The
Medicine and Healthcare Products Regulatory Agency
Why is government not acting?
We have invested power in an elite system charged to act in the interests of the public. Their motto. : "Safeguarding Public Health"
Much discussion and internet traffic has been devoted to the behaviour and attitude of the MHRA, the UK government drug regulatory agency. The agency is widely regarded as an obfuscating body that acts against the public interest. Some have accused it of colluding with or ignoring industrial scientific fraud, and of acting based on severe conflicts of interest. It has been accused of failing to examine or secure raw data in drug licensing applications. The actions and omissions of agency may have led to deaths resulting from undisclosed, delayed or undiscovered information about pharmaceuticals in the UK.
Despite widespread professional and public concern about this agency, no meaningful steps have yet been taken by the UK government to safeguard pharmaceutical science, the public interest or public health.
The most comprehensive "official" report on the functioning of this agency can be found in the report of the Parliamentary Health Select Committee of 2005.
Extracts of The House of Commons Select Committee Report of March 2005 on the Pharmaceutical Industry
www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
"The consequences of lax oversight is that the industry’s influence has expanded and a number of practices have developed which act against the public interest. "
Page 4: The industry is by no means solely to blame for the difficulties we describe. The regulators and prescribers are also open to criticism.
Page 8: The industry is hugely influential ....Its influence in Parliament is extensive. The Annex lists the All-Party Groups the pharmaceutical industry supports.
Page 4: The regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate. 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 for licence application business.
Page 5: The Government, like the MHRA, has tended to assume that all is for the best... In view of the failings of the MHRA, we recommend a fundamental review of the organisation
Page 30: The MHRA is unusual in being one of
few European agencies where the operation of the medicines regulatory system 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.Much of the criticism was essentially of the lack of transparency and the difficulties for
doctors and others in assessing the research which is undertaken.
Page 52: The major impetus for greater transparency with medicines came from a lawsuit
brought in August 2004 by the New York State Attorney General against GSK, alleging the
company had concealed negative clinical trial results. As part of the settlement, GSK agreed
to set up a public register of all clinical trials on all of its drugs.This breached a 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 78: The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry ...Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it.
Page 79: Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process.239 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: Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; ..
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, in the absence of effective audit and verification of data that companies provide. ...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: In evidence to this Committee, Mr Brook expressed concerns about the influence of the
industry on drug regulation, specifically the perceived threat by MHRA staff of legal
entanglement resulting from regulatory action:
…every time we made difficult decisions there was always this issue of: ‘We have got
to be very careful because the pharmaceutical companies will sue us if we get this
wrong; they will take us to court and take us through legal processes’; and 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 of the
public.
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 publication of misleading promotional material is a criminal
offence and the punishment should befit such a status.
Page 106: The MHRA, like many regulatory organisations, is entirely funded by fees from those
it regulates. However, unlike many regulators, it competes with other European agencies
for fee income... dangers of the present arrangements....During this long inquiry we became aware of 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,
except those that could be remedied by more transparency. The Agency’s attitude to its
public health responsibilities suggested some complacency and a lack of requisite
competency, reducing our confidence in its ability to undertake the reforms needed to earn
and deserve public trust.
Page 117: The MHRA should put in place systematic procedures to randomly audit raw data.
"MHRA should be ashamed "
British Medical Journal News report on the ill fated TGN1412 drug trial and the MHRA is accused of coverup and whitewash in its investigation of itself. Drug safety expert Professor Joe Collier states "the MHRA should be ashamed.” Solicitors for the injured volunteers call foul and whitewash. (BMJ 2006;332;1290)
http://bmj.com/cgi/content/full/332/7553/1290-a
Do core MHRA staff have insight into scientific norms or an understanding of medicine?
Intellectual acrobatics
Here is an astonishing medical fact determined by the MHRA
(courtesy of Mr Ian Oulsnam , GCP inspector of the MHRA to the press on 3/6/2006).
One fracture. Now that's some blistering insight. A GCP inspector for the MHRA might be expected to have some medical insight particularly when when making public comment to the press on behalf of the MHRA.
