…“The process of using this interface for analysis is unnecessarily maddening and a severe obstruction to the task”..
Does Ben Goldacre really believe that a multi-billion dollar corporation like GSK can’t provide an easier, more technologically advanced, and productive route- for researchers to access their data?
GSK are taking the absolute piss out of Alltrials, the BMJ, the entire scientific and medical community, and the public at large, with their ‘transparency charade’ but most of all they are harming patients -and that is utterly indefensible… the system GSK have in place is obviously a deliberate attempt to block researchers gathering data properly…
…as a member of the RIAT team who was granted access to the Data from Paxil Study 329 to do an independent reanalysis by GSK, we’ve now had months of experience working with their “remote desktop” interface as a portal to their information. It is a single windowed multiple document interface, totally self contained that can’t be accessed by any software other than that provided inside the window. Multiple passwords are required multiple times for access, and on some days, one is frequently thrown from the system without warning, necessitating repeated logins. There’s another internal window from SAS that contains the data and allows one to run SAS programs to analyze the data. The data is also provided as text-based CSV files that can be moved outside the internal SAS window and displayed in spreadsheets [Open Office is provided]. The open source statistical program, “R” is also provided. In our case having no-one fluent in SAS procedures and programming, we are using “R” which has the necessary statistical functions. Getting the data into the proper format required by “R” means using multiple spreadsheets – which is very difficult in the cramped space provided – sometimes taking days and involving many “start-overs.” Once the data is analyzed, one can only export non-data containing files with results, and that’s only by application for approval. Using the primitive graphing functions of Open Office or “R’ in the “remote desktop” is very difficult and the graphs can’t be exported. That finally lead us to copy the information for the graphs by hand to get it into the computer proper to create our images. The process of using this interface for analysis is unnecessarily maddening and a severe obstruction to the task.
The original hand written CRFs are provided as PDF documents. In our case, there are some 275 subjects, many with several pdfs, each pdf containing 200+pages. In the interface provided, we can see only one page at a time of the nearly 60,000 pages. Tallying the adverse events from the pdfs is hard enough work, but doing to without being able to make printed copies and referring back and forth is a double nightmare, requiring days of wasted time, and delegation is impossible. Working inside of this little window brings home how important it is to have a workspace that allows simultaneous display of lots of information, and this isn’t it. One of our team has lost one assistant already over this interface. The EMA’s decision to even consider using this kind of interface is at best, ill advised, and a negation of the initial promise of Data Transparency. If I weren’t retired and instead had a job to do, I don’t think I could do it. If I were a graduate student given the task, I might go to the chairman of the department and ask for another major professor. It’s impossible to imagine that anyone contemplating this decision who knows the ins and outs of data analysis has tried it out in this kind of environment. As I said before, it’s like going to sea to see the world in a submarine, looking through a periscope.
GSK have received a lot of good press over the past year for their promises of transparency and access to data. They received particularly glowing praise by Ben Goldacre (author of Bad Pharma). However, no real transparency has actually occurred. Even if GSK did fulfill their promises- for Seroxat users and ex-Seroxat users- damaged by the drug- this will be of no use-whatsoever because GSK said they will only be giving (controlled) access to data post-2000 therefore that leaves out Seroxat data (and data for many other dangerous/dubious GSK drugs). So much for transparency!…
Good PR though..
To what extent the Glaxo effort will take hold remains to be seen. Nisen says the drugmaker has, so far, received 10 proposals and about 100 inquiries for data. Already, though, Glaxo has encountered criticism. For one, there is concern that its independent panel, which was established to review data requests, is not fully independent, if only because one member previously worked as a consultant to the drugmaker (see this). Glaxo has refused such assertions.
Separately, the drugmaker is haggling with a group of researchers who want clinical study reports for an infamous study of its Paxil antidepressant. They maintain Glaxo has balked at the request and has raised doubts about its commitment to releasing data. In the process, the dispute has raised questions about whether Glaxo complied with a 2004 consent order with the New York State Attorney General to publicly disclose the Paxil trial data (more here).
Peter Gøtzsche says that psychiatric drugs are the worst killers of patients world-wide.
“what I have seen in psychiatry is the worst I have seen anywhere”…
Three days ago I wrote a blog post titled: “Would The Real Ben Goldacre Please Stand Up?”. The gist of the blog post was a general illustration of how people (particularly doctors, psychiatrists and academics) can be seduced and manipulated by the pharmaceutical industry. I used Ben Goldacre as an example because quite frankly- his stance on the pharmaceutical industry confused me. On the one hand- he writes about drug company corruption and advocates for better access to clinical trail data- but on the other- he accepts awards from GSK (one that I am aware of anyhow) and gushes undue praise on the management of the company (GSK ) that he criticizes in his books.
