A true skeptic does not reserve their skepticism for alternative and complementary medicine.

September 8, 2010
By

 

Picturbnne1 The article below was published in Pulse “MHRA under pressure to withdraw Rosiglitazone”.  and another article was published earlier in the week in the Independent newspaper

This is another example of why “evidence” does not necessarily make something true and should be the principle guideline for scope of practice.

It is also interesting that the justification for this drugs continued use is that there is nothing out there with better evidence of efficacy . In April I asked skeptics for  evidence of a better intervention than chiropractic for colic and am still waiting.

Nevertheless skeptics are still whinging to the GCC because chiropractors are still recommending a spinal adjustment as being an effective intervention for colic, unfortunately skeptics seem to have limited their understanding of the relationship between the function of spine and the central nervous system, to paralysis and death.

 

07 Sep 10

By Lilian Anekwe

The UK drug regulator has come under fire for failing to act on an expert recommendation to withdraw the type 2 diabetes drug rosiglitazone.

A Freedom of Information Act request by the BMJ has uncovered a report from July from the Commission on Human Medicines, an advisory group to the Medicines and Healthcare Products Regulatory Agency, saying the drug’s risks ‘outweigh its benefits and it no longer has a place on the UK market.’

It followed evidence that the drug increased the risk of myocardial infarction and heart failure. But instead the MHRA issued advice prescribers should follow ‘current contraindications and monitoring requirements for rosiglitazone‘.

A BMJ editorial has called for the drug to be withdrawn immediately but the MHRA has said it is waiting for an EU decision, expected later this month.

Dr Richard Lehman, a GP and senior research fellow at the University of Oxford, writing in the BMJ, said: ‘If the regulatory bodies do not insist on definite evidence of greater benefit than harm to patients, rather than changes in surrogate end points, they are failing in their basic purpose.’

Professor Nick Fremantle, professor of clinical epidemiology and biostatistics at the University of Birmingham, said: ‘If we are to avoid similar problems in other clinical areas, we need a far more widespread overhaul in the standards of regulatory trials.’

A spokesperson for rosiglitazone manufacturer GSK said: ‘No other diabetes medicine introduced in the last ten years has such an extensive safety database.

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  • Rosemary

    Oh dear, Eugene, I want to weep. You’re skeptical about an awful lot of things aren’t you? Even high volume, although I’m not sure what you classify as high volume. Did no one teach you what chiropractic is? I mean, chiropractic – the art, the science and the philosophy. Above down inside out.

    It seems to me that you are a frustrated medic, which is fine but what you want to do is not chiropractic. Chiropractic is a natural, drug free profession. You can’t alter the nature of it just because you want to and maintain it’s still chiropractic. Just like you can’t change the nature of cricket and maintain it’s still cricket. It wouldn’t be – it would be something else but definitely not cricket! Need we go with this ridiculous discussion?

  • Eugene Pearce

    NOT is a technique right, I hope no one thought I wasnt skeptical about high volume and its motives, or is it NET, these techniques are invented so often I cant keep up. Just to clarify I am skeptical about the relative benefits of high volume wellness type care.

  • Eugene Pearce

    Couldnt agree more, if the same degree of skeptisism was applied to physiotherapy then we would truely have a fair and level playing field.

    The problem chiropractic specifically has is that it is not open about the fact all manual therapies including chiropractic have little evidence except possibly for the field of low back pain.

    It doesnt take a “skeptic or professor of comp. therapies” to tell me what should be blatantly obvious. We are a complementary medicine, as such I would expect to have a lesser level of evidence to support what we do, otherwise one would assume we would be mainstream. Hasnt anyone noticed chiropractic is now available evrywhere on the NHS for subacute low back pain, ahh the level playing field again.

    I am skeptical about some areas of chiropractic KST AK SOT Network NOT high volume, subluxation causing disease (dis-ease is ok in terms of discomfort or pain though) and some parts make sense to me and are logical. But at the very least, what we do must be biologically plausible. If we all assume chiropractic is just great and effective because its chiropractic we become a religeon, not a healthcare profession. (We should still have the option to prescribe if we want to though, couldnt resist).

  • http://spinaljoint.com Richard Lanigan

    Who said these findings should be ignored? More likly the original research should have been ignored and the drug should not have been put on the market.

    I am saying “data”/evidence comes in many forms not just RCTs, thats all.

  • Angel Lynn

    So the “scientific evidence” of problems with rosiglitazone is part of a modernist paradigm and should be ignored?

    If this drug is problematic and a large data set has revealed more harm than good, surely it should be withdrawn.

    It sounds like you are saying this data is unreliable because it doesn’t take into account the experience of the practitioner, but this seems too trusting to me.

  • http://spinaljoint.com Richard Lanigan

    I suppose when I post I assume that people have read all the other stuff on the blog . I will try and explain what I mean.

    The whole debate in relation to Simon Singh and the BCA’s “plethora of evidence” focused exclusively on so called “scientific evidence”. Skeptics demand RCTs and attach little or no weight to the experience of the practitioner, empirical evidence and the knowledge base of the practitioner in this modernist paradigm , possibly because few sceptics would have the physiological knowledge to asses the theory and hypothesis being proposed .
    Eg; there is a relationship between the function of spinal joints the central nervous system and peoples wellbeing.

    I have no problem with people being genuinely skeptical about chiropractic/CAM or whatever , unfortunatly most skeptics dont apply that same scepticism to medical interventions particularly in the area of vaccinations, apparently I am an “antivaxer” rather than a skeptic, when it comes to this area of medical science.

  • Angel Lynn

    “This is another example of why “evidence” does not necessarily make something true and should be the principle guideline for scope of practice.”

    This seems very confused. There are two facts based on medical evidence here: One, that rosiglitazone has some positive effect on diabetes. Two, that it has a negative effect on heart health, possibly a greater cost than the diabetes benefit.

    How does this invalidate the idea of using evidence?

  • Paul

    “A spokesperson for rosiglitazone manufacturer GSK said: ‘No other diabetes medicine introduced in the last ten years has such an extensive safety database.”

    Are these other less safe drugs still being prescribed?

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