Healthy Skepticism Library item: 19088

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Electronic Source

Silverman E
Feds Join Lawsuit Over Abbott Off-Label Marketing
Pharmalot 2011 Feb 4
http://www.pharmalot.com/2011/02/feds-join-lawsuit-over-abbott-off-label-marketing/

Full text:

The US Department of Justice has decided to intervene – or join – a whistleblower lawsuit that was filed in late 2008 by three former Abbott Laboratories sales reps, who accused the drugmaker of concocting an illegal scheme to promote its Depakote seizure med. The charges include paying kickbacks to docs to boost prescriptions and, subsequently, defrauding Medicare and Medicaid.
The fact that the feds are interested is not a surprise. In late 2009, Abbott disclosed in a Securities and Exchange Commission filing that the Justice Department ws investigating Abbott’s sales and marketing activities of the pill, which is used to treat bipolar disorder, seizures and migraines. The probe centers on possible violations of the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-Kickback Statute (back story).
By intervening, however, the feds are raising the ante. Although numerous whistleblower, or qui tam, lawsuits are filed every year, the Justice Department only intervenes in a minority of cases. By joining this case against Abbott, the feds are sending a signal that they believe there is merit to the allegations. The feds also recently intervened in a lawsuit against Pfizer’s Wyeth over Rapamune (see this).
In the Abbott lawsuit, the former employees charge Abbott illegally marketed Depakote to treat dementia and behavior seen in Alzheimer’s patients to nursing homes and the US Veterans Administration. How so? Their lawsuit alleges the drugmaker provided sales reps with materials that required them to encourage nursing homes to use Depakote on an off-label basis and designed ‘Selling Skills Workshops’ for instructing reps on off-label marketing tactics.
What else? Abbott allegedly disguised seminars for docs that were actually sessions on off-label usage; offered reps bonuses and incentives for off-label promotion; failed to disclose that favorable articles were written by docs who were paid by Abbott; paid docs to prescribe the med; trained reps to avoid being detected when promoting off-label; and, generally, lied to nursing homes about the drug and its uses (you can read the lawsuit here).