Influence of pharmaceutical & Mhra

MHRA Karma is a bitch ...

“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 the agency may have led to deaths resulting from undisclosed, delayed or undiscovered information about pharmaceuticals in the UK.”
  This article goes on to quote several extracts from The House of Commons Select Committee Report of March 2005 on the Pharmaceutical Industry, which found: “The organisation MHRA 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.”

"  Now that their behaviour is being exposed, questioned, and held to account by the masses, it is increasingly hard for these agencies to spin their lies, and especially to defend them. And this is not just the case in the UK. "

Swedish Journalist Takes on British Drug Regulator 
And we come to the role of MHRA and my questions to you:
1. Did MHRA “handle” aggression, and other serious adverse events, in the same way as the Swedish authorities did? (In other words, not at all.)
2. If so, how could MHRA, considering what the agency knew about the harmful effects of the almost identical drug Concerta, fail to go further with the investigation about this manipulation of data?
3. If MHRA actually challenged the manipulated data about adverse effects in Novartis’ application for Ritalin, I assume the agency arrived at the same conclusion as in the Concerta investigation – that the drug could not be approved. I would be happy to get a copy of that important assessment report.
Yours sincerely,Read more 

Britains shadow government Unelected, Unbalanced and Unaccountable.. 
12 March 2012  Democracy itself is being undermined by publicly funded agencies crawling with conflicts of interest and devoid of scrutiny  Other health agencies seem similarly unbalanced. MHRA, the medicines and healthcare products regulatory agency, is the body that has been criticised for failing adequately to regulate breast and hip implants, with grim consequences for some patients. While the board contains retired senior executives from AstraZeneca and Merck Sharp & Dohme, it includes no one from a patient group, or any other body representing people whose health could be damaged by its decisions. The web of unelected bodies functions as a kind of shadow government, drafting and enforcing policies, disbursing money, regulating – or failing to regulate – business, quietly, unobtrusively, without effective public scrutiny or restraint. When it is unbalanced, crawling with conflicts of interest, it makes a nonsense of democracy. This is how governments get what they want, regardless of what the voters might think. Read more

The MHRA, Ian Hudson and the House of Commons
January 15, 2012   A short while ago, I wrote a post about Dr Ian Hudson. Hudson is currently the MHRA’s Director of Licensing – but the job he had before he joined the agency was at GlaxoSmithKline – he was their Worldwide Director of Safety and we know from his CV that one of the drugs he had “significant involvement with” was, in fact, Seroxat…In my previous post I bemoaned the fact that Hudson had decided to go elsewhere on the day he was expected to be questioned by the House of Commons Health Select Committee about Seroxat safety and trial data. The MHRA has been questioned about the secret data that Glaxo kept hidden for more than a decade. The MHRA replied that they were “confident that neither Professor Breckenridge nor Dr Hudson had prior knowledge of the data discussed in Dr Breggin’s report.” Does the MHRA really expect us to believe that Glaxo’s Worldwide Director of Safety, who had a “significant involvement in Paroxetine ” (Seroxat), did not have full knowledge of ALL the trials and data that appertained to this particular drug? Does Ian Hudson expect us to believe this?   Read more;

Glaxo & the MHRA
June 8, 2010  Certainly the MHRA (the UK’s medicines watchdog) has always had VERY close ties to the drug industry, and I mean VERY close. The revolving door that connects the MHRA and GlaxoSmithKline (in particular) has always been well used. The Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK (then known as SmithKline Beecham), as is the Head of Licensing at the MHRA, Dr Ian Hudson . Hudson is much more interesting – he worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing. During his time at SmithKline Beecham and Glaxo he had “significant involvement” with a number of drugs, especially Paroxetine (Seroxat) and two others. We know this because of this document – Ian Hudson Interests  which he filled in before joined the European Medicines Agency.  Read more;

Everything you ever wanted to know about… Ian Hudson
February 5, 2007  The job he had before he joined the MHRA was at Glaxo – he was their Worldwide Director of Safety and we know from his declaration of interests to the European Medicines Agency,  , that one of the drugs he had “significant involvement with” was, in fact, Paroxetine (Seroxat).

Time to review the MHRA?
Jan 15 2007    In 2005, the Health Select Committee Report outlined the problems with the MHRA. Dr Aubrey Blumsohn (who is not a psychiatrist and yet has similar concerns about the regulation of ‘medical’ drugs) sets this out well, and you can read about it here The report did not mince words when it came to the MHRA: “The Government, like the MHRA, has tended to assume that all is for the best…”“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 closeness that has developed between regulators and companies has deprived the industry of rigorous quality control and audit.” “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 … The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency…”  Despite this report on the MHRA being published in 2005, as we move into 2007 has any action taken by the government?  None at all. Download the
report here – just scroll down to 5 April 2005, Fourth Report, “The Influence of the Pharmaceutical Industry”    Read more;

Drugs watchdog linked to pesticide company
30 October 2005  Britain’s top drugs safety watchdog has been forced to declare an interest in one of the world’s largest pesticide companies, following an investigation by the Sunday Herald. Sir Alasdair Breckenridge, the chairman of the UK government’s MHRA, decided late last week to formally register his involvement with Swiss agrochemical giant, Syngenta. This was despite previously saying that there was no need to declare his interest. He changed his mind only after responding to a series of allegations about potential conflicts of interest.The Sunday Herald can reveal that Breckenridge has been chairman of Syngenta’s ethics committee for the last five years. The committee is responsible for approving company arrangements for testing toxic pesticides on human volunteers, a controversial and secretive practice. The revelation has prompted fierce criticism from health and pesticides campaigners. Read more

UK parliamentary Inquiry into pharmaceutical industry
June 18 2004   In March this year Mr Brook resigned from an MHRA advisory panel on SSRI antidepressants, expressing concern that the agency had been aware of these problems, but had failed to act .Richard Brook said,  "The announcement that the Commons Health Committee is to investigate the role of the drugs companies in relation to the way medicines are developed, promoted and regulated is a significant victory for the British consumer. In particular, it is testament to the determination of ordinary people to have their concerns over antidepressant side effects heard and acted upon by the regulatory authorities Read more

The drugs industry and its watchdog; a relationship too close for comfort
4 October 2004    
Read the documents obtained by the Guardian about the drug industries relationship with its regulatory body
MHRA documents - 1 |   Special Reports |  The drugs industry and its watchdog: a relationship too close for comfort? ...drugs 4 drugs 5 drugs 6 drugs 7 drugs 8 drugs 9
MRHA documents - 2 |   Special Reports |  The drugs industry and its watchdog: a relationship too close for comfort? ...drugs 14 drugs 15 drugs 16 drugs 17 drugs 18

MPs have also been worried by the agency’s behaviour. In 2005, a highly critical report by the Commons health select committee objected to a lack of openness and the MHRA’s closeness to the pharmaceutical industry. It warned that scandals on the scale of Vioxx would happen again because the regulators were not sufficiently independent. In response, the agency said: ‘Since November 2005 all staff and immediate members of their families are not allowed to have any financial or other interests in the pharmaceutical industry

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