AstraZeneca 'pushed drug for untested uses'

Firm on defensive after documents support patients' law suit over Seroquel

AstraZeneca launched a public relations push to get doctors to prescribe its best-selling psychiatric drug Seroquel for a string of uses that were not approved by safety regulators, according to a damning internal document released yesterday.

The UK's second biggest drug maker is being sued by 16,000 patients in the US for "spinning, skewing and concealing" information on the drug's potential side-effects, including diabetes and weight gain, and lawyers unearthed emails and strategy documents showing what they say are repeated violations of the law.

The company was forced on to the defensive yesterday after more than 230 internal documents were made public, supporting a legal assault that wil cost it hundreds of millions of dollars if successful.

In particular, the material shows that AstraZeneca worked hard in the early years of this decade to turn Seroquel into a blockbuster drug with sales far beyond its originally approved market as a treatment for adult schizophrenia. It would be several more years before clinical trials showed it was safe and effective in a broader range of illnesses, including bipolar disorder, yet the company quickly made a substantial part of its revenues from doctors prescribing the drug for uses not officially sanctioned.

Regulators such as the Food and Drug Administration in the US carefully set out what claims can be made for every drug, and control the exact wording of the drug's label. Companies promoting products for unapproved uses face large fines.

A public relations strategy document emailed around the company in February 2001 by a brand manager, Alison Wilkie, said that "2001 communications will focus on increasing the existing off-label usage of Seroquel in [bipolar disorder], estimated to account for around 20 per cent of current prescriptions and growing strongly."

The documents also show that David Brennan, then head of AstraZeneca's US business and now chief executive of the company, was alerted by an employee that salesmen were targeting doctors who specialised in treating children, despite the fact that Seroquel has never been approved for use by minors.

A spokesman for AstraZeneca said that anti-psychotic drugs have always been widely prescribed by doctors for uses beyond the official label, and regulators are well aware that they are. "In that robust off-label environment, we sought to expand the approved indications for Seroquel," he said. "These documents do not advocate the inappropriate promotion of Seroquel."

Before the employee raised the issue to Mr. Brennan, AstraZeneca, as part of its ongoing compliance efforts, had made extensive efforts to monitor and align its sales calls with physicians who were prescribing Seroquel on label.

Other documents show AstraZeneca keeping a close eye on the legal line between promoting clinical studies of Seroquel in disorders for which it is not yet approved and outright marketing of the drug for off-label use by the commercial department. One 2004 email said that slides prepared in connection with a study involving off-label use of Seroquel were "financed outside of Commercial for obvious legal reasons". On another document, the minutes of a meeting about doctors' attitudes to anti-psychotic drugs, a brand manager had scrawled that the sales force could "grease the skids" for Seroquel's use as a treatment for dementia.

Ed Blizzard, attorney for 6,000 Seroquel patients suing AstraZeneca, said: "These strategy plans are not accidental. They are approved by people at the highest levels of the company. This is not just a few people, this is the strategy of the company." Mr Blizzard is leading the legal effort to win compensation for patients who claim that Seroquel caused their diabetes or medical complications due to their weight gain.

AstraZeneca has had two cases dismissed due to lack of evidence, but the first trial is expected in June. The company says there is no scientific evidence Seroquel causes diabetes and it is committed to a strong defence effort, taking each individual case on its merits.

