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Thread: MHRA licenses medicine without proof of efficacy shock horror!

  1. #1

    MHRA licenses medicine without proof of efficacy shock horror!

    The MHRA has announced its "landmark" registration of a medicine without requiring evidence of efficacy: Press release
    The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first UK product registration under the European Directive on traditional herbal medicinal products.

    ...

    Under the traditional herbal registration scheme products are required to meet assured standards of quality, safety and patient information. Minor claims are permitted on the basis of evidence of traditional usage.
    "Traditional usage". >:(

    In other words, if people have been wrong about something for a long time, it becomes right.

    The MHRA is the government agency that is responsible for ensuring that medicines and medical devices work...
    Oh yeah? >:( >:( >:(

  2. #2
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    Re: MHRA licenses medicine without proof of efficacy shock horror!

    I see that product information doesn't include trifles such as the fact that it doesn't work:

    http://www.mhra.gov.uk/home/idcplg?I...AGE&nodeId=595

    It's a wonder they don't make solicited testimonials a legal requirement...

  3. #3

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    With reference to:

    "I see that product information doesn't include trifles such as the fact that it doesn't work"

    A contention that is no doubt backed by comprehensive and rigorous research using the full "scientific method" plus peer reviews and extensive publication for each remedy that comes under the generality.

  4. #4

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    Quote Originally Posted by Richard King
    With reference to:

    "I see that product information doesn't include trifles such as the fact that it doesn't work"

    A contention that is no doubt backed by comprehensive and rigorous research using the full "scientific method" plus peer reviews and extensive publication for each remedy that comes under the generality.
    Pretty much.

    As I've mentioned numerous times (not to you, I know). Herbal medicine can work and valid remedies can come of it. Herbal remedy companies should be held to the same standard that pharmaceutical companies are though. If they wish to sell a product they should have to prove it's efficacy, they should then have to sell their herbs at a guaranteed level of purity and quantity of active ingredient per tablet\capsule.


  5. #5
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    Re: MHRA licenses medicine without proof of efficacy shock horror!

    Quote Originally Posted by Richard King
    With reference to:

    "I see that product information doesn't include trifles such as the fact that it doesn't work"

    A contention that is no doubt backed by comprehensive and rigorous research using the full "scientific method" plus peer reviews and extensive publication for each remedy that comes under the generality.
    I stand corrected, to this extent: some of it may pass tests for efficacy. If they are made.

    However, there is no pressure on manufacturers from MHRA to carry out such tests.

    Have another look at the foot of the link in the OP ( point 5):

    http://www.mhra.gov.uk/home/idcplg?I...rgetNodeId=389

    The MHRA is not doing its job of ensuring that medicines work and that benefits justify risks. Where there is no evidence of benefit in the form of efficacy, no such balancing can be done.




  6. #6
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    Re: MHRA licenses medicine without proof of efficacy shock horror!

    I see that Mongrel has got there first, and more neatly. :)

  7. #7

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    "Pretty much.

    As I've mentioned numerous times (not to you, I know). Herbal medicine can work and valid remedies can come of it."

    I am surprised that you have read up and verified so much material.

    Many medicines derive from nature anyway; not that they are necessarily the same by the time the chemical companies have finished with them.

    Several years ago, at a local Scientific and Medical Network meeting, I said that I had heard that over fifty percent of the prescriptions and advice provided by General Practitioners were not "scientifically proven". I was advised by the medical people present that was true. The Network Membership comprises approximately two-thirds medically qualified people.

    In addition, mainstream medical practitioners frequently prescribe "off label", outside the use parameters established by research.

    Recently, in Hampshire, a woman was cleared of murdering her baby by poisoning him with salt. There was a great deal of salt in the medication prescribed by the Consultant at the Hospital. He had based the medication given to the baby on a formula for adults.

    There are many failings in mainstream medicine and it is very fallible in its own right.

    Mainstream medicine also uses approaches and drugs without necessarily knowing how they work or what they are really doing; schizophrenia being a case in point.

    What is the scientific explanation for the cause of Schizophrenia? Not known.
    What is the scientific explanation for how drugs used control schizophrenia? Not known.
    That interesting information was on a the Web Site of a company that produces such drugs. The drugs are used though, presumably on an experience basis; which is, potentially, reasonable on the case studies providing evidence basis.

    "I see that product information doesn't include trifles such as the fact that it doesn't work:"

    Unless there is evidence, why include it in the product information?

  8. #8
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    Re: MHRA licenses medicine without proof of efficacy shock horror!

    " Unless there is evidence, why include it in the product information?"


    If there is no evidence of efficacy, we should be told.

