The Medicines and Healthcare Products Regulatory Agency
Note: We're delighted to share this post by Martin Walker. Martin covered the GMC trial in the UK moment by moment and is a copious author whose book "Dirty Medicine" is sharp and thought provoking. Please visit his website Slingshot Publications. Ordering information is at the bottom of this post.
By Martin Walker
Just this morning I saw Robert Kennedys meme about the control of the CDC by pharmaceutical companies and pharmaceutical company licensing. The situation is not quite the same in the UK but his statement ‘The CDC is not an independent agency, it is a vaccine company’ rang bells with me.
By infiltration the pharmaceutical companies have take over completely the regulation of pharmaceutical medicines in the UK. The most powerful of the groups involved is the Medicines and Healthcare Regulatory Agency, (MHRA), like the CDC the agency, responsible for licensing. Most people in Britain see the Agency as part of the UK government with a supportive civil service. However the MHRA, although apparently attached to the UK government, is actually a free standing ‘executive agency’.
The Agency employs more than 1,200 people and has facilities in London, York and South Mimms, Hertfordshire. It deals with the licensing of all drugs and has various departments which carry the pharmaceutical cause further. The group also has ex-police investigators there to harry alternative medicine practitioners and bring charges against them if necessary, and a small unit which sends out letters under the names of fictitious patients asking for information on alternative treatments. The executive Agency is wholly funded by the pharmaceutical industry.
Although the pharmaceutical companies pay the whole bill for the MHRA, there are occasions when the MHRA sees fit to make a criminal prosecution - yes the MHRA has the power to prosecute in criminal law - against an alternative health distributor or practitioner. Clearly it would be unfair to expect the pharmaceutical companies to pay for such cases, so when they do bring them, despite the fact that they do not pass through the Crown Prosecution Service (the governemt check on the validity of cases) they draw on the common purse getting the tax payer to fund their case.
The agency is run by a management board at present headed by Dr Ian Hudson who became chief executive in September 2013. Hudson is a physician who practiced as a paediatrician for a number of years, before working in the pharmaceutical industry in clinical research and development between 1989 and 2001, at which time he joined the Medicines Control Agency (former organisation to the MHRA) as director of its licensing division.
The head since 2014 of the licensing division, the most inbred of departments, which receives the majority of funding for MHRA from drug companies desperate to get their drugs licensed, is Dr Siu Ping Lam who the MHRA site assures us, has over 24 years’ experience in medicines regulation.
Dr Siu Ping Lam the MHRA site claims, has shaped many changes in European directives for pharmaceuticals, set up the traditional herbal medicines registration scheme, and the homeopathic medicines registration scheme.
A third member of the MHRA Board, worth noting is Gerald Hedell a microbiologist who is a Chartered Biologist and a member of the Society of Biology and the Royal Society of Chemistry. Hedell, previously worked for the National Health Service (NHS) but left in 1978, since then Hedell has worked in senior roles for the late Wellcome Foundation, Glaxo Wellcome and GlaxoSmithKline.
How the MHRA came into being is instructive. The Evans Cunliffe report, Study of Control of Medicines, published in 1987 written by a senior civil servant at the Department of Health with an ICI chemicals executive, a leading member of the Association of British Pharmaceucal Industries (ABPI), acknowledged the cosy, informal relationship between ‘officials’ in the DoH and ‘applicant companies’ seeking to license their products.
The report - that had come about because of the massive backlog of chemicals, drugs and apparatus in need of licences, which were piling up on the books of the Medicines Division - determined this informal co- operation to be a healthy state of affairs, which had regrettably been lost over the years. The report recommended that there was a return to this ‘informal communication’ between parties and that ‘both parties should take steps to encourage informal communication’.
DHSS (Department of Health and Social Security) and the pharmaceutical industry agree that communication between officials and applicant companies has become more formal in recent years, with more reliance on written notices referring to the terms of the Medicines Act. All parties agree the need for informal communication by telephone, letter and meetings help to remove misunderstanding and aid the smooth dispatch of business. (22)
This report signalled the first momentum in modern British history that ushered corporations into the structure of the Government’s civil service.
