Oregon Attorney General Ellen Rosenblum today announced that pharmaceutical giant GlaxoSmithKline has agreed to pay $90 million to Oregon and 37 other states to settle claims that it unlawfully promoted its diabetes drug, Avandia.
The 38 Attorneys General claimed lawsuits filed Nov. 15 that GlaxoSmithKline misrepresented the cardiovascular risks posed by Avandia. A negotiated consent judgment was filed shortly thereafter.
As the co-leader of the lawsuit, Oregon will receive $3.9 million of the settlement.
“It's fine to promote a product; it's not fine to misrepresent a drug's potential health risks,” said Attorney General Rosenblum. “When pharmaceutical companies cross the line, the Oregon Department of Justice will hold them accountable.”
Avandia was a blockbuster drug for GlaxoSmithKline. First approved by the Food and Drug Administration in 1999, annual sales peaked at more than $2.5 billion in 2006.
The drug made cells more sensitive to insulin, a seeming boon for diabetes sufferers. Type 2 diabetes results from the body’s failure to produce enough insulin or to properly process the hormone, the substance needed for the body to convert sugar and other food into energy. Without insulin, sugar builds up in the bloodstream leading to numerous health dangers, heart attack and stroke chief among them.
Diabetes is the seventh leading cause of death in the U.S.
A 2007 study linked Avandia to increased risk of heart attacks, one of the very conditions diabetics are predisposed to.
Consumers filed thousands of lawsuits. Avandia sales plummeted.
The Oregon Department of Justice launched its investigation two years ago. Oregon and the 37 other states claim GlaxoSmithKline made safety claims about Avandia not supported by the scientific evidence. The states allege the company failed to disclose negative information about Avendia’s cardiovascular health effects.
Attorney General Rosenblum credited Department of Justice attorney David Hart and the rest of the lawyers in the Consumer Protection and Financial Fraud division for their work on the case. Since 2011, the department has collected more than $18.8 million in five consumer protection court actions against large pharmaceutical companies.
As part of the consent judgment between the parties, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. It agreed to several conditions:
- To refrain from making false, misleading, or deceptive claims about any diabetes drug;
- To refrain from making comparative safety claims not supported by substantial evidence or substantial clinical experience;
- To refrain from presenting favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;
- To refrain from misusing statistics or otherwise misrepresenting the nature, applicability, or significance of clinical trials.
The Consent Judgment also has the following terms that are effective for at least eight years:
- GlaxoSmithKline must post summaries of all company sponsored observational studies or meta-analyses conducted by the company that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;
- The company post summaries of company-sponsored clinical trials of diabetes products within eight months of the primary completion date;
- GlaxoSmithKline register and post all company-sponsored clinical trials as required by federal law.
Other states participating in the Avandia action were Illinois, Washington, Arizona, Florida, Maryland, Pennsylvania, Tennessee, Texas, Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Hawaii, Idaho, Iowa, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Rhode Island, South Dakota, Vermont, and Wisconsin.
Jeff D. Manning, email@example.com, 503-378-6002