Patients at risk after scientists withhold test results from clinical trials of new medicines

  • Test results are deliberately hidden
  • ‘These changes have long been called for, and delay has already caused harm’, say BMJ authors

By
Sadie Whitelocks

Last updated at 2:07 PM on 4th January 2012

The British Medical Journal has raised concern that some test results are deliberately hidden

The British Medical Journal has raised concern that some test results are deliberately hidden

Missing data from clinical trials could endanger patients, health experts have warned.

The British Medical Journal has raised concern that some test results go unreported and are deliberately hidden, enabling pharmaceutical firms to make unfounded claims.

Commenting on the findings, Dr Richard Lehman from Oxford University and the journal’s Dr Elizabeth Loder stated that more effective regulation is needed to prevent this trend.

They called for an end to the ‘culture of haphazard publication and incomplete data disclosure’.

The medical publication released several papers looking into the problem of unpublished data, and highlighted that missing data ‘distorts the scientific record’ and undermines the ‘whole endeavour of clinical medicine’.

Dr Lehman and Dr Loder continued: ‘Clinical medicine involves making decisions under uncertainty.

‘Clinical research aims to reduce this uncertainty, usually by performing experiments on groups of people who consent to run the risks of such trials in the belief that the resulting knowledge will benefit others.

‘Most clinicians assume that the complex regulatory systems that govern human research ensure that this knowledge is relevant, reliable and properly disseminated.

‘It generally comes as a shock to clinicians, and certainly to the public, to learn that this is far from the case.’

One U.S. study from Yale University found that fewer than half of the 635 National Institutes of Health funded trials were published in a peer-reviewed, medical journal within 30 months of trial completion.

Lead researcher Joesph Ross said: ‘Physicians and policy-makers generally depend on peer-reviewed publications to learn about clinical trial findings.

‘However, extensive research has shown that the results of studies are often not shared publicly in a timely way.’

More robust regulation and full access to the raw data, is now being called for to ensure greater transparency.

BMJ authors stated that those who deliberately hide findings ‘have breached their ethical duty to trial participants’.

The pair concluded: ‘These changes have long been called for, and delay has already caused harm.

‘The evidence we publish shows that the current situation is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine.’

The BMJ has previously attacked the drug industry for being slow to publish data from trials of drugs in development, and also from trials of medicines already licensed and on the market.

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Champix/Chantrix comes to mind immediately. GSK claimed the data on the horrendous side-effects had been “misfiled”.

Doctor’s also hide side effects! Some are too busy or cannot be bothered to check!

It is about time. Never opt for any ‘new’ drug, over and over again ‘new’ drugs are touted and eagerly taken only to gradually have the adverse effects and death stories creep into the news until warnings are added or the drug is pulled from the market.

The pharmaceutical companies have been doing this for years, many medications on the market have had scary results in clinical trials and left people with organ failure, mental problems or even dead , these have been cleverly skewed or omiitetd to rush profit making drugs onto the market…disgusting!

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