When Pharmaceutical Companies Promote Unapproved Dosages and Market the Spread

Actress Mae West said, “If a little is great, and a lot is better, then way too much is just about right!” Some pharmaceutical company executives have apparently bought into this view, for recent False Claims Act cases and settlements have detailed off-label promotions that touted higher, unapproved dosages of drugs. To further seduce prescribers, these promotions have regularly “marketed the spread,” spotlighting the profit margins between what health care providers paid for drugs and what Medicare paid in reimbursement. The end result has been escalating average dosage levels for high-priced drugs, oftentimes at the expense of government health care programs and patient safety.

Recently, a Washington Post article explained how Amgen and Johnson & Johnson drove sales for their multibillion-dollar anemia drugs, Epogen, Procrit and Aranesp, while questions emerged about the products’ safety and efficacy. Generating more than $8 billion a year for the two companies, these products were approved by the FDA, primarily for patients undergoing dialysis treatment. Over the course of twenty years, however, the products’ FDA-approved label expanded and the prescribers started using the products at higher and higher off-label dosage levels, oftentimes well above FDA-approved levels.

The companies allegedly mounted an aggressive “marketing the spread” marketing campaign that spotlighted the tremendous profits available to health care providers. It was apparently an easy sale, for the profits were quite substantial. In fact, according to the Medicare Payment Advisory Commission, the markup that doctors, clinics and hospitals received on the drugs given to Medicare patients reached as high as 30 percent. As an added incentive, the companies reportedly offered discounts to practices that dispensed the drugs in big volumes. Furthermore, according to publicly disclosed qui tam actions, the companies also overfilled vials, adding as much as 25 percent extra, allowing health care providers to further widen profit margins.

Moreover, the companies allegedly encouraged physicians to turn a blind eye to the FDA-approved dosage levels for their products. Indeed, their sales forces were allegedly singing Mae West’s tune that “If a little is good, more is better,” according to Steven Bander, formerly chief medical officer with Gambro, one of the nation’s largest dialysis clinics. Subsequently, the average dosage for anemia drugs skyrocketed, doubling in just a few years.

Recently, however, it was discovered that the higher dosage levels posed serious safety risks to patients, and that the products offered no or limited benefits to patients. To make matters worse, there was evidence that the companies knew about the safety and efficacy problems for years.

Qui tam whistleblowers appear to have alerted the government to these concerns years ago, potentially derailing these practices before additional lives were lost. Indeed, according to recent public reports, Amgen has set aside $780 million to settle whistleblower lawsuits alleging that the company engaged in illegal sales tactics. If true, these cases could encourage other insiders to take a courageous stand against similar illegal marketing practices.

More information for whistleblowers is located at the Nolan & Auerbach, P.A. website.