSK seagull regularly sits on obscuring the view. Is this what AllTrials has been maneuvered into supporting?

AllTrials and GSK and now EMA also endorse a model whereby it is only people with an analytic plan that should be let access anything. This is the kind of qualification that would be put forward by anyone who believes in RCTs and statistical significance – its not an approach associated with bringing adverse events to light. It is almost in breach of the legal settlement GSK have signed up to with US States.

The Clinical Trial Blender

RCTs work for industry because they focus on one of the ninety-nine effects a drug has. Focusing on this one effect they nevertheless claim that they have told us all we need to know about this drug. If, despite being ignored, another effect of the drug pushes its way into view, standard RCT approaches will claim that if the effect wasn’t present to a statistically significant extent, it didn’t in fact happen.

Behind closed doors industry’s right hand dextrously files reports of adverse events that have been thoroughly assessed by clinical researchers and deemed linked to the drug. They will even in some cases override a researcher who doesn’t make the link to the drug and will say our drug caused this. But once the sinister left hand steps into the public domain the industry spokesperson will say there is absolutely no good scientific evidence our drug has caused this – by which they mean no statistically significant controlled trial evidence that our drug has caused this.

And if we don’t do the trial to look at this problem – who will? We of course can’t do such trials because it wouldn’t be ethical to do a trial to look for adverse events.

So even if all trials were registered, and none were ghostwritten, if you put poisons into the clinical trial blender you get fertilizer out the far end.

Doctors are increasingly faced on the one hand with people with clear and sometimes profound cognitive problems or profound weakness and fatigue on statins, or they are seeing people stop their statins and come back to life, while on the other hand the clinical trial evidence says these drugs have no problems. If doctors don’t prioritize the evidence of their own eyes over the clinical trial data they are going to go Blind. If the message they spin to patients is too at odds with reality, they are going to lose their patients trust - see Nearly Invisible. Evidence Based Medical Nemesis.

The very minimum ask for doctors and scientists is all the data (the CRFs). There can be no compromise here. Settling for redacted CSRs is a worse outcome than absolutely no access at all, because the redactions are primarily adverse events. Redacted CSRs will reinforce the message of efficacy and lead to greater prescribing. when the simple fact of redactions should bring prescribing to a full stop.

An Unparalleled Scandal

Its difficult to see why we wouldn’t boycott their brands if companies don’t make the adverse events available.

Companies withhold the data on the basis of informed consent forms patients have signed. This cuts two ways. No doctor prescribing a branded pharmaceutical at present can be doing so with informed consent. They simply cannot tell the patient to whom they are giving a brand what the risks of taking that brand might be.

There is no need to boycott all drugs – one key brand might be picked.

Company clinical trials could be boycotted, unless their consent forms required data access. In the absence of access to the data, these are not the scientific exercises they once were. In the absence of access to the data everyone participating in a clinical trial puts anyone who might later take that drug in a state of legal jeopardy. See Healy D (1999). Clinical trials and legal jeopardy. Bulletin of Medical Ethics 153, 13-18.

This withholding of data on the part of Andrew Witty (AW1) and colleagues is a far far greater scandal than Andrew Wakefield (AW2) ever was.

AllTrials is probably still the group best placed to call for a boycott. But the ambiguities come to a head here – it has a track record of picking on a minnow like AW2 while partnering a science troll like AW1.
Dan Markingson

Meanwhile, if you are concerned about these issues a great petition to sign, or cause to donate to, is the Dan Markingson petition – here.

Dan Markingson was killed in a University of Minnesota clinical trial – but his death we are coming to realise is just the tip of an iceberg of RCT deaths and injuries. These are the new Disappeared in a Dirty War. See Brand Fascism. This is what Pharma are most keen to hide,

Dan Markingson should be the note to end this post on, except this would let GSK and Astra-Zeneca off the hook, so we’ll return to DM at the end the series of posts.

Follow the Patient

Meanwhile we need an analysis of how the mess we live in has arisen and an account of what this means in patients’ lives. A good analysis would point to things that can be changed. It would get us beyond questions about whether clinical trial data should be downloaded or viewed through a GSMA-ESK scope.

There needs to be a recognition that patient confidentiality is a code for adverse events. Companies have little interest in your confidentiality or mine, they are primarily concerned to avoid information about adverse events coming to light.

Follow the money is a great lead for analyzing business. Follow the data is the key to analyzing science. In medicine, the patient is the data and the message is Follow the Patient."

 
 Respond to this message   
admin

"Sense about Science: Follow the Lawsuit"

June 17 2014, 8:57 AM 

http://davidhealy.org/sense-about-science-follow-the-lawsuit/

"Sense about Science: Follow the Lawsuit
June 16, 2014 9 Comments

Editorial Note: This is a third in a series of posts about Sense about Science and Access to Clinical Trial Data that began with Follow the Rhetoric and followed up with First Admit no Harm.

There are some facts in the last few posts. There are also some extrapolations that may not be right.

Tracey Brown has gone on the Parliamentary Record to make clear what AllTrials are asking for – its not the data and not even full Clinical Study Reports. If This is the AllTrials position, it is easy see why GSK felt they could sign up. Even ghostwriting companies have signed up. But perhaps AllTrials have moved on.

It may be that the GSK periscope is an invention of subversives within GSK who saw a way to persuade AW1 that this would block access to the data for ever – all the time intending to gradually make it more and more user friendly and accessible. Perhaps AW1 is the mastermind trying to leverage things forward.

