Friday, January 18, 2008

Patients raise fresh doubt over safety of cholesterol treatment

Unexplained seizures, dizziness and insomnia among symptoms claimed by statin users

POWERFUL testimony from patients suffering side-effects of a superdrug has emerged since the New Journal reported how a Hampstead schoolmaster died while suffering “psychic disturbances” linked to his prescription medication.
A form of statins, cholesterol-lowering drugs prescribed to over 3 million UK patients deemed at risk of heart attacks, was linked in an inquest to the dramatic change in character of University College School master Dr Allan Woolley.
He was killed under a train last April holding a note reading “Just burn my wretched body without ceremony”.
The Hornsey coroner’s jury last week rejected a suicide verdict and concluded that Mr Woolley “was suffering from psychic disturances, a known side-effect of the drug simvastatin”.
Although the drug has consistently passed scientific assessments from regulatory bodies and academic reviews, friends of Dr Woolley pushed for the inquest to examine its role in his death after reading a growing body of scientific and anecdotal dissent on the internet.
Lawyers acting on behalf of his family raised the possibility that the side-effects, described by a drug company doctor as ‘rare’ and ‘low occurrence’, may be under-reported or even ignored by GPs.
This week, patients and medical academics contacted the New Journal outlining their experience of and theories on statins, which at $12bn a year have become the most profitable pharmaceutical product in the world.
West Hampstead telecoms engineer Steve Hutchinson, 52, returned to work this week following an enforced four-month absence after breaking both his arms during an unexplained seizure.
Mr Hutchinson was prescribed simvastatin for above-average cholesterol earlier last year and links the sequence of insomnia, dizziness and amnesia that preceded the fit to the drug.
Mr Hutchinson said yesterday: “I was taking simvastatin up to the time of the seizure, and though I was quite fit and swimming everyday I couldn’t sleep and was feeling generally unwell.
“I couldn’t put my finger on what was wrong and went to the doctor, even suggesting it might be the statins.
“After the seizure – which neither my doctor nor a neurologist could explain after MRI and CT brain scans – I raised it again but they refused to admit that statin could be involved.
“From the day I had the seizure I haven’t had the statins and I have felt like myself again despite the fact that I am in pain.”
Music teacher Hugh De Camillis taught at University College School for over 30 years before retiring two years ago at the age of 75 and worked with Dr Woolley, who taught at the school for 26 years.
He was prescribed simvastatin following a heart attack. He is all but confined to his home by muscular pain, another acknowledged side-effect of statins, and blames the drug for increasing forgetfulness.
He said: “My muscular pain has become more and more debilitating. When I realised that this could be a side-effect of statins I discussed it with my doctor and he has lowered my dose, which has brought some improvement.
“I understand that I am at risk of heart attack and that if I stop the statins my cholesterol will go up, so my options are to live longer but in pain or to possibly die sooner but without. It was shocking to read about Dr Woolley, who I knew.”
A spokesman for Zocor producers Merck Sharp and Dohme (MSD), the $6bn-per-year drug company that produces the simvastatin Dr Woolley was prescribed, said yesterday (Wednesday) that advice on side-effects was given by the Medicines and Healthcare products Regulatory Agency in the UK.
The spokesman said: “We’re continuing to collect all the data and submitting it to regulatory authorities around the world. We’re continuing to monitor the safety of all our products but the numbers here are so small... There is no valid scientific evidence proving causal association between suicide and simvastatin or any of the other statin treatments.”
The company was waiting for a response from Hornsey Coroner’s Office before he could comment on whether MSD had received a report on side-effects in Dr Woolley’s case, he added.

Source:www.thecnj.co.uk