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Coverup: a British government agency refused to reveal clinical trial data for Glaxo’s Seroxat

Featured here earlier for its benevolence to the poorest, Glaxo, (Let them eat vaccines!) one of our biggest companies, has been fined £2 billion in the US for encouraging the prescription of unsuitable drugs to children, illegally promoting two antidepressants by bribing doctors, and withholding safety data about a diabetes drug.

Glaxo’s ‘encouragement’ had included: 
  • free trips for doctors, snorkelling, sailing, deep-sea fishing, balloon rides, spa treatments and cash payments, to persuade them to prescribe these drugs, or to reward them for doing so;
  • allegedly paying a medically-qualified radio host  more than £150,000 to ‘plug’ a GSK antidepressant for unapproved uses;
  • payment for articles approving its drugs to appear in reputable medical journals.
Causes for concern had been reported (and ignored) for many years. Two such instances follow: 

In 2003 Colin Whitfield, a retired headmaster, aged 56, slit his wrists in his garden shed two weeks after starting to take Seroxat. The coroner recorded an open verdict and said the drug should be withdrawn until detailed national studies were made.

In 2007 Sara Carlin, a 18-year-old Canadian student hanged herself despite official warnings (and warnings from her mother) that the drug could lead to self-harm.

In 2008 it was reported that Professor Irving Kirsch from the department of psychology at Hull University and his colleagues in the US and Canada requested and obtained a full set of trial data for four antidepressants under freedom of information rules from the Food and Drug Administration, which licenses medicines in the US and requires all data when it makes a decision.

A study then reviewed the data, including results from clinical trials that the manufacturers chose not to publish at the time.

GlaxoSmithKline which makes Seroxat, one of the named antidepressants, firmly declared the study unsound. 

Why did it take so long after the UK Medicines and Healthcare products Regulatory Agency had announced a review of Seroxat in 2002 and a British  coroner had called for Seroxat to be withdrawn in 2003? 

Clinical trial data for Seroxat given to the MHRA were not made public  

“Section 12 of the FOIA provides that public authorities are not required to comply with requests that they judge to constitute an excessive use of their resources.”

News of the Glaxo four follows

News of the Glaxo Four

Salute the four whistleblowers who had sales and marketing jobs with Glaxo in the US and have suffered unemployment for almost ten years since they first raised these concerns with the company.


This cartoon comes from the blog of David Hencke, an investigative journalist and writer, whose awards include being named as Journalist of the Year for his investigation uncovering the “Cash-for-questions affair” and the role played by Ian Greer Associates, one of the country’s biggest lobbying companies.  He also won Scoop of the Year’  for the story that caused the first resignation of Peter Mandelson and now works for Exaro news and as the Westminster correspondent for Tribune.

In a recent blog entry he reports that buried in the government’s new  Enterprise and Regulatory Reform Bill (Clause 14) is a plan to limit people with employment contract disputes using the whistleblowers law:

“Think for one second. A company gets a complaint from a whistleblower about a  nefarious practice. What better way to frighten a whistleblower than by going to the courts claiming this is not in the public interest and demanding a hearing before a judge. The company can then rubbish the whistleblower using the absolute privilege afforded by court hearings for maximum publicity  by claiming the complainer is  a bad worker, in breach of contracts etc – damaging the whistleblower’s reputation.”

He adds that there could be another agenda:

“The government’s fast track privatisation programme for public services has already led to whistleblowers revealing bad practice as shown in the recent private hearing of the House of Commons Public Accounts Committee. There I am told two Tory MPs put pressure on the committee not to hear in public whistleblowers’ allegations about bad practice in A4e, the private work provider, which has £200m of Department of Work and Pensions contracts.

“The next day the Daily Telegraph leaked some of their evidence and Chris Grayling, the minister for work but, one suspects, sympathetic to  A4e, used an appearance on BBC Newsnight to cast doubt on the motives of the whistle blowers.

We hope that many will support his call to back the campaign by Cathy James, chief executive at Public Concern at Work – to stop this piecemeal change.

At the very least the clause should be redrafted to define what should be excluded as a personal contract rather than submitting everything to a public interest test. 

Otherwise, as he writes, the public will rightly believe that the government has something very different in mind.