Partnering Pharma

I’ve been a consultant to pharma and an expert for both plaintiffs and pharmaceutical companies in lawsuits. These contacts definitely bias me – as much by virtue of the people you meet as the money you might be paid. Under oath when asked if I’m biased I have always said yes – absolutely.

But I’ve never thought when it comes to science that it matters whether I or anyone linked to RxISK are moral or even nice people. Science might be better served if I’ve got some strange biases or am being paid to try and find the flaws in an argument. The key thing is access to the data, and given access to the data the more biases the better. Sometimes it takes a true weirdo to see how the data hangs together.

Being motivated whether because you have suffered an adverse event or because you’re being paid makes a difference to the effort you put in to solving problems. But at the end of the day, if you aren’t free to access the data it’s not science. If you’re a doctor and accept not being given access to the data – such as all doctors and statins – that’s quackery not medicine.

Science moves ahead, when people with different biases have their views challenged by the data. This is the very definition of science as opposed to philosophy or the humanities or business.

Medicine moves ahead when things happen to patients and when doctors and patients work to understand what has happened.

Business would likely do better in the long run if it built on this framework of doctors and patients working together to generate new knowledge. But instead at the moment business is not open for business on this issue. Why?

Study 329 & The Lawsuit that Didn’t Bark

Linked to Peter Doshi’s RIAT initiative, a group of us are working on re-authoring Study 329 – close to the most famous RCT of all time. In this study GSK’s paroxetine (Paxil) was compared to imipramine and placebo in a group of children.

Those of us taking on this re-authoring job were among the first to be introduced to the GSMA-ESK scope – a periscope for looking at the data on which the GSK seagull regularly sits blocking the view.

The periscope gives the outside world the illusion GSK are offering transparency but it’s not meaningful transparency.

But periscopes are not the crux of the matter.

Damaging Children

Children became suicidal on paroxetine in Study 329.

Before they had the results of Study 329, GSK had seen patients in clinical practice and clinical trials become suicidal and homicidal on paroxetine where the company had coded the event as caused by their drug. They knew the profile of what happens when an SSRI causes a problem. In their adult trials from the late 1980s, there was a doubling of the rate of suicidal acts on paroxetine compared to placebo.

They have run clinical trials that use the fact that paroxetine caused people to become suicidal to hide the fact that paroxetine caused people to become suicidal.

In breach of FDA regulations they had moved wash-out suicidal acts into the placebo column in clinical trials to hide the problem.

But in public, they have consistently denied there is a problem.

In Study 329, paroxetine didn’t work and wasn’t safe. Sally Laden ghostwrote the 329 paper and made paroxetine safe and effective. There were 22 authors on the authorship line, possibly none of which barring company personnel had seen the full dataset.
Informed Consent?

The consent form says that in this trial you will be treated in just the same way as you would in normal clinical practice. Even from the protocol it was clear this was a lie.

The children taking imipramine were to be force titrated to 300mg where possible – this is just not normal clinical practice. This is double the standard dose for adults. It’s dangerous and seems designed to make imipramine look worse than paroxetine.

Even so imipramine wasn’t worse than paroxetine. There was a statistically significant elevation in the number of children on paroxetine who had a suicidal event in this trial alone compared to placebo.

In normal clinical practice if someone becomes suicidal on an SSRI it would be usual to make the link for them and tell them that in future they should try an antidepressant from another group. They are much more likely than the average person to become suicidal if exposed to another SSRI.

If the drug has caused the problem, it’s very important to their self-image that they know this. They are being done a further injury, in this case an unnecessary one, if this information is withheld from them.

Have any of the children who became suicidal on paroxetine been told that paroxetine may have caused their problem?

No.

Whose Baby is it?

GSK say it’s the doctors – the non-authors of the paper – who know these children, whose responsibility it is to say whatever needs to be said to any of these children.

These are doctors who refuse to retract a paper that has been deemed fraudulent by New York State Attorney General Elliott Spitzer’s office. (Elliott Spitzer of Good Wife fame).

To come full circle, this is the paper that led to the data access story we have today. In response to a fraud charge in 2004, GSK agreed to post the CSRs on the company website in downloadable (non-periscope form).

Without Study 329 and the subsequent fraud charge and later $3 billion fine, GSK would likely never have felt the need to sign on to AllTrials.

Tomorrow and Tomorrow and Tomorrow

This is not a piece of history. This is our future.

Right now today GSK are refusing to tell the children who have been injured by their drug in Study 329 that they were injured by their drug. Tomorrow GSK will do the same and tomorrow and tomorrow.

Their drugs never injure people.

The reason GSK, Pfizer, Lilly and AbbVie don’t want anyone to get access to the data is so that no-one can access the damage. No-one can find out about the Dan Markingsons who die or are injured in company trials.

They are not doing this out of a concern for Dan Markingson’s confidentiality. They are doing it in order to avoid being sued.

This, Ben and Iain, is why I think GSK are playing the confidentiality card.

What do you think? And what should we do about it?

The Cowardice of a Pampered Society

Tracey Brown and Dick Taverne of Sense about Science (SAS) have a publication:

Over-precautionary Tales: The precautionary principle represents the cowardice of a pampered society.

Is this Sense about Science?

What would the real SAS – the Short Arm Squad – say?

See SAS to Lisbeth"

 
 Respond to this message   
 
  << Previous Topic | Next Topic >>RETURN TO MESSAGES INDEX  


Visit RxISK ORG from Data Based Medicine
'the first free website (not sponsored by big pharma or advertising) for patients
and their doctors to research, and more importantly, easily report drug side effects'.