MHRA... A step in the right direction?

Never thought I'd say this but I have to applaud the MHRA for recently requesting public comments on how they run the agency. Although not widely publicised, you, the patient, can now have your say into matters regarding the running of the MHRA.

GO HERE

Obviously, I saw this as a great opportunity so I read through the word document that explains the framework of the MHRA (HERE) and added my comments which were then forwarded to the email address provided within the document.

I can't help but feel that the recent onslaught of Seroxat blogs and support groups has had something to do with this. It is, however, a crying shame that we, as members of the public, have to have our voices heard through websites, blogs, forums before any action is taken.

I doubt very much if my comments will be publicised because they are more or less negative into how the MHRA are currently run and let's face it, the MHRA have a history of ignoring negativity.

I have therefore made the decision to post my comments on here for your perusal. That way, every man and his dog can see a differing opinion to the one that will no doubt be published by the MHRA.

As ever, my responses are in blue text.

Bob

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Making Regulatory Decisions about Medicines and Medical Devices

Dear Mr Watkins,

Thank you for allowing further comments to this document. Below I have added comments under each question (in blue text). I would be grateful if you could take on board some of these comments.

Meantime, I look forward to your reply.

Regards
Mr Robert Fiddaman
Birmingham, UK



A. What kinds of decisions are made about safety, quality and performance?
The Agency makes a range of regulatory decisions. They involve answering questions such as:

1 Do the design and conduct of clinical trials for medicines and medical devices provide acceptable levels of protection for participants?
Taking the recent TeGenero study into account I would suggest not.

2 Should a medicine or medical device be allowed on to the market in the first place? In effect, should it have a licence or CE-mark, or not?
Absolutely not. Would you buy tyres that hadn't been given a safety check first?

3 Once on the market, should a medicine or medical device remain there in the light of new information about its benefits and/or risks, or about the quality of manufacture and supply? If so, should its use be restricted or changed?
It should be removed from the market until it the 'new claims' have been thoroughly and rigorously investigated. If the medicine in question has been claimed to show addictive qualities then current patients on the medication should be allowed to continue. However, whilst under investigation, the medicine SHOULD NOT be prescribed to 'new' patients.

4 How can we ensure that we receive enough reliable information from healthcare professionals, patients and the public, as well as from companies, about adverse events with medicines and devices?
By adding your contact details to every Patient Information Leaflet. But more importantly by advertising in doctors surgeries, hospitals and the media.

5 When new information becomes available about adverse effects with a medicine or medical device, what extra advice or warnings should we or companies issue to healthcare professionals or the public, with what urgency and through which channels?
A full page spread in the popular tabloids and announcements on the TV and radio. A small news release is not enough.

6 If we become aware that a medicine or medical device is inappropriately or incorrectly used, or is inadequately maintained, sterilised or tested, what advice should be given or what other action should we or companies take?
Again, the public should be made aware and steps should be taken with immediate effect to rectify the problem.

7 How widely available should medicines be? Should a product be available for purchase from any shop, available only under the supervision of a pharmacist, or available only with a prescription?
The claims that Seroxat cures shyness would have had queues of people buying the drug over the counter. Drugs in this class should remain prescription only drugs. In fact, any drugs with 'severe' side-effects should be prescription only.

8 Where can a medical device be used with adequate safeguards? Can a product be used at home or should it only be used in the hands of a competent practitioner?
Logistically, this is impossible to impose. If the 'device is unsafe then measures should be taken to make the device safe again before it is allowed to be used at home.

9 Is the supporting information for professionals and the public about a medicine or medical device appropriate, readable and fit for purpose, or should it be improved?
Absolutely not. The Patient Information Leaflet on Seroxat for example is misleading and does not emphasise enough the severe side-effects this drug causes. There are probably many other drugs too. The PIL needs to be seriously looked at and NOT with the help of the pharmaceutical company who are marketing the drug either!

