UK Medicines Control Agency (MCA)
renamed in 2003 the Medicines and Health Care
products Regulatory Agency (MHRA) & MRC
http://www.mca.gov.uk/
[The MCA became The Medicines and Health Care Regulatory Agency (MHCRA) and in 2005 the CSM became the Commission on Human Medicines.]
Committees: The Independent Review Panel for Advertising (IRPA) and the Independent Review Panel for Borderline Products (IRPBP).
On hearing of the MHRA for the first time, it might seem to many people that the MHRA is a 'normal' government regulatory agency. Few people would guess that the MHRA, while being the most important regulatory body for medicines in Great Britain, the organisation which, for example, processes Yellow Cards that notify the DH of averse reactions to drugs, is actually a trading company completely subsidised by the pharmaceutical industry. ....The history of the medicines regulatory agencies in Britain is a story of how the medical chicken crossed the road, from government participation and control of regulation to total immersion in the pharmaceutical industry.[Aug 2008] An Interest in Conflict? by Martin Walker MA
The Independent Review Panel for Advertising, primarily considers written representations from pharmaceutical companies as to the conformity of their advertising and promotional material with the Regulations, and to advise Health Ministers on the conformity of advertising and promotional material with the Regulations before a final decision is made by Health Ministers. Both the IRPA and the IRPBP has a policy of members declaring personal and non-personal interests. The latest declaration of interests that can be found on the internet for both these committees are for 2004 and 2005. It is frequent and common practice with both the MHRA and the DH, that they let site access to declared interests lapse over long periods....The IRPBP is an important committee within the MHRA. The committee decides which treatments are considered medicines and which are not allowed to call themselves medicines. In terms of pharmaceutical industry competitiveness, this committee is very important. One of the issues in the fitness to practice hearing held for Dr Wakefield et al, involves the use and prescription of Transfer Factor. I do not know whether this product has at any time been discussed by the IRPBP. [Aug 2008] An Interest in Conflict? by Martin Walker MA
The MHRA took over from the MCA in
2003. The MHRA is a Government Trading Fund; it might just as well be called a
business or a corporation. A Trading Fund is an almost entirely separate
economic entity which earns money by the provision of services and like any kind
of company, it must balance the books at the end of each year. A trading fund is
a government department, or an executive agency or part of the department, which
has been established as such by means of a Trading Fund Order made under the
Government Trading Funds Act 1973 (as amend the Government Trading Funds Act
1973, 26th July 1990). Typically, trading funds operate in very specialised
fields and rely on their ability to derive income from their activities in order
to cover their costs. Examples of trading funds are the COI and Ordnance Survey.
However, unlike a number of other
Government Trading Funds, which provide services, earn money and accept fees
from diverse ‘beyond government’ sources, the whole of the MHRA income is
provided by one funder; the pharmaceutical industry. Further, a percentage of
staff and executives of the agency, have come into it from the pharmaceutical
industry. It is therefore not surprising, that funded and partly staffed by the
industry, its policies are shaped to please this sector.
The MHRA has the largest policing and
enforcement department of any European medicines regulation agency, a part of
the Enforcement & Intelligence Division (E&ID) of the Agency. Although
contemporary government in Britain is characterised by quangos, and the
attachment to Government of private vested interests, the MHRA is, as has been
explained above, a business in itself which makes profit from the provision of
services to the pharmaceutical industry. Inevitably there exists a high level of
cynicism and some anger in the world of alternative medicine that, in effect,
non-pharmaceutical treatments, which have not on the whole been proven harmful
and against which no complaint has been levelled, are now regulated by a
commercial concern which is managed, staffed and funded by the pharmaceutical
industry. The cynicism is inevitably greater amongst those who realise that the
pharmaceutical industry are also charged with overseeing the adverse reactions
of their own medicines, which kill and maim many thousands of people.
