“Watchdog bans 14 prescription drugs over fear of multiple deaths”

Antony Barnett, public affairs editor
Sunday September 21, 2003
The Observer

Britain's drug watchdog has been forced to ban the use of 14 prescription drugs in the last five years after they were suspected of killing hundreds of people in the UK or harming thousands through serious side effects.

Official figures released for the first time highlight the growing number of controversial decisions made by the Medicines and Healthcare Regulatory Agency (MHRA), which gave the green light to the drugs in the first place. In some cases, concerns about the drugs' safety records were already known.

Last week the MHRA released data to The Observer confirming that the 14 drugs it has banned since 1997 have been cited as a possible cause in at least 71 deaths in Britain and more than 3,000 injuries. Because these 'adverse' incidents are only reported on a voluntary basis by a hospital or doctor, experts believe the true number of people killed by these drugs probably runs into several hundreds, with thousands more injured.

The disclosure of these figures will put further pressure on the agency, which was forced on Friday to announce a ban on the anti-depressant Efexor for children and adolescents with depression. The move came within months of a ban on under-18s taking another anti-depressant, Seroxat, after concerns that it increased the risk of suicide.

Most of the 14 withdrawn drugs were not emergency medications needed to save lives. Banned drugs included blood pressure medication Posicor, anti-cholesterol drug Lipobay, diet pill fenfluramine, tranquiliser Droperidol and heartburn drug cisapride. In total these are suspected of being responsible for almost 60 deaths in Britain and many hundreds worldwide. Other drugs banned since 1997 and suspected of causing deaths or serious side-effects include antibiotics Raxar and Trovan, diabetic drug troglitazone and anti-Parkinson's drug Tasmar. In some cases, safer alternatives were available on the market.

Consumer groups and other critics of the drug-licensing system are alarmed at how many dangerous drugs win approval in the UK and are later withdrawn after being linked to serious side- effects. In the five years prior to 1997, only six drugs had to be taken off the market.

They point to the fact the watchdog is funded by pharmaceutical firms and say it is too close to the industry it is supposed to regulate.

Wendy Garlick, principal policy adviser at the Consumers Association, said: 'The fact that the MHRA is entirely funded by the drug industry poses an obvious conflict of interest.'

In addition, out of the 36 members of the Committee on Safety of Medicines, which advises the agency on drug safety, more than 20 have declared interests with the pharmaceutical industry.

Charles Medawar, director of Social Audit, is a critic of the way drugs are scrutinised by the UK authorities and believes one of the problems is the 'excessive secrecy' surrounding the process.

He said: 'It's practically impossible to discover how a drug was approved or when serious concerns were raised. The secrecy means the author ities are unaccountable.'

However, the drug industry continues to press for less regulation. Last week Professor Michael Rawlins, head of the government body which monitors the cost-effectiveness of medicines, said excessive bureaucracy and an obsession with safety is stifling new drug development.

An MHRA spokesman denied the agency was failing in its role to protect the public or that drug industry funding impacted on its independence saying: 'The MHRA undertakes its role to protect public health without fear or favour.'

http://observer.guardian.co.uk/uk_news/story/0,6903,10 46607,00.html