A recent study raises concerns about the safety of Avandia, a drug widely used for diabetes control. This has attracted a lot of (I think too much) attention. Here are my concerns:
- The conclusion that Avandia can hurt your heart is based on a type of research called meta-analysis. The conventional wisdom is that conclusions drawn from such data should be viewed with great caution.
- This research studied the population (diabetics) that is already at a high risk for cardiovascular disease. We have to make sure there were no other confounding factors- other than Avandia- that could explain higher chances of cardiovascular disease. I could not see what percentage of people in this study smoked, had high blood pressure or any other cardiovascular risk factors.
- I do not know how much of the publicity for this trial results is driven by stick-it-to-the-man factor rather than real concern for our health. How much of it is because we feel happy that a ‘filthy rich pharma’ bit the dust.
- I am not comfortable with the fates of different drugs being decided in the media. The shares of GlaxoSmithKline tumbled 8% after the results of this study were made public. The medical literature is full of studies that showed the negative effects of drugs soon after they hit the market. Many of these drugs are still being used after the correct dose or indication was determined based on the lessons learned from negative studies. But for systematic and critical evaluation, these drugs may have been taken off the market after the initial brouhaha.
- I am concerned that many patients may stop Avandia after hearing about its ‘scary side effects’. Some of them may become so disillusioned with the medicines that they may decide not to do anything for their diabetes
Pro-Per™ Points
This study has raised an important point about possible bad effects of Avandia on the heart. We need to try to see if a better quality study will raise similar concerns. I am sure many physicians have received calls from their panicked patients on Avandia. Physicians need to continue to be the best advocates for their patients without feeding the frenzy. If they do decide to stop Avandia, they need to make sure that patients get an effective alternative.
I have no financial relation with GlaxoSmithKline, the manufacturer of Avandia
DrChander.com....Correction through action
With due respects, I share your concerns about media activism and over play on the meta-analysis of Avandia. However, your blogpost does not touch on the aspect that Avandia causes 43% increased risk for heart disease. This is a very high percentage. I still think the drug should be better studied. Remember the drug is even promoted along with ramipril for prediabetes (avoidance of development of Type 2 diabetes). So is this product promotion justified?
This drug needs to be scanned for its adverse effect profile and should not be used for long term treatment nor should it be positioned as a first line drug for prediabetes or diabetes.
This is my immediate response.
It is the age of internet, patient empowerment, and conversational marketing - so how to justify Avandia now? Avandia has lost some trust.