I find this attitude baffling. I really do.
I understand that there are obvious overlaps within the pharmaceutical world between the industry, regulation, academia, universities, marketing and science etc. It is common for scientists and academics to receive bursaries and funding for research (particularly early on in their careers) and this doesn’t always mean that a conflict of interest, a bias, or corruption comes along with that -but what really frustrates me is how the industry (and those attached to it) doesn’t seem to see anything wrong with this generally. It’s as if there is an attitude of- “it’s so rampant and ingrained” that they wonder why anyone would question it? The attitude seems to be- “everyone has either done it- is doing it- or will do it” so what’s the problem?
And herein lies exactly the problem…
Because it is so widespread: this forms the crux of the problem! Industry has too much power and influence. That’s the problem!
Companies like GSK have their monetary tentacles in literally every facet of UK society. Globally they are powerful too- but it is on their home-turf where they are virtually untouchable. They basically operate above the law.
Why is this?
It’s simply because they are the UK’s biggest drug company (and second biggest globally)- they are massively important for the UK economy- not just in terms of jobs in research, development, factories etc- but also in terms of what they donate to, support, and sponsor in regards to universities, science, scholarship etc. They are massively influential. Too influential.
Often it is difficult to entangle who is indirectly being funded by pharmaceutical companies because they can sometimes donate to organizations (patient groups, astro-turfing) who then funnel funding through to different people and on to individuals. And then we have the problem of who owns stocks and shares in companies like GSK? How does that influence policy? How much influence and power do GSK have over politicians, the government, regulation, academia, etc etc etc.
From what I have researched- GSK have immense power in the UK. Too much power.
This wouldn’t be a problem if GSK were an ethical and moral drug company who cared about patients before profits. But, alas they are not. They are just simply not ethical and they have never given any reason for us to believe that they ever will be.
I could rattle off dozens of instances of GSK’s unethical behavior but I won’t as I have almost 500 blog posts documenting that.. and I think anyone who knows the industry would have to be aware that GSK are amongst the worst offenders of corporate crime of recent times…but anyhow all that has been documented on this blog and all over the web so I won’t talk about that now…
But what I would like to talk about is Ben Goldacre’s comments on my blog-post.
I did not expect Ben Goldacre to comment on the blog-post and I was surprised when I noticed views coming from the Guardian. I did not expect the comments after the post to turn into something of a debate either. Furthermore, I honestly have had little interest in Ben Goldacre until recently. I was aware that he was involved in Alltrials and wrote Bad Pharma, but it wasn’t until I began to think to myself that he was possibly being manipulated by GSK that I started to research stuff online.
I don’t think that Ben Goldacre is corrupt at all. Not in the slightest bit. I think his heart is sincerely in the right place. I honestly think he is one of the good guys and I think he genuinely wants to do the right thing, but I do think he could be being misled by GSK and I think it could be precisely because of his trusting nature that GSK have endorsed him and his Alltrials organization. I also think GSK are cynically using his celebrity and popularity for PR purposes – and I hope Ben begins to see that too, or at least becomes a little aware of it…
That’s just what I think and that’s my opinion- and that was the purpose of the blog post. I hope I am proved wrong and that GSK will give access to all their trials- particularly the raw data- nobody would like that more than me- it’s what I have been calling for – for several years on this blog! I was prescribed Seroxat and I would love to know what GSK have hidden about that!
However, I have been scrutinizing GSK for a long time now- and I just do not trust them- nor will I ever -and I think it’s foolish to approach them with anything but mistrust and caution. They have broken every promise in relation to trial data so far so it is likely that they will not change their policy now, or they will find a way around all this… they always do. If they do give data it will be on their terms- they will not do anything that goes against their interest- they never do.
I could go on and on about how corrupt, fraudulent and criminal GSK are but everyone knows that- or at least they should!
But I would like to sincerely say to Ben..
and if you would like to contact Bob Fiddaman – he has information that he would like to pass on to you- it might help..
E-mail him here:
Good luck 🙂
Very interesting article and videos over on Forbes interviewing GSK’s CEO Andrew Witty. I find if laughable how Mr Witty claims he wants to clean up the industry image (particularly Glaxo’s) in light of the fact that he has ignored Janice Simmons of the Seroxat Users Group– and others who have contacted him in regards to addressing the continuing Seroxat controversy (such as Dr David Healy).
Sir-Andrew-Witty (David Healy Letter)
In a word….
Also just to correct Forbes… (Witty worked in a high level position in GSK so to claim that just because the majority of corruption and fraud pre-dated his tenure doesn’t mean he wasn’t aware of it! and also… The China fraud did not pre-date his tenure! Therefore is it not surprising why he refuses to comment on it!)
