Iowa will share in a settlement by a big drug company that admits peddling one of its products for unapproved uses. Bob Brammer is a spokesman in the Iowa Attorney General’s office. The states and federal government allege Warner-Lambert marketed a drug for “off-label” purposes. The Food and Drug Administration approves a drug for only certain uses that it’s officially designated to treat, and the drug in this case, Neurontin was okayed for one kind of case, for anti-seizure use by epilepsy patients, but over the years Warner-Lamber marketed the drug for use in treating bipolar syndrome, a mental disorder, migraine headaches, Lou Gehrig’s disease and other purposes, things we call “off-label.” One study found 95-percent of the drug’s use was for such “off-label” treatments, which also included back pain and attention-deficit disorder. Brammer says the illegal marketing violated state consumer-protection laws and also was a crime under federal law. This week the prosecutors announced a “global settlement,” resolution of the case at every level, state and federal. The company’s going to have to pay more than 430-million dollars, more than half of that a criminal penalty but also more than 80-million in civil damages to the federal government, almost 70-Million to state medicaid programs, and almost 38-million to the states. Most of the states’ money will go to advertise and educate doctors and consumers with fair and balanced information about drugs, and Iowa’s share for costs and consumer education is 25-thousand dollars. Just as important as the money, Brammer says, is a change in operations that will have the big drug company halt its fairly aggressive marketing of the drug for purposes other than its FDA-approved use. Any harm done was financial, not so much that it did anyone physical harm but that in many cases it was shown not effective, like bipolar syndrome in which a placebo, or fake pill, actually showed better results, and so Brammer says this “harmed people’s pocketbook.” Brammer says a month’s supply of the drug might have cost a patient a couple of hundred dollars and there were billions spent on the drug. Also considered were the spending of tax dollars, in Medicaid programs that funded prescriptions for low-income patients getting the drug.
