The FDA

Discussion in 'Politics & The Economy' started by karkus30, Feb 18, 2014.

  1. karkus30

    karkus30
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    In light of the British FSA and its failure to find horse meat, the FSA that failed to control the banking industry, the NHS that failed to look after thousands of patients properly, the EA that did bugger all about potential flood zones. Well this is about the Federal Drugs Authority in the USA.

    Listening to a podcast last night from an independent consultant that tests drugs and medical devices for insurance companies. He revealed a startling statistic.

    Most companies approach him with a product which has passed the FDA trials and tests which cost them millions and take up to ten years to release for consumption. However, the companies trying to get the products on the insurers approval list have to satisfy independent assessment.

    Of the products passed and stamped by the FDA 71% fail the insurance company trials. As far as the consultant is concerned the bureaucratic stamp of approval is a pointless irrelevance. The insurance companies have to satisfy themselves that they will not end up in expensive court cases before issuing compliance.

    Even more startling is that he also has a list of products that were not accepted by the FDA which the insurance companies would like to use. Along with that, the ten year trials stop useful products coming to market. The independent companies take only 3 years and carry out a far higher number of trials with more in depth testing like double blind.
     
    Last edited: Feb 19, 2014
  2. Stuey1

    Stuey1
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    Yeah, they may carry them out but the evidence suggests they only publish the trials that show products in a good light :)
     
  3. kav

    kav
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    There's currently a major loophole in how pharma companies submit data to support their trials - all are allowed to cherry pick the results they generate to include only the favourable data that supports their objective. They are (completely legally) allowed to withhold data that may show their product in a negative light. Example, but there's loads on it all over the place. Ben Goldacre has been pushing for years to get ALL trial data published, so that properly informed decisions can be made on pharmaceuticals.
     
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  4. Stuey1

    Stuey1
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    Yeah, read both books a few times now and each time little bits amaze me more and more...
     
  5. karkus30

    karkus30
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    You mean the FDA or the drug companies ?

    Without FDA approval they can't get into the US healthcare market. Unlike over here-where we have public sector health care- the US have a greater proportion of private sector health through insurers. The insurers ignore the FDA/Pharma results because they need the most efficacious and safe products for their customers. Hence the double stage testing and FDA monopoly is creating massive additional cost whilst providing zero benefits.
     
  6. Stuey1

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    You may want to enlighten Ben Goldacre, I'm also not convinced they have the resources to run an adequate number of trials on every drug/medical procedure they will cover.

    You are right in the sense that the FDA approval means very little, because they don't insist on knowing the truth, only what the Pharma companies want to tell them. I can imagine they may run some trials in some parts of medicine but they would have to do an awful lot to trial every drug available (and if they don't do it historically then some of the trialled drugs / procedures will be trialled inadeqautely)

    if your post is just to point out that the FDA is useless, you can add the EMA to the list to and practically every other healthcare governing body in the world, as none of them force pharma companies to reveal all their data, and some actively help in hiding that data until forced to do otherwise.

    It's just standard for regulators isn't it? the PR for the regulator appears to be that it's protecting consumers, when in reality it's protecting the interests of the companies they regulate
     
  7. karkus30

    karkus30
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    Exactly. All these regulators are ineffective in action. I think there is a lot of evidence to suggest that the interests of the bigger companies are looked after by some regulators, but the wider point is that even without that possibility they are surplus to requirement. They are only required because of the monopolies created by the state. When you think out the cost of running them and the damage most of them do its worse than poor value.
     
  8. Stuey1

    Stuey1
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    Yes in their current guise they are worse than useless, they are actively damaging people's health with ignorance.
     
  9. IronGiant

    IronGiant
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    There is no British FDA. If people mean the MHRA or even NICE, then please say so, so as to avoid confusion when others then talk about the FDA.
     
  10. Stuey1

    Stuey1
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    I don't think it has been suggested there is :confused:
     
  11. IronGiant

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    First post :) First sentence :laugh: So it's difficult to know what he was talking about :)

    If he meant DEFRA why did he call them the British FDA, and who was the FDA later in the same post? his British one or the US one? ;)
     
  12. karkus30

    karkus30
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    Corrected. I meant FSA- food standards agency UK. A slip of the Acronym.

    I said the rest was about the US FDA - federal drug administration.

    So many acronyms and so little time.
     
