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Multi-State Avandia Settlement Over False and Deceptive Claims

Defective Drugs

Once again we are reminded how money talks and drug companies will do whatever it takes to sell their product, even if it is illegal, not to mention unethical.

The state of Maine is the latest state expected to receive in excess of $1.2 million from GlaxoSmithKline LLC (GSK) over the way it misrepresented the diabetes drug Avandia to health care providers. Maine is the latest to join 37 other states in a $90 million settlement with GSK over Avandia.

Massachusetts reportedly will receive more than $2.1 million as part of the settlement from the British drug maker.

Connecticut will get nearly $1.7 million, some of which will go to fund the Department of Consumer Protection and the Attorney General’s General Consumer Fund. The settlement was announced November 15, 2012.

GSK is alleged to have made false and misleading claims about the safety and cardiovascular benefits of Avandia, claims that were not supported by evidence and, in fact, put patients at an increased risk. In addition, sales reps used outdated promotional information that had been disproven and misused statistics.

For example, GSK reps would bring popcorn to lunches with doctors to illustrate the change in the density of LDL particles. A GSK vice president suggested results of a study on rival drug, Actos, not be published because Actos appeared to result in a better lipid profile than Avandia.

Even though the FDA’s approved label for Avandia contained a warning on congestive heart failure, some GSK sales aids said Avandia may reduce the risk of heart attack by decreasing insulin resistance. GSK also paid doctors to promote the use of Avandia to others, suggesting the drug protected the heart even though there was no evidence of that.

In fact, Avandia was required to carry a black box warning, the strongest warning that appears on a drug label to caution about the increased risk of heart attack. A report in the May 2007 New England Journal of Medicine found a 43 percent increase in the risk of heart attack compared to a control group.

This multi-state settlement was headed by the attorneys general of Oregon and Illinois. States are reimbursed when they are Medicaid Participating States and their Medicare program’s pay for the named drug that was deceptively promoted.

Last July, GSK paid $3 billion to settle civil and criminal charges that it illegally promoted several drugs for off-label use including Paxil and Wellbutrin.

Among the charges, Glaxo omitted certain safety data, data from post-market studies and two studies on cardiovascular safety. Failing to report data to the FDA brought Glaxo a $242.6 million criminal fine as well.

No worries. While it was sold, Avandia made Glaxo $10.4 billion in sales in years covered by the settlement, from the late 1990s to the mid-2000s.

Part of the resolution requires Glaxo to sign a Corporate Integrity Agreement to keep it on the straight and narrow, however, the company does not have to admit to any wrongdoing.

In a statement, GSK said it stands by its testing, marketing and monitoring of Avandia.

This unprecedented settlement is the largest but not unprecedented in that every large global drug manufacturer has faced similar charges of aggressively pushing their product no matter what it takes including, breaking the law.

In 2011, the Department of Justice said the pharmaceutical industry brought in the most in civil and criminal settlements under the False Claims Act which was originated to check on war profiteering after the Civil War.

Perhaps only putting CEOs and top company officials in prison will ultimately do more to deter corporate malfeasance since clearly, fines are not working.

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