Drug safety agency accused of cover-up

[Guest guest]

> JustSayNo

> Thu, 29 Jul 2004 22:21:52 -0400

> [sSRI-Research] Drug safety agency accused

> of cover-up

>

> Drug safety agency accused of cover-up

>

> Sarah Boseley, health editor

> Saturday March 13, 2004

> The Guardian

>

http://society.guardian.co.uk/mentalhealth/story/0,8150,1168612,00.html

>

> The chief executive of Mind, the mental health

> charity, last night resigned from a high profile

> review of modern antidepressant drugs, accusing the

> British medicines regulatory body of negligence.

> Richard Brook had a unique position as a lay member

> of the expert working group on the class of

> antidepressants which includes Seroxat and Prozac.

>

> His resignation came in protest at what he

> considered a cover-up by the regulators, after

> months of pressure on him not to reveal the review's

> findings that Seroxat has for years been prescribed

> by doctors in an unsafe dose and that the regulators

> had the evidence in their possession for more than

> 10 years.

>

> Mr Brook's resignation sheds a rare light on the

> workings of the secretive drug regulation agency and

> its advisers, and will heighten public concern over

> their relationships with the pharmaceutical

> manufacturers.

>

> The expert group drew the attention of the

> government's advisory Committee on Safety of

> Medicines to the dosage issue in October. Mr Brook,

> who had been invited to represent patient interests

> because of concerns that the CSM is too close to the

> pharmaceutical industry, pressed for the findings on

> dosage to be put into the public domain.

>

> Mr Brook warned the CSM and the Medicines and

> Healthcare Products Regulatory Agency, which

> licenses drugs on the advice of the CSM, last week

> that he felt he had no choice but to go public

> because of the risks to patients. He was warned in a

> letter last Monday from the MHRA that he could risk

> prosecution under the Medicines Act 1968, which

> protects the commercial confidentiality of

> information from drug trials.

>

> But Lord Warner, the health minister, to whom Mr

> Brook had expressed his concerns, intervened, and on

> Thursday the CSM put out a " reminder " to all doctors

> that they should prescribe Seroxat only at the

> recommended dose, which is 20mg. Last year 17,000

> people were put on a higher dose by their doctors,

> running the risk of increased side-effects, which

> some have alleged include agitation and thoughts of

> violence and suicide.

>

> In his letter of resignation to Kent Woods, chief

> executive of the MHRA, Mr Brook said although he was

> pleased the information was now in the public domain

> he was unhappy that the announcement had stopped

> short of acknowledging that the crucial dosage data

> had been in the possession of the MHRA since 1990.

>

> " The nature of the announcement fails to make public

> the fact that the clinical trial data you issued was

> available to the regulator for over a decade, " he

> wrote.

>

> " 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. "

>

> He regretted the fact that consumers would now be

> without a voice in the review, but wrote: " I believe

> my continuation on the expert working group without

> a frank and open admission of these important facts

> has become impossible. Consumers are entitled to

> full information both about medicines and how the

> regulator operates. "

>

> The warning letter to him on Monday had made it

> clear to him that he could not carry on, he said. Mr

> Brook said it was unclear why the MHRA had not acted

> earlier to ensure nobody was on too high a dose.

>

> " Either they didn't understand the full implications

> of the available medical data at the time or, worse,

> that data was fully understood and they failed to

> act. Either way it amounts to extreme negligence and

> a clear dereliction of the MHRA's duty to safeguard

> the wellbeing of the British public. "

>

> Mind is calling for an independent review of the

> workings of drug regulation with patient

> representation at its heart. They were backed by

> Charles Medawar of the consumer group Social Audit.

>

> " Richard Brook's brave resignation is enormously

> significant, and the loss of the one independent

> consumer figurehead now calls into question the

> whole credibility of the CSM's review, " he said.

>

> " It is alarming that Brook was put under such

> pressure, and typical of the regulators to try to

> gag him - and then produce a statement that is

> profoundly misleading by omission. " Brook holds a

> public position of considerable importance, and the

> Department of Health is the major sponsor of MIND.

>

> " Brook's resignation pretty much mandates a formal

> parliamentary investigation of the UK medicines

> control system.

>

> " The drug regulators have made a series of bad

> errors; it is completely unacceptable that they

> should be now allowed to investigate their own

> mistakes. "

>

>

>

> [Non-text portions of this message have been

> removed]