by Melayna Lamb
One of the comforting myths about the powerful drugs used in modern medicine is that they are prescribed on the basis of good scientific evidence. Proper randomised clinical trials, we are regularly assured, compare them with a placebo and the results can tell us which are safe and effective.
However this is an illusion. For nearly thirty years drug experts have known that there was a major flaw in this assumption, which doctors and the agencies set up to regulate drugs have chosen largely to ignore.
The problem is that the results of trials are considered the property of the drug companies that had paid for them. This means that they have been able to hide results that failed to show their drugs in a good light and publish the favourable ones.
Cultural and regulatory failure
So drugs you have been getting may well have been prescribed on evidence that is closer to advertising than to reliable scientific data. A House of Commons report published last Saturday described the situation as a: “longstanding cultural and regulatory failure (that) impacts on all of medicine and undermines the ability of clinicians, researchers and patients to make informed decisions and the best treatments.”
However thanks to a long-running and fairly obscure European legal case between drug companies and the EU regulators, a new age of enforced drug company transparency could be dawning. What this legal tussle has revealed is the extraordinary lengths that the pharmaceutical industry is prepared to go to protect their control of the “evidence”, including the claim that they have a right to hide details of harmful side-effects on the grounds that revealing them could hurt sales.
It all began several years ago when a researcher with the prestigious and independent research organization called the Cochrane Collaboration started asking questions about the ‘flu drug Tamiflu that had been bought by governments in large quantities in response to widespread fears of an epidemic of bird flu in 2009 that never materialized. The UK spent nearly £500 million stockpiling it and the USA $1.5 billion. This is what the House of Commons Public Accounts Committee was investigating.
The researcher, Dr Peter Doshi, simply wanted to know what every doctor and patient wants to know; does it actually work? And by work he meant does it reduce ‘complications’ associated with the flu – i.e. pneumonia and death. To do that he needed to look at the records of what happened to the patients given Tamiflu during the trials the company had run to get a licence. Without seeing all the data, positive and negative, it’s impossible to assess whether a drug is safe, effective or good value.
Effectiveness exaggerated by 115%
The distorted picture that comes from companies concealing evidence was vividly illustrated by an investigation by the German drugs agency IQWiG into all the data on just one anti-depressant (Reboxetine). It revealed that 75% of all trials had not been published and when they were included, claims for the drug’s effectiveness compared to a placebo overestimated the benefits by 115%. Last year the NHS spent £600,000 on Reboxetine in England alone.
So what Doshi wanted to see was all the results but Roche, the manufacturer, refused to let the Cochrane Collaboration or anyone else to examine them.
Instead the company had hired ghostwriters to produce positive articles about the drug which were then published in respected medical journals. These articles then formed the evidence that Roche’s used to drive sales. The company claimed this was simply ‘common practice’.
In 2010 Doshi’s demands finally triggered action from the EU ombudsman who stepped in and ordered the company to release the data to Cochrane. After all, it was quite possible that paracetamol, at a fraction of the cost, could work just as well.
The company continued dragging its feet but then the European Medical Agency (EMA) – the body responsible for licensing drugs – stepped in. The Agency holds large amounts of data on drug trials that had never been made public before, including that on Tamiflu. It made some Tamiflu data available and also began releasing data on trials of other drugs to researchers who asked. It looked as if the pharmaceutical companies were going to lose their extraordinary and damaging privileged position.