In order to solve the ‘backlog of licencing’ problems, a department in the DHSS was designated for the pharmaceutical companies, who would fund 60% of its cost. Within a short time, this was a booming ‘department of Government’, running all aspects of regulation and licensing of pharmaceuticals and paid for in its entirety, by licensing fees, by the ABPI and separate pharmaceutical companies.
Just as with the CDC, governments have left the pharmaceutical regulators to get on with their own business. Throughout the 1980s and 1990s there was constant sniping from the media, usually restricted to the minor question of the involvement of those within the wide ranging committees of the MHRA with vested inters. The much larger question, however, of who controls pharmaceutical licensing, has been left entirely to the pharmaceutical companies.
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May I bring your attention to the website www.mhracorrupt.st ?
10 public bodies have written reports stating the MHRA is corrupt.
Martin Walker is quite correct.
Posted by: David Noakes | September 21, 2017 at 05:55 PM
Grace
In fact, I succeeded in getting this comment posted on BMJ Rapid Responses this morning:
"Thanks to Dr Thomas for his shrewd and measured comments. I wonder whether the British government considered going down the path of the US Vaccine Injury Act in the 1980s and rejected it? This at least in theory took the legal decision to vaccinate out of the hands of the parents and placed it with the state. And while we have a very tardy and modest vaccine damage payment scheme in this country it remains the parent who is responsible for the decision - though the issue of whether consent is properly informed in many cases has been raised. It is an interesting question, apart from anything else, whether the state needs to take on this serious liability at such an awkward juncture in our history.
"I suspect another difficulty is whether going down the route of other countries with financial sanctions and denial of services against refusers - leaving the wealthy and powerful to make their choice while being coercive for lesser citizens - would be acceptable in the United Kingdom. It sounds to me like humbug."
http://www.bmj.com/content/358/bmj.j4100/rr-3
It is interesting that the doctor wanted to escape responsibility either for himself or the state, but just possibly that has been the main assumption under-pinning UK policy for decades.
Of course, another feature of this story is all the mainstream outlets who simply seem to assume it is is their business to take on the agenda of an industrial lobby, without asking any questions - the BBC being among the very worst offenders.
John
Posted by: John Stone | September 21, 2017 at 07:56 AM
Dear Martin, thank you for finding all that out, and also for your original article. Between you and John Stone, who needs an encyclopedia?! As for Eindecker, I'm not surprised he's anti-Brexit. With apologies to those here of the opposite political persuasion, I have to say Power to the People! It seems to me that a lot of people must be making fat salaries out of these duplicated regulatory bodies, and the sooner we get the process under the auspices of democracy the better. Especially given the way so many European countries are turning to making vaccines mandatory. There was a phone-in discussion on Radio Scotland (BBC) yesterday about whether vaccines should be made mandatory here. Some anti=vaxxers were allowed by the chair to have their say, and did very well, but a Public Health "doctor" then phoned in with the usual propaganda. He did, however dismiss the possibility of mandating vaccines on the grounds that a tiny number of children might have anaphylaxis and then the agencies would be responsible!
At least we're now having the discussion. Thanks again for this info. Grace.
Posted by: Grace Green | September 21, 2017 at 06:23 AM
So let me see if I have this right: from Poland, to Italy, to France, to Germany; western Europe is exploding in protest against mandatory vaccination. Something that no one on Democracy Now, nor MSNBC, nor CNN, nor FOX covered.
Jimmy Kimmel, and John Oliver, both of whom have never shied away from an opportunity to make fun of those of us whom assert that vaccines can cause autism, and both of whom just had medically fragile infants, (nothing to do with vaccines during pregnancy of-course) are lighting up the American media right now.
Today, President Obama stood behind a GAVI podium and stated that the healthcare bill being proposed by the republicans is an abomination (pun intended) because it will cut off spending to families dealing with autism.
