Published On: Sun, Dec 8th, 2013

‘All Trials': because no test should go unheralded

If you have ever used a pharmaceutical product, or if you are a healthcare provider, you need to read this article. At the end of it you may well be shocked into a major paradigm shift.

Baz Bardoe (OLO) , – When most people use a pharmaceutical product, they assume that it has been independently tested, and found to be safe and effective before being released onto the marketplace. But the reality is very different. In some cases drug companies finance clinical trials and only selectively release data and reports that support their marketing goals. And many of the reports in medical journals which medical professionals rely upon to reach opinions about pharmaceutical products, are written by people with financial links to drug companies. In some cases reports are even being ‘ghost written’ by people employed by pharmaceutical companies. In short, medical literature and data is massively compromised by pharmaceutical marketing.

VaccineIf this seems like some preposterous conspiracy theory then consider the work of Dr Peter Doshi and the independent Cochrane Collaboration which should give us pause for thought. “The current system……. is one in which the meager details of clinical trials published in medical journals, often by authors with financial ties to the companies whose drugs they are writing about, is insufficient to the point of being misleading“.

And then there’s the even stronger position of epidemiologist Dr Ben Goldacre, as reported in The Guardian. “The decades-old industry practice of suppressing scientific evidence (and some independent researchers doing the same), leads Goldacre to declare that nothing we know about modern medicine should be assumed to be correct, and he makes the urgent case for forcing the release of all that pharma dark matter so scientists can re-run the numbers and work out what actually does work.”

Statements like this are sending shockwaves through the medical establishment, and with good reason. But as Goldacre indicates, it is an issue that has been brewing for a long time. Writing as editor of the prestigious medical journal ‘The Lancet’ in 2002, Richard Horton stated that “a study of the interactions between authors of clinical practice guidelines and the pharmaceutical industry……… found serious omissions in declarations of conflicts of interest. Almost 90% of authors received research funding from or acted as consultants for a drug company. Over half had connections with companies whose drugs were being reviewed in the guideline, and the same proportion indicated that there was no formal procedure for reporting these interactions.” He also wrote in 2004 that “journals have devolved into information laundering operations for the pharmaceutical industry”.

Clearly there is a problem. A very serious and shocking problem that goes to the core of which pharmaceutical products are safe and effective, and those which are not. And there is no doubt that consumers, policy makers and medical professionals alike have been consistently misled. Which brings me to the ‘All Trials’ initiative and Dr Peter Parry, a child and adolescent psychiatrist, and senior lecturer at the University of Queensland. All Trials is an initiative which began in the UK in January and is now attracting widespread support from the medical community there. Dr Parry is a staunch supporter and would like to see it gain traction here as well. He explains:

The ‘All Trials’ campaign calls for all clinical trials to be registered on a regulated and enforced website and the methodology and results of the trials to be published on the website so that researchers and journals can be sure of the data and the context of the data. In other words to make medical science transparent. There is a lot of detail to pin down the process and make it enforceable because voluntary and semi-voluntary systems such as just aren’t working. So the AllTrials website has a full explanation on their website if you follow the link “why this matters” and then “more information”.

Parry believes that the problem of pharmaceutical company influence on clinical data is pervasive and long standing.

The problem has been bad for a long time. It has been getting a little better in recent years, but only a full overhaul of the system – in other words the “AllTrials” process – can truly rectify things. I am mainly aware of my own specialty of psychiatry. In the last 3 or 4 years there has been a shift in awareness within the profession. Previously there was a collective view that the few “radicals” who were complaining about the overly cosy relationship with Pharma had a point but were exaggerating. However now I think the collective view accepts that the outspoken members of our profession have had a valid and vital point – our whole “evidence-base” for our clinical, research and teaching practice has been compromised. To what extent compromised is hard to say – and that is precisely because of the lack of transparency with the data. Some research and guidelines could be based on fully accurate scientific data – but we cannot be sure what is and what is not.

To an outsider this situation seems incredible and deeply shocking. It must have developed incrementally, but one wonders how it has been allowed to get to such a point?

That is a good question. Personally I haven’t researched the literature on the sociology of medicine-pharma relationship to be able to give a detailed answer. However my gut feeling and discussions with colleagues over the years is that doctors may be clever guys and gals but we are realizing we are not marketing savvy. Even in a specialty like psychiatry, where you’d think we should be wise to the possibility of subconscious influence and the power of persuasion, there must have been a lot of naivety and also not enough guarding against having one’s narcissism stroked in the past. Looking back, the level of advertising at conferences, the suave persuasiveness of the drug rep visits, using all the sophisticated psychology of marketing, seems outrageous – but surveys of doctors repeatedly showed that we thought we were above being persuaded and could remain rational, totally independent agents. In which case why did we even bother accepting all the marketing? Well, money has a lot to do with it.