  13. Stuey1

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    Sorry never even noticed it :)
     
  14. IronGiant

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    It's OK, karkus has now clarified (thanks karkus):thumbsup:

    And yes you (karkus) did state that the post was about the Federal Drug Agency, I must have skipped over that bit :suicide:
     
  15. tapzilla2k

    tapzilla2k
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    The coalition slashed the FSA's budget, moved some of it's responsibility to other Government departments. And It does not have it's own testing labs -
    BBC News - What is the Food Standards Agency?
    Therefore I do not believe you can pin all the blame on the FSA for failing to spot horse meat in the food supply chain. It's a failure of Central Government to insure that there are adequate measures in place to detect contamination in the food supply chain.

    The insurance companies insistence on safety trials is probably about medical malpractice suits in the US, more than the safety of patients. Big Pharma does rush through new drugs and can sometimes fudge the clinical trial data to get approval. The quicker they can get a drug to market, the quicker they can start recouping R&D costs and then make a profit. What you've said above is no surprise to me.

    Though you sometimes have to conduct in depth clinical trials of new drugs as you need to gather as much data about it as possible and to spot potential fatal side effects that may not show up in a short clinical trial with limited numbers of patients taking part. That takes time no matter which way you regulate new medications.
    You are raging against the state and failing to see the complexity of Chemistry and Biology in the world of big Pharma. Viagra started off as a heart/blood pressure medicine, but through the clinical trials the drug company noticed it's other effects on the male body and thus made millions. Even then it took them a while to get it to market. Sometimes mistakes = New use for a drug or it means needless deaths.

    I'd rather see draconian rules in place for safety testing and the gathering of clinical trial data over what you see in the world of Legal Highs. New Chemicals developed, might be tested by the creator (an Israeli scientist tests everything he creates on himself) and is then mass produced without much care for quality control in a lot of cases and people die as a result.

    As for NICE ? While I don't agree with all it's decisions it has an important job to do in terms of testing treatments/medications for their effectiveness and controlling costs. If we did not have NICE in place, then the NHS would have spun out of control a while ago.
     
  16. Stuey1

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    In Depth clinical trials should always be completed for any new drug, and they generally are - the issue is whether those trials are submitted to the regulators and the often questionable methods and conclusions of those trials

    Drugs only need a license for one specific use and they can then be prescribed for anything (off label)

    Again the issue isn't that there are draconian rules in place, actually quite the opposite - the regulators are better at protecting the companies interests rather than the patients interests. What the answer is (i.e tougher regulation / free market is debateable) - personally can't see the free market resolving anything here

    As far as I was aware NICE are in place to control the costs, but don't think they have any involvement in the testing and approval of drugs for use. (I could be wrong)

    As we are in the EU, I believe first and foremost the EMA have to approve the drug for use and once that is done the MHRA will approve it for use and then it can be prescribed for whatever a doctor feels it could work for. (which is another good reason all clinical trial data should be published)
     
  17. tapzilla2k

    tapzilla2k
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    NICE -
    I'm aware medications can be prescribed for other things, having been a lot of different medications for depression (I have a treatment resistant one, lucky me). Currently on a drug that is primarily one used for seizures but can also be used for Depression and Bipolar I or II.
     
  18. Stuey1

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    I did say I could be wrong, but if they do that I'm at a loss as to what the MHRA do...

    Cancel that - just noticed they publish Guidelines, they don't have a say in whether the drug is approved for use overall - just whether the NHS should be paying for it
     
  19. tapzilla2k

    tapzilla2k
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    I think it's basically that NICE recommends a treatment or drug and then it's the job of the MHRA to monitor what's in use. Probably more complex than that, but that's what I can make out of what it says on the MHRA website and wikipedia. So I also could be wrong.
     
  20. kav

    kav
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    MHRA audits pre-clinical and clinical trial data, and study data has to be submitted to them for review and approval prior to any drug being authorised for use in the UK (or even for progressing from pre-clinical to clinical trial stages). I used to work in pre-clinical trial pharma research, and the general view was that the MHRA weren't quite as rigorous (or bureaucratic, depending on your view) as the FDA - there were a whole host of other hoops to jump through to get a drug authorised for use in the US.
     
  21. IronGiant

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    Not wrong but the emphasis is the other way around. The MHRA is responsible for making sure that the treatment/drug do what is claimed and that they are safe to use. NICE then decides which of the available treatments passed by the MHRA they advise doctors to use, based both on their effectiveness and cost. (As I understand it :) ). As part of the MHRA brief is to continue to monitor whether the treatment/drug is safe and effective once it is in use, this might be what you picked up on.
     
  22. karkus30

    karkus30
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    My point is that they can't protect us from horsemeat. We would be better with independent private consultants doing this job as part of added value for manufacture, supplier, retailer and customer.
     

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