BMJ says Avandia should never have been licensed in Britain and should now be withdrawn

Is Glaxo going to get away with it… again?

After the scandal of Seroxat – an unsafe drug with dangerous side effects, that made billions in profit and gained a licence using dodgy data supplied by GlaxoSmithKline, we now have the Avandia scandal: the story of an unsafe drug with dangerous side effects, that made billions in profit and gained a licence using dodgy data supplied by GlaxoSmithKline.

See a pattern forming?

Two days ago, the British Medical Journal (BMJ) said Avandia should never have been licensed in Britain and should now be withdrawn, after medical experts advised that its risks “outweigh its benefits”.

The drug – also known as Rosiglitazone – was approved by the European Medicines Agency ten years ago to help lower blood sugar levels in patients with type two diabetes. However, the BMJ’s investigations editor, Dr Deborah Cohen, said the European drug approval process was not rigorous enough and raised concerns about the quality of data used by Glaxo SmithKline.

The journal said that no new patients should start taking the drug, while those already taking it should consult their GP. It said that those at a higher risk of heart disease should be advised to stop taking it.

But now it has emerged that the Commission on Human Medicines advised the Medicines and Healthcare products Regulatory Agency (MHRA) in July that Avandia “no longer has a place on the UK market” and should be withdrawn, as its risks outweighed its benefits.

The Commission’s advice has been revealed following an investigation by the BMJ in collaboration with the BBC Panorama programme. Dr Yoon Loke, a clinical pharmacologist based at the University of East Anglia, told Panorama that the drug could have caused an extra 1,000 heart attacks and about 600 extra cases of heart failure in the UK last year.

However Professor Donald Singer of the British Pharmacological Society said that patients should not be concerned in the short term. In what appears to be a confused statement he says “These are not acceptable risks in the long term and you scale up in the country, clearly that could lead to many hundreds of people being affected. But from day to day, the actual risk to a given patient is quite small.”

Thanks for clearing that up Donald… ?

7 Responses to “BMJ says Avandia should never have been licensed in Britain and should now be withdrawn”

  1. truthman30 Says:

    The British Pharmacological Society… Donald Singer… do these people get trained in ‘double-speak’? …I’m sorry, but his statement would be hilarious if the subject matter wasn’t so damn serious… If Avandia gets pulled.. I will eat my shorts… (and they’re baggy combat shorts so it would take a while) …

  2. Donald Singer Says:

    In response to your admin post above:
    the above ‘quote’ was taken from the C4 News story to accompany my live interview with Jon Snow on 6th Sep in advance of the EMA decision due on or around 23rd September ie in ~2 weeks. My key advice during the interview was as noted in the July 2010 MHRA Newsletter – rosiglitazone should not be used in high risk diabetic patients – ie those with heart failure or other serious vascular diseases. I made the explicit comment that patients on the treatment who have those problems should see their medical practitioners. It is clearly also not good for patients to have a sudden loss of blood sugar control from stopping rosiglitazone. Any change of treatment should therefore be managed promptly but with relevant clinical advice to maintain blood sugar control. My ‘day to day’ comment related to diabetic patients without current contra-indications and who await advice due in ~2 weeks.
    I should be interested in your own estimate, based on published independent data, of the range of probabilities of a cv event during 2 weeks attributable to rosiglitazone in a patient without contra-indications: in the setting of other risks from diabetes and its associated disorders.
    For info here is a link to the EMA statement following their meeting yesterday 8.9.10: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2010/09/news_detail_001110.jsp&murl=menus/news_and_events/news_and_events.jsp&mid=WC0b01ac058004d5c1

    • admin Says:

      Ouch! That’s me put in my place then…

      On the basis of “published independent data”… Problem being, I’ve learned that published independent data cannot always be relied on.

      I should be interested in your own estimate of the range of probabilities of anyone from Glaxo being prosecuted for murder over the Seroxat and the Avandia scandals.

  3. Donald Singer Says:

    re published data:
    from the academic viewpoint, it is always important to consider possible bias in study design and interpretation. However if you are saying you doubt reliability of recent data critical of Glaxo, how do you suggest taking the discussion forward?
    In practice, the recent reports critical of rosiglitazone in JAMA and elsewhere make an effort to describe a range of possible effects of rosiglitazine vs. other treatments of diabetes: ie by giving results estimating worst case vs. best case for potential risks of treatment, with the caveat that there are well-recognized limitations of the range of study approaches under discussion: open design (many flaws), retrospective studies (including risk of ‘reverse causation’) and meta-analyses (including risk of publication bias).

    • admin Says:

      Let’s cut to the chase shall we, Professor?

      While you bleat on about …recent reports critical of rosiglitazone in JAMA and elsewhere make an effort to describe a range of possible effects of rosiglitazine vs. other treatments of diabetes…” etc etc, in the real world, people have died because they took Avandia. People have died because they took Seroxat. And what about Vioxx? Do I need to go on?

      Drug companies have too much money and power, the regulators are useless and too many Doctors (and Professors!) can be bought like cheap tarts.

      Nothing will change. Glaxo’s data stinks – as it did for Seroxat in Study 329.

      I think, if I may be so bold, you need to get out more.

  4. Donald Singer Says:

    Are you saying studies can be relied upon or they can’t??
    The JAMA report I mentioned http://jama.ama-assn.org/cgi/content/abstract/304/4/411 suggests just that – in the real world people may indeed have had increased risks of cv disease and death while on rosiglitazone – or not – if as you wrote ‘published independent data cannot always be relied on.’
    When are you chosing not to rely on data?
    Your general points get to the heart of why there has not been a definitive policy statement earlier. Suppose it were shown in an observational real world study that a given drug instead appeared wonderful for an unexpected group of patients? Would you treat the data with caution and expect well-conducted studies to follow, rather than trust that the drug would work well in practice?
    Worth looking at a further critique of all players in this August 2010 editorial
    http://circoutcomes.ahajournals.org/cgi/rapidpdf/CIRCOUTCOMES.110.958413v1.pdf

  5. truthman30 Says:

    This is interesting, why do some people use semantics so obtusely? I agree with admin, the fact of the matter is the editor of the BMJ wants the drug pulled, Steve Nissen wanted the drug pulled, even the MHRA are looking for a withdrawl.. What’s the problem here? The drug needs to be pulled urgently, that’s as obvious as a deaf, dumb and blind organgutan..


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