'All Trials': because no test should go unheralded

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.

Every day people use pharmaceutical products in good faith, believing they are safe and effective. Medical professionals in turn condone products based upon what they believe to be Evidence Based Medicine, published in medical journals. This also has a direct bearing upon government health policies.

But if this turns out to be little more than the work of pharmaceutical PR professionals, consumers, medical professionals and policy makers are effectively playing a vast game of Russian Roulette. The Vioxx debacle, which saw a major pharmaceutical company withhold information from doctors and consumers for up to five years, and resulted in tens of thousands of deaths, is an extreme example of what can happen if we don't get this right. But it may also be that billions of dollars are being wasted on products that don't work as well as doctors and patients have been told they do; or symptoms may be worsened by some; or whole new medical problems may be being created by others. Right now we just don't know.

It may be that we will have to rewrite a great deal of what we think we know about medicine. And if that is the case, we need to start right away. No one wants to look back and say "We should have acted sooner!"