The MHRA invites your comments!

This just in from Seroxat Sufferers…

How Regulatory Decisions Are Made – Comments Invited – MHRA, UK

28 Mar 2007

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting comments on “Making Regulatory Decisions about Medicines and Medical Devices.” It has written a document that sets out:

— the main regulatory decisions that are made about medicines and medical devices;

— the principles that inform these decisions;

— the questions that are considered to ensure that the decisions are reasonable, and

— who makes decisions about medicines and medical devices – which includes bodies other than MHRA.

MHRA has drafted the document after consultation with a range of external stakeholders, including healthcare professionals, bodies which represent patients and the public, and the pharmaceutical and medical devices industries.

MHRA invites further comments on it. MHRA will consider all comments and expect to publish a revised version in the summer of 2007. Please e-mail any comments to john.watkins at mhra.gsi.gov.uk (at = @. @ was taken out to prevent spammers from picking up the email)

— You may want to mark up your comments on the Word version of the document, save it on your own computer and then e-mail it back to us.

— If you prefer just to use a simple e-mail, please make sure you note the page(s) and paragraph number(s) your comments refer to.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

We should let them know what we think… it’s only fair!

Posted in MHRA. 10 Comments »

10 Responses to “The MHRA invites your comments!”

  1. Matthew Holford Says:

    Tee hee! I’ve a sense that they already know what I think!

    Matt

  2. truthman30 Says:

    Hmmmm…
    Interesting…

  3. Matthew Holford Says:

    What thinkest, thou, Truthman? That’s a very pregnant “Hmmmm… Interesting,” if ever I saw one!

    Matt

  4. truthman30 Says:

    lol…
    What thinketh me is that the MHRA seems to be opening up to the idea of “good public relations” all of a sudden…
    I wonder why…

  5. Matthew Holford Says:

    Between us, I don’t think we’ve given them a whole of choice. As Karen Menzies pointed out to me, when I copied her on one of my recent missives to the MHRA, they know they’re being watched, and that the superficial PR flannel that they put out is being scrutinized very closely by a bunch of people who have become really rather skilled in cutting through the BS.

    Matt

  6. truthman30 Says:

    Hmmm..
    Maybe they have realized that there are many people out in the public domain who no longer have time for their BS…
    Still.. A step in the right direction it may “seem” to be..
    but how do we know for sure that they pay attention to any of the publics emails sent through this “new procedure”…
    How do we know that it is not just another PR move in order for it to appear that the MHRA listens to the publics concerns…?
    I will not trust the MHRA or any Drug regulatory board as long as former pharmaceutical industry employees sit on their governing panels influencing the regulation of drugs…
    Nor will I ever trust the MHRA until all employees are banned from holding shares/stocks or commercial interests in Pharmacetical companies …
    So, to the MHRA, (If you are reading this), I suggest you do some “weeding” of the organisation, as it seems to the general public at large that there is a lack of concern for the good of the patients well being …And it has become a widely held view that the MHRA is nothing but a smokescreen for Pharmacetical companies…
    And it seems to the vast majority also that protection of the pharmaceutical industry is in fact a much higher priority for the MHRA…
    Also I would like to say to the MHRA , (if you happen to be reading this), that you know well that Seroxat has caused as much harm as thalidomide and when are you going to act in the publics health interest and call for this dangerous , defective, highly toxic and intolerable drug to be withdrawn from sale?…
    How many deaths does it take from a drug for it to be termed a “publc health” catastrophe , how many piles of patient complaints does it take to mount up before you will listen to their concerns?…
    How many panorama documentaries will it take before criminal charges are brought against Glaxosmithkline and others involved for what is fast becoming the biggest medical scandal, cover up and gross fraud of our times?…
    When will the so called “criminal investigation” about the sinister Seroxat clincal trial data be brought to trial? …Why has it taken four years so far?.. And where is the transparency on this issue?..What stage is the “investigation” at ?…
    Who is accountable for the “seroxat scandal”…?
    Why did it happen?…Why was it “allowed” to happen?..
    Can we be 100 % sure that somethign similar will never happen again?…
    Until the public have closure and conclusion on the “seroxat Scandal” the MHRA will not be trusted…
    And until this happens , no drugs licenced by the MHRA can be deemed “trustworthy”…
    And until a full investigation into seroxat and the findings of that investigation are shown to the public , no “patient information leaflets” that the MHRA approves for any drug or “medicine” can be viewed as accurate …
    So… to the MHRA, why don’t you start doing the job which the public has entrusted you to do in the first place?…
    That is, to protect them from dangerous medications such as “seroxat”..And to listen to their concerns!
    And while you are at it, why not do a little in-house “spring cleaning”…Get rid of the weeds… They’re starting to rot…

    .

  7. truthman30 Says:

    http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030603&ssTargetNodeId=389

    The MHRA took it upon their good “regulatory” selves to warn of the dangers of BZP (PEP Pills), on the 20th of March this year, 2007…(clap clap clap, slap on the back)
    They went further to say that vendors of the “illegal” chemical may face prosecution…
    why?…
    Because the MHRA say that :

    BZP can result in agitation, vomiting, abdominal pain, seizures, abnormal heart rhythms, colic, diarrhoea, allergic reactions and fever. In rare cases, users may suffer from serotonin syndrome, which can result in death.

