MHRA admits to shortcomings
pharmafile | January 21, 2005 | News story | Sales and Marketing |
The MHRA has admitted that it has "suffered from not being professional enough" as it endeavoured to restore its reputation at the latest session of the Health Select Committee.
The chairman of the UK's regulator Sir Alasdair Breckenridge made this startling admission in light of criticism at the regulator's handling of the SSRI safety review and charges of it having a 'cosy' relationship with the pharma industry.
Indeed, the catalyst for the inquiry, scheduled to end on 3 February, had been the relentless negative press surrounding GSK's SSRI (selective serotonin reuptake inhibitor) antidepressant Seroxat, its side-effects and use in children.
But the MHRA chairman rebuffed claims that the regulator had been negligent at the time SSRIs came on the market.
He said: "We are looking back 15 years ago when SSRI licences had different adverse reaction profiles. The MCA (Medicines Control Authority – now part of the MHRA) was not in the business of designing studies and setting up investigations. The main lesson that has been learnt is that the safety profile [of SSRIs] is not very well known."
Sir Alasdair was lucid and articulate throughout, countering suggestions by Committee member Dr Richard Taylor who said that the chairman had appeared "to be pretty well tied up in knots and didn't really appear to have any defence at all", when he responded to questions on the BBC's Panorama television programme about the safety of GSK's Seroxat.
The Committee, which questioned the MHRA and NICE in successive sessions, also took issue with the chairman's role on SmithKline Beecham's Scientific Advisory Committee between 1992 and 1997, asking him if negative trial results were discussed.
"Certainly not," he responded, emphasising that the role was taken on with the "full cognisance of the MCA".
Asked to comment on the key issues now facing the MHRA, Sir Alasdair cited transparency, communications and educating the public – in terms of risk and benefit of drugs – as integral to the upholding of its integrity.
"We commissioned a report on communications strategy in June 2004 and made recommendations. This is absolutely critical. When we give a company a licence we will give a public assessment report and the public will be able to see evidence of why a drug has been licensed," he said.
He also highlighted the regulator's report into SSRIs last year and changes to the Yellow Card scheme, now expanded by the MHRA for the use of patients, as evidence that the regulator was changing.
The committee also broached the issue of the Clinical Trials Register, questioning the regulator on its benefits.
Professor Kent Woods, chief executive of MHRA, speaking alongside his chairman, admitted that there was still unanswered questions regarding the register.
He said: "It is early days and there are problems about where to put data and what you put on them. Should they be summaries? All information would be difficult for patients to understand."
Sir Alasdair added the proviso that the register's success depended on the willingness of companies to conform to the system.
Drug trial results were also fundamental to evidence given by the chairman of NICE Professor Sir Michael Rawlins, who said it concerned him as a physician and as an issue for NICE.
He said: "People talk about Intellectual Property Rights (IPR) but it's patients who take part in studies and we owe it to them that their efforts are not in vain."
The NICE chairman informed the Committee that it had developed a good relationship with MHRA, praising it for discovering problems about SSRIs. He also commended the increased role of universities in drug discovery.
The inquiry is scheduled to close with questions being put to Lord Warner, the government minister in charge of overseeing the pharma industry.