10 Are advertising or marketing claims for medicines justified and targeted at appropriate audiences?
No. Advertisng and marketing claims are false and misleading. The whole world and their dogs know this and I can't honestly see why the MHRA are so blinkered on this issue.

11 How can we best ensure that pharmaceutical companies and device manufacturers meet their legal obligations in respect of medicines and medical devices?
Remove from the MHRA any member that has or ever has had ties with any Pharmaceutical company. You currently have two on board at present who worked closely with Seroxat. Alisdair Breckenridge and Ian Hudson. For a start they need to be removed. I'm sure there are others who are former employees of Pharmaceutical companies.

12 How can we prevent or disrupt the supply of unauthorised or counterfeit medicines and medical devices? And how can we discourage inappropriate sales of second-hand devices?
A law change is the only way. The Government need to impose custodial sentences for anyone supplying counterfeit medicines.

13 What information in relation to our decisions can and cannot, for legal or other reasons, be made public? How do we strike a balance between the need for openness and the need to respect commercially sensitive information?
This should not be your choice. How can you make amendments or rules that suppresses information to an ever increasing public who have no faith in the medicines regulator? By doing so you are lengthening the gap of mistrust.


B. What principles inform decisions about safety, quality and performance?


1 Medicines and medical devices bring widespread benefits for patients and the public but no product is free of risk. Many decisions involve the weighing of risks of harm against the likelihood of benefits. If a product is available for use, its risks must be acceptable in relation to the potential benefits to patients and users.
..and must be clearly stated when before the patient agrees to take on the medicine or medical device. At present this is clearly not the case.


2 Some risks will be known when a product goes on the market but others will only become known later when it is widely used, especially if the adverse effects are rare.
RARE? You are having a laugh
1. www.paxilprogress.org
2. http://news.bbc.co.uk/1/hi/programmes/panorama/2982797.stm
3. http://news.bbc.co.uk/1/hi/programmes/panorama/2310197.stm
4. http://www.bbc.co.uk/pressoffice/pressreleases/stories/2003/05_may/11/panorama_seroxat.shtml
5. http://fiddaman.blogspot.com/
6. http://www.breggin.com/articlessummary.html
7. http://health.groups.yahoo.com/group/seroxat/
8. http://paxilfree.org/
9. http://web.archive.org/web/20040212065420/news.bbc.co.uk/1/hi/wales/north_east/2982056.stm
10. http://www.mind.org.uk/Information/SeroxatOMarticle.htm
11. http://news.bbc.co.uk/olmedia/cta/progs/03/forums/panorama/seroxat11may.ram
12. http://news.bbc.co.uk/media/video/39429000/rm/_39429728_seroxat_baldini_vi.ram
13. http://seroxatforever.wordpress.com/2007/03/07/hello-world/#comments
14. http://seroxatkillsbabies.wordpress.com/
15. http://shutah.wordpress.com/2007/03/04/sunday-3-march-2007/
16. http://bux2222.wordpress.com/%20Seroxat,%20The%20Damage%20is%20Done...%20Now%
17. http://news.bbc.co.uk/media/video/39429000/rm/_39429732_seroxat_disco_vi.ram
18. http://seroxatsecrets.wordpress.com/
19. http://www.sharisegatchell.com/
20. http://www.socialaudit.org.uk/
There are many, many more... and well you know it!

3 Decisions will be based on good science and robust methodology. Judgements on safety, quality and performance will be informed by all available, relevant and reliable evidence, with the burden of proof often resting on companies.
In other words.. Pharmaceutical companies can give the MHRA the data that is positive and NOT negative. What a proposterous way to safeguard human health!

4 A cautious approach to a decision will be needed where there is scientific uncertainty about the existence or extent of a risk but reasonable grounds for anticipating the possibility of severe adverse effects.
How many years will it take to investigate? Who will be responsible for the deaths and severe side effects bestowed upon the general public?