    But, they permit a chemical 100 times worse be legally prescribed by your doctor to you , that chemical is called Paroxetine : (trade name Seroxat… )

    And not only does Seroxat cause all of the reactions listed above, it can also cause a variety of hundreds of other damaging side effects…
    Ranging from inducing suicide, homicidal / violent behaviour, horrific withdrawals and addiction, malformations in newborns amongst many others…

    So we would have to ask ourselves, why would the MHRA allow Seroxat to be approved as a licenced chemical for human use and not BZP….? Even though Seroxat has a much worse Side effect profile than BZP….

    Could it be perhaps, that maybe the manufacturer of Seroxat have a certain influence in the regualtion system of the MHRA…?

  8. truthman30 Says:

    Did GSK break the Medicines Act …?

    “The Medicines Act 1968, which followed a review of
    the thalidomide tragedy, required controlled clinical trials to provide scientific evidence of the safety and efficacy of
    medicines, and applied strict controls on the marketing of medicines and the medical claims made on them. To
    protect the public the UK’s licensing body, the MHRA was set up to “enhance and safeguard the health of the
    public by ensuring that medicines and medical devices work and are acceptably safe.”

    Possibly? …

    http://www.socialaudit.org.uk/6060407.htm#1a

    In this link above, Charles Medewar of Social Audit recieves a reply from the MHRA regarding the criminal investigation…

    Suprisingly , ( or not ) as the case may be, it seems that this “investigation” is not yet complete…
    Makes you wonder if it is actually happening at all…
    And another interesting point, is , there have been articles relating to a possible manipulation of the original trial data of Seroxat… Mr medewar also addresses this in his letters …

    http://www.socialaudit.org.uk/6060116.htm#FOI
    http://www.socialaudit.org.uk/6060426.htm#Dear
    http://www.socialaudit.org.uk/6060217.htm#Dear

    What is the truth about this “alleged” manipulation of data, apparantly , according to some sources, GSK transferred the suicides from the paroxetine controlled group on to the placebo controlled group.. ( to make is seem like Seroxat outperformed the placebo) But it seems that access to information regarding this trial is murky at best, hidden at worst…

    Under the Medicines Act :

    http://216.239.59.104/search?q=cache:BmqIhkuWkJIJ:docs.justice.gov.mt/lom/Legislation/English/Leg/VOL_14/Chapt458.PDF+medicines+act&hl=en&ct=clnk&cd=10&client=safari

    …The MHRA has the power to suspend a licence for a drug if the drug breaks the medicines act, partcularly in the face of evidence of ineffectiveness and risk…

    These measures were brought in after the thalodomide tragedy around the 50’s and 60’s…

    It may be blatently obvious to some that Seroxat is the Thalidomide of our generation…
    But is it obvious to the MHRA, or are they just afraid to admit it for fear of the possible consequences of doing so…?
    Or maybe is it just easy to ignore a thalidomide-like tragedy with Seroxat , because Seroxat damage can be difficult to see, ( where as thalidomides is undeniable)…

    Seroxat causes internal psychological scars, damage to the brain , neuological impairment, memory loss, mind trauma and cognitive impairment .. All of these well documented and proven, but maybe much easier to deny than the deformed limbs caused by thalidomide…? ( but maybe the current evidence linking Seroxat Malformations in newborns could be the catalyst of this connection)

    What life lies ahead for those damaged by Seroxat?….
    What is the MHRA doing to help those damaged by Seroxat?..
    What does it propose those damaged by Seroxat should do?…
    Does the MHRA care about any of these issues?…
    Or will it continue to ignore the evidence of the Seroxat -21st Century – thalidomide until the internal scream of its own silence becomes so deafening that eventually it caves under the pressure?…

  9. Matthew Holford Says:

    Hey,

    I’ve been entertaining myself by reading the 2005 Health Select Committee Report “The Influence of the Pharmaceutical Industry”. It’s riveting stuff, in places, although the subject matter is hardly likely to make it a best seller!

    Dare I say it, however, the criticisms levelled at regulator and regulated appear not to have been addressed. The oldest of chestnuts, employment and contribution to GDP, have presumably been used as justification for inaction. I’m going to see if I can wake the debate up again, though.

    Personally, I don’t see that maintaining the status quo is an option. It may be a course of action, which favours a select few people, people who have the dubious ability to turn Tony Blair’s head, but I would question that as the acid test, when implementing public health strategy.

    Matt

  10. Matthew Holford Says:

    Oh, incidentally, I read in that Report that the DoH is ultimately responsible for drugs regulation in the UK, which it does through the MHRA, as we know. However, it is also responsible for the success of the UK pharmaceuticals industry. I wonder if the Ministry has a policy on the establishment of “Chinese walls”?

    The Select Committee recommended that responsibility for the success of Big Pharma be moved to the DTI, in order to avoid the obvious conflict of interest – has anybody seen anything announcing this, in the two years since the Report was published?

    Matt


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: