This is actually a sensible idea

Dear God, what are we coming to? Government doing something sensible?

NHS cancer patients to be offered experimental drugs
Cancer patients will get much quicker access to experimental drugs and other treatments still in development, David Cameron will announce today.

The biggest cost in pharmaceutical development is the trials. Phase III trials particularly. phase II trials clearly come before them.

If you wanted to aid the pharma industry then you\’d try and find a way in which organising such trails is easier, cheaper and above all, faster. For the patent clock starts running before these trials are even attempted.

No, really, you get 17 years on the patent and the first 6 to 7 of those years are spent in trying to show everyone that the drug actually does something useful and doesn\’t kill people in the meantime.

So, allowing earlier access to experimental drugs means that those tests can be done earlier/faster and then the few drugs that make it through the process have more patent time, are more profitable and hey, we\’ve just given pharma a boost.

And it\’s by definition a boost that will happen in the UK, for it\’s the NHS that will be offering these new drugs.

There\’s also the interesting side effect that those who get these new drugs that do work will live longer, some of them will even be cured of their ailments.

All very sensible: so the one thing we know about it is that a politician didn\’t think it up. But at least they\’ve picked up the idea, eh?

7 comments on “This is actually a sensible idea

  1. As a Freddie Mercury fan I find it very sad that he died just about when the revolutionary AIDS treatment saquinavir was entering phase II clinical trials. In certain situations the approach Florey and Chain used with penicillin is surely appropriate, basically pump it in as soon as you think it may work and the mice aren’t dead.

  2. Actually, it is the only way to run a full-scale test. You *do* need to run toxicology tests first and have a reasonable expectation that it will work *better* than the current treatment before you try it or Hippocrates will kick you out of the profession but currently you need to get people volunteering for, rather than just agreeing to, the trial treatment so you don’t get enough test subjects to produce adequate data. Lots more might volunteer if they were given the chance.

  3. Na, this isnt about helping the UK pharma industry. Its a very immoral way of trying to improve NHS healthcare outcomes without spending any extra money.

    And the NHS patient data dump will create about zero jobs in UK pharma (and probably several hundred NHS data admin jobs). What dear dave has forgotten is that data can be copied… The horror!. The data dumps will most likely be processed in (order) china, india, usa.

    @noel C. Only healthy patents are given the drug during phase I. Phase I is trying to work out how toxic the drug is in humans. Phase II trials are then performed to prove the drug actually works (and gather further safety data). So taking a drug that you dont know works, with a good possibility that it is harmful, is a good idea? A rather infamous German dude had the same idea too.

  4. @Alan, I don’t think Hitler made use of volunteers, a somewhat important difference. (And he was Austrian).

  5. @Alan

    I’m well aware of what happens in each phase of drug testing and indeed I would suggest that it is phase III that “proves” a drug “actually works”. To elaborate on my point, when Florey and Chain injected penicillin into a man with a severe bacterial infection they were carrying out what would now be considered a phase II trial using a drug not tested in phase I. They would have saved his life if only they had isolated enough penicillin for a full course.

    I am speculating that some lives could have been saved if that same approach was taken with saquinivir, i.e given to seriously ill AIDS patients once in vitro efficacy was shown and basic animal model toxicology complete.

    I think the current testing regime is sound, I am just suggesting that for a small number of severe conditions the inevitable delay introduced by said regime leads to an excessive unseen cost.

  6. I can’t tell from the reports what Cameron’s plan actually is, can you? Is he going to publish NHS data, or sell it? What’s he going to do to promote clinical trials, say he’s in favour of them or fund the administrative support in hospitals? Is he going to do anything to speed up NICE decision making? – currently they plan to make a decision on Abiraterone next May, 20 months after the success of the Phase III trial.

  7. @ChrisM, Currently some NHS doctors are not informing patients (and family) that they have issued a “Liverpool Pathway” order, so I have doubts that many of the NHS patients will be “volunteering”.

    @Noel C, fortunately the patient wasn’t allergic to penicillin. How will SUSAR’s (suspected unexpected serious adverse reactions) be reported? Normally thats part of a clinical trial. If a doctor is prescribing experimental drugs outside of a clinical trial will doctors report the SUSAR, or even realise its a SUSAR? And if Doctors do submit a SUSAR that has a direct impact on approval, and if the MRHA is doing its job then they will want to know a whole host of other patient details like concomitant medications, medical history etc. And even if you ignore safety reporting, the pharma is going to be interested in the patient data for efficacy.

    Also, I’ve never heard of a pharma company being sued because a patient in clinical trials has died of a SUSAR. So will the NHS patients receiving the experimental drug provide informed consent? If informed consent is not explicitly given and a patient dies the NHS is wide open to a major law suit.

    In summary. Informed consent – Check. Safety reporting – Check. Medical History – Check. Efficacy reporting – Check. Its starting to sound a lot like a clinical trial to me, but doing an end run around the Declaration of Helsinki.

    For me, there are so many red flags about Dave’s pharma stimulus package, that it looks a whole lot more like an stealth NHS stimulus package.

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