MHRA negligent over Seroxat, says MIND chief
MIND, the mental health charity, has accused the Medicines and Healthcare products Regulatory Agency of negligence. It argues that the agency failed to warn doctors until last week not to prescribe, in the first instance, above the recommended dose of paroxetine (Seroxat) (see below).
Richard Brook: Four reviews by the MHRA failed to establish key
facts |
The accusation was made by Richard Brook, MIND’s chief executive,
as he resigned from an expert group reviewing selective serotonin reuptake
inhibitors. Mr Brook was advised that he faced prosecution by the MHRA
if he published data that led to the warning being issued last week.
Mr Brook said that the data have been in the hands of the MHRA for more
than 10 years.
In his resignation letter, Mr Brook said: “Despite four major regulatory
reviews during this period and considerable consumer reporting and disquiet,
the Committee on Safety of Medicines failed either to identify or communicate
these key facts. As far as I am aware, the MHRA has not seen fit to acknowledge
or address what in my view appears to be extreme negligence.”
Separately, Mr Brook said: “On [11 March] the MHRA at last published
information advising that many thousands of men and women in this country
may have been taking Seroxat at a dose that was unsafe. What they failed
to mention — and what I am now making public — is the fact
that the regulator had the data on which the basis of this decision was
made for well over a decade as part of the original licence application.
Either they didn’t understand the full implications of the available
medical data at the time or, worse, those data were fully understood
and they failed to act.”
In Mr Brook’s view this amounts to extreme negligence and a clear
dereliction of the MHRA’s duty to safeguard the well-being of the
British public.
Mr Brook told The Journal that MIND had asked the MHRA to publish the
relevant licensing data so that there could be a sensible public discussion.
The MHRA had refused and MIND considered seeking a judicial review of
that decision.
Instead, because a judicial review would have meant a considerable delay,
MIND told the MHRA that it would publish the data itself unless prevented
by an injunction. The injunction application would have been resisted
on public interest grounds.
At this stage, on 8 March, Lord Warner intervened and obtained agreement
from MIND to delay publication. Later that day, Mr Brook received a letter
from the MHRA chief executive, Kent Woods, in which he was advised that
he would be prosecuted if data were published.
The prosecution would have been under Section 118 of the Medicines Act
1968, which prohibits the disclosure of licensing information.
Mr Brook said: “We have an amazingly secretive set of laws that
prevent sensible discussion. Why can’t we put this information
in the public domain? It should be freely available to researchers.”
A Department of Health spokeswoman said that the data held by the MHRA
had accumulated as and when licence applications were made for different
indications. The current review was the first time that the data had
been looked at as a whole across the range of indications. New evidence
had also come to light on how widespread prescribing of doses higher
than 20mg was.
She added that Mr Brook’s concerns were being taken on board. Lord
Warner, the Parliamentary Under-Secretary of State responsible for the
MHRA, is expected to meet Mr Brook to hear his concerns next week.
Commenting on Mr Brook’s resignation, Liberal Democrat health spokeswoman
Sarah Teather said: “Richard Brook was offered a place on the board
that reviews these medicines because of his knowledge of the needs of
patients. Serious questions must be asked by ministers as to why someone
who represents patient rights and interests feels that he cannot continue
on the working group. The public must be assured that medicine review
bodies are impartial and responding to the needs of the patient, as well
as the pharmaceutical industry. Ministers must ensure the system for
assessing prescription drugs is beyond reproach.” |
The
Pharmaceutical Journal