If Mr Oulsnam had done some reading (or had spoken to his GP) he might have understood the concept of relative risk on therapy, the number of fractures that occur in osteoporosis, and the relevance of yellow card scheme fractures to the rather meaningless question he seems to be asking.
Mr Oulsnam may be excellent at his job serving the MHRA, but that he feels able to make such insightful public medical comments to the press on behalf on the MHRA is interesting.
We will keep you posted here on more blistering medical insights from
the MHRA. Mr Oulsnam says that he was somehow involved with the inquiry into the ill fated TGN1412 drug experiment - lawyers acting for the affected volunteers are complaining of a whitewash. It may be equally likely that the MHRA just couldn't understand why it might be a mistake to give a potentially toxic drug to 6 volunteers simultaneously while ignoring scientific advice.
Public Survey on possible corruption of the MHRA
http://www.network54.com/Votelet/39199
Corporate Killing laws and the MHRA
MHRA caught in "flat out deception"
Report by the Alliance for Human Research Protection (AHRP)
Resignation of Richard Brook Chief Executive of mental health charity Mind from the MHRA expert panel
Mr Brook stated
"On Thursday the Agency 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 license application.
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 well-being of the British public.
Paul Flynn MP "Regulator investigates the regulator"
http://www.paulflynnmp.co.uk/newsdetail.jsp?id=456
"We cannot allow the regulators to investigate the regulators" Paul Flynn said.
Shame and more shame on the MHRA
The Seroxat Support Group Website
This group is concerned about asking questions of the MHRA, and is seeking to determine whether the MHRA contributed to scientific deception and hiding of critical clinical data about the bestselling antidepressant, Seroxat. So far they seem to be receiving few answers.
Why are corporate scientific crimes shielded from criminal prosecution?
See http://www.ahrp.org/cms/content/view/192/94/
The TGN1412 disaster: Company Knew of the Catastrophic Risk--so did the MHRA
http://www.ahrp.org/cms/content/view/138/26/
Predictions in 2004 - Deaths in 2006
http://www.ahrp.org/infomail/04/12/06.php
How many preventable SSRI induced deaths and human misery was directly related to that MHRA decision?
When did the MHRA know?
The MHRA in poetry
Patient groups and doctors are convinced that the MHRA appear have delayed telling the truth, some accuse it of colluding in the hiding of information and in the telling of lies, and most critics claim that it has avoiding the proper answering of questions which might allay these concerns.
HUMAN SACRIFICE (ODE TO THE MHRA)
40 Mgs of Seroxat
to keep me safe from harm.
These drugs are not addictive
say's the suited man with charm.
They didn't warn of feelings
that swim inside my head.
feelings of hate, anger and jealousy
and wishing I was dead.
The secrets of Seroxat
hidden from us all.
To line the pockets of the rich men
while those around all fall.
Thank you Mr Executive man
and Pharmaceutical Industry.
Thanks for all those lies & cover - ups
and what you've done to me.
Time to spread your wealth out
make ammends to us poor souls
whose lives have been shattered,
whose heads are full of holes.
Goodbye dear Seroxat
Hello withdrawal hell
Who will feel the wrath of me
underneath this angry spell?
Thank God, I'm not the only one
whose head cries out in pain.
While the bastards at GSK
drown in financial gain.
There was a society of men among us,
bred from their youth in the art of proving,
by word multiplied for the purpose,
that white is black and black is white according to how they are paid
Jonathan Swift
Obfuscation and patient protest
Obfuscating responses to questions about personal financial dealings on behalf of Professor Sir Alasdair Breckenridge
Obfuscating answers about data never properly scrutinised by the MHRA pertaining to suicides in clinical trals
Patients feel the need to write apparently satirical pieces here about the MHRA "You cannot get me... I am untouchable."
Patient support groups question the MHRA - again and again but receive no response
Specialist drugs trial solicitor criticises MHRA report into failed drugs trial
Specialist drugs trial solicitor Ann Alexander,who represents the two most seriously affected victims of the Northwick Park clinical drug trial condemned the report released today by the Medicines and Healthcare products Regulatory Body (MHRA).
---This webpage is a collaborative effort
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The supposed mission statement
Safeguarding Public Health
"The MHRA should be ashamed "
Professor Joe Collier
Drug Safety Expert, London 2006