GlaxoSmithKline is having trouble recruiting patients for a large clinical trial of its controversial diabetes drug Avandia, the Wall Street Journal reports this morning.
The drug has been linked to an increased risk of heart attack, but GSK officials have said it's a safe and effective product. Federal regulators are considering whether to halt the so-called TIDE clinical trial early because of Avandia's health risks.
Two sites, including Wake Forest University Baptist Medical Center in Winston-Salem, have pulled out of the safety study, GSK reports. The British company, which has its North American headquarters in Research Triangle Park, didn't name the second site.
Wake Forest's decision to withdraw wasn't related to any safety concerns, but because the medical school was struggling for months to find subjects, dean William Applegate told the Wall Street Journal.
GSK is eager to prove that Avandia is safe. The company added dozens of clinical-test sites overseas in April, the newspaper reports. The company is testing Avandia in Pakistan, India, Mexico, Latvia, Colombia and other countries.
In July, the U.S. Food and Drug Administration plans a meeting of outside advisors to discuss Avandia and the TIDE trial. The tests compare cardiovascular risks for Avandia and a rival diabetes drug.
Earlier this month, GSK reportedly agreed to pay about $60 million to settle 700 lawsuits alleging that Avandia caused heart attacks and other health problems. The company has declined to comment on possible settlements, which were reported by Bloomberg News. The company still faces more than 4,000 lawsuits over the drug.
Regulators approved Avandia for sale in the U.S. in 1999 and the medicine generated annual revenue of $3 billion by 2006. But sales plunged after a May 2007 report in the New England Journal of Medicine linked the drug to a 43 percent increased risk of heart attacks. That report prompted U.S. and European regulators to order GSK to strengthen its warnings.
Read today's full Wall Street Journal report online here.
Assistant Business Editor Alan M. Wolf joined the N&O in 1999 covering the business of health care. He became an editor in 2001, and helps oversee the paper's daily business coverage and Sunday Work&Money section. He lives in Clayton with his wife and two children. Reach him at 919-829-4572 or