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Editor – as identified by your report, “Yellow card” announcement
used to head off concerns, experts claim (News, 9 August 2003), it seems,
in fact, that the reverse is true. The recent damning report from the
House of Commons Public Accounts Committee ((PAC) Safety, Quality,
Efficacy: Regulating Medicines in the UK, 4 June 2003), described the
Medicine Control Agency’s performance as “lacklustre”. This followed the
earlier National Audit Office (NAO) report of the same title (16 January
2003), which was also critical of the Agency. One might therefore hope
and expect that the recently merged Medicines and Healthcare products
Regulatory Agency (MHRA) would take some concerted action to address the
highlighted shortcomings. The merger with the Medical Devices Agency,
which took effect from 1 April this year, and new Chair and management
structure, would indicate further opportunities to tackle these problems.
Yet, this announcement demonstrates that all appears to be continuing as
before.
The PAC and NAO reports confirm what is already widely recognised,
that there is significant under-reporting of side effects to the MHRA.
The research undertaken by Charles Medawar and Andrew Herxheimer also
raises critical questions about the usefulness of those reports that are
received. There can hardly be a clearer indication that a review of the
entire system is long overdue. However, rather than seeking to address
the problems in the system as a whole, we learn that the purpose of the
review is to be limited to the issue of access to data generated from
Yellow Cards, in response to requests from the pharmaceutical industry.
This raises a fundamental concern covered in both the PAC and NAO reports:
that of a potential conflict of interest between the Agency’s commitment
to protect public health and its mission to promote the development of the
pharmaceutical industry. The MHRA’s key stakeholder is the public, yet
its activities indicate that it has not yet recognised this.
There should be much greater awareness of the need to report drug
side effects, and of the need for access by all stakeholders to meaningful
– and anonymised - data to ensure that any safety concerns are both raised
and acted on swiftly and effectively. If the MHRA review does not address
these wider issues, the effect will be to undermine the quality of
healthcare, further reducing consumer confidence in its work.
Further information, both about both the review of Yellow Cards and
our evidence to the review of the safety of SSRI antidepressants, is at http://www.socialaudit.org.uk/5100what.htm#5.1
The Department of Health (DoH) spokesman quoted by the BMJ is clearly
unfamiliar with the issues. He suggested that the DoH was "more concerned
about who should receive detailed analysis of the (Yellow) cards, which
normally name a patient." To the best of our knowledge, the regulators
have never released data that allow patients to be identified, and we hope
they never will.
The issue here is whether the "Anonymised Single Person Prints" that
are derived from Yellow Cards should be available only to companies (who
pay) and to selected requesters. Our view is that freedom of information
becomes nonsensical, either if means-tested or if access is available only
to research workers who are officially approved.
Time to show the red card to the “yellow card" scheme?
13 August 2003
Editor – as identified by your report, “Yellow card” announcement
used to head off concerns, experts claim (News, 9 August 2003), it seems,
in fact, that the reverse is true. The recent damning report from the
House of Commons Public Accounts Committee ((PAC) Safety, Quality,
Efficacy: Regulating Medicines in the UK, 4 June 2003), described the
Medicine Control Agency’s performance as “lacklustre”. This followed the
earlier National Audit Office (NAO) report of the same title (16 January
2003), which was also critical of the Agency. One might therefore hope
and expect that the recently merged Medicines and Healthcare products
Regulatory Agency (MHRA) would take some concerted action to address the
highlighted shortcomings. The merger with the Medical Devices Agency,
which took effect from 1 April this year, and new Chair and management
structure, would indicate further opportunities to tackle these problems.
Yet, this announcement demonstrates that all appears to be continuing as
before.
The PAC and NAO reports confirm what is already widely recognised,
that there is significant under-reporting of side effects to the MHRA.
The research undertaken by Charles Medawar and Andrew Herxheimer also
raises critical questions about the usefulness of those reports that are
received. There can hardly be a clearer indication that a review of the
entire system is long overdue. However, rather than seeking to address
the problems in the system as a whole, we learn that the purpose of the
review is to be limited to the issue of access to data generated from
Yellow Cards, in response to requests from the pharmaceutical industry.
This raises a fundamental concern covered in both the PAC and NAO reports:
that of a potential conflict of interest between the Agency’s commitment
to protect public health and its mission to promote the development of the
pharmaceutical industry. The MHRA’s key stakeholder is the public, yet
its activities indicate that it has not yet recognised this.
There should be much greater awareness of the need to report drug
side effects, and of the need for access by all stakeholders to meaningful
– and anonymised - data to ensure that any safety concerns are both raised
and acted on swiftly and effectively. If the MHRA review does not address
these wider issues, the effect will be to undermine the quality of
healthcare, further reducing consumer confidence in its work.
Competing interests:
None declared
Competing interests: No competing interests