More on NICE, Big Pharma and the White House

In my previous post today ‘MPs to scrutinise drug watchdog – but it’s NOT the MHRA‘ I illustrated the difference between NICE and the MHRA as far as Big Pharma is concerned. Please read on for more background.

Decisions by NICE are crucial for the giant Pharamceutical companies. It decides whether a drug should be universally available to patients in the NHS. Chaired by Prof Sir Michael Rawlings, NICE draws on scientific experts and consults doctors, patients, drug companies and the Department of Health. The government invariably accepts its final recommendations. Although ministers say they cannot influence NICE, documents obtained by the Guardian under Freedom of Information legislation reveal a constant stream of high-level visitors to the Goverment from drug companies.

Manufacturers, led by Pfizer, have been complaining to ministers about NICE’s position on their controversial Alzheimer’s drugs. Originally NICE decided to allow them, then it reversed its position, saying they should be used only for a minority of patients with moderate disease.

At a meeting in October 2006 with the minister, Pfizer executives made it clear they “were unhappy with the NICE decision … and thought their processes were flawed”. They requested a special meeting with ministers where all the companies making Alzheimer’s drugs could put their case.

The documents prepared by civil servants for the Pfizer meeting outline the wealth and scale of the US company, which in 2004 had revenue of $52.5bn (£28bn) and a net income of over $11bn.

But, Pfizer executives warn the minister, it could always take its business elsewhere. “Pfizer … noted that there is complacency in some quarters of Whitehall regarding their continued investment in the UK,” the minutes record. “Pfizer asked for more public support from the government for a robust pharmaceutical industry in the UK and more consultation/dialogue with the government.”

This shocking information has been taken from an article in the Guardian by Rob Evans and Sarah Boseley in 2006 which goes into the matter much more detail.

Combine this story with what US deputy health secretary Alex Azar said in November 2006 and the recent news of the review of NICE, then I think we can all see how the pieces fit together.

Do we really want to be told how to run the NHS by the White House and Big Pharma? – because that looks like the way things are going at the moment.


One Response to “More on NICE, Big Pharma and the White House”

  1. truthman30 Says:

    And you can be pretty damn sure that Glaxo And other Big Pharmas threatened the UK government with a pull out if they were to do anything about the killer SSRI meds…

    NICE, the MHRA and The UK government department of Health play a subordinate role to Big Pharmaceutical companies.. They will not challenge nor bite the hand which feeds them…

    These Pharamceutical companies have a “Carte Blanche”, they can do what they like as long as they keep their business in the UK (the same applies to the FDA in the USA)

    Kirsch’s view is clear-cut. “These [SSRI] drugs should never have been licensed – that’s the logical response from our study,” he said. “If one can not draw positive conclusions from the data there is just no basis to conclude that antidepressants are effective interventions.”

    This view is radically different to that of the National Institute of Health and Clinical Excellence. Its 2004 guidelines on depression advises against doctors prescribing SSRIs to people with mild depression, but states SSRIs are clinically useful for moderate or severe depression

    “It would be highly difficult for Nice to go against what the drug regulators have decided, says David Healy, professor in psychological medicine at Cardiff University. “They could have the drug firms on its back trying to sue.”
    Nice’s guidelines are now being revised and are to be re-published in June next year. In a statement, Nice’s clinical and public health director, Professor Peter Littlejohns, has promised Kirsch’s Plos paper will be examined. But Kirsch’s 2002 paper was scrutinised by Nice in drawing up its 2004 guidelines.

    And the debate by researchers over whether Nice’s judgement on SSRIs is empirically valid continues.

    In The British Medical Journal, Kirsch and Dr Joanna Moncrieff, a senior lecturer in social and community psychiatry at University College of London, have criticised the methodology used by Nice for assessing antidepressant efficacy.

    In response, the guidelines’ authors accused Kirsch and Moncrieff of “an inaccurate and partial reading” of the evidence.

    “We believe Moncrieff and Kirsch have failed…to undermine the evidence base for antidepressants and to establish their case for a reconsideration of the NICE recommendations for their use,” they said.

    In some form the drug firm data needs to available to the public generally, not just the regulators, ensuring [independent] experts can look at the data,” he says.

    “There are good ethical grounds for doing this. Volunteers who sign up for a drug firm’s clinical trial would not have got involved if they thought that drug company would have put away the results.”

    A MHRA spokesman said independent researchers can apply to see drug firm trial data, unless it breaches commercial or patient information. Will such exceptions be dismantled under the new law? “We will have to see what is decided in drawing up the law,” said the MHRA spokesman.

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