psychotic reaction to Statins

[Guest guest]

" BE assured it is not the drug that is on trial here..., " Coroner

told Tuesday's inquest into the death of Allan Woolley,

who became psychotic as a side-effect of taking cholesterol-lowering

statins.

But the inquest's finding, which acknowledged psychic disturbances

caused by the most popular variant of the drug, will inevitably fuel

debate over their safety.

Statins are so spectacularly successful at combating heart disease –

the UK's biggest killer – that some experts have called for them to

be ­prescribed automatically to everyone over 50.

http://www.thecnj.co.uk/camden/2008/011008/news011008_01.html

Camden New Journal - By PAUL KEILTHY

Published: 10 January 2008

Allan Woolley

`SUPERDRUG' DEATH LINK?

Inquest blames cholesterol pills for psychic disturbances

A WONDER drug prescribed to millions caused " psychic disturbances "

which plunged a Hampstead schoolmaster into a living nightmare and

drove him to his death under a train, an inquest has ruled.

Students and colleagues at University College School were mystified

and distraught when chemistry master Dr Allan Woolley, 53, was killed

while standing on the tracks at North Wembley railway station last

April, holding a note which read: " Just burn my wretched body without

ceremony. "

But his family and friends were so convinced that suicide was out of

character they insisted that his inquest examine the role played in

his death by cholesterol-lowering statins, prescription " superdrugs "

taken by 2.5 million people in Britain at risk of heart attacks.

On Tuesday, after hearing how the outgoing house-master's character

had been transformed by nightmares, hallucinations and blackouts in

the days before his death, a jury at Hornsey Coroner's Court rejected

a suicide verdict.

Instead, they recorded a narrative verdict describing the

circumstances of his death and concluding: " At the time of his death

Allan Woolley was suffering from psychic disturbances, a known side-

effect of the drug simvastatin. "

Coroner summoned an expert witness from the $6 billion-

per-year drug company that manufactures Zocor, the brand of

simvastatin prescribed to Dr Woolley, after the teacher's sister

Lorraine Bubb wrote: " My brother had no history of depression and was

in full-time employment. The family believe that Allan did not intend

to kill himself. My brother had had nightmares which were so terrible

he could not distinguish between them and real life. "

On behalf of Zocor manufacturer Merck Sharpe and Dohme, Dr Fredric

Steinberg said psychic disturbances were among the " rare " side

effects, adding: " That is an unspecified term, psychic disturbances.

It is lumped together in that term because these events are very

rare... [but] it could be depression, it could be hallucination, it

could be anxiety. "

He said: " Simvastatins have been licenced since 1988 and the

accumulated tablets have been in the billions... Millions of people

have taken it; the number of incidences – over the 20 years it has

been diagnosed – of psychotic symptoms is in the range of 1,500. The

number of suicides is 52. "

Asked by the Woolley family's lawyer, Alan Weir, whether cases could

be underreported, Dr Steinberg said: " I cannot answer that. "

Statins, of which simvastatin is the cheapest of five types

prescribed on the NHS, have been hailed as a superdrug for their

effect on reducing cholesterol by up to 60 per cent.

Dr Woolley, who lived in Inglewood Road, West Hampstead, was

prescribed simvastatin be­cause as a diabetic with above average

cholesterol he was at risk of cardio-vascular illness, despite his

active lifestyle.

But friends, struggling to explain his sudden death, recalled his

complaints about side-effects from Zocor shortly before his death.

Fellow UCS " deme warden " Hawley said Dr Woolley had been pre-

occupied and had suffered 15-minute " black-outs " when he could not

recall his actions.

Mr Hawley described a conversation with Dr Woolley on the night of

his death: " Everything had changed in that phone call. I can only say

he was at his wits end.

" He said he couldn't carry on. He said he'd remembered the 15 minutes

and it was awful. I could tell he was desperate; he said I called to

say I love you and to say goodbye. I said we could talk tomorrow – he

said maybe, maybe not. It was not an Allan Woolley I'd ever spoken to

before. "

Mr Hawley also gave evidence that the note found on Dr Woolley's body

was not in character for a man described by his UCS headmaster

as " immensely popular and inspirational " .

The partly illegible note, read to the court by the coroner,

said: " Woken up four... I hadn't... at least the pain has now gone.

The pain I have caused is incalculable, I am sorry but it is not

enough. Just burn my wretched body without ceremony. I was unborn for

15,000 million years there was no pain then, being dead won't be any

different. I would like to write more but there isn't time. "

Coroner Dr directed the jury to name the drug in their

verdict. He said: " I have decided that this is not a case where you

can return a suicide verdict. You must not say that Allan Woolley

killed himself... or that he took his own life.

" You must include that the drug simvastatin was involved. "

After the verdict, the group of Dr Woolley's friends whose internet

researches into the effects of statins had prompted the coroner's

summons to the drug company issued a joint statement. They said: " We

are delighted by the verdict because it emphasises the role of his

medication in the tragic change in Allan in the days before his

death. We hope this may contribute to a greater understanding and

investigation of the potential dangers of these statins, especially

given the pressure to prescribe them ever more widely. "

In the UK, 2.5 million people take them –

but are statins safe?

" BE assured it is not the drug that is on trial here..., " Coroner

told Tuesday's inquest into the death of Allan Woolley,

who became psychotic as a side-effect of taking cholesterol-lowering

statins.

But the inquest's finding, which acknowledged psychic disturbances

caused by the most popular variant of the drug, will inevitably fuel

debate over their safety.

Statins are so spectacularly successful at combating heart disease –

the UK's biggest killer – that some experts have called for them to

be ­prescribed automatically to everyone over 50.

Not only do they interfere with the process which forms harmful

cholestorol in the body, they have been associated with lower rates

of stroke and the prevention of dementia, prompting the National

Institute for Clinical Excellence to call last year for an additional

3.3 million UK patients to become eligible for the drugs.

The NHS has made a major push to ensure that doctors prescribe

simvastatin, the form of the drug taken by Dr Woolley, as it is out

of patent and therefore significantly cheaper than some ­other forms.

It is also available over the counter.

More than 70 per cent of Camden Primary Care Trust prescriptions of

statins are for the cheaper drug, in line with NHS policy. Camden PCT

said yesterday that they did not hold records of the number of

patients prescribed with the statin.

A PCT spokesman added: " It is considered to be safe from data

reported from ­clinical studies and post-­marketing surveillance.

" The Medicines and Healthcare products Regulatory Agency [MHRA]

monitors and collates national safety data relating to drugs, as does

the European Medicines Evaluation Agency [EMEA]. "

Major studies have consistently found that the benefits of statins,

the world's biggest selling drug, ­massively outweigh the side-

effects, which can also include liver and muscle ­damage.

But dissent against the $12.6 billion-a-year statins business has

been expressed on the scientific peripherary, led in the US by former

NASA physician Dr Duane Graveline who experienced Transient Global

Amnesia (TGA) while on a statin variant. It was his work and other

internet sources which led Dr Woolley's friends and family to push

the inquest to examine the role of simvastatin in his death.