“But Witty’s tenure has not been scandal-free. In 2012 Glaxo paid a record $3 billion in a health care fraud case, but for misdeeds that predated his tenure. Witty issued a statement expressing the company’s regret and saying it had learned from its mistakes. This summer, new charges emerged relating to bribery in China. Witty couldn’t comment on the allegations…”
As far as ‘transparency’ is concerned…
David Healy has highlighted this GSK PR ‘smoke-screen’ many times on his blog…
“The joke has turned extremely black. This is almost exactly the mechanism Andrew Witty has just proposed for GSK’s data – to warm applause from the BMJ”
Witty is extremely skilled at deflecting the scandal in China, he is a veritable corporate robot- propaganda and PR spin just oozes off his lips… he says:
“First of all obviously i’ve been very disappointed to see the events and the allegations of the past several months in China and we’re committed to working with the authorities to try and resolve this as soon as possible. I think, though, it can’t knock us off course from what our primary mission is which is really to try and make sure that as a company we really contribute the most we can to society.”
GSK’s primary mission is to make profits, it was the same during JP’s tenure, it’s the same in his tenure and it will never change. GSK will attain profits any way it wants to- even at the expense of people’s lives. It’s a business model that works for them. The only difference between Witty and Garnier is Witty is smoother and less blatant about his arrogance. He is so smooth in his PR speak that he is almost convincing. Almost… but he doesn’t fool everyone…
Come on Mr Witty, take a ‘humility pill’ (as you put it) and do the right thing… address the Seroxat issues.. or at the very least apologize…
Guardian News and Media/London
Drug companies and medical researchers are putting patients’ lives in danger by failing to publish unfavourable results from clinical trials, MPs have warned.
The lack of transparency means many trials are not registered before they are done, while results are held as private documents that cannot be scrutinised by patients or independent experts.
The practice skews the information that is available to doctors because trials that show new experimental drugs in the best light are more likely to be published, and results that could prevent harm or save patients’ lives may never see the light of day.
Often, trials that indicate a new treatment is not effective are never published.
In a report delivered to ministers, MPs express dismay at the government’s efforts to tackle the problem and set out concrete proposals to make data from clinical trials more openly available.
“Many of the trials taking place today are unregistered and unpublished, meaning the information that they generate remains invisible to both the scientific community and the public. This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk,” said Andrew Miller, chair of the Commons science and technology committee.
The MPs’ report broadens the traditional battleground over clinical trials data to include academic researchers who fail to publish studies of companies’ drugs or other medical interventions. The pharmaceutical industry is under intense pressure to release more clinical trial data, and some companies, such as GSK, are already committed to greater openness.
But the MPs call for government action to speed the process, by requiring all future trials to be registered, and summaries of trial results to be made public. More detailed “clinical study reports” should also be released, with redactions to protect patient privacy, when they have already been prepared for regulators.
In another recommendation, the MPs urge the government to demand the registration of past trials too, with summary results released for all publicly funded trials since 2000. Failure to release clinical trials data has led to hefty fines for some pharmaceutical companies.
In 2004, GSK paid $2.5mn to settle a consumer fraud case during which it emerged that the company had lied about the safety and effectiveness of its antidepressant Paxil, also known as Seroxat.
But academics are also guilty of suppressing data that could have helped patients. In 2006, six volunteers suffered severe reactions to an experimental drug called TGN1412 in a trial at Northwick Park hospital in London. An inquiry into the incident found that a single patient had suffered the same catastrophic reaction after taking a similar drug, but the scientists had never reported the findings.
Scientists estimate that half of all clinical trials that have been completed have never been published in academic journals, and trials with favourable results are twice as likely to be published as others.
“There have been these examples of publication bias which have resulted in lots of people suffering and dying unnecessarily, which somehow people haven’t taken seriously,” said Iain Chalmers, co-ordinator of the James Lind Initiative at Oxford University, which lobbies for better trials.
Birth Defects, Suicide, Aggression, Withdrawal? …What other Seroxat side effects have GSK concealed in their clinical trial cupboards?
GSK’s Manifesto: Voyeurs of the World Unite!October 9, 2013 3 Comments
Editorial Note: There is a widespread impression that the pharmaceutical industry are split on the issue of access to clinical trial data with the bad guys like AbbVie taking legal actions to block access and the good guys like GSK in favor of transparency. An editorial like this one from GSK’s James Shannon in the Huffington Post on September 3rd might support such impressions. See Neal Parker Avoiding Adverse Events.
Nothing could be further from the truth. A recent House of Commons report on Clinical Trials in the UK, which entols the supreme virtues of GSK at every possible turn, contains the following summary recommendation:
“We are not in favor of placing anonymized individual patient-level data (IPD) in the public domain in an unrestricted manner… specific individuals should be provided with controlled access to IPD through carefully managed and secure “safe havens”. Access should be facilitated by an independent gatekeeper responsible for ensuring that the data … makes a useful contribution to scientific understanding”.