FootballGerman sparks three goals in four minutes at favourite No 10 role
Rumer was diagnosed with bipolarity, attention deficit hyperactivity disorder and post-traumatic stress disorder: 'I was convinced it was a misdiagnosis'
peopleHer debut album caused her post-traumatic stress - how will she cope as she releases her third record?
A long jumper competes in the 80-to-84-year-old age division at the 2007 World Masters Championships
Radamel Falcao was forced to withdraw from the World Cup after undergoing surgery
premier leagueExclusive: Reds have agreement with Monaco
Arts and Entertainment
'New Tricks' star Dennis Waterman is departing from the show after he completes filming on two more episodes
tvHe is only remaining member of original cast
Life and Style
Walking tall: unlike some, Donatella Versace showed a strong and vibrant collection
fashionAlexander Fury on the staid Italian clothing industry
Arts and Entertainment
Gregory Porter learnt about his father’s voice at his funeral
ebooksAn unforgettable anthology of contemporary reportage
Arts and Entertainment
tvHighs and lows of the cast's careers since 2004
Life and Style
Children at the Leytonstone branch of the Homeless Children's Aid and Adoption Society tuck into their harvest festival gifts, in October 1936
food + drinkThe harvest festival is back, but forget cans of tuna and packets of instant mash
Lewis Hamilton will start the Singapore Grand Prix from pole, with Nico Rosberg second and Daniel Ricciardo third
F1... for floodlit Singapore Grand Prix
New Articles
Life and Style
Couples have been having sex less in 2014, according to a new survey
Latest stories from i100
Have you tried new the Independent Digital Edition apps?
Independent Dating

By clicking 'Search' you
are agreeing to our
Terms of Use.

iJobs Job Widget
iJobs Money & Business

Senior BA - Motor and Home Insurance

£400 - £450 Per Day: Clearwater People Solutions Ltd: **URGENT CONTRACT ROLE**...

Market Risk & Control Manager

Up to £100k or £450p/d: Saxton Leigh: My client is a leading commodities tradi...

SQL Developer - Watford/NW London - £320 - £330 p/d - 6 months

£320 - £330 per day: Ashdown Group: The Ashdown Group have been engaged by a l...

Head of Audit

To £75,000 + Pension + Benefits + Bonus: Saxton Leigh: My client is looking f...

Day In a Page

Scottish referendum: The Yes vote was the love that dared speak its name, but it was not to be

Despite the result, this is the end of the status quo

Boyd Tonkin on the fall-out from the Scottish referendum
Manolo Blahnik: The high priest of heels talks flats, Englishness, and why he loves Mary Beard

Manolo Blahnik: Flats, Englishness, and Mary Beard

The shoe designer who has been dubbed 'the patron saint of the stiletto'
The Beatles biographer reveals exclusive original manuscripts of some of the best pop songs ever written

Scrambled eggs and LSD

Behind The Beatles' lyrics - thanks to Hunter Davis's original manuscript copies
'Normcore' fashion: Blending in is the new standing out in latest catwalk non-trend

'Normcore': Blending in is the new standing out

Just when fashion was in grave danger of running out of trends, it only went and invented the non-trend. Rebecca Gonsalves investigates
Dance’s new leading ladies fight back: How female vocalists are now writing their own hits

New leading ladies of dance fight back

How female vocalists are now writing their own hits
Mystery of the Ground Zero wedding photo

A shot in the dark

Mystery of the wedding photo from Ground Zero
His life, the universe and everything

His life, the universe and everything

New biography sheds light on comic genius of Douglas Adams
Save us from small screen superheroes

Save us from small screen superheroes

Shows like Agents of S.H.I.E.L.D are little more than marketing tools
Reach for the skies

Reach for the skies

From pools to football pitches, rooftop living is looking up
These are the 12 best hotel spas in the UK

12 best hotel spas in the UK

Some hotels go all out on facilities; others stand out for the sheer quality of treatments
These Iranian-controlled Shia militias used to specialise in killing American soldiers. Now they are fighting Isis, backed up by US airstrikes

Widespread fear of Isis is producing strange bedfellows

Iranian-controlled Shia militias that used to kill American soldiers are now fighting Isis, helped by US airstrikes
Topshop goes part Athena poster, part last spring Prada

Topshop goes part Athena poster, part last spring Prada

Shoppers don't come to Topshop for the unique
How to make a Lego masterpiece

How to make a Lego masterpiece

Toy breaks out of the nursery and heads for the gallery
Meet the ‘Endies’ – city dwellers who are too poor to have fun

Meet the ‘Endies’ – city dwellers who are too poor to have fun

Urbanites are cursed with an acronym pointing to Employed but No Disposable Income or Savings
Paisley’s decision to make peace with IRA enemies might remind the Arabs of Sadat

Ian Paisley’s decision to make peace with his IRA enemies

His Save Ulster from Sodomy campaign would surely have been supported by many a Sunni imam