UCB: The Migraine Posters Left Out the Failed Trial

The UCB Keppra settlement included a $25.7 million civil payment to resolve allegations that off-label promotion caused Medicaid and other federal healthcare programs to pay for uses they did not cover. The government alleged that UCB promoted its epilepsy drug for migraine with posters that left out its own unsuccessful migraine trial. For someone in clinical research, medical information or sales, the revealing comparison is between the evidence inside the company and the message that reached prescribers.

What the Civil Resolution Covered

UCB Inc., based in Smyrna, Georgia, was the U.S. subsidiary of Belgian pharmaceutical manufacturer UCB SA. It agreed to resolve allegations that its promotion of Keppra caused false claims under the False Claims Act. The Justice Department announced the resolution on June 9, 2011.

The civil settlement allocated $15,871,208 to the federal government and $9,893,322 to state Medicaid programs. Taxpayers paid for the prescriptions the government alleged should never have been covered.

The settlement resolved two qui tam whistleblower lawsuits, one in Washington, D.C., and one in Oregon.

What Is Considered Off-Label Promotion?

Off-label promotion means marketing an approved drug for a use outside its approved labeling. In the Keppra case, the Food and Drug Administration had approved the drug to treat seizures in adults and children with epilepsy. The civil allegations concerned promotion for headache, migraine, pain, bipolar disorder, mood disorders and anxiety.

That difference identifies the market UCB allegedly sought beyond its approved seizure use. It also gives a sales or medical-information employee a concrete comparison: the condition named in the approval and the condition named in the promotional material.

The manufacturer’s claims about the science matter alongside the use it promotes.

The Migraine Posters and the Missing Evidence

The government alleged that UCB generated and distributed posters presenting Keppra as safe and effective for migraine, based on purportedly independent, investigator-initiated studies. According to the Justice Department, they omitted UCB’s sponsorship of those studies and the fact that UCB’s own clinical trial had failed to demonstrate effectiveness for migraine.

UCB’s own trial had failed to show the migraine benefit. Its posters still told doctors the drug worked, the government alleged.

This is where an insider’s knowledge can change the account. Someone who worked on a study may know who funded it. Someone who reviewed the poster may know which findings appeared in a draft and which reached the final version. We compare those accounts with the materials physicians actually received and the decisions behind them.

Neurontin Shows Why the Scientific Presentation Matters

Warner-Lambert’s Neurontin promotion provides a close comparison. The Justice Department alleged that the company promoted the drug for bipolar disease even though a study showed that a placebo worked as well or better. It also described medical liaisons presenting themselves, sometimes falsely, as scientific experts in a particular disease. The same conflict appears in the Keppra allegations: a favorable sales message carried past an unfavorable result.

A Nordic Cochrane Centre literature review published in 2012, Corporate crime in the pharmaceutical industry is common, serious and repetitive, described another way the Neurontin campaign acquired an appearance of scientific support:

In the review’s account, Neurontin borrowed doctors’ names. UCB, the government alleged, hid its own sponsorship.

Are Pharmaceutical Companies Liable for False Claims?

Yes. A drug company can be responsible for knowingly causing false government health care claims even when a pharmacy sends the bill. UCB’s civil settlement concerned that connection between off-label promotion and government payment.

The drug’s distribution chain commonly runs from manufacturer to wholesaler to dispenser. A pharmacy’s claim for reimbursement sits at a different point from the manufacturer’s sale. The alleged influence of a manufacturer’s message can therefore reach a government payment through another business’s prescription claim.

For Medicaid outpatient drugs, medically accepted indications include FDA-approved uses and uses supported by citations included, or approved for inclusion, in specified drug reference works called compendia.

The government alleged that the Keppra uses covered by the settlement were not medically accepted indications and therefore were not covered by the programs receiving the claims.

The Integrity Agreement Reached Beyond the Payment

UCB also entered a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. It required procedures and reviews to prevent and detect similar conduct inside the company.

What Evidence Is Needed to Prove Fraud?

In a promotion case like Keppra, the important evidence connects the company’s scientific message, what it knew about the studies and the resulting government claims. We examine that connection with the insider, starting with the part of the business they understand.

A sponsorship agreement and a study report can answer different questions about the same poster. One identifies the company’s financial involvement. The other shows the result available to the people developing the message. Drafts, review comments and distribution records can help explain how that message took its final form and who received it.

The payment side adds another comparison: the use being promoted, the use for which the patient received the drug and the basis presented for coverage. Our work is to connect the insider’s account to those decisions and claims. A publications employee may understand the missing scientific detail, while someone in reimbursement may understand how the resulting message reached the payer.

How Much Money Do Pharmaceutical Whistleblowers Get for Exposing Fraud?

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. In the Keppra resolution, the Justice Department announced that the whistleblowers would receive more than $2.8 million from the federal share of the civil recovery.

You Know What the Poster Left Out

If you know why a promotional message left out an unfavorable study result, speak to one of our whistleblower experts about the campaign and the prescriptions it drove. We shape the science and the reimbursement trail into your strongest pharmaceutical whistleblower case, bring in pharmaceutical fraud whistleblower lawyers who know promotion cases, and stay your partners through the process.