From a legal point of view, perhaps the
most worrying aspect of the MHRA, is that like the Atomic Energy Authority,
it has its own police force, in this instance, paid for by the pharmaceutical
industry. The two Divisions of the MHRA which are important in relation to the
tracking of supplements and compliance and legal enforcement are firstly, the
Medicines Borderline Section and the Enforcement and Intelligence Group, which
gathers information on individuals who promote suspected medicines.
The Group raid premises, make and take statements and
confiscate products, computers and paper work. Although they are not police
officers they can obtain warrants for raids from Magistrates and Judges.
Enforcement often links up with Trading Standards Officers in local areas.
‘Officers’ in the enforcement group have their own powers conferred by the
Medicines Act 1968 and subordinate legislation applying to the Act. These powers
include the right to enter any premises to inspect, to take samples, to require
production of any books or documents and to take copies of, or of any entry in,
any such book or document. ‘Officers’ are bound by the Police and Criminal
Evidence Act (PACE) and PACE codes of practice. It is a criminal offence to
obstruct an enforcement officer. However, this particular police service stands
well outside the discursive apparatus of accountability which exists either
within the London Boroughs or at County level outside London. These enforcers
are literally a law unto themselves – or more specifically, the law of the
pharmaceutical companies.
When considering conflict of interests,
the workings of the MHRA have to be seen in light of the fact that the agency is
completely beholden to the multinational pharmaceutical industry. [Aug 2008] An
Interest in Conflict? by Martin Walker MA
See: FDA Vaccine Conflict of Interest quotes ACIP: The Advisory Committee on Immunizations Practices Joint Committee on Vaccination and Immunisation
The pharmaceutical industry has ferreted it's way into the medical-legal system in a way that no other industry could have managed. The regulatory body for the drugs industry, the MHRA (previously known by the massive euphemism as the Medicines Control Agency), which is meant to be a department of government within the Department of Health and answerable to the Minister for Health, is actually a trading organisation wholly funded by the pharmaceutical industry. In common with the Atomic Energy Authority and the British railway network, it has it's own police force, and is able to bring charges of the most serious nature against individuals; it takes people to court and the court can send them to prison. However none of the charges prepared and brought by the MHRA pass through the offices of the Crown Prosecution Service (CPS). None of the charges are overseen by any kind of independent body that measures the quality or even the quantity of the evidence. [21st July - 25 July] Tell me, how many forks are in your tongue? by Martin Walker MA
COMMITTEE ON SAFETY OF MEDICINES
MRC Announces New Chief Executive
The Medical Research Council UK has just appointed a new CEO to replace Colin
Blakemore, Sir Leszek Borysiewicz.
See MRC Press
Release, together with a
Borysiewicz
Backgrounder from Imperial College.
A dedicated proponent of the vaccine industry, Borysiewicz is noted for his
research into developing vaccines, in particular the vaccine associated with
cervical cancer over which the
adverse reactions data and death statistics continue to roll in. Borysiewicz
has also been governor of the Wellcome Trust.
It remains to be seen as to whether we will all welcome Borysiewicz's arrival as
CEO of the Medical Research Council UK.
The One Click Group
[UK Jan 2007 B17] Vitamin seller made a criminal----MHRA worked with BBC Wales to entrap Jim Wright.
[Media 2000] Alarm as drug company chief joins watchdog A top executive at one of the world's leading pharmaceutical companies is to become director of drugs licensing at the medicines control agency, raising questions about the independence of the MCA from the industry that it is supposed to police. Ian Hudson will take up his new job in February. He has worked in the drugs industry for the past 11 years and until recently was director and vice- president of Worldwide Clinical Safety, at SmithKline Beecham, and was to have led the worldwide drug safety group after the merger of SKB with Glaxo Wellcome, which came into effect yesterday.It's virtually impossible to sue a pharmaceutical company in Britain, partly because of the difficulty of getting any funding for such actions. There's no point appealing to the government drugs watchdog—the MHRA. It is a small outfit entirely funded by the drug industry. It has never taken any action against the academics who make fraudulent claims in ghostwritten articles, nor doctors working for the companies who repeat such claims, even when they have been shown to be untrue. So the only other body to turn to is the General Medical Council, whose job it is to investigate the conduct of doctors — but it has shown no inclination to act. Why you should never trust new wonder drugs by Prof David Healy
"The Medicines and Healthcare Products Regulation Agency found from information that had been in its possession for more than a decade that high doses of the anti-depressant can lead to aggression and thoughts of suicide. But instead of revealing the truth to the 17,000 people taking high doses and the other half-million Britons on a safer dose, the MHRA sat on its findings. Astonishingly, I was actually threatened with legal action by Professor Kent Woods, chief executive of the MHRA, if I revealed this."---RICHARD BROOK
"The inquiry into the safety of the widely prescribed antidepressant drugs Seroxat and Prozac, and others of their class, has been halted by the medicines control agency after the revelation that two of its members have drug company shareholdings."--Media March 2003
"Its meetings are held in secret, and no minutes of proceedings, apart from revealing the names of attendees, are ever made public. Any member who would dare step out of line and reveal proceedings to the press could face two years' imprisonment if the information compromised a drug company and its work.....It is one of the few drugs agencies in the world to be entirely funded by. . .the drugs industry."--WDDTY 2003
"The MCA is of course headed by a former top executive at SmithKline, Dr Ian Hudson."--Private Eye
"Professor Stephen Evans, of the Medicines Control Agency, said Dr Wakefield's paper was flawed and made a number of errors of fact. He said their trials had showed the MMR vaccine is as safe as the single measles vaccine."--Media
Professor Roderick MacSween, a professor of pathology at Glasgow Western Infirmary, had nearly £26,000 worth of shares in Glaxo ---SmithKline. [Media 3/2001] WATCHDOGS (MCA) LINKED TO MAKERS OF MMR JAB
Dr Michael Denham, a retired consultant in geriatric medicine and a member of the committee on Safety of Medicines External Advisory Panel, owned £250,000 worth of shares in GlaxoSmithKline. Professor Roderick MacSween, a professor of pathology at Glasgow Western Infirmary, had nearly £26,000 worth of shares in Glaxo ---SmithKline. [Media 3/2001] WATCHDOGS (MCA) LINKED TO MAKERS OF MMR JAB
Dr Michael Donaghy, a brain specialist at Oxford’s Radcliffe Infirmary Hospital, who sits on the MCA had £19,000 worth of shares. 11 professors and doctors have received fees for research from Aventis Pasteur. [Media 3/2001] WATCHDOGS (MCA) LINKED TO MAKERS OF MMR JAB
"A Sunday Express investigation has found that nearly a third of the 181 experts who sit on the Medicines Control Agency (MCA) committees are linked to GlaxoSmithKline, Aventis Pasteur or Merck, Sharpe and Dohme......The MCA has continued to endorse the triple measles, mumps and rubella (MMR) jab despite concerns linking it to autism and stomach disorders. But the extent of the MCA members’ financial ties to MMR manufacturers raises questions about potential conflicts of interest."--Sunday Express
"Two important new scientific studies 1,2 do not support the suggestions that MMR or MR vaccines may cause autism or Crohn's disease. These studies represent objective scientific work undertaken into theories about the safety of MMR or MR vaccine. Both studies support the conclusions of earlier safety reviews carried out in 1997/1998 by independent expert committees; the Committee on Safety of Medicines (CSM) and the Joint Committee on Vaccination and Immunisation, and the Medical Research Council. 1. Committee on Safety of Medicines, Report of the Working Party on MMR vaccine; May 1999. 2. Taylor, B. et al. Autism and measles, mumps and rubella vaccine: No epidemiological evidence for a causal association. Lancet in press; June 1999." http://www.open.gov.uk/mca/cpvol25cinsert.htm
It was impossible to prove or refute the suggested associations between MMR vaccine and autism or inflammatory bowel disease because of the nature of the information, the self-selection of cases and the lack of comparators. Nevertheless, the Working Party found that the information available did not support the suggested causal associations or give cause for concern about the safety of MMR or MR vaccines. http://www.open.gov.uk/mca/volume25jun.htm