Article in the Telegraph
"Drugs companies must reveal the results of clinical trials as soon as they uncover potential problems with their medicines, the Government has announced.
In a statement, Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), has said it will "take immediate steps to ensure the law is strengthened, so that there can be no doubt as to companies' obligations to report safety issues."
The move comes after a four-year investigation into how GlaxoSmithKline (GSK) withheld the full results of their trials into the anti-depressant Seroxat on children.
The Government watchdog criticised the company, which is Europe's biggest drugs manufacturer, for not handing over the trial data earlier.
But it added that criminal charges could not be brought as robust legislation was not in place at the time.
Mr Woods said: "I remain concerned that GSK could and should have reported this information earlier than they did. All companies have a responsibility to patients and should report any adverse data signals to us as soon as they discover them.
"This investigation has revealed important weaknesses in the drug safety legislation in force at the time."
The trial data revealed that there was a higher risk of suicidal behaviour among children younger than 18 on Seroxat than those given a placebo.
The results also found that Seroxat was ineffective in dealing with depression in those under 18.
It was handed to the Medicines and Healthcare Regulatory Authority (MHRA) in May 2003, despite GSK having allegedly been aware of the results since 1998.
A month later, in June 2003, the MHRA announced that doctors must stop giving Seroxat to those under 18.
Miss Primarolo will say that GSK should have informed the MHRA earlier than it did, but that the drugs company will not face criminal charges.
The MHRA investigation found that the company could have told them earlier, but did not break the letter of the law by not doing so, as current legislation is not clear as to when a company should reveal the results of its clinical trials."
This is shocking! - I can't say that I've much respect for the MHRA. - It seems to have had mixed loyalties. There's been a lot of GSK (GlaxoSmithKline) cash associated with the bank balances of members of the MHRA.
If anybody is under the misapprehension that the MHRA - Medicines and Healthcare products Regulatory Agency (An executive agency of the Department of Health) is doing a good job and is not overly influenced by or even in the pocket of the drug companies I invite you to read this page, the author of which has a particular interest in the drug, Seroxat - http://fiddaman.blogspot.com/2007_04_05_archive.html - Here is an extract from the page:
"I've looked through the pdf file for THE COMMITTEE ON SAFETY OF MEDICINES ANNUAL REPORT FOR 2004 and will show you all those members who have ties with Glaxosmithkline.
Remember, The Committee on the Safety of Medicines (CSM) was 'apparently' an independent advisory committee that for 40 years advised the UK Licensing Authority on the quality, efficacy and safety of medicines - In other words they offered advice to the MHRA. It was replaced on 30 October 2005 by the Commission on Human Medicines which combines the functions of both the former committee and the Medicines Commission
I've just gone through the declared Personal Interests to highlight the members whom had ties with Glaxosmithkline.
Professor A Blenkinsopp - GSK Specific – Fees
Professor H Dargie - GlaxoSmithKline Consultancy
Dr M Donaghy - GSK Shares
Dr J C Forfar - GSK Shares
Dr R Leonard - GSK Fees/ Publicity work
Prof D J Nutt - GSK Consultancy Psychotropics and 300 shares
Professor J F Smyth - GSK Consultancy
Professor Christopher Bucke - SKB Shares
Prof Nicholas Mitchison - GSK Shares
Dr Brian J Clark - GSK PHD student funding
Professor Robert Booy - GSK Consultancy
Professor S M Cobbe - GSK Research grant
Professor J E Compston - GSK Consultancy
Dr A Glasier - GSK Shares (£10,000)
Dr Andrew A Grace - GSK Consultancy
Dr P Hindmarsh - GSK Consultancy on growth, probably lapsed by now
Professor P D Home - GSK Consultancy
Dr R F A Logan - GSK Shares
Professor R MacSween - SmithKline Beecham Shares
Professor J O’D McGee - SmithKline Beecham Shares
Professor David R Matthews - GSK Honorarium for advice
Dr A Smyth - GSK Conference expenses
Professor A D Struthers - GSK Shares
Professor J C E - GSK Shares
Dr A Gerard Wilson - GSK Consultancy
Dr Rosemary Leonard - GSK Fees/ Publicity work
Mr David P S Dickinson - GSK Fee paid work
Dr Charlotte C D Williamson - GSK Shares
Professor Anthony H Barnett - GSK Advisory work and lectures diabetes related products
Professor V Krishna K Chatterjee - GSK Consultancy on preclinical research with a Vanillord Receptor antagonist (Consultancy end of 2004)
Professor Albert - GSK Shares
An 'independent' advisory committee huh?"
Surely personnel working to protect the public from the harm that prescription drugs can and do cause, should be strictly forbidden from being paid consultants to drug companies and doing research and publicity for them and from being holders of drug company shares?
Prescribed drugs do far, far more harm than good. Their side-effects account for most of the serious avoidable illness in the parts of the world that have the misfortune to be users of Westernised medicine.
As well as giving information about salt, salt sensitivity and about obesity, my blog heavily criticises the drug companies and their drug-pushers - i.e. the medical profession.
My website http://www.wildeaboutsteroids.co.uk/ is about the special harm that prescribed steroids. HRT, amitriptyline and some other drugs do. See in particular http://www.wildeaboutsteroids.co.uk/steroids.html
My Mensa article is here: Obesity and the Salt Connection
My 'political' page is http://www.wildeaboutsteroids.co.uk/story.html (Do, please, try to read the whole of the page.)
Anyone interested in anti-depressants would find this material very interesting indeed - The Antidepressant Web
Guard your health! - As far as you possibly can, steer clear of doctors and their dangerous drugs!