    If there is no such evidence because the manufacturer is not obliged by law to look for it, we should be told that too.

  9. #9

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    Very quick reply....
    Only 50% of prescription medication Scientifically proven - Bullshit. Source

    No I haven't read up on everything, give me a couple of your favourites and I'll look them up for you though, if you want to wait a couple of weeks I should have my hands on the latest, all new Martindales

    Yes there are failings within mainstream medicine, to deny it would be a lie. The human body isn't a machine
    made from parts on a shelf and no two will react exactly the same way. Doctors are only human and despite the large amount of checks and balances within the system mistakes will still happen. The psych stuff I'm happy to leave to Dr. B as that's his speciality.

    Unsurprisingly though the Scientific Method works for the the overwhelming majority of the people who use it. It's been proven through replicable tests and continues to be proven as more information is gathered when it's oon the market - the testing and replication of tests never stops. Personal anecdotes, especially when they're on a website trying to sell you the stuff are as near to meaningless as can be and lack the necessary objectivity which is crucial to any reliable test result.


    Herbal medicine has had years to get it's act together and prove it's worth and all they can do is lobby for rules changes and handwave the bad stuff. I use Ibuproen when I have a headache because it works, when I buy the tablets I'm assured by Law of getting 400mg in each tablet + various inactive fillers and binders. I know that it went through years of tests and clinical trials. I know that when it was first released it was monitored to all get out.

    Compare that to a herbal equivalent. It's 'evidence' is based on folklore. some plants are chopped up and put into an easy to swallow pill or capsule and it's sold. No standardisation of ingredients, no tests, dangerous interactions only come to light after it's on the market, no chain of responsibility and no advice when buying.

    If your trying to sell a cure (and they make a hell of a lot of money out of the rubes) without evidence of it working that's fraud in my book.

  10. #10
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    Re: MHRA licenses medicine without proof of efficacy shock horror!

    Richard,

    There are many failings in mainstream medicine and it is very fallible in its own right. Mainstream medicine also uses approaches and drugs without necessarily knowing how they work or what they are really doing
    You seem to be arguing that because there are sometimes failings in mainstream medicine, it is therefore OK for herbal medicine to be completely unregulated.

    This looks like a non sequitur. If you think that herbal medicine ought to be sold without proper regulation, please provide positive arguments which support this position. Your attack on conventional medicine looks like nothing more than an attempt to distract attention from the lack of evidence advanced to support your thesis.

  11. #11

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    Reply to “Mongrel”

    “Only 50% of prescription medication Scientifically proven - Bullshit. Source”

    I do not remember the original source of the 50% scientifically unproven medical remedy claim. It was several years ago and there was more than one source as I recall; as with many discussions these things go in phases and it was quite prominent at the time. The point is that a group of fully qualified medical practitioners confirmed it to be true during the discussion to which I referred.

    Logically, it is entirely understandable as it would take vast research programmes to cover all eventualities met in practice.

    Anyway, to the best of my knowledge nothing can be scientifically proven; such “proof” comes down to probabilities, not absolutes.

    The scientific method is extremely useful but has its limitations and there is no proof that it is the best method, just, effectively, anecdotal evidence over the last few centuries that it is very useful in many applications.

    “Bullshit “… an interesting turn of “scientific” phraseology.

    The “Source” quoted is veterinary rather than human.

    “The human body isn't a machine.”
    Agreed but that does not prevent many people treating the human body as if it is a machine, as well as other living organisms. Richard Dawkins often heads towards the mechanics side and quotes what he supposes is an engineer’s view to substantiate his point. He is not an engineer, only a scientist and it shows. It actually looks very different to an engineer, at least from the perspective of my knowledge and experience. I am an engineer, with “additional facilities, faculties” as it happens, and am very well aware of the limitations of the mechanics approach, more so than most.

    If you wish to take particular medicines, that is your choice. Other people should be allowed their choice.

    Referring to herbal medicines;
    ”dangerous interactions only come to light after it’s on the market”.

    In the 1960s I returned home to find that my father had been rushed to hospital with a suspected heart attack. I rapidly found myself driving my mother to the hospital to see him.

    What had happened, it eventually transpired, was that my father had been preparing the “Cheese Board” in the hotel they co-owned and, afterwards, ate several of the off cuts of cheese. He was on prescribed medication at the time and was one of the first victims of a violent reaction to a combination of that particular medication and cheese. It was a dangerous interaction with a tested, prescribed medication that only came to light after it was tested and put on the market. Only after my father’s experience, as well as those of others, was there advice not to eat cheese while taking that particular medication.

