FDA Panel: Avandia Causes Heart Attacks
On the 13th and 14th of July, after reviewing thousands of pages of reports, a panel of experts gathered at the request of the FDA, voted that Avandia could cause heart attacks. A strong majority of the panel, 22 of 33, voted to either remove Avandia from the market or allow it to remain on the market with its use restricted to a small minority of patients who do not respond to any other diabetes drug.
Avandia has been on the market since 1999. It is supposed to help patients with type II diabetes keep their blood sugar levels under control. Controlling blood sugar is believed to help prevent or delay long term complications of diabetes such as damage to the eyes, kidneys, and most importantly, the cardiovascular system. Diabetics are at increased risk of clogging of arteries (atherosclerosis), a condition that leads to heart attack and stroke. Heart disease is the number one cause of mortality among diabetic patients.
Avandia was approved by the FDA by promising that by helping lower blood sugar, it would help prevent diabetic complications, including heart disease. However, internal documents of the Avandia manufacturer GlaxoSmithKline (GSK) recently released to a Congressional Committee investigating the company, show that the British drug giant continually lied about Avandia’s safety in order to get the drug approved and keep it on the market.
It has now been revealed that GSK knew from the start that its drug had serious detrimental effects on the cardiovascular system. Data from clinical trials signaled to the company that their drug was causing increased heart attacks and deaths among the patients participating in the trials. However, instead of investigating those worrisome reports, GSK did everything in its power to conceal Avandia’s problems from the FDA and similar regulatory agencies in Europe. At all these steps, GSK chose to place its profits over patients’ safety. Obviously, GSK was successful at its efforts. Shortly after marketing Avandia became GSK’s second best-selling drug. In 2006 alone, before Avandia problems surfaced in 2007, GSK reaped over $3 billion in Avandia sales.
What has been disclosed from the GSK conduct with regard to Avandia shows a pattern of lies, half-truths, and spin. At the July 13-14 FDA meeting, Dr. Thomas Marciniak, a Medical Team leader at the FDA, showed how GSK tampered with clinical trial data to conceal the results that would reveal that avandia was causing higher heart attacks, strokes, and heart-related deaths among study participants. A recent study showed that over 80% of scientists publishing articles portraying Avandia in a positive light had financial ties to GSK. It was further revealed that a majority of published scientific articles in support of Avandia, which the company repeatedly cited in defense of its drug, was actually written and prepared by GSK, only using the names of “independent” scientists as authors.