You can't make this shit up. Putin is going to make mince meat of us all.
Please Kennedy, save us!
Posted by: annie | September 21, 2017 at 01:22 AM
"Self adjuvanting vaccine?"
https://badlymeattitude.com/2017/03/16/ides/
Posted by: Jeannette Bishop | September 20, 2017 at 10:30 PM
Dear Grace, You would think that I would know better than to write 'what I imagined was the case'. Of course I was wrong. Below is a description of both agencies, the European and the UK one.
There are two routes by which a drug may be granted a product licence in the UK:
• via the European Medicines Evaluation
Agency (EMEA)
• via the Medicines and Healthcare
products Regulatory Agency (MHRA).
The role of the EMEA in the licensing process
The EMEA was established in 1995 to co- ordinate the processing of European Union (EU) licence applications. The aim was to streamline the licensing process and ensure a homogeneous regulatory policy throughout the EU.
The EMEA is part of the EU Commission whose aim is “to promote the protection of human health and consumers of medicinal products”. In 2000, the Commission reviewed the role and function of the EMEA. The Commission’s recommendations are currently going through the process of agreement by EU Health Ministers and presentation to the EU Parliament for ratification.
The role of the MHRA in the licensing process
The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory authority for medicines in the UK. It was formed in 2003 from the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). Prior to the establishment of the EMEA in 1995, the MCA was the only route by which medicines could obtain a product licence in the UK. The role of the MCA/MHRA has changed substantially since 1995. A substantial part of the MHRA’s work is now to support the European process. However, whether the MHRA receives an application for a product licence as the sole agency or as part of the European system, the processes involved are essentially the same (see figure 3).
When applying for a licence the pharmaceutical company will submit a file to the MHRA, or the file will be received via the EMEA if the application is via the EU. The Committee on Safety of Medicines (CSM) within the MHRA will review the application and produce an independent assessment. The CSM is the advisory committee in the UK that can be considered equivalent to the CPMP in the EU. The CSM will either recommend a licence be granted, accept the application subject to modifications or reject the application with reasons.
Posted by: Martin John Walker | September 20, 2017 at 05:28 PM
Save your time Martin EMA licenses all the medicines across the EU, it was/is based in London but post Brexit who knows?
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
EMA protects public and animal health in 28 EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.
Posted by: Eindeker | September 20, 2017 at 04:44 PM
Dear Grace, Ye, to a degree your right about that: 'I might be completely muddled up, but I thought medicines were now regulated at a European', I don't know much about this but the European regulatory agency is in London - however it only deals with certain kinds of pharmaceuticals - I think things like biologicals, the plain bump and grind of 'health' drugs are handled by the MHRA in London. I'm sorry I don't know more about this, I look into it for you. Martin
Posted by: Martin John Walker | September 20, 2017 at 02:56 PM
Eindeker
Well, thank you for clarifying that, if that's what you did. Of course we are not only talking about Prof Pollard recommending products which he has developed via the JCVI, which has anyhow nothing to do with whether the MHRA or the EMA licensed them. Of course, Prof Pollard is professionally involved with both MHRA and the EMA as well.
http://www.ageofautism.com/2017/06/the-british-government-the-murdochs-prof-pollard-and-the-gsk-takeover-in-italy.html
https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership#clinical-trials-biologicals-and-vaccines-eag
I was of the impression that the price of Bexsero was negotiated between the British government and GSK which made an asset swap for Novartis's vaccine division, after Prof Pollard and the JCVI's recommendation - but it was the recommendation that led to global interest in the product. Might be another case of the Lord High Everything Else, eh what?
