The UK Government will investigate pharma’s withholding of clinical trial data within the next 12 months, according to the chair of the health select committee.
Speaking at the NHS Alliance meeting in Bournemouth yesterday, former Conservative health secretary Stephen Dorrell confirmed that MPs would examine the issue "as a matter of priority" within the next year.
According to the British Medical Journal, Dorrell said that the issue was “pretty close to the top of the list of subjects” that the committee would be examining but added that he needed to “secure consensus from 11 strong-minded people” on the committee before announcing further details.
The matter came to a head in September when the epidemiologist Dr Ben Goldacre published his new book Bad Pharma, which criticises both the industry and the European Medicines Agency for failure to allow doctors to see all of pharma’s clinical trial data.
Last month, the British Medical Journal also announced it would only publish studies of drugs and medical devices – whether industry-funded or not – where there is a commitment “to make the relevant anonymised patient level data available on reasonable request”.
Its editor, Dr Fiona Godlee, said she was compelled to take this course of action after Roche spent more than three years denying access to all of the data surrounding its influenza drug Tamiflu to the Cochrane Collaboration. Roche, bowing to pressure, said yesterday it was now looking to create a new multi-disciplinary review to look at the data.
Government buying drugs ‘at vast expense’
Sarah Wollaston, the MP for Totnes, a member of the health committee, and a former GP, also appeared on the NHS Alliance’s panel yesterday and said it was important to tackle the issue now while the European regulations were under review.
She said: “Patient safety is put at risk by inappropriate prescribing and when doctors do not know the full clinical data. The European regulations are under review, so there are certain aspects of this which are time critical if we are going to able to feed into that.
“For far too long now we have allowed the government to buy drugs at vast expense. If we take [the example of] Tamiflu, we spent £500 million - £1 in every £200 that was spent in the NHS in 2009 - without actually knowing all of the clinical trial data. I think that’s totally unacceptable. We’ve seen it happen with so many other drugs in the past. Would you buy a car without knowing how many miles to the gallon it does and what the safety data were?”
Speaking at an EMA open panel discussion on trials transparency yesterday, the European pharma lobby group EFPIA said it wants "a measured approach" when it comes to complete transparency on clinical trial data. It said it wanted to maintain patient trust and privacy, and worried that by allowing anyone to see the data, this could breach confidentiality rules.