Health Ministry surveying alleged dangers of diabetes drug

GlaxoSmithKline’s Avandia checked for possible risks of heart attack that were allegedly known to manufacturers for years.

By JUDY SIEGEL
avandia drug 311 (photo credit: Bloomberg)
avandia drug 311
(photo credit: Bloomberg)
The Health Ministry is investigating GlaxoSmithKline’s type 2 diabetes drug Avandia (rosiglitazone maleate) after the US Senate released results of an inquiry on Saturday that revealed that the manufacturer knew that the drug posed possible risks of heart attacks among users years before it made them public. In any case, patients are urged not to stop taking prescriptions without consulting their doctors about whether to take an alternate drug.
The Senate Finance Committee investigated the matter for two years after hearing reports that GlaxoSmithKline had minimized reports of increased cardiovascular risks posed by the oral pill. The committee concluded that the pharmaceutical company should have immediately told the US Food and Drug Administration (FDA) – which approved Avandia for sale in the US in May 1999 – about the concerns.
The use of Avandia – which is included in the basket of health services provided by Israel’s health funds – has declined in recent years, but some diabetologists and other doctors continued to prescribe it to specific patients because they were not at higher risk for heart disease. The pills are in a class of anti-diabetic drugs called thiazolidinediones, of which there are other products as well.
Type 2 diabetics cannot produce enough insulin in the pancreas, making the cells in their bodies unable to remove enough glucose from the blood and raising blood glucose to dangerous levels. Rosiglitazone is often referred to as an “insulin sensitizer” because it attaches to the insulin receptors on cells throughout the body and causes the cells to become more responsive to insulin and remove more glucose from the blood. At least some insulin must be produced by the pancreas for rosiglitazone to work.
The Associated Press reported that the senators who released the report, committee chairman Max Baucus and Charles Grassley, also demanded to know why the FDA permitted a clinical trial to continue even after it estimated that Avandia caused 83,000 heart attacks over a period of eight years, until 2007.
GlaxoSmithKline said in a statement that the drug is safe and that the committee report took data out of context from analyses of Avandia. “Contrary to the assertions in the report, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events,” the company maintained.
Four years ago, Avandia was GlaxoSmithKline’s third best selling drug and earned the company billions of dollars. Since then, its income from the drug has halved. The FDA said it is reassessing the data and analyzing new information and will issue a report in a few months.
As Avandia is included in health baskets but not used by many patientsin Israel, the scare could save the health funds money by allowing themto supply diabetic patients with cheaper medications. Some othereffective diabetes drugs that could replace Avandia are not in thebasket, and patients pay out of pocket for them. The only way to addnew diabetes drugs to the basket instead of Avandia would be approvalby the public committee advising the Health Ministry on the expansionof the basket for 2011 that is due to convene in the fall.
Numerous US patients, claiming they suffered personal injury from heartattacks after taking Avandia, have filed lawsuits and seek compensationfrom GlaxoSmithKline.