I hope you also enjoyed my re-visit to the swine flu saga last week.
http://www.ageofautism.com/2017/09/revisiting-the-swine-flu-fiasco-of-2009.html
Best,
John
Posted by: John Stone | September 20, 2017 at 12:47 PM
John let me try & explain for you: the European Medicines Agency (EMA) examines the clinical efficacy and safety data of any new pharmaceutical and if satisfied it grants marketing authorisation for that pharmaceutical to be sold anywhere within the EU (What is going to happen after the bloody farce called Brexit heaven only knows). It does not consider the cost effectiveness of that new drug, that is then the remit of the various national bodies such as the JVCI in the UK to negotiate reimbursement rates for the product, and indeed if it will be reimbursed at all. What national bodies such as the JVIC cannot prevent is a pharmaceutical company selling a product granted an EMA licence, but it can stop it being reimbursed if it is judged not cost effective as Pollard's JVIC did with Bexsero until the manufacturer lowered the price
If a pharmaceutical company only wanted to sell a product in a single country, such as the UK, it could apply for marketing authority just to that national body, eg the MHRA. This is a very rare case but it can occur if a pharmaceutical company wishes to extend to licensed applications for a drug that was licensed on a country by country basis before the existence of the EMA.
So John I am afraid that you are not correct in saying "the EMA and the MHRA are both licensing bodies, competing for business" I hope this has cleared this up for you.
Posted by: Eindeker | September 20, 2017 at 11:54 AM
Grace
I wouldn't claim to fully understand the situation but basically the EMA and the MHRA are both licensing bodies, competing for business. Nor would it surprise me if even after Brexit an EMA license will continue to be valid in the UK. I suppose if driving examiners only got paid if they passed candidates and were competing with each other it would be more or less similar.
Posted by: John Stone | September 20, 2017 at 10:15 AM
I might be completely muddled up, but I thought medicines were now regulated at a European level. Not that that would necessarily be any better, but could be affected by Brexit. A lot about this article is horrifying - I need to go away and digest it.
Posted by: Grace Green | September 20, 2017 at 09:19 AM
Martin
Are there other countries which are blocking these products?
Posted by: John Stone | September 19, 2017 at 04:32 PM
Yes John I have the privilege to read yours and Martins work explaining the most complex of organised criminal activity that is still to be believed by the mainstream press,public and politicians.
You both most certainly stood forward and were counted.
`Cometh the hour, cometh the man- well done you both!.
Pharma for Prison
MMR RIP
Posted by: Angus Files | September 19, 2017 at 04:15 PM
'The farce of non-regulation goes on. Of course, it just gets worse, more cynical, more corrupt, more daringly immoral by the decade.'
Couldn't agree more John. But it does bother me that in UK at least, these little skirmishes go on in relation to different products that do immense damage, when the whole system should be swept away and the culprits jailed.
.
Posted by: Martin John Walker | September 19, 2017 at 03:27 PM
Angus
Trouble is there are so many faces of the government industrial complex. The MHRA is an agency of the Department of Health but it is also entirely financially dependent on the industry it is supposed to regulate. What it means is that the powerful do exactly as they like and there is nothing to stop them.
Posted by: John Stone | September 19, 2017 at 02:57 PM
Very informative article Martin thanks.I never knew that the MHRA is independent ,another bit slotted into place.It would make the argument of all vaccines are independently tested even more absurd which I was having the other day with somebody that actually worked in one of the testing facilities the argument was won by me when I said who funds the testing company you work for-you moron?That was it debate over so obvious...
Pharma for Prison
MMR RIP,
Posted by: Angus Files | September 19, 2017 at 01:32 PM
Thank you Martin
Interesting to note the report of the House of Commons Health Committee in 2005 - it was bad then and nothing was done. Of course, that committee was dissolved immediately afterwards with the 2005 general election.
"The industry is by no means solely to blame for the difficulties we describe. The regulators
and prescribers are also open to criticism. 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 MHRA Chairman stated that trust
was integral to effective regulation, but trust, while convenient, may mean that the
regulatory process is not strict enough. 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."
https://publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
The farce of non-regulation goes on. Of course, it just gets worse, more cynical, more corrupt, more daringly immoral by the decade.
John
Posted by: John Stone | September 19, 2017 at 01:27 PM