Two whistleblower cases unsealed this week reveal how aggressive pharmaceutical marketing programs can cross the line into Medicare fraud and kickbacks. Trips to the Kentucky Derby for doctors and huge bonuses for sales reps can lead to bribes, conflicts of interest and poor-quality care.

Illustration: Tinker ReadyIn one case, a drug maker was competing with a far less expensive, easier-to-administer alternative. Sales reps reportedly told doctors they could shorten a two-to-three week treatment with the Questcor’s expensive anti-seizure drug to one week. However, the Food and Drug Administration had not vetterd the efficacy of the one-week course, according to the case.

US WorldMeds

In the settlement case, the company is charged with secretly covering co-pays for all Medicare patients –not just those in need — thus insulating them from a steep price hike. Good for the patients, whose co-pays could have reached $5,000, DOJ noted; bad for the rest of us, who have to pay the balance. That’s why the approach is considered a kickback.


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Blood MedicineKathleen Sharp’s book about pharmaceutical whistleblower Mark Duxbury will be released in paperback on September 1, 2012. It is Blood Medicine: Blowing the Whistle on One of the Deadliest Prescription Drugs Ever. I had the pleasure of interviewing journalist Kathleen Sharp on November 15, 2011.

Mark Duxbury was a star salesman for a subsidiary

Whistleblowers have succeeded in a $1.5 billion off-label marketing case against Abbott Laboratories Inc., the Department of Justice announced today. Combined, the $700 million criminal fines and $800 million civil fines are the second largest government recovery from a drug company in history.

The Department of Justice intervened after four whistleblowers filed suit against

Today the Department of Labor’s Administrative Review Board (ARB)ARB held its first oral argument in a case under the Sarbanes-Oxley Act (SOX). Last November, the ARB gave notice of today’s oral argument, and invited interested groups to submit friend-of-the-court (or “amicus”) briefs. The ARB asked the parties to address issues of how specific OSHA complaints have to be, whether Administrative Law Judges (ALJs) can grant motions to dismiss on the pleadings, and the nature of protected activity under SOX. A prior blog post covered the amicus briefs, including the briefs of the National Whistleblowers Center and Doug Evans. Pictured here are ARB Board Members Luis Corchado, Paul Igasaki (Chair), E. Cooper Brown (Vice-Chair) and Joanne Royce.

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Today, President Obama signed the FDA Food Safety Modernization Act (H.R. 2571), which contains landmark whistleblower protections for food safety employees.

Highlights of the Food Safety Whistleblower Provision:

  •   Covers all employers “engaged in the manufacture, processing, packing, transportation, distribution, reception, holding or importation of food;”
  • Allows workers have their case heard before a jury

The United States Government, along with the governments of 15 states and the District of Columbia, have joined with two whistleblowers who allege that drug manufacturer Wyeth bilked US taxpayers out of hundreds of millions of dollars. As reported in the Wall Street Journal and the FierceHealthcare website, Wyeth is accused of overcharging Medicare and