GlaxoSmithKline operates as the world’s second largest pharmaceutical company behind Pfizer. It markets a vast assortment of medication to treat patients with health problems and, according to its annual report for 2006, the diabetes medication Avandia is one of the top six pharmaceutical products it markets throughout the world,
At 30th September 2006, GSK held second position in the world pharmaceutical market with a market share of 6.3%, behind Pfizer with a market share of 8%. GSK had six of the world’s top 60 pharmaceutical products. These were Avandia, Lamictal, Seretide/Advair, Valtrex, Wellbutrin and Zofran.
In May, 2007, the Food and Drug Administration issued a medication safety alert claiming:
Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including an interim analysis of data from the RECORD trial (a large, ongoing, randomized open label trial) and unpublished reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the risks in patients treated with Avandia.
According to the FDA, based upon the data concerning possible heart related problems experienced after taking this medication, it advised patients to consult with their physicians about any heart-related concerns.
Its 2006 annual report mentions that Avandia accounted for approximately $2.4 billion dollars in sales in the United States alone:
GSK launched Avandia for the treatment of type 2 diabetes in 1999 and a combination product, Avandamet, for blood sugar control in 2002. The product group was expanded further in February 2006 with the launch in the USA of a fixed-dose combination treatment, Avandaryl, which combines Avandia with a sulfonylurea.
In 2006, sales of the Avandia product group grew 24% to Â£1.2 billion in the USA. In Europe, sales grew 39% to Â£217 million driven by the increasing use of Avandamet. Sales in International markets rose 17% to Â£234 million. The Avandia product group achieved in 2006 a market share by value in oral anti-diabetics of 37% in the USA and 19% in Europe, up 2 and 5 percentage points, respectively. In the USA, Avandamet prescription volume growth was adversely impacted by product supply issues during the year which have now been resolved.
In December, GSK presented data from the landmark ADOPT study, which demonstrated that Avandia is more effective than metformin, or a sulphonylurea, in long-term blood sugar control in type 2 diabetes. These data are in addition to those recently presented from the DREAM study, which showed that Avandia can reduce the risk of progression to type 2 diabetes. Data from both these studies are expected to be filed with regulatory agencies during the first half of 2007.
Based upon the sales volume alone, sales of this medication account for a huge source of profit for GlaxoSmithKline. In 1999, apparently after a medical researcher attempted to inform the pharmaceutical company about increased heart risks which have recently been disclosed publicly, company officers allegedly threatened litigation and:
warned him that some executives wanted to hold him accountable for a $4 billion drop in the company’s stock.
The medical researcher testified in a congressional hearing this week that he wrote to the company and:
In a letter to SmithKline distributed at the hearing, Buse wrote: “Please call off the dogs. I cannot remain civilized much longer under this kind of heat.”
In 2000, the researcher apparently outlined his concerns about increased heart risks to the FDA yet only recently did the oversight agency issue a safety alert about this medication.
If these reports present a true picture about conduct that occurred and safety concerns about the medication around since its release in 1999, do you believe that the Food and Drug Administration should have required a safety alert sooner? Should a pharmaceutical company properly threaten to sue a medical researcher who attempts to present safety concerns about a particular product? If you suffer from diabetes and have taken the medication Avandia, what medication safety information would you want to review with your doctor before making a decision to take this medicine? If you have heart disease and diabetes, would you want medication information concerning the possible risk of heart problems associated with Avandia?
In all fairness, the company continues to dispute whether the medication increases risk of heart problems. However, in my opinion, I would err on the side of disclosure of all research including increased heart risks and leave the decision about interpretation of study findings and whether to take the medicine in the capable hands of the treating physician and patient. I believe that the patient and doctor should have all tools and information available to them to properly evaluate risk and make proper decisions. If these public accusations are true, in my opinion, I am not sure patients were provided such an opportunity. What do you think?