5 The Agency is concerned about the safety, quality, performance and use of a medicine or device throughout its life. The Agency will continue to seek and require additional information on risk and benefit, particularly since the initial authorisation or compliance with requirements may have been based on limited information. If the relationship between risk and benefit changes, so may the approval or classification of the product, or the advice to prescribers and users
Complete poppycock! As long as you have former Pharmeceutical employees employed by the MHRA you will continue to robustly deny any wrong doing by their former employers because it will clearly highlight the incompetence of the MHRA.

6 The Agency is committed to the principles of equality, and will not improperly or arbitrarily discriminate, for example on the basis of age, sex or race. However, the initial and ongoing approval of a product will legitimately take account of factors such as age, sex or race, particularly if any of these populations is a specific target for benefits or poses specific risks. So, for example, the effects of a product on children, on the elderly or in pregnancy may require explicit consideration.
Tell Breckenridge this - also have a word with Dr Benbow at GSK regarding their comments on the safety of Seroxat in adults. Benbow was even quoted as saying Seroxat was safe for children! Dr June Raine was also warned of the dangers as long ago as 2000

7 The financial cost of a product does not enter into the Agency’s decision-making processes, though bodies such as NICE and the NHS are properly concerned with costs
Unless of course it effects the financial interests of MHRA members?

8 The Agency’s decisions will as far as possible take account of the known views of relevant stakeholders such as medical specialists and patient representative groups
Yeh, sure it will

9 Decisions will be made under processes which comply with legal obligations and in which the public can have confidence
Oh puhlease - enough of the bullshit!

10 The Agency’s decisions will as far as possible be transparent and open to public scrutiny; a reasonable person reviewing our decision should understand the rationale
HAHAHAHAHAHAHA - (My last and final correspondence with the MHRA saw Mr Tim Berridge totally blind me with science. In fact a biological scientist would have had trouble reading the content of his 'transparent' answer to me)

11 If the Agency withholds information because of legal obligations such as the requirement to protect confidentiality, it is ready to give its reasons for doing so.
Yes, I and many others have heard these reasons - Exemption rule this, exemption rule that - purely rules invented to keep the public from knowing the truth.

12 The staff of the Agency and the members of its Advisory Committees are not influenced in their decisions by financial or other interests in the industries concerned.
Absolute and utter rubbish!



C. What questions should be considered to ensure that reasonable decisions are made?
We do not expect that all these questions will be considered in all situations or that there will be simple yes or no answers to many of them. The list is not exhaustive, and other questions may be relevant.


1 Does the product work and offer useful clinical benefit if used in its specified way?
Is there robust evidence that the product will do what the company says it will do?
On that basis the MHRA are in total agreement that Seroxat is safe in adults - despite the papers of Dr Peter Breggin that suggest otherwise.

2 What impact will the product have, or is it having, on both the quality and length of life in those patients who are treated with it or on whose behalf it is used?
Go to the websites (see Q, B2) and then YOU tell me

3 Has the manufacturer demonstrated that it can consistently and reliably make the product to the required level of quality?
Has the manufacturer demonstrated the data it supplied to the MHRA showed negativity as well as positivity?

4 Does the evidence available before a product is marketed give a clear indication of all adverse effects that have been discovered, the likelihood that they will occur and their severity?
In Seroxat's case, NO - Yet the MHRA still granted a licence for it.

5 If the evidence on safety, quality or performance is uncertain or unclear, is more needed before a decision can be made?
How much 'more' do YOU want? You have been sitting on Seroxat information for over 7 years!

6 Is there relevant evidence about everyday use of this or similar products, or do we need to seek such evidence?
A scientifically excellent clinical trial is of limited value if its design does not reflect the likely use of the product in everyday situations
Yes, SSRi's can cause suicide in both adults and children - You must do your homework

7 From knowledge of how the product works, is it possible to predict other adverse effects that may occur when the product is used with larger and wider groups of people, or in conjunction with other products? If so, are there clear plans in place to track and manage the risks?
Obviously not in the case of the MHRA - or Seroxat would have been pulled some time ago.

