Avandia might be unsafe; do the benefits for diabetics outweigh the risks?

Since 1999, when GlaxoSmithKline’s (GSK) blockbuster diabetes drug Avandia (also known as Rosiglitazone) was approved by the FDA (US Food and Drug Administration), it has caused nothing more than a rollercoaster ride for the global pharmaceutical company. Sales of this insulin sensitizing drug that notably makes diabetic’s cells more responsive to insulin - which effectively led the way in type 2 diabetic treatment - boomed throughout its first 7 years culminating in a reported sales peak of $2.5bn in 2006. Sadly for GSK a much dreaded meta-analysis published by The New England Journal of Medicine found what they referred to as a "significant increase in the risk of myocardial infarctions" and even death from other related heart issues stemming from the use of this previously much praised drug. These findings and other evidence spurred the FDA advisory panel to limit the distribution of Avandia with almost immediate effect in the U.S.



The resulting limitations for distribution of Avandia have seen the European Medicines Agency (EMA) follow through with a full suspension of the drug to their market. Professor Hans-Georg Eichler explained that the agency had concluded that the benefits didn’t outweigh the risks. The seemingly odd difference in conclusion between the two agencies, according to Eichler comes down to their different ideas of risk management. Patients in the EU who were using the drug had a period to reassess the use of this drug and change to an alternative. This limitation is very much in effect, however there is still severe speculation about the significance of the risk of these side effects and the necessity of such limitations for a drug that still to this day has such benefit for glycemic control.



It has since come to light that these findings were not a shock to GSK and had been deliberately hidden for fear that their competitor Actos would walk away with the multi-billion dollar market share. GSK have seen the wrong end of over 13,000 lawsuits relating to this drug and have agreed settlements on more than 11,500.



At present 600,000 U.S. citizens with type 2 diabetes are using Avandia and the burden has been placed on the individual and their doctor to decide whether they should carry on using it. It seems as if we are being left with a choice between the lesser of two evils...! As is the case for many medicines, people react differently to their effects and side effects; it is this thinking that has spurred many to persist with its use and to ‘throw care to the wind’ with regard to the ‘proven’, potentially life- threatening negative effects. Margaret Hamburg, Commissioner of the FDA, has expressed that she has heard "very clearly from both providers and patients that some patients felt that they were unable to tolerate other diabetes medication and that this drug was effective for them". The current approach in the U.S. is to enable patients who are adamant about the effectiveness of the drug against its competitors to carry on using it as long as they are fully informed of the risks. Should we really be given the opportunity to decide for ourselves whether or not to carry on administering a drug that is proven to be harmful?