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FDA Doctor’s Studies of Diabetes Drug May Prove Drug is Dangerous


Pills Studies of Avandia, a popular diabetes drug, will be reviewed in order for today’s panel to recommend whether sales of the drug should be stopped or restricted. Avandia, manufactured by GlaxoSmithKline, helps Diabetes patients to gain better control of their blood sugar levels. Millions of prescriptions of Avandia have been sold in the past 11 years, totaling billions of dollars.

According to GlaxoSmithKline, the major clinical trial of Avandia, known as the Record, conducted by GlaxoSmithKline and Quintiles, a clinical drug company, has found that Avandia is safe. The Food and Drug Administration (FDA) does not test drugs—that right is left to drug companies themselves. The Record study was conducted at 338 sites across 23 countries, testing 4,447 patients with Type 2 Diabetes who were studied between April 2001 and April of 2004 and continued for nearly six years. One half of the patients took two older Diabetes medications during the study, while the other half took one older Diabetes medication with Avandia. GlaxoSmithKline spokeswoman Mary Anne Rhyne states that Avandia is safe and that “the Record study was conducted according to good clinical practices and the data are reliable.”

Yet, questionability surrounding Avandia’s safety has led to a review by the FDA medical officers to educate today’s panel. Avandia is shown to increase risks of bone fractures and cause swelling which can lead to heart failure and eye problems. Other studies have found that Avandia can increase risks of heart attacks, strokes, and death GlaxoSmithKline claims that the risks of heart attacks, stroke, and death are exaggerated.

Key to the study conducted by the FDA is Dr. Thomas Marciniak, who works in the FDA’s Office of New Drugs. Dr. Marciniak’s study of Avandia is part of the reassessment of Avandia’s safety by the FDA. Dr. Marciniak’s study has found that, contrary to GlaxoSmithKline’s claim that the risk of heart attacks, stroke, and death are exaggerated, heart problems are an adverse affect of Avandia. The doctor found a dozen instances of patients suffering serious heart problems due to Avandia in the Record. These conditions were not listed in Avandia’s adverse effects. Dr. Marciniak says certain studies of those with heart problems in the Record are stricken or are recorded as an affect of another cause (not that of Avandia). He claims that when these cases listed in the Record are taken into account, Avandia may cause heart attacks and strokes.

Dr. Marciniak’s findings will be presented to today’s panel of experts who will meet to consider whether the FDA should recommend that GlaxoSmithKline stop or restrict sales of Avandia.

Prior studies of the Record were conducted by the FDA in 2007 and no problems with the Record were found, despite claims by other researchers that Avandia was unsafe. An FDA advisory meeting in 2007 concluded that heart attacks are a risk of taking Avandia but Avandia should stay on the market. Following this review Avandia’s sales fell but there were still nearly 2 million prescriptions in 2009. GlaxoSmithKline is already facing lawsuits that claim that Avandia has caused injuries. If Avandia is withdrawn, GlaxoSmithKline’s reliability will be heavily questioned. While the panel is meeting today, GlaxoSmithKline has agreed to pay $460 million to settle around 10,000 lawsuits which state that Avandia causes heart attacks and strokes.

Source: Harris, Gardiner. “Caustic Government Report Deals Blow to Diabetes Drug.” The Herald Tribune. 10 July 2010.



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