Avandia Makers Hit With Another $90 Million Settlement

One incredibly expensive drug for GSK.

Pharma biggie GlaxoSmithKline has already been slapped upside the head with a $3 billion settlement with the federal government regarding the marketing of, among others, the once-popular diabetes drug Avandia. Today, the attorneys general of 37 states rubbed a bit of salt in the wound with a $90 million settlement of their own.

The states involved in the claim — Oregon, Illinois, 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, Washington and Wisconsin — alleged that the marketing for Avandia misled patients by downplaying the potential risk for heart attacks and strokes.

“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,” said Wisconsin Attorney General J.B. Van Hollen about the settlement.

Per the settlement, GSK is barred from:

· Making any false, misleading, or deceptive claims about any diabetes drug (though we’re pretty sure that’s a general no-no with regard to all drugs);

· Making comparative safety claims not supported by substantial evidence or substantial clinical experience;

· Presenting favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information;

· Promoting investigational drugs; or

· Misusing statistics or otherwise misrepresent the nature, applicability, or significance of clinical trials (again, another on that should be a no-brainer).

In addition, for the next eight years, GSK must:

· Post summaries of all GSK-sponsored observational studies or meta-analyses conducted by GSK that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs;

· Post summaries of GSK-sponsored clinical trials of diabetes products within eight months of the primary completion date;

· Register and post all GSK-sponsored clinical trials as required by federal law; and

· Comply with the International Committee of Medical Journal Editors (ICMJE) Uniform Requirements for Manuscripts submitted to Biomedical Journals.

After years of reports of heart attacks and strokes related to Avandia patients — and calls from advocates for the drug to be pulled — the FDA finally yanked Avandia from the retail market in 2011.

This latest settlement means that GSK has tallied up more than $6 billion in settlements and penalties over its questionable marketing practices, mainly for Avandia and antidepressant medication Paxil.

Of course, at its height, Avandia was pulling in more than $2 billion a year for GSK, so one has to wonder if it will really learn a lesson from this debacle.