I think you get the message. I doubt very much if any of my comments will be taken on board. Your framework is commendable - Your ethics stink. You have far too much in common with the pharmaceutical companies whose drugs you are supposed to regulate. The general public have little or no confidence in you because of this.

8 Can the risk of adverse effects be limited by restricting the product’s use to specific groups of patients, or to particular dosages or durations of use?
There should be no risk of 'adverse' effects. All drug data should be properly scrutinised before a licence is granted to the company

9 What risks are associated with the condition the product is designed to manage?
Do the risks of not treating the condition outweigh the risks associated with the product? Is it a very serious/debilitating condition, or a mild and self-limiting one? Greater risks may be acceptable for products that markedly reduce suffering or treat life-threatening conditions, especially those for which no other effective treatment is available
It's alright asking these questions... I honestly have to ask myself whether or not the MHRA actually answer them as there seems to be an awful lot of 'bad drugs' being prescribed to patients here in the UK.

10 Can the Agency accept less evidence on which to base its decision if the rarity of the clinical condition means that more detailed evidence cannot reasonably be gathered?
Absolutely not! Would you let someone babysit your child without first doing a background check on that person?

11 Is the Agency prepared to accept early and limited evidence on which to come to a decision if a product, while appearing to have acceptable risks, offers significant or urgent benefits to public health or outstanding benefits to patients?
Based on the evidence the Pharmaceutical companies give you then yes. But you have to remember that their goal is to make money. Any risk will be played down and spun in such a way that only benefits the manufacturer. This IS NOT why the MHRA was set up!

12 Are there, or can there be, warnings for the public as well as for healthcare professionals about the nature and likelihood of adverse effects, warnings that are understandable and specific enough for them to make informed choices or to restrict the usage?
If not, how else might the risks be managed? Would it be better not to allow the product to come onto or to remain on the market, or to restrict its availability?
Cigarette boxes are straight to the point with their warnings - The public have a right to know that anything they consume or administor can be life threatening. This should not even be up for debate!

13 Does the Agency’s decision take account of the views of the public about the balance between risks and benefits? Should it, if the public’s views are in conflict with robust and comprehensive scientific evidence?
The MHRA only listen to the Pharmaceutical Companies. For years the MHRA have been recieving reports from the public about serious withdrawal problems from SSRi's. I, for one, have been banging the drum loudly in speaking out against Seroxat as have countless others, including Charles Medawar, David Healy etc. What has the MHRA done about this? - Absolutely nothing! Shameful.

14 Does the Agency need to seek further views from relevant parties?
In addition to the scientific evidence, do we need views from healthcare professionals, organisations concerned with specific conditions, and/or patients who have used the product?
Once, again, this question should not even be up for debate. It's common sense to find out as much information as possible about something you are about to grant licence to. Currently the MHRA grant licence to a drug based on positive data they recieve from the manufacturer. With ex employees of that manufacturer working for the MHRA it comes as no surprise that drugs will eventually be found to cause adverse reactions to the patient. You have to remove ex pharma employees from the MHRA immediately. Making press statements regarding ex employees having to leave the rooms when certain drugs are mentioned does not dupe the public. Get rid - and restore faith in the public - until then the MHRA will always be seen as Pharma's left arm.


D. Who makes the decisions?


1 There are three main groups within the MHRA involved in regulatory decisions about the safety, quality and performance of medicines and medical devices:

2 · Staff – the Agency’s professional staff make many decisions about the safety and performance of medicines and medical devices on a day-to-day basis, and about the quality of manufacturing and distribution. An Executive Board of senior staff oversees the work of the Agency and takes ultimate responsibility for the decisions made.

3 · Advisory Committees – groups of independent experts and lay representatives who advise on whether medicines and devices work and are acceptably safe, based on an evaluation of all relevant evidence, including that from the Agency. These groups include the Commission on Human Medicines, its Expert Advisory Groups, and the Committee on the Safety of Devices.

