Diabetes drug linked with adverse effects on health – again

Back in December, I wrote a post which focused on the apparent ability of pharmaceutical companies to divert our attention away from what is really important (health) to what are often referred to as ‘surrogate’ outcomes such as blood pressure or cholesterol levels. The problem here is that while it is often assumed that, say, bringing down cholesterol levels or blood pressure is likely to bring health benefits, this is most certainly not assured. In this post, I cited examples of how unreliable surrogate endpoints can be markers for true effects on health [1].

I focused specifically, on the diabetes drug rosiglitazone. This medicament, manufactured by GlaxoSmithKline (GSK), had been found to help blood sugar control in diabetics. GSK were understandably keen to trump this apparent benefit. However, the research found that, in reality, rosiglitazone did not improve blood sugar control much. And besides, its use was found to be associated with a significantly increased risk of weight gain, swelling (oedema), bone fractures, and perhaps most worryingly of all, ‘cardiovascular’ complications such as heart failure.

There is an addendum to this story, as this week saw the publication of a study in the new England Journal of medicine which amassed evidence from 42 trials in an effort to assess the effects rosiglitazone on risk of heart attack and deaths due to ‘cardiovascular’ causes (e.g. heart attack and stroke). This research found that rosiglitazone use was associated with a 43 per cent increased risk of heart attack [2].

The Food and Drugs Administration (FDA) in the USA has, via its website, issued a statement regarding the safety of rosiglitazone. In it, the FDA refer to ‘conflicting results’ and ‘complex sources of data [3].

While the evidence is being weighed up, those taking rosiglitazone have been advised to consult their doctors to discuss treatment options. I admit that science is very rarely clear-cut. However, in the context of previous evidence, this new research finding I suspect represents genuine cause for concern.

And it’s another example of why it can sometimes be so important for us to keep focused not so much supposed surrogate markers of health, but health itself.


References:

1. How drug companies can cause us to forget what ‘medicine’ is really for

2. Nissen SE, et al. Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes. N Engl J Med. 2007 May 21;[Epub ahead of print]

3. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html

16 Responses to Diabetes drug linked with adverse effects on health – again

  1. Carol Godsmark 25 May 2007 at 7:04 pm #

    I was due to start this drug, prescribed to me by my doctor after unfortunate side effects with Metformin. But once I had read that the side effects of taking Avandia could include bone fractures (I have weak ankles and have a tendency to keel over), weight gain (no thanks!) and swelling, I put it aside. Now, having read the Guardian’s piece and your piece, I will definitely be putting these tablets aside forever.

    It has put me in a quandary of course. What is a good alternative which doesn’t harm? Is there something on the non-mainstream medical market to help those with type 2?

    Needless to say, I thank you for your research. It would be of help to know what those in my position should consider as a treatment. Apart from diet and exercise, of course which is part of my dna.

    It beggars belief that a drugs company could put a drug such as Avandia on the market without lengthy trials. The recent one with its 30 – 40 % greater risk of heart attack (to a group already in the increased risk area) is alarming, to put it mildly.

  2. Tiggy 26 May 2007 at 1:43 am #

    Hey, I had the same thing Carol. I couldn’t take Metformin for PCOS to help with insulin resistance, so the Endocrinology Dept at the hospital were going to put me on Avandia. I had to sign a special disclaimer form which I thought was odd. A week or so later, the hospital rang up to say not to take it as it wasn’t licensed for PCOS. Because of this confusion I was left with no treatment at all and just signed off.

    There are lots of natural ways to regulate blood sugar such as chromium supplements and liquorice pills. Also pistachios!

    Tigs.

  3. Neil 26 May 2007 at 11:54 am #

    This site by USA Doctor Mary Vernon is well worth a read Carol, if you haven’t already seen it. She doesn’t put up new material very often, but as she works with people who are ‘diabetic’ and also with overweight people, her opinions are staright from the front line as it were.

    http://rjr10036.typepad.com/askdrvernon/

  4. ally 26 May 2007 at 3:06 pm #

    just looked at her site – how much do u reckon atkins is paying her . The website is another one making money!

  5. Neil 26 May 2007 at 9:29 pm #

    More to the point, ally, what do you think Atkins is paying her? Any evidence?