    In addition, I recall a recent report of side effects, very belatedly coming to light, relating to a common brand of pain killer; I believe it is the one that is your stated preference to take.

    “… and that’s fraud in my book”
    The dictionary definition of fraud is deception by intent. If there is no intent to deceive, there is no fraud. Assistance provided in good faith, whether free or at a cost, is, therefore, not fraud.

    While not perfect, I do try to be careful and accurate with words and keep to accepted definitions rather than redefinitions; from technical articles to technical papers, First Degree projects, a Master’s Degree Dissertation, engineering reports and manufacturing standards where precision is essential. Hence, my forthcoming book, while being autobiographical and unique, is written, as close as possible, to the standards I am used to in engineering, despite the content.

    “... and they make a hell of a lot of money out of the rubes”
    “Rubes”?
    n. Slang
    “An unsophisticated country person”
    The Free Dictionary - Internet

    I tend to try to avoid pejorative language, references to people and ideas as it comes close to the ad hominem, argument against the person, personal attack, type of argument, which comes in the list of argument fallacies on the U.K. Skeptics Web Site, as well as elsewhere.

    I do tend towards being sceptical, despite my experiences and knowledge gained, but in the English Language, Oxford Dictionary sense, rather than the redefined, sort of mid-Atlantic, experienced conjuror equals a qualified scientist (it would seem), quasi, pseudo sense. I am prone to doubt rather than the tendency to deny.

    Drug companies also make “a hell of a lot of money” and, from reports I have read over the years, there is “scientific research” that tends to be suitably skewed in favour of that situation; much the same as with the tobacco companies.

    Closing Note:
    Due to commitments in the run-up to publication of my own book and involvement in a book being completed by a regression therapist colleague, my time to continue a dialogue in this detail is very restricted.


  12. #12

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    Reply to “Jocky”

    “You seem to be arguing that because there are sometimes failings in mainstream medicine, it is therefore OK for herbal medicine to be completely unregulated.”

    No, I am pointing out that mainstream medicine, the associated science, practice, etc., are imperfect, so perfection should not be expected in other areas.

    I come across many woolly argumenst, inaccurate statements, unsubstantiated categorical statemtens (as opposed to opinions, tentative or qualified views), approaches that are really justinsults, etc., directed at what is perceived to be non-science, etc. Often it is because of the way science, or some views of it tend to be described, and try not to fall into te same traps. Though huge assumptions are made about the efficacy of science anyway; it is a belief system, a religion, in its own right with some people, though they may well nto recognise it as such.

    In mnay areas it comes down to double standards.

    I would like to see more research into herbal remedies and many other aeras, though I would not like to see people being deined the right to choose what medicines they wish to use, other approaches to helath they may choose, or way of life they wish to follow by others who claim to know better but are not necessarily in that postion, or have that knowledge.


  13. #13

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    Quote Originally Posted by Richard King
    In mnay areas it comes down to double standards.
    Indeed it does. What we are talking about here is new products being introduced onto the market. The fact that some existing products have been grandfathered into the system without going through the current procedures is not relevant.

    Orthodox medicines being newly introduced onto the market need to produce evidence of efficacy before they can be licenced for use. Why should the same standards not be required for herbal medicines? After all, some of them certainly have effects, there is no question of that. Why not expect them to demonstrate this as any orthodox medicine must?

    It's not as if they have the problem that homoeopathic medicines have, that none of them can demonstrate any efficacy at all. This meant that following the implemention of the Medicines Act in 1971 no new homoeopathic medicines were placed on the market until the MHRA decided in 1992 that it was somehow unfair to expect useless medicines to demonstrate efficacy, and introduced a simplified scheme allowing them to be put on the market without demonstrating that they did anything at all (in fact, it required them to demonstrate that they were so dilute that they could not have any effect).

    If herbal medicines can be effective, why shouldn't they have to go through the same procedure as orthodox medicines? The double standard here is in not holding all types of medicine to the same standards. If they're effective, they don't need the same double standard that homoeopathy needs.

  14. #14

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    "Indeed it does. What we are talking about here is new products being introduced onto the market. The fact that some existing products have been grandfathered into the system without going through the current procedures is not relevant."

    It is relevant in that it is along the lines of moving the goal posts.

    If people wish to make use of particualr methods and systems, that should be their choice.

  15. #15

    Re: MHRA licenses medicine without proof of efficacy shock horror!

    Do you think it is necessary or desirable for herbal medicines to have their own set of goalposts? If so, why? "Customer choice" is not a valid reason for allowing manufacturers to put unverified and potentially misleading information on their products. If anything, it deprives the customer of the ability to make a properly informed choice.

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