4 · The Agency Board – which is made up largely of external members, acts in a supervisory and advisory capacity and has a particular role in assuring the quality of decision-making.
All of whom have failed to regulate Seroxat in the use of adults. All of whom have review after review robustly denied there is any link to Seroxat and suicidality in adults despite the overwhelming evidence. The majority of staff will have ties with pharmaceutical companies too - This is proposterous!

5 In law, decisions by the Agency are decisions of the Secretary of State for Health who is accountable to Parliament. Ministers also make decisions on matters of significant public concern from time to time, advised by the Agency or its expert committees.
The people from the MHRA that advise the Sec of State are either ex-employees of Pharmaceutical Companies or have a financial interest in Pharmaceutical Companies. Patient support groups should offer advise to the Sec of State because we are the guinea pigs and have no vested interest in Pharma

6 There are other organisations and bodies outside MHRA which are also concerned with safety, quality and/or performance, principally in that:

7 · Organisations called Notified Body carry out a compliance assessment before manufacturers can place certain medical devices on the market.

8 · Many decisions made by or within other Member States of the European Union and by the European Medicines Agency must be respected or taken into account within the UK, just as decisions of MHRA can have an impact on other Member States. Experiences of problems are also shared in both directions.
Problems may be shared with Directors but little or nothing has ever been done about them, particularly in the case of Seroxat!

9 · Clinical trials of products are subject to the approval of ethics committees, complementing the role of MHRA, which is principally concerned with the scientific evidence.
An absolute nonesense! If the MHRA were concerned of the scientific evidence they would ask for RAW data to be presented to them, apparently this is not the case

10 We do not and should not have direct influence over ethics committees or European partners but recognise that their decision-making often follows similar principles; where we have cause for concern about decisions taken by others, we make that known through appropriate channels. A 'Dear Doctor' letter is NOT useful to the patient. Some Doctor's will ignore these letters because they too have targets to meet regarding the promotion and selling of drugs.

11 It is for doctors and other healthcare professionals to determine the suitability of particular medicines or medical devices for patients under their care, weighing benefits against risks and considering costs subject to guidance from the NHS and NICE.
This is a total cop out. On this premise it is an utter waste of time that the MHRA were set up. If the regulator did it's job in the first place the onus would not have to be put on GP's and Healthcare specialists to make a decision about the safety of a drug in a particular type of patient's illness. This is nothing more than passing your responsibilities over to someone who has even less knowledge about the drug than the actual regulator. What a complete farce!

12 Patients and the public will often have their own views about the suitability of particular medicines or medical devices. They are usually free to decide for themselves whether to use the products or not, supported by reliable information about risks and benefits.
How naive the MHRA must be. Yes, the public have a choice but that choice is taken away when the drug they take causes severe withdrawal that they have no option but to keep taking it.

13 We encourage both patients and healthcare professionals to report adverse events, through the Yellow Card scheme for medicines or Adverse Incident report forms for devices. These reports are important to the Agency, which analyses them alongside other new sources of information to determine whether action is needed.
Great idea on paper but does it really work? If the CEO of the MHRA personally believes a drug is safe then any yellow card report WILL NOT alter his opinion. The yellow card reports are followed up on a 40-50% basis - This IS NOT good enough - too many reports are either slipping through the net or are purposely ignored because they show that the regulaor has failed - personally I choose the latter.


I doubt very much if my comments will be taken on board because the MHRA, it seems, refuse to accept negativity. Such is the power of the internet though, these comments WILL be posted if no feedback is recieved. The public have a right to know. If the MHRA continue down the path they are going then the Patient support groups will get louder and louder.

There is a cancer running right through the Medicines Regulator - this cancer, however, is treatable - if it goes untreated it will be the demise of you. Remove members from the agency who have close ties with Pharma. Investigate (impartially and independently) every patient report. Set up a team to read patient support groups and to work with them and NOT against them and act with immediate effect when evidence comes to light that a manufaturer has been lying to you.


The following will be published on http://fiddaman.blogspot.com in the near future.

Yours sincerely
Mr Robert Fiddaman

Birmingham, UK