  6. ally 28 May 2007 at 7:31 am #

    neil – probe the site – in the about us who is there – the man himself and his wife. Just remember noone runs a site unless someone is paying for it or adverising.

    I posted on the wrong thread yesterday ! but my own feeling on this is that atkins has to be the most dull and boring regime to follow. When it was at its peak alot of my friends were following it and they all dumped it because they got sick of the lack of variety and without exception they all felt they were lacking fresh food like fruit and veg. my feeling as an idiot is that we need all foods but def need to get rid of refined carbs and too much fat – cakes , biscuits , crisps etc.
    The problem is that there are too many experts contradicting themselves and some who are just dangerous – like that nuuty mckeith woman. Also seems to me that most of them also have a sideline – selling vitamin pills!
    Not for me – i eat most foods except sweets, cakes etc and am healthy and slim. Everyone is looking for a quick fix – trying to undo years of abuse!

  7. Kate 28 May 2007 at 7:58 am #

    I was advised to go on the Atkins diet by my GP in 1999. I had very, very high triglycerides and low HDL with moderately raised LDL. I most definitely had type 2 diabetes waiting in the wings.
    It worked very well but I was constantly amazed by the hostility of other doctors and ‘healthy’ people.
    Lo-carb diets aren’t for everyone. There are many people with very low body fat who do just fine on an Ornish-type diet, but they just don’t can’t or won’t understand that not everyone is the same.
    My big problem came when I was diagnosed with MS. After my experiences with Atkins/low GI, I believed that diet does make a difference, but struggled to find an MS diet plan that encompassed a lo-carb lifestyle. The most successful diets to help with MS recommend no wheat or pulses or dairy.
    It’s taken several months of tweaking and combining Roy Swank’s approach and the Best Bet diet with a raw food approach combined with lo-carb, but I think I’ve finally got it cracked.
    If you replace the animal fats (butter, cream, lard) with coconut oil, lots of nuts, oily fish and my favourite fruit, the avocado and eat a 80% raw fruit and veg diet, then hunger and energy swings disappear. No brain fog and an enormous reduction in fatigue levels. I was taking Amantadine for the fatigue and I don’t need it at all now.

    I’m so pleased that back in 1999, my doctor (who has the same syndrome X problem) didn’t recommend these drugs. We did go through the statins, but they didn’t work for me. I know why now, thanks to this blog.

  8. ally 28 May 2007 at 1:04 pm #

    blimey just looked at swanks web site – what a contradiction to atkins. I am not sure how u marry the two but I am sure most people would be totally confused. you see that is the problem all these so called experts have different ideas. They just don’t make it practical and so strange how so many come from the US. i reckon all money making – swank is selling supplements too! so many are doctors too – why dont they stick to medicine or dont they make as much money!

  9. Neil 29 May 2007 at 8:13 pm #

    Ally,
    re probing Dr Vernon’s site. I can’t say I’m particularly up to speed on this sort of thing, unless you mean looking at the background link which appears to be written by a Richard Rothstein. Presumably thats Dr Vernon’s wife. I don’t have a problem with a profit element as long as it is open and disclosed, the nature of the advice is the thing IMO. Docs and pharmaceutical companies seem to fall short here.
    In the short term, most weight loss diets seem to work, some better than others. Relatively few people manage to translate short term into long term it seems, ultimately maybe people resent the restrictions, or perhaps its boredom as you suggest.
    If anyone finds a way of eating that suits them, then good luck to them, horeses for courses and all that.
    I’m with you on refined carbs probably being a less good thing to eat as opposed to meat and veg (not so much of the starchy root veg), though I don’t think saturated fat is harmful (I’m trusting to 100,000s of years of evolution to have got to grips with that element).
    Personally, I don’t follow any diet, never have in fact. If I was diabetic, I would definitely chop out those cakes bread etc. Even chocolate. But I do believe there’s a lot of good advice in the Atkins camp. More than there is in the official Diabetes and Heart Disease establishment anyway.

    Cheers,
    Neil

  10. ally 30 May 2007 at 6:54 am #

    the thing is that links to atkins! I also think that studies are one thing but people are not studies. I reckon that the experts do not look at that effect – just look at the people who loose wt on tv progs what happens when they diappear!