This is GSK’s preferred way to deny access to the data written into a House of Commons recommendation. In practice, as outlined in April Fool in Harlow. GSK are offering an opportunity for voyeurism rather than the full-bodied engagement with the data that is science.
Several researchers are at present attempting to write up GSK’s most famous ever clinical trial – Study 329, a study of Paxil given to children, that led to charges of fraud from New York State and contributed to GSK’s recent $3Billion dollar fine. Despite an undertaking given to the Courts to make the data from this study available, GSK are currently refusing to do so – requiring investigators instead to apply through their “safe haven” which seems exquisitely designed to make it impossible to establish what the data actually shows. See Reading the RIAT Act. This is a space to watch.
You’d never guess at GSK’s stonewalling tactics from James Shannon’s editorial below. This editorial suggests the company is supremely confident it has successfully pulled the wool over the eyes of academics and politicians – as suggested last April Fool’s Day – See April Fool in Harlow.
Unlocking Access to Clinical Trial Data – what are we afraid of? James Shannon, GlaxoSmithKline’s Chief Medical Officer. Huffington Post 03/09/2013 Today thousands of people all over the world will take part in clinical trials. Why do they volunteer, willingly sacrifice their time and in some cases experience discomfort and inconvenience? Of course there is the hope that perhaps they can benefit from the medicine under the microscope. But they also do it to contribute something to the wider population – the hope that they can play their part in developing new medicines for diseases like cancer or Alzheimer’s disease that we are still trying to tackle. And I think they expect something else – when that trial is over, regardless of whether it results in a new medicine on the pharmacy shelves, they expect that the data gathered – their contribution – will be used to help others, to drive forward discovery through the scientific community learning from research already undertaken. In recent months the words ‘data transparency’ have found their way into our vernacular, with calls for pharmaceutical companies to be more transparent about their research and to publish results from all their clinical trials. The pharmaceutical industry has been the source of a great many advances and there are many people in the world today living longer, healthier lives because of the medicines researched and developed by the industry. But despite this, it is an industry which still draws criticism and concern. Historically, being open and transparent aren’t traits the industry has been famed for. We haven’t always done a good enough job to be transparent so that people trust and feel proud of how we operate and what we achieve. Increasing transparency about our research is a critical area we’ve been pursuing at GlaxoSmithKline for almost a decade. In 2004 we launched an online study register which means visitors to our website can see any trial that we are running or are about to start. We also post every set of results here, regardless of whether they are positive or negative. Since then we’ve taken more action to increase the information we share, culminating this year with our commitment to disclose detailed reports of our studies and support for the AllTrials campaign, led by Sense about Science and British doctor, Ben Goldacre. We’ve also launched a new website allowing scientists to request access to the very detailed, anonymised patient-level data sitting behind the results of our clinical trials. This will mean independent researchers, with a fresh perspective, can conduct further research which could advance medical science and improve patient care. It’s inevitable that some will still worry that we are hiding something. Honestly, we’re not. GSK is not alone in its drive to increase transparency, as we have seen from the growing support for the likes of the AllTrials campaign. It is obviously for others to decide the approach they take in this space but it is certainly an issue that has captured the attention of not just pharmaceutical companies but academic and public institutions carrying out research. So what could we possibly be afraid of? Concerns have been raised about greater transparency introducing a competitive disadvantage. We don’t see it. People have asked me, “what if a new side effect comes to light for one of your medicines? Or what if a scientist discovers that you made a mistake in your research?” My answer back is “why wouldn’t we want that to happen? Isn’t it better that we know? There is always the potential for us to find a better way to do things.” We still need new treatments to tackle diseases and there are still many scientific unknowns that stand in the way of us developing those treatments. Who knows? Perhaps increased transparency in clinical research and the sharing of knowledge and data will help solve some of our trickiest scientific questions. We hear from scientists that making more information available will be incredibly helpful – it will enable them to study the science behind today’s medicines more closely, combine data from different studies and look at how medicines can best be used. Ultimately this has the potential to improve patient care, which can only be a good thing. There is more to be done. All those carrying out clinical research, whether they are companies like GSK, academic institutions or other research organisations, have a role to play in ensuring information from their clinical trials is made publicly available. There is also a clear need for a broad, independent system to be created where researchers can access data from any trial from multiple companies and organisations. We want a truly independent organisation from the public or charity sector to take on the oversight of this and make it a reality as soon as possible. There is a lot to be gained by having that transparency at the core of how we work. I think science, society and, most importantly, patients, will be better for it. [As for scientists we figure they’ll get by looking]. –