You are hereTruthout: Anatomy of a $30 Billion Medicare Crime

Truthout: Anatomy of a $30 Billion Medicare Crime

-by Kathleen Sharp

October 3, 2011- Like all great capers, this $30 billion Medicare crime unfolded in plain sight. A drug rep sat in the doctor's office, balancing folders on his knees and flipping through the patient files. He wore a starched shirt, navy slacks and a golf tan from that day he'd convinced the doctor-client to participate in his company's "mini-trial." The deal was this: if the oncologist would inject his patients with high doses of a poorly tested drug, he could pocket $1,500.

But the doctor was too busy to select patients for this "study." So, the salesman, Dean McClellan, combed through the confidential patient files himself, searching for a few human guinea pigs to enroll. He found his subjects and, over the ensuing weeks, tracked their reactions to the high doses of the anti-anemia drug Procrit. "Cancer to the brain was worse," the rep wrote in one patient chart. "But anemia was better."

Let us count the ways in which this was illegal. First, the payments were bribes used to seduce doctors to pump Procrit doses to levels not approved by the Food and Drug Administration. Procrit helps cancer patients produce enough red blood cells so they can avoid blood transfusions and withstand chemotherapy. Yet, some patients in McClellan's "trials" weren't undergoing chemo. Many didn't even know they were being used as guinea pigs. Worse, there was no investigative review board, control group or protocol as there'd be in a bona fide scientific study. If there had been, someone might have noticed that three out of five people were dying in McClellan's jerry-rigged trials.

Such shocking human tests are not supposed to happen in our day and age. In the 1930s, officials conducted the Tuskegee "experiment" and allowed poor black men to die painfully from untreated syphilis. In the 1940s, people were injected with plutonium to see how long they'd survive. These appalling tests produced strict rules that make it unethical to experiment on people today without their informed consent.

But no such rules applied to those "mini-trials," which were thinly-veiled sales gimmicks. Indeed, McClellan's employer, a unit of Johnson & Johnson (J&J), was so confident of its top-selling drug, it believed more was better. So, imagine McClellan's horror when he learned that Procrit triggered strokes and multiplied cancer cells. "I never would have sold the stuff if I'd known it was killing people," he told me.

These allegations are detailed in McClellan's 2006 complaint pending in US District Court in Boston. Whistleblower McClellan and his buddy, the late Mark Duxbury, claim their bosses paid doctors about $17 million to gun Procrit doses and company profits. They were told to give doctors the drug free and discounted, and to show them how to submit false insurance claims.

J&J is not the only one pushing off-label promotions, however. In 2007, Bristol-Myers Squib paid $515 million to settle charges it promoted an adult bipolar medicine for children. In 2009, Pfizer paid $2.3 billion to resolve off-label activities around Bextra. Last year, Allergan pled guilty and paid $600 million for illegally promoting Botox.



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