It is inconceivable that a product could remain on the market after it has been directly linked to tens of thousands of deaths. But this is exactly the case we have with two popular diabetes drugs, Avandia and Actos.
Avandia was introduced in 1999 and a study performed by its maker, SmithKline Beechem (later acquired by Glaxo) found that it posed a significantly increased risk of cardiovascular events and bone fractures. What did they do? They suppressed the data for the next 11 years! A SmithKline executive was quoted in a recently uncovered internal email written in 2001: “This was done for the US business, way under the radar. Per senior management request, these results should never see the light of day to anyone outside of GSK.” Since its introduction, an estimated 47,000 people taking Avandia have suffered serious cardiovascular events or died just by taking the drug to treat their type-2 diabetes.[1] Sales of Avandia peaked at $3.4 billion in 2006.
Evidence of significant heart risks was apparent since at least 2007 when the FDA strengthened warnings about heart failure.[2] [3] Several later studies have linked Avandia (Rosiglitizone) with an increased risk of heart attacks, heart failure and strokes, by as much as 30-40%.[4] [5] GlaxoSmithKline, its maker continued to defend Avandia’s safety profile. The FDA again began investigating Avandia earlier this summer when the previously suppressed info came to light. Despite pretty damning evidence, the FDA ultimately decided not to remove it from the market. Instead they have imposed very strict limitations on its use that will take several more months to go into effect. Curiously, looking at the same data, the European advisory committee has banned it completely.
Actos is in the same chemical family as Avandia, but most studies have not found similar cardiovascular risks with Actos. On the heels of Avandia’s problems, Actos sales have risen to over $4.6 billion. A recent study, however, has found similar heart risks with Actos as Avandia.[6] If that was not enough, the FDA is currently investigating data linking long-term use of Actos to an increased risk of bladder cancer. [7]
So, we have a group of individuals already at increased risk for cardiovascular disease by virtue of their diabetes, and many have an additional independent risk from being obese. Then the very drugs developed ostensibly to help them, further increases that heart risk; and the critical information is hidden from doctors and the public for more than a decade.
What can you do? Adopting a healthier lifestyle can prevent the vast majority of type-2 diabetes cases. Clearly avoiding diabetes and other preventable chronic diseases, reduces the need for prescription medication and is preferable to treating it after the fact. Get an in-depth evaluation and know your risks. Take a proactive approach to your health. How you live now will directly influence the length and quality of your life in the decades to come.
[1] Graham D, Quellett-Hellstrom R, et al. “Risk of Acute Myocardial Infarction, Stroke, Heart Failure, and Death in Elderly Medicare Patients Treated With Rosiglitazone or Pioglitazone”. JAMA. 2010;304(4):(doi:10.1001/jama.2010.920).
[2]Singh S, Loke Y, Furberg C. “Long Term risk of Cardiovascular Events with Rosiglitizone: a meta analysis. JAMA, September 12, 2007—Vol 298, No. 10
[3] Nissen S, Wolski K. “Effect of rosiglitizone on the risk of Myocardial Infarction and Death from Cardiovascular causes”. N Engl J Med, June 2007 356;24
[4] Nissen S, Wolski K. “Rosiglitizine Revisited: an updated meta-analysis for myocardial infarction and cardiovascular mortality”. Arch Intern Med. 2010;170(14):1191-1201.
[5] Home P, Pocock S, et al. “Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): a multicentre, randomised, open-label trial”. The Lancet, Volume 373, Issue 9681, Pages 2125 – 2135, 20 June 2009
[6] Wertz D, Chang C, et al. “Risk of Cardiovascular Events and All-Cause Mortality in Patients Treated With Thiazolidinediones in a Managed-Care Population”. Circulation: CV Quality and Outcomes. 2010;3:538-545. Published online before print August 24, 2010, doi: 1161/CIRCOUTCOMES.109.911461
[7] U.S. Food and Drug Administration. FDA drug safety communication: ongoing safety review of Actos (pioglitazone) and potential increased risk of bladder cancer after two years exposure. (http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm.)
