UCB’s guilty plea and $34 million settlement of a case in which it was accused of illegally promoting the epilepsy drug Keppra for migraines shows how severe headaches are becoming a catchall category for drug companies pushing dubious therapies for unapproved, “off-label” purposes.The case against UCB, a Belgian pharmaceutical company, also highlights something not previously alleged by the DOJ: That illegal off-label sales at one company encourage illegal sales at other companies. The criminal information sheet in the case claims that UCB studied Keppra for migraines in 2000 but found that it did no good. In 2004, however, the company decided to push Keppra for migraines anyway because of competitive pressures from other companies:
Defendant UCB, Inc. prepared business plans which observed that the markets for Keppra to treat off-label uses, including migraine, offered a much higher sales potential than the epilepsy market. Defendant UCB, Inc. was aware of the competitive pressures from other rival drugs, including Neurontin, and noted that UCB, Inc. was being outspent by competitors who were “aggressively pursuing off-label business.”
Defendant UCB, Inc.’s business plans projected that off-label sales of Keppra would grow substantially in the coming years and cited the “need to put structures and budgets in place now to fully exploit the current and future market potential for Keppra within and outside epilepsy.”
At least four other companies have pushed non-migraine drugs as headache treatments in violation of the law:
- Allergan: Paid a $600 million fine for promoting Botox injections for migraine. Although the drug was later approved for the condition, Botox is only somewhat more effective than a placebo.
- Cephalon: Pushed the highly addictive lollipop painkiller Actiq for migraines with the slogan, “an ER on a stick.”
- Pfizer: Pushed Neurontin, another antiseizure med, for migraines. The Kaiser Foundation Health Plan ended up paying $90 million in overcharges for wrongly prescribed Neurontin.
- AstraZeneca: Sales reps at this company touted the antipsychotic Seroquel for severe headaches. It is not approved for that use.
There are therapies on the market for migraine — Relpax, Topamax, and Imitrex are among them. But migraine is a poorly understood condition, the drugs aren’t completely effective, and there is no cure. Sufferers often find that therapies work for a while and then lose their strength.
It’s the nebulous nature of migraine that attracts off-label sales. Nothing works well anyway, and patients are desperate to believe that a new pill will help. That’s a powerful set of conditions for a placebo effect to occur, and the off-label sales that follow.
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