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Solvay's Alleged Off-Label Switcheroo: 2 Legit Indications Reversed

Here's a new twist on the off-label sales racket: Rather than inventing new, unapproved uses for a drug, why not take a pair of the drug's existing approvals for separate conditions and switch them around?

That's what Solvay (SOLB.BR) allegedly did for Marinol, its marijuana-like appetite booster for cancer and HIV patients, according to a federal court ruling. The ruling kicked the lawsuit out of court because the plaintiffs -- two Solvay drug sales reps -- had not offered any specific evidence Solvay actually caused Medicaid to overpay for off-label Marinol prescriptions.

The ruling notes that Marinol has two approved uses:

  1. As an appetite stimulant for AIDS patients
  2. To prevent nausea and vomiting for cancer patients
The judge wrote:
According to the relators, Marinol is not particularly effective for these on-label uses, so sales of the drug did not generate substantial profits for Solvay. To increase Marinol sales, the relators allege, Solvay implemented an off-label marketing campaign for the drug beginning in 2001.
That off-label scheme simply reversed the indications for the two conditions, HIV and cancer, the judge wrote:
The relators assert that Solvay instructed its sales representatives to encourage physicians to prescribe Marinol for appetite loss in cancer patients and for treatment of nausea in HIV patients, ...
The plaintiffs, James Hopper and Colin Hutto, argued that 70-90 percent of Marinol sales are off-label. They gave this breakdown:
  • 80% for appetite stimulation in cancer patients
  • 10% appetite stimulation in the elderly
  • 5% appetite stimulation in HIV (indicated)
  • 5% nausea in cancer patients (indicated)
The usual treats, in the form of honoraria and ice cream, were offered to doctors as kickbacks, the suit claimed.

Hat tip to Pharmalot.

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