But the overt marketing has been shown to be the lesser problem. The greater problem lies with what doctors always thought was the real science – the peer-reviewed articles published in the journals. It is interesting that Pharma have taken the increased restrictions on overt marketing with relative equanimity, but seem to have drawn a line in the sand over handing over the raw scientific data that the articles in medical journals are supposedly based upon.

There now seems to be an impetus towards demanding change. All Trials has gained huge support in the UK. But given how pervasive the pharmaceutical companies influence has been on the medical edifice, one wonders what has prompted the more recent demands for transparency?

I think the evidence simply became overwhelming that the academic medical literature has been severely compromised. Authors on articles in journals may not have had access to the raw data themselves, many it now seems were recruited late in the study and articles were “ghost-written” by undisclosed authors within or working for the pharmaceutical company. Authors usually signed commercial confidentiality agreements that restricted their rights to publish the data. I know a professor of psychiatry who was involved in half a dozen trials of an antipsychotic medication in a developing nation. He told me four of those trials were negative and the results never published, only the positive findings from the remaining two were published. He was appalled but legally could do nothing because of the confidentiality agreement he had signed. Behind the scenes these things got talked about and outrage gradually grew, too slowly to be sure, but thankfully it has reached a critical mass now.

Parry suggests the independent Cochrane Collaboration has played a big part in the push for change, but even they have found investigating the thousands of articles that may be compromised a bit like “sifting through mud”. The literature is simply too “opaque”.

The momentum has come from the UK, probably because of the Cochrane Collaboration’s base there but also because of the strong stance taken by the British Medical Journal. The previous chief-editor of the BMJ, Richard Smith, after he finished his 25 years as editor wrote an article in the high-ranking PLoS Medicine journal titled “Medical Journals are an Extension of the Marketing Arm of Pharmaceutical Companies”. And the current chief-editor of the BMJ, Fiona Godlee, said to a British parliamentary committee in 2013 that ‘drug companies should not be allowed to evaluate their own products’. This leadership, coupled with the energy and drive of British medical epidemiologist, Ben Goldacre seems to have super-charged the drive for change within the UK. The All Trials campaign started in the UK in January 2013 and quickly got most of the British medical specialty colleges and other prominent medical academic organisations signed up as supporters. The question now is will the rest of the world follow? I am glad to see that the College I belong to, the RANZCP, is now looking at the AllTrials proposal. Hopefully we’ll soon follow the British RCPsych and sign on for this game changing reform of the academic medical base.

Parry agrees with Goldacre’s view that if transparency can be achieved it will effectively rewrite the book on everything believed to be true in modern medicine.

He is right as I understand it, the AllTrials process would bring to light data and methodology from clinical trials going back years, as well as clean up the mess to provide an Evidence Based Medicine future rather than a Marketing Based Medicine one. As data comes to light about past clinical trials, then this may well shed light on current guidelines and clinical practices that need revising. Thus the implications are huge. AllTrials hopefully will mean we have a world of EBM and cost-effective medicine. There will be some red-faces, there is almost certainly a lot of fraudulent behaviour that may result in legal scrutiny. Many journal articles may need to be corrected or withdrawn and republished.

He cites the example of an infamous article published on the drug Paroxetine in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP). The article was sponsored by Paroxetine’s manufacturer SmithKlineBeecham, now known as GlaxoSmithKline (GSK) and is also known as “Study 329″.

The data and methodology of the clinical trial was released in a court case and shows that the published article markedly overstated the benefits of Paroxetine (strictly speaking it didn’t differentiate from placebo) but was published as being “generally well tolerated and effective for depression in adolescents. The sales pitch in the company advertising went further stating Paroxetine ‘delivers remarkable efficacy and safety in adolescent depression’. Worse still, the article suppressed data on suicidal agitation and other “serious adverse events” of the adolescents on Paroxetine………….Enough is enough, things have to change. Thank goodness for AllTrials and I hope it works. In my opinion any health professional not supporting it needs to think again.

Despite the importance of All Trials, Parry has been disappointed by the response in Australia to date.

Almost none of the colleagues I’ve spoken to know about it, including across other specialties and general practice. I asked friends at a recent medical school reunion and they hadn’t heard about AllTrials. However the Australian Medical Students Association signed up months ago, and good on them. Clearly they have an eye to the future! I’m hopeful though that the specialty colleges and the RACGP and our academic institutions such as the NH&MRC will follow their British counterparts soon.

Baz Bardoe, On Line Opinion – Baz Bardoe is a military officer, a PhD candidate and a journalist with material published in a wide range of publications including Popular Science, Defence Today and Australian Musician.

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