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 .
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 .
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 .
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.
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]