Thousands of deaths blamed on stroke drug

The Sunday Times 15 June 2014

A CLOT-BUSTING drug given to stroke patients is being blamed for thousands of extra deaths.

The treatment is being widely used despite original research indicating that up to 10% of patients may be killed because, although it cleared blockages in blood vessels in some people, it promoted uncontrollable fatal brain bleeds in others.

The most recent studies showed 4% more patients died within the first week of a stroke if they were given the latest version of the drug Alteplase, but now there are claims that stroke physicians have been misled about its risks because trial data has been misinterpreted.

Doctors in favour of using the drug argue that it dramatically reduces the paralysing effects of stroke in one in three survivors.

The issue has been reviewed by the Medicines and Healthcare Products Regulatory Agency (MHRA) following a detailed statistical analysis by Roger Shinton, a former stroke specialist at Birmingham’s Heartlands Hospital.

He has been backed by a group of other consultants who have also raised their concerns with Sir Bruce Keogh, medical director of NHS England, and Sir Richard Thompson, president of the Royal College of Physicians.

Every year at least 152,000 people in Britain suffer a stroke — a bleed into the brain or a blocked blood vessel causing death in 20% of cases, loss of mental functions or partial paralysis.

About one in five victims suffer a blocked artery rather than a burst blood vessel, and it is this group that is being targeted for Alteplase treatment.

Shinton is concerned that Alteplase is causing significant numbers of additional fatal bleeds in the head or stomach.

He declined to comment ahead of publication of his findings.

Other senior doctors who support his position said they were afraid to speak publicly. “It is career suicide to question clinical guidelines for the treatment of anything,” said one. The MHRA said its review of available safety data to be published later this month, “did not impact on the current licence or indications for Alteplase in treating ischaemic stroke”.

The manufacturer, the German group Boehringer Ingelheim, said the drug had been reviewed in September 2012.

“We have made all data available to the appropriate authorities and stand by the safety of this important medicine,” he said.