Tuesday, July 11, 2006

The MHRA : Why is the government not acting?

The UK Medicine and Healthcare Products Regulatory Agency (MHRA) is widely accused of tying itself into knots trying to accommodate commercial scientific misconduct. Criticisms include failure to properly scrutinise data before licensing drugs (watch this space), and an unhealthy inclination to accept "scientific" reports from companies with blind faith without reviewing or retaining raw data.

No meaningful steps have been taken by the UK government to implement critical recommendations of the House of Commons Health Select Committee Report of 2005 despite a barrage of problems (e.g. here).

The key recommendation of the Select Committee Report of 2005 was:

"In view of the failings of the MHRA, we recommend a fundamental review of the organisation."

Yet nothing has happened. Extracts of the report are below:

"practices have developed which act against the public interest." Page 4: The MHRA has failed to adequately scrutinise licensing data .... The organisation has been too close to the industry, a closeness underpinned by common policy objectives, agreed processes, frequent contact, consultation and interchange of staff. We are concerned that a rather lax regime is exacerbated by the MHRA’s need to compete with other European regulators ....

Page 5: The Government, like the MHRA, has tended to assume that all is for the best... Page 30: The MHRA is ...funded entirely by fees derived from services to industry

Page 31: The MHRA relies on company data, presented as a series of detailed assessment reports, in its decision whether or not to licence a drug. Raw data is very rarely analysed.

Page 49: The consent forms do not inform patients that the raw data may be maintained by the industry, not made available to the general public or even reviewed by the regulatory authorities.

Page 52: ... longstanding convention, vigorously upheld by the regulators, whereby clinical trial results were regarded as company property and commercially confidential.

Page 52: Too many problems appear to persist unnoticed or unacknowledged by the organisations that are central to the co-ordination, conduct and review of the clinical trials.

Page 79: The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.

Page 79: ..the MHRA is too trusting.
The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, .....Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.

Page 79: Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem:

Page 82: In setting up the review of SSRI antidepressants, the MHRA/CSM responded to another long-standing concern about regulatory activity: the possible conflicts of interest of regulators.

Page 83: user reports of often serious problems had been systematically discounted or ignored.

Page 85: ... the perceived threat by MHRA staff of legal entanglement resulting from regulatory action.. it was very clear that the MRHA officials were very mindful the whole time of that dimension, to my view, more than the dimension of public health and public responsibility

Page 87: Further concerns, relating to the MHRA’s reliance on company summaries of data, rather than raw data are discussed elsewhere.

Page 96: A statement to the effect that heart problems were associated with Celebrex was issued by the MHRA in December 2004. In the statement, the Agency made it clear that it had not seen the actual data from the drug company but that its advice was based on information from Pfizer’s website.

Page 98: The regulatory authority, which is responsible for controlling much of the behaviour of the industry has significant failings. Lack of transparency has played a major part in allowing failings to continue. The traditional secrecy in the drug regulatory process has insulated regulators from the feedback that would otherwise check, test and stimulate their policies and performance. Failure can be measured by the MHRA’s poor history in recognising drug risks, poor communication and lack of public trust. Regulatory secrecy also underpins publication bias, and other unacceptable practices. The closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.

Page 102: Thirdly, procedures for investigating complaints about breaches of regulations are too slow, poorly enforced and weakly sanctioned.

Page 103: The MHRA does not routinely examine raw data submitted with the licence application but is dependent on summaries provided by the applicant. The Expert Working Group on SSRI’s report of December 2004 showed that summaries of information may not provide the detail required to assess drug risks adequately.

Page 106: The MHRA.... is entirely funded by fees from those it regulates.... it competes with other European agencies for fee income... serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings ... The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency...

Comment: Having himself dealt with the MHRA, this blogger is waiting patiently for action to safeguard public health and science.

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