    It seems to me that alot of alt docs and practitioners who i feel are as bad as the dieting industry because they are in it to make money seem to be dismissing the real problem – rubbish in our diet and poor quality food. They also do not seem to have the indepth knowlwdge of cooking and putting reality into meals. its not their fault – they are doctors. Just my opionion – one only has to look at the menus on atkins – very american also!

  11. Carol Godsmark 31 May 2007 at 1:37 pm #

    Thanks for your helpful comments, Neil. I have read Dr Vernon’s website with interest and have since gone onto other sites, chromium picolinate of particular interest.

    However, I would still love to have a comment from John Briffa what he suggests those with diabetes type 2 take. If it’s not via drugs like metformin and avandia, what does he suggest? Apart from diet and exercise, that is?

    And, as soil depletion, use of pesticides and chemicals, means that no matter how much ‘good’ food we eat, we can never achieve high enough vitamins and minerals,. Therefore, should we be taking supplements such as calcium, Vidamin D and others?

  12. ally 31 May 2007 at 4:06 pm #

    just think about this logically – are there epedemics of scurvy and bei beri! Who are the ones pushing the effects of pesticides – th comapnies who sell th pills. It is a huge money making scam – there are very few supplements and vitamins that have any credibility. Oh there is the possibility of overdosing – just look atthe study published today about iron and pregant women!

  13. Carol 3 June 2007 at 11:29 am #

    I think you should be acquainted with knowledge from different sources including Graham Harvey’s book We Want Real Food before coming to snap decisions, Ally. What we do know is that the number of pesticides and additives are adding to the poor health of the nation alongside a diet of fast food. By depending on synthesised nitrate fertilsers, agribusinesses have depleted the soil of the minerals it needs to grow healthy foodstuffs. Over the past 50 years UK veg have lost a quarter of their magnesium, more than a quarter of their iron and hearly HALF their calcium. The result is impoverished food, sick animals and a catalogue of degenerative human diseases. Just witness corn syrup in thousands of food products masquerading as stablisers and gels, the nutrient content of the food very diluted.
    You rightly point out that there are many vitamins that are pushed and that are not needed by some but we don’t have to buy them. It is a highly confusing subject for all and we need guidance.

    What we also need to do is to find out about the food we eat, however. And eat a sensible, non-processed food diet with plenty of variety, the average British diet really quite out of kilter.
    However, we are getting away from the subject of diabetes and what medication is best. It would be good to have a comment from John Briffa on this. John, over to you!

  14. ally 3 June 2007 at 12:00 pm #

    just found an interesting piece of research in the European Journal of Clinical Nutrition – shows that eating a low carb/high protein diet is associated with an inc risk of death from cardiovascular disease!
    Bet the atkins site wont promote that! I would also like to find some resarch re atkins, lack of fibre and inc risk of bowel cancer.
    We should be promoting getting rid of all the unwholesome foods like refined carbs, crisps, etc rather than getting people to give up wholegrains and excessive protein intakes.

  15. John Briffa 5 June 2007 at 6:03 am #

    Hi Carol – sorry for the delay in responding (work pressure, I’m afraid).
    In case my position isn’t obvious, I strongly recommend that diabetics keen to control blood sugar levels and reduce medication use adopt a low-carb/carb-restricted/low glycaemic load diet.
    Regular activity is also highly recommended (obviously).

    On top of this, I do often use supplementation in individuals with diabetes. I generally have two strategies in mind here:

    1. improving blood sugar control
    2. reducing the potential for the complications of diabetes.

    For 1 – I generally recommend agents such as chromium, niacin (vitamin B3) and the herb gymnema sylvestre.

    For 2 – I generally recommend supplementation with B6, vit C and vit E (all of which have the capacity to reduce the ‘glycosylation’ reaction that is at the heart of diabetic complications).

    The dosages used in practice do tend to vary a lot according to individual circumstances, but I hope this information is a good starting point for you.

  16. Carol 5 June 2007 at 7:27 am #

    Noting the time you wrote, John, I thank you! And for the advice on supplementation and other agents which I will take up.

Leave a Reply