Industry ready to reply after critics savage practices
pharmafile | November 2, 2004 | News story | |Â Â Â
UK regulator the MHRA and the pharmaceutical industry have been condemned for being engaged in a closed and uncritical relationship, with critics now calling for a complete rethink in the way drugs are regulated in the country.
The second evidence session of the House of Commons' select committee investigation into the 'influence of the pharmaceutical industry' assembled some of the industry's staunchest critics.
These included consultant psychiatrist Dr David Healey, whose own investigations into serious side-effects seen in some patients using GSK's Seroxat forced the MHRA to launch an inquiry into the SSRI class, which in turn sparked the MP's probe.
Representatives from the industry including the ABPI director general Dr Richard Barker were present to witness sustained criticism of the industry, regulators and doctors, with large payments to opinion leaders, distortion of clinical data and lack of transparency, among the many allegations made.
Dr Healey told the committee: "There was a feeling about ten to fifteen years ago that the practices of pharmaceutical companies based in the US were somewhat sharper than the practices of the companies based here."
He added that the sector increasingly employed aggressive marketing, saying ghost-written clinical trial papers were distorting clinical decisions.
"Increasingly the articles written in the BMJ and The Lancet will not just be ghost-written but will not represent the raw data from the clinical trials that they purport to represent," he said, adding that this resulted in drugs being put on formularies based on misleading evidence.
Giving evidence alongside Dr Healey was Richard Brook, chief executive of mental health charity MIND and a former member of the committee which is still investigating the safety profile of GSK's Seroxat and other antidepressants.
Brook was particularly damning of the MHRA's culture of secrecy and closeness to the industry, saying first-hand experience of the committee's workings had alarmed him.
"Every time we made difficult decisions there was always this issue of 'We have got to be careful because the pharmaceutical companies will sue us if we get this wrong.'"
He added: "It was very clear that the MHRA officials were very mindful of that dimension, to my view, more than the dimension of public health and public responsibility."
A broad consensus emerged among the witnesses that it was not the sole responsibility of the industry to maintain high ethical standards.
"I am not sure the industry is the problem. I think there are two groups, one is the MHRA, who are not doing their job all that well, and the other is physicians generally," said Dr Healey, adding the Royal College of Psychiatrists and Royal College of Physicians had been completely silent in the face of disturbing evidence.
"Actually, we are supposed to be the expert advocates for the consumers, and from us you have heard complete silence."
Responding to the barrage of criticism Dr Barker said: "I don't think anyone thinks we are living in a perfect world," but said he would not back one suggestion to split drug regulation in two, with one granting marketing authorisations and another to monitor their safety and efficacy post-marketing.
He also dismissed the suggestion that the composing of product labels should be taken away from the industry, claiming that any other group would have less knowledge of the drug.
On the overall question of transparency, he hinted that the ABPI might be willing to see change, commenting: "I would like to say the ABPI's position on this is formulated, but it is not. The question is: 'How do you balance the confidential data of companies with the public and patients' needs?' – that's not an easy thing."
The ABPI has made its own written submission to the Commons committee, with a chance to answer the criticism in person at the next evidence session likely to come in December.
But ABPI spokesman Richard Ley expressed his concern about the overall aims and approach of the inquiry. Long-standing industry critics Joe Collier, former editor of the Drug and Therapeutics Bulletin and Charles Medawar, author of a number of anti-industry books have been selected as two of the four advisors to the committee, something which Ley described as "very odd".
He added: "Clearly the whole business of the select committee is to come up with constructive suggestions on those things that can be improved – if they come up with suggestions, we will look at them," but said the inquiry appeared imbalanced so far.
"I hope they are not, but it's starting to look as if they might simply be finding sticks to beat us with," he said.
Meanwhile, the withdrawal of Vioxx because of safety concerns has produced further concerns about the ability of regulators to police the industry. In the US, a number of Congressional committees are investigating the FDA.
Senator Charles Grassley, chairman of the committee on finance said: "As my investigative staff continues looking into how the Food and Drug Administration handles drug safety issues, particularly with antidepressants and Vioxx, a picture is emerging of an agency that can't see the forest for the trees."
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