Special to the AmNews

In March, a New Jersey-based drug maker agreed to pay more than $45 million in penalties and fees and settle claims that it marketed a drug exclusively approved to promote weight gain for people living with HIV/AIDS to geriatric patients confined to long-term care centers and nursing homes.

Par Pharmaceuticals, based in Woodcliff Lake, marketed the drug Megace ES to elderly patients after being advised on at least two occasions that the Food and Drug Administration (FDA) only approved the drug to prevent wasting or rapid weight loss–a common condition in people with HIV/AIDS.

The FDA approved the drug in July 2005 for the treatment of anorexia, unexplained weight loss and the specific condition of wasting seen in people with HIV/AIDS. On at least two occasions in the past several years, the FDA warned the mega drug maker to conduct additional research and clinical trials if it wanted to fully and accurately expand the marketing scope of the drug to include non-AIDS geriatric and elderly patients. The feds were tipped off to the off-label marketing ploy by a whistleblower, a disgruntled middle-management employee. According to the feds, Par never followed through on any extensive additional research and continued to market the drug to senior citizens who were not diagnosed with HIV/AIDS.

“Par’s unlawful scheme is not only illegal; it cost taxpayers tens of millions of dollars and the company consciously ignored serious patient safety issues,” said Brian Kenney of the Kenney and McCafferty Law Firm in Philadelphia.

Kenney added that mounds of evidence included senior executive emails to Par drug reps strongly encouraging the reps to promote Megace ES to nursing homes and long-term care facilities. Court documents indicate at least one patient developed a complication from taking the drug and that Par executives were aware of the potential side effects related to the drug.

“Thrombosis is the formation of blood clots in the veins,” said Dr. Jabar Zafar, a family physician at Branchburg Family Health Center in Branchburg, N.J. “It’s common in elderly patients due in part to their sedentary lifestyle.”