The manufacturer of popular diabetes drug Avandia agreed to settle lawsuits from 38 states by paying $90 million in fines — without admitting guilt. GlaxoSmithKline was accused of downplaying the risks of heart attacks and stroke associated with the blockbuster drug.
“When aggressive pharmaceutical marketing misrepresents known risks of a drug or deceptively markets positive attributes of a drug that are not supported by the scientific data, consumers and doctors alike are unable to make informed choices about the risks of taking the medication,” Wisconsin Attorney General J.B. Van Hollen said in a statement about the settlement.
In the settlement, drugmaker GlaxoSmithKline agreed it would not misrepresent or overstate the benefits of any diabetes drug by misusing data from clinical trials. The company also agreed that for the next eight years, it will post summaries of all studies and trials of diabetes products that the company sponsors.
Studies Linked Avandia to Heart Issues
Avandia (rosiglitazone) was widely prescribed by doctors to treat type 2 diabetes, and it grew into the most popular prescription drug for that condition.
But clinical trials showed from the beginning that Avandia was associated with an increased risk of cardiovascular complications. GlaxoSmithKline was accused of knowingly suppressing that data, including information that taking Avandia elevates the risk of heart attack by 43 percent and can double the risk of heart failure after a year of treatment.
In 2007, the U.S. Food and Drug Administration (FDA) stepped in, requiring Avandia to carry a black-box warning — the agency’s most stringent warning — about the heart risks.
In 2010, the FDA updated Avandia labels to specify that only patients who have taken the drug previously and cannot control their blood sugar with other methods should take the drug. It also pulled Avandia from the market, making it only available through a government program.
Settlement in Addition to $3 Billion Agreement with Justice Dept.
The $90 million Avandia agreement is separate from a $3 billion settlement GlaxoSmithKline reached with the U.S. Department of Justice in July. In that agreement, the company pleaded guilty to charges it failed to report critical data for Avandia, and it also was charged with illegal marketing of its antidepressants Paxil and Wellbutrin. That fraud settlement was the largest payment from a pharmaceutical company in United States history.
Last month, GlaxoSmithKline pledged to be the first drug maker to share its highly confidential data from clinical trials with outside researchers. The voluntary move toward transparency will begin next year when the company will review scientific requests.
More than 50,000 Avandia lawsuits are filed in the United States, accusing GlaxoSmithKline of not giving patients a fair and accurate picture of the risks they faced if they took the diabetes drug.
The manufacturer has settled most of the claims out of court, but new cases continue to be filed.