Background – page 2

Warnings ignored

During a long evening Healy explained what they showed and transformed my view of the drug industry. I guess it was the equivalent of chatting to a renegade banker ten years ago about the reality behind credit default swaps. Like most people I vaguely assumed the industry was carefully regulated with patients’ well-being and safety paramount. But a very different picture rapidly emerged.

He explained that even though companies had known about the suicide problem, any trials that revealed it were simply not published. Even though there was an easy way to avoid it – put a patient who shows signs of agitation after starting the drug on a tranquiliser – this advice was not passed on to doctors because it would mean admitting to the suicide risk.

Even worse the German regulator had insisted on including such advice with every pack of the pills but UK and USA regulators had not been informed of this. Experts knew there was a problem because there had been a number of USA court cases but the strategy was to settle them out of court and get the plaintiffs to sign a gagging order to prevent the details from becoming public.

The UK watchdog the MHRA certainly knew about it because he had repeatedly warned the agency and he showed me a thick file of correspondence to prove it. However their response was to stonewall.

Story of deaths concealed

After that I worked on several features about the story and was told authoritatively by one company spokesperson that Healy was an unreliable maverick who was making a big mistake because he didn’t know how to read the data. Healy’s outspokenness came at a personal cost. In the early 2000s an offer of a top job running a psychiatric research unit in the States was pulled following drug company intervention.

However the whole story eventually became a public scandal about five years after my evening with the boxes as the result of a Panorama investigation in 2004 

This revealed that data showing that children were at more risk of committing suicide on the drugs than on a placebo had been hidden for years. It also reported that thousands of web reports of suicide had just been ignored and that far from being totally non-addictive, has had been claimed for a decade, 20% of patients had withdrawal problems.

All of that was bad enough but it soon became clear to me that the failure to warn about serious risks was not a one-off. It was the way companies regularly dealt with such threats to sales.

Shortly after two Panorama investigations into SSRIs it emerged that the makers of the anti-inflammatory painkiller Vioxx had also hidden data, this time about a raised risk of heart disease. Again it had been suspected from the beginning and again academics who spoke out were threatened and intimidated. {Continues: Mind the gap…}