A migraine headache can cause intense throbbing or pulsing in one area of the head and is commonly accompanied by nausea, vomiting, and extreme sensitivity to light and sound. Migraine attacks can cause significant pain for hours to days and be so severe that all you can think about is finding a dark, quiet place to lie down.
Put it this way. Migraine sufferers don’t need any more grief in their lives. But it turns out, one pharmaceutical company, which should be figuring out how to help these folks, decided to make things worse for them by lying about a treatment that never worked, just so they could cash in on the migraine market.
Yesterday, the U.S. subsidiary of Belgian manufacturer UCB, which manufactures the epilepsy treatment Keppra, agreed "to pay more than $34 million for marketing the medication to treat migraine headaches in violation of U.S. drug laws.” It also pleaded guilty “to a misdemeanor in connection with the misbranding. … The federal government will get $15.8 million of the civil settlement and nearly $10 million will go to state Medicaid programs.” Writes the New York Times, “The case is among scores of whistle-blower complaints that the Justice Department has brought in recent years against pharmaceutical companies for illegal marketing.”
Wanna know what they did?
UCB prepared business plans that recognized the market for off-label uses of Kempra “offered a much higher sales potential than the epilepsy market,” the document states. At the time, UCB was being outspent by competitors who were aggressively pursuing off-label business, according to prosecutors.
UCB’s marketing included sponsorship of doctor-paid “studies,” posters, publications and oral presentations about the supposed benefits of using Keppra to treat migraines. Prosecutors said UCB failed to disclose that a 2000 study showed that Keppra was not effective in preventing migraine….
“UCB put its pursuit of profits ahead of its obligations to patients,” Ronald C. Machen Jr., U.S. attorney for the District of Columbia, said in an e-mailed statement. “Today’s guilty plea and UCB’s $34 million payout should remind drug companies that try to cleverly design off-label marketing schemes that we will not allow them to compromise patient safety.”
Really? A misdemeanor plea will do that? Paying a $34 million penalty, when the company made $1.37 billion in sales last year from this drug alone?
Excuse my cynicism, but I think a little more “deterrence” may be needed here. Any defrauded migraine sufferers out there?
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